Devices for less invasive intracardiac interventions

• US 6,346,074 B1
• Filed: 06/12/1996
• Issued: 02/12/2002
• Est. Priority Date: 02/22/1993
• Status: Expired due to Fees

• Current Assignee: Heartport, Inc. (Johnson & Johnson)
• Original Assignee: Heartport, Inc. (Johnson & Johnson)
• Inventors: Roth, Alex T.
• Primary Examiner(s): Isabella, David J.
• Application Number:
  US08/662,119
• Time in Patent Office: 2,071 Days
• Field of Search: 600/114, 600/104, 600/106, 600/117, 600/121, 600/133, 604/108, 604/104, 604/264, 604/164, 604/165, 604/96, 604/101, 606/185, 606/192, 606/194
• US Class Current: 600/121
• 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 2039/0273 : for introducing catheters into the body
• 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

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. An assembly for visualization and access within a body cavity comprising:

a sleeve having a distal end, a proximal end, and a lumen therebetween, the sleeve also having a rigid, transparent bulb disposed at the distal end of the sleeve, the transparent bulb having a convex surface;

a scope having a shaft with a distal end and a proximal end, the shaft being slidably positionable in the lumen, a channel extending longitudinally through the shaft, and a lens in the channel near the distal end, the shaft being disposed in the lumen so that the lens is optically aligned with the rigid, transparent bulb; and

a guide sleeve having a lumen, the sleeve being slidably positionable in the lumen to a predetermined position in which the convex surface protrudes from a distal end of the guide sleeve.

2. The assembly of claim 1 wherein the transparent bulb is made of a material selected from glass, acrylic, polystyrene, and polycarbonate.

3. The assembly of claim 1 wherein the transparent bulb has a transverse cross-sectional area larger than the transverse cross-sectional area of the shaft.

4. The assembly of claim 1 wherein the transparent bulb has a distal surface, the distal surface being convex.

5. The assembly of claim 1 wherein sleeve has a length sufficient to reach an interior of a patient'"'"'s heart from outside the patient'"'"'s chest.

6. The assembly of claim 5 wherein the sleeve has a length of at least about 15 cm.

7. A repair system for repairing a septal defect in a patient'"'"'s heart, the repair system comprising:

a sleeve having a distal end, a proximal end, and a lumen therebetween, the sleeve having a rigid, transparent bulb at the distal end;

a scope having a shaft with a distal end and a proximal end, the shaft being slidably positionable in the lumen, a channel extending longitudinally through the shaft, and a lens in the channel near the distal end, the lens being optically aligned with the transparent bulb when the shaft is positioned in the lumen;

a guide sleeve having a lumen, the sleeve being slidably positionable in the lumen to a predetermined position in which the convex surface protrudes from a distal end of the guide sleeve; and

a septal defect closure device positionable through the lumen of the sleeve.

8. The repair system of claim 7 wherein the septal defect closure device comprises a delivery shaft having a distal end, a proximal end, and a patch releasably held at the distal end, the patch having a deployed configuration for positioning across a septal defect and a collapsed configuration for positioning through the lumen in the sleeve.

9. The repair system of claim 7 wherein the septal defect closure device is configured to apply a suture to the cardiac septum.

10. The repair system of claim 7 wherein the transparent bulb has a transverse cross-sectional area larger than the transverse cross-sectional area of the shaft.

11. The repair system of claim 7 wherein the transparent bulb has a distal surface, the distal surface being convex.

12. The repair system of claim 7 wherein sleeve has a length sufficient to reach an interior of a patient'"'"'s heart from outside the patient'"'"'s chest.

13. The repair system of claim 12 wherein the sleeve has a length of at least about 15 cm.

14. The repair system of claim 7 wherein the sleeve has an outer diameter of less than about 12 mm.

15. The repair system of claim 7 wherein the sleeve is substantially rigid.

16. The repair system of claim 7 further comprising an access cannula having a distal end positionable through a wall of the heart, a proximal end, and an access channel therebetween, the sleeve being slidably positionable through the access channel into the heart.

17. The repair system of claim 16 wherein the access cannula has a flange on a distal end thereof for engaging an interior wall of the heart.

18. The repairs system of claim 16 further comprising an obturator removably positionable in the access channel.

19. The repair system of claim 18 wherein the obturator has a distal end configured to penetrate the wall of the heart.