Devices and methods for port-access multivessel coronary artery bypass surgery

• US 5,799,661 A
• Filed: 06/07/1995
• Issued: 09/01/1998
• 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: Rapacki, Alan R., Peters, William S., Boyd, Stephen W.
• Primary Examiner(s): Polutta, Mark O.
• Application Number:
  US08/486,941
• Time in Patent Office: 1,182 Days
• Field of Search: 128/898, 604/264, 604/49, 604/48, 606/7, 606/8, 623/66, 623/1-3
• 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 17/2804 with two or more pivotal connections A61B17/29 takes precedence
• 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 2017/0237 : for heart surgery
• 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 2017/2912 : transmission of forces to actuating rod or piston
• CPC Class Codes: A61B 2017/2927 : the angular position of the head being adjustable with respect to the shaft
• CPC Class Codes: A61B 2017/2932 : Transmission of forces to jaw members
• 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 2017/308 : with suction cups
• CPC Class Codes: A61B 2017/320056 : Tunnelers
• 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 2090/306 : using optical fibres
• CPC Class Codes: A61B 2217/005 : with suction drainage system
• CPC Class Codes: A61B 90/36 : Image-producing devices or illumination devices not otherwise provided for
• 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 2007/0001 : Body part
• CPC Class Codes: A61F 2007/0054 : with a closed fluid circuit, e.g. hot water
• CPC Class Codes: A61F 2007/101 : for cooling organs in the body before or during surgery
• CPC Class Codes: A61F 7/10 : Cooling bags, e.g. ice-bags
• 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 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 25/1011 : 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

Surgical methods and instruments are disclosed for performing port-access or closed-chest coronary artery bypass (CABG) surgery in multivessel coronary artery disease. In contrast to standard open-chest CABG surgery, which requires a median sternotomy or other gross thoracotomy to expose the patient'"'"'s heart, port-access CABG surgery is performed through small incisions or access ports made through the intercostal spaces between the patient'"'"'s ribs, resulting in greatly reduced pain and morbidity to the patient. In situ arterial bypass grafts, such as the internal mammary arteries and/or the right gastroepiploic artery, are prepared for grafting by thoracoscopic or laparoscopic takedown techniques. Free grafts, such as a saphenous vein graft or a free arterial graft, can be used to augment the in situ arterial grafts. The graft vessels are anastomosed to the coronary arteries under direct visualization through a cardioscopic microscope inserted through an intercostal access port. Retraction instruments are provided to manipulate the heart within the closed chest of the patient to expose each of the coronary arteries for visualization and anastomosis. Disclosed are a tunneler and an articulated tunneling grasper for rerouting the graft vessels, and a finger-like retractor, a suction cup retractor, a snare retractor and a loop retractor for manipulating the heart. Also disclosed is a port-access topical cooling device for improving myocardial protection during the port-access CABG procedure. An alternate surgical approach using an anterior mediastinotomy is also described.

Claims

1. A method of performing coronary artery bypass graft surgery at a surgical site on a heart within a chest of a patient, the chest having a sternum and a plurality of ribs, each rib being separated from an adjacent rib by an intercostal space, the method comprising the steps of:

making first and second access ports into the chest through at least one intercostal space, the surgical site being on an aspect of the heart facing away from the first access port;

arresting the patient'"'"'s heart;

introducing a retraction instrument through the second access port;

manipulating the retraction instrument to reposition the heart within the chest into a retracted position wherein the aspect of the heart containing the surgical site is facing the first access port; and

anastomosing a vascular graft to a coronary artery at the surgical site using an anastomosing instrument introduced through the first access port;

wherein the ribs and sternum remain intact during each of said steps.

2. The method of claim 1 wherein the second access port is made in a left lateral portion of the chest.

3. The method of claim 1 wherein the first access port is made in an anterior portion of the chest.

4. The method of claim 3 wherein the aspect of the heart is selected from the group including a posterior aspect, a right lateral aspect, and a left lateral aspect.

5. The method of claim 1, further comprising the step of:

visualizing the heart with a visualization instrument introduced into the chest of the patient through a third access port positioned within an intercostal space.

6. The method of claim 1 wherein the anastomosing step comprises anastomosing the vascular graft onto a circumflex artery.

7. The method of claim 1, wherein the anastomosing step comprises anastomosing the vascular graft onto a right coronary artery.

8. The method of claim 1 wherein the anastomosing step comprises anastomosing the vascular graft onto a posterior descending coronary artery.

9. The method of claim 1, wherein the vascular graft is selected from the group including a left internal mammary artery, a right internal mammary artery, a gastroepiploic artery, a radial artery, a saphenous vein, and a prosthetic vascular graft.

10. The method of claim 1 further comprising the step of:

dissecting an internal mammary artery from an anterior wall of the patient'"'"'s chest;

temporarily clamping the internal mammary artery; and

wherein the anastomosing step comprises anastomosing the internal mammary artery onto the coronary artery.

11. The method of claim 10 wherein the step of dissecting comprises dissecting the right internal mammary artery from an anterior wall of the chest using a dissection instrument introduced through an access port in an intercostal space in a right lateral portion of the chest.

12. The method of claim 10 further comprising routing the right internal mammary into a left portion of the chest using a grasping instrument introduced through an access port in an intercostal space.

13. The method of claim 12 wherein the right internal mammary artery is routed through a transverse epicardial sinus of the patient into the left portion of the chest.

14. The method of claim 13 wherein the grasping instrument is introduced through an access port in a left lateral portion of the chest, further comprising tunneling the grasping instrument through the transverse epicardial sinus into a right portion of the chest before the step of routing.

15. The method of claim 1, further comprising the step of:

anastomosing the vascular graft onto a second coronary artery using an anastomosing instrument introduced through an access port within an intercostal space.

16. The method of claim 15, wherein the first anastomosing step comprises creating a side-to-side anastomosis between the vascular graft and the coronary artery and the second anastomosing step comprises creating an end-to-side anastomosis between the vascular graft and the second coronary artery.

17. The method of claim 1, further comprising the step of:

anastomosing a second vascular graft onto a second coronary artery using an anastomosing instrument introduced through an access port within an intercostal space.

18. The method of claim 17 wherein the second vascular graft is selected from the group including a left internal mammary artery, a right internal mammary artery, a gastroepiploic artery, a radial artery, a saphenous vein, and a prosthetic vascular graft.

19. The method of claim 17 wherein the second coronary artery is selected from the group including a left anterior descending coronary artery, a circumflex artery, a right coronary artery, and a posterior descending coronary artery.

20. The method of claim 17, further comprising the step of:

anastomosing the second vascular graft onto a third coronary artery.

21. The method of claim 20, wherein the second anastomosing step comprises creating a side-to-side anastomosis between the second vascular graft and the second coronary artery and the third anastomosing step comprises creating an end-to-side anastomosis between the second vascular graft and the third coronary artery.

22. The method of claim 1 wherein the manipulating step comprises the substep of applying a vacuum between a surface of the retraction instrument and a surface of the heart to grip the heart with the retraction instrument.

23. The method of claim 1 wherein the manipulating step comprises the substep of lifting the heart with a rigid finger on the retraction instrument.

24. The method of claim 1 wherein the manipulating step comprises the substeps of placing a flexible loop on the retraction instrument around the heart and tightening the loop.

25. The method of claim 1 wherein the manipulating step comprises rotating the heart.

26. The method of claim 25 wherein the heart is rotated about an axis extending longitudinally through the heart from an aortic root generally toward an apex of the heart.

27. The method of claim 25 wherein the heart is rotated about an axis disposed at an angle between 0 degrees and 90 degrees relative to a longtidudinal axis extending from an aortic root toward an apex of the heart.

28. The method of claim 1, further comprising the step of:

cooling the patient'"'"'s heart with a myocardial cooling device inserted into the chest of the patient through an access port in an intercostal space.

29. The method of claim 1, further comprising the step of:

partitioning an ascending aorta of the patient, paralyzing the heart, and maintaining circulation of oxygenated blood in the patient.

30. The method of claim 29 wherein the partitioning step comprises the substep of introducing an intraluminal occlusion device into a peripheral artery of the patient, transluminally advancing the intraluminal occlusion device into the ascending aorta and occluding the ascending aorta between the patient'"'"'s coronary ostia and brachiocephalic artery.

31. The method of claim 1 wherein the introducing step comprises the substeps of inserting the retraction instrument through the access port in a predeployed state and deploying the retraction instrument into a deployed state within the chest of the patient.

32. The method of claim 31 wherein the retraction instrument has a profile in the predeployed state which is smaller than its profile in the deployed state.

33. The method of claim 32 wherein the profile in the predeployed state has a diameter of less than about 12 mm.

34. The method of claim 1 wherein the step of anastomosing comprises forming an opening in the coronary artery with a cutting instrument introduced through an access port in an intercostal space, and attaching the vascular graft to the coronary artery around the opening.

35. The method of claim 34 wherein the step of attaching comprises suturing the vascular graft to the coronary artery using a suturing instrument introduced through an access port in an intercostal space.

36. The method of claim 34 wherein the step of attaching comprises introducing a suture into the chest of the patient through an access port in an intercostal space and suturing the vascular graft to the coronary artery with the suture.

37. The method of claim 36 wherein the suture has a first end and a second end, a first needle attached to said first end and a second needle attached to said second end, said suture having a length of about 8 to 10 centimeters, and wherein the step of attaching comprises tying the suture within the chest of the patient using a suturing instrument introduced through an access port in an intercostal space.

38. The method of claim 1 further comprising the step of dissecting a gastroepiploic artery within an abdomen of the patient to create a free end thereof, clamping the gastroepiploic artery, and routing the free end into the chest, the step of anastomosing comprising anastomosing the free end to the coronary artery.

39. The method of claim 38 wherein the step of dissecting comprises dissecting the gastroepiploic artery using a dissection instrument introduced into the abdomen an access cannula positioned in a wall of the abdomen.

40. The method of claim 39 wherein the step of dissecting further comprises visualizing the interior of the abdomen using a scope introduced through an access cannula into the abdomen.

41. The method of claim 38 wherein the step of routing comprises creating an opening in a diaphragm of the patient between the abdomen and the chest, and introducing the free end of the gastroepiploic artery through the opening into the chest.

42. A method of performing coronary artery bypass graft surgery at a surgical site on a heart within a chest of a patient, the chest having a sternum and a plurality of ribs, each rib being connected to the sternum by a costal cartilage, the method comprising the steps of:

creating a mediastinotomy by a method selected from (i) making an intercostal incision between two ribs and (ii) cutting a costal cartilage to disconnect a rib from the sternum;

introducing a retraction instrument through the mediastinotomy;

arresting the patient'"'"'s heart;

manipulating the retraction instrument to reposition the heart within the chest into a retracted position wherein an aspect of the heart containing the surgical site is visible through the mediastinotomy; and

anastomosing a vascular graft to a coronary artery at the surgical site using an anastomosing instrument introduced through the mediastinotomy.

43. The method of claim 42 wherein the mediastinotomy is less than about 60 mm in length.

47. The method of claim 42, further comprising the steps of:

transecting a free end of the vascular graft from the patient, the vascular graft being an artery of the patient; and

temporarily clamping the vascular graft so that blood does not pass through the free end of the vascular graft for a period of time.

44. A method of performing coronary artery bypass graft surgery at a surgical site on a heart within a chest of a patient, the chest having a sternum and a plurality of ribs, each rib being separated from an adjacent rib by an intercostal space, the method comprising the steps of:

placing a catheter in an ascending aorta leading away from the patient'"'"'s heart;

arresting the patient'"'"'s heart;

occluding the ascending aorta by means of an occluding member on the catheter;

circulating oxygenated blood through the patient'"'"'s arterial system downstream of the occluding member;

making at least one access port into the chest through at least one intercostal space, the surgical site being on an aspect of the heart facing away from the access port;

introducing a retraction instrument through one of the at least one access ports;

manipulating the retraction instrument to reposition the heart within the chest into a retracted position wherein the aspect of the heart containing the surgical site is visible through one of the at least one access ports; and

anastomosing a vascular graft to a coronary artery at the surgical site using an anastomosing instrument introduced through one of the at least one access ports.

48. The method of claim 44, further comprising the steps of:

transecting a free end of the vascular graft from the patient, the vascular graft being an artery of the patient; and

temporarily clamping the vascular graft so that blood does not pass through the free end of the vascular graft for a period of time.

45. A method of performing coronary artery bypass graft surgery at first and second surgical sites on a heart within a chest of a patient, the chest having a sternum and a plurality of ribs, each rib being separated from an adjacent rib by an intercostal space, the method comprising the steps of:

making at least one access port into the chest through at least one intercostal space, the first surgical site being on a first aspect of the heart facing the access port;

arresting the patient'"'"'s heart;

anastomosing a first vascular graft to a first coronary artery at the first surgical site using an anastomosing instrument, the anastomosing instrument being manipulated from outside the chest by means of a handle extending out of the chest through one of the at least one access ports;

introducing a retraction instrument through one of the at least one access ports, the retraction instrument having a proximal end extending out of the chest through one of the at least one access ports;

manipulating the proximal end of the retraction instrument to reposition the heart within the chest into a retracted position wherein a second aspect of the heart containing a second surgical site is facing one of the at least one access ports; and

anastomosing a second vascular graft to a second coronary artery at the second surgical site using an anastomosis instrument having an elongaged handle after the manipulating step, the anastomosis instrument being manipulated from outside the chest by means of the handle which extends out of the chest through one of the at least one access ports.

49. The method of claim 45, further comprising the steps of:

transecting a free end of the first vascular graft from the patient, the first vascular graft being an artery of the patient; and

temporarily clamping the first vascular graft so that blood does not pass through the free end of the first vascular graft for a period of time.

46. A method of performing coronary artery bypass graft surgery at a surgical site on a heart within a chest of a patient, the chest having a sternum and a plurality of ribs, each rib being separated from an adjacent rib by an intercostal space, the method comprising the steps of:

making at least one access port into the chest through at least one intercostal space, the surgical site being on an aspect of the heart facing away from the access port;

arresting the patient'"'"'s heart;

introducing a retraction instrument through one of the at least one access ports;

manipulating the retraction instrument to reposition the heart within the chest into a retracted position wherein the aspect of the heart containing the surgical site is visible through one of the at least one access ports; and

anastomosing a vascular graft to a coronary artery at the surgical site using an anastomosing instrument introduced through one of the at least one access ports, wherein the retraction instrument and the anastomosing instrument are manipulated substantially entirely from outside the chest.

50. The method of claim 46, further comprising the steps of:

transecting a free end of the vascular graft from the patient, the vascular graft being an artery of the patient; and

temporarily clamping the vascular graft so that blood does not pass through the free end of the vascular graft for a period of time.