Delivery systems and methods of implantation for prosthetic heart valves

• US 8,157,853 B2
• Filed: 01/22/2009
• Issued: 04/17/2012
• Est. Priority Date: 01/24/2008
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Laske, Timothy G., Ryan, Timothy R., Majkrzak, Carolyn C., Bloom, Eliot, Tabor, Charles
• Primary Examiner(s): Jackson, Gary
• Assistant Examiner(s): COLELLO, ERIN L
• Application Number:
  US12/357,980
• Publication Number:
  US 20090198316A1
• 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 method of deploying an implantable stented device in an anatomical location of a patient, including the steps of providing a delivery system with first and second stent engagement structures at its distal end, attaching a first structural element of the stented device to the first stent engagement structure and attaching a second structural element of the stented device to the second stent engagement structure, advancing the stented device to an implantation site, and sequentially disengaging the first structural element of the stented device from the first stent engagement structure of the delivery system and then disengaging the second structural element of the stented device from the second stent engagement structure.

Claims

1. A method of deploying an it stented device in an anatomical location of a patient, the stented device comprising a proximal end and a distal end, the method comprising the steps of:

providing a delivery system comprising first and second stent engagement structures at its distal end, wherein the first and second stent engagement structures each comprise a wire haying a distal end that is coiled for engagement with the first and second structural elements at the proximal end of the stented device, respectively, and wherein the coiled distal end of a first wire includes a first number of windings and the coiled distal end of a second wire includes a larger number of windings than the first wire;

attaching a first structural element at the proximal end of the stented device to the first stent engagement structure and attaching a second structural element at the proximal end of the stented device to the second stent engagement structure;

advancing the stented device to an implantation site; and

sequentially disengaging the first structural element at the proximal end of the stented device from the first stent engagement structure of the delivery system and then disengaging the second structural element at the proximal end of the stented device from the second stent engagement structure.

2. The method of claim 1, wherein the first and second structural elements of the stented device comprise first and second stent crowns, respectively.

3. The method of claim 1, wherein the step of sequentially disengaging the first and second structural elements from their respective stent engagement structures further comprises activating an actuation device that simultaneously axially moves the first and second wires.

4. The method of claim 3, wherein the activation of the actuation device causes the coiled distal end of the first wire to uncoil for disengagement from the first structural element and then causes the coiled distal end of the second wire to uncoil for disengagement from the second structural element.

5. The method of claim 1, wherein the step of sequentially disengaging the first and second structural elements from their respective stent engagement structures further comprises activating an actuation device in multiple steps to sequentially axially move the first and second wires.

6. The method of claim 1, further comprising the step of attaching additional stent engagement structures of the delivery system to additional corresponding structural elements at the proximal end of the stented device and then sequentially disengaging the additional stent engagement structures from their respective structural elements after the stented device is advanced to the implantation site and after the first and second structural elements are disengaged from their respective stent engagement structures.

7. The method of claim 1, wherein the delivery system further comprises a plurality of sleeves that are moveable relative to each other, wherein each of the wires is at least partially positioned within one of the sleeves, and wherein the wires are axially moveable relative, to the sleeves in which they are positioned to cause the coiled distal wire ends to contact a distal end of the sleeves and uncoil for disengagement from their respective structural elements.

8. The method of claim 7, wherein at least one of the sleeves has a different length than the rest of the sleeves of the plurality of sleeves.

9. The method of claim 1, wherein the stented device further comprises a prosthetic valve.

10. A method of deploying;

an implantable stented device having a proximal end and a distal end in an anatomical location of a patient, comprising the steps of;

providing a delivery system comprising a plurality of stent engagement structures at its distal end wherein each of the plurality of engagement structures comprise a wire having a distal end that is coiled for engagement with the proximal end of the stented device, and wherein the coiled distal end of at least one of the wires includes a larger number of windings than at least one of the other wires comprising the plurality of engagement structures;

providing a stented device comprising a proximal end, a distal end, and a plurality of structural elements at the proximal end of the stented device;

engaging each of the structural elements at the proximal end of the stented device with one of the stout engagement structures;

advancing the stented device to an implantation site; and

sequentially disengaging the structural elements at the proximal end of the stented device from their respective stent engagement structures of the delivery system.

11. The method of claim 10, wherein the step of sequentially disengaging the structural elements from their respective stent engagement structures further comprises disengaging a first set of structural elements and then disengaging a second set of structural elements, wherein the first and second sets of structural elements each comprise at least two structural elements.

12. The method of claim 11, wherein the step of sequentially disengaging the structural elements from stent engagement structures comprises disengaging the first and second sets of structural elements from their respective stent engagement structures to allow the stented device to radially expand.

13. The method of claim 10, wherein the delivery system further comprises a plurality of sleeves that each at least partially surround one of the wires, and wherein the wires are axially moveable relative to the sleeves in which they are positioned.

14. The method of claim 13, wherein at least one of the sleeves has a different length than at least one of the other sleeves.

15. The method of claim 10, wherein the coiled distal end of each of the wires can be at least temporarily deformed for engagement and disengagement with the structural elements of the stented device.

16. A method of deploying an implantable stented device in an anatomical location of a patient, comprising the steps of:

providing a delivery system comprising first and second wire structures, wherein each of the first and second wire structures comprises a proximal end and a coiled distal end, wherein the coiled distal end of a first wire includes a first number of windings and the coiled distal end of a second wire includes a larger number of windings than the first wire;

attaching a first structural element of the stented device to the first wire structure and attaching a second structural element of the stented device to the second wire structure;

advancing the stented device to an implantation site; and

sequentially disengaging the first structural element of the stented device from the coiled distal end of the first wire structure of the delivery system and then disengaging the second structural element of the stented device from the coiled distal end of the second wire structure.