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.
RELATED APPLICATION
[0001] This application claims priority to U.S. Provisional Application No. 60/466,940, “Cardiac Valve Modification Method and Device” to Jeffrey W. Allen et al., filed Apr. 30, 2003, the entirety of which is incorporated by reference.
Provisional Applications (1)
|
Number |
Date |
Country |
|
60466940 |
Apr 2003 |
US |