APPARATUSES AND METHODS FOR CUTTING A TISSUE BRIDGE AND/OR REMOVING A HEART VALVE CLIP OR SUTURE

• US 20140228871A1
• Filed: 09/28/2012
• Published: 08/14/2014
• Est. Priority Date: 09/28/2011
• Status: Active Grant

• Current Assignee: Evalve, Inc. (Abbott Laboratories)
• Original Assignee: Mitracore Technologies, Inc.
• Inventors: Berrada, Marwane, Cohen, Gideon, Lagace, Etienne, Perkins, Charles, Chu, Boby
• Granted Patent: US 9,770,256 B2
• Time in Patent Office: Days
• US Class Current: 606/170
• CPC Class Codes: A61B 10/06 Biopsy forceps , e.g. with cup-shaped jaws
• CPC Class Codes: A61B 17/295 combined with cutting implements
• 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 17/3201 Scissors for biopsy A61B10/02
• CPC Class Codes: A61B 17/32053 Punch like cutting instruments, e.g. using a cylindrical or oval knife A61B17/326 takes precedence; trepans A61B17/1695; for use on the cornea A61F9/007
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00323 Cables or rods
• CPC Class Codes: A61B 2017/00353 one mechanical instrument performing multiple functions, e.g. cutting and grasping
• CPC Class Codes: A61B 2017/00398 using powered actuators, e.g. stepper motors, solenoids
• CPC Class Codes: A61B 2017/00539 hydraulically
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/22039 eccentric
• CPC Class Codes: A61B 2017/2905 flexible
• CPC Class Codes: A61B 2017/2926 Details of heads or jaws
• CPC Class Codes: A61B 2017/308 with suction cups
• CPC Class Codes: A61B 2017/3488 Fixation to inner organ or inner body tissue

Abstract

A medical device for safely and effectively removing a clip or a suture from a heart valve is operable in association with a guidewire for positioning the device in proximity to the heart valve. The apparatus may include a blade for cutting a tissue bridge including the clip and an arrangement for removing the tissue bridge from the heart valve. The apparatus may include two arms that secure the clip. The blade may be deployed to core out a central portion of a tissue bridge, including the clip or the suture, from the heart valve. The blade may be activated by an actuator. A retrieval member may be configured to capture the tissue bridge and the clip or suture after excision by the blade.

Claims

1. An apparatus for excising and removing a clip or suture attached to a heart valve, the clip or suture forming a tissue bridge in said heart valve, the apparatus comprising:

an elongated shaft defining a hollow interior, said shaft having a first end and a second end;

a handle attached to the second end of the shaft;

an elongate clamping member for engaging and securing said clip or suture, said clamping member being attached to the first end of the shaft, the clamping member having a first end attached to the shaft and a second end;

a blade located in said interior of said shaft and being moveable longitudinally in said shaft between said second end of the shaft and the second end of said clamping member, the blade being configured to completely encompass said clip and tissue bridge for cutting said tissue bridge when the clamping member is engaged to said tissue bridge;

a clamping member actuating member attached to the handle, said clamping member actuating member being coupled to the clamping member for actuating the clamping member between the open and closed positions;

a blade actuating member attached to the handle, said blade actuating member being coupled to said blade for actuating the blade from said second end of the shaft to said second end of said clamping member for cutting said tissue bridge;

said clamping member further comprising a lumen extending therethrough to receive a guidewire;

wherein said guidewire having been introduced into said heart valve adjacent said tissue bridge, and said guidewire having been introduced through each of said guidewire lumen, said apparatus being configured to be introduced over each of said guidewire to bring said clamping member into proximity to said tissue bridge.

2. An apparatus according to claim 1 further comprising a retractable cap attached to at least one of said clamping members, the retractable cap being moveable in said passageways of said arm members when the arm members are in the closed position between the second end of said clamping members and the second end of the shaft for retrieving said clip after cutting of said tissue bridge by said blade;

and a cap retracting actuating member located on said handle and coupled to said cap for moving the cap between the second end of said clamping members and the second end of the shaft.

3. An apparatus according to claim 1 wherein said arm members each have a saw toothed section for engaging said tissue bridge.

4. An apparatus according to claim 1 wherein a track is formed on an inner surface of said elongate shaft, the blade being moveably attached to said track for guided movement along said track between the first and said ends of said elongate shaft.

5. An apparatus according to claim 4 wherein the blade comprises a cylindrical member having a sharpened distal edge, wherein by forward movement along said track within said elongate shaft moves into proximity with said tissue bridge, thereby cutting said tissue bridge to remove said suture or clip from said heart valve tissue.

6. An apparatus according to claim 2 wherein the cap comprises two separate cap sections, each of said cap sections being moveably attached to a respective one of said arm members.

7. An apparatus according to claim 6 wherein each of said cap sections is adapted to engage and move along said track whereby the cap sections are capable of moving along said track when the arm members are in the closed position to retrieve and move said tissue bridge and said clip from the second end of the clamping member to the second end of the shaft.

8. An apparatus according to claim 1 wherein said handle includes a trigger that is connected to the blade actuating member for actuating the actuating member to move the blade from said second end of the shaft toward said second end of said clamping member.

9. An apparatus according to claim 1 wherein a lever is attached to the handle, the lever being connected to the clamping member actuating member for moving the arm members from the open to the closed position.

10. An apparatus according to claim 9 wherein the clamping member actuating member is a tube that is received in the first end of the shaft and is configured to move in a telescoping fashion in said shaft between a first position wherein the clamping member actuating member is disengaged from the arm members leaving the arm members in the open position, the arm members being biased to the open position by a biasing member, and a second position wherein the clamping member actuating member encompasses the arm members thereby urging the arm members to the closed position.

11. An apparatus according to claim 1 wherein a rotating member is attached to the shaft for rotating the shaft to enable positioning of said arm members.

12. An apparatus according to claim 8 wherein a safety member is located between the trigger and a gripping member on said handle to controllably inhibit or permit release of the trigger.

18. The apparatus of claim 1, wherein the clamping member comprises two arm members moveable between an open position where the arm members are spaced apart and a closed position where the arm members are closed in abutting engagement, the arm members being configured to engage said clip or suture in the closed position, each of said arm members defining a longitudinal passageway formed therein, the blade being moveable longitudinally in said longitudinal passageway.

13. An apparatus for cutting a tissue bridge in a heart valve, the apparatus comprising:

two elongate cutting members connected by a rotating joint, the cutting members each having a first end and a second end, each of said cutting members defining an inner cutting surface and being moveable between an open position where the cutting members are spaced apart and a closed position where the cutting members are closed with said cutting surfaces in abutting engagement for cutting said tissue bridge;

two gripping members, one of said gripping members being attached to the first end of one of said cutting members for actuating the cutting members between the open and closed positions,

wherein the apparatus defines an entry port for a guidewire and an exit port for said guidewire, the apparatus being configured to move along said guidewire positioned within a heart.

14. An apparatus according to claim 13 wherein the gripping members are handles.

15. An apparatus according to claim 13 wherein said inner cutting surfaces define a saw toothed section.

16. A method for excising and removing a clip or suture attached to a heart valve, the clip or suture forming a tissue bridge in said heart valve, the method comprising the following steps:

placing a purse string suture at a previously determined site along the left ventricular epicardial surface to correspond with a planned incision;

making an incision in the heart muscle within the borders of the purse string;

introducing at least two guidewires through said incision into a heart and locating each of at least two guidewires on opposite sides of a tissue bridge formed in a heart valve by a clip or suture, said at least two guidewires providing a navigation passageway for guiding a tissue removal apparatus to the tissue bridge for purposes of removing said tissue bridge;

providing a tissue removal apparatus comprising an elongated shaft having at least two guidewire lumens extending therethrough to receive each of said at least two guidewires, said tissue removal apparatus comprising;

(1) an elongated shaft having a clamping member disposed at the distal end of the shaft for gripping said tissue bridge;

(2) a blade disposed at the distal end of the shaft for cutting said tissue bridge; and

(3) a containment member for capturing an removing said tissue bridge following cutting of said tissue bridge;

inserting the proximal end of each of said at least two guidewires into said guidewire lumens of said tissue removal apparatus;

opening said incision and moving said tissue removal apparatus along said guidewires into proximity of said tissue bridge;

securing said tissue removal apparatus to said tissue bridge with said clamping member;

cutting said tissue bridge with said blade; and

removing said tissue bridge including said clip or suture with said containment member.

17. A method according to claim 16 wherein the movement and positioning of said tissue removal apparatus in monitored by ultrasound or fluoroscopy (x-ray) guidance.

19. An apparatus for cutting a tissue bridge in a heart valve, the apparatus comprising:

an elongated shaft having a proximal end and a distal end;

a handle attached to the proximal end of the shaft;

at least one blade disposed at the distal end of the shaft;

a blade cover removably mounted at the distal end of the shaft, said cover configured to be controllably moved from a closed position which covers the blade, to an open position which exposes said blade to facilitate cutting of said tissue bridge;

a blade cover actuating member attached to said handle, said actuating member coupled to said blade cover for actuating the cover to move from a closed position to an open position;

a stabilizing member retractably mounted at the distal end of the shaft, said stabilizing member configured to be controllably moved from a closed position which retracts said stabilizing member to configuration approximating the diameter of the shaft, to an open position which extends said stabilizing member outwardly from the distal end of the shaft to engage heart tissue adjacent the tissue bridge to stabilize the distal end of the blade during cutting of said tissue bridge; and

a stabilizing member actuating member attached to said handle, said actuating member coupled to said stabilizing member for actuating said stabilizing member to move from a closed position to an open position.

20. An apparatus according to claim 19, wherein the apparatus defines an entry port for a guidewire and an exit port for said guidewire, the apparatus being configured to move along said guidewire positioned within a heart.