Method and apparatus for thoracoscopic intracardiac procedures

• US 5,797,960 A
• Filed: 04/20/1995
• Issued: 08/25/1998
• 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:
  US08/425,179
• Time in Patent Office: 1,223 Days
• Field of Search: 606/185, 606/213, 606/215, 606/151, 606/153, 606/191, 604/164, 604/174, 604/101, 604/93, 600/204, 600/207, 600/201, 600/208, 600/215, 128/898
• US Class Current: 606/213
• 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 system for closing a cardiac septal defect in a chamber of a patient'"'"'s heart having a muscular outer wall by passing an instrument through a percutaneous penetration in the patient'"'"'s chest wall and into a cardiac penetration in the muscular outer wall of the heart, said system comprising:

a patch for securing across the cardiac septal defect to occlude blood flow therethrough;

an introducing instrument comprising an elongate shaft having a proximal end and a distal end, the distal end of the introducing instrument being configured for releasably holding the patch; and

an access device having a distal end positionable through a cardiac penetration in the outer wall of the heart, a proximal extremity configured to extend outside the chest through the percutaneous penetration in the chest wall with the distal end positioned in the cardiac penetration, and a passage therebetween adapted for introduction of the patch therethrough into the chamber using the introducing instrument, the proximal extremity being generally rigid to facilitate manipulation of the access device from outside the chest.

2. The system of claim 1 wherein the access device comprises a tubular body having an inner lumen for introducing the patch into the chamber through the inner lumen.

3. The system of claim 1 wherein the access device has an outer diameter less than about 15 mm.

4. The system of claim 1 wherein the access device includes a sealing device for inhibiting blood flow through the penetration around the access device.

5. The system of claim 2 wherein the inner lumen has a diameter of at least 5 mm.

6. The system of claim 1 wherein the patch is collapsible into a collapsed configuration for introduction through the access device.

7. The system of claim 6 wherein the introducing instrument comprises a delivery sleeve positionable through the access device and at least one control rod positionable in the delivery sleeve for releasably holding the patch, the delivery sleeve having an interior lumen for slidably receiving the at least one control rod and the patch in the collapsed configuration.

8. The system of claim 1 wherein the patch includes a wire frame for supporting the patch in a generally planar configuration.

9. The system of claim 1 wherein the patch includes means for at least partially penetrating the cardiac septum to anchor the patch thereto.

10. The system of claim 1 wherein the patch includes a rigid hub attached to a central portion of the patch.

11. The system of claim 10 wherein the rigid hub includes a coupling for releasable attachment to the introducing instrument.

12. The system of claim 11 wherein the coupling comprises a hole in the hub, the introducing instrument having a tip for engagement with the hole.

13. The system of claim 1 wherein the patch includes an engagement device for engaging the cardiac septum for securing the patch thereto.

14. The system of claim 13 wherein engagement device is configured to engage the cardiac septum on a side of the cardiac septum opposite the patch.

15. The system of claim 14 wherein the engagement device comprises a plurality of struts attached to a central portion of the patch and having outer ends biased toward the patch for engaging the cardiac septum.

16. The system of claim 15 wherein the struts are connected to a rigid hub so as to extend radially outward therefrom, the hub being attached to a central portion of the patch.

17. The system of claim 16 wherein the hub includes a coupling for releasable attachment to the introducing instrument.

18. The system of claim 15 wherein the outer ends of the struts have points oriented generally perpendicular to the struts for penetrating into the cardiac septum.

19. The system of claim 1 wherein the patch comprises a material selected from the group consisting of polyester, expanded polytetrafluoroethylene, pericardial tissue, and polyhydroxybutyrate.

20. The system of claim 1 wherein the obturator has a distal end extendable from the distal end of the access device configured to penetrate the muscular wall of the heart to form the cardiac penetration.

21. A system for closing an opening in tissue within a heart in a patient'"'"'s chest, the heart having a muscular outer wall, by passing an instrument through a percutaneous penetration in the patient'"'"'s chest, the system comprising:

a patch for securing across the opening to inhibit blood flow therethrough;

an introducing instrument comprising an elongate shaft having a proximal end and a distal end, the distal end being configured for releasably holding the patch;

an access device having a distal end positionable through a cardiac penetration in the outer wall of the heart, a proximal extremity configured to extend outside the chest through a percutaneous penetration with the distal end positioned through the cardiac penetration, and an inner lumen therebetween, the patch being positionable through the inner lumen using the introducing instrument; and

a sealing device cooperative with the distal end of the access device for inhibiting blood flow through the penetration in the muscular outer wall of the heart around the access device.

22. A system for closing an opening in tissue within a heart in a patient'"'"'s chest by passing an instrument through a cardiac penetration formed in a muscular outer wall of the heart, the system comprising:

a patch for securing across the opening to inhibit blood flow therethrough;

an introducing instrument comprising a substantially rigid elongate shaft having a proximal end and a distal end, the distal end being configured for releasably holding the patch; and

an access device having a distal end positionable through the cardiac penetration in the outer wall of the heart, a proximal extremity configured to extend outside the chest through a percutaneous penetration in the chest wall with the distal end positioned in the cardiac penetration, and an inner lumen therebetween, the patch being positionable through the inner lumen using the introducing instrument, wherein the distal end of the access device is provided with means for forming a seal against the outer wall of the heart to inhibit blood flow through the cardiac penetration in the outer wall of the heart.

23. A system for closing an opening in tissue within a heart in a patient'"'"'s chest, the heart having a muscular outer wall, the system comprising:

a patch for securing across the opening to inhibit blood flow therethrough;

an introducing instrument comprising an elongate shaft having a proximal end and a distal end, the distal end being configured for releasably holding the patch; and

an access device having a distal end positionable through a cardiac penetration in the outer wall of the heart, a proximal extremity configured to extend outside the chest through a percutaneous penetration in the chest wall with the distal end positioned in the cardiac penetration, a distal opening in the distal end, a proximal opening in the proximal extremity, and an inner lumen therebetween, the patch being positionable through the inner lumen using the introducing instrument, wherein the access device has a length of about 10-30 cm between the proximal and distal openings.

24. A system for closing an opening in tissue within a heart in a patient'"'"'s chest, the heart having a muscular outer wall, the system comprising:

a patch for securing across the opening to inhibit blood flow therethrough;

an introducing instrument comprising an elongate shaft having a proximal end and a distal end, the distal end being configured for releasably holding the patch;

a delivery sleeve having an interior lumen, the patch being removably positionable in the interior lumen when held by the introducing instrument, wherein the delivery sleeve is formed of a rigid, substantially inflexible material; and

an access device having a distal end positionable through a cardiac penetration in the outer wall of the heart, a proximal extremity configured to extend outside the chest through a percutaneous penetration in the chest wall with the distal end positioned in the cardiac penetration, and an inner lumen between the distal end and the proximal extremity, the delivery sleeve being positionable through the inner lumen.

25. A system for closing an opening in tissue within a heart in a patient'"'"'s chest, the heart having a muscular outer wall, the system comprising:

a patch for securing across the opening to inhibit blood flow therethrough;

an introducing instrument comprising an elongate shaft having a proximal end and a distal end, the distal end being configured for releasably holding the patch;

an access device having a distal end positionable through a penetration in the outer wall of the heart, a proximal extremity configured to extend outside the chest through a percutaneous penetration in the chest wall with the distal end positioned in the cardiac penetration, and an inner lumen therebetween; and

an obturator positionable in the inner lumen of the access device, the obturator having a distal end extendable from the distal end of the access device, the distal end of the obturator being configured to penetrate the outer wall of the heart.

26. A system for closing an opening in tissue within a heart in a patient'"'"'s chest, the heart having a muscular outer wall, by passing an instrument through the chest wall and an intercostal space defined between adjacent ribs, the system comprising:

a patch for securing across the opening to inhibit blood flow therethrough;

an introducing instrument comprising an elongate shaft having a proximal end and a distal end, the distal end being configured for releasably holding the patch; and

an access device having a distal end positionable through a cardiac penetration in the outer wall of the heart, a proximal extremity configured to extend outside the chest through the chest wall and the intercostal space with the distal end positioned in the cardiac penetration, and an inner lumen therebetween, the patch being positionable through the inner lumen using the introducing instrument, wherein the access device is formed at least in part of substantially rigid material selected from the group consisting of stainless steel, titanium, and a substantially inflexible polymer.