Prosthesis delivery

• US 6,251,132 B1
• Filed: 10/20/1998
• Issued: 06/26/2001
• Est. Priority Date: 05/20/1993
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Corporation
• Inventors: Roberts, George T., Ravenscroft, Adrian C.
• Primary Examiner(s): Millin, V.
• Assistant Examiner(s): STEWART, ALVIN J
• Application Number:
  US09/175,791
• Time in Patent Office: 980 Days
• Field of Search: 623/1, 623/12, 623/1.11, 623/1.12, 623/1.18, 623/1.19, 623/1.2, 623/1.21, 623/1.23, 606/108, 606/191, 606/194, 606/195, 606/198, 606/192
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• 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 2210/0019 operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

This invention provides smooth delivery and accurate positioning of prostheses in the body. In embodiments, systems are provided that include elongate members extending generally along the axis of a supporting catheter to a free ends. The elongate members extend through openings in the prosthesis to maintain the position of the prosthesis on the catheter. The prosthesis can be released from the catheter by relative axial motion of the catheter and the elongate members such that the free ends are removed from the openings in the prosthesis. In embodiments, the elongate members hold the distal end of a self-expanding stent at a desired axial location and in radial compaction as a restraining sheath is withdrawn. The friction between the sheath and stent puts the stent under tension, which reduces the radial force on the sheath wall, allowing smoother retraction. Proximal portions of the stent radially expand and axially shorten. The distal end, however, is maintained at the desired axial location and released from the catheter to contact the body lumen wall without substantial axial shortening.

Claims

1. A system for positioning a prosthesis in contact with tissue within a patient from a remote location, comprising:

a prosthesis having a proximal end and a distal end further from said remote location than said proximal end and a tissue-engaging body between said proximal end and said distal end, and having a radially compact state for delivery into the patient and a radially expanded state for making contact with tissue, the prosthesis having a variable length dependent upon the state of expansion of said prosthesis, said prosthesis comprising at least one opening near said distal end, and

a catheter for supporting said prosthesis in said compact state during delivery into the patient and constructed for allowing said prosthesis to expand and make contact with tissue, wherein said catheter includes at least one elongate member having a free end adapted to extend through said opening to maintain a distal portion of said prosthesis radially compact at a predetermined axial location while proximal portions of said prosthesis radially expand to make contact with tissue, and

wherein said radially compact, distal portion of said prosthesis engaged by said at least one member is releasable from said catheter at an axial location substantially corresponding to said predetermined location by relative axial motion between said at least one member and said prosthesis.

2. The system of claim 1 wherein said at least one member extends at an angle with respect to an axis of said catheter to form a predetermined wedge space between said member and said catheter for engaging said prosthesis.

3. The system of claim 2 wherein the angle is between about 3 to about 8 degrees.

4. The system of claim 2 wherein the catheter further comprises a radial step against which a base of said member is deflected to create said angle.

5. The system of claim 4 wherein said radial step comprises a band attached to said catheter.

6. The system of claim 5 wherein said band is a radiopaque marker.

7. The system of claim 2 wherein said catheter has a tapered diameter.

8. The system of claim 7 wherein the tapered diameter has an taper angle with respect to the catheter axis that is about equal to or slightly less than the angle of the member with respect to the catheter axis.

9. The system of claim 2 wherein said member is formed of a flexible material and is adapted to deflect outwardly in response to a radial force to release said free end of said member from said opening.

10. The system of claim 9 wherein said radial force is a radial self-expansion force of said prosthesis.

11. The system of claim 2 wherein said prosthesis has an expanded radius in the radially expanded state and the member has a protruding length between said catheter axis and said free end that is smaller than the expanded radius of the prosthesis.

12. The system of claim 1 wherein said at least one member comprises superelastic wire.

13. The system of claim 1 wherein said prosthesis comprises a patterned filament, said patterned filament defining said at least one opening.

14. The system of claim 13 wherein said patterned filament comprises a knit pattern and said openings comprise end loops of said knit pattern.

15. A system for positioning a prosthesis in contact with tissue within a patient from a remote location, comprising:

a prosthesis having a proximal end and a distal end further from said remote location than said proximal end and a tissue-engaging body between said proximal end and said distal end, and having a radially compact state for delivery into the patient and a radially expanded state for making contact with tissue, the prosthesis having a variable length dependent upon the state of expansion of said prosthesis, and

a catheter for supporting said prosthesis in said compact state during delivery into the patient and constructed for allowing said prosthesis to expand and make contact with tissue, wherein said catheter includes at least one member positioned to engage said prosthesis near the distal end to maintain a distal portion of said prosthesis radially compact at a predetermined axial location while proximal portions of said prosthesis radially expand to make contact with tissue, and

wherein said radially compact, distal portion of said prosthesis engaged by said at least one member is releasable from said catheter at an axial location substantially corresponding to said predetermined location by relative axial motion between said at least one member and said prosthesis and the distal end of said prosthesis is maintained in compact form by said member and portions remote from said member are maintained in compact form by an axially retractable sheath during introduction of the prosthesis to the body, said prosthesis having a radial force sufficient to frictionally engage the sheath during retraction of said sheath and to correspondingly place said prosthesis under tension between the member and the retracting sheath.

16. A system for positioning a prosthesis in contact with tissue within a patient, comprising:

a self-expanding prosthesis having a proximal end, a distal end, and a tissue-engaging body therebetween, and having a radially compact state for delivery into the patient and a radially expanded state for contacting said tissue;

a catheter having a portion for supporting said prosthesis in said compact state during delivery into the patient and at least one member fixed to said catheter to releasably engage the distal end of said prosthesis at an axial position relative to said catheter; and

an axially retractable sheath extending over said prosthesis when the prosthesis is in said compacted form;

wherein said at least one member is adapted to maintain the distal end of the prosthesis in the axial position during retraction of said sheath, placing the prosthesis under tension between the member and the retracting sheath, the retracting sheath being in frictional engagement with the prosthesis.

17. The system of claim 16 wherein the prosthesis further comprises near its distal end at least one opening through the tissue-engaging body, and the at least one member comprises at least one elongated member having a free end that engages the distal end of said prostheses by extending through the at least one opening, said elongated member adapted to disengage said prosthesis as a result of axial motion between said catheter and said prosthesis.

18. A stent delivery system adapted to deliver a stent having a proximal end and a distal end to a distal deployment location inside a body lumen from a proximal access location outside the body lumen, the stent having a radial compact state for introduction into the lumen and a radially expanded state for deployment in the lumen and having at least one opening adjacent the distal end, the stent delivery system comprising:

a catheter having at least one elongated member located adjacent the stent distal end, the member adapted to engage the distal end of the compressed stent and to maintain engagement of the distal end during deployment of the proximal end of the stent, wherein the member is adapted to maintain engagement of the stent distal end in one of;

a predetermined axial position, the radial compact state, or a combination thereof, during deployment of the proximal end, the elongated member having a free end adapted to extend through the opening in the stent.

19. A catheter comprising at least one member adapted to releasably engage a portion of a distal end of a compressed stent and to maintain engagement of the distal end during deployment of a proximal end of the stent in a distal deployment location inside a body lumen from a proximal access location outside the body lumen, wherein the at least one member is elongated and the stent comprises at least one opening adjacent the distal end, the elongated member having a free end adapted to extend through the opening in the stent.

20. The catheter of claim 19 wherein the member is adapted to maintain engagement of the stent distal end in one of:

a predetermined axial position, the radial compact state, or a combination thereof, during deployment of the proximal end.

27. The catheter of claim 19 having a longitudinal axis and and wherein said at least one member extends from said catheter at an angle to said axis.

28. The catheter of claim 27 wherein said at least one elongated member comprises a plurality of elongated members and the plurality of elongated members are distributed along a circumference of the catheter in a single axial location.

29. The catheter of claim 28 wherein the elongated members are attached to the catheter by one of:

an epoxy, a radiopaque band, a heat shrink tube, or a combination thereof.

31. The catheter of claim 19 wherein said at least one member comprises a plurality of elongated members and the plurality of elongated members are distributed along a circumference of the catheter in a single axial location.

21. A method for loading a stent delivery system adapted to deliver a compressed stent, having a proximal end, a distal end, and at least one opening adjacent the distal end, to a distal deployment location inside a body lumen from a proximal access location outside the body lumen, the stent delivery system comprising a catheter having at least one elogated member having a free end and located adjacent the stent distal end;

the method comprising;

loading at least the compressed stent and the catheter within an outer sheath, including releasably engaging a portion of the stent distal end with the at least one elongated member of the catheter having a free end, wherein releasably engaging the portion of the stent distal end comprises inserting the elongated member through the opening such that the free end extends therethrough, thereby wedging the distal end of the stent between the elongated member and the catheter.

22. A method for deploying a stent in a distal deployment location inside a body lumen from a proximal access location outside the body lumen, the method comprising:

a) introducing a pre-loaded stent delivery system into the body lumen, the stent delivery system comprising a compressed stent having at least one opening, a proximal end and a distal end, the stent mounted coaxially on a catheter, the catheter having at least one elongated member having a free end that releasably engages the stent distal end, and an outer sheath overlying the compressed stent and the catheter, the at least one elongated member adapted to engage the stent by insertion of the free end through the opening in the stent at the distal end such that the distal end of the stent is wedged between the elongated member and the catheter;

b) navigating the stent delivery system to a desired location for deploying the stent;

c) retracting the outer sheath to deploy a proximal portion of the stent into the desired location, the catheter member maintaining the distal end of the stent in a predetermined axial position during deployment of the proximal portion; and

d) releasing and deploying the distal end of the stent by unwedging the distal end by moving the catheter proximal relative to the stent.

23. The method of claim 22 wherein step (d) further comprises proximally retracting the catheter.

24. The method of claim 23 in which the at least one elongated member is flexible and the stent is self-expandable and exerts a predetermined radial force, the step of releasing the distal end of the stent in step (d) comprising retracting the catheter until the radial force exerted by the self-expandable stent deflects the member away from said catheter such that the free end is withdrawn from said openings.

25. The method of claim 22 comprising deploying the stent in a first lumen in a position near an intersection of the first lumen with a second lumen wherein maintaining engagement of the distal end during deployment of the proximal end prevents the proximal end from being deployed in a position in which the proximal end protrudes from said first lumen into said second lumen.

26. The method of claim 25 wherein the first lumen is a bile duct and the second lumen is a duodenum.

30. In a method for deploying a stent in a distal deployment location inside a body lumen from a proximal access location outside the body lumen comprising introducing a pre-loaded stent delivery system into the body lumen containing a compressed stent having a proximal end, a distal end, and an opening adjacent the distal end, the improvement comprising inserting a free end of an elongated member of a catheter through said opening and exerting a radially inward and axially distal force on the distal end of the compressed stent while deploying said stent to maintain the distal end of the stent in a predetermined axial position until the proximal portion of the stent is deployed.