Method and apparatus for thoracoscopic intracardiac procedures

• US 5,823,956 A
• Filed: 05/07/1996
• Issued: 10/20/1998
• Est. Priority Date: 02/22/1993
• Status: Expired due to Term

• Current Assignee: Heartport, Inc. (Johnson & Johnson)
• Original Assignee: Heartport, Inc. (Johnson & Johnson)
• Inventors: Roth, Alex T., Gifford, Hanson S.
• Primary Examiner(s): ISABELLA, DAVID J
• Application Number:
  US08/646,210
• Time in Patent Office: 896 Days
• Field of Search: 623/2, 128/898, 600/374, 600/375, 607/122, 607/98, 607/99, 606/41
• US Class Current: 600/374
• 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 thoracoscopic electrophysiology device for introduction into an interior chamber of a patient'"'"'s heart by passing through an intercostal space defined between the patient'"'"'s ribs and through an opening in a muscular wall of the patient'"'"'s heart, the device comprising:

a substantially rigid shaft having a distal end and a proximal end, the shaft being dimensioned and configured for introduction through an intercostal space defined between a patient'"'"'s ribs and through an opening in a muscular wall of the patient'"'"'s heart;

a flexible tip mounted to the distal end of the shaft;

a handle mounted to the proximal end of the shaft;

a movable actuator on the handle;

a linkage coupled to the actuator, extending through the shaft and coupled to the flexible tip, wherein moving the actuator deflects the flexible tip;

at least one electrode mounted to the flexible tip;

an electrical connector mounted to the handle configured for connection to a radiofrequency generator or an electrocardiogram machine; and

electrical coupling means extending through the shaft for connecting the electrode to the electrical connector.

2. The electrophysiology device of claim 1 wherein the shaft and deflectable tip have a combined length in a range of 10 cm to 40 cm.

3. The electrophysiology device of claim 1 wherein the shaft has a diameter of at least about 5 mm.

4. The electrophysiology device of claim 1 wherein the shaft is substantially straight and has a minimum durometer of 75 Shore A.

5. The electrophysiology device of claim 1 wherein the flexible tip comprises an expandable basket having a plurality of electrodes mounted thereto.

6. The electrophysiology device of claim 1 wherein a plurality of electrode bands are mounted to the flexible tip.

7. The electrophysiology device of claim 1 wherein the linkage comprises at least one pull wire slidably disposed in a lumen in the shaft and coupled to a distal end of the flexible tip.

8. The electrophysiology device of claim 1 further comprising a tubular cardiac access device positionable through an intercostal space and through a muscular wall of the heart, the tubular access device having an inner lumen for positioning the flexible tip therethrough into the heart.

9. The electrophysiology device of claim 8, wherein the cardiac access device is provided with a sealing member for inhibiting leakage of blood through the opening in the wall of the patient'"'"'s heart.

10. In combination, a cardiac access device for introduction into an interior chamber of a patient'"'"'s heart by passing through an intercostal space defined between adjacent ribs and through an opening in a muscular wall of the patient'"'"'s heart, and a thoracoscopic electrophysiology device configured to pass through the access device and into the interior chamber of the heart, the combination comprising:

a cardiac access device comprising an elongate body configured to extend through an intercostal space defined between a patient'"'"'s adjacent ribs and also through an opening in a muscular wall of the patient'"'"'s heart, the elongate body having a proximal end, a distal end, and an inner lumen extending between the proximal and distal ends, the elongate body including a first portion configured to extend through the intercostal space so as to be located within the patient'"'"'s body, and a second portion distal to the first portion configured to extend through said opening so as to be located in the interior chamber of the patient'"'"'s heart; and

an electrophysiology device comprising a substantially rigid shaft having a distal end and a proximal end, the shaft being dimensioned and configured for introduction through the lumen of said cardiac access device, and a flexible tip mounted to the distal end of the shaft;

wherein the flexible tip of the electrophysiology device is provided with at least one electrode coupled to an electrical connector configured for connection to a radiofrequency generator or an electrocardiogram machine.

11. The combination of claim 10, wherein the cardiac access device further comprises a sealing member adjacent the second portion of the elongate body to inhibit leakage of blood through the opening in the wall of the patient'"'"'s heart.

12. The combination of claim 10, wherein the electrophysiology device is an ablating instrument comprising at least one electrode carried by the flexible tip for delivering electrical current to cardiac tissue.

13. The combination of claim 12, wherein the ablating instrument comprises an actuator for moving the flexible tip into a desired orientation to position the electrode against cardiac tissue.

14. The combination of claim 10, wherein the electrophysiological instrument is a mapping instrument comprising an expandable mechanism supporting a plurality of electrodes coupled to a device for detecting electrical potential between the electrodes, and the expandable mechanism is movable from a collapsed orientation to an expanded orientation to move the electrodes into contact with the cardiac tissue.

15. The combinations of claim 14, wherein the mapping instrument comprises an actuator for moving the expandable mechanism into said expanded orientation to position the electrodes against cardiac tissue.

16. The combination of claim 10, wherein the distal end of the cardiac access device is provided with means for forming an opening in the wall of the patient'"'"'s heart.