Intracardiac cell delivery and cell transplantation

• US 7,749,215 B1
• Filed: 08/24/1999
• Issued: 07/06/2010
• Est. Priority Date: 02/05/1998
• Status: Expired due to Term

• Current Assignee: Biosense, Inc. (Cardinal Health, Inc.)
• Original Assignee: Biosense, Inc. (Cardinal Health, Inc.)
• Inventors: Matcovitch, Avraham, Yaron, Uri, Weinfeld, Ze'ev, Schwartz, Yitzhak, Ben-Haim, Shlomo
• Primary Examiner(s): Sirmons; Kevin C
• Assistant Examiner(s): GRAY, PHILLIP A
• Application Number:
  US09/379,540
• Time in Patent Office: 3,969 Days
• Field of Search: 604/510, 604500-503, 604505-513, 604518-522, 604/526, 604/170, 604/66, 604/131, 604134-137, 604156-157, 604/523, 128/899, 424/93, 536/23.2, 600/365, 600/549, 600/41, 600/103, 600/139, 606/194, 606/91, 606/1, 606/10, 606/15, 514/44, 607/120, 607/122
• US Class Current: 604/510
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00106 ultrasonic
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/22082 after introduction of a substance
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 2034/105 Modelling of the patient, e.g. for ligaments or bones
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2034/2063 Acoustic tracking systems, e.g. using ultrasound
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61M 2025/0076 Unidirectional valves
• CPC Class Codes: A61M 2025/0089 Single injection needle protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip
• CPC Class Codes: A61M 2025/0166 Sensors, electrodes or the like for guiding the catheter to a target zone, e.g. image guided or magnetically guided
• CPC Class Codes: A61M 25/0075 Valve means
• CPC Class Codes: A61M 25/0082 Catheter tip comprising a tool
• CPC Class Codes: A61M 25/0084 being one or more injection needles
• CPC Class Codes: A61M 25/0105 Steering means as part of the catheter or advancing means; Markers for positioning systems for detection of markers A61B

Abstract

A method for delivering a cell to a heart of a patient comprises the steps of providing an apparatus for intracardiac drug administration comprising a catheter wherein the catheter has at least one position sensor which generates signals responsive to the position of a catheter and a drug delivery device for delivering the cell. The catheter is inserted into a chamber of the heart at a site and the cell is delivered to the site with the drug delivery device in response to the signals from the position sensor. Typical cells useful for delivery are either myoblasts or myocytes. These cells may be utilized as either an expression vector for promoting angiogenesis or for cell transplantation and fusion through myogenesis.

Claims

1. A method for inducing angiogenesis or myogenesis in a heart of a patient comprising the steps of:

providing a system for intracardiac drug administration comprising a catheter, said catheter having at least one position sensor which generates signals responsive to an applied field for determining the position and orientation of said catheter, said signals being used to generate position and orientation coordinates, and a drug delivery device for delivering said cell, the system also comprising control circuitry for determining position and orientation coordinates of a distal end of said catheter and for generating a viability map of said heart comprising a site suitable for targeted therapy by said catheter;

generating the viability map of the heart;

identifying said site suitable for targeted therapy on said viability map;

inserting said catheter into a chamber of said heart at said site;

delivering said cell to said site with said drug delivery device based on position and orientation coordinates in response to said signals from said position sensor, and inducing angiogenesis or myogenesis in said site of said heart from said delivered cell.

2. The method according to claim 1, wherein said cell is a myoblast or a myocyte.

3. The method according to claim 2, including assessing the viability of said heart prior to delivering said cell.

4. The method according to claim 3, including delivering said cell based on the assessed viability of said heart.

5. The method according to claim 4, including assessing the viability of said heart with said viability map of said heart.

6. The method according to claim 5, including identifying an ischemic zone of said heart on said map as the site suitable for targeted therapy.

7. The method according to claim 6, including determining a delivery site within said ischemic zone.

8. The method according to claim 7, including assessing the viability of said heart after delivering said cell.

9. The method according to claim 5, including identifying an infarct region of said heart on said map as the site suitable for targeted therapy.

10. The method according to claim 9, including determining a delivery site at said infarct region.

11. The method according to claim 10, including assessing the viability of said heart after delivering said cell.

12. The method according to claim 2, wherein said cell is an expression vector capable of expressing an angiogenic factor.

13. The method according to claim 12, wherein said expression vector includes a recombinant molecule.

14. The method according to claim 13, wherein said recombinant molecule is a gene.

15. The method according to claim 12, wherein said angiogenic factor is a growth factor.

16. The method according to claim 2, wherein said cell is capable of cell fusion with other cells.

17. The method according to claim 16, wherein said cell fusion results in myogenesis.

18. The method according to claim 17, wherein said cell is derived from a donor.

19. The method according to claim 18, wherein said cell is treated prior to delivery.

20. The method according to claim 19, wherein said cell is treated with an immunosuppressant.

21. The method according to claim 17, wherein said cell is harvested from said patient.

22. The method according to claim 21, wherein said cell is treated prior to delivery.

23. The method according to claim 22, wherein said treatment results in a genetically superior cell.

24. The method according to claim 22, wherein said cell is a xenograft.

25. The method according to claim 1, including creating a channel at said site prior to delivering said cell.

26. The method according to claim 25, including creating said channel with a laser.

27. The method according to claim 12, including creating a channel at said site prior to delivering said cell.

28. The method according to claim 27, including creating said channel with a laser.

29. The method according to claim 16, including creating a channel at said site prior to delivering said cell.

30. The method according to claim 29, including creating said channel with a laser.

31. The method according to claim 1, including delivering said cell at said site at an oblique angle.

32. The method according to claim 31, wherein said drug delivery device includes a needle.

33. The method according to claim 31, wherein said drug delivery device is capable of providing a pressure burst.

34. The method according to claim 32, wherein said needle is retractable.

35. The method according to claim 25, wherein said drug delivery device includes a needle.

36. The method according to claim 25, where said drug delivery device is capable of providing a pressure burst.

37. The method according to claim 35, wherein said needle is retractable.

38. The method according to claim 27, wherein said drug delivery device includes a needle.

39. The method according to claim 27, wherein said drug delivery device is capable of providing a pressure burst.

40. The method according to claim 38, wherein said needle is retractable.