Alignment of an implantable medical device

• US 9,566,153 B2
• Filed: 07/29/2014
• Issued: 02/14/2017
• Est. Priority Date: 09/12/2013
• Status: Active Grant

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Inventors: Geiger, Gary W., Chalekian, Aaron J.
• Primary Examiner(s): SHI, KATHERINE MENGLIN
• Application Number:
  US14/445,976
• Publication Number:
  US 20150073539A1
• Time in Patent Office: 931 Days
• Field of Search: 606/108, 623/1.23, 623/2.11, 600/142, 600/146, 600/149
• US Class Current: 1/1
• CPC Class Codes: A61B 2017/3484 Anchoring means, e.g. spreading-out umbrella-like structure
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2/962 having an outer sleeve
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61M 2025/0293 Catheter, guide wire or the like with means for holding, centering, anchoring or frictionally engaging the device within an artificial lumen, e.g. tube natural lumen, e.g. vessels A61M25/04
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/02 Holding devices, e.g. on the body

Abstract

A medical device delivery system includes an inner shaft having a proximal end and a distal end, a support shaft having a proximal end and a distal end and an articulating assembly disposed between the inner shaft and the support shaft. The support shaft is sized for insertion into the circulatory system of a patient. The articulating assembly includes a first portion at the distal end of the inner shaft and a second portion at the proximal end of the support shaft. The first portion is pivotable relative to the second portion to change orientation of the support shaft relative to the inner shaft.

Claims

1. A medical device delivery system comprising:

an inner shaft having a proximal end and a distal end;

a support shaft having a proximal end and a distal end, the support shaft being sized for insertion into the circulatory system of a patient;

an articulating assembly disposed between the inner shaft and the support shaft, the articulating assembly including a first portion at the distal end of the inner shaft and a second portion at the proximal end of the support shaft, the first portion being pivotable relative to the second portion to change the orientation of the support shaft relative to the inner shaft;

a retainer secured to the second portion of the articulating assembly and configured to retain a medical device on the support shaft between the retainer and the distal end of the support shaft;

a plurality of control wires, movement of one of the control wires proximally causing the second portion of the articulating assembly to pivot relative to the first portion of the articulating assembly;

a handle disposed proximally of the inner shaft;

an actuator assembly secured to the handle, the actuator assembly including a housing pivotably mounted to the handle, the plurality of control wires being secured to the housing so that a pivoting movement of the housing relative to the handle pulls at least one of the control wires proximally;

an anchor for securing the plurality of control wires; and

a wedge mounted within the anchor for securing the plurality of control wires.

2. The delivery system of claim 1, wherein one of the first and second portions of the articulating assembly is a ball and another of the first and second portions of the articulating assembly is a socket sized to pivotably receive the ball.

3. The delivery system of claim 1, wherein the plurality of control wires includes four control wires secured to the second portion of the articulating assembly.

4. The delivery system of claim 3, wherein a first two of the control wires lie in a first plane and a second two of the control wires lie in a second plane perpendicular to the first plane.

5. The delivery system of claim 1, wherein the wedge comprises a frustoconical body and the anchor includes a slot configured for accommodating the wedge.

6. The delivery system of claim 1, wherein the inner shaft includes a plurality of notches proximal to the distal end.

7. A medical device delivery system of claim 1, comprising:

an inner shaft having a proximal end and a distal end;

a support shaft having a proximal end and a distal end, the support shaft being sized for insertion into the circulatory system of a patient;

an articulating assembly disposed between the inner shaft and the support shaft, the articulating assembly including a first portion at the distal end of the inner shaft and a second portion at the proximal end of the support shaft, the first portion being pivotable relative to the second portion to change the orientation of the support shaft relative to the inner shaft;

a retainer secured to the second portion of the articulating assembly and configured to retain a medical device on the support shaft between the retainer and the distal end of the support shaft;

a distal outer sheath configured to cover the inner shaft and the support shaft in a first condition, and movable to a second condition exposing the support shaft; and

a proximal outer sheath configured to cover the inner shaft.

8. The delivery system of claim 7, further comprising a constricting element mounted on the inner shaft and comprising a generally cylindrical portion and an outwardly flaring portion facing the articulating assembly.

9. The delivery system of claim 8, wherein the outwardly flaring portion has a diameter greater than a diameter of the proximal outer sheath.

10. The delivery system of claim 7, wherein the inner shaft includes a plurality of notches proximal to the distal end.

11. The delivery system of claim 7, wherein the support shaft has a first diameter and the retainer has a second diameter greater than the first diameter.

12. The delivery system of claim 7, further comprising a plurality of control wires, movement of one of the control wires proximally causing the second portion of the articulating assembly to pivot relative to the first portion of the articulating assembly.

15. The delivery system of claim 12, wherein the plurality of control wires includes four control wires secured to the second portion of the articulating assembly.

16. The delivery system of claim 15, wherein a first two of the control wires lie in a first plane and a second two of the control wires lie in a second plane perpendicular to the first plane.

17. The delivery system of claim 7, wherein one of the first and second portions of the articulating assembly is a ball and another of the first and second portions of the articulating assembly is a socket sized to pivotably receive the ball.

13. The delivery system of 12, further comprising:

a handle disposed proximally of the inner shaft; and

an actuator assembly secured to the handle, the actuator assembly including a housing pivotably mounted to the handle, the plurality of control wires being secured to the housing so that a pivoting movement of the housing relative to the handle pulls at least one of the control wires proximally.

14. The delivery system of claim 13, further comprising an anchor for securing the plurality of control wires.

18. A medical device delivery system comprising:

an inner shaft having a proximal end and a distal end;

a support shaft having a proximal end and a distal end, the support shaft being sized for insertion into the circulatory system of a patient;

an articulating assembly disposed between the inner shaft and the support shaft, the articulating assembly including a first portion at the distal end of the inner shaft and a second portion at the proximal end of the support shaft, the first portion being pivotable relative to the second portion to change the orientation of the support shaft relative to the inner shaft; and

a retainer secured to the second portion of the articulating assembly and configured to retain a medical device on the support shaft between the retainer and the distal end of the support shaft,

wherein one of the first and second portions of the articulating assembly includes a generally concave bearing surface and another of the first and second portions of the articulating assembly includes a ball pivotably engaging the bearing surface,

the delivery system further including a sheath covering the first and second portions of the articulating assembly and longitudinally constraining the ball relative to the bearing surface.

19. A medical device delivery system comprising:

a support shaft configured to retain a medical device in a collapsed condition and having a proximal end and a distal end;

an inner shaft having a proximal end and a distal end;

an articulating assembly disposed between the support shaft and the inner shaft, the articulating assembly including a ball at the distal end of the inner shaft and a socket at the proximal end of the support shaft, the ball being pivotably engaged in the socket;

a retainer secured to a portion of the articulating assembly and configured to retain the medical device on the support shaft between the retainer and the distal end of the support shaft;

a handle disposed proximally of the inner shaft;

an actuator mechanism pivotably secured to the handle; and

a plurality of control wires operatively interconnecting the articulating assembly and the actuator mechanism such that pivoting movement of the actuator mechanism causes a corresponding pivoting movement of the support shaft relative to the inner shaft, and

wherein the plurality of control wires have first ends secured to the socket.

20. A medical device delivery system comprising:

a support shaft configured to retain a medical device in a collapsed condition and having a proximal end and a distal end;

an inner shaft having a proximal end and a distal end;

an articulating assembly disposed between the support shaft and the inner shaft;

a retainer secured to a portion of the articulating assembly and configured to retain the medical device on the support shaft between the retainer and the distal end of the support shaft;

a handle disposed proximally of the inner shaft;

an actuator mechanism pivotably secured to the handle;

a plurality of control wires operatively interconnecting the articulating assembly and the actuator mechanism such that pivoting movement of the actuator mechanism causes a corresponding pivoting movement of the support shaft relative to the inner shaft; and

a distal outer sheath and a proximal outer sheath for covering the inner shaft, the articulating assembly and the support shaft.