CA2284998A1 - Intracardiac drug delivery - Google Patents

Intracardiac drug delivery Download PDF

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Publication number
CA2284998A1
CA2284998A1 CA002284998A CA2284998A CA2284998A1 CA 2284998 A1 CA2284998 A1 CA 2284998A1 CA 002284998 A CA002284998 A CA 002284998A CA 2284998 A CA2284998 A CA 2284998A CA 2284998 A1 CA2284998 A1 CA 2284998A1
Authority
CA
Canada
Prior art keywords
catheter
drug
administering
treatment
heart
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.)
Granted
Application number
CA002284998A
Other languages
French (fr)
Other versions
CA2284998C (en
Inventor
Shlomo Ben Haim
Uri Yaron
Avraham Matcovitch
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Biosense Webster Inc
Original Assignee
Individual
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Priority claimed from US09/019,453 external-priority patent/US6309370B1/en
Priority claimed from PCT/US1998/002195 external-priority patent/WO1999039624A1/en
Publication of CA2284998A1 publication Critical patent/CA2284998A1/en
Application granted granted Critical
Publication of CA2284998C publication Critical patent/CA2284998C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0067Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0082Catheter tip comprising a tool
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical 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
    • A61B18/14Probes or electrodes therefor
    • A61B18/1492Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/06Devices, other than using radiation, for detecting or locating foreign bodies ; determining position of probes within or on the body of the patient
    • A61B5/061Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body
    • A61B5/062Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body using magnetic field
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0067Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0074Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
    • A61M25/0075Valve means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0067Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0082Catheter tip comprising a tool
    • A61M25/0084Catheter tip comprising a tool being one or more injection needles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/05Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/056Transvascular endocardial electrode systems
    • A61N1/0565Electrode heads
    • A61N1/0568Electrode heads with drug delivery
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A61B18/22Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
    • A61B18/24Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor with a catheter
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238Type of minimally invasive operation
    • A61B2017/00243Type of minimally invasive operation cardiac
    • A61B2017/00247Making holes in the wall of the heart, e.g. laser Myocardial revascularization
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345Vascular system
    • A61B2018/00351Heart
    • A61B2018/00392Transmyocardial revascularisation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/06Devices, other than using radiation, for detecting or locating foreign bodies ; determining position of probes within or on the body of the patient
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/72Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7271Specific aspects of physiological measurement analysis
    • A61B5/7285Specific aspects of physiological measurement analysis for synchronising or triggering a physiological measurement or image acquisition with a physiological event or waveform, e.g. an ECG signal
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0067Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0074Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
    • A61M25/0075Valve means
    • A61M2025/0076Unidirectional valves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0067Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0082Catheter tip comprising a tool
    • A61M25/0084Catheter tip comprising a tool being one or more injection needles
    • A61M2025/0089Single injection needle protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2210/00Anatomical parts of the body
    • A61M2210/12Blood circulatory system
    • A61M2210/125Heart
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/05Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/056Transvascular endocardial electrode systems
    • A61N1/057Anchoring means; Means for fixing the head inside the heart
    • A61N2001/058Fixing tools

Abstract

Apparatus for intracardiac drug administration, including a catheter (20, 45, 64) which is inserted into a chamber of the heart and brought into engagement with a site in the heart wall (72). The catheter includes at least one position sensor (32), which generates signals responsive to the position of the catheter within the heart, and a drug delivery device (24, 27), which administers a desired dose of a therapeutic drug at the site determined responsive to the signals from the position sensor.

Claims (65)

1. Apparatus for intracardiac drug administration, comprising: a catheter (20, 45, 64) which is inserted into a chamber of the heart and brought into engagement with a site in the heart wall (72), the catheter comprising:
at least one position sensor {32), which generates signals responsive to the position of the catheter within the heart; and a drug delivery device (24, 47), which administers a desired dose of a therapeutic drug at the site determined responsive to the signals from the position sensor.
2. Apparatus according to claim 1, wherein the therapeutic drug comprises a growth factor.
3. Apparatus according to claim 1, wherein the drug is contained in a slow-release matrix.
4. Apparatus according to claim 3, wherein the matrix comprises a solid capsule.
5. Apparatus according to any of claims 1-4, wherein the catheter comprises a contact sensor (36) disposed on a distal surface of the catheter, which senses contact of the surface with the heart wall.
6. Apparatus according to claim 5, wherein the contact sensor comprises a pressure sensor.
7. Apparatus according to any of the preceding claims, wherein the position sensor comprises a magnetic position sensor, which generates signals responsive to an externally-applied magnetic field.
8. Apparatus according to any of the preceding claims, wherein the position sensor signals are used to generate position and orientation coordinates, responsive to which the drug dose is delivered.
9. Apparatus according to any of the preceding claims, wherein the catheter comprises at least one physiological sensor (38), which generates signals indicative of the viability of heart tissue at the site.
10. Apparatus according to claim 9, wherein the at least one physiological sensor comprises an electrode.
11. Apparatus according to claim 9 or 10, wherein the apparatus generates a viability map of the heart based on the signals and administers the drug responsive thereto.
12. Apparatus according to any of the preceding claims, and comprising a radiation source (94) for irradiation of the myocardial tissue, wherein the catheter comprises a waveguide (H2), which communicates with the radiation source.
13. Apparatus according to claim 12, wherein the drug delivery device administers the drug into a channel produced in the tissue by the irradiation.
14. Apparatus according to claim 13, wherein the drug delivery device inserts a solid capsule into the channel.
15. Apparatus according to any of the preceding claims, wherein the drug delivery device comprises a hollow needle (24, 47), which extends distally from the catheter and penetrates the heart tissue to deliver the drug dose.
16. Apparatus according to claim 15, wherein the needle has a helical shape.
17. Apparatus according to claim 16, wherein the needle is fastened to the site in the heart wall by a rotational movement of the needle.
18. Apparatus according to claim 15, wherein the needle is retracted into the catheter before and after the drug dose is delivered.
19. Apparatus according to claim 18, wherein the needle extends from the catheter through an opening in the catheter, which opening is covered by a puncture seal.
20. Apparatus according to claim l9, wherein the drug delivery device comprises a displacement mechanism, which extends and retracts the needle.
21. Apparatus according to claim 20, wherein the displacement mechanism controls the distance by which the needle extends from the catheter, so as to administer the drug at a predetermined depth within the heart wall.
22. Apparatus according to any of the preceding claims, wherein the drug administration is controlled responsive to variations in the thickness of the heart wall at the site.
23. Apparatus according to claim 22, wherein the catheter comprises an ultrasound transducer, which generates signals indicative of the thickness of the heart wall.
24. Apparatus according to claim 22 or 23, wherein the drug delivery device is gated to administer the drug when the wall at a predetermined thickness.
25. Apparatus for intracardiac therapy, comprising:
a catheter (64, 78), which is inserted into a chamber of the heart for administration of therapeutic treatment to the heart wall;
a sensor (32, 60), which generates signals responsive to the thickness of the heart wall; and a controller (50), which receives the signals from the sensor and controls the treatment responsive the thickness of the heart wall.
26. Apparatus according to claim 25, wherein the sensor comprises an ultrasound transducer.
27. Apparatus according to claim 26, wherein the transducer is fixed to the catheter adjacent to a distal end thereof.
28. Apparatus according to claim 25, wherein the sensor comprises a position sensor, which is fixed to the catheter adjacent to a distal end thereof.
29. Apparatus according to any of claims 25-28, wherein the catheter comprises a drug delivery device, and wherein the treatment comprises administration of a therapeutic substance at a site in the heart wall.
30. Apparatus according to any of claims 25-29, and comprising a radiation source, wherein the treatment comprises irradiation of the myocardial tissue using the source, and wherein the catheter comprises a waveguide, which communicates with the radiation source.
31. Apparatus according to any of claims 25-30, wherein the controller gates the treatment so that the treatment is administered during a portion of the heart cycle.
32. Apparatus according to claim 31, wherein the controller gates the treatment so that the treatment is administered when the thickness is at a maximum.
33. Apparatus according to claim 31, wherein the controller gates the treatment so that the treatment is administered when the thickness is at a minimum.
34. A method for intracardiac drug administration, comprising:
introducing a catheter into a chamber of the heart;

sensing position coordinates of the catheter;
positioning the catheter, using the coordinate, in engagement with the heart wall at a desired site; and administering a therapeutic drug at the site using the catheter.
35. A method according to claim 34, wherein administering the therapeutic drug comprises administering a growth factor.
36. A method according to claim 35, wherein the growth factor comprises a fibroblast growth factor (FGF).
37. A method according to claim 35, wherein the growth factor comprises a vascular endothelial growth factor (VEGF).
38. A method according to claim 35, wherein the growth factor comprises a gene encoding the growth factor.
39. A method according to any of claims 34-38, wherein administering the therapeutic drug comprises injecting a slow-release preparation of the drug into the myocardium.
40. A method according to claim 39, wherein administering the slow-release preparation comprises administering a liquid.
41. A method according to claim 39, wherein administering the slow-release preparation comprises inserting a capsule containing the drug into the myocardium.
42. A method according to any of claims 34-4l, and comprising irradiating the heart wall for engendering revascularization of the myocardium.
43. A method according to claim 42, wherein irradiating the heart wall comprises generating a channel in the myocardium, and wherein administering the therapeutic drug comprises inserting the drug into the channel.
44. A method according to any of claims 34-43, wherein positioning the catheter comprises verifying contact between the catheter and the heart wall by receiving signals generated by a contact sensor disposed on the catheter.
45. A method according to any of claims 34-44, and comprising receiving physiological signals from the heart, wherein administering the therapeutic drug comprises administering the drug responsive to the physiological signals.
46. A method according to claim 45, wherein the physiological signals comprise mechano-physiological signals.
47. A method according to claim 45, wherein the physiological signals comprise electrophysiological signals.
48. A method according to any of claims 45-47, wherein administering the therapeutic drug comprises administering the drug responsive to a measure of tissue viability determined from the physiological signals.
49. A method according to claim 48, wherein administering the therapeutic drug comprises administering the drug substantially only in ischemic but viable areas of the heart.
50. A method according to claim 48 or 49, wherein administering the therapeutic drug comprises administering the drug responsive to a map of tissue viability.
51. A method according to any of claims 34-50, wherein sensing the position coordinates comprises sensing orientation coordinates of the catheter, and wherein positioning the catheter comprises orienting the catheter in a desired orientation relative to the heart wall responsive to the coordinates.
52. A method according to any of claims 34-51, wherein positioning the catheter comprises positioning the catheter relative to a grid of points delineating a zone for drug administration on a geometrical map of the heart.
53. A method according to claim 52, and comprising marking sites on the map at which the drug has been administered.
54. A method of intracardiac therapy, comprising:
receiving signals indicative of variations in the thickness of a wall of the heart; and administering a therapeutic treatment to a site in the heart wall responsive to the thickness variations.
55. A method according to claim 54, wherein administering the treatment comprises inserting a catheter into the heart and bringing the catheter into proximity with the site.
56. A method according to claim 55, wherein administering the treatment comprises irradiating the heart wall with laser radiation conveyed via the catheter.
57. A method according to claim 55 or 56, wherein administering the treatment comprises introducing a therapeutic drug into the heart wall using the catheter.
58. A method according to any of claims 55-57, wherein receiving the signals comprises receiving signals from a sensor fixed to the catheter.
59. A method according to claim 58, wherein receiving the signals comprises receiving signals from a position sensor fixed to the catheter.
60. A method according to any of claims 54-59, wherein receiving the signals comprises receiving ultrasound signals.
61. A method according to any of claims 54-60, wherein receiving the signals comprises receiving electrophysiological signals.
62. A method according to any of claims 54-61, wherein administering the treatment comprises gating the treatment responsive to the thickness variations.
63. A method according to claim 62, wherein gating the treatment comprises administering the treatment when the thickness is substantially at a maximum thereof during a cardiac cycle.
64. A method according to claim 62, wherein gating the treatment comprises administering the treatment when the thickness is substantially at a minimum thereof during a cardiac cycle.
65. A method according to any of claims 62-64, wherein gating the treatment comprises controlling the treatment so that the treatment is applied at a desired depth within the heart wall.
CA2284998A 1998-02-05 1998-02-05 Intracardiac drug delivery Expired - Lifetime CA2284998C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US09/019,453 US6309370B1 (en) 1998-02-05 1998-02-05 Intracardiac drug delivery
PCT/US1998/002195 WO1999039624A1 (en) 1998-02-05 1998-02-05 Intracardiac drug delivery
US09/019,453 1998-02-05

Publications (2)

Publication Number Publication Date
CA2284998A1 true CA2284998A1 (en) 1999-08-12
CA2284998C CA2284998C (en) 2010-04-20

Family

ID=56289821

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2284998A Expired - Lifetime CA2284998C (en) 1998-02-05 1998-02-05 Intracardiac drug delivery

Country Status (4)

Country Link
EP (1) EP0980226B1 (en)
AU (1) AU748491B2 (en)
CA (1) CA2284998C (en)
DE (1) DE69832974T2 (en)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6540725B1 (en) 1998-06-04 2003-04-01 Biosense Webster, Inc. Injection catheter with controllably extendable injection needle
US7416547B2 (en) 1999-03-29 2008-08-26 Biosense Webster Inc. Injection catheter
US6623473B1 (en) 1998-06-04 2003-09-23 Biosense Webster, Inc. Injection catheter with multi-directional delivery injection needle
JP4566390B2 (en) 1999-11-12 2010-10-20 バイオセンス・ウエブスター・インコーポレーテツド Infusion catheter
WO2003021858A1 (en) 2001-09-04 2003-03-13 Rumi Sheryar Gonda Method for supporting sdh/sonet aps on ethernet
CN111712277A (en) * 2018-02-06 2020-09-25 瓦卓尼克科技控股公司 Device for attachment to a portable liquid injection device

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2242356C (en) * 1996-01-08 2005-08-23 Biosense, Inc. Methods and apparatus for myocardial revascularization
DE19621099C2 (en) * 1996-05-24 1999-05-20 Sulzer Osypka Gmbh Device with a catheter and a needle that can be inserted into the heart wall from the inside as a high-frequency electrode
DE19622827B4 (en) * 1996-06-07 2009-04-23 Ulrich, Heinrich Implant for insertion between vertebrae as a placeholder

Also Published As

Publication number Publication date
AU6756398A (en) 1999-08-23
EP0980226B1 (en) 2005-12-28
DE69832974T2 (en) 2006-09-21
CA2284998C (en) 2010-04-20
AU748491B2 (en) 2002-06-06
DE69832974D1 (en) 2006-02-02
EP0980226A1 (en) 2000-02-23

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Effective date: 20180205