Method of Forming a Lesion in Heart Tissue

• US 7,100,614 B2
• Filed: 03/15/2002
• Issued: 09/05/2006
• Est. Priority Date: 02/22/1993
• Status: Expired due to Fees

• Current Assignee: Heartport, Inc. (Johnson & Johnson)
• Original Assignee: Heartport, Inc. (Johnson & Johnson)
• Inventors: Stevens, John H., Roth, Alex T., Peters, William S., Gifford, Hanson S., Reitz, Bruce A.
• Primary Examiner(s): Isabella, David J.
• Application Number:
  US10/099,690
• Publication Number:
  US 20020100485A1
• Time in Patent Office: 1,635 Days
• Field of Search: 128/898, 606/41, 606/33, 606/34, 606/32, 606/47, 607/122
• 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 17/2909 Handles
• CPC Class Codes: A61B 17/320016 Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes A61B10/0233, A61B17/29, A61B17/3207 take precedence
• CPC Class Codes: A61B 17/3211 Surgical scalpels, knives; Accessories therefor
• CPC Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 18/1442 Probes having pivoting end effectors, e.g. forceps
• CPC Class Codes: A61B 18/1482 having a long rigid shaft for accessing the inner body transcutaneously in minimal invasive surgery, e.g. laparoscopy
• 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 2017/00053 Mapping
• 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 2017/00349 Needle-like instruments having hook or barb-like gripping means, e.g. for grasping suture or tissue A61B17/06066 takes precedence
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00579 Barbed implements
• CPC Class Codes: A61B 2017/00592 : Elastic or resilient implements
• CPC Class Codes: A61B 2017/00597 : Implements comprising a membrane
• CPC Class Codes: A61B 2017/00606 : Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61B 2017/00619 : Locking means for locking the implement in expanded state
• CPC Class Codes: A61B 2017/00623 : Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/00867 : shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/00907 : for light
• 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 2017/2946 : 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 2017/3486 : Balloon
• 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 2018/00898 : Alarms or notifications created in response to an abnormal condition
• CPC Class Codes: A61B 2018/00982 : combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes
• CPC Class Codes: A61B 2018/1465 : Deformable electrodes
• CPC Class Codes: A61B 90/37 : Surgical systems with images on a monitor during operation
• 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 2025/028 : 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 2039/0297 : at least part of it being inflatable, e.g. for anchoring, sealing or removing
• 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 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 623/904 : Heart

Abstract

Devices, systems, and methods are provided for accessing the interior of the heart and performing procedures therein while the heart is beating. In one embodiment, a tubular access device having an inner lumen is provided for positioning through a penetration in a muscular wall of the heart, the access device having a means for sealing within the penetration to inhibit leakage of blood through the penetration. The sealing means may comprise a balloon or flange on the access device, or a suture placed in the heart wall to gather the heart tissue against the access device. An obturator is removably positionable in the inner lumen of the access device, the obturator having a cutting means at its distal end for penetrating the muscular wall of the heart. The access device is preferably positioned through an intercostal space and through the muscular wall of the heart. Elongated instruments may be introduced through the tubular access device into an interior chamber of the heart to perform procedures such as septal defect repair and electrophysiological mapping and ablation. A method of septal defect repair includes positioning a tubular access device percutaneously through an intercostal space and through a penetration in a muscular wall of the heart, passing one or more instruments through an inner lumen of the tubular access device into an interior chamber of the heart, and using the instruments to close the septal defect. Devices and methods for closing the septal defect with either sutures or with patch-type devices are disclosed.

Claims

1. A method of forming a lesion in heart tissue of a patient to treat atrial fibrillation, consisting essentially of:

providing an electrophysiological ablating device comprising at least one electrode;

creating an opening in a patient'"'"'s chest, the opening passing through the chest wall and into the patient'"'"'s thoracic cavity;

passing the electrode through the opening;

positioning the electrode adjacent to heart tissue; and

ablating the heart tissue with the electrode to create a lesion in the heart tissue while the heart is beating to treat atrial fibrillation.

2. The method of claim 1, comprising the steps of:

creating a second opening in the wall of the patient'"'"'s heart, the second opening passing through the wall of the heart and into an interior chamber of the heart;

positioning the electrode through the second opening and within an interior chamber of the heart prior to the step of ablating the heart tissue with the electrode.

3. The method of claim 2, wherein the step of positioning the electrode within a chamber of the patient'"'"'s heart comprises the steps of:

introducing a tubular access device into the second opening, the access device having an inner lumen and a distal end;

inserting the electrophysiological ablation device through the inner lumen of the tubular access device such that the electrode extends beyond the distal end of the access device and within an interior chamber of the heart.

4. The method of claim 1, wherein the opening is created intercostally and the electrophysiological ablation device is introduced through the intercostal space.

5. The method of claim 4, wherein the opening is a small percutaneous incision in the space between the ribs.

6. The method of claim 1, wherein the opening is created without retracting the sternum.

7. The method of claim 1, wherein the opening is created without retracting the ribs.

8. The method of claim 1, wherein the step of ablating the heart tissue comprises the step of applying radiofrequency energy to create the lesion in the heart tissue.

9. A method of forming a lesion in heart tissure of a patient, comprising:

provding a device comprising a rigid shaft having a distal end and a proximal end, a flexible tip attached to the distal end of the shaft, and at least one ablating element carried on the flexible tip;

creating an opening in a patient'"'"'s chest, the opening passing through the chest wall and into the patient'"'"'s thoracic cavity;

passing at least a portion of the flexible tip of the device through the opening;

positioning the flexible tip of the device adjacent to hear tissue; and

ablating the heart tissue with energy delivered form the energy source to create a lesion in the heart tissue while the heart is beating.

10. The method of claim 9, comprising the steps of:

creating a second opening in the wall of the patient'"'"'s heart, the second opening passing through the wall of the heart and into an interior chamber of the heart;

positioning at least a portion of the flexible tip of the device through the second opening and within an interior chamber of the heart prior to the ablating step.

11. The method of claim 10, wherein the step of positioning the at least a portion of the flexible tip of the device within a chamber of the patient'"'"'s heart comprises the steps of:

introducing a tubular access device into the second opening, the access device having an inner lumen and a distal end;

inserting the device through the inner lumen of the tubular access device such that the at least one ablating element extends beyond the distal end of the access device and within an interior chamber of the heart.

12. The method of claim 9, wherein the opening is created intercostally and the device is introduced through the intercostal space.

13. The method of claim 9, wherein the opening is a small percutaneous incision in the space between the ribs.

14. The method of claim 9, wherein the opening is created without retracting the sternum.

15. The method of claim 9, wherein the opening is created without retracting the ribs.

16. The method of claim 9, wherein the step of ablating the heart tissue comprises the step of applying radiofrequency energy to create the lesion in the heart tissue

17. The method of claim 9, wherein the energy source is radiofrequency energy.

18. The method of claim 9, wherein the energy source is laser.

19. The method of claim 9, wherein the device has a first configuration and a second configuration, and comprising the step of actuating the device to step of ablating.

20. The method of claim 19, wherein the actuating step causes at least the distal end of the device to deflect.

21. The method of claim 19, wherein the actuating step creates a compressive force.

22. The method of claim 19, comprising the step of actuating the device to create a compressive force.

23. The method of claim 9, wherein the step of ablating comprises creating ablation lines in the myocardium to create a directed conduction pathway.

24. The method of claim 9, wherein the step of ablating comprises creating at least one ablation line of the Cox maze procedure.

25. The method of claim 9, wherein the step of ablating comprises creating ablation lines in the myocardium to treat atrial fibrillation.

26. The method of claim 25, wherein the ablation lines are for creating a directed conduction pathway is between the sinoatrial node and the atrioventricular node.

27. The method of claim 9, wherein the device comprises at least one electrode and wherein the positioning step positions the at leasat one electrode against the heart tissue.

28. The method of claim 9, wherein the device has a length of approximately 20 to 30 cm.

29. The method of claim 9, wherein the device has a length of at least 20 cm.

30. A method of forming a lesion in heart tissue of a patient, comprising:

providing a device comprising a rigid shaft having a distal end and a proximal end, a flexible tip attached to the distal end of the shaft, and at least one ablating element carried on the flexible;

creating an opening in a patient'"'"'s chest, the opening passing through the chest wall and into the patient'"'"'s thoracic cavity;

passing the distal end of the device through the opening;

positioning the distal end of the device adjacent to heart tissue; and

delivering energy via the device to the distal end of the device to create a lesion in the heart tissue while the heart is beating.

31. A method of forming a lesion in heart tissue of a patient, comprising:

providing a device comprising a rigid shaft having a distal end and a proximal end, a flexible tip attached to the distal end of the shaft, and at least one ablating element carried on the flexible tip;

creating an opening in a patient'"'"'s chest without retracting the sternum, the opening passing through the chest wall and into the patient'"'"'s thoracic cavity;

passing at least the distal end of the device through the opening;

positioning the distal end of the device adjacent to heart tissue; and

delivering energy via the device to the distal end of the device to create a lesion in the heart tissue while the heart is beating.

32. The method of claim 31, wherein the opening is created without retracting the ribs.

33. The method of claim 31, wherein the opening is created intercostally.

34. The method of claim 33, wherein the opening is a small percutaneous incision in the space between the ribs.