Surgical instruments and procedures for stabilizing the beating heart during coronary artery bypass graft surgery

• US 6,743,169 B1
• Filed: 10/10/2001
• Issued: 06/01/2004
• Est. Priority Date: 02/20/1996
• Status: Expired due to Fees

• Current Assignee: Maquet Cardiovascular LLC (Getinge AB)
• Original Assignee: Cardiothoracic Systems, Inc. (Boston Scientific Corporation)
• Inventors: Regan, Brent, Aldrich, William N., Ginn, Richard S., Witt, William F., Morejohn, Dwight P., Glines, Robert C., Fogarty, Thomas J., Salahieh, Amr, Weller, Gary B., Sherman, Benjamin, Subramanian, Valavanur A., Frantzen, John J., Billig, Michael J., Baughman, Thomas L., Skieller, Christian, Bennett, Brian J., Sepetka, Ivan, Reis, Eugene E., Taylor, Charles S., Benetti, Federico J., Green, Harry L.
• Primary Examiner(s): WEHNER, CARY ELLEN
• Application Number:
  US09/975,392
• Time in Patent Office: 965 Days
• Field of Search: 600/201, 600/204, 600/210, 600/226, 600/227, 600/228, 600/229, 600/231, 600/232, 600/235, 600/233, 600/37
• US Class Current: 600/204
• 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 17/02 for holding wounds open; Tractors specula A61B1/32 ; drainage appliances for wounds A61M27/00
• CPC Class Codes: A61B 17/0206 with antagonistic arms as supports for retractor elements
• 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 17/0642 for bones, e.g. for osteosynthesis or connecting tendon to bone
• CPC Class Codes: A61B 17/12 for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord specially adapted for vas deferens or fallopian tubes A61F6/20; materials for ligaturing blood vessels A61L17/00
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 17/3423 Access ports, e.g. toroid shape introducers for instruments or hands access sites for liquids A61M39/0247
• CPC Class Codes: A61B 17/8076 for the ribs or the sternum
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00539 hydraulically
• CPC Class Codes: A61B 2017/00703 correcting for movement of heart, e.g. ECG-triggered
• CPC Class Codes: A61B 2017/00858 high friction or non-slip
• CPC Class Codes: A61B 2017/00991 Telescopic means
• CPC Class Codes: A61B 2017/0243 for immobilizing local areas of the heart, e.g. while it beats
• CPC Class Codes: A61B 2017/0648 threaded, e.g. tacks with a screw thread
• CPC Class Codes: A61B 2017/1139 Side-to-side connections, e.g. shunt or X-connections
• CPC Class Codes: A61B 2017/2825 Inserts of different material in jaws
• CPC Class Codes: A61B 2017/2913 cams or guiding means
• CPC Class Codes: A61B 2017/2929 with a head rotatable about the longitudinal axis of the shaft
• CPC Class Codes: A61B 2017/306 : holding by means of suction
• CPC Class Codes: A61B 2017/349 : Trocar with thread on outside
• CPC Class Codes: A61B 90/00 : Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges protective face masks A41D13/11; surgeon's or patient's gowns or dresses A41D13/12; devices for carrying-off, for treatment of, or for carrying-over, body liquids A61M1/00

Abstract

The invention is methods and devices which a surgeon may use to stabilize the beating heart during a surgical procedure on the heart. Pursuant to the invention, a stabilizing device is introduced through an opening in the chest and brought into contact with the beating heart. By contacting the heart with the device and by exerting a stabilizing force on the device, the motion of the heart caused by the contraction of the heart muscles is effectively eliminated such that the heart is stabilized and the site of the surgery moves only minimally if at all. Typically, in separate steps, the surgeon contacts the heart with the stabilizing means, assesses the degree of movement of the anastomosis site, and exerts a force on the stabilizing means such that the contraction of the beating heart causes orgy minimal excess motion at the surgery site. By fixing the position of the stabilizing means in a configuration where the motion of the beating heart is effectively eliminated, the surgeon is able to stabilize the beating heart for the duration of the procedure. The stabilizing means may be attached to a rigid support or may be attached to a semi-rigid support which is rendered motionless mechanically, chemically, or by human intervention. In certain preferred embodiments, the stabilizing means is affixed to a semi-rigid support which is caused to become rigid, by any of a variety of techniques, such that the position of the stabilizing means becomes fixed by the support, and the heart remains substantially motionless for the duration of the procedure.

Claims

1. A device for use in a cardiovascular surgery on the beating heart comprising:

a means for stabilizing the beating heart comprising a contact member shapeable to conform to and engage the surface of the beating heart; and

adapted to stabilize the beating heart by exerting a mechanical stabilizing force on the exterior of the heart; and

means for introducing a positive or negative pressure to said contact member to fix a shape of said contact member.

2. A device for use in a cardiovascular surgery on the beating heart comprising:

a means for stabilizing the beating heart comprising a contact member shaped to engage the surface of the beating heart; and

wherein said contact member has a hollow portion containing a conformable material therein.

3. The device of claim 2 wherein said conformable material is granular, a polymeric, or a gel.

4. A device for use in a cardiovascular surgery on the beating heart comprising:

a means for stabilizing the beating heart comprising a contact member shaped to engage the surface of the beating heart; and

wherein said contact member is formed of a single continuous wire.

5. A device for use in a cardiovascular surgery on the beating heart comprising:

a means for stabilizing the beating heart comprising a contact member shaped to engage the surface of the beating heart; and

wherein said contact member is inflatable.

6. A device for use in cardiovascular surgery on the beating heart, comprising:

a shaft means for adjusting the position and orientation of said device, having a distal end portion and a proximal end portion; and

at least one continuously adjustable contact member connected to said distal end portion of said shaft means for adjusting the position and orientation of said device, said at least one continuously adjustable contact member comprising a flexible tube and adapted to be adjusted to change a conformation of said at least one continuously adjustable contact member and to maintain the changed conformation, to substantially conform to a surface of the heart.

7. The device of claim 6, wherein said at least one continuously adjustable contact member is adapted to be bent into a U-shaped configuration.

8. The device of claim 6, wherein said at least one continuously adjustable contact member is configured for application of a vacuum thereto to substantially fix the at least one contact member in its currently adjusted configuration.

9. The device of claim 6, wherein said flexible tube contains a plurality of particles or beads.

10. The device of claim 9, further comprising a vacuum lumen connecting with said flexible tube, wherein upon application of vacuum through said vacuum lumen, said particles or beads are compressed by atmospheric pressure causing said flexible tube to become substantially rigid.

11. The device of claim 9, further comprising a malleable member extending along at least a portion of a length of said flexible tube.

12. The device of claim 11, wherein said malleable member comprises a wire.

13. The device of claim 11, further comprising a plurality of disks disposed along said malleable member.

14. The device of claim 6, further comprising a malleable member extending along least a portion of a length of said flexible tube.

15. The device of claim 14, wherein said malleable member comprises a wire.

16. The device of claim 14, further comprising a plurality of disks disposed along said malleable member.

17. The device of claim 6, wherein said flexible tube is inflatable.

18. The device of claim 6, wherein said at least one continuously adjustable contact member comprises a pair of continuously adjustable contact members.

19. The device of claim 18, wherein each of said pair of continuously adjustable contact members comprises a flexible tube.

20. The device of claim 19, wherein each said flexible tube contains a plurality of particles or beads.

21. The device of claim 20, further comprising a vacuum lumen connecting with each said flexible tube, wherein upon application of vacuum through said vacuum lumen, said particles or beads are compressed by atmospheric pressure causing said flexible tubes to become substantially rigid.

22. The device of claim 21, further comprising a malleable member extending along least a portion of a length of each said flexible tube.

23. The device of claim 22, wherein each said malleable member comprises a wire.

24. The device of claim 22, further comprising a plurality of disks disposed along each said malleable member.

25. The device of claim 19, wherein each said flexible tube is inflatable.

26. The device of claim 6, wherein said at least one continuously adjustable contact member comprises a plurality of continuously adjustable contact members.

27. A device for use in cardiovascular surgery on the beating heart, comprising:

a shaft means having a distal end portion, a proximal end portion, and a central lumen disposed therethrough; and

a preformed inflatable member connected to said distal end portion of said shaft means, said preformed inflatable member being inflatable to form a contact member adapted to contact a surface of the heart.

28. The device of claim 27, further comprising an insertion tube having an inside diameter allowing said shaft means to pass therethrough, wherein, when said inflatable member is adapted to pass through said insertion tube when in a deflated state, and is impassable through said insertion tube when in an inflated state.

29. The device of claim 27, wherein said preformed inflatable member is an inflatable balloon.

30. The device of claim 27, wherein said preformed inflatable member forms a pair of said contact members upon inflation thereof.

31. A method of preparing a device for use in cardiovascular surgery on the beating heart, wherein the device has at least one continuously adjustable contact member adapted to be adjusted to substantially conform to a surface of the heart, said method comprising the steps of:

manipulating the at least one continuously adjustable contact member into a desired configuration; and

applying a vacuum to the at least one continuously adjustable contact member to substantially fix the desired configuration.

32. The method of claim 31, wherein the device is deployed for use in minimally invasive cardiovascular surgery, said method further comprising the steps of:

prior to said manipulating into a desired configuration, manipulating the at least one continuously adjustable contact member into a configuration capable of passing through a minimally invasive opening providing access to the heart; and

passing the at least one continuously adjustable contact member through the minimally invasive opening which provides access to the heart.

33. A method of deploying a device for use in minimally invasive cardiovascular surgery, wherein the device has a preformed inflatable member which is inflatable to form a contact member adapted to contact a surface of the heart, said method comprising the steps of:

passing said inflatable member, in a deflated state through a minimally invasive incision which provides access to the heart;

inflating said inflatable member to form the contact member; and

contacting the surface of the heart with said contact member.

34. The method of claim 33, wherein said passing step is performed by passing said inflatable member through an insertion tube which is inserted through the minimally invasive incision.

35. A device for stabilizing a portion of a beating heart during cardiovascular surgery, said device, comprising:

a shaft means having a distal end portion and a proximal end portion; and

at least one continuously adjustable contact member adapted to be adjusted to substantially conform to a surface of the heart; and

an opening in said at least one continuously adjustable contact member through which negative pressure may be applied, wherein upon application of negative pressure, said at least one continuously adjustable contact member substantially rigidifies in a position to which said contact member was adjusted at the time of application of vacuum.

36. The device of claim 35, wherein said at least one continuously adjustable contact member is substantially U-shaped.

37. The device of claim 36, further comprising a shaft means connected to said at least one continuously adjustable contact member and extending therefrom.

38. The device of claim 37, wherein said shaft means comprises a flexible, lockable arm.

39. The device of claim 35, wherein said at least one continuously adjustable contact member contains a plurality of particles or beads.