Multi-sheath delivery catheter

• US 20010037141A1
• Filed: 06/28/2001
• Published: 11/01/2001
• Est. Priority Date: 11/14/1997
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Carl E. Yee, Frank A. Occidentale, George T. Roberts, Robert A. Christie
• Inventors: Roberts, George T., Yee, Carl E., Occidentale, Frank A., Christie, Robert A.
• Granted Patent: US 6,589,251 B2
• Time in Patent Office: Days
• US Class Current: 623/1.11
• 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 2250/0097 Visible markings, e.g. indicia
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00
• CPC Class Codes: A61M 25/0023 by the form of the lumen, e.g. cross-section, variable diameter

Abstract

A multi-sheath delivery catheter and method for introducing a prosthesis into a body lumen involving use of (a) an outer sheath adapted to contain a portion of the prosthesis and having an inner surface with a non-round cross-section; (b) a middle sheath slideably disposed at least partly within the outer sheath and adapted to contain another portion of the prosthesis, the middle sheath having a distal end with a first handle attached to it that has a non-round cross-section corresponding to and engaging the non-round cross-section of the inner surface of the outer sheath; and (c) a pusher slideably disposed at least partly within the middle sheath and adapted to engage the prosthesis, whereby relative rotational movement between the outer sheath and the middle sheath is prevented by virtue of the engagement of the non-round cross-section of the first handle with the non-round cross-section of the inner surface of the outer sheath. In another aspect, the invention provides a delivery catheter having a mechanism for sequentially retracting concentric tubes to deploy the prosthesis. In another aspect, the invention provides a mechanism for preventing relative axial movement of concentric tubes. In another aspect, the invention provides a delivery system for introducing a prosthesis to a body lumen including a nose cone having a hole formed through it that is adapted to communicate with both the interior of the catheter and the ambient environment before insertion of the nose cone into the body lumen, whereby said hole allows flushing of the catheter to remove air bubbles therefrom before insertion into the body lumen. In another aspect, this invention provides a method for preventing leakage of fluid from an interior of a delivery catheter by disposing the outer tube on a mandrel having a cross-sectional area substantially equivalent to that of the inner tube, applying a compressive force to a portion of the outer tube, heating the outer tube to shrink it around the mandrel, and assembling the outer tube concentrically over the inner tube such that a seal is created between the portion of the outer tube and the inner tube.

Claims

1. A multi-sheath delivery catheter for introducing a prosthesis into a body lumen comprising:

(a) an outer sheath adapted to contain a portion of the prosthesis and having an inner surface with at least a portion having a non-round cross-section;

(b) a middle sheath slideably disposed at least partly within said outer sheath and adapted to contain another portion of the prosthesis, said middle sheath having a distal end with a first handle attached thereto that has at least a portion with a non-round cross-section corresponding to and engaging said non-round cross-section of said inner surface of said outer sheath; and

(c) a pusher slideably disposed at least partly within said middle sheath and adapted to engage the prosthesis;

whereby relative rotational movement between said outer sheath and said middle sheath is prevented by virtue of the engagement of said non-round cross-section of said first handle with said non-round cross-section of said inner surface of said outer sheath.

2. The multi-sheath delivery catheter of

claim 1

wherein said portion of said outer sheath having a non-round cross-section is a separate member attached to said outer sheath.

3. The multi-sheath delivery catheter of

claim 1

wherein said pusher further comprises a distal end with a second handle attached thereto that has a non-round cross-section corresponding to and engaging said non-round cross-section of said first handle, whereby relative rotational movement between said pusher and said middle sheath is prevented by virtue of the engagement of said non-round cross-section of said second handle with said non-round cross-section of said first handle.

4. The multi-sheath delivery catheter of

claim 3

wherein said non-round cross-sections of said inner surface of said outer sheath, said first handle, and said second handle are square.

5. The multi-sheath delivery catheter of

claim 3

wherein said non-round cross-sections of said inner surface of said outer sheath, said first handle, and said second handle are rectangular.

6. The multi-sheath delivery catheter of

claim 3

wherein said non-round cross-sections of said inner surface of said outer sheath, said first handle, and said second handle are triangular.

7. The multi-sheath delivery catheter of

claim 3

wherein said non-round cross-sections of said inner surface of said outer sheath, said first handle, and said second handle are ovular.

8. The multi-sheath delivery catheter of

claim 3

wherein said non-round cross-sections of said inner surface of said outer sheath, said first handle, and said second handle are creased.

9. The multi-sheath delivery catheter of

claim 3

wherein said non-round cross-sections of said inner surface of said outer sheath, said first handle, and said second handle are flattened.

10. The multi-sheath delivery catheter of

claim 3

wherein said first and second handles and integral with said middle sheath and said pusher, respectively.

11. In a multi-sheath delivery catheter for introducing a prosthesis to a body lumen having an outer sheath with an inner surface, a middle sheath having a distal end and being slideably disposed at least partly within said outer sheath, and a pusher having a distal end and being slideably disposed at least partly within said middle sheath, the improvement comprising:

(a) a non-round cross-section formed in said inner surface; and

(b) a handle attached to the distal end of the middle sheath that has a non-round cross-section corresponding to and engaging said non-round cross section formed in said inner surface.

12. The multi-sheath delivery catheter of

claim 11

further comprising a handle attached to the distal end of the pusher that has a non-round cross-section corresponding to and engaging said non-round cross section of said middle sheath.

13. A method for introducing a prosthesis to a body lumen using a multi-sheath delivery catheter having an outer sheath with an inner surface, a middle sheath having a distal end and being slideably disposed at least partly within said outer sheath, and a pusher having a distal end and being slideably disposed at least partly within said middle sheath, said method comprising the steps of:

(a) forming a non-round cross-section in said inner surface of said outer sheath; and

(b) attaching to the distal end of the middle sheath a handle that has a non-round cross-section corresponding to and engaging said non-round cross section formed in said inner surface of said outer sheath.

14. The method of

claim 13

further comprising the step of attaching to the distal end of the pusher a handle that has a non-round cross-section corresponding to and engaging said non-round cross section of said middle sheath.

15. A delivery catheter for introducing a prosthesis to a body lumen comprising a plurality of concentric tubes, at least one of which is adapted to contain at least a portion of the prosthesis, and means for sequentially retracting said tubes to deploy the prosthesis.

16. The delivery catheter of

claim 15

wherein said plurality of concentric tubes includes an outer tube with an inner surface and an inner tube with an outer surface, and said means for sequentially retracting said tubes comprises a first protrusion on said inner surface of said outer tube and a second protrusion, adapted to engage said first protrusion, on said outer surface of said inner tube, wherein said outer tube is adapted to be retracted over said inner tube before engagement of said first and second protuberances, and said outer tube and said inner tube are adapted to be retracted together upon said engagement.

17. A delivery catheter for introducing a prosthesis to a body lumen comprising a plurality of concentric tubes, at least a portion of one of which is adapted to contain at least a portion of the prosthesis during introduction to the body lumen, and means for preventing relative axial movement of said tubes.

18. The delivery catheter of

claim 17

wherein said plurality of concentric tubes includes a first tube having a distal end and an inner surface and a second tube disposed at least partly within said first tube and having a periphery, and said means for preventing relative axial movement of said tubes comprises:

(a) at least one notch on said second tube;

(b) a prong assembly disposed on the periphery of said second tube and abutting said distal end of said first tube, said prong assembly having at least one prong adapted to engage said notch in said second tube;

(c) a lock ring having a first portion adapted to be disposed over said distal end of said first tube and a second portion adapted to be disposed over said prong assembly abutting said distal end; and

(d) a protrusion on said inner surface of said first tube;

wherein said second portion of said lock ring is adapted to exert a force on said prong assembly sufficient to maintain the engagement of said prong with said notch and thereby prevent relative axial movement of said first and second tubes.

19. The delivery catheter of

claim 18

wherein said protrusion is adapted to (a) engage said first portion of said lock ring during retraction of said first tube, (b) slide said first portion off said distal end of said first tube, and (c) allow said prong of said prong assembly to disengage from said notch, thereby allowing relative axial movement between said first and second tubes.

20. The delivery catheter of

claim 17

wherein said plurality of concentric tubes includes a first tube having a distal end and a second tube disposed at least partly within said first tube and having a periphery, and said means for preventing relative axial movement of said tubes comprises:

(a) at least one notch on said second tube;

(b) a cam-lock assembly having;

(i) a hub fixedly attached to said distal end of said first tube; and

(ii) a cam-lock knob rotationally attached to said hub around the periphery of said second tube;

(iii) said cam-lock knob having a detailed inner cam surface adapted to engage said notch in a first position, thereby preventing relative axial motion between said first and second tubes, and disengage said notch in a second position, thereby permitting relative axial motion between said first and second tubes.

21. The delivery catheter of

claim 18

further comprising a plurality of said means for preventing relative axial movement of said tubes.

22. The delivery catheter of

claim 20

further comprising a plurality of said means for preventing relative axial movement of said tubes.

23. A delivery system for introducing a prosthesis to a body lumen comprising:

(a) a guidewire;

(b) a catheter with a lumen adapted to slide over said guidewire, a proximal end, an interior, and a plurality of concentric tubes, at least one of which is adapted to contain at least a portion of the prosthesis during introduction to the body lumen; and

(c) a nose cone disposed around said guide wire at said proximal end of said catheter, said nose cone having means for flushing of said catheter and prosthesis to remove air therefrom before insertion into the body lumen.

24. A delivery system as claimed in

claim 23

wherein said means for flushing is a through-hole.

25. A delivery system as claimed in

claim 23

wherein said means for flushing is a groove.

26. A method for preventing leakage of fluid from an interior of a delivery catheter having an outer tube and an inner tube used for introducing a prosthesis to a body lumen comprising the steps of:

(a) disposing said outer tube on a mandrel having a cross-sectional area substantially equivalent to that of the inner tube;

(b) applying a compressive force to a portion of said outer tube;

(c) heating said outer tube to shrink it around said mandrel; and

(d) assembling said outer tube concentrically over said inner tube such that a seal is created between said portion of said outer tube and said inner tube.

27. A method as claimed in

claim 26

wherein said compressive force is applied by a Teflon heat shrink tube.

28. A method as claimed in

claim 26

wherein mandrel is said inner tube.

29. A delivery catheter for introducing a prosthesis into a body lumen comprising a visual indicator, disposed on said prosthesis, illustrating the orientation of the prosthesis.