Devices and methods for intracardiac procedures

• US 20030145865A1
• Filed: 07/10/2001
• Published: 08/07/2003
• Est. Priority Date: 12/03/1992
• Status: Active Grant

• Current Assignee: Edwards Lifesciences LLC (Edwards Lifesciences Corporation)
• Original Assignee: Heartport, Inc. (Johnson & Johnson)
• Inventors: Garrison, Michi E., Gifford, Hanson S. III, Stevens, John H., Peters, William S., Sterman, Wesley D.
• Granted Patent: US 6,899,704 B2
• Time in Patent Office: Days
• US Class Current: 128/898
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/0218 for minimally invasive surgery A61B17/0281, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/0467 Instruments for cutting sutures surgical cutting instruments A61B17/32
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/06061 Holders for needles or sutures, e.g. racks, stands hand-held holding instruments A61B17/0483; holders for articles A61B50/20; racks for syringes or for hypodermic or infusion needles A61M5/008
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/12013 for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/122 Clamps or clips , e.g. for the umbilical cord for the vas deferens A61F6/206
• CPC Class Codes: A61B 17/1227 Spring clips
• CPC Class Codes: A61B 17/1285 for minimally invasive surgery
• CPC Class Codes: A61B 17/29 Forceps for use in minimally invasive surgery
• CPC Class Codes: A61B 17/2909 Handles
• CPC Class Codes: A61B 17/30 Surgical pincettes without pivotal connectionsfor holding suture needles or materials A61B17/0483; wound clamps A61B17/08 ; hand-held gripping tools without pivotal connections in general B25B9/02
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• CPC Class Codes: A61B 18/1442 Probes having pivoting end effectors, e.g. forceps
• 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 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00637 : for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/00663 : the implement being a suture
• CPC Class Codes: A61B 2017/0243 : for immobilizing local areas of the heart, e.g. while it beats trocars attached to inner organs or inner body tissue A61B2017/3488
• CPC Class Codes: A61B 2017/047 : having at least one proximally pointing needle located at the distal end of the instrument, e.g. for suturing trocar puncture wounds starting from inside the body J-shaped suture needles A61B2017/0608
• CPC Class Codes: A61B 2017/0472 : Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/0474 : Knot pushers
• CPC Class Codes: A61B 2017/0475 : using sutures having a slip knot
• CPC Class Codes: A61B 2017/2943 : Toothed members, e.g. rack and pinion
• CPC Class Codes: A61B 2017/306 : holding by means of suction
• CPC Class Codes: A61B 2017/3405 : using mechanical guide means
• CPC Class Codes: A61B 2017/3427 : for intercostal space
• CPC Class Codes: A61B 2017/3492 : against the outside of the body
• CPC Class Codes: A61B 2018/00214 : Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/00232 : having an irregular shape
• CPC Class Codes: A61B 2018/00261 : arranged in a line
• CPC Class Codes: A61B 2018/00291 : using suction
• CPC Class Codes: A61B 2018/00363 : Epicardium
• CPC Class Codes: A61B 2018/00392 : Transmyocardial revascularisation
• CPC Class Codes: A61B 2018/00577 : Ablation
• CPC Class Codes: A61B 2090/064 : for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 90/50 : Supports for surgical instruments, e.g. articulated arms
• CPC Class Codes: A61F 2/2427 : Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2496 : Devices for determining the dimensions of the prosthetic valve to be implanted, e.g. templates, sizers
• CPC Class Codes: A61M 1/3623 : Means for actively controlling temperature of blood
• CPC Class Codes: A61M 1/3664 : for preparing cardioplegia solutions
• CPC Class Codes: A61M 2025/0003 : having an additional lumen transmitting fluid pressure to the outside for measurement
• CPC Class Codes: A61M 2025/028 : having a mainly rigid support structure
• CPC Class Codes: A61M 2025/1052 : for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2039/027 : having a particular valve, seal or septum septum A61M2039/0036
• CPC Class Codes: A61M 2039/0279 : for introducing medical instruments into the body, e.g. endoscope, surgical tools
• CPC Class Codes: A61M 2202/047 : cardioplegic
• CPC Class Codes: A61M 2205/3344 : Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 2205/3355 : Controlling downstream pump pressure
• CPC Class Codes: A61M 2205/366 : by liquid heat exchangers
• CPC Class Codes: A61M 2210/127 : Aorta
• CPC Class Codes: A61M 2230/005 : Parameter used as control input for the apparatus
• CPC Class Codes: A61M 25/0023 : by the form of the lumen, e.g. cross-section, variable diameter
• CPC Class Codes: A61M 25/0032 : characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
• CPC Class Codes: A61M 25/1011 : Multiple balloon catheters
• CPC Class Codes: A61M 39/0247 : Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body peritoneal dialysis catheters A61M1/285; tracheostomy devices A61M16/0465; measuring pressure within the body A61B5/03; colostomy devices A61F5/445; gastrotomy feeding tubes A61J15/0015; means for fixing a feeding tube outside of the body A61J15/0053

Abstract

The invention provides devices and methods for performing less-invasive surgical procedures within an organ or vessel. In an exemplary embodiment, the invention provides a method of closed-chest surgical intervention within an internal cavity of a patient'"'"'s heart or great vessel. According to the method, the patient'"'"'s heart is arrested and cardiopulmonary bypass is established. A scope extending through a percutaneous intercostal penetration in the patient'"'"'s chest is used to view an internal portion of the patient'"'"'s chest. An internal penetration is formed in a wall of the heart or great vessel using cutting means introduced through a percutaneous penetration in an intercostal space in the patient'"'"'s chest. An interventional tool is then introduced, usually through a cannula positioned in a percutaneous intercostal penetration. The interventional tool is inserted through the internal penetration in the heart or great vessel to perform a surgical procedure within the internal cavity under visualization by means of the scope. In a preferred embodiment, a cutting tool is introduced into the patient'"'"'s left atrium from a right portion of the patient'"'"'s chest to remove the patient'"'"'s mitral valve. A replacement valve is then introduced through an intercostal space in the right portion of the chest and through the internal penetration in the heart, and the replacement valve is attached in the mitral valve position.

Claims

1. A method of closed-chest surgical intervention within an internal cavity of a patient'"'"'s heart or great vessel, the method comprising:

establishing cardiopulmonary bypass;

arresting the patient'"'"'s heart;

viewing an internal portion of the patient'"'"'s chest through a scope extending through a percutaneous intercostal penetration in the patient'"'"'s chest;

forming an internal penetration in a wall of the heart or great vessel using cutting means introduced through a percutaneous intercostal penetration in the patient'"'"'s chest; and

introducing an interventional tool through a percutaneous intercostal penetration and through the internal penetration to perform a surgical procedure within the internal cavity under visualization by means of said scope.

2. The method of claim 1 wherein the patient'"'"'s heart is arrested by occluding the patient'"'"'s aorta between the patient'"'"'s coronary arteries and the patient'"'"'s brachiocephalic artery with an expandable member on a distal end of an endovascular catheter, and perfusing the patient'"'"'s myocardium with cardioplegic fluid.

3. The method of claim 1 wherein the interventional tool is introduced through a cannula positioned in a percutaneous intercostal penetration.

4. The method of claim 1 wherein the surgical procedure comprises surgically treating a heart valve.

5. The method of claim 4 further comprising the step of removing at least a portion of the heart valve by means of a cutting tool introduced through a percutaneous intercostal penetration and through the internal penetration.

6. The method of claim 4 further comprising the step of introducing a replacement valve through a percutaneous intercostal penetration and through the internal penetration into the internal cavity.

7. The method of claim 6 further comprising fastening the replacement valve within the internal cavity by means of an instrument introduced through a percutaneous intercostal penetration and through the internal penetration.

8. The method of claim 6 wherein the replacement valve is introduced through a cannula positioned in a percutaneous intercostal penetration.

9. The method of claim 4 wherein a percutaneous intercostal penetration is created in a right lateral portion of the patient'"'"'s chest.

10. The method of claim 9 wherein the internal penetration is made in a wall of the patient'"'"'s left atrium.

11. The method of claim 10 wherein the heart valve comprises a mitral valve.

12. The method of claim 10 wherein the heart valve comprises an aortic valve.

13. A method of closed-chest replacement of a heart valve in a patient'"'"'s heart, the method comprising:

establishing cardiopulmonary bypass;

arresting the patient'"'"'s heart;

viewing the patient'"'"'s heart through a scope extending through a percutaneous intercostal penetration in the patient'"'"'s chest;

forming an internal penetration through a wall of the patient'"'"'s heart using a cutting tool introduced through a percutaneous intercostal penetration in the patient'"'"'s chest;

positioning a replacement valve through a percutaneous intercostal penetration in the patient'"'"'s chest and through the internal penetration into a chamber of the heart; and

securing the replacement valve in a valve position in the heart.

14. The method of claim 13 wherein the patient'"'"'s heart is arrested by occluding the patient'"'"'s aorta between the patient'"'"'s coronary arteries and the patient'"'"'s brachiocephalic artery with an expandable member on a distal end of an endovascular catheter, and perfusing the patient'"'"'s myocardium with cardioplegic fluid.

15. The method of claim 13 wherein the heart valve comprises a mitral valve, the valve position comprising a mitral valve position.

16. The method of claim 15 wherein the chamber comprises a left atrium of the patient'"'"'s heart.

17. The method of claim 13 wherein the percutaneous intercostal penetration is disposed in a right lateral portion of the patient'"'"'s chest.

18. The method of claim 13 further comprising the step of removing at least a portion of the patient'"'"'s heart valve using a cutting tool introduced through a percutaneous intercostal penetration and through the internal penetration.

19. The method of claim 13 further comprising sizing the patient'"'"'s heart valve by means of a sizing instrument introduced through a percutaneous intercostal penetration and through the internal penetration.

20. The method of claim 13 wherein the replacement valve is positioned by means of an introducer, the introducer comprising an elongated shaft and means at a distal end of the shaft for holding the replacement valve.

21. The method of claim 13 wherein the step of fastening comprises suturing the replacement valve to an annulus at the valve position.

22. The method of claim 21 wherein the step of suturing comprises applying a plurality of sutures to an annulus at the valve position, drawing the sutures out of the patient'"'"'s body through the internal penetration and through a percutaneous intercostal penetration, and applying the sutures to the replacement valve.

23. The method of claim 22 further comprising radially arranging the sutures in spaced-apart locations about an organizing ring disposed outside of the patient'"'"'s body.

24. The method of claim 23 further comprising holding the sutures in tension in the organizing ring as the replacement valve is positioned in the valve position.

25. The method of claim 13 wherein the replacement valve is introduced through a cannula positioned in a percutaneous intercostal penetration.

26. A system for closed-chest surgical intervention within a patient'"'"'s heart or great vessel, the system comprising:

means for forming a percutaneous penetration in an intercostal space in the patient'"'"'s chest;

a visualization scope configured to pass through an intercostal space in the patient'"'"'s chest for viewing an internal chest cavity;

means for arresting the patient'"'"'s heart from a location outside of the chest cavity;

a cardiopulmonary bypass system, including means for delivering oxygenated blood to the patient'"'"'s arterial system;

cutting means positionable through a percutaneous intercostal penetration into the chest cavity for forming an internal penetration in a wall of the patient'"'"'s heart or great vessel; and

interventional means positionable through a percutaneous intercostal penetration and through the internal penetration for performing a surgical procedure within the heart or great vessel.

27. The system of claim 26 wherein the means for arresting the heart comprises an endovascular catheter having expandable means for occluding the patient'"'"'s ascending aorta between the patient'"'"'s coronary arteries and the patient'"'"'s brachiocephalic artery, and an internal lumen for delivering cardioplegic fluid into the ascending aorta upstream of the expandable means.

28. The system of claim 26 wherein the interventional means comprises means for securing a replacement valve at a valve location within the patient'"'"'s heart.

29. The system of claim 28 further comprising a cannula positionable in a percutaneous intercostal penetration, the cannula having a lumen therein through which the replacement valve may be introduced into the internal chest cavity.

30. The system of claim 28 wherein the replacement valve comprises an annular portion for attachment to a valve annulus in the heart, the annular portion having an outer diameter, wherein the lumen in the cannula has a cross-sectional height at least equal to the outer diameter, and a cross-sectional width less than the width of the intercostal space.

31. The system of claim 28 further comprising cutting means positionable through a percutaneous intercostal penetration and through the internal penetration for removing at least a portion of the patient'"'"'s heart valve.

32. The system of claim 28 further comprising means positionable through a percutaneous intercostal penetration and through the internal penetration for sizing a valve annulus of the patient'"'"'s heart valve.

33. The system of claim 32 wherein the sizing means comprises an elongated shaft and sizing means at a distal end of the shaft, wherein the shaft and sizing means may be introduced through a percutaneous intercostal penetration and through the internal penetration to position the sizing means near the valve annulus.

34. The system of claim 28 further comprising means for introducing the replacement valve into the patient'"'"'s heart, the introducing means comprising an elongated shaft having means at a distal end thereof for releasably holding the replacement valve.

35. The system of claim 34 wherein the introducing means further comprises means actuated from a proximal end of the shaft for pivoting the replacement valve, relative to the shaft from a first position for introduction through a percutaneous intercostal penetration to a second position for attachment at the valve location.

36. The system of claim 28 wherein the means for securing the replacement valve comprises means positionable through a percutaneous intercostal penetration for suturing the replacement valve to a valve annulus at the valve location.

37. The system of claim 36 further comprising organizing means for maintaining sutures in spaced-apart positions outside of the chest cavity after the sutures have been applied to the valve annulus.

38. The system of claim 37 wherein the organizing means is fixed to a proximal end of a cannula disposed in a percutaneous intercostal penetration, the cannula having a lumen through which the replacement valve may be introduced into the chest cavity.

39. The system of claim 37 further comprising means on the organizing means for maintaining tension on ends of the sutures to facilitate advancing the replacement valve along the sutures into the patient'"'"'s heart.

40. The system of claim 26 further comprising retraction means positionable through an intercostal space in the patient'"'"'s chest for opening the internal penetration in the wall of the heart or great vessel.

41. The system of claim 26 wherein the interventional means is configured to reach the interior of the heart or great vessel from a percutaneous penetration in a right lateral portion of the patient'"'"'s chest.

42. The system of claim 41 wherein the interventional means is at least about 20 cm in length.

43. A percutaneous access cannula to facilitate closed-chest replacement of a heart valve in a patient'"'"'s heart, the access cannula comprising:

a cannula body configured for placement in an intercostal space in the patient'"'"'s chest, the cannula body having a distal end, a proximal end, and a lumen extending therebetween, the lumen being configured to allow passage of a replacement valve therethrough; and

an obturator positionable in the lumen, the obturator having a cross-sectional width less than the width of the intercostal space and a cross-sectional height greater than the cross-sectional width.

44. The access cannula of claim 43 wherein the valve prosthesis has an annular attachment portion with an outer diameter, the obturator having a cross-sectional height at least equal to the outer diameter.

45. The access cannula of claim 43 wherein the cross-sectional height is about 2 to 6 times the cross-sectional width.

46. The access cannula of claim 43 wherein the obturator has a generally rectangular cross-section.

47. The access cannula of claim 43 wherein the obturator has a generally oval cross-section.

48. The access cannula of claim 44 wherein the lumen in the cannula body has a cross-sectional shape in an unstressed condition with a width less than the width of the intercostal space and a height greater than the outer diameter of the valve prosthesis.

49. The access cannula of claim 48 wherein the lumen has a generally rectangular cross-section.

50. The access cannula of claim 48 wherein the lumen has a generally oval-shaped cross-section.

51. The access cannula of claim 48 wherein the cross-sectional height of the lumen is 2 to 6 times the cross-sectional width of the lumen.

52. The access cannula of claim 43 further comprising means at the proximal end of the cannula body for retaining a plurality of sutures extending through the lumen in a spaced apart relationship.

53. The access cannula of claim 52 wherein the suture retaining means comprises a plurality of slots in the proximal end of the cannula body in circumferentially spaced positions around the lumen.

54. The access cannula of claim 52 further comprising means at the proximal end of the cannula body for maintaining tension on the sutures.

55. The access cannula of claim 54 wherein the means for maintaining tension comprises an organizing ring having an interior passage through which the sutures may extend and a plurality of means circumferentially spaced around the passage for frictionally engaging the sutures.

56. The access cannula of claim 55 wherein the organizing ring comprises an inner ring, an outer ring rotatably coupled to the inner ring, a first plurality of apertures circumferentially spaced about the inner ring, and a second plurality of apertures circumferentially spaced about the outer ring, the first and second plurality of apertures being aligned when the outer ring is in a first rotational position, and nonaligned when the outer ring is in a second rotational position.

57. A cannula system to facilitate surgical intervention in a patient'"'"'s body cavity, the cannula system comprising:

a cannula body having a distal end, a proximal end, and a lumen therebetween, the lumen being configured for introduction of surgical instruments therethrough; and

organizer means at the proximal end of the cannula body for retaining a plurality of sutures extending through the lumen from the body cavity in spaced apart positions outside of the body cavity.

58. The cannula system of claim 57 wherein the cannula body is configured for positioning in an intercostal space in the patient'"'"'s chest.

59. The cannula system of claim 57 wherein the organizer means comprises a first organizing ring having an interior passage and a plurality of suture retaining means circumferentially spaced about the interior passage.

60. The cannula system of claim 59 wherein the first organizing ring is fixed to the proximal end of the cannula body with the interior passage aligned with the lumen.

61. The cannula system of claim 59 wherein the suture retaining means comprise a plurality of slots in the first organizing ring circumferentially spaced about the interior passage.

62. The cannula system of claim 60 further comprising means at the proximal end of the cannula body for maintaining the sutures in tension.

63. The cannula system of claim 62 wherein the means for maintaining the sutures in tension comprises a second organizing ring spaced apart from the first organizing ring, the second organizing ring having an interior passage and a plurality of means circumferentially spaced about the interior passage for holding the sutures in tension.

64. The cannula system of claim 63 wherein the means for holding the sutures in tension comprise slits in the second organizing ring for frictionally engaging the sutures.

65. The cannula system of claim 62 wherein the means for maintaining the sutures in tension comprises slits in the first organizing ring for frictionally engaging the sutures.

66. The cannula system of claim 58 further comprising means for holding a replacement valve outside the chest in proximity to the organizer means, whereby a suture extending from the body cavity through the lumen in the cannula may be applied to the replacement valve and secured in the organizer means.

67. The cannula system of claim 66 wherein the lumen is configured to facilitate introduction of the replacement valve therethrough into the body cavity.

68. A thoracoscopic device for placement of a replacement valve in a valve position of a patient'"'"'s heart, the thoracoscopic device comprising:

an elongated handle having a distal end and a proximal end, the handle configured for positioning through an intercostal space in the patient'"'"'s chest, and

means at the distal end of the handle for releasably holding a replacement valve in an orientation for introduction through the intercostal space.

69. The thoracoscopic device of claim 68 wherein the handle is at least about 20 cm in length.

70. The thoracoscopic device of claim 68 further comprising means for pivoting the replacement valve relative to the handle from a first orientation for introduction through the intercostal space, to a second orientation for placement in the valve position.

71. The thoracoscopic device of claim 68 wherein the pivoting means includes an actuator disposed at the proximal end of the handle.

72. The thoracoscopic device of claim 68 further comprising means at the proximal end of the handle for releasing the replacement valve from the holding means.

73. A prosthesis assembly for closed-chest replacement of a heart valve, the prosthesis assembly comprising:

replacement valve having an annular attachment portion and a movable valve portion coupled to the attachment portion; and

holder means releasably mounted to the attachment portion, wherein the holder means is configured to allow introduction of the replacement valve through an intercostal space in the patient'"'"'s chest.

74. The prosthesis assembly of claim 73 wherein the intercostal space has an intercostal width, the replacement valve and holder means together having a profile with a width less than the intercostal width.

75. The prosthesis assembly of claim 74 wherein the attachment portion of the replacement valve has an outer diameter which is greater than the intercostal width.

76. The prosthesis assembly of claim 73 wherein the holder means comprises an elongated handle having a distal end mounted to the replacement valve and a proximal end opposite the distal end, the handle being configured for introducing the replacement valve into the patient'"'"'s heart through the intercostal space.

77. The prosthesis assembly of claim 76 wherein the handle is at least about 20 cm in length so as to allow positioning the replacement valve in the heart from a right lateral portion of the chest.

78. The prosthesis assembly of claim 76 wherein the handle comprises means for releasing the replacement valve, the releasing means being configured for actuation from a proximal end of the handle.

79. The prosthesis assembly of claim 76 wherein the handle comprises means for pivoting the replacement valve from a first orientation for introduction through the intercostal space to a second orientation for attachment within the patient'"'"'s heart, the pivoting means being configured for actuation from a proximal end of the handle.

80. The prosthesis assembly of claim 73 wherein the intercostal space is less than about 20 mm in width.

81. The prosthesis assembly of claim 73 wherein the replacement valve and holding means are contained in a sterile pack.