Delivery device for prosthetic mitral valve annuloplasty ring and prosthetic mitral valve annuloplasty ring delivery system

• US 10,966,831 B2
• Filed: 11/25/2016
• Issued: 04/06/2021
• Est. Priority Date: 09/26/2016
• Status: Active Grant

• Current Assignee: Shanghai Newmed Medical Co., Ltd.
• Original Assignee: Shanghai Newmed Medical Co., Ltd.
• Inventors: Yu, Qifeng, Hou, Lihong, Wang, Zhijie, Wang, Haishan, Qin, Tao
• Primary Examiner(s): Fishback, Ashley L
• Application Number:
  US16/336,866
• Publication Number:
  US 20190247192A1
• Time in Patent Office: 1,593 Days
• CPC Class Codes: A61F 2/2448 D-shaped rings
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument

Abstract

A prosthetic mitral annuloplasty ring includes a wire, an adjustment member for changing a length of the wire and a jacketing annulus for adjusting a radial dimension of the mitral valve annuloplasty ring. The jacketing annulus is sleeved over the wire and forms, together with the adjustment member, a shape matching that of a native mitral valve annulus. After the prosthetic mitral annuloplasty ring is implanted by suturing in a conventional surgical procedure and the patient'"'"'s heart starts to beat again, the adjustment member can be connected to the delivery device and the wire length therein can be adjusted by a rotating operation of the delivery device so that the mitral valve annuloplasty ring will be expanded or contracted until the prosthetic mitral annuloplasty ring perfectly fits the native mitral valve annulus in shape, effectively avoiding the problem of incomplete mitral leaflet coaptation.

Claims

1. A delivery device for a prosthetic mitral annuloplasty ring, the prosthetic mitral annuloplasty ring comprising an adjustment member which is configured to adjust a size of the prosthetic mitral annuloplasty ring and provided with an internal thread, the delivery device for the prosthetic mitral annuloplasty ring comprising a driving member and a connecting member disposed at a distal end of the driving member, wherein:

the connecting member comprises an outer tube, an intermediate tube and an adjusting core, the driving member comprising an intermediate tube knob for adjusting a position of the intermediate tube and a core knob for adjusting a position of the adjusting core;

the outer tube has one end fixed to the distal end of the driving member and the other end configured to be fixed to the adjustment member;

the intermediate tube has a first end connected to the intermediate tube knob and a second end passing through a body of the outer tube along an axial direction of the outer tube, such that a portion of the intermediate tube is exposed, wherein the portion of the intermediate tube exposed from the outer tube is provided with an external thread complementary to the internal thread of the adjustment member, and the intermediate tube is movable within the body of the outer tube through manipulation of the intermediate tube knob; and

the adjusting core has a first end connected to the core knob and a second end passing through a body of the intermediate tube along an axial direction of the intermediate tube, the adjusting core being able to telescope within the body of the intermediate tube through manipulation of the core knob.

2. The delivery device for a prosthetic mitral annuloplasty ring of claim 1, further comprising a fixing claw for fixing the prosthetic mitral annuloplasty ring to the outer tube at a distal end of the outer tube.

3. The delivery device for a prosthetic mitral annuloplasty ring of claim 2, wherein the fixing claw is fabricated from a nickel titanium alloy, a medical grade stainless steel or a cobalt-based alloy.

4. The delivery device for a prosthetic mitral annuloplasty ring of claim 1, further comprising a sliding block for driving the intermediate tube to move, the intermediate tube knob being connected to the first end of the intermediate tube through the sliding block, wherein the intermediate tube is movable within the body of the outer tube through manipulation of the intermediate tube knob to engage the external thread on the intermediate tube with the internal thread of the adjustment member.

5. The delivery device for a prosthetic mitral annuloplasty ring of claim 1, wherein the driving member further comprises a graduated indicator showing a status of the core knob.

6. The delivery device for a prosthetic mitral annuloplasty ring of claim 1, wherein the adjusting core comprises a first core segment and a second core segment, the first core segment connected to the driving member at one end and coupling with the second core segment at the other end.

7. The delivery device for a prosthetic mitral annuloplasty ring of claim 6, wherein the first core segment is a circular cylinder, and the second core segment has a rectangular, cross-shape or star-shaped cross-section.

8. The delivery device for a prosthetic mitral annuloplasty ring of claim 1, wherein the intermediate tube comprises a first section and a second section coupling with the first section, the first section of the intermediate tube passing through the body of the outer tube along the axial direction of the outer tube, the second section of the intermediate tube projecting out of the body of the outer tube, and wherein the external thread is formed on a wall of the second section of the intermediate tube.

9. The delivery device for a prosthetic mitral annuloplasty ring of claim 1, wherein the adjusting core is fabricated from a nickel titanium alloy, a medical grade stainless steel or a cobalt-based alloy.

10. A delivery system for a prosthetic mitral annuloplasty ring, comprising a delivery device for a prosthetic mitral annuloplasty ring and a prosthetic mitral annuloplasty ring that is connected at a distal end of the delivery device for the prosthetic mitral annuloplasty ring, the prosthetic mitral annuloplasty ring comprising an adjustment member which is configured to adjust a size of the prosthetic mitral annuloplasty ring and provided with an internal thread, the delivery device for the prosthetic mitral annuloplasty ring comprising a driving member and a connecting member disposed at a distal end of the driving member, wherein:

the connecting member comprises an outer tube, an intermediate tube and an adjusting core, the driving member comprising an intermediate tube knob for adjusting a position of the intermediate tube and a core knob for adjusting a position of the adjusting core;

the outer tube has one end fixed to the distal end of the driving member and the other end configured to be fixed to the adjustment member;

the intermediate tube has a first end connected to the intermediate tube knob and a second end passing through a body of the outer tube along an axial direction of the outer tube, such that a portion of the intermediate tube is exposed, wherein the portion of the intermediate tube exposed from the outer tube is provided with an external thread complementary to the internal thread of the adjustment member, and the intermediate tube is movable within the body of the outer tube through manipulation of the intermediate tube knob; and

the adjusting core has a first end connected to the core knob and a second end passing through a body of the intermediate tube along an axial direction of the intermediate tube, the adjusting core being able to telescope within the body of the intermediate tube through manipulation of the core knob.

11. The delivery system for a prosthetic mitral annuloplasty ring of claim 10, wherein the prosthetic mitral annuloplasty ring further comprises a wire and a jacketing annulus which is sleeved over the wire and forms, together with the adjustment member, a shape matching a shape of a native mitral valve annulus.

12. The delivery system for a prosthetic mitral annuloplasty ring of claim 11, wherein the adjustment member comprises a housing, a spool accommodated within the housing and adapted to wind a portion of the wire thereon, a washer for securing the spool and a damper for restraining a wound wire portion, the washer and the damper disposed on opposing sides of the spool, the spool provided with a revolving shaft disposed along an axial direction thereof, the washer defining an opening through which the revolving shaft projects and is anchored to the adjusting core.

13. The delivery system for a prosthetic mitral annuloplasty ring of claim 10, wherein the delivery device for the prosthetic mitral annuloplasty ring further comprises a fixing claw for fixing the prosthetic mitral annuloplasty ring to the outer tube at a distal end of the outer tube.

14. The delivery system for a prosthetic mitral annuloplasty ring of claim 13, wherein the fixing claw is fabricated from a nickel titanium alloy, a medical grade stainless steel or a cobalt-based alloy.

15. The delivery system for a prosthetic mitral annuloplasty ring of claim 10, wherein the delivery device for the prosthetic mitral annuloplasty ring further comprises a sliding block for driving the intermediate tube to move, the intermediate tube knob being connected to the first end of the intermediate tube through the sliding block, wherein the intermediate tube is movable within the body of the outer tube through manipulation of the intermediate tube knob to engage the external thread on the intermediate tube with the internal thread of the adjustment member.

16. The delivery system for a prosthetic mitral annuloplasty ring of claim 10, wherein the delivery device for the prosthetic mitral annuloplasty ring further comprises a graduated indicator showing a status of the core knob.

17. The delivery system for a prosthetic mitral annuloplasty ring of claim 10, wherein the adjusting core comprises a first core segment and a second core segment, the first core segment connected to the driving member at one end and coupling with the second core segment at the other end.

18. The delivery system for a prosthetic mitral annuloplasty ring of claim 17, wherein the first core segment is a circular cylinder, and the second core segment has a rectangular, cross-shape or star-shaped cross-section.

19. The delivery system for a prosthetic mitral annuloplasty ring of claim 10, wherein the intermediate tube comprises a first section and a second section coupling with the first section, the first section of the intermediate tube passing through the body of the outer tube along the axial direction of the outer tube, the second section of the intermediate tube projecting out of the body of the outer tube, and wherein the external thread is formed on a wall of the second section of the intermediate tube.

20. The delivery system for a prosthetic mitral annuloplasty ring of claim 10, wherein the adjusting core is fabricated from a nickel titanium alloy, a medical grade stainless steel or a cobalt-based alloy.