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

• US 6,701,930 B2
• Filed: 11/06/2001
• Issued: 03/09/2004
• 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., Sepetka, Ivan, Taylor, Charles S., Benetti, Federico J., Glines, Robert C., Salahieh, Amr, Frantzen, John J.
• Primary Examiner(s): WEHNER, CARY ELLEN
• Application Number:
  US10/007,550
• Publication Number:
  US 20020040182A1
• Time in Patent Office: 854 Days
• Field of Search: 600/201, 600/204, 600/206, 600/210, 600/232, 600/233, 600/37, 600/226, 600/227, 600/228, 128/898
• 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 17/02 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 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• 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 2017/0243 for immobilizing local areas of the heart, e.g. while it beats
• 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 device, assesses the degree of movement of the anastomosis site, and exerts a force on the stabilizing device such that the contraction of the beating heart causes only minimal excess motion at the surgery site. By fixing the position of the stabilizing device 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 device 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 device 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 device becomes fixed by the support, and the heart remains substantially motionless for the duration of the procedure.

Claims

1. A method to install a coronary artery bypass graft from a source artery to a target coronary artery while the heart is beating comprising the steps of:

1) providing an access space to the beating heart by a surgical procedure selected from the group consisting of a thoracotomy and a sternotomy,

2) introducing a stabilizing means through the access space,

3) contacting the surface of the beating heart proximate to the target artery at an anastomosis with a stabilizing means,

4) exerting a stabilizing force on the beating heart by positioning the stabilizing means,

5) restricting blood flow through the target artery while allowing the heart to continue to beat,

6) sewing an anastomosis to the target artery,

7) re-establishing blood flow through the target artery.

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

a flexible lockable arm having a distal end and a proximal end;

a pair of contact members mounted to said distal end of said flexible lockable arm and adapted to contact a portion of the beating heart; and

a cable extending substantially the length of said flexible lockable arm and adapted to lock said arm in a substantially rigid state as well as unlock said arm to assume a substantially flexible state.

3. The device of claim 2, wherein said pair of contact members are positioned substantially in parallel to one another.

4. The device of claim 2, wherein said flexible lockable arm assumes said substantially rigid state upon tensioning said cable and said flexible lockable arm assumes said substantially flexible state upon releasing tension from said cable.

5. The device of claim 2, wherein said flexible lockable arm comprises a plurality of interconnecting links.

6. The device of claim 5, wherein each said link comprises a ball portion and a receiving portion, such that said ball portion fits conformingly into an adjacent one of said receiving portions.

7. The device of claim 5, wherein said cable runs through a center of each of said plurality of interconnecting links.

8. The device of claim 2, wherein each of said pair of contact members comprises a pair of contact elements.

9. The device of claim 8, wherein each said pair of contact elements are substantially in parallel alignment.

10. The device of claim 8, further comprising a snap fixture received between each said pair of contact elements and adapted to be affixed to a portion of the beating heart.

11. The device of claim 10, further comprising a suture associated with each said snap fixture and adapted to suture said snap fixture to the surface of the heart.

12. The device of claim 11, wherein each said suture is further affixed to a respective one of said contact members.

13. The device of claim 2, wherein said flexible lockable arm may be oriented in several directions when in said substantially flexible state.

14. The device of claim 2, wherein said flexible lockable arm allows positioning in every direction to place and orient said contact member.

15. A device for use in cardiovascular surgery on a beating heart, comprising:

a plurality of interconnecting links forming a flexible arm having a distal end and a proximal end;

a cable extending substantially the length of said flexible arm through said plurality of interconnecting links; and

a pair of contact members mounted to said distal end of said flexible arm and adapted to contact a portion of the beating heart.

16. The device of claim 15, wherein tensioning of said cable locks said flexible arm into a substantially rigid state, and release of tension from said cable allows said flexible arm to resume a substantially flexible state.

17. The device of claim 15, wherein said flexible arm allows positioning in every direction to place and orient said contact members.

18. A method of stabilizing a portion of a beating heart, said method comprising the steps of:

contacting a surface of the beating heart with a contact member of a device comprising a flexible lockable arm having a distal end and a proximal end, a contact member mounted to said distal end of said flexible lockable arm, and a cable extending substantially the length of said flexible lockable arm and adapted to lock said arm in a substantially rigid state as well as unlock said arm to assume a substantially flexible state;

contacting the surface of the beating heart with the contact member; and

tensioning the cable to place said flexible lockable arm in said substantially rigid state.

19. The method of claim 18, further comprising manipulating said flexible arm while in said substantially flexible state to achieve a desired orientation of the contact member for contacting the surface of the beating heart.

20. The method of claim 18, further comprising fixing the position of the device by attaching the device to a fixed support.

21. The method of claim 18, wherein said contacting a surface of the beating heart is performed with a pair of contact members.

22. A method of stabilizing a portion of a beating heart, said method comprising the steps of:

contacting a surface of the beating heart with at least one contact member of a stabilizing device having a stabilizing member capable of assuming a fixed state and an unfixed state;

maintaining the at least one member in contact with the surface of the beating heart; and

fixing the stabilizing member to assume the fixed state, relative to the beating heart to maintain the contact of the at least one contact member on the surface of the beating heart.

23. The method of claim 22, wherein a retractor is used to form an access opening to the beating heart, and wherein said fixing comprises fixing the stabilizing device to the retractor.

24. The method of claim 22, wherein the stabilizing device comprises a pair of contact members, the pair of contact members stabilizing surface portions of the beating heart on opposite sides of a target artery.

25. A method of creating an anastomosis to a target coronary artery of a beating heart during performance of a coronary artery bypass surgical procedure, said method comprising the steps of:

making an incision in the chest cavity of a patient;

inserting a retractor into the incision and actuating the retractor to form an access opening for accessing the beating heart;

introducing a stabilizing device through the access opening;

engaging a surface of the beating heart proximate to the target coronary artery with at least one contact member of the stabilizing device; and

fixing the stabilizing device to the retractor to maintain the position of the at least one contact member on the surface of the beating heart, for a duration of the surgical procedure sufficient to create the anastomosis.