CN104146855A - Heart auxiliary device - Google Patents
Heart auxiliary device Download PDFInfo
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- CN104146855A CN104146855A CN201410434307.2A CN201410434307A CN104146855A CN 104146855 A CN104146855 A CN 104146855A CN 201410434307 A CN201410434307 A CN 201410434307A CN 104146855 A CN104146855 A CN 104146855A
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Abstract
The invention discloses a heart auxiliary device which comprises an outer shell. The outer shell is formed by bonding and fixing a non-elastic flexible rope on the outer surface of a heart model in a spiral mode, a sealed left air bag is arranged along the outer surface of a left heart chamber of the heart model and located in the outer shell, a sealed right air bag is arranged along the outer surface of a right heart chamber of the heart model and located in the outer shell, buckling rings are arranged on the upper portions of the inner walls, close to the side wall of the left air bag and the side wall of the right air bag, of the outer shell respectively, the upper end of the left air bag and the upper end of the right air bag are fixed on the buckling rings, a lower opening of the left air bag is communicated with a left air inlet pipe, a lower opening of the right air bag is communicated with a right air inlet pipe, the left air inlet pipe and the right air inlet pipe penetrate out of the heart apex at the bottom of the outer shell and extend outwards, and the extending parts of the left air inlet pipe and the right air inlet pipe are communicated with an air source control device. The heart auxiliary device is not in direct contact with blood, anticoagulation is not needed in the application process, a series of blood vessel complications like bleeding, thrombosis, hemolysis and immunoreactions are avoided, the infection rate is reduced, and the heart auxiliary device can be suitable for single-heart-chamber assistance and double-heart-chamber assistance, and is flexible in using method.
Description
Technical field
The present invention relates to a kind of medical apparatus and instruments, be specifically related to a kind of heart-assist device.
Background technology
Approximately there are 1,000 ten thousand patients in the whole world every year because of heart failure death now, become one of disease that global mortality rate is the highest, according to statistics, the U.S. increases heart failure patient 800,000 people every year newly at present, estimate may rise to 1,000 ten thousand people to the year two thousand thirty patient number, same, in China, also there are more than 600 ten thousand heart failure patients, there is every year hundreds thousand of newly-increased patients.At present, the common method for the treatment of heart failure has Drug therapy, heart transplantation and assist treatment etc.And wherein whether machinery auxiliary treatment contacts with blood according to ventricular assist device, can be divided into direct blood contact-type and non-blood contact-type two classes.Directly blood contact-type device needs directly in ventricle and aorta upper shed intubate, when implanting with taking-up, be all to complete by open chest surgery, and implant surgery difficulty is very large, not only increased patient's misery, also increased medical expense, and auxiliary device directly contacts with blood, easily cause the diseases such as nonfunction of thrombosis, hemorrhage, Blood damage, lower limb ischemia, arterial injury, important organ.
But not blood contact-type do not need to contact with blood, be wrapped on heart surface, compress weak heart, make heart put out more blood.Compare the auxiliary device of the heart contacting with blood, it can avoid bio-compatibility problem, and can install in the very short time.In addition, many patients' heart can recover blood-pumping function through auxiliary, and just because of these advantages, some direct heart-assist devices are studied, develop and use.But also there is no the auxiliary device of the multi-functional non-blood contact-type heart that a kind of therapeutic effect is good, use is flexible, little to cardiac load at present, for example, the documents 1 retrieving: the patent No. " 200610012565.7 ", patent name " complete heart-aided air bag ", in documents 1 description, disclosed complete heart-aided air bag is also the auxiliary device of the heart of the direct contact-type of a kind of non-blood, but " U " type air bag of the as a whole formula of this air bag, only has an air inlet pipe, air bag is " U " type parcel heart, during use, left side that must be to heart, right ventricle is pressed auxiliary simultaneously, be positioned at the apex of base of heart, also must be subject to certain external force pressure, cause apex contraction of the centripetal end, make the suffered duty ratio of heart larger, heart is caused to certain extra wound, and this air bag using method is single, can not to heart, carry out part targetedly presses auxiliary, therapeutic effect is bad, cause certain wasting of resources.
Summary of the invention
The object of the invention is for problems of the prior art; a kind of heart-assist device is provided; this device is made two independently air bags according to the surface configuration of Ventricular and size respectively; air bag is wrapped in to heart surface; compress weak heart; make heart put out more blood; compare the auxiliary device of the heart contacting with blood; it can avoid bio-compatibility problem; and easy to use, flexible, little to heart compressing, the maximized cardioprotection of energy; treat targetedly, therapeutic effect is good.
Technical scheme: a kind of heart-assist device, comprise shell, described shell is revolved and is bondd by inelastic pliable and tough cheese along heart model outer surface and fixedly forms, layer arranges the left side air bag of a sealing along heart model left ventricle outer surface in the enclosure, layer arranges the right side air bag of a sealing along heart model right ventricle outer surface in the enclosure, described left and right side air bag is quality of rubber materials, and all can cover heart model left and right ventricles outdoor face completely, described right side balloon thickness is 1.5～2.5 times of left side air bag; The outer casing inner wall that is close to left and right air bag sidewall is respectively arranged with a clasp in position on the upper side, left and right side air bag upper end is fixed on described clasp, the end opening of described left side air bag is communicated with left side air inlet pipe, the end opening of right side air bag is communicated with right side air inlet pipe, air inlet pipe aperture, right side is less than left side air inlet pipe, described left and right air inlet pipe passes and stretches out from the apex of the heart position of outer casing bottom, extension is communicated with control air source equipment, described control air source equipment is controlled according to electrocardiogram or pacing signal, synchronizes inflation/deflation with the diastole of heart autogenous shrinkage.
Preferably, described pliable and tough rope is terylene or silica gel material.
Preferably, first described left and right air inlet pipe extension is communicated with by three way cock, connects by the road control air source equipment after connection again.Be more convenient for regulating left and right ventricles or the biventricular assist of heart.
Preferably, described left and right air bag is double-layer seal air bag.
Preferably, described right side balloon thickness is 2 times of left side air bag.
Preferably, described pliable and tough rope diameter is 1.5mm.
Preferably, described in the pliable and tough rope that spirals from the apex of the heart end extend outwards of shell, and it is fixing to stretch out together with air inlet pipe.
Preferably, described left and right air inlet pipe is latex material, and left air inlet pipe diameter is 1mm, and right air inlet pipe diameter is 0.5mm.
Beneficial effect of the present invention:
(1) this device does not directly contact with blood, does not need anticoagulant in application process, has avoided a series of vascular complications such as hemorrhage, thrombosis, haemolysis, immunoreation, has reduced the incidence rate infecting simultaneously yet.
(2) this device can provide pulsate flow, meets the needs of Human Physiology performance.
(3) this device can increase myocardium output in the situation that not increasing myocardial oxygen consumption, makes blood pressure maintain normal level, has reduced myocardium acting, has guaranteed the hemoperfusion of human body important organ.
(4) although this device by extruding heart mode assist, but existing research shows, heart is not affected at the coronary perfusion of systole and relaxing period, on the contrary because the rising of relaxing period pressure, coronary flow has increase to a certain degree, add that myocardial oxygen consumption reduces, and is conducive to myocardium recovery on the contrary.
(5) this device is inserted simply, and external is wrapped on heart surface, adopts by ECG signal excitation, synchronize with beating of heart, pushes heart, thereby make weak heart increase stroke volume reach auxiliaring effect with the contraction of heart.This device has not only reduced hemorrhage, and injury of myocardium not, the cardiac damage of having avoided direct blood contact-type device to cause, this device can be inserted when cardiac surgery operation finishes, freely take out completing after auxiliary, easy to operate, once patient occurs that blood pressure is low, medication effect is poor, can apply in time this device, strive for rescue time.
(6) this device comprises two air bags, and has respectively two independently air inlet pipe, goes for Single Cardiac Ventricle and assists, and a side pipe road presss from both sides and closes, and only carries out opposite side and assists.Also both sides trachea can be opened simultaneously, be carried out biventricular assist, using method is very flexible.And during biventricular assist, because right side balloon thickness is larger than left side air bag, and air inlet pipe aperture, right side is less than left side air inlet pipe, is more convenient for reasonably distributing chamber, left and right pressure.
(7) this device has guaranteed when carrying out heart assistance, and the centripetal end of apex must not shrink.
Accompanying drawing explanation
Fig. 1 is the overall structure schematic diagram of heart-assist device of the present invention;
Fig. 2 is the using state figure of Fig. 1;
Fig. 3 is the top view of Fig. 1.
Number in the figure, 1 is shell, and 2 is left side air bag, and 2a is left side inflated condition, and 3 is right side air bag, 3a is right side inflated condition; 4 is left side air inlet pipe, and 5 is right side air inlet pipe, and 6 is pliable and tough rope extension, and 7 is heart, and 8 is clasp.
The specific embodiment
Below in conjunction with specific embodiment, the invention will be further described.
Embodiment 1: a kind of heart-assist device, referring to Fig. 1, Fig. 3, comprise shell 1, and described shell 1 is revolved and is bondd by inelastic pliable and tough cheese along heart model outer surface and fixedly forms, and wherein pliable and tough rope requires not only flexible but also can be stretching.Be preferably silica gel and terylene material.Heart model can be made various sizes according to different crowd.Shell is when implanting heart, and lower end arises from apex, and upper end terminates in aorta and pulmonary artery section start, and shell inner cavity diameter is than the bigger 1cm of real heart, and described pliable and tough rope diameter is 1.5mm.Layer arranges the left side air bag 2 of a sealing along heart model left ventricle outer surface in the enclosure, layer arranges the right side air bag 3 of a sealing along heart model right ventricle outer surface in the enclosure, described left and right side air bag is quality of rubber materials, and all can cover heart model left and right ventricles outdoor face completely, described right side air bag 3 thickness are 2 times of left side air bag 2.
The outer casing inner wall that is close to left and right air bag sidewall is respectively arranged with a clasp 8 in position on the upper side, can clasp 8 be set apart from cover top portion 2cm position, left and right side air bag upper end is fixed on clasp 8, so that air bag is carried out to effective location, prevent from when air bag from shrinking, expanding being shifted, affect therapeutic effect.The end opening of described left side air bag 2 is communicated with left side air inlet pipe 4, and the end opening of right side air bag 3 is communicated with right side air inlet pipe 5, is specially: left and right air bag opening and admission line near shell apex are bonded together, and are fixed on the apex of the heart position of outer shell wall.Left and right air inlet pipe is latex material, and air inlet pipe 5 apertures in right side are less than left side air inlet pipe 4, and the setting in aperture is more convenient for distributing left and right chamber pressure.Wherein, optional, left air inlet pipe diameter is 1mm, and right air inlet pipe diameter is 0.5mm.Described left and right air inlet pipe passes and stretches out from the apex of the heart position of outer casing bottom, specifically when implanting heart, may extend to externally, extend to external rear connection control air source equipment, described control air source equipment can be conventional IABP equipment clinically, or is directly manual gasbag.By inflating when the heart contraction, during diastole, exit, to reach the effect of accessory heart, specifically referring to the air bag shown in Fig. 2, filling, exitting the squeezing action of different conditions to heart.The present embodiment also can, by the heart tip-extension of pliable and tough rope, pass external and fixing together with air inlet pipe when implanting heart.Pliable and tough rope heart tip-extension is convenient to haul pliable and tough end head solution body case, make air bag implanted auxiliary after, when taking out, the disintegration of shell noresidue smoothly, exit, easy to use, safe.
It should be noted that, in the present embodiment, IABP machine is a kind of total intra aortic balloon counterpulsation equipment, adopts mechanicalness assist circulation method, by physical action, improves diastolic pressure in aorta, increases coronary artery blood supply and improves myocardial function.Rescue and the treatment of the critical patients such as cardiac insufficiency have been widely used in.
To sum up, the present embodiment is according to the size of left and right ventricles and pressure distribution, during use by two of auxiliary device air bags independently, be placed in respectively the surface of left and right ventricles, set up a physiological left ventricular ejection process, and air bag fits tightly at heart surface, guaranteed can not produce in extrusion process the shortening (being the apex of the heart motion of the centripetal end) on long axis direction.This device is external mechanicalness extruding and diastole heart, according to electrocardiosignal, quenching frequency by 1:1 operates, when heart contraction, with ballon pump pump, make airbag aeration, extruding is obviously shortened heart outside-interventricular septum direction (transverse axis), and fore-and-aft direction and long axis direction (being with apex-to-base direction) extend, and reduces end-systolic volume.When air bag deflation, have and produce certain negative pressure, make air bag be close to heart, contribute to the diastole of heart, heart outside-interventricular septum direction (transverse axis) is extended relatively, end-diastolic dimension is increased, relative increase stroke volume, so that cardiac output is improved.
Embodiment 2: another kind of heart-assist device, the present embodiment content and embodiment 1 content are basic identical, same section content no longer repeats, as different from Example 1: the present embodiment middle left and right air inlet pipe extends to outer body and first by three way cock, is communicated with, after connection, connect by the road again control air source equipment.Three way cock's setting is more convenient for regulating left and right ventricles or biventricular assist.
Above embodiment is with respect to the auxiliary device of the heart of direct blood contact-type, in the time of can outside the heart, routine operation finishes, implants, and freely takes out completing after auxiliary, easy to operate.Concrete removing method under can be is optionally:
Visual in the situation that, the present embodiment heart-assist device is implanted to baffle plate on one side, and on baffle plate, leave major axis 1.5cm, the ellipse of minor axis 0.7cm, because this crust of the device is to be revolved and formed by pliable and tough cheese, now hold termination, pliable and tough rope one end, this shell just can disintegrate and make air bag to pass through this elliptical aperture smoothly, quick, the safety of implement device are taken out, and in taking-up process, heart be there is no to impact.And in the recovery experiment process of animal, observe the recovering state of this device when inserting the mouth of pipe by animal, and after reclaiming, carry out animal thoracic cavity and detect, find there is no device and omit and the situation of being obstructed.
The heart-assist device of above embodiment is as follows to the hemodynamic effects experiment of acute heart failure dog:
Experiment purpose: observe heart-assist device for the impact of the hemodynamic parameter of acute heart-failure dog.
Experiment material: 10 dogs that health is clean, body weight 25-35kg, infusion pump (Infusomat (r) P, B.Braun Melsungen AG), Animal Anesthesia machine (Datex.ohmeda Aespire7100), electrocardiogram monitor (Mindray, MINDRAY), ballon pump pump (Autocat2, ARROW international company), Ultrasound Instrument (Philip IE33, PHILIPS Co.), heart-assist device, Zhengzhou University's laboratory.
Experimental procedure: 10 dogs are implemented basal anesthesia by intravenous applications ketalar 10mg/kg, and intravenous injection ketalar 2mg/kg, 1-2mg/kg propofol are anaesthetized and maintained.At femoral artery, insert the capable coronary angiography of angiography tube of 6F, at the microtubular with 3F to thromboembolism position (left anterior descending branch the first diagonal angle props up), injectable microsphere (98-115 μ m), 40000/L of microsphere concentration, each 1-2ml, 2-3 time continuously, by the kinemic variation of ultrasound observation (CO reduces 30%-50%), reach acute heart failure model standard.
The successful animal of all modelings is adopted to biventricular assist, and adopt 1:1(heartbeat 1 time when experiment starts, auxiliary 1 time of device) frequency, record aortic pressure, cardiac output etc.By femoral artery put catheter monitoring aortic blood pressure value.Under ultrasonic guidance, and again measure above related data and carry out statistical analysis, the directly impact of heart-assist device on hemodynamic parameter.
Experimental statistics method: application SPSS 17.0 software statistics analyses, sample average ± standard deviation for data acquisition (
) represent.The relatively employing method of analysis of variance (ANOVA) of data wherein, a plurality of sample averages between two relatively with the t check of Bonferroni method, pairing.
Experimental result: 10 dogs all do not have sudden death or arrhythmia occurs.The heart of acute heart failure is under direct heart-assist device auxiliary, and hemodynamic parameter changes, but the variation of heart rate is little.Accept after heart assistance, cardiac output and blood pressure are obviously changed.
Compare with normal baseline, the Heart Failure Model forming by coronary microembolization method, its hemodynamic parameter all at least declines 30%.Cardiac output drops to (1.58 ± 0.23) L/min from original (2.88 ± 0.38) L/min, after auxiliary, has increased 28.8%[(1.58 ± 0.23) than (2.41 ± 0.34) L/min;
p<0.05].Aortic systolic pressure drops to (93.6 ± 8.03) mmHg from original (141.0 ± 6.8) mmHg, after auxiliary, has increased 23.5%[(93.6 ± 8.03) than (126.8 ± 7.8) mmHg;
p<0.05].Aortic diastolic pressure drops to (60.4 ± 5.0) mmHg from original (102.1 ± 8.1) mmHg, and by auxiliary also increase accordingly, [(60.4 ± 5.0) are than (87.0 ± 6.1) mmHg;
p<0.05].Mean aortic pressure drops to (75.0 ± 6.7) mmHg from original (117.2 ± 9.0) mmHg, after auxiliary, has increased 23.9%[(75.0 ± 6.7) than (103.8 ± 10.0) mmHg;
p<0.05], assist front and back changes in heart rate little (125.4 ± 9.0) than (129.0 ± 10.3) beat/min, difference not statistically significant (
p>0.05).
Analysis of conclusion: the heart-assist device of synchronizeing with heart contraction can improve the contractility of heart for acute heart failure dog, the contraction of accessory heart, improves its cardiac output, and its hemodynamic parameter is improved.This device makes the hemodynamic parameter of Heart Failure Dogs return to normal 80-90% left and right, by auxiliary device of the present invention, and on the impact of heart rate little, the difference not statistically significant between auxiliary front and back.Auxiliary heart is not affected at the coronary perfusion of systole and relaxing period, and because of the rising of relaxing period pressure, coronary flow has increase to a certain degree on the contrary, adds that myocardial oxygen consumption reduces, and is conducive to myocardium recovery.Because the variation of heart rate before and after auxiliary is not obvious, but still lower than the heart rate of state before auxiliary, relaxing period extends relatively, increases the perfusion of arteria coronaria, has reduced the consumption of myocardium energy, storage compartment cardiac energy.Because the periodically full of device compresses left ventricle and pump blood with diastole, increase end-diastolic dimension, reduced end-systolic volume, increase stroke volume, arterial pressure is raise, cardiac output improves, and has guaranteed the perfusion of histoorgan.
Claims (8)
1. a heart-assist device, it is characterized in that: comprise shell, described shell is revolved and is bondd by inelastic pliable and tough cheese along heart model outer surface and fixedly forms, layer arranges the left side air bag of a sealing along heart model left ventricle outer surface in the enclosure, layer arranges the right side air bag of a sealing along heart model right ventricle outer surface in the enclosure, described left and right side air bag is quality of rubber materials, and all can cover heart model left and right ventricles outdoor face completely, described right side balloon thickness is 1.5～2.5 times of left side air bag; The outer casing inner wall that is close to left and right air bag sidewall is respectively arranged with a clasp in position on the upper side, left and right side air bag upper end is fixed on described clasp, the end opening of described left side air bag is communicated with left side air inlet pipe, the end opening of right side air bag is communicated with right side air inlet pipe, air inlet pipe aperture, right side is less than left side air inlet pipe, described left and right air inlet pipe passes and stretches out from the apex of the heart position of outer casing bottom, extension is communicated with control air source equipment, described control air source equipment is controlled according to electrocardiogram or pacing signal, synchronizes inflation/deflation with the diastole of heart autogenous shrinkage.
2. heart-assist device according to claim 1, is characterized in that: described pliable and tough rope is terylene or silica gel material.
3. heart-assist device according to claim 1, is characterized in that: first described left and right air inlet pipe extension is communicated with by three way cock, connects by the road control air source equipment after connection again.
4. heart-assist device according to claim 1, is characterized in that: described left and right air bag is double-layer seal air bag.
5. heart-assist device according to claim 1, is characterized in that: described right side balloon thickness is 2 times of left side air bag.
6. heart-assist device according to claim 1, is characterized in that: described pliable and tough rope diameter is 1.5mm.
7. heart-assist device according to claim 1, is characterized in that: described in the pliable and tough rope that spirals from the apex of the heart end extend outwards of shell, and it is fixing to stretch out together with air inlet pipe.
8. according to the heart-assist device described in claim 1-7 any one, it is characterized in that: described left and right air inlet pipe is latex material, left air inlet pipe diameter is 1mm, and right air inlet pipe diameter is 0.5mm.
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106730081A (en) * | 2016-12-02 | 2017-05-31 | 卫洪超 | Artificial heart |
| CN107411951A (en) * | 2016-05-23 | 2017-12-01 | 俞晓立 | A kind of pneumatic type sacculus heart-assist device |
| CN108888813A (en) * | 2018-04-09 | 2018-11-27 | 复旦大学附属华山医院 | A kind of left ventricular assist device and application method |
| CN109938994A (en) * | 2019-04-30 | 2019-06-28 | 曾建新 | A kind of artificial heart auxiliary device |
| CN110464896A (en) * | 2019-08-22 | 2019-11-19 | 徐俊波 | A kind of magnetomotive ventricle auxiliary system |
| CN113230533A (en) * | 2021-06-07 | 2021-08-10 | 卫洪超 | Power pump type artificial intelligence heart |
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Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107411951A (en) * | 2016-05-23 | 2017-12-01 | 俞晓立 | A kind of pneumatic type sacculus heart-assist device |
| CN106730081A (en) * | 2016-12-02 | 2017-05-31 | 卫洪超 | Artificial heart |
| CN108888813A (en) * | 2018-04-09 | 2018-11-27 | 复旦大学附属华山医院 | A kind of left ventricular assist device and application method |
| CN109938994A (en) * | 2019-04-30 | 2019-06-28 | 曾建新 | A kind of artificial heart auxiliary device |
| CN110464896A (en) * | 2019-08-22 | 2019-11-19 | 徐俊波 | A kind of magnetomotive ventricle auxiliary system |
| CN110464896B (en) * | 2019-08-22 | 2022-01-28 | 成都市第三人民医院 | Magnetomotive ventricular assist system |
| CN113230533A (en) * | 2021-06-07 | 2021-08-10 | 卫洪超 | Power pump type artificial intelligence heart |
| CN113230533B (en) * | 2021-06-07 | 2022-11-11 | 卫洪超 | Power pump type artificial intelligence heart |
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Application publication date: 20141119 |