Apparatus and methods for stimulating revascularization and/or tissue growth

• US RE42,959 E1
• Filed: 09/17/2002
• Issued: 11/22/2011
• Est. Priority Date: 12/02/1996
• Status: Expired due to Term

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Inventors: Ream, John H., Saadat, Vahid
• Primary Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US10/246,030
• Time in Patent Office: 3,353 Days
• Field of Search: 606/185, 606/186, 606/213, 606/219, 606/220, 606/148, 606/144, 606/139, 606/159, 606/170, 606/7, 606/15, 606/10, 606/46, 606/1, 606/14, 604/30, 604/20, 424/423
• US Class Current: 606/7
• 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 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00026 Conductivity or impedance, e.g. of tissue
• CPC Class Codes: A61B 2017/00106 ultrasonic
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00398 using powered actuators, e.g. stepper motors, solenoids
• CPC Class Codes: A61B 2018/00196 reciprocating lengthwise
• CPC Class Codes: A61B 2018/00208 actively driven, e.g. by a motor
• CPC Class Codes: A61B 2018/00267 having a basket shaped structure
• CPC Class Codes: A61B 2018/00279 deployable
• CPC Class Codes: A61B 2018/00291 using suction
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 2018/00738 Depth, e.g. depth of ablation
• CPC Class Codes: A61B 2018/00761 Duration
• CPC Class Codes: A61B 2018/00839 Bioelectrical parameters, e.g. ECG, EEG
• CPC Class Codes: A61B 2018/00916 with means for switching or controlling the main function of the instrument or device
• CPC Class Codes: A61B 2018/1435 Spiral
• CPC Class Codes: A61B 2018/1437 whereby the windings of the spiral touch each other such as to create a continuous surface
• CPC Class Codes: A61B 2018/1861 : with an instrument inserted into a body lumen or cavity, e.g. a catheter
• CPC Class Codes: A61B 2090/3782 : transmitter or receiver in catheter or minimal invasive instrument
• CPC Class Codes: A61B 2218/002 : Irrigation
• CPC Class Codes: A61B 2218/007 : Aspiration
• CPC Class Codes: A61B 34/20 : Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 8/0841 : for locating instruments
• CPC Class Codes: A61B 90/37 : Surgical systems with images on a monitor during operation
• CPC Class Codes: A61M 37/0069 : Devices for implanting pellets, e.g. markers or solid medicaments for introducing of radioactive sources for interstitial radiation therapy, i.e. brachytherapy A61N5/1027

Abstract

Apparatus and methods for stimulating revascularization and tissue growth are provided using an apparatus having a directable end region carrying a tissue piercing end effector. The apparatus optionally includes electrodes for depositing RF energy to form a controlled degree of scar tissue formation, means for delivering a controlled amount of a bioactive agent at the treatment site, or both.

Claims

1. Apparatus for treating an interior region of a cardiac chamber, the apparatus comprising:

a catheter configured for insertion into a cardiac chamber, the catheter having a deflectable end region;

an end effector disposed within distal to the delectable end region, the end effector adapted to form a needle track at a treatment site in an interior region of the cardiac chamber, the end effector movable between a first position, wherein the end effector is retracted within the end region, and a second position, wherein the end effector is extended beyond a distal endface of the catheter; and

means for moving the end region between the first and second positions, wherein the end effector further comprises means for depositing a controlled amount of a bioactive agent at the treatment site and wherein the catheter has a plurality of lumens, one of which contains the bioactive agent and wherein the catheter has a conductor extending from a proximal end of the catheter to an electrode which is distal to the deflectable end region.

2. The apparatus of claim 1 wherein the end effector comprises a non-coring sharpened tip.

3. The apparatus of claim 1 wherein the end effector further comprises an electrode adapted to deliver RF energy to the treatment site.

4. The apparatus of claim 1 wherein the end effector further comprises a plurality of fine wires, the fine wires movable between a retracted position and an extended position, the plurality of fine wires forming a matrix of additional needle tracks at the treatment site when extended.

5. The apparatus of claim 1 wherein the end effector is coupled to a drive shaft, the apparatus further comprising a controller including a hydraulic mechanism coupled to the drive shaft to extend and retract the end effector.

6. The apparatus as defined in claim 1 wherein the end effector is coupled to a drive shaft, the apparatus further comprising a controller including a pneumatic mechanism coupled to the drive shaft to extend and retract the end effector.

7. The apparatus as defined in claim 1 wherein the end effector is coupled to a drive shaft, the apparatus further comprising a manually actuated mechanism coupled to the drive shaft to extend and retract the end effector.

8. Apparatus for treating an interior region of a cardiac chamber, the apparatus comprising:

a catheter having a deflectable end region;

an end effector adapted to form a needle track at a treatment site in an interior region of the cardiac chamber, the end effector movable between a first position, wherein the end effector is retracted within the end region, and a second position, wherein the end effector is extended beyond a distal endface of the catheter; and

means for depositing a bioactive agent in the needle track when the end effector is in the second position and wherein the catheter has a plurality of lumens, one of which contains the bioactive agent and wherein the catheter has a conductor extending from a proximal end of the catheter to an electrode which is distal to the deflectable end region.

9. The apparatus of claim 8 wherein the end effector comprises a non-curing sharpened tip.

10. The apparatus of claim 8 wherein the end effector further comprises an electrode adapted to deliver RF energy to the treatment site.

11. The apparatus of claim 10 wherein the bioactive agent is a fluid and the means for depositing comprises supplies the fluid to the end effector under pressure.

12. The apparatus of claim 8 wherein bioactive agent has a pellet form and the means for depositing the bioactive agent comprises a push rod.

13. A method of treating an interior region of a cardiac chamber the method comprising:

providing apparatus having a catheter adapted for insertion into a cardiac chamber, the catheter having a deflectable end region including an end effector adapted to form a needle track at a treatment site in an interior region of the cardiac chamber, wherein the catheter has a plurality of lumens, one of which contains a bioactive agent, wherein the catheter has a conductor extending from the proximal end of the catheter to the distal end of the catheter and the conductor is coupled to the end effector;

inserting the apparatus within a cardiac chamber;

deflecting the end region to dispose the end effector at a selected orientation relative to an endocardial surface;

actuating the end effector to form a needle track in an interior region of the cardiac chamber at a treatment site; and

delivering a controlled amount of a the bioactive agent at the treatment site, wherein the needle track, after the delivering, is substantially closed onto the bioactive agent.

14. The method of claim 13 further comprising delivering RF energy to the treatment site to create a controlled depth of necrosis at the treatment site.

15. The method of claim 13 wherein delivering a controlled amount of a bioactive agent at the treatment site further comprises injecting the bioactive agent under pressure sufficient to form a pocket of bioactive agent in the tissue.

16. The method of claim 13 wherein delivering a controlled amount of a bioactive agent at the treatment site further comprises injecting a pellet comprising a bioactive agent.

17. The method as defined in claim 13 wherein the end effector further comprises a plurality of fine wires, the fine wires movable between a retracted position and an extended position, the method further comprising extending the plurality of fine wires to form a matrix of additional needle tracks at the treatment site.

18. The method as defined in claim 13 further comprising, following delivering a controlled amount of a bioactive agent at the treatment site:

translating the end region to relocate the end effector; and

repeating actuation of the end effector.

19. An apparatus, comprising:

a catheter configured for percutaneous insertion into a cardiac tissue, the catheter having a proximal region, a steerable distal region, and a lumen extending from the proximal region to the steerable distal region;

a needle disposed distal to the steerable distal region and movable between a first position, wherein the needle is retracted within the distal region, and a second position, wherein the needle is extended beyond the distal region; and

a controller coupled near the proximal region and having a source of a bioactive agent, wherein the controller mechanically measures a controlled amount of the bioactive agent, and wherein the bioactive agent is passed through the lumen, in fluid communication with the needle, for delivery into the cardiac tissue, wherein the needle further comprises a means for depositing the controlled amount of the bioactive agent into the cardiac tissue, and wherein the catheter has a plurality of lumens, one of which contains the bioactive agent and wherein the catheter has a conductor extending from a proximal end of the catheter to an electrode which is distal to the steerable distal region.

20. The apparatus of claim 19, wherein the bioactive agent has a pellet form.

21. The apparatus of claim 19, wherein the bioactive agent has a fluid form.

22. The apparatus of claim 19, wherein the controller releases a plurality of discrete units of the bioactive agent through the lumen of the needle.

23. The apparatus of claim 22, wherein the plurality of discrete units of the bioactive agent comprises a predetermined amount of the bioactive agent.

24. The apparatus of claim 19, wherein the needle further comprises an electrode adapted to delivery RF energy to the cardiac tissue.

25. The apparatus of claim 19, wherein the controller comprises a chamber adapted to contain the bioactive agent.

26. The apparatus of claim 19, further comprising a mechanical driver coupled near the proximal region, wherein the mechanical driver retracts and extends the needle a controlled depth into the cardiac tissue.

27. An apparatus, comprising:

a catheter configured for percutaneous insertion into a cardiac tissue, the catheter having a proximal region, a steerable distal region, and a lumen extending from the proximal region to the steerable distal region;

a needle disposed distal to the steerable distal region and movable between a first position, wherein the needle is retracted within the distal region, and a second position, wherein the needle is extended beyond the distal region; and

a controller coupled near the proximal region and having a source of a bioactive agent, wherein the controller passes a predetermined amount of the bioactive agent through the lumen, in fluid communication with the needle, for delivery into the cardiac tissue, wherein the needle further comprises a means for depositing the predetermined amount of the bioactive agent into the cardiac tissue, and wherein the catheter has a plurality of lumens, one of which contains the bioactive agent and wherein the catheter has a conductor extending from a proximal end of the catheter to an electrode which is distal to the steerable distal region.

28. The apparatus of claim 27, wherein the bioactive agent has a pellet form.

29. The apparatus of claim 27, wherein the bioactive agent has a fluid form.

30. The apparatus of claim 27, wherein the controller mechanically measures a controlled amount of the bioactive agent.

31. The apparatus of claim 27, wherein the needle further comprises an electrode adapted to delivery RF energy to the cardiac tissue.

32. The apparatus of claim 27, further comprising a mechanical driver coupled near the proximal region, wherein the mechanical driver retracts and extends the needle a controlled depth into the cardiac tissue.

33. A method for delivering a bioactive agent to a patient'"'"'s cardiac tissue, the method comprising:

providing a catheter adapted for percutaneous insertion into the cardiac tissue, the catheter having a steerable end region and a hollow needle adapted to deliver discrete units of a bioactive agent having a predetermined dosage and a push rod to push the discrete units, wherein the catheter has a plurality of lumens, one of which contains the bioactive agent, wherein the catheter has a conductor extending from the proximal end of the catheter to the distal end of the catheter and the conductor is coupled to an electrode which is distal to the steerable end region;

inserting the catheter within the cardiac tissue;

steering the steerable end region to dispose the hollow needle at a selected orientation relative to an interior surface of the cardiac tissue; and

delivering and mechanically measuring a controlled amount of the bioactive agent to the cardiac tissue.

34. The method of claim 33, further comprising delivering a plurality of discrete units of the bioactive agent to the cardiac tissue.

35. The method of claim 33 wherein delivering comprises injecting the bioactive agent under pressure sufficient to form a pocket of the bioactive agent in the cardiac tissue.

36. The method of claim 33 wherein delivering comprises injecting the bioactive agent in a pellet form.

37. The method of claim 33 wherein delivering comprises injecting the bioactive agent in a fluid form.

38. The method of claim 33, further comprising delivering RF energy to the cardiac tissue.

39. The method of claim 33, further comprising mechanically retracting and extending the needle a controlled depth into the cardiac tissue.

40. A method for delivering a bioactive agent to a patient'"'"'s cardiac tissue, the method comprising:

providing a catheter adapted for percutaneous insertion into the cardiac tissue, the catheter having a steerable end region and a needle adapted to deliver discrete units of a bioactive agent having a predetermined dosage, wherein the catheter has a plurality of lumens, one of which contains the discrete units, and a push rod to push the discrete units, wherein the catheter has a conductor extending from the proximal end of the catheter to the distal end of the catheter and the conductor is coupled to an electrode coupled to the needle near the steerable end region;

inserting the catheter within the cardiac tissue;

steering the steerable end region to dispose the needle at a selected orientation relative to an interior surface of the cardiac tissue; and

mechanically delivering the predetermined dosage of the bioactive agent through the needle into the cardiac tissue using the push rod.

41. The method of claim 40, further comprising delivering a plurality of discrete units of the bioactive agent to the treatment site.

42. The method of claim 41, further comprising mechanically measuring a controlled amount of the bioactive agent.

43. The method of claim 41 wherein delivering comprises injecting the bioactive agent under pressure sufficient to form a pocket of the bioactive agent in the cardiac tissue.

44. The method of claim 41 wherein delivering comprises injecting the bioactive agent in a pellet form.

45. The method of claim 41 wherein delivering comprises injecting the bioactive agent in a fluid form.

46. The method of claim 41, further comprising delivering RF energy to the cardiac tissue.

47. The method of claim 40, further comprising mechanically driving the needle to control a penetration depth of the needle into the cardiac tissue.

48. An apparatus for delivering a bioactive agent to a patient'"'"'s cardiac tissue, the apparatus comprising:

means for providing a catheter adapted for percutaneous insertion into the cardiac tissue, the catheter having a steerable end region and a hollow needle adapted to deliver discrete units of a bioactive agent having a predetermined dosage, wherein the catheter has a plurality of lumens, one of which contains the discrete units, and a push rod to push the discrete units, wherein the catheter has a conductor extending from the proximal end of the catheter to the distal end of the catheter and the conductor is coupled to an electrode which is distal to the steerable end region;

means for inserting the catheter within the cardiac tissue;

means for steering the steerable end region to dispose the hollow needle at a selected orientation relative to an interior surface of the cardiac tissue; and

means for delivering and mechanically measuring a controlled amount of the bioactive agent.

49. An apparatus for delivering a bioactive agent to a patient'"'"'s cardiac tissue, the apparatus comprising:

means for providing a catheter adapted for percutaneous insertion into the cardiac tissue, the catheter having a steerable end region and a needle adapted to deliver discrete units of a bioactive agent having a predetermined dosage, wherein the catheter has a plurality of lumens, one of which contains the discrete units, and a push rod to push the discrete units, wherein the catheter has a conductor extending from the proximal end of the catheter to the distal end of the catheter and the conductor is coupled to an electrode which is distal to the steerable end region;

means for inserting the catheter within the cardiac tissue;

means for steering the steerable end region to dispose the needle at a selected orientation relative to an interior surface of the cardiac tissue; and

means for mechanically delivering the predetermined dosage of the bioactive agent through the needle into the cardiac tissue.

50. An apparatus, comprising:

a catheter configured for percutaneous insertion into a cardiac tissue, the catheter having a proximal region, a steerable distal region which is deflectable, and a lumen extending from the proximal region to the steerable distal region;

a needle disposed distal to the steerable distal region and movable between a first position, wherein the needle is retracted within the distal region, and a second position, wherein the needle is extended beyond the distal region and wherein the needle is deflectable within the steerable distal region; and

a controller coupled near the proximal region and having a source of a bioactive agent in the form of discrete units, wherein the controller passes a predetermined amount of the bioactive agent through the lumen, in fluid communication with the needle, for delivery into the cardiac tissue, wherein the needle further comprises a means for depositing the predetermined amount of the bioactive agent into the cardiac tissue, and wherein the catheter has a plurality of lumens, one of which contains the bioactive agent and wherein the catheter has a conductor extending from a proximal end of the catheter to an electrode which is distal to the steerable distal region.

51. The apparatus of claim 50, wherein the bioactive agent has a pellet form.

52. A method for delivering a bioactive agent to a patient'"'"'s cardiac tissue, the method comprising:

providing a catheter adapted for percutaneous insertion into the cardiac tissue, the catheter having a steerable end region and a hollow needle adapted to deliver granules of a bioactive agent having a predetermined dosage, wherein the catheter has a plurality of lumens, one of which contains the granules, and a push rod to push the granules, wherein the catheter has a plurality of lumens, one of which contains the bioactive agent, wherein the catheter has a conductor extending from the proximal end of the catheter to the distal end of the catheter and the conductor is coupled to an electrode which is distal to the steerable end region;

inserting the catheter within the cardiac tissue;

steering the steerable end region to dispose the hollow needle at a selected orientation relative to an interior surface of the cardiac tissue; and

mechanically delivering a controlled amount of the granules using the push rod.

53. The method of claim 52, wherein the catheter includes a plurality of granules.

54. The method of claim 53, wherein mechanically delivering comprises separating a single granule from the plurality of granules.

55. The method of claim 54 additionally comprising inserting a single granule within the cardiac tissue.

56. The method of claim 52 additionally comprising inserting at least one granule into the cardiac tissue and wherein the mechanically delivering comprises measuring the controlled amount.

57. The method of claim 52, wherein inserting comprises inserting the hollow needle into the cardiac tissue.

58. The method of claim 57, wherein a portion of the catheter allows only the hollow needle to insert into the cardiac tissue.

59. The method of claim 57, wherein a path into the cardiac tissue is created by inserting the hollow needle.

60. The method of claim 59, wherein the path substantially closes after the hollow needle is withdrawn from the cardiac tissue such that the granule is in complete contact with the cardiac tissue.