Medical device for constricting tissue or a bodily orifice, for example a mitral valve

• US 9,744,038 B2
• Filed: 10/06/2010
• Issued: 08/29/2017
• Est. Priority Date: 05/13/2008
• Status: Active Grant

• Current Assignee: Kardium Inc.
• Original Assignee: Kardium Inc.
• Inventors: Dahlgren, Jon, Goertzen, Doug, Gelbart, Daniel
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): Schutte, Wade P
• Application Number:
  US12/899,407
• Publication Number:
  US 20110022166A1
• Time in Patent Office: 2,519 Days
• Field of Search: 623 236, 623 237, 606228
• 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 17/0485 Devices or means, e.g. loops, for capturing the suture thread and threading it through an opening of a suturing instrument or needle eyelet
• CPC Class Codes: A61B 2017/00331 with preformed bends
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0437 the barbs being resilient or spring-like
• CPC Class Codes: A61B 2017/0441 the shaft being a rigid coil or spiral
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2454 Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses

Abstract

A medical apparatus positionable in a cavity of a bodily organ (e.g., a heart) may constrict a bodily orifice (e.g., a mitral valve). The medical apparatus may include tissue anchors that are implanted in the annulus of the orifice. The tissue anchors may be guided into position by an intravascularly or percutaneously deployed anchor guiding frame. Constriction of the orifice may be accomplished by cinching a flexible cable attached to implanted tissue anchors. The medical device may be used to approximate the septal and lateral (clinically referred to as anterior and posterior) annulus of the mitral valve in order to move the posterior leaflet anteriorly and the anterior leaflet posteriorly and thereby improve leaflet coaptation and eliminate mitral regurgitation.

Claims

1. A medical system to perform percutaneous medical procedures, the medical system comprising:

a plurality of multi-lumen push tubes, each of the multi-lumen push tubes concurrently including at least a respective first longitudinal lumen and a respective second longitudinal lumen, the respective first longitudinal lumen located entirely outside of the respective second longitudinal lumen, and the respective second longitudinal lumen located entirely outside of the respective first longitudinal lumen;

a plurality of release rods, at least a portion of a respective one of each of the release rods movably received by the respective first longitudinal lumen of a respective one of the multi-lumen push tubes for longitudinal translation with respect thereto, the release rods selectively releasably coupled to respective ones of a plurality of tissue anchors; and

a plurality of guide rails, at least a portion of at least a respective one of each of the guide rails moveably received by the respective second longitudinal lumen of a respective one of the multi-lumen push tubes for longitudinal translation of the respective one of the multi-lumen push tubes with respect thereto, each of the multi-lumen push tubes slideable along a respective one of the guide rails to deliver a respective one of the tissue anchors to a respective anchor position at least proximate a portion of the respective guide rail.

2. The medical system of claim 1, further comprising:

at least one articulated mechanism including a plurality of lumens, at least a respective one of each of the multi-lumen push tubes at least partially received by a respective one of the lumens of the articulated mechanism for translation and articulation therewith.

3. The medical system of claim 1, further comprising:

a plurality of constricting tubes, at least a respective one of each of the constricting tubes coupled to a respective one of the multi-lumen push tubes to translate therewith, at least a portion of at least a respective one of the tissue anchors received by a respective one of the constricting tubes at a first time and selectively releasable therefrom during a second time, the second time following the first time.

4. The medical system of claim 3 wherein each respective one of the tissue anchors includes a barb, and the portion of each respective one of the tissue anchors received by the respective one of the constricting tubes includes the barb of the respective one of the tissue anchors.

5. The medical system of claim 1 wherein each of the tissue anchors is physically constrained to move along the respective one of the guide rails to the respective anchor position at least proximate an end portion of the respective guide rail.

6. The medical system of claim 1 wherein each of the tissue anchors is physically constrained to move along the respective one of the guide rails to the respective anchor position at least proximate a bend portion of the respective guide rail.

7. The medical system of claim 1 wherein at least two of the guide rails are physically coupled to one another distally from the multi-lumen push tubes to form a guide frame.

8. The medical system of claim 7 wherein the guide frame includes a self-location structure arranged to physically interact with leaflets of an anatomical valve to self locate the guide frame.

9. The medical system of claim 1, further comprising:

at least one tensionable cable that physically couples at least two of the tissue anchors to form a constricting assembly.

10. The medical system of claim 9, further comprising:

at least one fastener that selectively physically fastens the at least one tensionable cable under tension.

11. The medical system of claim 9, further comprising:

at least one actuator physically coupled to the at least one tensionable cable, the at least one actuator responsive to an applied stimulus to change a dimension of the at least one actuator.

12. The medical system of claim 11 wherein the at least one actuator is responsive to a magnetic field.

13. The medical system of claim 9, further comprising:

at least one spreader physically coupled to the at least one tensionable cable between at least a pair of the tissue anchors to fix a distance therebetween.

14. The medical system of claim 1 wherein each tissue anchor of the tissue anchors includes a hole which releasably receives a portion of a respective one of the release rods, the portion of the respective one of the release rods removed from the hole when the respective one of the release rods is physically uncoupled from the respective tissue anchor.

21. The medical system of claim 14 further comprising:

a plurality of constricting tubes, each of the constricting tubes including a slot sized to receive a portion of a respective one of the tissue anchors with the hole extending therefrom.

22. The medical system of claim 21 wherein each constricting tube of the constricting tubes constricts a number of barbs of the respective one of the tissue anchors.

15. A method of operating a medical system to perform percutaneous medical procedures, the method comprising:

percutaneously delivering at least a portion of a device to a bodily organ, the portion of the device including a plurality of multi-lumen push tubes each concurrently including at least a respective first longitudinal lumen and a respective second longitudinal lumen other than the respective first longitudinal lumen;

a plurality of release rods, at least a portion of each release rod movably received by the respective first longitudinal lumen of a respective one of the multi-lumen push tubes for longitudinal translation with respect thereto, each of the release rods selectively releasably coupled to a respective one of a plurality of tissue anchors; and

a plurality of guide rails, at least a portion of at least a respective one of each of the guide rails movably received by the respective second longitudinal lumen of a respective one of the multi-lumen push tubes for longitudinal translation of the respective one of the multi-lumen push tubes with respect thereto, the respective second longitudinal lumen of each of the multi-lumen push tubes slideable along a respective one of the guide rails to cause movement of at least the respective first longitudinal lumen and to deliver a respective one of the tissue anchors to a respective anchor position at least proximate a portion of the respective guide rail;

positioning each of the guide rails with respect to the respective anchor position on tissue of the bodily organ;

advancing the multi-lumen push tubes along the guide rails at least until the tissue anchors are at least partially embedded in the tissue; and

causing the release rods to release the tissue anchors while the tissue anchors are at least partially embedded in the tissue.

16. The method of claim 15, further comprising:

withdrawing the multi-lumen push tubes after causing the release rods to release the tissue anchors.

17. The method of claim 15 wherein at least one tensionable cable physically couples at least two of the tissue anchors, and the method further comprises:

tensioning the at least one tensionable cable to constrict an orifice in the tissue.

18. The method of claim 17, further comprising:

securing at least one fastener to the tensioned at least one tensionable cable to physically fasten the at least one tensionable cable under tension.

19. The method of claim 17 wherein at least one actuator is physically coupled to the at least one tensionable cable, and the method further comprises:

applying a stimulus to the at least one actuator to change a dimension of the at least one actuator.

20. The method of claim 19 wherein the applying the stimulus to the at least one actuator includes applying a magnetic field externally from the bodily organ.

25. The method of claim 15 wherein, for each multi-lumen push tube of the plurality of multi-lumen push tubes, the respective first longitudinal lumen is located entirely outside of the respective second longitudinal lumen, and the respective second longitudinal lumen is located entirely outside of the respective first longitudinal lumen.

23. A medical system to perform a percutaneous medical procedure, the medical system comprising:

a plurality of multi-lumen push tubes, each of the multi-lumen push tubes concurrently including at least a respective first longitudinal lumen and a respective second longitudinal lumen side-by-side with the respective first longitudinal lumen;

a plurality of release rods, each release rod of the plurality of release rods including a first end and a second end, the second end including a bent portion that includes a bend in the release rod, at least a portion of a respective one of each of the release rods movably received by the respective first longitudinal lumen of a respective one of the multi-lumen push tubes for longitudinal translation with respect thereto, each one of the release rods selectively releasably coupled to the bent portion to a respective one of a plurality of tissue penetrating anchors, to selectively completely decouple the release rod from the respective one of the plurality of tissue penetrating anchors at least when the respective one of the tissue penetrating anchors is positioned at a respective anchor position, leaving no portion of the release rods attached to the respective tissue penetrating anchor; and

a plurality of guide rails, at least a portion of at least a respective one of each of the guide rails moveably received by the respective second longitudinal lumen of a respective one of the multi-lumen push tubes for longitudinal translation of the respective one of the multi-lumen push tubes with respect thereto, the respective second longitudinal lumen of each of the multi-lumen push tubes slideable along a respective one of the guide rails to move at least the respective first longitudinal lumen and to deliver a respective one of the tissue penetrating anchors to the respective anchor position at least proximate a portion of the respective guide rail.

26. The medical system of claim 23 wherein, for each multi-lumen push tube of the plurality of multi-lumen push tubes, the respective first longitudinal lumen is located entirely outside of the respective second longitudinal lumen, and the respective second longitudinal lumen is located entirely outside of the respective first longitudinal lumen.

24. A medical system to perform percutaneous medical procedures, the medical system comprising:

a plurality of multi-lumen push tubes, each of the multi-lumen push tubes concurrently including at least a respective first longitudinal lumen and a respective second longitudinal lumen other than the respective first longitudinal lumen;

a plurality of tissue anchors, each of the tissue anchors movably received by and extendable from the respective first longitudinal lumen of a respective one of the multi-lumen push tubes; and

a plurality of guide rails, at least a portion of at least a respective one of each of the guide rails moveably received by the respective second longitudinal lumen of a respective one of the multi-lumen push tubes for longitudinal translation of the respective one of the multi-lumen push tubes with respect thereto, the respective second longitudinal lumen of each of the multi-lumen push tubes slideable along a respective one of the guide rails to cause movement of at least the respective first longitudinal lumen and to deliver a respective one of the tissue anchors to a respective anchor position at least proximate a portion of the respective guide rail.

27. The medical system of claim 24 wherein, for each multi-lumen push tube of the plurality of multi-lumen push tubes, the respective first longitudinal lumen is located entirely outside of the respective second longitudinal lumen, and the respective second longitudinal lumen is located entirely outside of the respective first longitudinal lumen.