Rapid deployment artificial chordae Tendinae system

• US 10,213,303 B2
• Filed: 10/26/2016
• Issued: 02/26/2019
• Est. Priority Date: 02/02/2015
• Status: Active Grant

• Current Assignee: On-X Life Technologies, Inc. (Cryolife Incorporated)
• Original Assignee: On-X Life Technologies, Inc. (Cryolife Incorporated)
• Inventors: Medema, Ryan, Seeley, Mark
• Primary Examiner(s): Eastwood, David C
• Application Number:
  US15/334,888
• Publication Number:
  US 20170105838A1
• Time in Patent Office: 853 Days
• 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 17/06066 Needles, e.g. needle tip configurations making needles B21G1/00
• CPC Class Codes: A61B 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• CPC Class Codes: A61B 2017/00539 hydraulically
• CPC Class Codes: A61B 2017/00946 malleable
• CPC Class Codes: A61B 2017/0406 Pledgets
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/042 plastically deformed during insertion
• CPC Class Codes: A61B 2017/06052 Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle
• CPC Class Codes: A61B 2017/061 hollow or tubular
• CPC Class Codes: A61B 2017/0619 thermoplastic, e.g. for bonding, welding, fusing or cutting the suture by melting it
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2250/0007 for adjusting length

Abstract

An embodiment includes an apparatus comprising: a hollow needle with a narrowed inner diameter in a distal third of the needle; and a flexible chord coupled to proximal and distal conduits; wherein the distal conduit is in the needle and distal to the narrowed inner diameter and the proximal conduit is in the needle and proximal to the narrowed inner diameter; wherein: (a)(i) long axes of the proximal and distal conduits are substantially parallel to a long axis of the needle when the proximal and distal conduits are in the needle, and (a)(ii) the proximal and distal conduits are configured to rotate when deployed from the needle such that their long axes are not parallel to a long axis of the chord when the chord is fully extended. Other embodiments are described herein.

Claims

1. An artificial chordae tendineae kit comprising:

a hollow first needle including a first proximal end portion having a first proximal aperture, a first distal end portion having a first distal aperture, and a first middle portion coupling the first proximal end portion to the first distal end portion;

a flexible first chord coupled to both a first proximal anchor and a first distal anchor;

wherein the first proximal end portion includes a first proximal inner diameter directly adjacent the first proximal aperture, the first distal end portion includes a first distal inner diameter directly adjacent the first distal aperture, the first middle portion includes a first narrowed portion with a first middle inner diameter that is less than either of the first proximal inner diameter and the first distal inner diameter;

wherein the first chord, the first proximal anchor, and the first distal anchor are all included within the first needle with the first distal anchor distal to the first narrowed portion and the first proximal anchor proximal to the first narrowed portion;

wherein the first needle includes a long axis, the first chord includes a long axis, the first proximal anchor includes a long axis, and the first distal anchor includes a long axis;

wherein the long axes of the first proximal and distal anchors are substantially parallel to the long axis of the first needle when the first chord is included within the first needle;

wherein the first proximal and distal anchors are each configured to rotate when deployed from the first needle such that the long axes of the first proximal and distal anchors are each nonparallel to the long axis of the first chord;

wherein the first proximal anchor is deformable and configured to deform to slide past the first narrowed portion.

2. The kit of claim 1 comprising:

a hollow second needle including a second proximal end portion having a second proximal aperture, a second distal end portion having a second distal aperture, and a second middle portion coupling the second proximal end portion to the second distal end portion;

a flexible second chord coupled to both a second proximal anchor and a second distal anchor;

wherein the second proximal end portion includes a second proximal inner diameter directly adjacent the second proximal aperture, the second distal end portion includes a second distal inner diameter directly adjacent the second distal aperture, the second middle portion includes a second narrowed portion with a second middle inner diameter that is less than either of the second proximal inner diameter and the second distal inner diameter;

wherein the second chord is included within the second needle with the second distal anchor distal to the second narrowed portion and the second proximal anchor proximal to the second narrowed portion;

wherein the second needle includes a long axis, the second chord includes a long axis, the second proximal anchor includes a long axis, and the second distal anchor includes a long axis;

wherein the long axes of the second proximal and distal anchors are substantially parallel to the long axis of the second needle when the second chord is included within the second needle;

wherein the second proximal and distal anchors are each configured to rotate when deployed from the second needle such that the long axes of the second proximal and distal anchors are each nonparallel to the long axis of the second chord;

wherein the first chord has a first length between its first proximal and distal anchors and the second chord has a second length between its second proximal and distal anchors substantially equal to the first length.

3. The kit of claim 1, comprising:

a first proximal obstruction between the first proximal anchor and a proximal end of the first chord; and

a first distal obstruction between the first distal anchor and a distal end of the first chord;

wherein each of the first proximal and distal obstructions includes an outer diameter greater than an outer diameter of the first chord.

4. The kit of claim 1, wherein the first chord passes through the first distal anchor.

5. The kit of claim 4, wherein:

the first distal anchor couples to a parabolic portion coupled to a proximal end of the first distal anchor;

a first axis, orthogonal to the long axis of the first distal anchor, intersects two portions of the first distal anchor and the first chord;

a second axis, orthogonal to the long axis of the first distal anchor, intersects only a single portion of the parabolic portion and the first chord.

6. The kit of claim 5, wherein:

the first chord passes through the first proximal anchor;

the first proximal anchor couples to an additional parabolic portion coupled to a distal end of the first proximal anchor;

an additional first axis, orthogonal to the long axis of the first proximal anchor, intersects two portions of the first proximal anchor and the first chord; and

an additional second axis, orthogonal to the long axis of the first proximal anchor, intersects only a single portion of the additional parabolic portion and the first chord.

7. The kit of claim 1 comprising a syringe configured to couple to the first proximal aperture of the first needle.

8. The kit of claim 1, wherein the first proximal anchor has an outer diameter that is greater than the first middle inner diameter.

9. The kit of claim 1, wherein the first distal anchor has an outer diameter that is greater than the first middle inner diameter.

10. The kit of claim 1, wherein at least one of the first proximal and distal anchors are slidably coupled to the first chord.

11. The kit of claim 1, wherein the first chord includes a first chord material, the first proximal anchor includes a first proximal anchor material, and the first distal anchor includes a first distal anchor material that is the same as the first chord material and the first proximal anchor material.

12. The kit of claim 11, wherein the first distal anchor material includes polytetrafluoroethylene.

13. The kit of claim 1, wherein the first narrowed portion is included in a distal third of the first needle.

14. An apparatus comprising:

a hollow needle with a narrowed inner diameter in a distal third of the needle; and

a flexible chord coupled to proximal and distal anchors;

wherein the distal anchor is in the needle and distal to the narrowed inner diameter and the proximal anchor is in the needle and proximal to the narrowed inner diameter;

wherein;

(a)(i) long axes of the proximal and distal anchors are substantially parallel to a long axis of the needle when the proximal and distal anchors are in the needle, (a)(ii) the proximal and distal anchors are configured to rotate when deployed from the needle such that their long axes are not parallel to a long axis of the chord; and

(a)(iii) the proximal anchor is deformable and configured to deform to slide past the narrowed inner diameter.

15. The apparatus of claim 14, wherein:

(b)(i) the chord passes through the proximal and distal anchors, and (b)(ii) the proximal anchor has an outer diameter that is greater than the narrowed inner diameter.

16. The apparatus of claim 14, wherein the proximal and distal anchors each include a shape memory material.

17. The apparatus of claim 14, wherein the proximal and distal anchors include proximal and distal conduits.

18. A method comprising:

providing a hollow needle, with a narrowed inner diameter in a distal third of the needle, and a flexible chord coupled to proximal and distal anchors;

wherein (a)(i) the distal anchor is in the needle and distal to the narrowed inner diameter, and the proximal anchor is in the needle and proximal to the narrowed inner diameter; and

(a)(ii) long axes of the proximal and distal anchors are substantially parallel to a long axis of the needle;

traversing a mitral leaflet with the needle;

traversing papillary muscle with the needle while still traversing the mitral leaflet with the needle;

deploying the distal anchor from the needle and positioning the distal anchor against a first side of the papillary muscle;

retracting the needle from the papillary muscle while leaving a portion of the chord traversing the papillary muscle from the first side of the papillary muscle to a second side of the papillary muscle;

retracting the needle from the mitral leaflet while leaving an additional portion of the chord traversing the mitral leaflet from a first side of the mitral leaflet to a second side of the mitral leaflet; and

deploying the proximal anchor from the needle and positioning the proximal anchor against the second side of the mitral leaflet;

wherein the proximal anchor is deformable and configured to deform to slide past the narrowed inner diameter.

19. The method of claim 18, wherein deploying the distal and proximal anchors comprises rotating the distal and proximal anchors so their long axes are not parallel to a long axis of the chord.

20. The method of claim 18, wherein deploying the distal anchor comprises injecting a liquid into the needle to force the distal anchor out of the needle.