US20140180277A1 - Multi-pole synchronous pulmonary artery radiofrequency ablation catheter - Google Patents
Multi-pole synchronous pulmonary artery radiofrequency ablation catheter Download PDFInfo
- Publication number
- US20140180277A1 US20140180277A1 US14/079,230 US201314079230A US2014180277A1 US 20140180277 A1 US20140180277 A1 US 20140180277A1 US 201314079230 A US201314079230 A US 201314079230A US 2014180277 A1 US2014180277 A1 US 2014180277A1
- Authority
- US
- United States
- Prior art keywords
- pulmonary artery
- annular ring
- electrodes
- wire
- flexible
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
- 210000001147 pulmonary artery Anatomy 0.000 title claims abstract description 181
- 230000005405 multipole Effects 0.000 title claims abstract description 20
- 238000007674 radiofrequency ablation Methods 0.000 title claims abstract description 20
- 230000001360 synchronised effect Effects 0.000 title claims abstract description 19
- 238000002679 ablation Methods 0.000 claims abstract description 64
- WABPQHHGFIMREM-UHFFFAOYSA-N lead(0) Chemical compound [Pb] WABPQHHGFIMREM-UHFFFAOYSA-N 0.000 claims abstract description 28
- 239000010935 stainless steel Substances 0.000 claims description 12
- 239000000463 material Substances 0.000 claims description 11
- 238000001802 infusion Methods 0.000 claims description 8
- 229910001000 nickel titanium Inorganic materials 0.000 claims description 8
- 229910001256 stainless steel alloy Inorganic materials 0.000 claims description 7
- 239000004642 Polyimide Substances 0.000 claims description 6
- 229920001721 polyimide Polymers 0.000 claims description 6
- 239000002861 polymer material Substances 0.000 claims description 6
- 238000003848 UV Light-Curing Methods 0.000 claims description 5
- 239000000853 adhesive Substances 0.000 claims description 5
- 230000001070 adhesive effect Effects 0.000 claims description 5
- 229910001220 stainless steel Inorganic materials 0.000 claims description 5
- 229910001020 Au alloy Inorganic materials 0.000 claims description 4
- 229910000990 Ni alloy Inorganic materials 0.000 claims description 4
- 229910000566 Platinum-iridium alloy Inorganic materials 0.000 claims description 4
- RTAQQCXQSZGOHL-UHFFFAOYSA-N Titanium Chemical compound [Ti] RTAQQCXQSZGOHL-UHFFFAOYSA-N 0.000 claims description 4
- PCHJSUWPFVWCPO-UHFFFAOYSA-N gold Chemical compound [Au] PCHJSUWPFVWCPO-UHFFFAOYSA-N 0.000 claims description 4
- 239000010931 gold Substances 0.000 claims description 4
- HWLDNSXPUQTBOD-UHFFFAOYSA-N platinum-iridium alloy Chemical class [Ir].[Pt] HWLDNSXPUQTBOD-UHFFFAOYSA-N 0.000 claims description 4
- 229910001285 shape-memory alloy Inorganic materials 0.000 claims description 4
- 239000010936 titanium Substances 0.000 claims description 4
- 229910052719 titanium Inorganic materials 0.000 claims description 4
- 239000012530 fluid Substances 0.000 claims description 3
- 230000008859 change Effects 0.000 claims description 2
- 238000000034 method Methods 0.000 abstract description 50
- 208000002815 pulmonary hypertension Diseases 0.000 abstract description 20
- 230000002685 pulmonary effect Effects 0.000 abstract description 19
- 230000002638 denervation Effects 0.000 abstract description 15
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 abstract description 9
- 239000011780 sodium chloride Substances 0.000 abstract description 9
- 230000008901 benefit Effects 0.000 abstract description 5
- 210000004026 tunica intima Anatomy 0.000 abstract description 5
- 230000010412 perfusion Effects 0.000 abstract description 4
- 210000005036 nerve Anatomy 0.000 description 19
- 238000010586 diagram Methods 0.000 description 14
- 230000002889 sympathetic effect Effects 0.000 description 13
- 238000011282 treatment Methods 0.000 description 12
- 241001465754 Metazoa Species 0.000 description 10
- 210000001367 artery Anatomy 0.000 description 9
- 239000008280 blood Substances 0.000 description 9
- 210000004369 blood Anatomy 0.000 description 9
- 238000005259 measurement Methods 0.000 description 8
- 230000002474 noradrenergic effect Effects 0.000 description 8
- 206010064911 Pulmonary arterial hypertension Diseases 0.000 description 7
- 210000003050 axon Anatomy 0.000 description 7
- 230000030214 innervation Effects 0.000 description 7
- 210000004072 lung Anatomy 0.000 description 7
- 230000003730 sympathetic denervation Effects 0.000 description 7
- 241000282472 Canis lupus familiaris Species 0.000 description 6
- 208000004248 Familial Primary Pulmonary Hypertension Diseases 0.000 description 6
- 210000003484 anatomy Anatomy 0.000 description 6
- 241000282465 Canis Species 0.000 description 5
- 241000282414 Homo sapiens Species 0.000 description 5
- 208000020875 Idiopathic pulmonary arterial hypertension Diseases 0.000 description 5
- 230000007423 decrease Effects 0.000 description 5
- LOKCTEFSRHRXRJ-UHFFFAOYSA-I dipotassium trisodium dihydrogen phosphate hydrogen phosphate dichloride Chemical compound P(=O)(O)(O)[O-].[K+].P(=O)(O)([O-])[O-].[Na+].[Na+].[Cl-].[K+].[Cl-].[Na+] LOKCTEFSRHRXRJ-UHFFFAOYSA-I 0.000 description 5
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 5
- 239000000835 fiber Substances 0.000 description 5
- 239000002953 phosphate buffered saline Substances 0.000 description 5
- 210000002808 connective tissue Anatomy 0.000 description 4
- 230000003205 diastolic effect Effects 0.000 description 4
- 201000010099 disease Diseases 0.000 description 4
- 238000010438 heat treatment Methods 0.000 description 4
- 230000036593 pulmonary vascular resistance Effects 0.000 description 4
- 230000009467 reduction Effects 0.000 description 4
- 241000894007 species Species 0.000 description 4
- 210000001519 tissue Anatomy 0.000 description 4
- SFLSHLFXELFNJZ-QMMMGPOBSA-N (-)-norepinephrine Chemical compound NC[C@H](O)C1=CC=C(O)C(O)=C1 SFLSHLFXELFNJZ-QMMMGPOBSA-N 0.000 description 3
- 241000700199 Cavia porcellus Species 0.000 description 3
- 238000002583 angiography Methods 0.000 description 3
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 description 3
- 108091008698 baroreceptors Proteins 0.000 description 3
- 230000000903 blocking effect Effects 0.000 description 3
- 230000017531 blood circulation Effects 0.000 description 3
- 210000000038 chest Anatomy 0.000 description 3
- 230000001684 chronic effect Effects 0.000 description 3
- 239000004020 conductor Substances 0.000 description 3
- 238000012790 confirmation Methods 0.000 description 3
- 230000003247 decreasing effect Effects 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 238000000386 microscopy Methods 0.000 description 3
- 230000001537 neural effect Effects 0.000 description 3
- 229960002748 norepinephrine Drugs 0.000 description 3
- SFLSHLFXELFNJZ-UHFFFAOYSA-N norepinephrine Natural products NCC(O)C1=CC=C(O)C(O)=C1 SFLSHLFXELFNJZ-UHFFFAOYSA-N 0.000 description 3
- 229910052760 oxygen Inorganic materials 0.000 description 3
- 239000001301 oxygen Substances 0.000 description 3
- 210000001774 pressoreceptor Anatomy 0.000 description 3
- 239000000243 solution Substances 0.000 description 3
- 230000002792 vascular Effects 0.000 description 3
- 238000003466 welding Methods 0.000 description 3
- 108010065372 Dynorphins Proteins 0.000 description 2
- 208000005189 Embolism Diseases 0.000 description 2
- PXGOKWXKJXAPGV-UHFFFAOYSA-N Fluorine Chemical compound FF PXGOKWXKJXAPGV-UHFFFAOYSA-N 0.000 description 2
- 241000282412 Homo Species 0.000 description 2
- 239000004962 Polyamide-imide Substances 0.000 description 2
- 102100024622 Proenkephalin-B Human genes 0.000 description 2
- 102000055135 Vasoactive Intestinal Peptide Human genes 0.000 description 2
- 108010003205 Vasoactive Intestinal Peptide Proteins 0.000 description 2
- 238000004458 analytical method Methods 0.000 description 2
- 230000004872 arterial blood pressure Effects 0.000 description 2
- 210000002565 arteriole Anatomy 0.000 description 2
- 230000001746 atrial effect Effects 0.000 description 2
- 230000009286 beneficial effect Effects 0.000 description 2
- 238000001816 cooling Methods 0.000 description 2
- 230000006378 damage Effects 0.000 description 2
- 238000013461 design Methods 0.000 description 2
- 238000009826 distribution Methods 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
- 238000002592 echocardiography Methods 0.000 description 2
- 210000003191 femoral vein Anatomy 0.000 description 2
- 229910052731 fluorine Inorganic materials 0.000 description 2
- 239000011737 fluorine Substances 0.000 description 2
- 230000006870 function Effects 0.000 description 2
- 239000003292 glue Substances 0.000 description 2
- 230000000004 hemodynamic effect Effects 0.000 description 2
- 238000007689 inspection Methods 0.000 description 2
- VBUWHHLIZKOSMS-RIWXPGAOSA-N invicorp Chemical compound C([C@@H](C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CO)C(=O)N[C@@H]([C@@H](C)CC)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC(N)=O)C(O)=O)NC(=O)[C@H](CCCCN)NC(=O)[C@H](CCCCN)NC(=O)[C@@H](NC(=O)[C@H](C)NC(=O)[C@H](CCSC)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CCCCN)NC(=O)[C@H](CCCNC(N)=N)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCCNC(N)=N)NC(=O)[C@@H](NC(=O)[C@H](CC=1C=CC(O)=CC=1)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CC(O)=O)NC(=O)[C@@H](NC(=O)[C@H](CC=1C=CC=CC=1)NC(=O)[C@@H](NC(=O)[C@H](C)NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CO)NC(=O)[C@@H](N)CC=1NC=NC=1)C(C)C)[C@@H](C)O)[C@@H](C)O)C(C)C)C1=CC=C(O)C=C1 VBUWHHLIZKOSMS-RIWXPGAOSA-N 0.000 description 2
- 238000002372 labelling Methods 0.000 description 2
- 239000007788 liquid Substances 0.000 description 2
- 238000012544 monitoring process Methods 0.000 description 2
- 210000004126 nerve fiber Anatomy 0.000 description 2
- 230000007383 nerve stimulation Effects 0.000 description 2
- 210000002569 neuron Anatomy 0.000 description 2
- 210000000056 organ Anatomy 0.000 description 2
- 230000008506 pathogenesis Effects 0.000 description 2
- 229920002312 polyamide-imide Polymers 0.000 description 2
- 229920000728 polyester Polymers 0.000 description 2
- 229920002635 polyurethane Polymers 0.000 description 2
- 239000004814 polyurethane Substances 0.000 description 2
- 210000003492 pulmonary vein Anatomy 0.000 description 2
- 230000011514 reflex Effects 0.000 description 2
- 230000011218 segmentation Effects 0.000 description 2
- BNRNXUUZRGQAQC-UHFFFAOYSA-N sildenafil Chemical compound CCCC1=NN(C)C(C(N2)=O)=C1N=C2C(C(=CC=1)OCC)=CC=1S(=O)(=O)N1CCN(C)CC1 BNRNXUUZRGQAQC-UHFFFAOYSA-N 0.000 description 2
- 238000012360 testing method Methods 0.000 description 2
- 230000001732 thrombotic effect Effects 0.000 description 2
- 210000005166 vasculature Anatomy 0.000 description 2
- 210000001631 vena cava inferior Anatomy 0.000 description 2
- 206010003658 Atrial Fibrillation Diseases 0.000 description 1
- 241000283707 Capra Species 0.000 description 1
- 241000700198 Cavia Species 0.000 description 1
- 206010008479 Chest Pain Diseases 0.000 description 1
- JZUFKLXOESDKRF-UHFFFAOYSA-N Chlorothiazide Chemical compound C1=C(Cl)C(S(=O)(=O)N)=CC2=C1NCNS2(=O)=O JZUFKLXOESDKRF-UHFFFAOYSA-N 0.000 description 1
- LTMHDMANZUZIPE-AMTYYWEZSA-N Digoxin Natural products O([C@H]1[C@H](C)O[C@H](O[C@@H]2C[C@@H]3[C@@](C)([C@@H]4[C@H]([C@]5(O)[C@](C)([C@H](O)C4)[C@H](C4=CC(=O)OC4)CC5)CC3)CC2)C[C@@H]1O)[C@H]1O[C@H](C)[C@@H](O[C@H]2O[C@@H](C)[C@H](O)[C@@H](O)C2)[C@@H](O)C1 LTMHDMANZUZIPE-AMTYYWEZSA-N 0.000 description 1
- 208000000059 Dyspnea Diseases 0.000 description 1
- 206010013975 Dyspnoeas Diseases 0.000 description 1
- 241000289659 Erinaceidae Species 0.000 description 1
- 206010015548 Euthanasia Diseases 0.000 description 1
- 241000282326 Felis catus Species 0.000 description 1
- 241000124008 Mammalia Species 0.000 description 1
- 241000282346 Meles meles Species 0.000 description 1
- 241000699670 Mus sp. Species 0.000 description 1
- 108090000189 Neuropeptides Proteins 0.000 description 1
- 102000003797 Neuropeptides Human genes 0.000 description 1
- 241000283973 Oryctolagus cuniculus Species 0.000 description 1
- 229930040373 Paraformaldehyde Natural products 0.000 description 1
- 241001494479 Pecora Species 0.000 description 1
- 208000010378 Pulmonary Embolism Diseases 0.000 description 1
- 208000020193 Pulmonary artery hypoplasia Diseases 0.000 description 1
- 241000700159 Rattus Species 0.000 description 1
- 208000025747 Rheumatic disease Diseases 0.000 description 1
- 201000001943 Tricuspid Valve Insufficiency Diseases 0.000 description 1
- 206010044640 Tricuspid valve incompetence Diseases 0.000 description 1
- 229920004890 Triton X-100 Polymers 0.000 description 1
- 239000013504 Triton X-100 Substances 0.000 description 1
- 108091000117 Tyrosine 3-Monooxygenase Proteins 0.000 description 1
- 102000048218 Tyrosine 3-monooxygenases Human genes 0.000 description 1
- 208000027418 Wounds and injury Diseases 0.000 description 1
- HZEWFHLRYVTOIW-UHFFFAOYSA-N [Ti].[Ni] Chemical compound [Ti].[Ni] HZEWFHLRYVTOIW-UHFFFAOYSA-N 0.000 description 1
- 238000011298 ablation treatment Methods 0.000 description 1
- 230000004913 activation Effects 0.000 description 1
- 230000001464 adherent effect Effects 0.000 description 1
- 239000000956 alloy Substances 0.000 description 1
- 238000010171 animal model Methods 0.000 description 1
- 210000002376 aorta thoracic Anatomy 0.000 description 1
- 238000011888 autopsy Methods 0.000 description 1
- 229960002890 beraprost Drugs 0.000 description 1
- CTPOHARTNNSRSR-APJZLKAGSA-N beraprost Chemical compound O([C@H]1C[C@@H](O)[C@@H]([C@@H]21)/C=C/[C@@H](O)C(C)CC#CC)C1=C2C=CC=C1CCCC(O)=O CTPOHARTNNSRSR-APJZLKAGSA-N 0.000 description 1
- 210000004204 blood vessel Anatomy 0.000 description 1
- GJPICJJJRGTNOD-UHFFFAOYSA-N bosentan Chemical compound COC1=CC=CC=C1OC(C(=NC(=N1)C=2N=CC=CN=2)OCCO)=C1NS(=O)(=O)C1=CC=C(C(C)(C)C)C=C1 GJPICJJJRGTNOD-UHFFFAOYSA-N 0.000 description 1
- 229960003065 bosentan Drugs 0.000 description 1
- 230000000747 cardiac effect Effects 0.000 description 1
- BPHHNXJPFPEJOF-UHFFFAOYSA-J chembl296966 Chemical compound [Na+].[Na+].[Na+].[Na+].[O-]S(=O)(=O)C1=CC(S([O-])(=O)=O)=C(N)C2=C(O)C(N=NC3=CC=C(C=C3OC)C=3C=C(C(=CC=3)N=NC=3C(=C4C(N)=C(C=C(C4=CC=3)S([O-])(=O)=O)S([O-])(=O)=O)O)OC)=CC=C21 BPHHNXJPFPEJOF-UHFFFAOYSA-J 0.000 description 1
- 230000008045 co-localization Effects 0.000 description 1
- 208000018631 connective tissue disease Diseases 0.000 description 1
- 230000001276 controlling effect Effects 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 230000018109 developmental process Effects 0.000 description 1
- 238000003745 diagnosis Methods 0.000 description 1
- LTMHDMANZUZIPE-PUGKRICDSA-N digoxin Chemical compound C1[C@H](O)[C@H](O)[C@@H](C)O[C@H]1O[C@@H]1[C@@H](C)O[C@@H](O[C@@H]2[C@H](O[C@@H](O[C@@H]3C[C@@H]4[C@]([C@@H]5[C@H]([C@]6(CC[C@@H]([C@@]6(C)[C@H](O)C5)C=5COC(=O)C=5)O)CC4)(C)CC3)C[C@@H]2O)C)C[C@@H]1O LTMHDMANZUZIPE-PUGKRICDSA-N 0.000 description 1
- 229960005156 digoxin Drugs 0.000 description 1
- LTMHDMANZUZIPE-UHFFFAOYSA-N digoxine Natural products C1C(O)C(O)C(C)OC1OC1C(C)OC(OC2C(OC(OC3CC4C(C5C(C6(CCC(C6(C)C(O)C5)C=5COC(=O)C=5)O)CC4)(C)CC3)CC2O)C)CC1O LTMHDMANZUZIPE-UHFFFAOYSA-N 0.000 description 1
- 208000035475 disorder Diseases 0.000 description 1
- 238000002224 dissection Methods 0.000 description 1
- 239000002934 diuretic Substances 0.000 description 1
- 230000001882 diuretic effect Effects 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 230000002526 effect on cardiovascular system Effects 0.000 description 1
- 230000008030 elimination Effects 0.000 description 1
- 238000003379 elimination reaction Methods 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 210000000609 ganglia Anatomy 0.000 description 1
- 239000011521 glass Substances 0.000 description 1
- 230000036571 hydration Effects 0.000 description 1
- 238000006703 hydration reaction Methods 0.000 description 1
- 229960002003 hydrochlorothiazide Drugs 0.000 description 1
- 230000000393 hypersympathetic effect Effects 0.000 description 1
- 238000003384 imaging method Methods 0.000 description 1
- 208000014674 injury Diseases 0.000 description 1
- 239000007928 intraperitoneal injection Substances 0.000 description 1
- 238000011835 investigation Methods 0.000 description 1
- 210000004731 jugular vein Anatomy 0.000 description 1
- 230000001404 mediated effect Effects 0.000 description 1
- 238000001531 micro-dissection Methods 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 210000001640 nerve ending Anatomy 0.000 description 1
- 210000000653 nervous system Anatomy 0.000 description 1
- 239000012188 paraffin wax Substances 0.000 description 1
- 229920002866 paraformaldehyde Polymers 0.000 description 1
- 230000001734 parasympathetic effect Effects 0.000 description 1
- 229960001412 pentobarbital Drugs 0.000 description 1
- WEXRUCMBJFQVBZ-UHFFFAOYSA-N pentobarbital Chemical compound CCCC(C)C1(CC)C(=O)NC(=O)NC1=O WEXRUCMBJFQVBZ-UHFFFAOYSA-N 0.000 description 1
- 230000000144 pharmacologic effect Effects 0.000 description 1
- 208000007232 portal hypertension Diseases 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 238000003825 pressing Methods 0.000 description 1
- 230000002265 prevention Effects 0.000 description 1
- 201000008312 primary pulmonary hypertension Diseases 0.000 description 1
- 230000006425 pulmonary artery denervation Effects 0.000 description 1
- 208000005069 pulmonary fibrosis Diseases 0.000 description 1
- 201000010298 pulmonary valve insufficiency Diseases 0.000 description 1
- 208000009138 pulmonary valve stenosis Diseases 0.000 description 1
- 208000030390 pulmonic stenosis Diseases 0.000 description 1
- 230000035485 pulse pressure Effects 0.000 description 1
- 230000001105 regulatory effect Effects 0.000 description 1
- 238000007634 remodeling Methods 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 230000000241 respiratory effect Effects 0.000 description 1
- 230000000284 resting effect Effects 0.000 description 1
- 230000000552 rheumatic effect Effects 0.000 description 1
- 210000005245 right atrium Anatomy 0.000 description 1
- 210000005241 right ventricle Anatomy 0.000 description 1
- 230000001953 sensory effect Effects 0.000 description 1
- 210000002966 serum Anatomy 0.000 description 1
- 230000009528 severe injury Effects 0.000 description 1
- 229960003310 sildenafil Drugs 0.000 description 1
- LXMSZDCAJNLERA-ZHYRCANASA-N spironolactone Chemical compound C([C@@H]1[C@]2(C)CC[C@@H]3[C@@]4(C)CCC(=O)C=C4C[C@H]([C@@H]13)SC(=O)C)C[C@@]21CCC(=O)O1 LXMSZDCAJNLERA-ZHYRCANASA-N 0.000 description 1
- 229960002256 spironolactone Drugs 0.000 description 1
- 238000010186 staining Methods 0.000 description 1
- 210000004686 stellate ganglion Anatomy 0.000 description 1
- 230000000638 stimulation Effects 0.000 description 1
- 210000001321 subclavian vein Anatomy 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 208000024891 symptom Diseases 0.000 description 1
- 230000035488 systolic blood pressure Effects 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 210000000115 thoracic cavity Anatomy 0.000 description 1
- 230000000451 tissue damage Effects 0.000 description 1
- 231100000827 tissue damage Toxicity 0.000 description 1
- 238000002604 ultrasonography Methods 0.000 description 1
- 238000011144 upstream manufacturing Methods 0.000 description 1
- 210000001186 vagus nerve Anatomy 0.000 description 1
- 239000005526 vasoconstrictor agent Substances 0.000 description 1
- 229940124549 vasodilator Drugs 0.000 description 1
- 239000003071 vasodilator agent Substances 0.000 description 1
- 210000003462 vein Anatomy 0.000 description 1
- 230000002861 ventricular Effects 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
- A61B18/14—Probes or electrodes therefor
- A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
- A61M25/0133—Tip steering devices
- A61M25/0147—Tip steering devices with movable mechanical means, e.g. pull wires
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/06—Electrodes for high-frequency therapy
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N7/00—Ultrasound therapy
- A61N7/02—Localised ultrasound hyperthermia
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
- A61B2017/00292—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
- A61B2017/003—Steerable
- A61B2017/00318—Steering mechanisms
- A61B2017/00323—Cables or rods
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00831—Material properties
- A61B2017/00867—Material properties shape memory effect
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00005—Cooling or heating of the probe or tissue immediately surrounding the probe
- A61B2018/00011—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids
- A61B2018/00029—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids open
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00053—Mechanical features of the instrument of device
- A61B2018/00166—Multiple lumina
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00053—Mechanical features of the instrument of device
- A61B2018/00214—Expandable means emitting energy, e.g. by elements carried thereon
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
- A61B2018/00345—Vascular system
- A61B2018/00351—Heart
- A61B2018/00375—Ostium, e.g. ostium of pulmonary vein or artery
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
- A61B2018/00345—Vascular system
- A61B2018/00404—Blood vessels other than those in or around the heart
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
- A61B2018/00577—Ablation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00636—Sensing and controlling the application of energy
- A61B2018/00773—Sensed parameters
- A61B2018/00791—Temperature
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00636—Sensing and controlling the application of energy
- A61B2018/00773—Sensed parameters
- A61B2018/00791—Temperature
- A61B2018/00797—Temperature measured by multiple temperature sensors
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00636—Sensing and controlling the application of energy
- A61B2018/00773—Sensed parameters
- A61B2018/00791—Temperature
- A61B2018/00821—Temperature measured by a thermocouple
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
- A61B18/14—Probes or electrodes therefor
- A61B2018/1405—Electrodes having a specific shape
- A61B2018/1407—Loop
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
- A61B18/14—Probes or electrodes therefor
- A61B2018/1467—Probes or electrodes therefor using more than two electrodes on a single probe
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2218/00—Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2218/001—Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body having means for irrigation and/or aspiration of substances to and/or from the surgical site
- A61B2218/002—Irrigation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N7/00—Ultrasound therapy
- A61N2007/0004—Applications of ultrasound therapy
- A61N2007/0021—Neural system treatment
- A61N2007/003—Destruction of nerve tissue
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
- F04C—ROTARY-PISTON, OR OSCILLATING-PISTON, POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS; ROTARY-PISTON, OR OSCILLATING-PISTON, POSITIVE-DISPLACEMENT PUMPS
- F04C2270/00—Control; Monitoring or safety arrangements
- F04C2270/04—Force
- F04C2270/041—Controlled or regulated
Definitions
- the present inventions relate to medical devices for treatment of pulmonary hypertension in the pulmonary artery by de-sympathetic methods, for example, with multi-pole synchronous pulmonary artery radiofrequency ablation catheters, as well as methods for diagnosis and method of treating pulmonary hypertension.
- Pulmonary hypertension is to be an intractable diseases in the cardiovascular, respiratory, connective tissue, immune and rheumatic systems.
- Currently available clinical treatments of pulmonary hypertension are limited and therapy efficacy thereof is poor.
- Incidence of primary pulmonary hypertension is low but those secondary to pulmonary interstitial fibrosis, connective tissue disease, portal hypertension, chronic pulmonary artery embolism and left heart system disorder are common, with five-year mortality rate up to 30%. Therefore, prevention and treatment for pulmonary hypertension is of great significance.
- An aspect of at least one of the inventions disclosed herein includes the realization, supported by experimental data which demonstrates, that pulmonary hypertension is associated with hyper sympathetic activity in pulmonary artery and hyperactive baroreceptor. Blocking the sympathetic nerves in the pulmonary artery or permanently damaging the baroreceptor structure and function thereof can decrease the pulmonary artery pressure, which can provide more successful treatments of pulmonary hypertension.
- Some of the embodiments disclosed herein provide a multi-pole synchronous pulmonary artery radiofrequency ablation catheter for treatment of pulmonary hypertension in the pulmonary artery by a de-sympathetic method.
- the catheter only heats the adherent tissue rather than the blood.
- the catheter can be configured to provide cold saline perfusion at or near the ablation site to protect the vascular intima.
- a multi-pole synchronous pulmonary artery radiofrequency ablation catheter can comprise a control handle, a catheter body and an annular ring.
- the control handle can be provided with an adjustment apparatus.
- the catheter body can be hollow and can include a cavity.
- One or a plurality of lead wires, one or more temperature sensing wires and one or more pull wires can be arranged in the cavity.
- One end of the catheter body can be flexible.
- the flexible end can be connected to an annular ring and the other end of the catheter body can be connected to the control handle.
- One end of the pull wire can be connected to the flexible end and the other end of the pull wire can be connected to the adjustment apparatus.
- Tension in the pull wire can be adjusted through the adjustment apparatus to achieve shape control, such as curvature control, of the flexible end.
- a shape memory wire can be arranged in the annular ring. One end of the shape memory wire can extend to the end of the annular ring and the other end of the shape memory wire can pass through the root of the annular ring and can be fixed on the flexible end of the catheter body.
- the annular ring can be provided with an electrode group with each electrode connected to the one or more lead wires and the one or more temperature sensing wires.
- the lead wire(s) and the temperature sensing wire(s) extend through the catheter body and are electrically connected to the control handle.
- An infusion tube can be arranged in the cavity of the catheter body and a through hole can be arranged on one or more of the electrodes.
- the infusion tube can be connected to the electrodes through the annular ring.
- the transfused fluid flows out from the through hole and thus can be used for cooling purposes during ablation procedures.
- the electrodes on the annular ring can be made of a material selected from the group consisted of platinum-iridium alloy, gold, stainless steel and nickel alloy, with the number in the range of 3-30 electrodes, a diameter in the range of 1.3-2.0 mm, a length in the range of 1.2-4 mm and an edge space between adjacent electrodes in the range of 0.5-10 mm.
- the flexible end of the catheter body can be provided with a counterbore, an inner diameter of the counterbore can be sized to fit an outer diameter of the root of the annular ring, and thus the root of the annular ring can be inserted and fixed into the counterbore.
- the flexible end of the catheter body is provided with a groove in which a connector is arranged, one end of the connector is connected to the pull wire and the other end of the connector is connected to the shape memory wire.
- the material of the shape memory wire in the annular ring can be a shape memory alloy selected from the group consisted of nickel titanium alloy, stainless steel or titanium, with a diameter of 0.25-0.5 mm.
- the diameter of the annular ring can be 12-40 mm.
- the annular ring can be configured so as to be biased toward a circumferential shape, having a desired diameter (e.g., in the range of 12-40 mm), for example, with the use of a memory shape material.
- 10 electrodes are arranged on the annular ring.
- the width of naked section of the electrode is 0.75 mm, and the space therebetween is 5 mm.
- the flexible end can be made of medical polymer materials with a length in the range of 30-80 mm.
- the connection can be achieved by a UV-curing adhesive.
- the joint between the flexible end and the annular ring can be sealed.
- the pull wire is made of stainless steel or nickel-titanium alloy.
- the outside of pull wire is provided with a spring coil, and the outside of the spring coil is provided with a spring sleeve made of polyimide material.
- the catheter can be packaged into a kit including a plurality of different annular rings that are biased to different diameters.
- a kit can include a plurality of different catheters, each having handles and flexible bodies, but differently sized annular rings.
- the catheter can heat, with radiofrequency energy, the tissue in direct contact with the electrode and avoid heating blood. Additionally, the catheter can provide advantages of simple operation, short operation time and controllable precise ablation.
- the catheter body can be preferably made of a polymer material, which is a poor heat conductor, so that it can avoid transmitting the heat when heating the electrodes to the flowing blood contacting the catheter body, thereby effectively avoid heating the blood.
- the shape or curvature of the flexible end can be adjusted by operating the adjustment apparatus, which allows the operator to control the handle with one hand, so as to adjust the curvature of the flexible end easily for purposes of placement of the annular ring and the electrodes.
- the electrodes on the annular ring can be pressed against the pulmonary artery and achieve ablation of pulmonary artery intima.
- the electrodes can produce high local temperature and cause severe damage on the vascular intima.
- the catheter can be configured to provide cold saline perfusion to cool down the local temperature.
- the saline is automatically and uniformly diffused through the through holes, which can provide beneficial cooling, for example, decreasing the local temperature to be below 60° C., thereby protecting the vascular intima.
- FIG. 1 is a schematic structural diagram of an embodiment of a catheter in accordance with an embodiment
- FIG. 2 is a partially enlarged view of Part B identified in FIG. 1 ;
- FIG. 3 is schematic sectional view taken along line A-A′ of FIG. 1 ;
- FIG. 4 is a schematic structural view of an optional outer surface of an electrode that can be used with the catheter of FIG. 1 .
- FIG. 5 is a front elevational and partial sectional view of a human heart
- FIG. 6 is a schematic sectional diagram of a pulmonary artery trunk including a distal portion of a main pulmonary artery and the proximal portions of the left and right pulmonary arteries;
- FIGS. 7A and 7B are photographs of the inner surfaces of two canine pulmonary arteries that have been dissected and laid flat;
- FIG. 8 is a schematic diagram of segmentations of dissected pulmonary arteries including the distal portion of the main pulmonary artery and the proximal portions of the left and right pulmonary arteries;
- FIG. 9 is a diagram of three of the segmentations identified in FIG. 8 ;
- FIGS. 10A-10D are enlargements of microscopy slides corresponding to the portions identified as S1-S4 of level A1 of the right pulmonary artery of FIG. 9 ;
- FIG. 11 is a photograph of microscopy of the portion identified as S6 of level A9 of the main pulmonary artery of FIG. 9 ;
- FIG. 12 is a posterior and perspective view of a model of the left pulmonary artery of FIGS. 7A and 7B ;
- FIG. 13 is an anterior view of the left pulmonary artery of FIG. 12 ;
- FIG. 14A is a diagram identifying the location corresponding to microscopy of six different locations on level A9 of the main pulmonary artery of FIG. 8 ;
- FIG. 14B is a table showing reductions in PAP resulting from the use of different ablation operating parameters
- FIG. 15A is a perspective view of a catheter device that can be used to perform pulmonary denervation
- FIG. 15B is an enlarged end view of a distal end of the catheter of FIG. 15A with indicia indicating positions of ten (10) RF electrodes;
- FIG. 15C is a perspective view of a controller that can be used for controlling the catheter of FIG. 15A during an ablation procedure;
- FIG. 15D is a top plan view of the controller of FIG. 15C ;
- FIG. 15E is a perspective view of the controller connected to the catheter device of FIG. 15A ;
- FIG. 16A is a fluoroscope image of a sheath device inserted into the main pulmonary artery for guiding the catheter device of FIG. 15A into the main pulmonary artery;
- FIGS. 16B-16D are additional fluoroscope images of the catheter device of FIG. 15A having been inserted and expanded within the left pulmonary artery of a human patient.
- FIG. 16D illustrates a position used for ablation and arterial denervation of the left pulmonary artery of the patient
- FIG. 16E illustrates the catheter of FIG. 15A being positioned within the main pulmonary artery of the patient in a position used for ablation;
- FIGS. 16F and 16G illustrate the catheter of FIG. 15A being positioned in the proximal right pulmonary artery and being pushed ( FIG. 16F ) and pulled ( FIG. 16G ) to determine if the catheter is properly seated for purposes of ablation;
- FIG. 16H is a fluoroscope image of the catheter of FIG. 15A in a position for performing ablation in a proximal portion of the right pulmonary artery;
- FIG. 17A is a schematic diagram of the trunk of a pulmonary artery and identifying locations for ablation in a distal portion of a main pulmonary artery;
- FIG. 17B is a schematic diagram of a pulmonary artery trunk and identifying locations for ablation in proximal portions of the left and right pulmonary arteries;
- FIG. 18A is a schematic diagram of a pulmonary artery trunk identifying a position for ablation in a portion of the left pulmonary artery proximal to a pulmonary artery duct;
- FIG. 18B is a schematic diagram of points of ablation in the anterior wall of the ablation position identified in FIG. 18A ;
- FIG. 19A is a schematic diagram of a pulmonary artery trunk identifying a position for ablation in a proximal portion of the right pulmonary artery for treatment of unilateral chronic thrombotic embolism;
- FIG. 19B is an enlarged schematic diagram of the portion identified in FIG. 20A and indicating positions for ablation in the anterior wall of the proximal portion of the right pulmonary artery.
- a multi-pole synchronous pulmonary artery radiofrequency ablation catheter for de-sympathetic in the pulmonary artery can include a catheter body 1 that has a distal end and a proximal end. The distal end can be provided with a flexible end 3 and the proximal end can be provided with a control handle 2 .
- a pull wire can extend in the catheter body.
- the catheter body can be made of a polymer material, which is a poor heat conductor, so that it can avoid transmitting or reduce the amount of heat transferred from the electrodes to the flowing blood contacting the catheter body, and thereby can better prevent the electrode from heating the blood flow.
- the flexible end 3 can include a proximal end and a distal end.
- An annular ring 4 can be arranged on the distal end.
- the flexible end 3 can be soft relative to the rest of the catheter body.
- the annular ring 4 can be provided with a plurality of electrodes 5 , wherein each electrode 5 can be configured to sense or extract neural electrical signals, sense temperature and conduct ablation.
- Each of the electrodes can be connected to lead wires and temperature sensing wires, which extend through the catheter body to the control handle, thus is electrically connected to the control handle.
- One or more temperature sensing wires can be embedded under each electrode for precise monitoring of the temperature during ablation. Additionally, in some embodiments, the temperature sensing wires can be connected to a thermocouple connected to an inner facing side of the electrodes 5 , or can include integrated thermocouples. Other configurations can also be used.
- a shape memory wire can be arranged in the annular ring 4 , and a distal end of the shape memory wire can extend to the distal end of the annular ring 4 .
- the proximal end of the shape memory wire can be fixed to the distal end of the flexible end.
- the shape memory wire in the annular ring 4 can be preferably made of various shape memory alloys such as nickel-titanium alloy, stainless steel or titanium, with a diameter in the range of 0.25-0.5 mm.
- the diameter of the annular ring is in the range of 12-40 mm.
- the shape memory wire can be configured to bias the annular ring 4 to a desired diameter, such as in the range of 12-40 mm.
- the pull wire can be used the change or adjust the diameter of the annular ring 4 through a range of diameters including 12-40 mm or other ranges.
- the length of the flexible end can be in the range of 30-80 mm, and can be made of medical polymer materials such as fluorine, polyesters, polyurethane, polyamide and polyimide.
- a counterbore can be arranged on the distal end of the flexible end, the proximal end of the annular ring can be fixed in the counterbore, wherein the proximal end of the annular ring is a ground thin end.
- a pull wire can be embedded in the catheter body, and one end of the pull wire can be fixed to the control handle.
- the curvature of the flexible end can be controlled by operating the control handle.
- one end of the pull wire can be fixed to a control button on the handle and the curvature of the flexible end can be controlled by operating the button. This allows the operator to control the handle with one hand and adjust the curvature of the flexible end easily, so that the electrodes 5 on the annular ring 4 can be pressed into contract with the pulmonary artery and achieve acceptable ablation of pulmonary artery intima.
- a counterbore can be made on the distal end of the flexible end 3 , and its depth can be set according to actual needs, preferably with a depth in the range of 2-8 mm.
- the proximal end of the annular ring 4 can be a ground thin end, and an outer diameter of the ground thin end fits an inner diameter of the counterbore.
- the ground-thin end can be inserted into the flexible end 3 and can be fixed to the distal end of the flexible end 3 by bonding, welding or other suitable means, preferably by UV-curing adhesive. The excess glue may be used to seal the distal end of the flexible end 3 and the proximal end of the annular ring 4 .
- FIG. 1 shows a schematic structural diagram of multi-pole synchronous pulmonary artery radiofrequency ablation catheter.
- the annular ring 4 can be arranged at the distal end of the flexible end 3 .
- the annular ring 4 can be an annular structure, the radius of the annular ring 4 can be effected with shape memory wire.
- the annular ring 4 can be provided with a plurality of electrodes 5 .
- Each electrode 5 can be configured to extract or detect neural electrical signals, sense the temperature and conduct ablation.
- the number of electrodes 5 can vary from the range of 3 to 30, preferably 5 to 20.
- the electrodes 5 are made of platinum-iridium alloy, gold, stainless steel or nickel alloy.
- the electrode diameter can be generally 1.3-2.0 mm, and the length of the electrode 5 can be generally in the range of 1.2-4 mm, more suitably 2-3.5 mm. Edge space between the adjacent electrodes suitably can be in the range of 0.5-10 mm, more suitably 1-5 mm.
- the pull wire 8 can be preferably made of stainless steel or nickel-titanium. As shown in FIG. 2 and FIG. 3 , the distal end of the pull wire 8 extends through a hollow cavity 9 to the proximal end of the annular ring 4 , and can be fixed to the distal end of the flexible end 3 .
- the method used for fixing the pull wire 8 to the distal end of the flexible end 3 can be any known method in the prior art.
- a groove can be arranged on the distal end of the flexible end 3 , and a connector 11 can be arranged in the groove.
- One end of the connector 11 can be connected to the pull wire 8 and the other end of the connector 11 can be connected to the shape memory wire 12 .
- the connector 3 can be fixed to the distal end of the flexible end 3 by injecting glue such as UV-curing adhesive into the groove.
- a segment of pull wire 8 extends in the flexible end 3 and a segment of pull wire 8 extends in the catheter body 1 .
- the pull wire can be preferably jacketed with a coil spring 13 , and the coil spring 13 can be jacketed with a spring sleeve 14 .
- the spring sleeve 14 may be made of any suitable material, preferably a polyimide material.
- the proximal end of the pull wire 8 can be fixed on or in the control handle 2 , which can be provided with an adjustment apparatus, and the adjustment apparatus can be configured to adjust the curvature or the diameter of the annular ring 4 .
- Lead wire 6 extends through the lead wire cavity 10 to the lead wire cavity of the annular ring 4 .
- the distal end of the lead wire 6 can be connected to electrode 5 .
- the distal end of the lead wire 6 can be fixed to electrode 5 by welding.
- the catheter includes one lead wire 6 for each of the electrodes 5 .
- the distal end of the temperature sensing wire 7 can be embedded under the electrode 5 and the distal end of the temperature sensing wire 7 can be fixed on electrode 5 by bonding, welding or other suitable means.
- the temperature sensing wire 7 can extend into the catheter body 1 in the lead wire cavity 10 of the flexible end 3 and then extend out from the control handle 2 and can be connected to a temperature control device.
- the catheter includes one temperature sensing wire 7 for each of the electrodes 5 .
- the pull wire 8 can be operated through the control handle 2 in order to deflect the flexible end 3 , thereby providing enhanced control for the user when positioning the annular ring 4 in a desired location, such as an orifice of the pulmonary artery. Then, with the electrodes 5 fully contacting the pulmonary artery. At this time, the electrodes 5 can be energized for performing ablation on pulmonary artery intima.
- the multi-electrode design can improve the efficacy and safety of ablation, achieve signal analysis and preferably simultaneous ablation by a plurality of electrodes. This can also improve target accuracy, achieve timely judgment of ablation effect and save operation time.
- the electrodes can be individually activated to perform ablation at selected sites. This can be a benefit because in some methods of treatment described below, ablation can be performed at selected sites, less than the entire circumferential surface of certain anatomy.
- a multi-pole synchronous pulmonary artery radiofrequency ablation catheter comprises a control handle 2 , a catheter body 1 , and an annular ring 4 .
- the control handle 2 can be provided with an adjustment apparatus, the catheter body 1 can be hollow, and a cavity can be arranged in the catheter body 1 .
- One or more lead wires 6 , temperature sensing wires 7 and a pull wire 8 can be arranged in cavity.
- One end of catheter body can be flexible, and the flexible end 3 can be connected to the annular ring 4 .
- the other end of the catheter body can be connected to the control handle 2 .
- One end of the pull wire 8 can be connected to the flexible end 3 , and the other end of the pull wire 8 can be connected to the adjustment apparatus of the control handle, the adjustment apparatus adjusts the tension of the pull wire 3 to control the curvature of the flexible end. This allows the operator to control the handle with one hand and adjust the curvature of the flexible end 3 easily.
- the electrodes 5 of the annular ring 4 can be pressed against to better contact an inner surface of a desired anatomy, such as a pulmonary artery, so as to enhance ablation of pulmonary artery intima.
- a shape memory wire 12 can be arranged in the annular ring 4 .
- One end of the shape memory wire 12 can extend to the end of the annular ring 4 , and the other end of the shape memory wire 12 goes through the root of the annular ring 4 and can be fixed on the flexible end 3 of the catheter body.
- the annular ring 4 can also be provided with an electrode group.
- Each electrode 5 can be connected to a lead wire 6 and a temperature sensing wire 7 and can be configured to extract or detect the nerve electrical signals, sense the temperature and conduct ablation.
- the lead wires 6 and temperature sensing wires 7 can extend through the catheter body 1 and can be electrically connected to the control handle 2 .
- the control handle 2 can be connected to an external temperature control device.
- the annular ring electrodes 5 can be made of a material selected from the group consisted of platinum-iridium alloy, gold, stainless steel and nickel alloy material, with the number in the range of 3-30, a diameter in the range of 1.3-2.0 mm, a length in the range of 1.2-4 mm and an edge space between adjacent electrodes in the range of 0.5-10 mm.
- the flexible end 3 of the catheter body can have a counterbore.
- An outer diameter of the root of the annular ring 4 can fit an inner diameter of the counterbore.
- the root of the annular ring 4 can be inserted into the counterbore and fixed.
- the flexible end 3 of the catheter body can be provided with a groove.
- a connector 11 can be arranged in the groove.
- One end of the connector can be connected to the pull wire 8 and the other end of the connector can be connected to the shape memory wire 12 .
- the shape memory wire can be made of shape memory alloy such as nickel titanium alloy, stainless steel or titanium, with a diameter in the range of 0.25-0.5 mm.
- the diameter of the annular ring 4 can be in the range of 12-40 mm.
- 10 electrodes are arranged on the annular ring, and the width of naked (exposed) side of electrodes can be 0.75 mm, and the space therebetween can be 5 mm.
- the flexible end 3 of the catheter body can be made of medical polymer materials such as fluorine, polyesters, polyurethane, polyamide and polyimide, with a length in the range of 30 mm to 80 mm.
- the connection can be via UV-curing adhesive.
- the joint between the flexible end of the catheter body and the annular ring can be sealed.
- the pull wire can 8 be made of stainless steel or nickel-titanium alloy.
- the pull wire 8 can be jacketed with a coil spring 13 , and the coil spring 13 can be jacketed with a spring sleeve 14 made of polyimide material.
- Example 3 is similar to Example 1 and Example 2, and the differences can include an infusion tube arranged in the catheter body, a group of evenly distributed through holes 15 ( FIG. 4 ) arranged on one or more of the electrodes 5 , with a bore diameter of 1 ⁇ m.
- One end of the infusion tube can be connected to the electrodes 5 through the annular ring 4 such that fluid diffuses out from the through holes 15 on each of the electrodes 5 .
- the annular ring 4 can include or define at least one lumen extending between a proximal end of the annular ring 4 and to the through holes 15 so as to form a closed fluidic connection.
- a distal end of the infusion tube can be connected to the proximal end of the lumen in the annular ring 4 .
- the other end of the infusion tube can be connected to a transfusion system, such as a constant-flux pump or other known pumps.
- the transfused liquid can be saline.
- the cold saline (4° C.) perfusion can help decrease local temperature.
- the saline can automatically diffuse from the through holes 15 , and thus can allow the local temperature to be controlled to a desired temperature, such as to below 60° C. and thereby protect the vascular intima.
- FIG. 5 is a schematic diagram of a human heart and surrounding vasculature, which can be an environment in which the catheter of FIGS. 1-4 can be used to perform ablation treatments such as, for example, but without limitation, denervation of the pulmonary artery.
- ablation treatments such as, for example, but without limitation, denervation of the pulmonary artery.
- access to the inner walls of the main pulmonary artery as well as the left and right pulmonary arteries can be achieved by passing a catheter, using well known techniques, into a femoral vein, upwardly into the inferior vena cava (lower left hand corner of FIG. 5 ). The catheter can then be pushed upwards into the right atrium, down into the right ventricle, then up through the pulmonary semilunar valve into the trunk of the main pulmonary artery.
- main pulmonary artery includes the proximal end of the main pulmonary artery which is the furthest upstream end of the main pulmonary artery, at the pulmonary semilunar valve, up to the bifurcation of the main pulmonary artery.
- the distal portion of the MPA includes the portions of the MPA near the bifurcation of the MPA into the left and right pulmonary arteries (LPA, RPA).
- the proximal ends of the RPA and LPA are those ends of the LPA and RPA which are adjacent and connected to the distal end of the MPA.
- the distal direction along the LPA and RPA would be the downstream direction of blood flow through the LPA and RPA toward the left and right lungs, respectively.
- a catheter can be used to provide access to the proximal and distal portions of the MPA as well as the proximal and distal portions of the LPA and RPA.
- FIG. 6 is a schematic diagram of the “trunk” of the pulmonary artery.
- the “trunk” of the MPA is intended to include at least the distal portion of the MPA and the proximal portions of the LPA and RPA.
- FIG. 6 also includes a schematic representation of a carina at the branch of the LPA and RPA from the MPA.
- an aspect of at least some of the inventions disclosed herein includes the realization that the trunk of the pulmonary artery of certain animals, including canine and humans, can include concentrated bundles of sympathetic nerves extending from the MPA into the LPA and RPA.
- the trunk of the pulmonary artery of certain animals can include concentrated bundles of sympathetic nerves extending from the MPA into the LPA and RPA.
- the sympathetic nerves bifurcate from this area of higher concentration into the anterior side of the proximal portions of the LPA and RPA.
- higher concentrations of the sympathetic nerves extend upwardly and toward the posterior side of the LPA and RPA.
- ablation is performed in the distal portion of the MPA and the proximal portions of the LPA and RPA.
- ablation is preferentially performed on the anterior side of the inner walls of these structures.
- ablation is performed preferentially on the anterior side of the proximal portion of the MPA and on the anterior side and an upper portion of the proximal portions of the LPA and RPA, such as at approximately the upper conjunctive site of the distal portion of the main pulmonary artery at the left and right pulmonary arteries.
- a dog was anesthetized with sodium pentobarbital (60 mg per kg, intraperitoneal injection). The chest was excised and opened carefully. The whole pulmonary artery was removed from the chest, with particular attention to avoid the injury of adventitia. In one dog, the pulmonary artery was longitudinally cut along the blood flow direction from the orifice of the main pulmonary artery (the proximal portion of the main pulmonary artery) toward the right and left branches. Then, a vernier focusing camera was used to take pictures in order to identify whether there is a visible difference in the surface of the pulmonary artery between different segments.
- connective tissue was manually dissected away from the pulmonary artery using fine microdissection scissors, under the guidance of stereomicroscope. During this procedure, great care was taken to avoid stripping off the adventitia and possible damage to the perivascular nerves. Vessels were stored at ⁇ 70° for further staining.
- Frozen vessels were processed in paraffin wax and fixed in 4% paraformaldehyde for 30 minutes and then incubated at 0.5% Pontamine Sky Blue (Sigma-Aldrich, St. Louis, Mo.) in phosphate-buffered saline (PBS) for 30 minutes to reduce background fluorescence. This was followed by 1 hour at room temperature in a blocking solution of 4% normal goat serum/0.3% Triton X-100 in PBS, then overnight at 4° C. in blocking solution containing an affinity-purified polyclonal antibody against tyrosine hydroxylase (Temecula, Calif.).
- PBS phosphate-buffered saline
- Vessel segments were then washed in PBS and incubated for 1 hour with secondary antibody (Invitrogen, Carlsbad, Calif.), washed again and positioned on a glass slide. Preparations remained immersed in PBS during image acquisition to maintain hydration and preserve vessel morphology.
- secondary antibody Invitrogen, Carlsbad, Calif.
- FIG. 6 schematically illustrates, not to scale, a 5 mm segment of the distal portion of the MPA and 5 mm long proximal portions of the LPA and RPA.
- transverse slices (2 ⁇ m of thickness) of the vessels were cut at 1.6 mm intervals, and are identified in the description set forth below in accordance with the labels of FIG. 8 . Care was taken to keep the luminal morphology of slices consistent with the vessel contour, in order to precisely position the location of nerves. The slices were examined by a pathologist.
- FIGS. 7A , 7 B showed that in the anterior wall of the main pulmonary artery, there was an obvious ridgy cystica close to the orifice of the left pulmonary artery.
- the site of the ridgy cystica felt rigid to the touch, compared to other areas of the pulmonary artery.
- each slice (“level”) was divided into 4 subsegments in the right and left pulmonary arteries and 6 subsegments in the main pulmonary artery along the counterclockwise direction ( FIG. 9 ).
- the minor and major radius of sympathetical axons in the main pulmonary artery were 85 ⁇ 2 ⁇ m and 175 ⁇ 14 ⁇ m, compared to 65 ⁇ 3 ⁇ m and 105 ⁇ 12 ⁇ m in the left pulmonary artery or 51 ⁇ 2 ⁇ m and 86 ⁇ 8 ⁇ m in the right pulmonary artery, respectively, resulting in significant differences in surface area of axons between the main pulmonary artery and the LPA and RPA ( FIG. 9 ).
- subsegment S6 in level A9 ( FIG. 11 ) of the MPA revealed that a bundle or main bundle of sympathetical nerves originate from approximately the middle of the anterior wall of the distal portion of the main pulmonary artery and that this main bundle is bifurcated to the left and right pulmonary arteries.
- This discovery provides a basis for more effective denervation of the pulmonary artery. For example, by selectively ablating only portions of the main pulmonary artery and the left and right pulmonary arteries, a higher success rate of denervation can be achieved with less unnecessary tissue damage. Such denervation can provide significant benefits in the treatment of diseases such as pulmonary hypertension, as described below.
- the lung receives axons from principal sympathetic neurons residing in the middle and inferior cervical and the first five thoracic ganglia (including the stellate ganglion), and the vasculature is the major sympathetic target in the lung.
- Sympathetic nerve stimulation increases pulmonary vascular resistance and decreases compliance, which is mediated by noradrenaline via a-adrenoreceptors, primarily of the a1-subtype.
- sympathetic noradrenergic innervation density is highest at the large extra-pulmonary and hilar blood vessels, both arteries and veins and then decreases toward the periphery. This is in marked contrast to many other organs, in which the highest innervation density is found at the level of the smallest arterioles.
- Such distribution varies from species to species with regard to the extent to which the sympathetic noradrenergic axons reach into the lung.
- guinea pigs rabbits, sheep, cats, dogs, and humans, small arteries down to 50 ⁇ m in diameter are innervated, whereas in rats, mice, hedgehogs, and badgers, noradrenergic innervation stops close to the lung.
- noradrenergic and NPY-containing fibers have been noted around pulmonary arteries of several species, but only a few studies used double-labeling techniques to evaluate the extent of colocalization.
- principally all noradrenergic fibers innervating pulmonary arteries and veins contain NPY and, in addition, dynorphin, a neuropeptide of the opioid family.
- pulmonary vascular innervation differs markedly from that of skin arteries in the same species, wherein three different combinations of noradrenaline, NPY, and dynorphin are used by sympathetic axons. Each of these populations is restricted to a specific segment of the arterial tree in the skin.
- noradrenergic and NPY-containing fibers do not match 1:1 in the lung either, as there is a minor population of axons innervating guinea pig pulmonary arteries and veins that contains NPY plus vasoactive intestinal peptide (VIP) but not noradrenaline. It remains to be clarified whether this less-frequent fiber population represents the non-noradrenergic neurons projecting to the guinea pig lung or originates from other systems.
- VIP vasoactive intestinal peptide
- IPAH idiopathic pulmonary arterial hypertension
- PAP mean pulmonary artery pressure
- PVR pulmonary vascular resistance
- the pathogenesis of IPAH was believed to be due to imbalance between locally produced vasodilators and vasoconstrictors. Recent studies have demonstrated that vascular wall remodeling also contributed to elevated PVR.
- the role of neural reflex in the mediation and development of IPAH has not been specifically investigated. In 1961, Osorio et al. reported the existence of a pulmo-pulmonary baroreceptor reflex that originates in the large pulmonary branches, with neither the afferent nor efferent fibers belonging to the vagus nerve.
- PADN pulmonary arterial denervation
- a human study was conducted. Prior to enrollment, all 21 patients received a diuretic (hydrochlorothiazide at a dose of 12.5 mg to 25 mg, once daily, and/or spironolactone at a dose of 20 mg to 40 mg, once daily) and beraprost (120 mg, 4 times daily) (Table 1), with either sildenafil (20 mg, 3 times a day) or bosentan (120 mg, twice daily) or digoxin (0.125 mg, once daily). Functional capacity of the patients was determined by a 6-minute walk test (6MWT), followed by an assessment of dyspnea using the Borg scale. The 6MWT was performed at 1 week, 1 month, 2 months, and 3 months following the PADN procedure. The WHO classification at rest and during exercise was recorded by a physician who was blinded to the study design.
- 6MWT 6-minute walk test
- Echocardiography was performed at 1 week, 1 month, 2 months, and 3 months following the procedure. Echocardiographic studies were done using a Vivid 7 ultrasound system with a standard imaging transducer (General Electric Co., Easton Turnpike, Conn., US). All of the echocardiograms were performed and interpreted in the Medical University Echocardiographic Laboratory. All of the measurements were performed following the recommendations of the American Society of Echocardiography. Digital echocardiographic data that contained a minimum of 3 consecutive beats (or 5 beats in cases of atrial fibrillation) were acquired and stored. RV systolic pressure is equal to systolic PAP in the absence of pulmonary stenosis.
- Systolic PAP is equal to the sum of right atrial (RA) pressure and the RV to RA pressure gradient during systole.
- RA pressure was estimated based on the echocardiographic features of the inferior vena cava and assigned a standard value.
- the RV to RA pressure gradient was calculated as 4v t 2 using the modified Bernoulli equation, where v t is the velocity of the tricuspid regurgitation jet in m/s.
- the mean PAP was estimated according to the velocity of the pulmonary regurgitation jet in m/s.
- the tricuspid excursion index (TEI) is defined as (A ⁇ B)/B, where A is the time interval between the end and the onset of tricuspid annular diastolic velocity, and B is the duration of tricuspid annular systolic velocity (or the RV ejection time).
- PA compliance for patients was calculated as stroke volume divided by pulse pressure (systolic PAP minus diastolic PAP).
- the PADN procedure was performed with a dedicated 7.5F multiple-function (temperature-sensor and ablation) catheter which comprised two parts, a catheter shaft 3 and handle 2 ( FIG. 15A ) which is an embodiment of the catheter illustrated in FIGS. 1-4 .
- the catheter of FIG. 15A had a tapered (to 5F) annular ring 4 with 10 pre-mounted electrodes 5 (E1-E10) each separated by 2 mm, however, other spacings can also be used.
- the electrodes 5 have been numbered, as shown in FIG. 15B , with the distal-most electrode 5 identified as electrode E1 and the proximal-most electrode 5 identified as electrode E10.
- the annular ring 4 or (“circular tip”) can be constructed so as to be biased into a circular shape, such as the circular shape illustrated in FIG. 15B and FIG. 1 to have any desired outer diameter.
- the annular ring 4 can be configured to be biased into a circular shape having an outer diameter of 20 mm, 25 mm, 30 mm, 35 mm, 40 mm, 45 mm, or other diameters.
- a kit containing the catheter of FIG. 1 can include a plurality of different annular rings 4 configured to be biased to a plurality of different outer diameters, such as those noted above, or other diameters.
- a controller or “connect box” can be connected to the handle 2 of the catheter for providing ablation energy.
- an ablation controller 100 can be configured to provide ablation energy to each of the electrodes E1-E10.
- the controller 100 includes a selector knob 102 configured to allow a user to select activation of all the electrodes E1-E10, or selective actuation of individual ones of the electrodes E1-E10, one at a time.
- the selector knob 102 includes a position indicator 104 which, by rotating the knob 102 can be aligned with indicia corresponding to the electrodes E1-E10.
- the indicia on the controller 100 includes the numbers 1-10 as well as a position identified as “OFF” and a position identified as “NULL.”
- the connect cable 106 can include a plurality of wires, for example, ten wires which correspond to the lead wire 6 described above with reference to FIGS. 1-4 , each one of which is individually connected to respective electrodes E1-E10.
- the controller 100 can include a physical switch for creating an electrical connection between a source of RF energy and a desired one of the electrodes E1-E10.
- An electrode (not shown) can be directly connected to the knob 102 with additional contacts (not shown) disposed around the electrode at approximately the positions identified as 1 through 10 on the controller 100 .
- rotation of the knob 102 will connect an internal electrode (not shown) with the contacts aligned with each one of the positions 1-10.
- the controller 100 can be configured to provide the desired amount of ablation energy when a circuit is created by the alignment of the position indicator 104 with the corresponding position (1 through 10) on the controller 100 thereby delivering electrical energy to the selected one of the electrodes E1-E10 causing electrical energy to pass through the selected electrode 5 into any conductive material in contact with that selected electrode.
- the electrodes E1-E10 can be in contact with an inner wall of the pulmonary artery trunk thereby allowing electrical energy from one of the electrodes E1-E10 to flow through the tissue of the inner wall of the pulmonary artery, described in greater detail below.
- the controller 100 can include a plurality of ports.
- the controller 100 can include a catheter port 120 , which can be configured for creating a fluidic connection to the annular ring for purposes of providing a flow of saline to the annular ring 4 .
- the controller 100 can also include an RF port 122 configured to connect to any known radiofrequency generator used with regard to ablation procedures.
- the controller 100 can include an “ECG” port 124 configured for connection with standard ECG monitoring equipment.
- the connect cable 106 can also include wires or conduits for transmitting data through the RF port 124 .
- the RF port 122 can be connected to a source of RF energy (not shown).
- One or more wires can connect the port 122 to a contact on the end of an electrode connected to the selector knob 102 .
- the ten wires can be configured to deliver RF electrical energy to the electrodes E1-E10 each of which can each be connected to contacts (not shown) associated with the selector positions 1-10 disposed around the periphery of the selector knob 102 .
- the electrode connected to the rotating selector knob 102 cab be moved into contact with the electrical contacts associated with each of the positions 1-10 thereby creating a circuit connecting the electrical energy entering the controller 100 through the port 122 with the associated lead wire 6 for conducting electrical energy to the desired electrode E1-E10.
- a method for treating pulmonary hypertension can include a step of identifying the position of the pulmonary trunk of the patient using angiography.
- baseline pulmonary artery angiography can be performed to identify the position of the pulmonary artery bifurcation from the main pulmonary artery into the left and right pulmonary arteries.
- the baseline pulmonary artery angiography can be used to determine the diameter of the portions of the pulmonary artery trunk upon which ablation is desired.
- the appropriate diameter of the annular ring 4 can be determined based on the determined diameters of the pulmonary artery trunk noted above.
- an annular ring 4 having a biased diameter slightly larger than the diameters of the targeted anatomy can be used so as to enhance the contact between the electrodes 5 and the inner surface of the targeted anatomy.
- the annular ring 4 when the annular ring 4 is moved out of a sheath and allowed to expand into its biased circumferential configuration which has an outer diameter slightly larger than the inner diameter of the targeted portions of the pulmonary artery trunk, the bias of the annular ring 4 will assist in pressing the electrodes 5 into contact with the targeted tissue.
- a method can include a step of positioning a catheter in a pulmonary artery trunk.
- a catheter for example, an 8 F long sheath can be inserted through the femoral vein and advanced to the main pulmonary artery, as shown in FIG. 16A .
- a PADN catheter such as the catheter illustrated in FIG. 1 and FIGS. 15A-15E can be advanced along the sheath shown in FIG. 16A to the location of the pulmonary artery trunk.
- the sheath With the distal end of the catheter maintained in place, the sheath can be withdrawn. It may be necessary to push on the catheter to maintain its position with the portion of the catheter forming the annular ring 4 held within the pulmonary artery trunk.
- the annular ring 4 As the annular ring 4 is released from the sheath, as illustrated in FIG. 16B , the annular ring 4 can adopt the shape and diameter to which it is biased.
- the annular ring 4 can be positioned at the proximal portion of the left pulmonary artery, such as at the ostium. In some embodiments, this initial position can be within a range of approximately five mm from the orifice of the left pulmonary artery or within a range of two millimeters, as illustrated in FIG. 16D .
- the desired one or plurality of the electrodes E1-E10 can be selectively energized so as to perform ablation at the desired location on the interior surface of the left pulmonary artery.
- it may be more effective to selectively ablate the posterior wall of the left pulmonary artery, so as to achieve at least some sympathetic denervation of the left pulmonary artery and the proximal portion thereof, such as within two or five millimeters of the ostium of the left pulmonary artery.
- the annular ring 4 can then be rotated, such as in the counterclockwise direction, by rotating and withdrawing the handle 2 in order to reposition the annular ring 4 into the distal portion of the main pulmonary artery such as at the bifurcation area.
- the annular ring 4 can be positioned within about 5 mm of the bifurcation in the pulmonary artery trunk.
- the annular ring 4 can be positioned within about 5 mm of the bifurcation in the pulmonary artery trunk.
- Ablation can then be performed using the desired one or plurality of the electrodes E1-E10.
- the selected one or plurality of electrodes E1-E10 can be energized to achieve the desired sympathetic denervation of the distal portion of the main pulmonary artery.
- further rotating and pushing the handle 2 can be performed until the annular ring 4 is positioned in the proximal portion of the right pulmonary artery, such as at the ostium. In some embodiments, this position can be within 5 mm of the ostium of the right pulmonary artery. Further, in some embodiments, this position can be within 2 mm of the ostium of the right pulmonary artery.
- the desired one or plurality of electrodes E1-E10 can be energized so as to achieve at least some sympathetic denervation in the proximal portion of the right pulmonary artery.
- a method for treating pulmonary hypertension can also include a step of confirming the appropriate contact between the electrodes E1-E10 and the endovascular surface corresponding to the three positions noted above. For example, in some embodiments, such confirmation can be performed by determining if there is strong manual resistance when attempting to rotate the handle 2 . Additionally, it can be determined if the annular ring 4 cannot be advanced distally, resulting in the deformation of the catheter as illustrated in FIG. 16G or if there is ease in withdrawing proximally, resulting in the deformation of the catheter illustrated in 16 H. Additionally, confirmation can be performed using angiographic confirmation.
- a method for treating pulmonary hypertension can include the sequential energization of each of the electrodes E1-E10.
- a method for treating pulmonary hypertension or for performing pulmonary denervation can include the step of repositioning the annular ring 4 so as to shift the location of the electrodes E1-E10 and then repeating energization of all of the electrodes E1-E10. As such, a more complete denervation of the entire inner surface of the associated vessel can be achieved.
- any desired energy levels or temperatures can be used for performing ablation using the electrodes E1-E10 noted above.
- ablation can be performed at temperatures above 50° C., drawing an electrical load of 8-10 W for a duration of 60-120 s.
- a method of treatment of pulmonary hypertension or a method of sympathetic denervation of the pulmonary artery can be performed with a patient anesthetized but conscious. Thus, any ablation procedure can be stopped if the patient complained of intolerable chest pain.
- EKG and hemodynamic pressure can be monitored and continuously recorded throughout the method.
- success was defined as a reduction in the mean PAP ⁇ 10 mmHg (as measured by the Swan-Ganz catheter). During the study, there were no complications. Additionally, the patients were monitored in the CCU for at least 24 hours after the PADN procedure was performed.
- a dedicated 7.5 F triple-function catheter can be used, which can include a tapered (to 5F) annular ring 4 with 10 electrodes (each has 0.75 mm electrode-width and is separated by 2-mm, B), pre-mounted. Electrodes are connected with a connect-cable 106 and a connect-box/controller 100 . There are 10 positions of the knob 102 ( FIG. 15D ) on the surface of controller 100 , and each is associated with one of the electrodes E1-E10 on the annular ring 4 of the ablation catheter. Sequential ablation can be performed by turning the knob 102 as desired after the whole system is set up.
- ablation of the distal portion of the main pulmonary artery can be performed preferentially on the anterior side thereof.
- ablation can be performed at the positions identified as M1, M2, M3, M4, and M5.
- the position identified as M1 is at the “6 o'clock” position in the distal portion of the main pulmonary artery.
- the positions identified as M3 and M5 are the sites where the anterior wall of the main pulmonary artery connects to the left and right pulmonary arteries, respectively.
- the positions identified as M2 and M4 correspond to the “5 o'clock” and the “7 o'clock” positions on the anterior side of the distal portion of the main pulmonary artery.
- sympathetic denervation in the left and right pulmonary arteries can be performed, preferentially, at approximately the middle of the anterior wall of the proximal portion of the left pulmonary artery (L1) and at approximately the upper conjunctive site of the distal portion of the main pulmonary artery in the left pulmonary artery (L2).
- ablation can be preferentially performed at a point approximately at the middle anterior wall of the proximal portion of the right pulmonary artery (L3) and at approximately the upper conjunctive site of the distal portion of the main pulmonary artery and the right pulmonary artery (L4).
- sympathetic denervation can be performed, for example, for treatment of pulmonary hypertension associated with a pulmonary duct artery (PDA).
- a pulmonary duct artery usually connects the descending aorta with the left pulmonary artery, as shown in FIG. 4A .
- the left pulmonary artery can be significantly larger than the right pulmonary artery.
- ablation can be performed at a position proximal to connection between the left pulmonary artery and the pulmonary duct artery, identified as “Level A” in FIG. 18A .
- the annular ring 4 can be positioned at a position corresponding to Level A of FIG. 18B . Ablation can then be performed around part or all of the interior wall of the left pulmonary artery at that location.
- ablation can be preferentially performed on the anterior wall of the left pulmonary artery proximal to the proximal end of the pulmonary duct artery.
- ablation can be performed at four or more sites, such as those identified as sites L1, L2, L3, L4.
- sites L1, L2, L3, L4 As illustrated in FIG. 18B , position L1 corresponds to “12 o'clock”, position L2 corresponds to “2 o'clock”, position L3 corresponds to “3 o'clock”, and position L4 corresponds to “6 o'clock.” Other positions can also be used.
- ablation can also be performed at positions M1-M5 illustrated in FIG. 17A and positions L1-L4 of FIG. 17B .
- a method for sympathetic denervation can be used for treating pulmonary hypertension resulting from unilateral chronic thrombotic embolism.
- a patient suffering from unilateral CTEH can have an occluded right pulmonary artery.
- the RPA can be significantly enlarged as illustrated on the left side of FIG. 19A .
- ablation can be performed at the position identified as “Level B” in FIG. 19A .
- Ablation can be performed at one or a plurality of locations along the inner surface of the right pulmonary artery at the position of Level B, or other positions. Additionally, ablation can be preferentially performed on a plurality of points along the anterior wall of the right pulmonary artery at the position of Level B.
- the positions identified in FIG. 20B can be considered such as position L1 corresponding to “12 o'clock”, position L2 corresponding to “2 o'clock”, position L3 corresponding to “3 o'clock”, and position L4 corresponding to “6 o'clock.” Additionally, in some embodiments, ablation can also be performed at positions M1-M5 illustrated in FIG. 17A and positions L1 and L2 illustrated in FIG. 17B .
- the term “animal” is intended to include human beings and other animals such canines, other mammals, etc.
- the terms “live”, “living”, “live animal” are intended to exclude methods of euthanasia, surgery performed on dead animals including dissection and autopsies, or other techniques for disposing of dead bodies.
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Surgery (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Heart & Thoracic Surgery (AREA)
- Otolaryngology (AREA)
- Medical Informatics (AREA)
- Molecular Biology (AREA)
- Radiology & Medical Imaging (AREA)
- Plasma & Fusion (AREA)
- Physics & Mathematics (AREA)
- Cardiology (AREA)
- Mechanical Engineering (AREA)
- Biophysics (AREA)
- Pulmonology (AREA)
- Anesthesiology (AREA)
- Hematology (AREA)
- Surgical Instruments (AREA)
- Media Introduction/Drainage Providing Device (AREA)
Abstract
A multi-pole synchronous pulmonary artery radiofrequency ablation catheter, wherein an adjustment apparatus is arranged on a control handle; a catheter body is hollow, and a cavity is arranged therein; a lead wire, a temperature sensing wire and a pull wire are arranged in the cavity; one end of the catheter body is flexible, and the flexible end is connected to an annular ring; the annular ring is provided with an electrode group with each electrode connected to the lead wire and temperature sensing wire; the lead wire and temperature sensing wire go through the catheter body and are electrically connected to the control handle. The device uses cold saline perfusion method to protect the vascular intima and possesses advantages of simple operation, short operation time and controllable precise ablation. The device can be used to treat pulmonary hypertension with pulmonary denervation.
Description
- This application claims priority to Chinese Application No. 201210453470.4, filed on Nov. 13, 2012 and Chinese Application No. 201310103141.1, filed on Mar. 27, 2013, the entire contents of each of which are hereby incorporated by reference.
- 1. Field of the Inventions
- The present inventions relate to medical devices for treatment of pulmonary hypertension in the pulmonary artery by de-sympathetic methods, for example, with multi-pole synchronous pulmonary artery radiofrequency ablation catheters, as well as methods for diagnosis and method of treating pulmonary hypertension.
- 2. Description of the Related Art
- Pulmonary hypertension is to be an intractable diseases in the cardiovascular, respiratory, connective tissue, immune and rheumatic systems. Currently available clinical treatments of pulmonary hypertension are limited and therapy efficacy thereof is poor. Incidence of primary pulmonary hypertension is low but those secondary to pulmonary interstitial fibrosis, connective tissue disease, portal hypertension, chronic pulmonary artery embolism and left heart system disorder are common, with five-year mortality rate up to 30%. Therefore, prevention and treatment for pulmonary hypertension is of great significance.
- In recent years, new targeted drugs have emerged based on the research into the pathogenesis of pulmonary hypertension. However, some of those drugs have serious limitations including many side effects, inappropriate dosage form, expensive cost and unreliable efficacy, and thus many have not been widely applied in clinical treatment.
- An aspect of at least one of the inventions disclosed herein includes the realization, supported by experimental data which demonstrates, that pulmonary hypertension is associated with hyper sympathetic activity in pulmonary artery and hyperactive baroreceptor. Blocking the sympathetic nerves in the pulmonary artery or permanently damaging the baroreceptor structure and function thereof can decrease the pulmonary artery pressure, which can provide more successful treatments of pulmonary hypertension.
- Some of the embodiments disclosed herein provide a multi-pole synchronous pulmonary artery radiofrequency ablation catheter for treatment of pulmonary hypertension in the pulmonary artery by a de-sympathetic method. In some embodiments, the catheter only heats the adherent tissue rather than the blood. Additionally, in some embodiments, the catheter can be configured to provide cold saline perfusion at or near the ablation site to protect the vascular intima. Some of the embodiments can also provide advantages of simple operation, short operation time and controllable, precise ablation.
- In some embodiments, a multi-pole synchronous pulmonary artery radiofrequency ablation catheter can comprise a control handle, a catheter body and an annular ring. The control handle can be provided with an adjustment apparatus. The catheter body can be hollow and can include a cavity. One or a plurality of lead wires, one or more temperature sensing wires and one or more pull wires can be arranged in the cavity. One end of the catheter body can be flexible. The flexible end can be connected to an annular ring and the other end of the catheter body can be connected to the control handle. One end of the pull wire can be connected to the flexible end and the other end of the pull wire can be connected to the adjustment apparatus. Tension in the pull wire can be adjusted through the adjustment apparatus to achieve shape control, such as curvature control, of the flexible end. A shape memory wire can be arranged in the annular ring. One end of the shape memory wire can extend to the end of the annular ring and the other end of the shape memory wire can pass through the root of the annular ring and can be fixed on the flexible end of the catheter body. The annular ring can be provided with an electrode group with each electrode connected to the one or more lead wires and the one or more temperature sensing wires. The lead wire(s) and the temperature sensing wire(s) extend through the catheter body and are electrically connected to the control handle.
- An infusion tube can be arranged in the cavity of the catheter body and a through hole can be arranged on one or more of the electrodes. The infusion tube can be connected to the electrodes through the annular ring. The transfused fluid flows out from the through hole and thus can be used for cooling purposes during ablation procedures.
- The electrodes on the annular ring can be made of a material selected from the group consisted of platinum-iridium alloy, gold, stainless steel and nickel alloy, with the number in the range of 3-30 electrodes, a diameter in the range of 1.3-2.0 mm, a length in the range of 1.2-4 mm and an edge space between adjacent electrodes in the range of 0.5-10 mm.
- The flexible end of the catheter body can be provided with a counterbore, an inner diameter of the counterbore can be sized to fit an outer diameter of the root of the annular ring, and thus the root of the annular ring can be inserted and fixed into the counterbore.
- The flexible end of the catheter body is provided with a groove in which a connector is arranged, one end of the connector is connected to the pull wire and the other end of the connector is connected to the shape memory wire.
- The material of the shape memory wire in the annular ring can be a shape memory alloy selected from the group consisted of nickel titanium alloy, stainless steel or titanium, with a diameter of 0.25-0.5 mm. The diameter of the annular ring can be 12-40 mm. For example, the annular ring can be configured so as to be biased toward a circumferential shape, having a desired diameter (e.g., in the range of 12-40 mm), for example, with the use of a memory shape material. Preferably, 10 electrodes are arranged on the annular ring. The width of naked section of the electrode is 0.75 mm, and the space therebetween is 5 mm.
- The flexible end can be made of medical polymer materials with a length in the range of 30-80 mm. The connection can be achieved by a UV-curing adhesive. The joint between the flexible end and the annular ring can be sealed.
- The pull wire is made of stainless steel or nickel-titanium alloy. The outside of pull wire is provided with a spring coil, and the outside of the spring coil is provided with a spring sleeve made of polyimide material.
- In some embodiments, the catheter can be packaged into a kit including a plurality of different annular rings that are biased to different diameters. In some embodiments, where the annular rings, flexible bodies, and handles are permanently connected together, a kit can include a plurality of different catheters, each having handles and flexible bodies, but differently sized annular rings.
- In some embodiments and/or methods of use, the catheter can heat, with radiofrequency energy, the tissue in direct contact with the electrode and avoid heating blood. Additionally, the catheter can provide advantages of simple operation, short operation time and controllable precise ablation. The catheter body can be preferably made of a polymer material, which is a poor heat conductor, so that it can avoid transmitting the heat when heating the electrodes to the flowing blood contacting the catheter body, thereby effectively avoid heating the blood.
- Furthermore, the shape or curvature of the flexible end can be adjusted by operating the adjustment apparatus, which allows the operator to control the handle with one hand, so as to adjust the curvature of the flexible end easily for purposes of placement of the annular ring and the electrodes. As such, after achieving the desired placement, the electrodes on the annular ring can be pressed against the pulmonary artery and achieve ablation of pulmonary artery intima. During application of the radiofrequency current, the electrodes can produce high local temperature and cause severe damage on the vascular intima.
- Thus, in some embodiments, the catheter can be configured to provide cold saline perfusion to cool down the local temperature. When the electrodes receive the current, the saline is automatically and uniformly diffused through the through holes, which can provide beneficial cooling, for example, decreasing the local temperature to be below 60° C., thereby protecting the vascular intima.
-
FIG. 1 is a schematic structural diagram of an embodiment of a catheter in accordance with an embodiment; -
FIG. 2 is a partially enlarged view of Part B identified inFIG. 1 ; -
FIG. 3 is schematic sectional view taken along line A-A′ ofFIG. 1 ; -
FIG. 4 is a schematic structural view of an optional outer surface of an electrode that can be used with the catheter ofFIG. 1 . -
FIG. 5 is a front elevational and partial sectional view of a human heart; -
FIG. 6 is a schematic sectional diagram of a pulmonary artery trunk including a distal portion of a main pulmonary artery and the proximal portions of the left and right pulmonary arteries; -
FIGS. 7A and 7B are photographs of the inner surfaces of two canine pulmonary arteries that have been dissected and laid flat; -
FIG. 8 is a schematic diagram of segmentations of dissected pulmonary arteries including the distal portion of the main pulmonary artery and the proximal portions of the left and right pulmonary arteries; -
FIG. 9 is a diagram of three of the segmentations identified inFIG. 8 ; -
FIGS. 10A-10D are enlargements of microscopy slides corresponding to the portions identified as S1-S4 of level A1 of the right pulmonary artery ofFIG. 9 ; -
FIG. 11 is a photograph of microscopy of the portion identified as S6 of level A9 of the main pulmonary artery ofFIG. 9 ; -
FIG. 12 is a posterior and perspective view of a model of the left pulmonary artery ofFIGS. 7A and 7B ; -
FIG. 13 is an anterior view of the left pulmonary artery ofFIG. 12 ; -
FIG. 14A is a diagram identifying the location corresponding to microscopy of six different locations on level A9 of the main pulmonary artery ofFIG. 8 ; -
FIG. 14B is a table showing reductions in PAP resulting from the use of different ablation operating parameters; -
FIG. 15A is a perspective view of a catheter device that can be used to perform pulmonary denervation; -
FIG. 15B is an enlarged end view of a distal end of the catheter ofFIG. 15A with indicia indicating positions of ten (10) RF electrodes; -
FIG. 15C is a perspective view of a controller that can be used for controlling the catheter ofFIG. 15A during an ablation procedure; -
FIG. 15D is a top plan view of the controller ofFIG. 15C ; -
FIG. 15E is a perspective view of the controller connected to the catheter device ofFIG. 15A ; -
FIG. 16A is a fluoroscope image of a sheath device inserted into the main pulmonary artery for guiding the catheter device ofFIG. 15A into the main pulmonary artery; -
FIGS. 16B-16D are additional fluoroscope images of the catheter device ofFIG. 15A having been inserted and expanded within the left pulmonary artery of a human patient. -
FIG. 16D illustrates a position used for ablation and arterial denervation of the left pulmonary artery of the patient; -
FIG. 16E illustrates the catheter ofFIG. 15A being positioned within the main pulmonary artery of the patient in a position used for ablation; -
FIGS. 16F and 16G illustrate the catheter ofFIG. 15A being positioned in the proximal right pulmonary artery and being pushed (FIG. 16F ) and pulled (FIG. 16G ) to determine if the catheter is properly seated for purposes of ablation; -
FIG. 16H is a fluoroscope image of the catheter ofFIG. 15A in a position for performing ablation in a proximal portion of the right pulmonary artery; -
FIG. 17A is a schematic diagram of the trunk of a pulmonary artery and identifying locations for ablation in a distal portion of a main pulmonary artery; -
FIG. 17B is a schematic diagram of a pulmonary artery trunk and identifying locations for ablation in proximal portions of the left and right pulmonary arteries; -
FIG. 18A is a schematic diagram of a pulmonary artery trunk identifying a position for ablation in a portion of the left pulmonary artery proximal to a pulmonary artery duct; -
FIG. 18B is a schematic diagram of points of ablation in the anterior wall of the ablation position identified inFIG. 18A ; -
FIG. 19A is a schematic diagram of a pulmonary artery trunk identifying a position for ablation in a proximal portion of the right pulmonary artery for treatment of unilateral chronic thrombotic embolism; -
FIG. 19B is an enlarged schematic diagram of the portion identified inFIG. 20A and indicating positions for ablation in the anterior wall of the proximal portion of the right pulmonary artery. - The following examples further illustrate embodiments of the present inventions, but should not be considered as to limit the present inventions. Without departing from the spirit and essence of the present inventions, modification or replacement of the method, steps or conditions of the embodiments disclosed below still falls in the scope of the present inventions.
- If not otherwise specified, the technical means used in the embodiments are conventional means well known by a person skilled in the art.
- Through the example below and with reference to
FIGS. 1-3 , some of the technical solutions that can be achieved by various embodiments are further described below. - In some embodiments, a multi-pole synchronous pulmonary artery radiofrequency ablation catheter for de-sympathetic in the pulmonary artery can include a
catheter body 1 that has a distal end and a proximal end. The distal end can be provided with aflexible end 3 and the proximal end can be provided with acontrol handle 2. A pull wire can extend in the catheter body. - Preferably, the catheter body can be made of a polymer material, which is a poor heat conductor, so that it can avoid transmitting or reduce the amount of heat transferred from the electrodes to the flowing blood contacting the catheter body, and thereby can better prevent the electrode from heating the blood flow.
- The
flexible end 3 can include a proximal end and a distal end. Anannular ring 4 can be arranged on the distal end. Theflexible end 3 can be soft relative to the rest of the catheter body. Theannular ring 4 can be provided with a plurality ofelectrodes 5, wherein eachelectrode 5 can be configured to sense or extract neural electrical signals, sense temperature and conduct ablation. Each of the electrodes can be connected to lead wires and temperature sensing wires, which extend through the catheter body to the control handle, thus is electrically connected to the control handle. One or more temperature sensing wires can be embedded under each electrode for precise monitoring of the temperature during ablation. Additionally, in some embodiments, the temperature sensing wires can be connected to a thermocouple connected to an inner facing side of theelectrodes 5, or can include integrated thermocouples. Other configurations can also be used. - A shape memory wire can be arranged in the
annular ring 4, and a distal end of the shape memory wire can extend to the distal end of theannular ring 4. The proximal end of the shape memory wire can be fixed to the distal end of the flexible end. The shape memory wire in theannular ring 4 can be preferably made of various shape memory alloys such as nickel-titanium alloy, stainless steel or titanium, with a diameter in the range of 0.25-0.5 mm. - The diameter of the annular ring is in the range of 12-40 mm. For example, the shape memory wire can be configured to bias the
annular ring 4 to a desired diameter, such as in the range of 12-40 mm. Additionally, in some embodiments, the pull wire can be used the change or adjust the diameter of theannular ring 4 through a range of diameters including 12-40 mm or other ranges. - The length of the flexible end can be in the range of 30-80 mm, and can be made of medical polymer materials such as fluorine, polyesters, polyurethane, polyamide and polyimide. A counterbore can be arranged on the distal end of the flexible end, the proximal end of the annular ring can be fixed in the counterbore, wherein the proximal end of the annular ring is a ground thin end.
- A pull wire can be embedded in the catheter body, and one end of the pull wire can be fixed to the control handle. The curvature of the flexible end can be controlled by operating the control handle. For example, one end of the pull wire can be fixed to a control button on the handle and the curvature of the flexible end can be controlled by operating the button. This allows the operator to control the handle with one hand and adjust the curvature of the flexible end easily, so that the
electrodes 5 on theannular ring 4 can be pressed into contract with the pulmonary artery and achieve acceptable ablation of pulmonary artery intima. - Furthermore, a counterbore can be made on the distal end of the
flexible end 3, and its depth can be set according to actual needs, preferably with a depth in the range of 2-8 mm. The proximal end of theannular ring 4 can be a ground thin end, and an outer diameter of the ground thin end fits an inner diameter of the counterbore. The ground-thin end can be inserted into theflexible end 3 and can be fixed to the distal end of theflexible end 3 by bonding, welding or other suitable means, preferably by UV-curing adhesive. The excess glue may be used to seal the distal end of theflexible end 3 and the proximal end of theannular ring 4. -
FIG. 1 shows a schematic structural diagram of multi-pole synchronous pulmonary artery radiofrequency ablation catheter. Theannular ring 4 can be arranged at the distal end of theflexible end 3. Theannular ring 4 can be an annular structure, the radius of theannular ring 4 can be effected with shape memory wire. - The
annular ring 4 can be provided with a plurality ofelectrodes 5. Eachelectrode 5 can be configured to extract or detect neural electrical signals, sense the temperature and conduct ablation. The number ofelectrodes 5 can vary from the range of 3 to 30, preferably 5 to 20. Theelectrodes 5 are made of platinum-iridium alloy, gold, stainless steel or nickel alloy. The electrode diameter can be generally 1.3-2.0 mm, and the length of theelectrode 5 can be generally in the range of 1.2-4 mm, more suitably 2-3.5 mm. Edge space between the adjacent electrodes suitably can be in the range of 0.5-10 mm, more suitably 1-5 mm. - The
pull wire 8 can be preferably made of stainless steel or nickel-titanium. As shown inFIG. 2 andFIG. 3 , the distal end of thepull wire 8 extends through ahollow cavity 9 to the proximal end of theannular ring 4, and can be fixed to the distal end of theflexible end 3. The method used for fixing thepull wire 8 to the distal end of theflexible end 3 can be any known method in the prior art. - Optionally, a groove can be arranged on the distal end of the
flexible end 3, and aconnector 11 can be arranged in the groove. One end of theconnector 11 can be connected to thepull wire 8 and the other end of theconnector 11 can be connected to theshape memory wire 12. Theconnector 3 can be fixed to the distal end of theflexible end 3 by injecting glue such as UV-curing adhesive into the groove. - A segment of
pull wire 8 extends in theflexible end 3 and a segment ofpull wire 8 extends in thecatheter body 1. The pull wire can be preferably jacketed with acoil spring 13, and thecoil spring 13 can be jacketed with aspring sleeve 14. Thespring sleeve 14 may be made of any suitable material, preferably a polyimide material. - The proximal end of the
pull wire 8 can be fixed on or in thecontrol handle 2, which can be provided with an adjustment apparatus, and the adjustment apparatus can be configured to adjust the curvature or the diameter of theannular ring 4. -
Lead wire 6, as shown inFIGS. 2 and 3 , extends through thelead wire cavity 10 to the lead wire cavity of theannular ring 4. The distal end of thelead wire 6 can be connected toelectrode 5. The distal end of thelead wire 6 can be fixed toelectrode 5 by welding. In some embodiments, the catheter includes onelead wire 6 for each of theelectrodes 5. - The distal end of the
temperature sensing wire 7 can be embedded under theelectrode 5 and the distal end of thetemperature sensing wire 7 can be fixed onelectrode 5 by bonding, welding or other suitable means. Thetemperature sensing wire 7 can extend into thecatheter body 1 in thelead wire cavity 10 of theflexible end 3 and then extend out from the control handle 2 and can be connected to a temperature control device. In some embodiments, the catheter includes onetemperature sensing wire 7 for each of theelectrodes 5. - When using the catheter, the
pull wire 8 can be operated through the control handle 2 in order to deflect theflexible end 3, thereby providing enhanced control for the user when positioning theannular ring 4 in a desired location, such as an orifice of the pulmonary artery. Then, with theelectrodes 5 fully contacting the pulmonary artery. At this time, theelectrodes 5 can be energized for performing ablation on pulmonary artery intima. - The multi-electrode design according to the some embodiments, can improve the efficacy and safety of ablation, achieve signal analysis and preferably simultaneous ablation by a plurality of electrodes. This can also improve target accuracy, achieve timely judgment of ablation effect and save operation time. For example, with the
annular ring 4 in a desired location, the electrodes can be individually activated to perform ablation at selected sites. This can be a benefit because in some methods of treatment described below, ablation can be performed at selected sites, less than the entire circumferential surface of certain anatomy. - A multi-pole synchronous pulmonary artery radiofrequency ablation catheter comprises a
control handle 2, acatheter body 1, and anannular ring 4. The control handle 2 can be provided with an adjustment apparatus, thecatheter body 1 can be hollow, and a cavity can be arranged in thecatheter body 1. One or morelead wires 6,temperature sensing wires 7 and apull wire 8 can be arranged in cavity. - One end of catheter body can be flexible, and the
flexible end 3 can be connected to theannular ring 4. The other end of the catheter body can be connected to thecontrol handle 2. One end of thepull wire 8 can be connected to theflexible end 3, and the other end of thepull wire 8 can be connected to the adjustment apparatus of the control handle, the adjustment apparatus adjusts the tension of thepull wire 3 to control the curvature of the flexible end. This allows the operator to control the handle with one hand and adjust the curvature of theflexible end 3 easily. Thereby theelectrodes 5 of theannular ring 4 can be pressed against to better contact an inner surface of a desired anatomy, such as a pulmonary artery, so as to enhance ablation of pulmonary artery intima. - A
shape memory wire 12 can be arranged in theannular ring 4. One end of theshape memory wire 12 can extend to the end of theannular ring 4, and the other end of theshape memory wire 12 goes through the root of theannular ring 4 and can be fixed on theflexible end 3 of the catheter body. - The
annular ring 4 can also be provided with an electrode group. Eachelectrode 5 can be connected to alead wire 6 and atemperature sensing wire 7 and can be configured to extract or detect the nerve electrical signals, sense the temperature and conduct ablation. Thelead wires 6 andtemperature sensing wires 7 can extend through thecatheter body 1 and can be electrically connected to thecontrol handle 2. The control handle 2 can be connected to an external temperature control device. - The
annular ring electrodes 5 can be made of a material selected from the group consisted of platinum-iridium alloy, gold, stainless steel and nickel alloy material, with the number in the range of 3-30, a diameter in the range of 1.3-2.0 mm, a length in the range of 1.2-4 mm and an edge space between adjacent electrodes in the range of 0.5-10 mm. - The
flexible end 3 of the catheter body can have a counterbore. An outer diameter of the root of theannular ring 4 can fit an inner diameter of the counterbore. The root of theannular ring 4 can be inserted into the counterbore and fixed. - The
flexible end 3 of the catheter body can be provided with a groove. Aconnector 11 can be arranged in the groove. One end of the connector can be connected to thepull wire 8 and the other end of the connector can be connected to theshape memory wire 12. - The shape memory wire can be made of shape memory alloy such as nickel titanium alloy, stainless steel or titanium, with a diameter in the range of 0.25-0.5 mm. The diameter of the
annular ring 4 can be in the range of 12-40 mm. Preferably, 10 electrodes are arranged on the annular ring, and the width of naked (exposed) side of electrodes can be 0.75 mm, and the space therebetween can be 5 mm. - The
flexible end 3 of the catheter body can be made of medical polymer materials such as fluorine, polyesters, polyurethane, polyamide and polyimide, with a length in the range of 30 mm to 80 mm. - The connection can be via UV-curing adhesive. The joint between the flexible end of the catheter body and the annular ring can be sealed. The pull wire can 8 be made of stainless steel or nickel-titanium alloy. The
pull wire 8 can be jacketed with acoil spring 13, and thecoil spring 13 can be jacketed with aspring sleeve 14 made of polyimide material. - Example 3 is similar to Example 1 and Example 2, and the differences can include an infusion tube arranged in the catheter body, a group of evenly distributed through holes 15 (
FIG. 4 ) arranged on one or more of theelectrodes 5, with a bore diameter of 1 μm. One end of the infusion tube can be connected to theelectrodes 5 through theannular ring 4 such that fluid diffuses out from the throughholes 15 on each of theelectrodes 5. For example, theannular ring 4 can include or define at least one lumen extending between a proximal end of theannular ring 4 and to the throughholes 15 so as to form a closed fluidic connection. In such embodiments, a distal end of the infusion tube can be connected to the proximal end of the lumen in theannular ring 4. The other end of the infusion tube can be connected to a transfusion system, such as a constant-flux pump or other known pumps. - When
electrodes 5 generates current, the liquid automatically diffuses from the through holes 15. The transfused liquid can be saline. The cold saline (4° C.) perfusion can help decrease local temperature. When the electrode generates current, the saline can automatically diffuse from the throughholes 15, and thus can allow the local temperature to be controlled to a desired temperature, such as to below 60° C. and thereby protect the vascular intima. -
FIG. 5 is a schematic diagram of a human heart and surrounding vasculature, which can be an environment in which the catheter ofFIGS. 1-4 can be used to perform ablation treatments such as, for example, but without limitation, denervation of the pulmonary artery. In some methods of treatment, access to the inner walls of the main pulmonary artery as well as the left and right pulmonary arteries can be achieved by passing a catheter, using well known techniques, into a femoral vein, upwardly into the inferior vena cava (lower left hand corner ofFIG. 5 ). The catheter can then be pushed upwards into the right atrium, down into the right ventricle, then up through the pulmonary semilunar valve into the trunk of the main pulmonary artery. As used herein, the term main pulmonary artery (MPA) includes the proximal end of the main pulmonary artery which is the furthest upstream end of the main pulmonary artery, at the pulmonary semilunar valve, up to the bifurcation of the main pulmonary artery. The distal portion of the MPA includes the portions of the MPA near the bifurcation of the MPA into the left and right pulmonary arteries (LPA, RPA). - Similarly, the proximal ends of the RPA and LPA are those ends of the LPA and RPA which are adjacent and connected to the distal end of the MPA. The distal direction along the LPA and RPA would be the downstream direction of blood flow through the LPA and RPA toward the left and right lungs, respectively.
- Thus, using well known techniques, a catheter can be used to provide access to the proximal and distal portions of the MPA as well as the proximal and distal portions of the LPA and RPA.
-
FIG. 6 is a schematic diagram of the “trunk” of the pulmonary artery. As used herein, the “trunk” of the MPA is intended to include at least the distal portion of the MPA and the proximal portions of the LPA and RPA.FIG. 6 also includes a schematic representation of a carina at the branch of the LPA and RPA from the MPA. - As described below, an aspect of at least some of the inventions disclosed herein includes the realization that the trunk of the pulmonary artery of certain animals, including canine and humans, can include concentrated bundles of sympathetic nerves extending from the MPA into the LPA and RPA. For example, it has been discovered that there are higher concentrations of sympathetic nerves on the anterior sides of the MPA and in particular, in the vicinity of the distal portion of the MPA. Additionally, it ahs been discovered that the sympathetic nerves bifurcate from this area of higher concentration into the anterior side of the proximal portions of the LPA and RPA. In the area of these proximal portions, it has also been discovered that higher concentrations of the sympathetic nerves extend upwardly and toward the posterior side of the LPA and RPA.
- Thus, in accordance with some of the inventions disclosed herein, ablation is performed in the distal portion of the MPA and the proximal portions of the LPA and RPA. In some embodiments ablation is preferentially performed on the anterior side of the inner walls of these structures. In some embodiments, ablation is performed preferentially on the anterior side of the proximal portion of the MPA and on the anterior side and an upper portion of the proximal portions of the LPA and RPA, such as at approximately the upper conjunctive site of the distal portion of the main pulmonary artery at the left and right pulmonary arteries. As such, high success rates of sympathetic nerve denervation can be achieved as well as high success rates of reduction or elimination of the symptoms of pulmonary hypertension.
- It is widely accepted that all vascular walls are regulated by sympathetical and parasympathetical nervous systems. Particularly, pulmonary vessels are known to be innervated by sensory nerve fibers. Previous studies have demonstrated that sympathetic noradrenergic innervation density along the pulmonary artery is highest at its proximal segments and then decreases toward the periphery, a typical finding that is different than arteries in other organs where highest innervation density is found at the level of the smallest arterioles. However, the conclusions of the above-noted study were based on procedures in which the identification of innervation in the pulmonary artery was mainly based on the stimulation of sympathetical nerves or equivalent methods, without direct evidence or other location of sympathetical nerve fibers. However, it has been discovered that some of the conclusions of the above-noted study are incorrect, through the use of techniques for identifying the presence and location of sympathetical nerves in the pulmonary artery using direct labeling techniques.
- In particular, experimental procedures were approved by the Institutional Animal Care and Use Committees of the Nanjing Medical University and were performed in accordance with the National Guide for the Care and Use of Laboratory Animals. Mongolia dogs (n=6, weight 7.8±1.2 kg) were obtained from the Nanjing Experimental Center (Nanjing, China). All animals were housed in a single room at 24° C. on a 12 h-light/12 h-dark cycle with fresh food and water.
- In this study, a dog was anesthetized with sodium pentobarbital (60 mg per kg, intraperitoneal injection). The chest was excised and opened carefully. The whole pulmonary artery was removed from the chest, with particular attention to avoid the injury of adventitia. In one dog, the pulmonary artery was longitudinally cut along the blood flow direction from the orifice of the main pulmonary artery (the proximal portion of the main pulmonary artery) toward the right and left branches. Then, a vernier focusing camera was used to take pictures in order to identify whether there is a visible difference in the surface of the pulmonary artery between different segments.
- With regard to five other dogs, connective tissue was manually dissected away from the pulmonary artery using fine microdissection scissors, under the guidance of stereomicroscope. During this procedure, great care was taken to avoid stripping off the adventitia and possible damage to the perivascular nerves. Vessels were stored at −70° for further staining.
- Frozen vessels were processed in paraffin wax and fixed in 4% paraformaldehyde for 30 minutes and then incubated at 0.5% Pontamine Sky Blue (Sigma-Aldrich, St. Louis, Mo.) in phosphate-buffered saline (PBS) for 30 minutes to reduce background fluorescence. This was followed by 1 hour at room temperature in a blocking solution of 4% normal goat serum/0.3% Triton X-100 in PBS, then overnight at 4° C. in blocking solution containing an affinity-purified polyclonal antibody against tyrosine hydroxylase (Temecula, Calif.). Vessel segments were then washed in PBS and incubated for 1 hour with secondary antibody (Invitrogen, Carlsbad, Calif.), washed again and positioned on a glass slide. Preparations remained immersed in PBS during image acquisition to maintain hydration and preserve vessel morphology.
- Based on previous studies, the sympathetical nerves were thought to be mainly localized at the proximal segment of the pulmonary artery. Thus the distal segment (5 mm in length) of the main pulmonary artery and proximal 5 mm segments of the right and left branches were selected for investigation in the present study.
FIG. 6 schematically illustrates, not to scale, a 5 mm segment of the distal portion of the MPA and 5 mm long proximal portions of the LPA and RPA. - Multiple transverse slices (2 μm of thickness) of the vessels were cut at 1.6 mm intervals, and are identified in the description set forth below in accordance with the labels of
FIG. 8 . Care was taken to keep the luminal morphology of slices consistent with the vessel contour, in order to precisely position the location of nerves. The slices were examined by a pathologist. - Images of each slices were recorded (magnification 40× to 200×) using stereomicroscope (Olympus), and the numbers of total sympathetical nerves bundles (SPNDs) per level were manually calculated. Then all images were input to Image Analysis Software (Image-proplus 5.0), to calculate the minor radius (μm), major radius (μm) and total surface area (TSA, μm2×103) area of axons.
- After the pulmonary artery was removed from the chest of the dog, the pulmonary artery was repeatedly cleaned with saline to clean away all blood on the surface of the vessel. Then the whole vessel was cut along the direction from the proximal portion of the main pulmonary artery up through the trunk and into the right and left branches. The above-noted pictures (
FIGS. 7A , 7B) showed that in the anterior wall of the main pulmonary artery, there was an obvious ridgy cystica close to the orifice of the left pulmonary artery. The site of the ridgy cystica felt rigid to the touch, compared to other areas of the pulmonary artery. - In the vicinity of the bifurcation portion of the pulmonary artery, segments 5-mm in length of the distal main pulmonary artery and the proximal portions of the right and left pulmonary arteries were studied. Four transverse slices (
thickness 2 μm, 1.6-mm intervals) from each segment were prepared for analysis. Each slice (“level”) was divided into 4 subsegments in the right and left pulmonary arteries and 6 subsegments in the main pulmonary artery along the counterclockwise direction (FIG. 9 ). - Upon inspection of these samples, it was observed that more SPNDs were identified in the posterior wall in both the left and right pulmonary arteries (
FIG. 10A ). However the number of SPNDs was 1.6±0.2 in the S1 subsegment of the A5 level in the left pulmonary artery branch, significantly different from 1.2±0.2 in the S1 subsegment of level A1 in the right pulmonary artery (p=0.033). In contrast, more SPNDs were labeled in the anterior wall (S6) of the main pulmonary artery (FIG. 11 ) and decreased gradually from the levels A9 to A12. - The minor and major radius of sympathetical axons in the main pulmonary artery were 85±2 μm and 175±14 μm, compared to 65±3 μm and 105±12 μm in the left pulmonary artery or 51±2 μm and 86±8 μm in the right pulmonary artery, respectively, resulting in significant differences in surface area of axons between the main pulmonary artery and the LPA and RPA (
FIG. 9 ). - Based on the results of the above-described observations, it has been determined that in canines, sympathetical nerves are distributed in higher concentrations along the anterior wall of the main pulmonary artery, then extend into the left and right pulmonary arteries, then extend upwardly and then toward the posterior walls of the left and right pulmonary arteries, as schematically represented in
FIGS. 12 and 13 . - Further, inspection of subsegment S6 in level A9 (
FIG. 11 ) of the MPA (magnification 200×) revealed that a bundle or main bundle of sympathetical nerves originate from approximately the middle of the anterior wall of the distal portion of the main pulmonary artery and that this main bundle is bifurcated to the left and right pulmonary arteries. - This discovery provides a basis for more effective denervation of the pulmonary artery. For example, by selectively ablating only portions of the main pulmonary artery and the left and right pulmonary arteries, a higher success rate of denervation can be achieved with less unnecessary tissue damage. Such denervation can provide significant benefits in the treatment of diseases such as pulmonary hypertension, as described below.
- With regard to the disease of pulmonary hypertension, it is well known that the lung receives axons from principal sympathetic neurons residing in the middle and inferior cervical and the first five thoracic ganglia (including the stellate ganglion), and the vasculature is the major sympathetic target in the lung. Sympathetic nerve stimulation increases pulmonary vascular resistance and decreases compliance, which is mediated by noradrenaline via a-adrenoreceptors, primarily of the a1-subtype.
- Previous studies have confirmed the multiplicity of transmitters released from one nerve ending which might explain why pharmacological blockade of the “classical” transmitter alone does not effectively abolish the effects elicited by nerve stimulation. The present study explained above supports the concept that more successful sympathetical denervation along the pulmonary trunk can be enhanced at the proximal segments of the left and right pulmonary arteries rather than at the distal basal trunks. Further, percutaneous pulmonary denervation (PADN) has potential for decreasing pulmonary pressure and resistance induced by unilateral balloon occlusion in the interlobar artery. However, until now, there was a lack of data showing the distribution of sympathetical nerves in the pulmonary trunk. Thus, the accurate identification of the position of sympathetical nerves is important for performing a successful PADN procedure. In the present study, significantly larger bundles of sympathetical nerves were identified in the mid-anterior wall of the distal portion of the main pulmonary artery, which is bifurcated into the posterior wall of the left and right pulmonary arteries. These results imply that one or more ablation procedures, for example, by PADN, especially around the distal portion of the main pulmonary bifurcation and the proximal portions of the LPA and RPA are more likely to provide enhanced results and more successful denervation, as was suggested in the animal study noted above.
- It is noted that sympathetic noradrenergic innervation density is highest at the large extra-pulmonary and hilar blood vessels, both arteries and veins and then decreases toward the periphery. This is in marked contrast to many other organs, in which the highest innervation density is found at the level of the smallest arterioles. Such distribution varies from species to species with regard to the extent to which the sympathetic noradrenergic axons reach into the lung. In guinea pigs, rabbits, sheep, cats, dogs, and humans, small arteries down to 50 μm in diameter are innervated, whereas in rats, mice, hedgehogs, and badgers, noradrenergic innervation stops close to the lung.
- An extensive network of noradrenergic and NPY-containing fibers has been noted around pulmonary arteries of several species, but only a few studies used double-labeling techniques to evaluate the extent of colocalization. In the guinea pig, principally all noradrenergic fibers innervating pulmonary arteries and veins contain NPY and, in addition, dynorphin, a neuropeptide of the opioid family. In this aspect, pulmonary vascular innervation differs markedly from that of skin arteries in the same species, wherein three different combinations of noradrenaline, NPY, and dynorphin are used by sympathetic axons. Each of these populations is restricted to a specific segment of the arterial tree in the skin. Still, noradrenergic and NPY-containing fibers do not match 1:1 in the lung either, as there is a minor population of axons innervating guinea pig pulmonary arteries and veins that contains NPY plus vasoactive intestinal peptide (VIP) but not noradrenaline. It remains to be clarified whether this less-frequent fiber population represents the non-noradrenergic neurons projecting to the guinea pig lung or originates from other systems.
- The present study explained above, which relied on the serial slicing at various levels through the pulmonary artery trunk demonstrates that larger bundles of nerves are more localized in the anterior wall of the main pulmonary artery and then bifurcate into the left and right pulmonary arteries along the posterior walls of the LPA and RPA. The above study was performed on canine anatomy.
- One of the diseases that can be treated with the present methods and devices is idiopathic pulmonary arterial hypertension (IPAH). IPAH is characterized by elevations of mean pulmonary artery pressure (PAP) and pulmonary vascular resistance (PVR). The pathogenesis of IPAH was believed to be due to imbalance between locally produced vasodilators and vasoconstrictors. Recent studies have demonstrated that vascular wall remodeling also contributed to elevated PVR. The role of neural reflex in the mediation and development of IPAH has not been specifically investigated. In 1961, Osorio et al. reported the existence of a pulmo-pulmonary baroreceptor reflex that originates in the large pulmonary branches, with neither the afferent nor efferent fibers belonging to the vagus nerve. In 1980, these findings were again confirmed by Jurastch et al. and Baylen et al. More recently, the present animal study described above demonstrates that pulmonary arterial denervation (PADN) can reduce or completely abolish elevations of PAP induced by balloon occlusion at interlobar segments, but not at the basal trunk.
- In a further phase of the present study, a human study was conducted. Prior to enrollment, all 21 patients received a diuretic (hydrochlorothiazide at a dose of 12.5 mg to 25 mg, once daily, and/or spironolactone at a dose of 20 mg to 40 mg, once daily) and beraprost (120 mg, 4 times daily) (Table 1), with either sildenafil (20 mg, 3 times a day) or bosentan (120 mg, twice daily) or digoxin (0.125 mg, once daily). Functional capacity of the patients was determined by a 6-minute walk test (6MWT), followed by an assessment of dyspnea using the Borg scale. The 6MWT was performed at 1 week, 1 month, 2 months, and 3 months following the PADN procedure. The WHO classification at rest and during exercise was recorded by a physician who was blinded to the study design.
- Echocardiography was performed at 1 week, 1 month, 2 months, and 3 months following the procedure. Echocardiographic studies were done using a
Vivid 7 ultrasound system with a standard imaging transducer (General Electric Co., Easton Turnpike, Conn., US). All of the echocardiograms were performed and interpreted in the Medical University Echocardiographic Laboratory. All of the measurements were performed following the recommendations of the American Society of Echocardiography. Digital echocardiographic data that contained a minimum of 3 consecutive beats (or 5 beats in cases of atrial fibrillation) were acquired and stored. RV systolic pressure is equal to systolic PAP in the absence of pulmonary stenosis. Systolic PAP is equal to the sum of right atrial (RA) pressure and the RV to RA pressure gradient during systole. RA pressure was estimated based on the echocardiographic features of the inferior vena cava and assigned a standard value. The RV to RA pressure gradient was calculated as 4vt 2 using the modified Bernoulli equation, where vt is the velocity of the tricuspid regurgitation jet in m/s. The mean PAP was estimated according to the velocity of the pulmonary regurgitation jet in m/s. The tricuspid excursion index (TEI) is defined as (A−B)/B, where A is the time interval between the end and the onset of tricuspid annular diastolic velocity, and B is the duration of tricuspid annular systolic velocity (or the RV ejection time). PA compliance for patients was calculated as stroke volume divided by pulse pressure (systolic PAP minus diastolic PAP). - Hemodynamic measurements and blood oxygen pressure/saturation determinations from the RA, RV, and PA were done prior to and immediately after the PADN procedure. These measurements were repeated at 24 hours and 3 months.
- A 7F flow-directed Swan-Ganz catheter (131HF7, Baxter Healthcare Corp., Irvine, Calif.) was inserted into an internal jugular or subclavian vein. Measurements of resting RA pressure, RV pressure, systolic/diastolic/mean PAP, pulmonary artery occlusive pressure (PAOP), cardiac output (CO) (using thermodilution method), and mixed venous oxygen saturation were recorded. The PVR [=(mean PAP−PAOP)/CO] and trans-pulmonary gradient (TPG=mean PAP−PAOP) were then calculated. All of the measurements were recorded at the end of expiration. Five criteria were used to evaluate if a PAOP measurement was valid: (1) the PAOP was less than the diastolic PAP; (2) the tracing was comparable to the atrial pressure waveform; (3) the fluoroscopic image exhibited a stationary catheter following inflation; (4) free flow was present within the catheter (flush test); and (5) highly oxygenated blood (capillary) was obtained from the distal portion in the occlusion position. If the PAOP measurement was unreliable, the left ventricular end-diastolic pressure was then measured and used rather than the PAOP. The blood samples from the SVC and pulmonary artery were obtained for the measurements of oxygen pressure and saturation. Particularly significant reductions in systolic and mean PAP were achieved using temperatures above 50° C., drawing an electrical load of 8-10 W for a duration of 60-120 s, for example as shown in
FIG. 14B . - The PADN procedure was performed with a dedicated 7.5F multiple-function (temperature-sensor and ablation) catheter which comprised two parts, a
catheter shaft 3 and handle 2 (FIG. 15A ) which is an embodiment of the catheter illustrated inFIGS. 1-4 . The catheter ofFIG. 15A had a tapered (to 5F)annular ring 4 with 10 pre-mounted electrodes 5 (E1-E10) each separated by 2 mm, however, other spacings can also be used. For purposes of the description set forth below, theelectrodes 5 have been numbered, as shown inFIG. 15B , with thedistal-most electrode 5 identified as electrode E1 and theproximal-most electrode 5 identified as electrode E10. - As described above with reference to
FIGS. 1-4 , theannular ring 4 or (“circular tip”) can be constructed so as to be biased into a circular shape, such as the circular shape illustrated inFIG. 15B andFIG. 1 to have any desired outer diameter. For example, in various embodiments, theannular ring 4 can be configured to be biased into a circular shape having an outer diameter of 20 mm, 25 mm, 30 mm, 35 mm, 40 mm, 45 mm, or other diameters. Additionally, a kit containing the catheter ofFIG. 1 can include a plurality of differentannular rings 4 configured to be biased to a plurality of different outer diameters, such as those noted above, or other diameters. - A controller or “connect box” can be connected to the
handle 2 of the catheter for providing ablation energy. For example, anablation controller 100 can be configured to provide ablation energy to each of the electrodes E1-E10. Thus, in some embodiments, thecontroller 100 includes aselector knob 102 configured to allow a user to select activation of all the electrodes E1-E10, or selective actuation of individual ones of the electrodes E1-E10, one at a time. - Thus, in some embodiments, as illustrated in
FIG. 15D , theselector knob 102 includes aposition indicator 104 which, by rotating theknob 102 can be aligned with indicia corresponding to the electrodes E1-E10. In the illustrated embodiment, the indicia on thecontroller 100 includes the numbers 1-10 as well as a position identified as “OFF” and a position identified as “NULL.” In some embodiments, theconnect cable 106 can include a plurality of wires, for example, ten wires which correspond to thelead wire 6 described above with reference toFIGS. 1-4 , each one of which is individually connected to respective electrodes E1-E10. - The
controller 100 can include a physical switch for creating an electrical connection between a source of RF energy and a desired one of the electrodes E1-E10. An electrode (not shown) can be directly connected to theknob 102 with additional contacts (not shown) disposed around the electrode at approximately the positions identified as 1 through 10 on thecontroller 100. Thus, rotation of theknob 102 will connect an internal electrode (not shown) with the contacts aligned with each one of the positions 1-10. - The
controller 100 can be configured to provide the desired amount of ablation energy when a circuit is created by the alignment of theposition indicator 104 with the corresponding position (1 through 10) on thecontroller 100 thereby delivering electrical energy to the selected one of the electrodes E1-E10 causing electrical energy to pass through the selectedelectrode 5 into any conductive material in contact with that selected electrode. - For example, during a PADN procedure, the electrodes E1-E10 can be in contact with an inner wall of the pulmonary artery trunk thereby allowing electrical energy from one of the electrodes E1-E10 to flow through the tissue of the inner wall of the pulmonary artery, described in greater detail below.
- In some embodiments, with continued reference to
FIG. 15D , thecontroller 100 can include a plurality of ports. For example, thecontroller 100 can include acatheter port 120, which can be configured for creating a fluidic connection to the annular ring for purposes of providing a flow of saline to theannular ring 4. Thecontroller 100 can also include anRF port 122 configured to connect to any known radiofrequency generator used with regard to ablation procedures. - Additionally, the
controller 100 can include an “ECG”port 124 configured for connection with standard ECG monitoring equipment. Thus, in some embodiments, theconnect cable 106 can also include wires or conduits for transmitting data through theRF port 124. - Thus, in some configurations, the
RF port 122 can be connected to a source of RF energy (not shown). One or more wires (not shown) can connect theport 122 to a contact on the end of an electrode connected to theselector knob 102. Additionally, the ten wires (not shown) can be configured to deliver RF electrical energy to the electrodes E1-E10 each of which can each be connected to contacts (not shown) associated with the selector positions 1-10 disposed around the periphery of theselector knob 102. - Thus, the electrode connected to the
rotating selector knob 102 cab be moved into contact with the electrical contacts associated with each of the positions 1-10 thereby creating a circuit connecting the electrical energy entering thecontroller 100 through theport 122 with the associatedlead wire 6 for conducting electrical energy to the desired electrode E1-E10. - Thus, specifically, when the
selector knob 102 is turned such that theposition indicator 104 is aligned withposition 1 on thecontroller 100, electrical energy from theRF port 122 is conducted through an associatedlead wire 6 to the electrode E1. Aligning theindicator 104 with the other positions on thecontroller 100 would conduct electrical energy to the other electrodes associated with those other positions. - In some embodiments, a method for treating pulmonary hypertension can include a step of identifying the position of the pulmonary trunk of the patient using angiography. For example, baseline pulmonary artery angiography can be performed to identify the position of the pulmonary artery bifurcation from the main pulmonary artery into the left and right pulmonary arteries.
- Additionally, the baseline pulmonary artery angiography can be used to determine the diameter of the portions of the pulmonary artery trunk upon which ablation is desired. As such, the appropriate diameter of the
annular ring 4 can be determined based on the determined diameters of the pulmonary artery trunk noted above. For example, in some embodiments, anannular ring 4 having a biased diameter slightly larger than the diameters of the targeted anatomy can be used so as to enhance the contact between theelectrodes 5 and the inner surface of the targeted anatomy. As such, for example, when theannular ring 4 is moved out of a sheath and allowed to expand into its biased circumferential configuration which has an outer diameter slightly larger than the inner diameter of the targeted portions of the pulmonary artery trunk, the bias of theannular ring 4 will assist in pressing theelectrodes 5 into contact with the targeted tissue. - In some embodiments, with reference to
FIGS. 16A-16H , a method can include a step of positioning a catheter in a pulmonary artery trunk. For example, an 8F long sheath can be inserted through the femoral vein and advanced to the main pulmonary artery, as shown inFIG. 16A . A PADN catheter, such as the catheter illustrated inFIG. 1 andFIGS. 15A-15E can be advanced along the sheath shown inFIG. 16A to the location of the pulmonary artery trunk. - With the distal end of the catheter maintained in place, the sheath can be withdrawn. It may be necessary to push on the catheter to maintain its position with the portion of the catheter forming the
annular ring 4 held within the pulmonary artery trunk. - As the
annular ring 4 is released from the sheath, as illustrated inFIG. 16B , theannular ring 4 can adopt the shape and diameter to which it is biased. - By slightly rotating and pushing the
handle 2 in a clockwise direction, theannular ring 4 can be positioned at the proximal portion of the left pulmonary artery, such as at the ostium. In some embodiments, this initial position can be within a range of approximately five mm from the orifice of the left pulmonary artery or within a range of two millimeters, as illustrated inFIG. 16D . - By observing the orientation of the
annular ring 4, the desired one or plurality of the electrodes E1-E10 can be selectively energized so as to perform ablation at the desired location on the interior surface of the left pulmonary artery. For example, in some embodiments, it may be more effective to selectively ablate the posterior wall of the left pulmonary artery, so as to achieve at least some sympathetic denervation of the left pulmonary artery and the proximal portion thereof, such as within two or five millimeters of the ostium of the left pulmonary artery. - The
annular ring 4 can then be rotated, such as in the counterclockwise direction, by rotating and withdrawing thehandle 2 in order to reposition theannular ring 4 into the distal portion of the main pulmonary artery such as at the bifurcation area. For example, in some embodiments, as illustrated inFIG. 16E , theannular ring 4 can be positioned within about 5 mm of the bifurcation in the pulmonary artery trunk. Optionally, theannular ring 4 can be positioned within about 5 mm of the bifurcation in the pulmonary artery trunk. Ablation can then be performed using the desired one or plurality of the electrodes E1-E10. - For example, positioned as such, the selected one or plurality of electrodes E1-E10 can be energized to achieve the desired sympathetic denervation of the distal portion of the main pulmonary artery. In some embodiments, it may be desirable to perform ablation preferentially on the anterior wall of the distal portion of the main pulmonary artery.
- Additionally, further rotating and pushing the
handle 2 can be performed until theannular ring 4 is positioned in the proximal portion of the right pulmonary artery, such as at the ostium. In some embodiments, this position can be within 5 mm of the ostium of the right pulmonary artery. Further, in some embodiments, this position can be within 2 mm of the ostium of the right pulmonary artery. - With the
annular ring 4 positioned as such, the desired one or plurality of electrodes E1-E10 can be energized so as to achieve at least some sympathetic denervation in the proximal portion of the right pulmonary artery. For example, in some embodiments, it may be beneficial to focus on the posterior wall of the right pulmonary artery. - In some embodiments, a method for treating pulmonary hypertension can also include a step of confirming the appropriate contact between the electrodes E1-E10 and the endovascular surface corresponding to the three positions noted above. For example, in some embodiments, such confirmation can be performed by determining if there is strong manual resistance when attempting to rotate the
handle 2. Additionally, it can be determined if theannular ring 4 cannot be advanced distally, resulting in the deformation of the catheter as illustrated inFIG. 16G or if there is ease in withdrawing proximally, resulting in the deformation of the catheter illustrated in 16H. Additionally, confirmation can be performed using angiographic confirmation. - When the appropriate contact has been confirmed with the
annular ring 4 is positioned as desired such as in the positions illustrated inFIGS. 16D , 16E and 16F, at least one of the electrodes E1-E10 can be energized so as to perform ablation. For example, in some embodiments, a method for treating pulmonary hypertension can include the sequential energization of each of the electrodes E1-E10. - Additionally, in some embodiments, a method for treating pulmonary hypertension or for performing pulmonary denervation can include the step of repositioning the
annular ring 4 so as to shift the location of the electrodes E1-E10 and then repeating energization of all of the electrodes E1-E10. As such, a more complete denervation of the entire inner surface of the associated vessel can be achieved. - In some embodiments, any desired energy levels or temperatures can be used for performing ablation using the electrodes E1-E10 noted above. For example, in some embodiments, ablation can be performed at temperatures above 50° C., drawing an electrical load of 8-10 W for a duration of 60-120 s. Additionally, in some embodiments, a method of treatment of pulmonary hypertension or a method of sympathetic denervation of the pulmonary artery can be performed with a patient anesthetized but conscious. Thus, any ablation procedure can be stopped if the patient complained of intolerable chest pain.
- In some embodiments, EKG and hemodynamic pressure can be monitored and continuously recorded throughout the method. In a study performed in accordance with the description noted above, success was defined as a reduction in the mean PAP≧10 mmHg (as measured by the Swan-Ganz catheter). During the study, there were no complications. Additionally, the patients were monitored in the CCU for at least 24 hours after the PADN procedure was performed.
- For example, in some embodiments of methods disclosed herein, a dedicated 7.5 F triple-function catheter (A) can be used, which can include a tapered (to 5F)
annular ring 4 with 10 electrodes (each has 0.75 mm electrode-width and is separated by 2-mm, B), pre-mounted. Electrodes are connected with a connect-cable 106 and a connect-box/controller 100. There are 10 positions of the knob 102 (FIG. 15D ) on the surface ofcontroller 100, and each is associated with one of the electrodes E1-E10 on theannular ring 4 of the ablation catheter. Sequential ablation can be performed by turning theknob 102 as desired after the whole system is set up. - In some embodiments of methods for performing pulmonary artery denervation or methods for treating primary PAH ablation of the distal portion of the main pulmonary artery can be performed preferentially on the anterior side thereof. For example, in some embodiments, as shown in
FIG. 17A , ablation can be performed at the positions identified as M1, M2, M3, M4, and M5. - With a continued reference to
FIG. 17A , the position identified as M1 is at the “6 o'clock” position in the distal portion of the main pulmonary artery. The positions identified as M3 and M5 are the sites where the anterior wall of the main pulmonary artery connects to the left and right pulmonary arteries, respectively. The positions identified as M2 and M4 correspond to the “5 o'clock” and the “7 o'clock” positions on the anterior side of the distal portion of the main pulmonary artery. - In some embodiments, with reference to
FIG. 17B , sympathetic denervation in the left and right pulmonary arteries can be performed, preferentially, at approximately the middle of the anterior wall of the proximal portion of the left pulmonary artery (L1) and at approximately the upper conjunctive site of the distal portion of the main pulmonary artery in the left pulmonary artery (L2). - Similarly, during a method of performing pulmonary denervation of the right pulmonary artery, ablation can be preferentially performed at a point approximately at the middle anterior wall of the proximal portion of the right pulmonary artery (L3) and at approximately the upper conjunctive site of the distal portion of the main pulmonary artery and the right pulmonary artery (L4).
- In some embodiments, sympathetic denervation can be performed, for example, for treatment of pulmonary hypertension associated with a pulmonary duct artery (PDA). For example, a pulmonary duct artery usually connects the descending aorta with the left pulmonary artery, as shown in
FIG. 4A . With this anatomy, the left pulmonary artery can be significantly larger than the right pulmonary artery. - Thus, in some embodiments, ablation can be performed at a position proximal to connection between the left pulmonary artery and the pulmonary duct artery, identified as “Level A” in
FIG. 18A . Thus, using the technique described above with reference toFIGS. 16A-16H , theannular ring 4 can be positioned at a position corresponding to Level A ofFIG. 18B . Ablation can then be performed around part or all of the interior wall of the left pulmonary artery at that location. - In some embodiments, ablation can be preferentially performed on the anterior wall of the left pulmonary artery proximal to the proximal end of the pulmonary duct artery. For example, ablation can be performed at four or more sites, such as those identified as sites L1, L2, L3, L4. As illustrated in
FIG. 18B , position L1 corresponds to “12 o'clock”, position L2 corresponds to “2 o'clock”, position L3 corresponds to “3 o'clock”, and position L4 corresponds to “6 o'clock.” Other positions can also be used. - Additionally, in some embodiments, ablation can also be performed at positions M1-M5 illustrated in
FIG. 17A and positions L1-L4 ofFIG. 17B . - In some embodiments, a method for sympathetic denervation can be used for treating pulmonary hypertension resulting from unilateral chronic thrombotic embolism. For example, a patient suffering from unilateral CTEH can have an occluded right pulmonary artery. For example, in some patients, the RPA can be significantly enlarged as illustrated on the left side of
FIG. 19A . Similarly to the method described above with reference toFIG. 18B , ablation can be performed at the position identified as “Level B” inFIG. 19A . Ablation can be performed at one or a plurality of locations along the inner surface of the right pulmonary artery at the position of Level B, or other positions. Additionally, ablation can be preferentially performed on a plurality of points along the anterior wall of the right pulmonary artery at the position of Level B. - For example, the positions identified in
FIG. 20B can be considered such as position L1 corresponding to “12 o'clock”, position L2 corresponding to “2 o'clock”, position L3 corresponding to “3 o'clock”, and position L4 corresponding to “6 o'clock.” Additionally, in some embodiments, ablation can also be performed at positions M1-M5 illustrated inFIG. 17A and positions L1 and L2 illustrated inFIG. 17B . - As used herein, the term “animal” is intended to include human beings and other animals such canines, other mammals, etc. As used herein, the terms “live”, “living”, “live animal” are intended to exclude methods of euthanasia, surgery performed on dead animals including dissection and autopsies, or other techniques for disposing of dead bodies.
- While at least a plurality of different embodiments are disclosed herein, it should be appreciated that a vast number of variations exist. It should also be appreciated that the embodiments described herein are not intended to limit the scope, applicability, or configuration of the claimed subject matter in any way. Rather, the foregoing detailed description will provide those skilled in the art with a convenient road map for implementing the described embodiments. It should be understood that various changes can be made in the function and arrangement of elements or steps without departing from the scope defined by the claims, which includes known equivalents and foreseeable equivalents at the time of filing this patent application.
Claims (17)
1. A multi-pole synchronous pulmonary artery radiofrequency ablation catheter, comprising:
a control handle including an adjustment apparatus;
a catheter body being hollow and comprising a cavity arranged in the catheter body; and
an annular ring;
wherein a lead wire, a temperature sensing wire and a pull wire are arranged in the cavity;
wherein one end of the catheter body is flexible, and the flexible end is connected to the annular ring, and wherein the other end of the catheter body is connected to the control handle;
wherein one end of the pull wire is connected to the flexible end, and the other end of the pull wire is connected to the adjustment apparatus on the control handle, the adjustment apparatus adjusts the tension of the pull wire to change a curvature of the flexible end;
a shape memory wire arranged in the annular ring, and one end of the shape memory wire extends to the end of the annular ring and the other end of the shape memory wire passes through the root of the annular ring and is fixed on the flexible end of the catheter body;
wherein the annular ring is provided with an electrode group comprising a plurality of electrodes, and each electrode of the electrode group is connected to the lead wire and temperature sensing wire;
wherein the lead wire and the temperature sensing wire go through the catheter body and are electrically connected to the control handle.
2. The multi-pole synchronous pulmonary artery radiofrequency ablation catheter according to claim 1 , wherein an infusion tube is arranged in the cavity of the catheter body and a through hole is arranged on the electrode, the infusion tube extending through the annular ring and connected to the electrode such that transfused fluid flows out from the through hole.
3. The multi-pole synchronous pulmonary artery radiofrequency ablation catheter according to claim 1 , wherein the electrode on the annular ring is made of a material selected from the group consisted of platinum-iridium alloy, gold, stainless steel and nickel alloy, with a number in the range of 3-30 electrodes, an electrode diameter in the range of 1.3-2.0 mm, a length in the range of 1.2-4 mm and an edge space between adjacent electrodes in the range of 0.5-10 mm.
4. The multi-pole synchronous pulmonary artery radiofrequency ablation catheter according to claim 1 , wherein, the flexible end of the catheter body is provided with a counterbore, an inner diameter of the counterbore fits around an outer diameter of root of the annular ring, the root of the annular ring is inserted and fixed in the counterbore.
5. The multi-pole synchronous pulmonary artery radiofrequency ablation catheter according to claim 1 , wherein the flexible end includes a groove, a connector is disposed in the groove, wherein one end of the connector is connected to the pull wire and the other end of the connector is connected to the shape memory wire.
6. The multi-pole synchronous pulmonary artery radiofrequency ablation catheter according to claim 1 , wherein the material of the shape memory wire is a shape memory alloy selected from the group consisted of nickel titanium alloy, stainless steel and titanium, with a diameter in the range of 0.25-0.5 mm, the diameter of the annular ring being in the range of 12-40 mm.
7. The multi-pole synchronous pulmonary artery radiofrequency ablation catheter according to claim 1 , wherein the flexible end of the catheter body is made of medical polymer materials with a length in the range of 30-80 mm.
8. The multi-pole synchronous pulmonary artery radiofrequency ablation catheter according to claim 1 , wherein the connector is connected with a UV-curing adhesive.
9. The multi-pole synchronous pulmonary artery radiofrequency ablation catheter according to claim 1 , wherein the joint between the flexible end of the catheter body and the annular ring is sealed.
10. The multi-pole synchronous pulmonary artery radiofrequency ablation catheter according to claim 1 , wherein the pull wire is made of stainless steel or nickel-titanium alloy, the pull wire including a coil spring, the coil spring includes a spring sleeve made of a polyimide material.
11. The multi-pole synchronous pulmonary artery radiofrequency ablation catheter according to claim 1 , wherein the shape memory wire is configured to bias the annular ring into a circumferential configuration with exposed surfaces of the electrodes facing radially outwardly.
12. A multi-pole pulmonary artery radiofrequency ablation catheter, comprising:
a catheter body including a handle;
a lumen member having a proximal end connected to the catheter body and a distal end;
an electrode assembly having a proximal end connected to the distal end of the lumen member, the electrode assembly comprising a longitudinally extending flexible lumen member and a plurality of ablation electrodes disposed along the flexible lumen member, each electrode having a surface exposed at an outer surface of the flexible lumen member, the flexible lumen member being biased into a circumferentially extending configuration wherein exposed surfaces of the electrodes face a radially outward direction when the flexible lumen member is in the circumferentially extending configuration.
13. The catheter according to claim 12 , additionally comprising an electrical connection having a proximal portion in the handle and extending from the handle to each of the plurality electrodes and configured to allow energy applied to the proximal portion of the electrical connection to be independently applied to each of the electrodes.
14. The catheter according to claim 13 , wherein the electrodes are separated and electrically isolated from each other.
15. The catheter according to claim 14 , wherein the electrical connection comprises a plurality of electrical wires connected to the electrode, respectively.
16. The catheter according to claim 12 , wherein each electrode further comprises a plurality of through holes and wherein the flexible lumen member includes at least one lumen extending from the proximal end of the flexible lumen member to the through holes on each of the electrodes thereby forming a fluidic connection from the proximal portion of the flexible lumen member to the through holes.
17-48. (canceled)
Priority Applications (9)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US14/530,588 US20150057599A1 (en) | 2012-11-13 | 2014-10-31 | Pulmonary artery ablation catheter |
US14/666,214 US9827036B2 (en) | 2012-11-13 | 2015-03-23 | Multi-pole synchronous pulmonary artery radiofrequency ablation catheter |
US14/672,021 US9872720B2 (en) | 2012-11-13 | 2015-03-27 | Multi-pole synchronous pulmonary artery radiofrequency ablation catheter |
US14/672,010 US9820800B2 (en) | 2012-11-13 | 2015-03-27 | Multi-pole synchronous pulmonary artery radiofrequency ablation catheter |
US14/672,013 US9918776B2 (en) | 2012-11-13 | 2015-03-27 | Multi-pole synchronous pulmonary artery radiofrequency ablation catheter |
US15/228,358 US10874454B2 (en) | 2012-11-13 | 2016-08-04 | Multi-pole synchronous pulmonary artery radiofrequency ablation catheter |
US15/873,721 US11241267B2 (en) | 2012-11-13 | 2018-01-17 | Multi-pole synchronous pulmonary artery radiofrequency ablation catheter |
US17/357,720 US20210338305A1 (en) | 2012-11-13 | 2021-06-24 | Multi-pole synchronous pulmonary artery radiofrequency ablation catheter |
US18/203,726 US20230380881A1 (en) | 2012-11-13 | 2023-05-31 | Multi-pole synchronous pulmonary artery radiofrequency ablation catheter |
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN2012104534704A CN102908191A (en) | 2012-11-13 | 2012-11-13 | Multipolar synchronous pulmonary artery radiofrequency ablation catheter |
CN201210453470.4 | 2012-11-13 | ||
CN201310103141.1A CN103142304B (en) | 2012-11-13 | 2013-03-27 | The synchronous pulmonary artery radio frequency ablation catheter of multipole |
CN201310103141.1 | 2013-03-27 |
Related Child Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US14/530,588 Continuation-In-Part US20150057599A1 (en) | 2012-11-13 | 2014-10-31 | Pulmonary artery ablation catheter |
US14/530,588 Continuation US20150057599A1 (en) | 2012-11-13 | 2014-10-31 | Pulmonary artery ablation catheter |
Publications (1)
Publication Number | Publication Date |
---|---|
US20140180277A1 true US20140180277A1 (en) | 2014-06-26 |
Family
ID=47606938
Family Applications (3)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US14/079,230 Abandoned US20140180277A1 (en) | 2012-11-13 | 2013-11-13 | Multi-pole synchronous pulmonary artery radiofrequency ablation catheter |
US14/530,588 Abandoned US20150057599A1 (en) | 2012-11-13 | 2014-10-31 | Pulmonary artery ablation catheter |
US15/228,358 Active 2036-04-24 US10874454B2 (en) | 2012-11-13 | 2016-08-04 | Multi-pole synchronous pulmonary artery radiofrequency ablation catheter |
Family Applications After (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US14/530,588 Abandoned US20150057599A1 (en) | 2012-11-13 | 2014-10-31 | Pulmonary artery ablation catheter |
US15/228,358 Active 2036-04-24 US10874454B2 (en) | 2012-11-13 | 2016-08-04 | Multi-pole synchronous pulmonary artery radiofrequency ablation catheter |
Country Status (8)
Country | Link |
---|---|
US (3) | US20140180277A1 (en) |
EP (1) | EP2910213B1 (en) |
JP (1) | JP6054415B2 (en) |
KR (1) | KR101640329B1 (en) |
CN (2) | CN102908191A (en) |
BR (1) | BR112014007594B1 (en) |
RU (1) | RU2587945C9 (en) |
WO (1) | WO2014075415A1 (en) |
Cited By (15)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20140213918A1 (en) * | 2013-01-29 | 2014-07-31 | St. Jude Medical, Cardiology Division, Inc. | Tissue sensing device for sutureless valve selection |
US20150305807A1 (en) * | 2014-04-24 | 2015-10-29 | Medtronic Ardian Luxembourg S.A.R.L. | Neuromodulation Catheters Having Braided Shafts and Associated Systems and Methods |
WO2016007851A1 (en) * | 2014-07-11 | 2016-01-14 | Shaoliang Chen | Multi-pole synchronous pulmonary artery radiofrequency ablation catheter |
US9820800B2 (en) | 2012-11-13 | 2017-11-21 | Pulnovo Medical (Wuxi) Co., Ltd. | Multi-pole synchronous pulmonary artery radiofrequency ablation catheter |
WO2018173047A1 (en) * | 2017-03-20 | 2018-09-27 | Sonivie Ltd. | Method for treating heart failure by improving ejection fraction of a patient |
US10357304B2 (en) | 2012-04-18 | 2019-07-23 | CardioSonic Ltd. | Tissue treatment |
US10874454B2 (en) | 2012-11-13 | 2020-12-29 | Pulnovo Medical (Wuxi) Co., Ltd. | Multi-pole synchronous pulmonary artery radiofrequency ablation catheter |
US10933259B2 (en) | 2013-05-23 | 2021-03-02 | CardioSonic Ltd. | Devices and methods for renal denervation and assessment thereof |
US10967160B2 (en) | 2010-10-18 | 2021-04-06 | CardioSonic Ltd. | Tissue treatment |
US11013554B2 (en) | 2014-11-14 | 2021-05-25 | Medtronic Ardian Lexembourg S.A.R.L. | Catheter apparatuses for modulation of nerves in communication with pulmonary system and associated systems and methods |
US11241267B2 (en) | 2012-11-13 | 2022-02-08 | Pulnovo Medical (Wuxi) Co., Ltd | Multi-pole synchronous pulmonary artery radiofrequency ablation catheter |
US11357447B2 (en) | 2012-05-31 | 2022-06-14 | Sonivie Ltd. | Method and/or apparatus for measuring renal denervation effectiveness |
US11534631B2 (en) * | 2014-06-18 | 2022-12-27 | Sonivie Ltd. | Method for treating secondary pulmonary hypertension |
US11717346B2 (en) | 2021-06-24 | 2023-08-08 | Gradient Denervation Technologies Sas | Systems and methods for monitoring energy application to denervate a pulmonary artery |
US11730506B2 (en) | 2010-10-18 | 2023-08-22 | Sonivie Ltd. | Ultrasound transducer and uses thereof |
Families Citing this family (13)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN104068930A (en) * | 2014-06-04 | 2014-10-01 | 远见企业有限公司 | Renal denervation ablation catheter with pre-bent catheter body |
CN105167840A (en) * | 2014-06-20 | 2015-12-23 | 上海安通医疗科技有限公司 | Multi-electrode renal artery radiofrequency ablation catheter |
CN105326562A (en) * | 2014-06-24 | 2016-02-17 | 上海安通医疗科技有限公司 | Catheter device for regulating renal nerves |
CN105286986B (en) * | 2014-07-30 | 2018-07-10 | 上海微创电生理医疗科技股份有限公司 | Catheter ablation device and its electrode radio-frequency ablation catheter |
CN105361943B (en) * | 2014-08-27 | 2021-04-20 | 上海安通医疗科技有限公司 | Catheter device for regulating nerves |
WO2017021834A1 (en) * | 2015-07-31 | 2017-02-09 | Koninklijke Philips N.V. | Side-loading connectors with inline cabling for use with intravascular devices and associated systems and methods |
TWI626035B (en) * | 2016-01-28 | 2018-06-11 | 財團法人工業技術研究院 | Radiofrequency ablation electrode needle |
EP3413823B1 (en) * | 2016-02-10 | 2022-01-19 | Amir Belson | Personalized atrial fibrillation ablation |
CN106963452A (en) * | 2017-04-01 | 2017-07-21 | 上海心玮医疗科技有限公司 | A kind of snare |
WO2022214870A1 (en) | 2021-04-07 | 2022-10-13 | Btl Medical Technologies S.R.O. | Pulsed field ablation device and method |
IL309432A (en) | 2021-07-06 | 2024-02-01 | Btl Medical Dev A S | Pulsed field ablation device and method |
CN113616318B (en) * | 2021-09-06 | 2022-05-20 | 上海康德莱医疗器械股份有限公司 | Renal sympathetic nerve ablation system and method |
CN114081617A (en) * | 2021-11-23 | 2022-02-25 | 武汉拓扑转化医学研究中心有限公司 | Ablation catheter |
Citations (10)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5643197A (en) * | 1993-12-21 | 1997-07-01 | Angeion Corporation | Fluid cooled and perfused tip for a catheter |
US5715817A (en) * | 1993-06-29 | 1998-02-10 | C.R. Bard, Inc. | Bidirectional steering catheter |
US5833604A (en) * | 1993-07-30 | 1998-11-10 | E.P. Technologies, Inc. | Variable stiffness electrophysiology catheter |
US5919188A (en) * | 1997-02-04 | 1999-07-06 | Medtronic, Inc. | Linear ablation catheter |
US6090104A (en) * | 1995-06-07 | 2000-07-18 | Cordis Webster, Inc. | Catheter with a spirally wound flat ribbon electrode |
US6123702A (en) * | 1998-09-10 | 2000-09-26 | Scimed Life Systems, Inc. | Systems and methods for controlling power in an electrosurgical probe |
US6198974B1 (en) * | 1998-08-14 | 2001-03-06 | Cordis Webster, Inc. | Bi-directional steerable catheter |
US20050010095A1 (en) * | 1999-04-05 | 2005-01-13 | Medtronic, Inc. | Multi-purpose catheter apparatus and method of use |
US20060241366A1 (en) * | 2002-10-31 | 2006-10-26 | Gary Falwell | Electrophysiology loop catheter |
US20100249568A1 (en) * | 2009-03-24 | 2010-09-30 | Stehr Richard E | Medical devices having an atraumatic distal tip segment |
Family Cites Families (172)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
SU1119663A1 (en) | 1980-10-27 | 1984-10-23 | Челябинский медицинский институт | Method of treatment of bronchial asthma |
CA1231392A (en) | 1982-10-14 | 1988-01-12 | Edward E. Elson | Flexible tip cardiac pacing catheter |
SU1412745A1 (en) | 1985-06-24 | 1988-07-30 | Горьковский государственный медицинский институт им.С.М.Кирова | Method of surgical treatment of bronchial asthma |
SU1734708A1 (en) | 1989-09-29 | 1992-05-23 | Иркутский институт усовершенствования врачей | Method of surgical treatment of bronchial asthma |
WO1993001862A1 (en) | 1991-07-22 | 1993-02-04 | Cyberonics, Inc. | Treatment of respiratory disorders by nerve stimulation |
US5263493A (en) | 1992-02-24 | 1993-11-23 | Boaz Avitall | Deflectable loop electrode array mapping and ablation catheter for cardiac chambers |
RU2074645C1 (en) | 1992-12-07 | 1997-03-10 | Гиллер Дмитрий Борисович | Method for surgical treatment of bronchial asthma |
US5797960A (en) * | 1993-02-22 | 1998-08-25 | Stevens; John H. | Method and apparatus for thoracoscopic intracardiac procedures |
US5431168A (en) * | 1993-08-23 | 1995-07-11 | Cordis-Webster, Inc. | Steerable open-lumen catheter |
WO1995013111A1 (en) | 1993-11-10 | 1995-05-18 | Medtronic Cadiorhythm | Electrode array catheter |
US5797905A (en) | 1994-08-08 | 1998-08-25 | E. P. Technologies Inc. | Flexible tissue ablation elements for making long lesions |
US5836947A (en) | 1994-10-07 | 1998-11-17 | Ep Technologies, Inc. | Flexible structures having movable splines for supporting electrode elements |
US5830214A (en) | 1994-11-08 | 1998-11-03 | Heartport, Inc. | Fluid-evacuating electrosurgical device |
US6575969B1 (en) * | 1995-05-04 | 2003-06-10 | Sherwood Services Ag | Cool-tip radiofrequency thermosurgery electrode system for tumor ablation |
RU2102090C1 (en) | 1995-05-22 | 1998-01-20 | Карашуров Сергей Егорович | Method for treating bronchial asthma |
US7269457B2 (en) | 1996-04-30 | 2007-09-11 | Medtronic, Inc. | Method and system for vagal nerve stimulation with multi-site cardiac pacing |
US6096036A (en) | 1998-05-05 | 2000-08-01 | Cardiac Pacemakers, Inc. | Steerable catheter with preformed distal shape and method for use |
US6411852B1 (en) | 1997-04-07 | 2002-06-25 | Broncus Technologies, Inc. | Modification of airways by application of energy |
US5913856A (en) * | 1997-05-19 | 1999-06-22 | Irvine Biomedical, Inc. | Catheter system having a porous shaft and fluid irrigation capabilities |
US5782900A (en) | 1997-06-23 | 1998-07-21 | Irvine Biomedical, Inc. | Catheter system having safety means |
US6120500A (en) | 1997-11-12 | 2000-09-19 | Daig Corporation | Rail catheter ablation and mapping system |
US6645201B1 (en) * | 1998-02-19 | 2003-11-11 | Curon Medical, Inc. | Systems and methods for treating dysfunctions in the intestines and rectum |
US6115626A (en) | 1998-03-26 | 2000-09-05 | Scimed Life Systems, Inc. | Systems and methods using annotated images for controlling the use of diagnostic or therapeutic instruments in instruments in interior body regions |
US6064902A (en) | 1998-04-16 | 2000-05-16 | C.R. Bard, Inc. | Pulmonary vein ablation catheter |
US6493589B1 (en) | 1998-05-07 | 2002-12-10 | Medtronic, Inc. | Methods and apparatus for treatment of pulmonary conditions |
US6292695B1 (en) | 1998-06-19 | 2001-09-18 | Wilton W. Webster, Jr. | Method and apparatus for transvascular treatment of tachycardia and fibrillation |
JP2000118291A (en) | 1998-10-15 | 2000-04-25 | Stanley Electric Co Ltd | Car body installing means of vehicular lighting fixture |
US6709427B1 (en) | 1999-08-05 | 2004-03-23 | Kensey Nash Corporation | Systems and methods for delivering agents into targeted tissue of a living being |
EP1233716B1 (en) | 1999-11-22 | 2014-07-30 | Boston Scientific Limited | Loop structures for supporting diagnostic and therapeutic elements in contact with body tissue |
US6645199B1 (en) * | 1999-11-22 | 2003-11-11 | Scimed Life Systems, Inc. | Loop structures for supporting diagnostic and therapeutic elements contact with body tissue and expandable push devices for use with same |
US6690971B2 (en) | 1999-11-30 | 2004-02-10 | Biotronik Mess - Und Therapiegeraete Gmbh & Co. Ingenieurbuero Berlin | Device for regulating heart rate and heart pumping force |
US6532378B2 (en) | 2000-01-14 | 2003-03-11 | Ep Medsystems, Inc. | Pulmonary artery catheter for left and right atrial recording |
US7570982B2 (en) * | 2000-01-27 | 2009-08-04 | Biosense Webster, Inc. | Catheter having mapping assembly |
JP4926359B2 (en) | 2000-05-03 | 2012-05-09 | シー・アール・バード・インコーポレーテッド | Apparatus and method for mapping and cauterization in electrophysiological procedures |
US7623926B2 (en) | 2000-09-27 | 2009-11-24 | Cvrx, Inc. | Stimulus regimens for cardiovascular reflex control |
US6728563B2 (en) | 2000-11-29 | 2004-04-27 | St. Jude Medical, Daig Division, Inc. | Electrophysiology/ablation catheter having “halo” configuration |
US6564096B2 (en) | 2001-02-28 | 2003-05-13 | Robert A. Mest | Method and system for treatment of tachycardia and fibrillation |
US20060116736A1 (en) | 2001-07-23 | 2006-06-01 | Dilorenzo Daniel J | Method, apparatus, and surgical technique for autonomic neuromodulation for the treatment of obesity |
US20060167498A1 (en) | 2001-07-23 | 2006-07-27 | Dilorenzo Daniel J | Method, apparatus, and surgical technique for autonomic neuromodulation for the treatment of disease |
US20090118780A1 (en) | 2001-07-23 | 2009-05-07 | Dilorenzo Daniel John | Method and apparatus for conformal electrodes for autonomic neuromodulation for the treatment of obesity and other conditions |
US7734355B2 (en) | 2001-08-31 | 2010-06-08 | Bio Control Medical (B.C.M.) Ltd. | Treatment of disorders by unidirectional nerve stimulation |
US7591818B2 (en) | 2001-12-04 | 2009-09-22 | Endoscopic Technologies, Inc. | Cardiac ablation devices and methods |
US20090024124A1 (en) | 2005-07-14 | 2009-01-22 | Lefler Amy | Methods for treating the thoracic region of a patient's body |
US8774913B2 (en) | 2002-04-08 | 2014-07-08 | Medtronic Ardian Luxembourg S.A.R.L. | Methods and apparatus for intravasculary-induced neuromodulation |
US7756583B2 (en) | 2002-04-08 | 2010-07-13 | Ardian, Inc. | Methods and apparatus for intravascularly-induced neuromodulation |
US20110207758A1 (en) | 2003-04-08 | 2011-08-25 | Medtronic Vascular, Inc. | Methods for Therapeutic Renal Denervation |
US7620451B2 (en) | 2005-12-29 | 2009-11-17 | Ardian, Inc. | Methods and apparatus for pulsed electric field neuromodulation via an intra-to-extravascular approach |
US8347891B2 (en) | 2002-04-08 | 2013-01-08 | Medtronic Ardian Luxembourg S.A.R.L. | Methods and apparatus for performing a non-continuous circumferential treatment of a body lumen |
US8145316B2 (en) | 2002-04-08 | 2012-03-27 | Ardian, Inc. | Methods and apparatus for renal neuromodulation |
US6866662B2 (en) | 2002-07-23 | 2005-03-15 | Biosense Webster, Inc. | Ablation catheter having stabilizing array |
US8116883B2 (en) | 2003-06-04 | 2012-02-14 | Synecor Llc | Intravascular device for neuromodulation |
US7149574B2 (en) | 2003-06-09 | 2006-12-12 | Palo Alto Investors | Treatment of conditions through electrical modulation of the autonomic nervous system |
US7738952B2 (en) | 2003-06-09 | 2010-06-15 | Palo Alto Investors | Treatment of conditions through modulation of the autonomic nervous system |
US7789877B2 (en) | 2003-07-02 | 2010-09-07 | St. Jude Medical, Atrial Fibrillation Division, Inc. | Ablation catheter electrode arrangement |
US7235070B2 (en) | 2003-07-02 | 2007-06-26 | St. Jude Medical, Atrial Fibrillation Division, Inc. | Ablation fluid manifold for ablation catheter |
US8073538B2 (en) | 2003-11-13 | 2011-12-06 | Cardio Polymers, Inc. | Treatment of cardiac arrhythmia by modification of neuronal signaling through fat pads of the heart |
US7783353B2 (en) | 2003-12-24 | 2010-08-24 | Cardiac Pacemakers, Inc. | Automatic neural stimulation modulation based on activity and circadian rhythm |
US8126559B2 (en) | 2004-11-30 | 2012-02-28 | Cardiac Pacemakers, Inc. | Neural stimulation with avoidance of inappropriate stimulation |
US7899527B2 (en) | 2004-05-13 | 2011-03-01 | Palo Alto Investors | Treatment of conditions through modulation of the autonomic nervous system during at least one predetermined menstrual cycle phase |
US20050261672A1 (en) | 2004-05-18 | 2005-11-24 | Mark Deem | Systems and methods for selective denervation of heart dysrhythmias |
US7260431B2 (en) | 2004-05-20 | 2007-08-21 | Cardiac Pacemakers, Inc. | Combined remodeling control therapy and anti-remodeling therapy by implantable cardiac device |
US7747323B2 (en) | 2004-06-08 | 2010-06-29 | Cardiac Pacemakers, Inc. | Adaptive baroreflex stimulation therapy for disordered breathing |
US20050283148A1 (en) | 2004-06-17 | 2005-12-22 | Janssen William M | Ablation apparatus and system to limit nerve conduction |
US20120277839A1 (en) | 2004-09-08 | 2012-11-01 | Kramer Jeffery M | Selective stimulation to modulate the sympathetic nervous system |
US7540872B2 (en) | 2004-09-21 | 2009-06-02 | Covidien Ag | Articulating bipolar electrosurgical instrument |
US20060074272A1 (en) | 2004-10-06 | 2006-04-06 | Diubaldi Anthony | Portable system for assessing urinary function and peforming endometrial ablation |
US7828795B2 (en) | 2005-01-18 | 2010-11-09 | Atricure, Inc. | Surgical ablation and pacing device |
US7367951B2 (en) | 2005-01-27 | 2008-05-06 | Medtronic, Inc. | System and method for detecting cardiovascular health conditions using hemodynamic pressure waveforms |
US7587238B2 (en) | 2005-03-11 | 2009-09-08 | Cardiac Pacemakers, Inc. | Combined neural stimulation and cardiac resynchronization therapy |
US7660628B2 (en) | 2005-03-23 | 2010-02-09 | Cardiac Pacemakers, Inc. | System to provide myocardial and neural stimulation |
US8052668B2 (en) | 2005-05-13 | 2011-11-08 | Cardiac Pacemakers, Inc. | Neurotoxic agents and devices to treat atrial fibrillation |
CA2612679A1 (en) | 2005-06-20 | 2007-01-04 | Richardo D. Roman | Ablation catheter |
US8777929B2 (en) | 2005-06-28 | 2014-07-15 | St. Jude Medical, Atrial Fibrillation Division, Inc. | Auto lock for catheter handle |
US8660647B2 (en) | 2005-07-28 | 2014-02-25 | Cyberonics, Inc. | Stimulating cranial nerve to treat pulmonary disorder |
ATE480198T1 (en) | 2005-08-02 | 2010-09-15 | Neurotherm Inc | APPARATUS TO DIAGNOSE AND TREAT NERVOUS DYSFUNCTION |
US8657814B2 (en) | 2005-08-22 | 2014-02-25 | Medtronic Ablation Frontiers Llc | User interface for tissue ablation system |
US7616990B2 (en) | 2005-10-24 | 2009-11-10 | Cardiac Pacemakers, Inc. | Implantable and rechargeable neural stimulator |
US7630760B2 (en) | 2005-11-21 | 2009-12-08 | Cardiac Pacemakers, Inc. | Neural stimulation therapy system for atherosclerotic plaques |
EP1962949B1 (en) | 2005-12-20 | 2015-02-25 | The Cleveland Clinic Foundation | Apparatus for modulating the baroreflex system |
EP1984064A4 (en) | 2006-02-10 | 2009-11-11 | Electrocore Inc | Methods and apparatus for treating anaphylaxis using electrical modulation |
US20070191904A1 (en) | 2006-02-14 | 2007-08-16 | Imad Libbus | Expandable stimulation electrode with integrated pressure sensor and methods related thereto |
US20100241188A1 (en) | 2009-03-20 | 2010-09-23 | Electrocore, Inc. | Percutaneous Electrical Treatment Of Tissue |
US8652201B2 (en) | 2006-04-26 | 2014-02-18 | The Cleveland Clinic Foundation | Apparatus and method for treating cardiovascular diseases |
US8019435B2 (en) | 2006-05-02 | 2011-09-13 | Boston Scientific Scimed, Inc. | Control of arterial smooth muscle tone |
CN103222894B (en) | 2006-06-28 | 2015-07-01 | 美敦力Af卢森堡公司 | Methods and systems for thermally-induced renal neuromodulation |
WO2008008796A2 (en) | 2006-07-10 | 2008-01-17 | Voyage Medical, Inc. | Methods and apparatus for treatment of atrial fibrillation |
US8457734B2 (en) | 2006-08-29 | 2013-06-04 | Cardiac Pacemakers, Inc. | System and method for neural stimulation |
US7801604B2 (en) | 2006-08-29 | 2010-09-21 | Cardiac Pacemakers, Inc. | Controlled titration of neurostimulation therapy |
US7925342B2 (en) | 2006-10-06 | 2011-04-12 | Cardiac Pacemakers, Inc. | Implantable device for responsive neural stimulation therapy |
US7664548B2 (en) | 2006-10-06 | 2010-02-16 | Cardiac Pacemakers, Inc. | Distributed neuromodulation system for treatment of cardiovascular disease |
US7744618B2 (en) | 2006-12-07 | 2010-06-29 | Cardiac Pacemakers, Inc. | Device and method for modulating renal function |
US20100217347A1 (en) | 2006-12-16 | 2010-08-26 | Greatbatch, Inc. | Neurostimulation for the treatment of pulmonary disorders |
US7715915B1 (en) | 2006-12-22 | 2010-05-11 | Pacesetter, Inc. | Neurostimulation and neurosensing techniques to optimize atrial anti-tachycardia pacing for prevention of atrial tachyarrhythmias |
US7826899B1 (en) | 2006-12-22 | 2010-11-02 | Pacesetter, Inc. | Neurostimulation and neurosensing techniques to optimize atrial anti-tachycardia pacing for termination of atrial tachyarrhythmias |
US7937147B2 (en) | 2007-02-28 | 2011-05-03 | Cardiac Pacemakers, Inc. | High frequency stimulation for treatment of atrial fibrillation |
US8249705B1 (en) | 2007-03-20 | 2012-08-21 | Cvrx, Inc. | Devices, systems, and methods for improving left ventricular structure and function using baroreflex activation therapy |
JP4027411B1 (en) | 2007-03-29 | 2007-12-26 | 日本ライフライン株式会社 | Electrode catheter |
US8641704B2 (en) * | 2007-05-11 | 2014-02-04 | Medtronic Ablation Frontiers Llc | Ablation therapy system and method for treating continuous atrial fibrillation |
US11395694B2 (en) | 2009-05-07 | 2022-07-26 | St. Jude Medical, Llc | Irrigated ablation catheter with multiple segmented ablation electrodes |
US8983609B2 (en) | 2007-05-30 | 2015-03-17 | The Cleveland Clinic Foundation | Apparatus and method for treating pulmonary conditions |
US8027724B2 (en) | 2007-08-03 | 2011-09-27 | Cardiac Pacemakers, Inc. | Hypertension diagnosis and therapy using pressure sensor |
US7983748B2 (en) | 2008-02-26 | 2011-07-19 | Ruse Richard B | Apparatus and method for treating atrial fibrillation and atrial tachycardia |
US20090254142A1 (en) | 2008-04-08 | 2009-10-08 | Silhouette Medical, Usa | Treating Medical Conditions of Hollow Organs |
CN102014779B (en) | 2008-05-09 | 2014-10-22 | 赫莱拉公司 | Systems, assemblies, and methods for treating a bronchial tree |
US8882761B2 (en) * | 2008-07-15 | 2014-11-11 | Catheffects, Inc. | Catheter and method for improved ablation |
EP2355736A1 (en) | 2008-09-02 | 2011-08-17 | Medtronic Ablation Frontiers LLC | Irrigated ablation catheter system and methods |
US8414508B2 (en) | 2008-10-30 | 2013-04-09 | Vytronus, Inc. | System and method for delivery of energy to tissue while compensating for collateral tissue |
US20100152726A1 (en) | 2008-12-16 | 2010-06-17 | Arthrocare Corporation | Electrosurgical system with selective control of active and return electrodes |
US8475450B2 (en) | 2008-12-30 | 2013-07-02 | Biosense Webster, Inc. | Dual-purpose lasso catheter with irrigation |
US8600472B2 (en) * | 2008-12-30 | 2013-12-03 | Biosense Webster (Israel), Ltd. | Dual-purpose lasso catheter with irrigation using circumferentially arranged ring bump electrodes |
US8808345B2 (en) | 2008-12-31 | 2014-08-19 | Medtronic Ardian Luxembourg S.A.R.L. | Handle assemblies for intravascular treatment devices and associated systems and methods |
US8672917B2 (en) | 2009-01-05 | 2014-03-18 | Medtronic, Inc. | Pressure monitoring to control delivery of therapeutic agent |
WO2010110785A1 (en) | 2009-03-24 | 2010-09-30 | Electrocore, Inc. | Electrical treatment of bronchial constriction |
US8287532B2 (en) * | 2009-04-13 | 2012-10-16 | Biosense Webster, Inc. | Epicardial mapping and ablation catheter |
US8483832B2 (en) | 2009-05-20 | 2013-07-09 | ElectroCore, LLC | Systems and methods for selectively applying electrical energy to tissue |
US9572624B2 (en) | 2009-08-05 | 2017-02-21 | Atricure, Inc. | Bipolar belt systems and methods |
US9387035B2 (en) * | 2009-08-25 | 2016-07-12 | Medtronic Ablation Frontiers Llc | Bi-modal catheter steering mechanism |
CN112089394A (en) | 2009-10-27 | 2020-12-18 | 努瓦拉公司 | Delivery device with coolable energy emitting assembly |
WO2011060200A1 (en) | 2009-11-11 | 2011-05-19 | Innovative Pulmonary Solutions, Inc. | Systems, apparatuses, and methods for treating tissue and controlling stenosis |
US8911439B2 (en) | 2009-11-11 | 2014-12-16 | Holaira, Inc. | Non-invasive and minimally invasive denervation methods and systems for performing the same |
US20120302909A1 (en) | 2009-11-11 | 2012-11-29 | Mayse Martin L | Methods and systems for screening subjects |
RU2420245C2 (en) * | 2009-11-18 | 2011-06-10 | Общество с ограниченной ответственностью "Лаборатория медицинской электроники "Биоток" | Catheter with thermoballoon for isolation of pulmonary vein orificis |
EP2512330A1 (en) | 2009-12-14 | 2012-10-24 | Mayo Foundation for Medical Education and Research | Device and method for treating cardiac disorders by modulating autonomic response |
US9907607B2 (en) * | 2009-12-30 | 2018-03-06 | St. Jude Medical, Atrial Fibrillation Division, Inc. | Guide and flexible sleeve for use with catheters |
US9072894B2 (en) | 2010-01-18 | 2015-07-07 | The Board Of Trustees Of The Leland Stanford Junior University | Method and apparatus for radioablation of regular targets such as sympathetic nerves |
WO2011091069A1 (en) | 2010-01-19 | 2011-07-28 | Ardian, Inc. | Methods and apparatus for renal neuromodulation via stereotactic radiotherapy |
WO2011127216A2 (en) | 2010-04-06 | 2011-10-13 | Innovative Pulmonary Solutions, Inc. | System and method for pulmonary treatment |
US8369923B2 (en) | 2010-04-14 | 2013-02-05 | St. Jude Medical, Atrial Fibrillation Division, Inc. | Dual-deflecting electrophysiology catheter |
WO2011130488A2 (en) | 2010-04-15 | 2011-10-20 | Cardiac Pacemakers, Inc. | Autonomic modulation using transient response with intermittent neural stimulation |
EP3175808B1 (en) * | 2010-04-26 | 2019-08-21 | Medtronic Ardian Luxembourg S.à.r.l. | Catheter apparatuses and systems for renal neuromodulation |
US9943363B2 (en) * | 2010-04-28 | 2018-04-17 | Biosense Webster, Inc. | Irrigated ablation catheter with improved fluid flow |
US8478404B2 (en) | 2010-05-07 | 2013-07-02 | Cardiac Pacemakers, Inc. | Output circuit for both cardiac contractile electrostimulation and non-contractile neural modulation |
US20120029505A1 (en) | 2010-07-30 | 2012-02-02 | Jenson Mark L | Self-Leveling Electrode Sets for Renal Nerve Ablation |
US9408661B2 (en) | 2010-07-30 | 2016-08-09 | Patrick A. Haverkost | RF electrodes on multiple flexible wires for renal nerve ablation |
US9084609B2 (en) | 2010-07-30 | 2015-07-21 | Boston Scientific Scime, Inc. | Spiral balloon catheter for renal nerve ablation |
US9463062B2 (en) | 2010-07-30 | 2016-10-11 | Boston Scientific Scimed, Inc. | Cooled conductive balloon RF catheter for renal nerve ablation |
US20120029512A1 (en) | 2010-07-30 | 2012-02-02 | Willard Martin R | Balloon with surface electrodes and integral cooling for renal nerve ablation |
US20120065554A1 (en) | 2010-09-09 | 2012-03-15 | Michael Pikus | Dual Balloon Ablation Catheter with Vessel Deformation Arrangement for Renal Nerve Ablation |
CN202665687U (en) * | 2010-10-25 | 2013-01-16 | 美敦力Af卢森堡有限责任公司 | Catheter device used for treatment of human patient via renal denervation |
US20120143294A1 (en) | 2010-10-26 | 2012-06-07 | Medtronic Adrian Luxembourg S.a.r.l. | Neuromodulation cryotherapeutic devices and associated systems and methods |
US9028485B2 (en) | 2010-11-15 | 2015-05-12 | Boston Scientific Scimed, Inc. | Self-expanding cooling electrode for renal nerve ablation |
US9089350B2 (en) | 2010-11-16 | 2015-07-28 | Boston Scientific Scimed, Inc. | Renal denervation catheter with RF electrode and integral contrast dye injection arrangement |
EP4137199A1 (en) | 2010-11-17 | 2023-02-22 | Medtronic Ireland Manufacturing Unlimited Company | Systems for therapeutic renal neuromodulation for treating dyspnea |
US9023034B2 (en) | 2010-11-22 | 2015-05-05 | Boston Scientific Scimed, Inc. | Renal ablation electrode with force-activatable conduction apparatus |
US20120157992A1 (en) | 2010-12-15 | 2012-06-21 | Scott Smith | Off-wall electrode device for renal nerve ablation |
US10016233B2 (en) * | 2010-12-06 | 2018-07-10 | Biosense Webster (Israel) Ltd. | Treatment of atrial fibrillation using high-frequency pacing and ablation of renal nerves |
US20120157993A1 (en) | 2010-12-15 | 2012-06-21 | Jenson Mark L | Bipolar Off-Wall Electrode Device for Renal Nerve Ablation |
US9308041B2 (en) * | 2010-12-22 | 2016-04-12 | Biosense Webster (Israel) Ltd. | Lasso catheter with rotating ultrasound transducer |
DE112011104637T5 (en) | 2010-12-28 | 2015-10-22 | Cibiem, Inc.(n.d.Ges.d.Staates Delaware) | Method for restoring the autonomic balance of a patient |
US8792962B2 (en) | 2010-12-30 | 2014-07-29 | Biosense Webster, Inc. | Catheter with single axial sensors |
US20120184952A1 (en) | 2011-01-19 | 2012-07-19 | Jenson Mark L | Low-profile off-wall electrode device for renal nerve ablation |
CN102651153A (en) | 2011-02-25 | 2012-08-29 | 吴铭远 | Hand-hold dentistry appliance dispensing device |
CN103764225B (en) | 2011-03-04 | 2017-06-09 | 彩虹医疗公司 | By applying the instrument that energy is treated and monitored to tissue |
JP5647059B2 (en) | 2011-04-27 | 2014-12-24 | アイダエンジニアリング株式会社 | Tandem press line |
EP2701795B1 (en) | 2011-04-28 | 2020-12-09 | Interventional Autonomics Corporation | Neuromodulation systems for treating acute heart failure syndromes |
WO2012149341A1 (en) | 2011-04-29 | 2012-11-01 | Barry Mullins | Systems and methods related to selective heating of cryogenic balloons for targeted cryogenic neuromodulation |
CN102198015B (en) * | 2011-05-03 | 2013-11-06 | 上海微创电生理医疗科技有限公司 | Retractable spiral laminar ring type electrode catheter |
US20120290024A1 (en) | 2011-05-11 | 2012-11-15 | St. Jude Medical, Inc. | Transvenous renal nerve modulation for treatment of hypertension, cardiovascular disorders, and chronic renal diseases |
CN102551874B (en) * | 2011-10-20 | 2015-07-22 | 上海微创电生理医疗科技有限公司 | Renal artery radiofrequency ablation catheter |
ES2767093T3 (en) | 2011-11-07 | 2020-06-16 | Medtronic Ardian Luxembourg | Endovascular nerve monitoring devices and associated systems |
AU2012351954B2 (en) | 2011-12-15 | 2016-08-11 | The Board Of Trustees Of The Leland Stanford Junior University | Apparatus and methods for treating pulmonary hypertension |
CN202589653U (en) * | 2012-04-29 | 2012-12-12 | 殷跃辉 | Double-direction controllable saline infusion type renal artery radiofrequency ablation catheter |
US10639099B2 (en) * | 2012-05-25 | 2020-05-05 | Biosense Webster (Israel), Ltd. | Catheter having a distal section with spring sections for biased deflection |
CN102688091B (en) * | 2012-06-15 | 2014-06-25 | 上海安通医疗科技有限公司 | Renal artery radio frequency ablation catheter |
CN102688093B (en) * | 2012-06-20 | 2014-08-27 | 深圳市惠泰医疗器械有限公司 | Renal artery cold saline water radio frequency ablation controllable electrode catheter |
US11241267B2 (en) | 2012-11-13 | 2022-02-08 | Pulnovo Medical (Wuxi) Co., Ltd | Multi-pole synchronous pulmonary artery radiofrequency ablation catheter |
CN102908191A (en) | 2012-11-13 | 2013-02-06 | 陈绍良 | Multipolar synchronous pulmonary artery radiofrequency ablation catheter |
US9827036B2 (en) | 2012-11-13 | 2017-11-28 | Pulnovo Medical (Wuxi) Co., Ltd. | Multi-pole synchronous pulmonary artery radiofrequency ablation catheter |
CN202982207U (en) * | 2012-11-13 | 2013-06-12 | 陈绍良 | Multi-electrode synchronous radio-frequency ablation catheter for curing pulmonary hypertension |
US9050010B2 (en) | 2012-12-31 | 2015-06-09 | Biosense Webster (Israel) Ltd. | Double loop lasso with single puller wire for bi-directional actuation |
US20160128767A1 (en) * | 2013-06-05 | 2016-05-12 | Metavention, Inc. | Modulation of targeted nerve fibers |
EP4014908A1 (en) | 2014-07-11 | 2022-06-22 | Pulnovo Medical (Wuxi) Co., Ltd. | Multi-pole synchronous pulmonary artery radiofrequency ablation catheter |
-
2012
- 2012-11-13 CN CN2012104534704A patent/CN102908191A/en active Pending
-
2013
- 2013-03-27 CN CN201310103141.1A patent/CN103142304B/en active Active
- 2013-03-28 RU RU2014112769/14A patent/RU2587945C9/en active
- 2013-03-28 WO PCT/CN2013/073338 patent/WO2014075415A1/en active Application Filing
- 2013-03-28 EP EP13840133.6A patent/EP2910213B1/en active Active
- 2013-03-28 BR BR112014007594-8A patent/BR112014007594B1/en active IP Right Grant
- 2013-03-28 JP JP2014546305A patent/JP6054415B2/en active Active
- 2013-03-28 KR KR1020147009077A patent/KR101640329B1/en active IP Right Grant
- 2013-11-13 US US14/079,230 patent/US20140180277A1/en not_active Abandoned
-
2014
- 2014-10-31 US US14/530,588 patent/US20150057599A1/en not_active Abandoned
-
2016
- 2016-08-04 US US15/228,358 patent/US10874454B2/en active Active
Patent Citations (10)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5715817A (en) * | 1993-06-29 | 1998-02-10 | C.R. Bard, Inc. | Bidirectional steering catheter |
US5833604A (en) * | 1993-07-30 | 1998-11-10 | E.P. Technologies, Inc. | Variable stiffness electrophysiology catheter |
US5643197A (en) * | 1993-12-21 | 1997-07-01 | Angeion Corporation | Fluid cooled and perfused tip for a catheter |
US6090104A (en) * | 1995-06-07 | 2000-07-18 | Cordis Webster, Inc. | Catheter with a spirally wound flat ribbon electrode |
US5919188A (en) * | 1997-02-04 | 1999-07-06 | Medtronic, Inc. | Linear ablation catheter |
US6198974B1 (en) * | 1998-08-14 | 2001-03-06 | Cordis Webster, Inc. | Bi-directional steerable catheter |
US6123702A (en) * | 1998-09-10 | 2000-09-26 | Scimed Life Systems, Inc. | Systems and methods for controlling power in an electrosurgical probe |
US20050010095A1 (en) * | 1999-04-05 | 2005-01-13 | Medtronic, Inc. | Multi-purpose catheter apparatus and method of use |
US20060241366A1 (en) * | 2002-10-31 | 2006-10-26 | Gary Falwell | Electrophysiology loop catheter |
US20100249568A1 (en) * | 2009-03-24 | 2010-09-30 | Stehr Richard E | Medical devices having an atraumatic distal tip segment |
Cited By (35)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US11730506B2 (en) | 2010-10-18 | 2023-08-22 | Sonivie Ltd. | Ultrasound transducer and uses thereof |
US10967160B2 (en) | 2010-10-18 | 2021-04-06 | CardioSonic Ltd. | Tissue treatment |
US10357304B2 (en) | 2012-04-18 | 2019-07-23 | CardioSonic Ltd. | Tissue treatment |
US11357447B2 (en) | 2012-05-31 | 2022-06-14 | Sonivie Ltd. | Method and/or apparatus for measuring renal denervation effectiveness |
US11241267B2 (en) | 2012-11-13 | 2022-02-08 | Pulnovo Medical (Wuxi) Co., Ltd | Multi-pole synchronous pulmonary artery radiofrequency ablation catheter |
US9827036B2 (en) | 2012-11-13 | 2017-11-28 | Pulnovo Medical (Wuxi) Co., Ltd. | Multi-pole synchronous pulmonary artery radiofrequency ablation catheter |
US9872720B2 (en) | 2012-11-13 | 2018-01-23 | Pulnovo Medical (Wuxi) Co., Ltd. | Multi-pole synchronous pulmonary artery radiofrequency ablation catheter |
US9918776B2 (en) | 2012-11-13 | 2018-03-20 | Pulnovo Medical (Wuxi) Co., Ltd. | Multi-pole synchronous pulmonary artery radiofrequency ablation catheter |
US9820800B2 (en) | 2012-11-13 | 2017-11-21 | Pulnovo Medical (Wuxi) Co., Ltd. | Multi-pole synchronous pulmonary artery radiofrequency ablation catheter |
US10874454B2 (en) | 2012-11-13 | 2020-12-29 | Pulnovo Medical (Wuxi) Co., Ltd. | Multi-pole synchronous pulmonary artery radiofrequency ablation catheter |
US20140213918A1 (en) * | 2013-01-29 | 2014-07-31 | St. Jude Medical, Cardiology Division, Inc. | Tissue sensing device for sutureless valve selection |
US9314163B2 (en) * | 2013-01-29 | 2016-04-19 | St. Jude Medical, Cardiology Division, Inc. | Tissue sensing device for sutureless valve selection |
US10933259B2 (en) | 2013-05-23 | 2021-03-02 | CardioSonic Ltd. | Devices and methods for renal denervation and assessment thereof |
US10736690B2 (en) * | 2014-04-24 | 2020-08-11 | Medtronic Ardian Luxembourg S.A.R.L. | Neuromodulation catheters and associated systems and methods |
US20150305807A1 (en) * | 2014-04-24 | 2015-10-29 | Medtronic Ardian Luxembourg S.A.R.L. | Neuromodulation Catheters Having Braided Shafts and Associated Systems and Methods |
US11464563B2 (en) | 2014-04-24 | 2022-10-11 | Medtronic Ardian Luxembourg S.A.R.L. | Neuromodulation catheters and associated systems and methods |
US11534631B2 (en) * | 2014-06-18 | 2022-12-27 | Sonivie Ltd. | Method for treating secondary pulmonary hypertension |
AU2015287691B2 (en) * | 2014-07-11 | 2019-04-11 | Pulnovo Medical (Wuxi) Co., Ltd. | Multi-pole synchronous pulmonary artery radiofrequency ablation catheter |
EP4014908A1 (en) * | 2014-07-11 | 2022-06-22 | Pulnovo Medical (Wuxi) Co., Ltd. | Multi-pole synchronous pulmonary artery radiofrequency ablation catheter |
EP3166524A4 (en) * | 2014-07-11 | 2018-04-11 | Pulnovo Medical (Wuxi) Co., Ltd. | Multi-pole synchronous pulmonary artery radiofrequency ablation catheter |
JP2017521214A (en) * | 2014-07-11 | 2017-08-03 | プルノヴォ メディカル (ウーシー) カンパニー リミテッド | Multipolar simultaneous pulmonary artery radiofrequency ablation catheter |
AU2020250197B2 (en) * | 2014-07-11 | 2022-02-03 | Pulnovo Medical (Wuxi) Co., Ltd. | Multi-pole synchronous pulmonary artery radiofrequency ablation catheter |
RU2692219C2 (en) * | 2014-07-11 | 2019-06-21 | Пулново Медикал (Уси) Ко., Лтд. | Multipolar synchronous radio-frequency ablation catheter for pulmonary artery |
JP2022028883A (en) * | 2014-07-11 | 2022-02-16 | プルノヴォ メディカル (ウーシー) カンパニー リミテッド | Multipolar simultaneous pulmonary artery high frequency ablation catheter |
JP2020044338A (en) * | 2014-07-11 | 2020-03-26 | プルノヴォ メディカル (ウーシー) カンパニー リミテッド | Multi-pole synchronous pulmonary artery radiofrequency ablation catheter |
WO2016007851A1 (en) * | 2014-07-11 | 2016-01-14 | Shaoliang Chen | Multi-pole synchronous pulmonary artery radiofrequency ablation catheter |
US11013554B2 (en) | 2014-11-14 | 2021-05-25 | Medtronic Ardian Lexembourg S.A.R.L. | Catheter apparatuses for modulation of nerves in communication with pulmonary system and associated systems and methods |
US11154351B2 (en) | 2014-11-14 | 2021-10-26 | Medtronic Ardian Luxembourg S.A.R.L. | Catheter apparatuses for modulation of nerves in communication with the pulmonary system and associated systems and methods |
US11318331B2 (en) | 2017-03-20 | 2022-05-03 | Sonivie Ltd. | Pulmonary hypertension treatment |
WO2018173052A1 (en) * | 2017-03-20 | 2018-09-27 | Sonievie Ltd. | Pulmonary hypertension treatment |
WO2018173047A1 (en) * | 2017-03-20 | 2018-09-27 | Sonivie Ltd. | Method for treating heart failure by improving ejection fraction of a patient |
CN110621345A (en) * | 2017-03-20 | 2019-12-27 | 索尼维有限公司 | Pulmonary hypertension treatment |
US11717346B2 (en) | 2021-06-24 | 2023-08-08 | Gradient Denervation Technologies Sas | Systems and methods for monitoring energy application to denervate a pulmonary artery |
US11744640B2 (en) | 2021-06-24 | 2023-09-05 | Gradient Denervation Technologies Sas | Systems and methods for applying energy to denervate a pulmonary artery |
US11950842B2 (en) | 2021-06-24 | 2024-04-09 | Gradient Denervation Technologies Sas | Systems and methods for applying energy to denervate a pulmonary artery |
Also Published As
Publication number | Publication date |
---|---|
BR112014007594B1 (en) | 2022-03-22 |
CN102908191A (en) | 2013-02-06 |
WO2014075415A1 (en) | 2014-05-22 |
EP2910213A4 (en) | 2015-12-16 |
JP2015502823A (en) | 2015-01-29 |
US20150057599A1 (en) | 2015-02-26 |
RU2587945C2 (en) | 2016-06-27 |
KR101640329B1 (en) | 2016-07-15 |
CN103142304B (en) | 2015-12-02 |
US10874454B2 (en) | 2020-12-29 |
RU2014112769A (en) | 2016-02-27 |
EP2910213B1 (en) | 2019-03-20 |
BR112014007594A2 (en) | 2017-04-25 |
US20160338774A1 (en) | 2016-11-24 |
KR20140088087A (en) | 2014-07-09 |
CN103142304A (en) | 2013-06-12 |
JP6054415B2 (en) | 2016-12-27 |
EP2910213A1 (en) | 2015-08-26 |
RU2587945C9 (en) | 2016-09-27 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
US10874454B2 (en) | Multi-pole synchronous pulmonary artery radiofrequency ablation catheter | |
US20210338305A1 (en) | Multi-pole synchronous pulmonary artery radiofrequency ablation catheter | |
AU2020250197B2 (en) | Multi-pole synchronous pulmonary artery radiofrequency ablation catheter | |
JP6453769B2 (en) | Induction cauterization method, system and induction cautery equipment | |
US11241267B2 (en) | Multi-pole synchronous pulmonary artery radiofrequency ablation catheter | |
US20200030022A1 (en) | Method And Device For Interventricular Septal Ablation | |
US20230380881A1 (en) | Multi-pole synchronous pulmonary artery radiofrequency ablation catheter |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
AS | Assignment |
Owner name: PULNOVO MEDICAL (WUXI) CO., LTD., CHINA Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:CHEN, SHAOLIANG;REEL/FRAME:037589/0041 Effective date: 20151208 |
|
STCB | Information on status: application discontinuation |
Free format text: ABANDONED -- FAILURE TO RESPOND TO AN OFFICE ACTION |