IP Library Granted Patent US 12,076,241
Granted Patent B2
US 12,076,241 · App. 17/524,133 · Granted Sep 3, 2024

Adjustable implant system

Inventors: Samuel Shaolian (Newport Beach, CA); Scott Pool (Laguna Hills, CA); Ross Tsukashima (San Diego, CA); Daniel Anderson (Brea, CA)
Assignee: NuVasive Specialized Orthopedics, Inc.
A61F2/2442A61F2/2448A61F2/2445A61F2210/009A61F2250/0001A61F2250/0004
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Quick Facts
Patent No.
US 12,076,241
App. No.
17/524,133
Granted
Sep 3, 2024
Kind
B2
Abstract

Systems and methods treat a heart valve using a magnetically adjustable annuloplasty ring attached to or near a cardiac valve annulus. A changing magnetic field may be used to selectively increase or decrease a circumference of, or otherwise modify the shape of, the implanted annuloplasty ring. The adjustable annuloplasty ring includes a tubular body member, one or more adjustable members, and an internal magnet within the tubular body member. The tubular body member and the one or more adjustable members form a ring shape. The internal magnet is configured to rotate in response to a rotating external magnetic field. The internal magnet is coupled to the one or more adjustable members to change a dimension of the ring shape as the internal magnet rotates. A system for treating a heart valve may include an external adjustment device having one or more external magnets to generate the rotating external magnetic field.

Claims (51)

1. A system for treating a heart valve, the system comprising:

an adjustable annuloplasty ring configured to be attached to or near a cardiac valve annulus, the adjustable annuloplasty ring comprising:

a tubular body member;

one or more adjustable members, the tubular body member and the one or more adjustable members forming a ring shape; and

an internal magnet within the tubular body member, the internal magnet configured to rotate in response to a rotating external magnetic field;

wherein the internal magnet is coupled to the one or more adjustable members to change a dimension of the ring shape as the internal magnet rotates,

wherein the adjustable annuloplasty ring is approximately D-shaped as defined by: an anterior/posterior (AP) dimension and a commissure to commissure (CC) dimension, and wherein changing the dimension of the ring shape includes changing the AP dimension of the ring without substantial change to the CC dimension of the ring; and

wherein the adjustable annuloplasty ring further comprises:

a magnet housing in the tubular body member; and

a drive cable connected with the magnet housing, and

wherein rotation of the magnet housing turns the drive cable.

2. The system of claim 1 , wherein changing the AP dimension of the ring includes symmetrically changing a left side and a right side of the annuloplasty ring.

3. The system of claim 1 , wherein the adjustable annuloplasty ring further comprises a drive spindle connected at a first end thereof with the drive cable and connected at a second end thereof with a lead screw, wherein turning the drive cable turns the drive spindle.

4. The system of claim 3 , wherein the adjustable annuloplasty ring further comprises:

a first fixed arm connected with a first end of the tubular body member, and a second fixed arm coupled with a second end of the tubular body member;

a first swivel arm connected with the first fixed arm and a second swivel arm connected with the second fixed arm;

a drive nut connected with the second swivel arm and the lead screw; and

a spindle nut connected with the first swivel arm and the lead screw.

5. The system of claim 4 , wherein rotating the lead screw causes the lead screw to rotate into or out of the drive nut, causing the first swivel arm and the second swivel arm to pivot at respective joints to change the AP dimension of the ring.

6. The system of claim 1 , wherein the annuloplasty ring is sized to be inserted through a trocar.

7. The system of claim 6 , wherein the one or more adjustable members includes a hinged arm including a latch for engaging a superelastic wire after implantation through the trocar.

8. The system of claim 7 , wherein the latch includes a socket configured to receive a lock pin attached to a free end of the superelastic wire.

9. A system for changing a dimension of a portion of a subject, the system comprising:

an adjustable implant configured for implantation within a patient comprising:

a tubular body member;

an internal magnet disposed within the tubular body member, the internal magnet configured to rotate in response to a rotating external magnetic field originating external to the subject; and

an adjustable member operatively coupled to the internal magnet, wherein the internal magnet is configured to rotate in response to the moving magnetic field and change a dimension of the adjustable implant as the internal magnet rotates, and wherein the tubular body member and the adjustable member substantially form an annulus and are configured to be placed around at least the portion of the subject,

wherein the adjustable annuloplasty implant is approximately D-shaped as defined by: an anterior/posterior (AP) dimension and a commissure to commissure (CC) dimension, and wherein changing the dimension of the adjustable implant shape includes changing the AP dimension of the adjustable implant without substantial change to the CC dimension of the adjustable implant; and

wherein the adjustable implant is sized to be inserted through a trocar,

wherein the adjustable implant further comprises:

a magnet housing in the tubular body member; and

a drive cable connected with the magnet housing, and

wherein rotation of the magnet housing turns the drive cable.

10. The system of claim 9 , wherein the adjustable implant further comprises a drive spindle connected at a first end thereof with the drive cable and connected at a second end thereof with a lead screw, wherein turning the drive cable turns the drive spindle.

11. The system of claim 10 , wherein the adjustable implant further comprises:

a first fixed arm connected with a first end of the tubular body member, and a

second fixed arm coupled with a second end of the tubular body member;

a first swivel arm connected with the first fixed arm and a second swivel arm connected with the second fixed arm;

a drive nut connected with the second swivel arm and the lead screw; and

a spindle nut connected with the first swivel arm and the lead screw, wherein rotating the lead screw causes the lead screw to rotate into or out of the drive nut, causing the first swivel arm and the second swivel arm to pivot at respective joints to change the AP dimension of the adjustable implant.

12. The system of claim 9 , wherein changing the AP dimension of the adjustable implant includes symmetrically changing a left side and a right side of the annuloplasty adjustable implant.

13. The system of claim 9 , wherein the one or more adjustable members includes a hinged arm including a latch for engaging a superelastic wire after implantation through the trocar, and wherein the latch includes a socket configured to receive a lock pin attached to a free end of the superelastic wire.

14. A system for treating a heart valve, the system comprising:

an adjustable annuloplasty ring configured to be attached to or near a cardiac valve annulus, comprising:

a tubular body member;

one or more adjustable members, the tubular body member and the one or more adjustable members forming a ring shape;

an internal magnet within the tubular body member, the internal magnet configured to rotate in response to a rotating external magnetic field;

a first lead screw coupled to a first end of the internal magnet by a first drive cable, wherein rotation of the internal magnet rotates the first drive cable which communicates said rotation to the first lead screw; and

a drive nut coupled to the one or more adjustable members, wherein threads of the drive nut engage threads of the first lead screw, and wherein rotation of the first lead screw advances the first lead screw through the drive nut to pull or push the one or more adjustable members changing a dimension of the ring shape,

wherein the adjustable annuloplasty ring is approximately D-shaped as defined by: an anterior/posterior (AP) dimension and a commissure to commissure (CC) dimension, and wherein changing the dimension of the ring shape includes changing the AP dimension of the ring without substantial change to the CC dimension of the ring.

15. The system of claim 14 , wherein changing the AP dimension of the ring includes symmetrically changing a left side and a right side of the annuloplasty ring.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 15, 2021
From: SHAOLIAN, SAMUEL M.; POOL, SCOTT L.; TSUKASHIMA, ROSS; ANDERSON, DANIEL C.
To: ELLIPSE TECHNOLOGIES, INC.
Reel/Frame 058400/0661 →
MERGER AND CHANGE OF NAME Recorded Dec 15, 2021
From: ELLIPSE TECHNOLOGIES, INC.; NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
To: NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
Reel/Frame 058400/0680 →
Continuity (6)
Continuation 16103710 · Aug 14, 2018
Continuation 14885749 · Oct 16, 2015
Continuation 13625725 · Sep 24, 2012
Continuation 12411107 · Mar 25, 2009
Provisional Application 61039349 · Mar 25, 2008
Related Publication 20220061989A1 · Mar 3, 2022