Endoprosthesis delivery catheter with sequential stage control

• US 6,395,017 B1
• Filed: 11/15/1996
• Issued: 05/28/2002
• Est. Priority Date: 11/15/1996
• Status: Expired due to Term

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Dwyer, Clifford J., Robinson, Timothy
• Primary Examiner(s): Dawson, Glenn K.
• Application Number:
  US08/751,087
• Time in Patent Office: 2,020 Days
• Field of Search: 606/108,191-200 623/1.11-1.25
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• 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 2002/9665 with additional retaining means

Abstract

A delivery device for intraluminally positioning and controllably releasing a vascular prosthesis includes an elongate delivery sheath and a control handle at the proximal end of the device. The handle has components movable and arranged to define at least three relative positions including (1) an implant capture position in which the sheath fully encloses and contains the implant, (2) an intermediate position in which the implant is partially deployed but in which the trailing end of the implant remains attached to the delivery device, and (3) a release position in which the implant has been freed from the delivery device and fully released within the blood vessel. The movable parts of the handle include a shifting mechanism that must be operated deliberately through a detent by the physician to enable the handle to be manipulated from one position to the other.

Claims

1. A device for delivering, positioning and releasing, within a body lumen, a self-expandable implant comprising:

an elongate tubular sheath for maintaining the implant in a low profile configuration, the sheath having a leading end and a trailing end and being open at its leading end;

a control handle having a body and a movable portion, the movable portion being connected to a trailing portion of the sheath, the movable portion being movable along the body of the handle to effect forward and rearward motion of the sheath with respect to the body of the handle;

an implant retainer engageable with the trailing end of the implant and being disposed to maintain the implant in a fixed position with respect to the body of the handle, the implant retainer being receivable within the sheath whereby the sheath may be moved between a forward, implant-capturing position in which the implant retainer is contained within the sheath and a rearward, implant-release position in which the implant retainer is disposed forwardly beyond the leading end of the sheath;

the movable portion of the handle being movable between a forward implant-capturing position and a rearward implant release position, the implant retainer being constructed to engage the implant to enable the leading end of the implant to self-expand as the sheath is moved toward the implant-release position and;

a detent carried by the handle to prevent continuous forward-rearward movement of the movable portion of the handle from the implant capture position to the implant release position.

2. A device as defined in claim 1 wherein the detent is manually releasable to free the movable portion of the handle for movement to a release position.

3. A device as defined in claim 2 wherein the detent is constructed so that it is movable to the release position only when the movable portion of the handle is disposed at the detent.

4. A device as defined in claim 1 further comprising a positioning tube extending through the sheath and the handle, the implant retainer being attached to the positioning tube.

5. A device as defined in claim 1 further comprising:

the handle being elongate and hollow and having forward and rearward ends;

the movable portion of the handle comprising a slide connected to the sheath, the slide being movable along the handle;

the handle further having a gating mechanism engageable with the slide to confine movement of the slide to defined segments along the length of the handle, the gating mechanism having a position in which rearward movement of the slide is limited to a position between the capture and release positions;

the gating mechanism being movably mounted to the handle to enable further rearward movement of the slide to the release position.

6. A device as defined in claim 5 further comprising:

the slide being contained within the handle;

the rear end of the sheath extending through the forward end of the handle and being connected to the slide within the handle.

7. A device as defined in claim 5 further comprising:

the gating mechanism including a gate rotatable within the handle and including at least two elongate longitudinally extending sequential, circumferentially spaced slots;

a control member disposed outside of the handle connected to the gate for effecting rotation of the gate.

8. A device as defined in claim 7 further comprising:

the rotatable gate comprising a tubular member rotatable within the handle, the tubular member having a circumferential slot disposed at a juncture of the elongate slots, the slide having a portion thereof extendable through the elongate slots and the circumferential slot.

9. A device as defined in claim 8 further comprising:

the forward-most end of the forward-most elongate slot having a circumferential slot engageable with the slide to enable locking the slide in a fully forward position.

10. A device as defined in claim 1 further comprising:

the movable portion of the control handle having a fluid chamber in communication with the lumen of the sheath and an inlet port; and

a conduit connected at one end to the inlet port and connectible at its other end to a fluid source.

11. A device as defined in claim 10 further comprising a positioning tube extending through the sheath and the handle, the positioning tube extending through the fluid chamber;

a seal carried by the movable member and engageable with the positioning tube to effect a seal about the positioning tube.

12. A device as defined in claim 11 further comprising:

a portion of the conduit being coiled about the positioning tube.

13. A device as defined in claim 1 further comprising:

means for automatically locking the movable portion of the handle to a fixed portion of the handle when the handle has been withdrawn to the implant release position.

31. A device as defined in claim 1 further comprising:

the handle being elongate and hollow and having forward and rearward ends;

the movable portion of the handle comprising a slide connected to the sheath, the slide being movable along the handle;

the handle further having a gating mechanism engageable with the slide to confine movement of the slide to defined segments along the length of the handle, the gating mechanism having a position in which rearward movement of the slide is limited to a position between the capture and release positions;

the gating mechanism being movably mounted to the handle to enable further rearward movement of the slide to the release position.

14. A device for delivering, positioning and releasing, within a body lumen, an expandable implant comprising:

an elongate tubular sheath for maintaining the implant in a low profile configuration, the sheath having a leading end and a trailing end and being open at its leading end;

a control handle having a movable portion thereof connected to a trailing portion of the sheath, the movable portion being movable along the handle to effect forward and rearward motion of the sheath with respect to the handle;

an implant retainer engageable with the trailing end of the implant and being operatively associated with the handle to maintain the implant retainer in a fixed position with respect to the handle, the implant retainer being receivable within the sheath whereby the sheath may be moved between a forward implant capturing position in which the implant retainer is contained within the sheath and a rearward implant release position in which the implant retainer is disposed forwardly beyond the leading end of the sheath;

the movable portion of the handle being movable between a forward implant-capturing configuration and a rearward implant release configuration;

a positioning tube extending through the sheath and the handle, the implant retainer being attached to the positioning tube;

the positioning tube being movable along the longitudinal axis of the device; and

a locking element carried by the handle for locking the positioning tube in a selected position with respect to the handle.

15. A device as defined in claim 14 wherein the locking element comprises a collett disposed at the rear end of the handle, the collett receiving the rearward portion of the positioning tube and a locking nut to releasably tighten the collett about the positioning tube.

16. A method for selectively delivering, positioning and releasing, within a body lumen, a self-expandable implant having leading and trailing ends comprising:

providing an elongate tubular sheath for maintaining the implant in a low profile configuration, the sheath having a leading end and a trailing end and being open at its leading end to receive the implant, an implant retainer engageable with the trailing end of the implant to retain the trailing end of the implant in a fixed position while enabling the sheath to be withdrawn rearwardly relative to the implant retainer and implant, the method further comprising;

inserting the sheath and implant retainer together with the implant contained within the sheath, into the body lumen and advancing them as a unit to a location in the body lumen;

providing a detent to prevent direct continuous movement of the sheath from a capture position to a release position;

withdrawing the sheath to the detent between the captured and release positions while exposing the leading end of the implant to enable the leading end of the implant to self-expand;

while in the detent configuration, determining whether the implant is in a desired position and orientation; and

thereafter selectively (1) moving the detent to permit the sheath to be withdrawn to a release position or (2) without shifting the detent, returning the sheath to the capture position.

17. A device for delivering, positioning and releasing, within a body lumen, a self-expandable implant comprising:

an elongate tubular sheath for maintaining the implant in a low profile configuration, the sheath having a leading end and a trailing end and being open at its leading end;

a control handle having a body and a movable portion, the movable portion being connected to a trailing portion of the sheath, the movable portion being movable along the body of the handle to effect forward and rearward motion of the sheath with respect to the body of the handle;

means, engageable with the trailing end of the implant, for maintaining the implant in a fixed position with respect to the body of the handle, said means being receivable within the sheath whereby the sheath may be moved between a forward, implant-capturing position in which said means is contained within the sheath and a rearward, implant-release position in which said means is disposed forwardly beyond the leading end of the sheath;

the movable portion of the handle being movable between a forward implant-capturing position and a rearward implant release position, said means being constructed to engage the implant to enable the leading end of the implant to self-expand as the sheath is moved toward the implant-release position and;

a detent carded by the handle to prevent continuous forward-rearward movement of the movable portion of the handle from the implant capture position to the implant release position.

18. A device as defined in claim 17 wherein the detent is manually releasable to free the movable portion of the handle for movement to the release position.

19. A device as defined in claim 17 wherein the detent is constructed so that it is movable to the release position only when the movable portion of the handle is disposed at the detent.

20. A device as defined in claim 17 further comprising a positioning tube extending through the sheath and the handle, said means being attached to the positioning tube.

21. A device as defined in claim 17 further comprising:

the movable portion of the control handle having a fluid chamber in communication with the lumen of the sheath and an inlet port; and

a conduit connected at one end to the inlet port and connectable at its other end to a fluid source.

22. A device as defined in claim 21 further comprising a positioning tube extending through the sheath and the handle, the positioning tube extending through the fluid chamber;

a seal carried by the movable member and engageable with the positioning tube to effect a seal about the positioning tube.

23. A device as defined in claim 17 further comprising:

means for automatically locking the movable portion of the handle to a fixed portion of the handle when the handle has been withdrawn to the implant release position.

24. A device for delivering, positioning and releasing, within a body lumen, an expandable implant comprising:

an elongate tubular sheath for maintaining the implant in a low profile configuration, the sheath having a leading end and a trailing end and being open at its leading end;

a control handle having a movable portion thereof connected to a trailing portion of the sheath, the movable portion being movable along the handle to effect forward and rearward motion of the sheath with respect to the handle;

means, engageable with the trailing end of the implant and being operatively associated with the handle, for maintaining the implant in a fixed position with respect to the handle, said means being receivable within the sheath whereby the sheath may be moved between a forward implant capturing position in which said means is contained within the sheath and a rearward implant release position in which said means is disposed forwardly beyond the leading end of the sheath;

the movable portion of the handle being movable between a forward implant-capturing position and a rearward implant release position;

a positioning tube extending through the sheath and the handle, said means being attached to the positioning tube;

the positioning tube being movable along the longitudinal axis of the device; and

a locking element carried by the handle for locking the positioning tube in a selected position with respect to the handle.

25. A device as defined in claim 24 further comprising:

a slide being contained within the handle;

the trailing end of the sheath extending through the forward end of the handle and being connected to the slide within the handle.

26. A device as defined in claim 25 further comprising:

a gating mechanism including a gate rotatable within the handle and including at least two elongate longitudinally extending sequential, circumferentially spaced slots;

a control member disposed outside of the handle connected to the gate for effecting rotation of the gate.

27. A device as defined in claim 26 further comprising:

the rotatable gate comprising a tubular member rotatable within the handle, the tubular member having a circumferential slot disposed at a juncture of the elongate slots, the slide having a portion thereof extendable through the elongate slots and the circumferential slot.

28. A device as defined in claim 27 further comprising:

the forward-most end of the forward-most elongate slot having a circumferential slot engageable with the slide to enable locking the slide in a fully forward position.

29. A device as defined in claim 24 further comprising:

a portion of a conduit being coiled about the positioning tube.

30. A device as defined in claim 24 wherein the locking element comprises a collett disposed at the rear end of the handle, the collett receiving a rearward portion of the positioning tube and a locking nut to releasably tighten the collett about the positioning tube.