Thoracoscopic devices and methods for arresting the heart

• US 5,536,251 A
• Filed: 04/03/1995
• Issued: 07/16/1996
• Est. Priority Date: 02/22/1993
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences LLC (Edwards Lifesciences Corporation)
• Original Assignee: Heartport, Inc. (Johnson & Johnson)
• Inventors: Gifford, Hanson S. III, Roth, Alex T., MacHold, Timothy R., Evard, Philip C., Sterman, Wesley D., Siegel, Lawrence C.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): VANOVER, PERRY
• Application Number:
  US08/415,273
• Time in Patent Office: 470 Days
• Field of Search: 604/28, 604/36, 604/53, 604/158, 604/19, 604/27, 604/93, 604/115-117, 604/164, 604/51-52, 604/56, 604/44, 604/4, 606/205-211, 128/DIG. 26
• US Class Current: 604/93.01
• 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 17/295 combined with cutting implements
• 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 17/34 Trocars; Puncturing needles pointed biopsy instruments A61B10/0233; devices for piercing the ear-lobes A44C7/001; seals or hemostasis valves A61M39/06
• 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 2017/00353 : one mechanical instrument performing multiple functions, e.g. cutting and grasping
• CPC Class Codes: A61B 2017/00544 : pneumatically
• 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
• 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
• 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 2017/2905 : flexible
• CPC Class Codes: A61B 2017/2933 : camming or guiding means
• CPC Class Codes: A61B 2017/2943 : Toothed members, e.g. rack and pinion
• CPC Class Codes: A61B 2017/2945 : Curved jaws
• CPC Class Codes: A61B 2017/2946 : Locking means
• 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 2017/3445 : used as instrument channel for multiple instruments
• 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 2018/1432 : curved
• 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: A61M 2025/0003 : having an additional lumen transmitting fluid pressure to the outside for measurement
• 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 2025/028 : having a mainly rigid support structure
• 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 25/01 : Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence
• 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
• CPC Class Codes: Y10S 128/26 : Cannula supporters

Abstract

The invention provides devices and methods for thoracoscopically arresting the heart and establishing cardiopulmonary bypass, thus facilitating a variety of less-invasive surgical procedures on and within the heart and great vessels of the thorax. In one embodiment, the invention provides a thoracoscopic system for arresting a patient'"'"'s heart including a clamp configured for introduction into the patient'"'"'s thoracic cavity through a percutaneous intercostal penetration in the patient'"'"'s chest. The clamp is positionable about the patient'"'"'s ascending aorta between the coronary arteries and the brachiocephalic artery. The clamp is coupled to the distal end of an elongated handle means for manipulating the clamp from a location outside of the patient'"'"'s thoracic cavity. A means for actuating the clamp is coupled to the proximal end of the handle means. When actuated, the clamp blocks blood flow through the ascending aorta. A delivery cannula may be used to deliver cardioplegic fluid into the ascending aorta upstream from the clamp to arrest cardiac function.

Claims

1. A thoracoscopic system for arresting a patient'"'"'s heart, the system comprising:

a clamp positionable about a patient'"'"'s ascending aorta between a coronary artery and a brachiocephalic artery, the clamp being configured for introduction into a thoracic cavity of the patient through a percutaneous intercostal penetration in the patient'"'"'s chest, the clamp being movable between an open position and a closed position;

an elongated handle having a distal end and a proximal end opposite the distal end for positioning the clamp about the ascending aorta from a location outside of the patient'"'"'s thoracic cavity, the elongated handle including an outer shaft having a length sized so that the clamp can reach the ascending aorta from a lateral side or an anterior side of the patient'"'"'s chest;

means coupled to the proximal end of the handle for actuating the clamp and moving the clamp from the open position to the closed position so as to block blood flow through an aortic lumen in the ascending aorta; and

a cardioplegic fluid delivery device for delivering cardioplegic fluid into the aortic lumen upstream of the clamp from a location outside of the patient'"'"'s thoracic cavity.

2. The system of claim 1 wherein:

the means for delivering cardioplegic fluid includes an endovascular delivery catheter transluminally positionable within the aortic lumen from an artery downstream of the ascending aorta, the endovascular delivery catheter being positionable within a portion of the ascending aorta; and

the clamp being positionable about the portion of the ascending aorta.

3. The system of claim 2 wherein the clamp is configured to block blood flow through the aortic lumen with the delivery catheter positioned therein.

4. The system of claim 1 wherein the cardioplegic fluid delivery device includes a delivery cannula positionable through a percutaneous penetration in the patient'"'"'s chest, the delivery cannula having a distal end with a port therein, a proximal end, a delivery lumen in fluid communication with the port, means at the distal end for penetrating a wall of the aorta, and means at the proximal end for delivering cardioplegic fluid into the delivery lumen.

5. The system of claim 4 wherein the delivery cannula is coupled to the handle and/or the clamp to facilitate penetration of the aorta at a predetermined location relative to the clamp.

6. The system of claim 4 further comprising means coupled to the distal end of the handle means for closing a penetration in the aorta formed by the penetrating means of the delivery cannula.

7. The system of claim 6 wherein the closing means includes closure actuation means at the proximal end of the handle.

8. The system of claim 7 further comprising a delivery actuator at the proximal end of the handle coupled to the delivery cannula to facilitate selective penetration of the delivery cannula into the aorta.

9. The system of claim 6 wherein the closing means comprises means for applying a staple to the wall of the aorta.

10. The system of claim 9 wherein the staple has a first leg, a second leg, and a connecting segment therebetween, the first and second legs each having a proximal end and a distal point for penetrating a portion of the wall of the aorta.

11. The system of claim 10 wherein the first and second legs are configured such that the points are closer together than the proximal ends thereof in an unstressed condition.

12. The system of claim 11 wherein the connecting segment is resiliently bendable to facilitate spreading the points of the first and second legs to an open position.

13. The system of claim 12 wherein the staple applying means is configured to apply the staple with the first and second legs in the open position.

14. The system of claim 12 wherein the staple applying means comprises a sleeve having a proximal end, a distal end, a passage therebetween, and means at the distal end of the passage for holding the staple in the open position.

15. The system of claim 14 further comprising means in the passage of the sleeve for ejecting the staple from the passage.

16. The system of claim 15 wherein the delivery cannula is slidably disposed in the passage of the sleeve.

17. The system of claim 16 wherein the delivery cannula is configured to engage the staple as the delivery cannula is advanced distally within the passage to eject the staple therefrom.

18. The system of claim 1, further comprising:

a source of cardioplegic fluid;

the cardioplegic fluid delivery device being fluidly coupled to the source of cardioplegic fluid.

19. The system of claim 1, further comprising:

a cardiopulmonary bypass system configured to place the patient on cardiopulmonary bypass.

20. The system of claim 1 wherein the clamp comprises a flexible cable or strap positionable around the aorta, and means for tensioning the cable or strap.

21. The system of claim 1 wherein the clamp comprises a first jaw having a first contact surface for engaging a first side of the aorta, and a second jaw having a second contact surface for engaging a second side of the aorta, the first and second jaws being movable toward each other from an open position to a clamping position configured to block blood flow through the aortic lumen.

22. The system of claim 21 wherein the first jaw is pivotally coupled to the second jaw.

23. The system of claim 21 wherein the first and second contact surfaces are generally parallel in the clamping position.

24. The system of claim 23 wherein the first and second contact surfaces are generally parallel through a range of motion between the open position and the clamping position.

25. A thoracoscopic system for arresting a patient'"'"'s heart, the system comprising:

a clamp positionable about a patient'"'"'s ascending aorta between a coronary artery and a brachiocephalic artery, the clamp being configured for introduction into a thoracic cavity of the patient through a percutaneous intercostal penetration in the patient'"'"'s chest;

elongated handle means having a distal end coupled to the clamp and a proximal end opposite the distal end for positioning the clamp about the ascending aorta from a location outside of the patient'"'"'s thoracic cavity;

means coupled to the proximal end of the handle means for actuating the clamp so as to block blood flow through an aortic lumen in the ascending aorta; and

means for delivering cardioplegic fluid into the aortic lumen upstream of the clamp from a location outside of the patient'"'"'s thoracic cavity, the means for delivering cardioplegic fluid having an endovascular delivery catheter transluminally positionable within the aortic lumen from an artery downstream of the ascending aorta, the delivery catheter being transluminally positionable into the aortic lumen from a femoral artery.

26. A thoracoscopic system for arresting a patient'"'"'s heart, the system comprising:

a clamp positionable about a patient'"'"'s ascending aorta between a coronary artery and a brachiocephalic artery, the clamp being configured for introduction into a thoracic cavity of the patient through a percutaneous intercostal penetration in the patient'"'"'s chest;

elongated handle means having a distal end coupled to the clamp and a proximal end opposite the distal end for positioning the clamp about the ascending aorta from a location outside of the patient'"'"'s thoracic cavity;

means coupled to the proximal end of the handle means for actuating the clamp so as to block blood flow through an aortic lumen in the ascending aorta; and

means for delivering cardioplegic fluid into the aortic lumen upstream of the clamp from a location outside of the patient'"'"'s thoracic cavity, the means for delivering cardioplegic fluid having a delivery cannula positionable through a percutaneous penetration in the patient'"'"'s chest, the delivery cannula comprising a distal end with a port therein, a proximal end, a delivery lumen in fluid communication with the port, means at the distal end for penetrating a wall of the aorta, and means at the proximal end for delivering cardioplegic fluid into the delivery lumen, the delivery cannula being coupled to the handle means and/or the clamp to facilitate penetration of the aorta at a predetermined location relative to the clamp, and the delivery cannula being longitudinally slidable relative to the clamp.

27. The system of claim 26 wherein the delivery cannula is slidably positioned within an inner lumen through the handle means.

28. The system of claim 26 wherein the delivery cannula may be positionally adjusted relative to the clamp to select the location at which to penetrate the aorta.

29. A thoracoscopic system for arresting a patient'"'"'s heart, the system comprising:

a clamp positionable about a patient'"'"'s ascending aorta between a coronary artery and a brachiocephalic artery, the clamp being configured for introduction into a thoracic cavity of the patient through a percutaneous intercostal penetration in the patient'"'"'s chest;

elongated handle means having a distal end coupled to the clamp and a proximal end opposite the distal end for positioning the clamp about the ascending aorta from a location outside of the patient'"'"'s thoracic cavity;

means coupled to the proximal end of the handle means for actuating the clamp so as to block blood flow through an aortic lumen in the ascending aorta; and

means for delivering cardioplegic fluid into the aortic lumen upstream of the clamp from a location outside of the patient'"'"'s thoracic cavity, the means for delivering cardioplegic fluid having a delivery cannula positionable through a percutaneous penetration in the patient'"'"'s chest, the delivery cannula comprising a distal end with a port therein, a proximal end a delivery lumen in fluid communication with the port, means at the distal end for penetrating a wall of the aorta, and means at the proximal end for delivering cardioplegic fluid into the delivery lumen, the delivery cannula being coupled to the handle means and/or the clamp to facilitate penetration of the aorta at a predetermined location relative to the clamp, the means for delivering cardioplegic fluid having a delivery lumen within the handle means extending from the proximal end to the distal end thereof, and a means coupled to the distal end of the handle means for penetrating a wall of the aorta, the penetrating means having an inner lumen therethrough in fluid communication with the delivery lumen in the handle means.

30. A thoracoscopic system for arresting a patient'"'"'s heart, the system comprising:

a clamp positionable about a patient'"'"'s ascending aorta between a coronary artery and a brachiocephalic artery, the clamp being configured for introduction into a thoracic cavity of the patient through a percutaneous intercostal penetration in the patient'"'"'s chest;

elongated handle means having a distal end coupled to the clamp and a proximal end opposite the distal end for positioning the clamp about the ascending aorta from a location outside of the patient'"'"'s thoracic cavity;

means coupled to the proximal end of the handle for actuating the clamp so as to block blood flow through an aortic lumen in the ascending aorta;

means for delivering cardioplegic fluid into the aortic lumen upstream of the clamp from a location outside of the patient'"'"'s thoracic cavity, the means for delivering cardioplegic fluid including a delivery cannula positionable through a percutaneous penetration in the patient'"'"'s chest, the delivery cannula comprising a distal end with a port therein, a proximal end, a delivery lumen in fluid communication with the port, means at the distal end for penetrating a wall of the aorta, and means at the proximal end for delivering cardioplegic fluid into the delivery lumen;

means coupled to the distal end of the handle means for closing a penetration in the aorta formed by the penetrating means of the delivery cannula, the closing means including closure actuation means at the proximal end of the handle; and

a delivery actuator at the proximal end of the handle coupled to the delivery cannula to facilitate selective penetration of the delivery cannula into the aorta;

the closure actuation means being coupled to the delivery actuator such that the closing means is actuated upon removal of the delivery cannula from the aorta.

31. An endoscopic system for clamping a hollow or tubular body structure and infusing a fluid therein, the system comprising:

a clamp positionable about the body structure, the clamp being configured for introduction into a body cavity of the patient through a percutaneous penetration, the clamp having a first jaw and a second jaw, the first and second jaws having contact surfaces which engage one another when the first and second jaws are in a closed position;

elongated handle means having a distal end coupled to the clamp and a proximal end opposite the distal end for positioning the clamp about the body structure from a location outside of the body cavity, the handle means including an outer tube having a longitudinal axis;

means coupled to the proximal end of the handle means for actuating the clamp so as to block an inner lumen in the body structure; and

a fluid delivery device for delivering a fluid into the inner lumen from a location outside of the patients body cavity, the fluid delivery device being at least partially positioned on the longitudinal axis of the outer tube;

the contact surfaces of the first and second jaws being offset relative to the longitudinal axis of the outer tube when the first and second jaws are in the closed position.

32. A clamp for clamping a structure in a body, comprising:

a handle having a distal end and a proximal end;

a flexible element having an end, the flexible element being coupled to the handle and extending from the distal end;

a coupler configured to engage the end of the flexible element; and

a tensioning device attached to at least one of the flexible element and the coupler, the tensioning device being configured to tension the flexible element.

33. A system for clamping an aorta in a patient and delivering a fluid into the aorta, comprising:

a clamp for clamping an aorta having an aortic lumen; and

a fluid delivery device configured to be transluminally positionable within the aortic lumen, the fluid delivery device including a first lumen having an opening for delivering a fluid into the aortic lumen;

the clamp being configured to be positioned around a portion of the aorta and the fluid delivery device being configured to be positioned within the portion of the aorta.

34. The system of claim 33, further comprising:

a pressure measuring device;

the fluid delivery device having a second lumen coupled to the pressure measuring device.

35. The system of claim 33, further comprising:

a source of cardioplegic fluid fluidly coupled to the first lumen of the fluid delivery device.

36. A device for clamping a structure in a patient and delivering a fluid into the structure, comprising:

an outer tube;

an inner tube at least partially disposed within the outer tube;

a first jaw and a second jaw each being coupled to at least one of the inner and outer tubes;

an actuator for moving the jaws between an open position and a closed position; and

a fluid delivery cannula at least partially positioned within the inner and outer tubes.

37. The device of claim 36, wherein:

the delivery cannula is coupled to the inner tube.

38. The device of claim 36, wherein:

the delivery cannula is not coupled to the inner tube.

39. A device for clamping an ascending aorta in a patient, comprising:

a handle including an elongate outer tube having a longitudinal axis;

a first jaw coupled to the handle;

a second jaw movable relative to the first jaw between an open position and a closed position, the first and second jaws being configured to clamp an ascending aorta in a patient; and

an actuator configured to move the second jaw from the open position to the closed position, the actuator having a slidable element which slidably engages the second jaw, the slidable element being slidably movable in a direction parallel to the longitudinal axis of the elongate outer tube and being at least partially positioned within the outer tube.

40. The device for clamping an ascending aorta of claim 39, wherein:

the slidable element slidably engages the first and second jaws.

41. A device for clamping an aorta in a patient and closing an opening in the aorta, comprising:

a handle;

a clamp configured to clamp around an aorta in a patient, the clamp being coupled to the handle and being movable between an open position and a closed position;

an actuator configured to move the clamp between the open and closed positions; and

means for closing an opening in the aorta, the closing means being coupled to the handle.

42. The device of claim 41, wherein:

the closing means is a stapler configured to apply a staple to close the opening in the aorta.

43. The device of claim 41, further comprising:

a fluid delivery device configured to deliver a fluid into the aorta.

44. The system of claim 43, wherein:

the closing means is a stapler configured to apply a staple to close the opening in the body structure.

45. The system of claim 44, wherein:

the closing means is configured to apply a staple having a bore therethrough; and

the fluid delivery device includes a needle extending through the bore in the staple.

46. A system for clamping an aorta and removing fluids from the aorta, comprising:

a clamp configured to clamp around a portion of an aorta;

a cardioplegic fluid delivery device having an occluding member configured for occluding the aorta, the cardioplegic fluid delivery device also having a first lumen for delivering cardioplegic fluid to the ascending aorta; and

means for removing air, fluids thrombus and/or other emboli from the aorta, the removing means being coupled to the cardioplegic fluid delivery device.

47. The system of claim 46, further comprising:

a source of cardioplegic fluid coupled to the cardioplegic fluid delivery device.

48. The system of claim 46, further comprising:

a pressure measuring device;

the cardioplegic fluid delivery device having a lumen coupled to the pressure measuring device.

49. The system of claim 46, wherein:

the occluding member is a balloon.

50. The system of claim 46, wherein:

the occluding member is funnel-shaped.