DELIVERY SYSTEM FOR VASCULAR IMPLANT

• US 20100082089A1
• Filed: 10/01/2009
• Published: 04/01/2010
• Est. Priority Date: 10/01/2008
• Status: Active Grant

• Current Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Original Assignee: Cardiaq Valve Technologies Incorporated
• Inventors: Ratz, J. Brent, Quadri, Arshad
• Granted Patent: US 8,337,541 B2
• Time in Patent Office: Days
• US Class Current: 623/1.110
• 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 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• 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 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0067 conical

Abstract

A medical treatment system and method of treatment is described having an implant that can be positioned and deployed, then undeployed to allow repositioning of the implant. The system includes a self-expanding medical implant that longitudinally foreshortens upon radially expanding from a radially compacted state, a distal interface configured to attach the implant to a distal mount of a delivery device, and a proximal interface configured to attach the implant to a proximal mount of the delivery device. Moving the distal mount longitudinally away from the proximal mount applies a longitudinal tension to the implant causing the implant to expand longitudinally and contract radially, and moving the distal mount toward the proximal mount reduces a longitudinal tension in the implant allowing the implant to expand radially toward a fully expanded state.

Claims

1. A medical treatment system, comprising:

a first elongate support member having a distal mount;

a second elongate support member having a proximal mount, the second elongate support member being selectively movable relative to the first elongate support member along a longitudinal axis;

a self-expanding medical implant that foreshortens upon radially expanding from a radially compacted state;

a distal interface configured to attach the distal mount to the implant;

a proximal interface configured to attach the proximal mount to the implant;

wherein moving the distal mount away from the proximal mount applies a longitudinal tension to the implant causing the implant to expand longitudinally and contract radially and wherein moving the distal mount toward the proximal mount reduces a longitudinal tension in the implant allowing the implant to expand radially toward a fully expanded state.

2. The medical treatment system of claim 1, wherein the distal mount is attached to the distal interface by at least one distal flexible member and the proximal mount is attached to the proximal interface by at least one proximal flexible member.

3. The medical treatment system of claim 2, wherein the distal flexible member and the proximal flexible member comprise a suture.

4. The medical treatment system of claim 1, wherein the distal interface comprises at least one distal eyelet and the proximal interface comprises at least one proximal eyelet.

5. The medical treatment system of claim 1 additionally comprising a release mechanism configured to release the distal and proximal mounts from the implant.

6. The medical treatment system of claim 1, wherein the distal interface has a length and the implant has a length in the expanded state, and the distal interface length is at least the same as the implant length.

7. The medical treatment system of claim 1 additionally comprising an endoscope that extends through the first elongate support member so as to provide a view adjacent the distal end of the first elongate support member.

8. The medical treatment system of claim 1, wherein a controller controls the movement of the first elongate support member longitudinally relative the second elongate support member.

9. The medical treatment system of claim 1, wherein an actuator selectively moves the first elongate support member in a longitudinal direction relative to the second elongate support member.

10. The medical treatment system of claim 1 in combination with a secondary restraint system.

11. The medical treatment system of claim 10, wherein the secondary restraint system comprises a sheath configured to hold the implant at least partially therein in a compacted state.

12. A medical treatment system, comprising:

a first elongate support member having a first engagement member;

a second elongate support member having a second engagement member, the second elongate support member being selectively movable relative to the first elongate support member along a longitudinal axis;

a distal mount;

a proximal mount slidingly coupled relative to the distal mount along the longitudinal axis;

a first spring interposed between the proximal and distal mounts so as to bias the proximal and distal mounts longitudinally away from one another;

a self-expanding medical implant that foreshortens upon radially expanding from a radially compacted state;

a distal interface configured to attach the distal mount to the implant;

a proximal interface configured to attach the proximal mount to the implant;

wherein moving the distal mount away from the proximal mount applies a longitudinal tension to the implant causing the implant to expand longitudinally and contract radially and wherein moving the distal mount toward the proximal mount reduces a longitudinal tension in the implant allowing the implant to expand radially toward a fully expanded state.

13. The medical treatment system of claim 12, wherein the proximal and distal mounts are arranged between the first and second engagement members.

14. The medical treatment system of claim 12, wherein at least one of the proximal and distal interfaces comprises a ring assembly having at least one flexible arm fixedly attached to the ring at a first end and releasably attached to the implant at a second end, the second end extending beyond the diameter of the ring, and wherein the at least one flexible arm is resilient.

15. The medical treatment system of claim 12, wherein the first and second engagement members are configured so that as the first and second engagement are moved toward one another, the proximal and distal mounts are urged toward each other and the biasing of the center spring is overcome so that the implant contracts longitudinally and expands radially.

16. The medical treatment system of claim 15, wherein a second spring is interposed between the second engagement member and one of the proximal and distal mounts, and a third spring is interposed between the first engagement member and the other of the proximal and distal mounts, and the second and third springs each have a spring constant greater than a spring constant of the first spring.

17. The medical treatment system of claim 16, wherein the spring constants of the second and third springs are substantially the same.

18. A method of delivering a medical implant, comprising:

providing an implant delivery system comprising a self expanding implant configured to longitudinally foreshorten upon radially expanding from a compacted radial state, a delivery device comprising proximal and distal mounts that selectively connect to the implant by a proximal and a distal interface, respectively, the delivery device configured so that the proximal and distal mounts can be selectively moved relative to one another so as to selectively apply a longitudinal tension on the implant to urge the implant into the compacted radial state;

advancing the implant in a compacted radial state within a patient to a desired deployment location;

positioning the implant adjacent the desired deployment location;

actuating the delivery device so as to move the proximal and distal mounts toward one another so as to reduce the longitudinal tension on the implant and allow the implant to radially expand toward a fully expanded state;

verifying the implant is properly positioned at the desired deployment location within the patient.

19. The method of delivering a medical implant of claim 18, wherein if it is determined that the implant is not properly positioned, additionally comprising moving the proximal and distal mounts away from one another so as to increase the longitudinal tension on the implant to longitudinally expand and radially contract the implant so as to disengage the implant from the patient'"'"'s tissues.

20. The method of delivering a medical implant of claim 19 additionally comprising adjusting the position of the implant, and again moving the proximal and distal mounts toward one another so as to allow the implant to radially expand.

21. The method of delivering a medical implant of claim 18, additionally comprising verifying whether the implant is poised to be properly positioned after partially expanding the implant.

22. The method of delivering a medical implant of claim 18 additionally comprising providing an endoscope, and using the endoscope to verify whether the implant is properly positioned.