Stent delivery device and method

• US 6,926,732 B2
• Filed: 09/25/2001
• Issued: 08/09/2005
• Est. Priority Date: 06/01/2001
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Ams Research Corporation (Endo International PLC)
• Inventors: Bolea, Stephen L., Westrum, John W. Jr., Derus, Patricia M.
• Primary Examiner(s): Woo, Julian W.
• Assistant Examiner(s): Baxter, Jessica R.
• Application Number:
  US09/962,402
• Publication Number:
  US 20020183827A1
• Time in Patent Office: 1,414 Days
• Field of Search: 606/191, 606/192, 606/194, 606/195, 606/198, 606/200, 623/1.11, 623/1.12, 623/1.23
• US Class Current: 623/1.12
• 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 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/9525 using a funnel
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• CPC Class Codes: A61L 31/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61L 31/14 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials

Abstract

A stent delivery system and method for intraluminal delivery and deployment of a self-expanding prosthesis at a site within a body canal is provided. The delivery system comprises a housing removably attached to a delivery tool. The housing stores the self-expanding prosthesis in an expanded state. The delivery tool has a catheter assembly with a capture zone. The capture zone receives and contains the self-expanding prosthesis in a compressed state. A securing mechanism couples the catheter assembly to the self-expanding prosthesis, wherein the securing mechanism transfers the self-expanding prosthesis from the housing to the capture zone immediately prior to the delivery and deployment procedure.

Claims

1. A delivery system for intraluminal delivery of a self-expanding prosthesis at a site within a body canal, comprising:

a housing sized and shaped to retain a self-expanding prosthesis in a first state;

a delivery tool for manipulation by an operator and having a catheter assembly extending distally from the delivery tool and including a lumen with a capture zone, the capture zone sized and shaped to retain the self-expanding prosthesis in a compressed state that is radially smaller than the first state, the housing removably attached to the catheter assembly; and

a securing mechanism movably disposed relative to the lumen and including a first portion slidable within the lumen and a second portion that is positionable within the housing to extend at least partially through the self-expanding prosthesis and including a radially extending feature to engage with the self-expanding prosthesis when in the first state thereof so that the securing mechanism and lumen can be moved relative to one another for transferring the self-expanding prosthesis from the housing to the capture zone.

2. The delivery system of claim 1, wherein the catheter assembly further comprises:

an outer tube with the lumen;

an inner tube with an inner lumen, the inner tube slideably received within the lumen of the outer tube and operably connected to the first portion of the securing mechanism; and

,

wherein the second portion of the securing mechanism comprises at least a portion of at least one flexible arm extending axially from a distal portion of the inner tube, the flexible arm having at least one lug engageable with the self-expanding prosthesis in the first state thereof, wherein the arm is radially movable between a first position to engage with the self-expanding prosthesis within the housing in the first state and a second position to be engaged with the prosthesis in the compressed state.

3. The delivery system of claim 2, wherein the housing further comprises:

a casing with a funnel portion; and

a guide with a funnel portion, the guide disposed within the casing to form a guide space therebetween, the flexible arm and self-expanding prosthesis being disposable within the guide space, and the self-expanding prosthesis being collapsible from an expanded first state to a compressed state when passing through the funnel portion.

4. The delivery system of claim 3, wherein the flexible arm and self-expanding prosthesis can pass through the guide space and into the capture zone when the outer tube is moved relative to the inner tube.

5. The delivery system of claim 4, wherein an outer surface of the lug can be positioned sufficiently proximate an inner wall of the outer tube when the flexible arm is in its second position such that the self-expanding prosthesis can be secured to the lug when in the capture zone.

6. The delivery system of claim 5, wherein the self-expanding prosthesis is releasable from the lug when the lug is outside the lumen of the outer tube.

7. The delivery system of claim 3, wherein the delivery tool further comprises a hand piece, the hand piece comprising:

a main body;

a rear loop handle disposed on the main body; and

a forward loop handle moveable between a retracted position and a forward position; and

,

wherein the outer tube is fixed to the forward loop handle and thereby movable between the refracted position and the forward position.

8. The delivery system of claim 1, wherein the catheter assembly further comprises:

an outer tube with the lumen; and

an inner tube with an inner lumen, the inner tube slidably received within the lumen of the outer tube; and

the securing mechanism comprises;

a piston slidable for forming the second portion of the securing mechanism and positioned within a chamber of the housing, the piston being positionable so that a distal end of the self-expanding prosthesis can be abutted by a proximal face of the piston; and

a shaft including the first portion of the securing mechanism and having a proximal portion removably attached to the inner tube and a distal portion coupled to the piston.

9. The delivery system of claim 8, wherein the securing mechanism further comprises:

at least one aperture at a distal portion of the inner tube, the at least one aperture having a contact surface; and

lugs extending outwardly from the inner tube, the lugs engageable with the self-expanding prosthesis;

wherein the shaft has at least one arm member with a releasing surface and a contact surface;

wherein the shaft is secured to the inner tube when the contact surface of the shaft is engaged with the contact surface of the at least one aperture; and

wherein the shaft is released from the inner tube when outer tube is moved distally relative to the inner tube, wherein the releasing surface of the shaft engages an interior wall of the outer tube such that the contact surface of the shaft disengages with the contact surface of the at least one aperture, and wherein the self-expanding prosthesis can be collapsed from the expanded state to a compressed state when transferred from the chamber to the lumen of the outer tube.

10. The delivery system of claim 9, wherein the housing further comprises a funnel portion, the self-expanding prosthesis collapsible from an expanded state to a compressed state when passing through the funnel portion.

11. The delivery system of claim 9, wherein outer surfaces of the lugs can be positioned sufficiently proximate an inner wall of the inner tube such that the self-expanding prosthesis can be secured to the lugs when in the capture zone of the outer tube.

12. The delivery system of claim 11, wherein the self-expanding prosthesis is deployable from the delivery tool by moving the outer tube proximally relative to the inner tube such that the lugs exit the lumen of the outer tube and are thereby disengageable with the self-expanding prosthesis.

13. The delivery system of claim 8, further comprising:

wherein the delivery tool further comprises a hand piece, the hand piece comprising;

a main body;

a rear loop handle disposed on the main body; and

a forward loop handle moveable between a retracted position and a forward position;

wherein the outer tube is fixedly attached to the forward loop handle and moveable between the retracted position and the forward position.

14. The delivery system of claim 1, further comprising in combination a self-expanding prosthesis provided within the housing, wherein the self-expanding prosthesis is a self-expanding stent.

15. The delivery system of claim 14, wherein the self-expanding stent is metallic.

16. The delivery system of claim 14, wherein the self-expanding stent is polymeric.

17. The delivery system of claim 14 wherein the self-expanding stent is a braided stent.

18. The delivery system of claim 14 wherein the self-expanding stent is a fenestrated stent.

19. The delivery system of claim 1, wherein the housing is a cartridge.

20. A method for preparing an expandable prosthesis to be delivered within a body canal, the method comprising:

providing a delivery system having a housing removably attached to a delivery tool, the delivery tool including a catheter assembly with a lumen and a capture zone;

wherein the expandable prosthesis is stored in a first state within the housing; and

transferring the expandable prosthesis from the housing to the capture zone of delivery tool by engaging the expandable prosthesis with a radially extending feature of securing mechanism that is at least partially positioned through the expandable prosthesis and movably disposed relative to the lumen while the expandable prosthesis is in the first state and pulling the expandable prosthesis into the capture zone while also compressing the expandable prosthesis from the first state to a compressed state during the transfer.

21. The method of claim 20, wherein transferring the expandable prosthesis from the cartridge to the delivery tool further comprises:

moving an outer tube distally relative to an inner tube;

wherein the inner tube is disposed within the lumen provided through at least a portion of the outer tube, the inner tube having at least one flexible arm extending outwardly from the inner tube, the at least one flexible arm having at least one lug secured to the expandable prosthesis such that the expandable prosthesis passes from the housing into the capture zone of the lumen of the outer tube when the outer tube is moved distally relative to the inner tube.

22. The method of claim 21, wherein the expandable prosthesis is collapsed from the first state to the compressed state when passed through a funnel portion of the housing.

23. The method of claim 22, further comprising:

forming a guide space within the housing; and

passing the at least one flexible arm, at least one lug, and expandable stent through the guide space and into the lumen of the outer tube;

wherein the expandable prosthesis is collapsed from the first state to the compressed state when passing through the guide space adjacent the funnel portion, the guide space also moving the lug of the flexible arm radially from a first position within the housing to a second position to fit within the lumen.

24. The method of claim 23 wherein passing the at least one flexible arm, at least one lug, and expandable stent through the guide space and into the lumen of the outer tube comprises passing a plurality of flexible arms, each having one lug, and expandable stent through the guide space and into the lumen of the outer tube.

25. The method of claim 23, further comprising:

providing the delivery tool with a main body, a rear loop handle disposed on the main body, and a forward loop handle moveable between a retracted position and a forward position;

fixedly attaching the outer tube to the forward loop handle such that the outer tube is moveable between the retracted position and the forward position.

26. The method of claim 20, wherein transferring the expandable prosthesis from the housing to the delivery tool further comprises:

engaging the expandable prosthesis by a surface of a piston that is slidably disposed within the housing, the piston having a shaft with a release surface engageable with an inner wall of the outer tube, the shaft further having a contact surface;

securing the piston to an inner tube which is slideably disposed within the lumen of an outer tube, the inner tube having at least one aperture at a distal portion thereof, the at least one aperture having a contact surface engaged with the contact surface of the shaft, the inner tube having lugs extending radially outwardly, the lugs engageable with the expandable prosthesis; and

,

releasing the piston and the shaft from the inner tube by sliding the outer tube distally relative to the inner tube such that the release surface engages the inner wall of the outer tube and disengages the contact surface of the shaft from the contact surface of the at least one aperture;

wherein the expandable prosthesis is secured to the inner tube when the lugs engage with the expandable prosthesis.

27. The method of claim 26, further comprising:

deploying the expandable prosthesis from the delivery tool by moving the outer tube proximally relative to the inner tube such that the lugs exit the lumen of the outer tube and disengage with the expandable prosthesis.

28. The method of claim 26, further comprising:

providing the delivery tool with a hand piece, the hand piece having a main body, a rear loop handle disposed the main body, and a forward loop handle moveable between a retracted position and a forward position; and

fixedly attaching the outer tube to the forward loop handle such that the outer tube is moveable between the retracted position and the forward position.

29. The method of claim 20, wherein the expandable prosthesis is a self-expanding stent.

30. The method of claim 29, wherein the self-expanding stent is metallic.

31. The method of claim 29, wherein the self-expanding stent is polymeric.

32. The method of claim 20, wherein the housing is a cartridge.

33. The method of claim 20, wherein the body canal is a urethra.

34. A delivery system for intraluminal delivery of a prosthesis at a site within a body canal, comprising:

a cartridge comprising;

a stent guide sized and shaped to fit within an interior of the prosthesis, thereby permitting a prosthesis to be retained in a substantially expanded state;

a housing for operably supporting the stent guide and having a receiving chamber being sized and shaped to substantially encase at least a portion of said guide and to provide a space between said guide and an inner surface of the housing to retain said prosthesis, said housing and guide also including tapered portions that define a further radially decreasing space that leads to a proximal opening of the housing, the radially decreasing space to direct and reshape said prosthesis when said prosthesis is moved toward the proximal opening in said housing; and

a securing member having a first portion at a proximal end and a second portion at a distal end, said second portion being removably attachable to the prosthesis and useable to move the prosthesis through said proximal opening in said housing; and

a delivery tool having a catheter assembly including a lumen with a capture zone, the capture zone sized and shaped to retain the expandable prosthesis in a compressed state, the delivery tool removably attachable to the cartridge and the first portion of the securing member being slidably disposable relative to and at least partially within the lumen.

35. The delivery system of claim 34, wherein said delivery tool further comprises an inner tube slideably disposed within the lumen of said catheter assembly, and having a distal end attachable to said securing member proximal end, said inner tube constructed and arranged such that when said inner tube is attached to said securing member, sliding said inner tube proximally relative to said catheter assembly causes said securing member to move the prosthesis into said capture zone.

36. The delivery system of claim 35 wherein said inner tube distal end and said securing member proximal end each comprise threads constructed and arranged to mate with each other.

37. The delivery system of claim 34 further comprising a cap attachable to said cartridge housing and useable to maintain a closed environment in said space when said cartridge is detached from said delivery tool.

38. A cartridge, attachable to a delivery device for intraluminal delivery of a self-expanding prosthesis at a site within a body canal, the cartridge useable to transfer the self-expanding prosthesis from within the cartridge to a capture zone within the delivery device, the cartridge comprising:

a housing sized and shaped to retain the self-expanding prosthesis in a first state, the housing also having a tapered portion leading to a proximal opening that is for connection to a capture zone of a lumen of the delivery device;

a self-expanding prosthesis provided within the housing in the first state, which is a substantially expanded state thereof, and

a securing mechanism operably attached at a first portion thereof to the self-expanding prosthesis and attachable at a second portion thereof to the delivery device, the first portion of the securing mechanism at least partially extending within the substantially expanded prosthesis, and the second portion of the securing mechanism being connectable to the delivery device to pull the self-expanding prosthesis from the housing to the capture zone within the delivery device when the securing member is attached to the delivery device.

39. The cartridge of claim 38, wherein the securing mechanism has at least one flexible arm extending axially from the second portion, each of the at least one flexible arms having at least one lug engageable with the self-expanding prosthesis.

40. The cartridge of claim 39, wherein the housing further comprises:

a casing with a funnel portion; and

a guide with a funnel portion, the guide disposed within the casing to form a guide space therebetween, the at least one flexible arm and self-expanding prosthesis disposed within the guide space, and the self-expanding prosthesis being collapsible from an expanded state to a compressed state when passing through the funnel portions.

41. The cartridge of claim 38 further comprising a cap constructed and arranged to cover an open end of the housing and removably attached thereto, the cap thereby protecting the prosthesis from contamination prior to transferring the prosthesis from the cartridge to the delivery device.

42. The cartridge of claim 41 wherein the cap is further constructed and arranged to form a gas tight seal over the open end of the housing such that the housing may be pressurized with a gas during storage.

43. The cartridge of claim 38 wherein the securing member second portion comprises threads attachable to mating threads formed on a tube of said delivery device.