Medical device delivery sheath

• US 20080188928A1
• Filed: 12/20/2005
• Published: 08/07/2008
• Est. Priority Date: 09/16/2005
• Status: Abandoned Application

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Hildebrand, Daniel, Haug, Ulrich R., Salahieh, Amr, Saul, Tom, Morejohn, Dwight, Lepak, Jonah, Leung, Emma
• Application Number:
  US11/314,183
• Publication Number:
  US 20080188928A1
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2002/9528 for retrieval of stents
• CPC Class Codes: A61F 2002/9534 for repositioning of stents
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/0051 made from fenestrated or weakened tubing layer
• CPC Class Codes: A61M 25/0053 having a variable stiffness along the longitudinal axis, e.g. by varying the pitch of the coil or braid
• CPC Class Codes: A61M 25/0054 with regions for increasing flexibility
• CPC Class Codes: A61M 25/0074 Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/008 Strength or flexibility characteristics of the catheter tip
• CPC Class Codes: A61M 25/0138 having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils
• CPC Class Codes: A61M 25/0662 Guide tubes

Abstract

A support member for a catheter sheath is disclosed. The support member has a series of ribs with a distal member having integrated fingers for providing radial compliance. The support member provides sufficient axial stiffness to provide a desired pushability of a minimally invasive device for replacing a heart valve. Various alternative embodiments are also described.

Claims

1. A catheter comprising a radially expandable tip on a distal end of the catheter, the tip comprising:

a cuff having a first end and a second end distal to the first end, the second end comprising a plurality of irregular tabs; and

a polymer jacket surrounding the cuff,

the cuff and the polymer jacket being adapted to allow the second end of the cuff to expand more easily than the first end of the cuff in response to an axially directed force on the tip of the catheter.

2. The catheter of claim 1, wherein the irregular tabs comprise axially aligned strips of various length.

3. The catheter of claim 1, wherein one or more of the irregular tabs comprises an aperture.

4. The catheter of claim 1, wherein the irregular tabs comprise a plurality of irregular invaginated spaces.

5. The catheter of claim 1, wherein the tip is further adapted to fittingly engage a nose cone.

6. A delivery tool for endovascularly delivering a replacement heart valve, the delivery tool comprising a sheath comprising:

a support member comprising a ribcage structure with at least one spine and a plurality of ribs; and

a polymer jacket surrounding the support member.

7. The delivery tool of claim 6, wherein the support member has a plurality of axially aligned wires.

8. A support member for a catheter, the support member comprising a spine and a substantially continuous rib cage substantially along the length of said spine.

9. The support member of claim 8, wherein the catheter comprises a sheath for an implant deployment tool.

10. An endovascular valve delivery system comprising:

a deployment tool having a proximal end, a distal end, and a sheath, the sheath having a proximal zone and a distal zone wherein the distal zone of the sheath has a reduced radial stiffness compared to said proximal zone such that the distal zone may be expanded to form a funnel in response to an axially directed force; and

an implant releasably engaged to the deployment tool distal end and adapted to be drawn into the sheath by engaging the implant with the sheath to expand the sheath distal zone into a funnel.

11. The system of claim 10, wherein the axial stiffnesses of the proximal zone and the distal zone are different.

12. The system of claim 10, wherein the sheath further comprises an intermediate zone having a different axial stiffness compared to axial stiffnesses of the proximal zone and the distal zone.

14. The system of claim 10, wherein the sheath further comprises an intermediate zone with a different radial stiffness compared to the radial stiffnesses of the proximal zone and the distal zone.

15. The system of claim 10, wherein the proximal zone and distal zone further comprise polymer jackets having different compliance values.

16. The system of claim 10, wherein the distal zone has a variable radial stiffness along its axial length.

17. The system of claim 10, wherein the sheath further comprises:

a support member comprising a ribcage structure with at least one spine and a plurality of ribs; and

a polymer jacket surrounding the support member.

18. The system of claim 17, wherein the plurality of ribs further comprises one or more cutouts.

19. The system of claim 17, wherein the plurality of ribs further comprises one or more apertures.

20. The system of claim 10, wherein the deployment tool is adapted to be steerable.

21. The system of claim 10, wherein the sheath comprises a plurality of substantially axially aligned wires arranged to form a plurality of loops at the distal zone.

22. A system for endovascular replacement of a heart, the system comprising:

a handle;

a deployment tool attached to said handle, the deployment tool comprising one or more actuation elements extending therethrough;

a replacement heart valve releasably engaged to the deployment tool; and

a sheath extending substantially over the length of the deployment tool and replacement heart valve, the sheath comprising a support member comprising;

a first zone of uniform stiffness, said first zone extending substantially over the entire length of the deployment tool; and

a second zone of variable stiffness, said second zone forming a distal tip of the sheath, the second zone being capable of expansion to form a funnel for assisting in the capture of the replacement heart valve.

23. The system as described in claim 22, wherein the support member further comprises at least one intermediate zone disposed between the first zone and the second zone and having a stiffness less than that of said first zone and said second zone.

24. A method of drawing a replacement heart valve into a deployment system having an inner deployment tool member in sliding engagement with an outer sheath member, the deployment tool member supporting the replacement valve, the sheath member having a radially expandable distal tip, the method comprising the steps of:

holding one of the members in a substantially stationary position relative to the patient; and

moving the other member relative to the stationary member to draw the replacement heart valve within the sheath member.

25. The method of claim 24, wherein the moving step comprises the step of operating an actuator mechanically engaged to the moving member.

26. The method of claim 24, further comprising:

repositioning the deployment system;

withdrawing the sheath member with respect to the deployment tool member; and

securing the replacement heart valve into a desired location by actuating a locking mechanism at least partially incorporated into the replacement heart valve.

28. The method of claim 26, further comprising:

separating the replacement heart valve from the deployment tool member.

29. A method of deploying a replacement heart valve using a deployment system having an inner deployment tool member and an outer sheath member, wherein the deployment tool member and the sheath member are releasably engaged to an implant, the method comprising the steps of:

moving at least one of the members with respect to the other member to bend a tip of the sheath member; and

releasing an engagement between the sheath member and the implant.

30. The method of claim 29 wherein the deployment system further comprises an actuator handle, the releasing step comprising moving an actuator on the actuator handle.