Delivery systems and methods of implantation for prosthetic heart valves

• US 8,157,852 B2
• Filed: 01/22/2009
• Issued: 04/17/2012
• Est. Priority Date: 01/24/2008
• Status: Expired due to Fees

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Bloom, Eliot, Ryan, Timothy R., Tabor, Charles, Laske, Timothy G., Majkrzak, Carolyn C.
• Primary Examiner(s): Jackson, Gary
• Assistant Examiner(s): Colello, Erin
• Application Number:
  US12/357,958
• Publication Number:
  US 20090192585A1
• Time in Patent Office: 1,181 Days
• Field of Search: 623/1.11, 623/1.23, 623/1.24, 623 126- 128, 623/2.11
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• 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 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/016 made from wire-like elements
• CPC Class Codes: A61F 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2220/0091 connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0054 : V-shaped
• CPC Class Codes: A61F 2230/008 : paraboloidal
• CPC Class Codes: A61F 2250/0018 : differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/003 : differing in adsorbability or resorbability, i.e. in adsorption or resorption time
• CPC Class Codes: A61F 2250/0039 : differing in diameter
• CPC Class Codes: A61F 2250/0098 : radio-opaque, e.g. radio-opaque markers

Abstract

A delivery system for delivering a stented prosthetic heart valve to a lumen of a patient, the delivery system including a tubular body having a proximal end and a distal end, and a plurality of wires extending from the distal end of the tubular body, wherein each of the wires has a distal end that is coiled for engagement with a stent of a stented prosthetic heart valve.

Claims

1. A delivery system for delivering an implantable stented device to a lumen of a patient, the delivery system comprising:

a tubular body having a proximal end and a distal end; and

a plurality of wires extending from the distal end of the tubular body, wherein each of the wires comprises a distal portion that is shaped into a coil for engagement with a stent of the implantable stented device, and wherein each coil comprises at least one complete winding of wire and an overlap portion adjacent to a distal end of the coil, and

wherein the coil of at least one of the wires has a different number of windings of wire than the coils of at least one of the other wires of the plurality of wires.

2. The delivery system of claim 1, further comprising a central post that extends through at least a portion of the tubular body, wherein a proximal end of each of the wires is attached to the central post.

3. The delivery system of claim 2, wherein the central post is linearly moveable generally along a longitudinal axis of the tubular body.

4. The delivery system of claim 3, wherein the central post comprises a first portion that extends from the proximal end of the delivery system toward the distal end of the delivery system, and a second portion that is removably attached to the first portion, wherein the second portion comprises the plurality of wires.

5. The delivery system of claim 1, wherein each of the plurality of wires has the same length.

6. The delivery system of claim 1, wherein at least one of the plurality of wires has a different length than the other wires of the plurality of wires.

7. The delivery system of claim 1, wherein at least one of the plurality of wires is formed from a shape memory material.

8. The delivery system of claim 1, wherein at least one of the plurality of wires is formed from a high tensile spring material.

9. The delivery system of claim 1, wherein at least one of the plurality of wires is formed from a malleable material.

10. The delivery system of claim 1, further comprising a plurality of sleeves, wherein each of the wires is at least partially positioned within one of the sleeves, and wherein each of the wires is axially moveable relative to the sleeve in which it is positioned.

11. The delivery system of claim 10, wherein at least one of the sleeves has a different length than at least one of the other sleeves.

12. The delivery system of claim 10, wherein an outer diameter of the coil of the distal portion of each wire is larger than an opening in the sleeve in which it is positioned so that the distal portion of each wire cannot be moved axially into its respective sleeve when in its coiled configuration.

13. The delivery system of claim 12, wherein the distal portion of each wire can be moved axially into its respective sleeve when in its uncoiled configuration.

14. The delivery system of claim 1, wherein the coil of each of the wires is at least temporarily deformable for engagement and disengagement with a stent crown of a stented heart valve.

15. The delivery system of claim 1, further comprising a sheath positioned at least partially around the tubular body, wherein the tubular body and sheath are moveable relative to each other from a first position where the coil of each of the wires extends beyond a distal end of the sheath to a second position where the coil of at least one of the wires is in contact with the distal end of the sheath.

16. A cartridge for use with a delivery system for delivering a stented prosthetic heart valve to a lumen of a patient, the cartridge comprising a cylindrical body portion and a plurality of wires extending from a distal end of the cylindrical body, wherein each of the plurality of wires comprises a distal portion that is shaped into a coil for engagement with a stent of a stented prosthetic valve, wherein each coil comprises at least one complete winding of wire and an overlap portion adjacent to a distal end of the coil, wherein the coil of at least one of the wires has a different number of windings of wire than the coils of at least one of the other wires of the plurality of wires, and wherein the cartridge is engageable with a distal end of a delivery system.

17. A method of deploying an implantable stented device with a delivery system that comprises a tubular body having a proximal end and a distal end, and a plurality of wires extending from the distal end of the tubular body, wherein each of the wires comprises a distal portion that is shaped into a coil for engagement with a stent of an implantable stented device, and wherein each coil comprises at least one complete winding of wire and an overlap portion adjacent to a distal end of the coil, and the coil of at least one of the wires has a different number of windings of wire than the coils of at least one of the other wires of the plurality of wires, the method comprising the steps of:

providing an implantable stented device comprising at least one stent engagement component;

engaging the coil of at least one of the plurality of wires with one of the stent engagement components;

positioning the implantable stented device at an implantation location;

axially moving at least one of the plurality of wires relative to the tubular body to disengage the coil of the wire from the stent engagement component with which it is engaged.

18. The method of claim 17, wherein the step of axially moving at least one of the plurality of wires further comprises axially moving at least one wire until its coil first contacts a distal end of the tubular body and then at least partially uncoils and disengages from the stent engagement component.

19. The method of claim 17, wherein the step of axially moving at least one of the plurality of wires further comprises sequentially disengaging each of the plurality of wires from their respective stent engagement components one at a time.