Single catheter mitral valve repair device and method for use

• US 7,083,628 B2
• Filed: 09/03/2002
• Issued: 08/01/2006
• Est. Priority Date: 09/03/2002
• Status: Active Grant

• Current Assignee: Edwards Lifesciences LLC (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Bachman, Alan
• Primary Examiner(s): Woo, Julian W.
• Application Number:
  US10/233,879
• Publication Number:
  US 20040044365A1
• Time in Patent Office: 1,428 Days
• Field of Search: 606/139, 606/194, 606/153, 606/142, 606/213, 227/175.1, 227/179.1, 227/181.1
• US Class Current: 606/139
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• CPC Class Codes: A61B 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/00991 Telescopic means
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/306 holding by means of suction

Abstract

A single catheter mitral valve repair device for stabilizing a tissue portion and selectively applying a tissue fastener thereto. The single catheter mitral valve repair device of the present invention includes an extendable engagement tip having at least one vacuum port formed thereon, at least one deployable fastener in communication with the engagement tip, and at least one actuator member in communication with the port. The deployable fastener is capable of controllably engaging and fastening a tissue segment located proximal to the engagement tip.

Claims

1. An apparatus for fastening a tissue segment within the heart of a patient in vivo, comprising:

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

a fastener deployment housing at the distal end of the elongated body, the fastener deployment housing having at least one vacuum port and at least one fastener deployment port formed thereon;

an extendable engagement tip capable of moving in telescopic relation to the fastener deployment housing, the extendable engagement tip having at least one fastener receiving port formed thereon, the extendable tip capable of telescoping distally of the distal end of the fastener deployment housing and the elongated body;

at least one deployable fastener disposed within the fastener deployment housing, the deployable fastener capable of engaging the tissue segment when positioned proximal to the engagement tip; and

at least one fastener deployment actuator in communication with the deployable fastener and capable of causing the fastener to engage the tissue segment.

2. The apparatus of claim 1 further comprising multiple vacuum ports formed on the fastener deployment housing.

3. The apparatus of claim 1 wherein the vacuum port further comprises at least one tissue support traversing the vacuum port.

4. The apparatus of claim 1 wherein the at least one fastener deployment port is capable of receiving the deployable fastener therein.

5. The apparatus of claim 1 wherein the fastener receiving port is capable of receiving the deployable fastener therein.

6. The apparatus of claim 1 wherein the deployable fastener is selected from the group consisting of needles, sutures, staples, buttons, tissue-graspers, tissue clasps, and barbs.

7. The apparatus of claim 1 further comprising a handle in communication with the engagement tip.

8. The apparatus of claim 7 wherein the handle comprises a engagement tip actuator in communication with the engagement tip, a fastener deployment actuator in communication with the deployable fastener, and a vacuum actuator in communication with the vacuum port.

9. The apparatus of claim 1 wherein the elongated body is flexible.

10. The apparatus of claim 9 wherein the elongated body contains one or more actuation members therein.

11. The apparatus of claim 10 wherein each actuation member is in communication with at least one device selected from the group consisting of the engagement tip, the port, the deployable fastener, the actuator, the handle, and an external vacuum source.

12. The apparatus of claim 1 further comprising at least one lumen formed within the elongated body.

13. The apparatus of claim 12 wherein the auxiliary lumen is capable of receiving at least one device therein, the device selected from the group consisting of a fastener, fastener material, and a guidewire.

14. An apparatus for fastening a tissue segment within the heart of a patient in vivo, comprising:

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

a fastener deployment housing at the distal end of the elongated body, the fastener deployment housing having at least one vacuum port and at least one fastener deployment port formed thereon;

an extendable engagement tip capable of moving in telescopic relation to the fastener deployment housing, the extendable engagement tip having at least one fastener receiving port formed thereon, the extendable tip further comprising an actuation flange that telescopically couples the fastener deployment housing with the extendable tip;

at least one deployable fastener disposed within the fastener deployment housing, the deployable fastener capable of engaging the tissue segment when positioned proximal to the engagement tip; and

at least one fastener deployment actuator in communication with the deployable fastener and capable of causing the fastener to engage the tissue segment.

15. The apparatus of claim 14 further comprising an extendable tip actuator in communication with the extendable tip, wherein the extendable tip actuator is capable of causing the extendable tip to move in telescopic relation to the fastener deployment housing.

16. An apparatus for fastening a tissue segment within the heart of a patient in vivo, comprising:

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

a fastener deployment housing at the distal end of the elongated body, the fastener deployment housing having at least one vacuum port and at least one fastener deployment port formed thereon;

an extendable engagement tip capable of moving in telescopic relation to the fastener deployment housing, the extendable engagement tip having at least one fastener receiving port formed thereon;

at least one deployable fastener disposed within the fastener deployment housing, the deployable fastener capable of engaging the tissue segment when positioned proximal to the engagement tip; and

at least one fastener deployment actuator in communication with the deployable fastener and capable of causing the fastener to engage the tissue segment;

wherein the vacuum port and fastener port are one in the same.

17. An apparatus for fastening a tissue segment within the heart of a patient in vivo, comprising:

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

a fastener deployment housing at the distal end of the elongated body, the fastener deployment housing having at least one vacuum port and at least one fastener deployment port formed thereon;

an extendable engagement tip capable of moving in telescopic relation to the fastener deployment housing, the extendable engagement tip having at least one fastener receiving port formed thereon;

at least one deployable fastener disposed within the fastener deployment housing, the deployable fastener capable of engaging the tissue segment when positioned proximal to the engagement tip; and

at least one fastener deployment actuator in communication with the deployable fastener and capable of causing the fastener to engage the tissue segment;

wherein the fastener receiving port further comprises at least one fastener catch capable of engaging and retaining the deployable fastener.

18. The apparatus of claim 17 wherein the fastener catch is in communication with a fastener material.

19. The apparatus of claim 18 wherein the fastener material is selected from the group consisting of thread, wire, monofilament, braided filament and suture material.

20. An apparatus for fastening a tissue segment within the heart of a patient in vivo, comprising:

an elongated body having a proximal end and a distal end, wherein the elongated body is flexible;

a fastener deployment housing at the distal end of the elongated body, the fastener deployment housing having at least one vacuum port and at least one fastener deployment port formed thereon;

an extendable engagement tip capable of moving in telescopic relation to the fastener deployment housing, the extendable engagement tip having at least one fastener receiving port formed thereon;

at least one deployable fastener disposed within the fastener deployment housing, the deployable fastener capable of moving the tissue segment when positioned proximal to the engagement tip; and

at least one fastener deployment actuator in communication with the deployable fastener and capable of causing the fastener to engage the tissue segment;

one or more actuation members within the elongated body, wherein each actuation member is in communication with at least one device selected from the group consisting of the engagement tip, the port, the deployable fastener, the actuator, the handle, and an external vacuum source; and

wherein the external vacuum source is in communication with at least one vacuum lumen located within the elongated body, wherein the vacuum lumen communicates with the actuation members and the vacuum port.

21. A system for repairing tissue within the body of a patient, comprising

a handle comprising:

a stationary handle body;

a engagement tip actuator connected to the stationary handle body;

a fastener deployment actuator coupled to the stationary handle body; and

a vacuum connector;

an elongated body comprising;

a flexible body member;

at least one vacuum lumen integral with the body member;

at least one actuation lumen integral with the body member,

wherein the actuation lumen is capable of receiving at least one actuation member therein; and

at least one fastener lumen integral with the body member, wherein the fastener lumen is capable of receiving at least one deployable fastener therein; and

,

an engagement tip comprising;

a fastener deployment housing capable of attaching to the elongated body;

an actuation flange attached to the fastener deployment housing;

an extendable tip attached to the actuation flange end in communication with the engagement tip actuator;

a vacuum port in communication with the vacuum connector; and

,

at least one deployable fastener in communication with the fastener deployment actuator.