Cardiac valve modification method and device

• US 20040267357A1
• Filed: 04/28/2004
• Published: 12/30/2004
• Est. Priority Date: 04/30/2003
• Status: Abandoned Application

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Lamson, Theodore C., Rafiee, Nasser, Coppin, Chris M., Allen, Jeffrey W., Brin, David S.
• Application Number:
  US10/833,448
• Publication Number:
  US 20040267357A1
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/00893 pharmaceutically effective
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 2017/22098 Decalcification of valves
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2210/0004 bioabsorbable

Abstract

The cardiac valve modification device of the present invention provides a catheter; an injection assembly disposed on the catheter, the injection assembly having lobes, and a neck disposed between the lobes; and at least one injector operably disposed at the neck. The injector can be an injection barb, made of a biodegradable material including a therapeutic agent, and deposited in the valve annulus, or an injection needle, which delivers a therapeutic agent to the valve annulus. The therapeutic agent can be a pro-fibrotic growth factor or a bulking agent. The cardiac valve modificaton method comprises inserting an injection catheter to the valve annulus; and injecting a therapeutic agent into the valve annulus with the injection catheter. The procedure can be repeated to modify the cardiac valve in a series of steps.

Claims

1. A device for cardiac valve modification comprising:

a catheter;

an injection assembly disposed on the catheter, the injection assembly having a first lobe, a second lobe, and a neck disposed between the first lobe and the second lobe; and

at least one injector operably disposed at the neck.

2. The device of claim 1 wherein the first lobe and the second lobe are inflatable.

3. The device of claim 1 wherein the injector is selected from the group consisting of an injection barb and an injection needle.

4. The device of claim 1 wherein the neck includes an inner balloon and at least one port, the injector being disposed behind the port and the inner balloon being disposed behind the injector.

5. The device of claim 4 wherein the port is closed with a membrane.

6. The device of claim 4 wherein the injector is enclosed in a viscous material.

7. The device of claim 4 wherein the injector comprises a pointed shaft, at least one barb disposed on the pointed shaft, an injector attachment, and a fracture point disposed between the barb and the injector attachment, the injector attachment being attached to the inner balloon.

8. The device of claim 4 wherein the injector comprises an injection needle attached to the inner balloon.

9. The device of claim 8 wherein the injection needle includes a lumen for delivery of a therapeutic agent, the therapeutic agent selected from the group consisting of pro-fibrotic growth factor, transforming growth factor-β

(TGF-β

), connective tissue growth factor (CTGF), platelet derived growth factor (PDGF), insulin-like growth factor (IGF), and the like.

10. The device of claim 9 wherein the therapeutic agent is included in microspheres.

11. The device of claim 8 wherein the injection needle includes a lumen for delivery of a bulking agent.

12. The device of claim 11 wherein the bulking agent is collagen.

13. The device of claim 1 wherein the injector comprises a biodegradable material and a therapeutic agent.

14. The device of claim 13 wherein the biodegradable material is selected from the group consisting of bioabsorbable polymers, polydioxanone, polyglycolic acid (PGA), polylactide (PLA), PGA/PLA copolymers, polycaprolactone, poly-b-hydroxybutyrate (PHB), combinations thereof, and the like.

15. The device of claim 13 wherein the therapeutic agent is selected from the group consisting of pro-fibrotic growth factor, transforming growth factor-β

(TGF-β

), connective tissue growth factor (CTGF), platelet derived growth factor (PDGF), insulin-like growth factor (IGF), and the like.

16. The device of claim 1 wherein the injector comprises a pointed shaft, and at least one barb disposed on the pointed shaft.

17. The device of claim 16 wherein the injector has a pointed end, and the injector further comprises a foot disposed on the pointed shaft opposite the pointed end.

18. The device of claim 1 wherein the injection assembly includes a lumen.

19. The device of claim 18 further comprising a check valve disposed in the lumen.

20. The device of claim 1 wherein the injection assembly further comprises a balloon and an actuator body, the balloon including the first lobe, the second lobe, and the neck disposed between the first lobe and the second lobe;

the injector comprising a needle; and

the balloon being furled within the actuator body when the balloon is deflated.

21. A method of cardiac valve modification comprising:

inserting an injection catheter to the valve annulus;

injecting a therapeutic agent into the valve annulus with the injection catheter; and

removing the injection catheter.

22. The method of claim 21 further comprising:

characterizing a valve annulus;

23. The method of claim 22 wherein characterizing a valve annulus comprises characterizing a valve annulus by a method selected form the group consisting of echocardiography, magnetic resonance imaging, and ultrafast computed tomography.

24. The method of claim 21 wherein injecting the therapeutic agent into the valve annulus with the injection catheter further comprises injecting pro-fibrotic growth factor at a target site identified from characterizing the valve annulus.

25. The method of claim 21 wherein inserting an injection catheter to the valve annulus further comprises locating an injection assembly at the valve annulus.

26. The method of claim 21 wherein inserting an injection catheter to the valve annulus further comprises deploying an injection assembly at the valve annulus.

27. The method of claim 21 wherein inserting an injection catheter to the valve annulus further comprises steering the injection catheter to the valve annulus.

28. The method of claim 21 wherein inserting an injection catheter to the valve annulus further comprises tracking the injection catheter using a system selected from the group consisting of a fluoroscopic system, a non-fluoroscopic navigation system, and a combination thereof.

29. The method of claim 21 wherein the injection catheter is selected from the group consisting of single needle catheters and multi-needle catheters.

30. The method of claim 24 further comprising testing a patient for sensitivity to the pro-fibrotic growth factor.

31. The method of claim 24 wherein injecting pro-fibrotic growth factor into the valve annulus generates scar tissue in the valve annulus, and further comprising checking valve function after the scar tissue forms.

32. The method of claim 31 further comprising injecting pro-fibrotic growth factor into the valve annulus if the valve function can be improved.

33. The method of claim 21 further comprising monitoring inflammation of the valve annulus.

34. The method of claim 33 wherein monitoring inflammation of the valve annulus comprises monitoring C-reactive protein (CRP).

35. The method of claim 24 wherein injecting pro-fibrotic growth factor into the valve annulus generates scar tissue in the valve annulus, and further comprising modifying the scar tissue.

36. The method of claim 35 wherein modifying the scar tissue comprises modifying the scar tissue by a method selected from the group consisting of injecting the scar tissue with gluteraldehyde, and exposing the scar tissue to ultraviolet light.

37. The method of claim 21 wherein injecting a therapeutic agent into the valve annulus comprises injecting a bulking agent.

38. The method of claim 29 wherein the multi-needle injection catheter comprises a plurality of needles positioned for deployment into a portion of the valve annulus.

39. The method of claim 38 where in the needles are positioned for deployment into the portion of the valve annulus adjacent an anterior leaflet of a mitral valve.

40. A system for cardiac valve modification comprising:

means for modifying a valve annulus;

means for injecting the modifying means into the valve annulus; and

means for locating the injecting means at the valve annulus.

41. The system of claim 40 wherein the modifying means is a scarring means selected from the group consisting of pro-fibrotic growth factor, transforming growth factor-β

(TGF-β

), connective tissue growth factor (CTGF), platelet derived growth factor (PDGF), insulin-like growth factor (IGF), and the like.

42. The system of claim 40 further comprising means for deploying the injecting means

43. The system of claim 40 further comprising means for tracking the injecting means.

44. The system of claim 41 further comprising means for testing patient sensitivity to the scarring means.

45. The system of claim 40 further comprising means for monitoring inflammation of the valve annulus.

46. The system of claim 41 wherein the scarring means produces scar tissue in the valve annulus and further comprising means for modifying the scar tissue.