CA2422722A1 - Apparatus for delivering endoluminal prostheses and methods of making and using them - Google Patents

Apparatus for delivering endoluminal prostheses and methods of making and using them Download PDF

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Publication number
CA2422722A1
CA2422722A1 CA002422722A CA2422722A CA2422722A1 CA 2422722 A1 CA2422722 A1 CA 2422722A1 CA 002422722 A CA002422722 A CA 002422722A CA 2422722 A CA2422722 A CA 2422722A CA 2422722 A1 CA2422722 A1 CA 2422722A1
Authority
CA
Canada
Prior art keywords
tubular member
prosthesis
lumen
distal
bumper
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002422722A
Other languages
French (fr)
Other versions
CA2422722C (en
Inventor
Ranier Betelia
Edward Gillis
Jonathan M. Rourke
Yi Yang
David White
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Boston Scientific Scimed Inc
Original Assignee
Endotex Interventional Systems, Inc.
Ranier Betelia
Edward Gillis
Jonathan M. Rourke
Yi Yang
David White
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Endotex Interventional Systems, Inc., Ranier Betelia, Edward Gillis, Jonathan M. Rourke, Yi Yang, David White filed Critical Endotex Interventional Systems, Inc.
Publication of CA2422722A1 publication Critical patent/CA2422722A1/en
Application granted granted Critical
Publication of CA2422722C publication Critical patent/CA2422722C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/97—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve the outer sleeve being splittable

Abstract

A delivery apparatus (10) includes a tubular sheath (12) including proximal, intermediate (20) , and distal (18) portions defining a lumen (16). A wall o f the distal portion is transparent, allowing observation of the lumen (16) within the distal portion. The distal portion (18) terminates in a rounded distal tip including a plurality of leaflets (24) integrally molded thereto. A self-expanding stent (59) is disposed within the intermediate portion (20), and a bumper member (30) is slidably disposed within the lumen (16) proximat e the stent (50). Before use, the sheath (12) is retracted to bump the stent (50) forward into the distal portion (18) until the stent is observed within the distal portion. After the apparatus (10) has been pre-loaded, the distal portion is advanced into a blood vessel, e.g., across a stenosis, and the sheath (12) is retracted, causing the leaflets (24) to open and allow the stent (50) to be deployed, whereupon the stent (50) automatically expands to dilate the stenosis.

Claims (67)

1. An apparatus for delivering a prosthesis into a blood vessel of a patient, comprising:
an elongate tubular member having a proximal end, a distal end, and a lumen extending between the proximal and distal ends, the distal end having a size for endoluminal insertion into a blood vessel and terminating in a substantially atraumatic distal portion comprising a plurality of flexible leaflets integrally molded thereto, the leaflets being deflectable from a closed position wherein the leaflets engage one another to an open position wherein the leaflets define an opening communicating with the lumen;
a tubular prosthesis disposed within the lumen proximate the distal portion;
and an elongate bumper member having a proximal end and a distal end, the bumper member being slidably disposed within the lumen of the sheath, the distal end having a blunt edge disposed adjacent a proximal end of the prosthesis for preventing axial displacement of the prosthesis upon retraction of the tubular member with respect to the bumper member.
2. The apparatus of claim 1, wherein the prosthesis comprises a self expanding stent, the stent being biased to assume an expanded condition having a cross-section larger than the lumen of the tubular member, and being compressible to a contracted condition to facilitate insertion into the lumen.
3. The apparatus of claim 1, wherein the leaflets define a substantially rounded bullet shape in the closed position.
4. The apparatus of claim 1, wherein the leaflets define a substantially conical shape in the closed position.
5. The apparatus of claim 1, wherein the leaflets are substantially flexible and independently deflectable at a temperature less than body temperature.
6. The apparatus of claim 1, wherein the leaflets are biased towards the closed position, but are resiliently deflectable to the open position.
7. The apparatus of claim 1, wherein adjacent leaflets are connected to one another by weakened regions, the weakened regions being tearable upon retraction of the tubular member with respect to the prosthesis to allow the leaflets to be deflected towards the open position.
8. The apparatus of claim 1, wherein adjacent leaflets are separated by a slit such that the leaflets are independently deflectable.
9. The apparatus of claim 1, wherein the leaflets include a portion having a thickness that is substantially thinner than a wall thickness of the distal portion of the sheath from which the leaflets extend.
10. The apparatus of claim 1, wherein the bumper member comprises a helical coil.
11. An apparatus for delivering a prosthesis into a blood vessel of a patient, comprising:
an elongate tubular member having a proximal end, a distal end, and a lumen extending between the proximal and distal ends, the distal end having a size for endoluminal insertion into a blood vessel;
a tubular prosthesis disposed within the lumen proximate the distal end; and an elongate bumper member comprising a helical coil having a proximal end and a distal end, the bumper member being slidably disposed within the lumen of the sheath, the distal end having a blunt distal edge disposed adjacent a proximal end of the prosthesis for preventing axial displacement of the prosthesis upon retraction of the tubular member with respect to the bumper member.
12. The apparatus of claim 11, wherein the tubular member comprises a substantially atraumatic distal portion comprising a plurality of flexible leaflets integrally molded thereto, the leaflets being deflectable from a closed position wherein the leaflets engage one another to an open position wherein the leaflets define an opening communicating with the lumen.
13. The apparatus of claim 12, wherein the leaflets define a substantially rounded bullet shape in the closed position.
14. The apparatus of claim 12, wherein the leaflets are substantially flexible and independently deflectable at a temperature less than body temperature.
15. The apparatus of claim 12, wherein the leaflets are biased towards the closed position, but are resiliently deflectable to the open position.
16. The apparatus of claim 11, wherein the bumper member comprises a helical wire compression coil extending between its proximal and distal ends.
17. The apparatus of claim 11, wherein the bumper member comprises a plastic bumper element extending from a distal end of the helical coil, the bumper element including the blunt distal edge thereon.
18. The apparatus of claim 17, wherein the bumper member further comprises an extension element extending from the bumper element, the extension element having a cross-section substantially smaller than the bumper element, whereby the extension element may extend through the prosthesis disposed within the lumen of the tubular member.
19. The apparatus of claim 18, wherein the extension element comprises a lumen for receiving a guidewire therethrough.
20. The apparatus of claim 11, further comprising a radiopaque marker on the distal end of the bumper member.
21. A method for making a sheath for delivering a treatment element within a body lumen of a patient, the method comprising:
providing a tubular member formed from a substantially flexible material, the tubular member having a proximal end, a distal end, and a lumen extending axially between the proximal and distal ends, the distal end having a size for endoluminal insertion into a body lumen;
providing a die having a bore therein, the bore having a tapered shape;
heating the die to a temperature in excess of a melting point of the flexible material from which the tubular member is formed;
inserting the distal end of the tubular member into the bore of the heated die until a distal portion of the tubular member is softened and deformed into a tapered shape substantially enclosing the distal end;
creating one or more slits in the distal portion of the tubular member after it is deformed into the tapered shape, the slits defining a plurality of leaflets;
and inserting a treatment element into the lumen of the tubular member until it is disposed proximate the distal portion.
22. The method of claim 21, further comprising inserting a bullet having a tapered-shaped distal end into the distal end of the tubular member before inserting the distal end of the tubular member into the bore.
23. The method of claim 22, wherein the bullet and the bore have corresponding substantially rounded shapes defining a mold cavity therebetween when the distal end of the tubular member is inserted into the bore.
24. The method of claim 21, wherein the treatment element comprises a tubular prosthesis for implantation within a body lumen of a patient.
25. The method of claim 24, further comprising inserting an elongate bumper member into the lumen of the tubular member, the bumper member being slidably disposed within the lumen of the tubular member, the distal end having a blunt distal edge for abutting a proximal end of the prosthesis.
26. The method of claim 25, further comprising:
providing an elongate helical coil having a proximal end and a distal end; and attaching a tubular bumper element to the distal end of the helical coil to provide the bumper member, the bumper element comprising the blunt distal edge of the bumper element.
27. The method of claim 26, further comprising attaching a tubular extension element to the bumper element, the extension element having a cross-section substantially smaller than the bumper element.
28. The method of claim 26, wherein the bumper element comprises plastic, and wherein the step of attaching the bumper element to the helical coil comprises:
heating the bumper element until it is softened; and directing the softened bumper element over the distal end of the helical coil.
29. The method of claim 24, wherein the prosthesis comprises a self expanding stent biased to assume an expanded condition having a cross-section larger than the lumen, and compressible to a contracted condition before being inserted into the lumen of the tubular member.
30. The method of claim 24, wherein the prosthesis is inserted into the lumen of the tubular member before inserting the distal end of the tubular member into the bore.
31. The method of claim 24, wherein the prosthesis is inserted into the lumen from the distal end of the tubular member.
32. The method of claim 24, wherein the prosthesis is inserted into the lumen from the proximal end of the tubular member.
33. The method of claim 21, wherein the step of creating one or more slits comprises cutting a plurality of slits in the tapered shape distal portion, the slits extending substantially radially from an apex of the tapered shape distal portion.
34. The method of claim 21, wherein the slits extend only partially through a wall of the tapered shape distal portion, thereby defining weakened regions between the leaflets.
35. The method of claim 21, wherein the slits extend completely through a wall of the tapered shape distal portion, whereby the leaflets are independently deflectable.
36. The method of claim 35, wherein the leaflets are biased to a closed position substantially enclosing the lumen of the tubular member, and are resiliently deformable to an open position defining an opening communicating with the lumen of the tubular member.
37. An apparatus for delivering a prosthesis into a body lumen of a patient, comprising:
a tubular member comprising a proximal portion, a distal portion having a size for insertion into a body lumen, and an intermediate portion between the proximal and distal portions, each portion comprising a wall defining a lumen extending between the proximal and distal portions, the wall of the distal portion comprising material allowing observation of the lumen within the distal portion;
a prosthesis disposed within the tubular member proximal to the distal portion; and a bumper member comprising a proximal end and a distal end, the bumper member being slidably disposed within the lumen of the tubular member, the distal end being disposed adjacent a proximal end of the prosthesis for preventing axial displacement of the prosthesis upon retraction of the tubular member such that the prosthesis may be moved at least partially into the distal portion, whereupon the prosthesis may be observed through the wall of the distal portion.
38. The apparatus of claim 37, wherein the prosthesis comprises a stent biased to assume an expanded condition having a cross-section larger than the lumen of the tubular member, and being compressible to a contracted condition to facilitate insertion into the lumen.
39. The apparatus of claim 37, wherein the prosthesis is disposed entirely within the intermediate portion of the tubular member until the tubular member is retracted relative to the bumper member.
40. The apparatus of claim 37, wherein the intermediate portion of the tubular member is substantially opaque or is translucent.
41. The apparatus of claim 37, wherein the intermediate portion of the tubular member comprises a reinforcing element.
42. The apparatus of claim 37, wherein the distal portion is substantially transparent.
43. The apparatus of claim 37, wherein the distal portion is free from reinforcing elements.
44. The apparatus of claim 37, wherein the distal portion terminates in a distal tip having a rounded bullet shape.
45. The apparatus of claim 44, wherein the distal tip comprises a plurality of leaflets that are deflectable from a closed position, wherein adjacent leaflets abut one another, to an open position, for delivering the prosthesis from the lumen.
46. An apparatus for delivering a prosthesis into a body lumen of a patient, comprising:
a tubular member comprising a proximal portion, a distal portion having a size for insertion into a body lumen, and an intermediate portion between the proximal and distal portions, each portion comprising a wall defining a lumen extending between the proximal and distal portions, the wall of the distal portion comprising material allowing observation of the lumen within the distal portion;
a self expanding prosthesis disposed within the tubular member proximal to the distal portion;
a bumper member comprising a proximal end and a distal end, the bumper member being slidably disposed within the lumen of the tubular member, the distal end being disposed adjacent a proximal end of the prosthesis for preventing axial displacement of the prosthesis upon retraction of the tubular member such that the tubular member may be retracted until at least a portion of the prosthesis is observed through the distal portion; and an actuator coupled to the tubular member and the bumper member, the actuator configured for retracting the tubular member relative to the bumper member, the actuator maintaining the tubular member under tension when the tubular member is retracted.
47. The apparatus of claim 46, wherein the actuator comprises a handle device coupled to the proximal portion of the tubular member and the proximal end of the bumper member.
48. The apparatus of claim 46, wherein the prosthesis is disposed entirely within the intermediate portion of the tubular member until the tubular member is retracted relative to the bumper member.
49. The apparatus of claim 46, wherein the intermediate portion of the tubular member is substantially opaque.
50. The apparatus of claim 46, wherein the intermediate portion of the tubular member is translucent.
51. The apparatus of claim 46, wherein the intermediate portion of the tubular member comprises a reinforcing element.
52. The apparatus of claim 46, wherein the distal portion is substantially transparent.
53. The apparatus of claim 46, wherein the distal portion is free from reinforcing elements.
54. The apparatus of claim 46, wherein the distal portion terminates in a distal tip having a rounded bullet shape, the distal tip comprising a plurality of leaflets that are deflectable from a closed position, wherein adjacent leaflets abut one another, to an open position, for delivering the prosthesis from the lumen.
55. A method for preparing a delivery apparatus comprising a tubular member comprising a distal portion having a size for insertion into a body lumen, the distal portion comprising material allowing observation of a lumen of the tubular member within the distal portion, and a prosthesis disposed within the lumen proximal to the distal portion, the method comprising:
retracting the tubular member proximally with respect to the prosthesis; and ceasing retraction when at least a portion of the prosthesis is observed within the distal portion of the tubular member.
56. The method of claim 55, wherein the prosthesis comprises a self expanding stent having a length, and wherein the tubular member is retracted a distance equal to or greater than the length of the stent.
57. The method of claim 55, wherein the retracting step comprises applying a proximal tension to the tubular member, thereby removing any substantial slack in the tubular member.
58. The method of claim 57, further comprising maintaining a proximal tension applied to the tubular member after retraction is ceased, thereby preventing any substantial slack from returning into the tubular member.
59. The method of claim 55, wherein the tubular member comprises a substantially opaque or translucent portion proximal to the distal portion, and wherein the prosthesis is initially disposed entirely within the substantially opaque or translucent portion before the tubular member is retracted.
60. The method of claim 55, wherein the delivery apparatus further comprises a bumper member slidably disposed within the lumen adjacent the prosthesis, and wherein the retracting step comprises retracting the tubular member relative to the bumper member, the bumper member for preventing axial displacement of the prosthesis while the tubular member is retracted.
61. The method of claim 55, wherein the distal portion is substantially transparent.
62. A method for preparing a delivery apparatus comprising a tubular member comprising a lumen extending between proximal and distal portions, the distal portion having a size for insertion into a body lumen, and a prosthesis defining a length disposed within the lumen proximal to the distal portion, the method comprising:
retracting the tubular member proximally with respect to the prosthesis; and ceasing retraction when the tubular member has moved a distance at least as long as the length of the prosthesis but before the prosthesis has emerged from a distal tip of the distal portion.
63. The method of claim 62, wherein the retracting step comprises applying a proximal tension to the tubular member, thereby removing any substantial slack in the tubular member.
64. The method of claim 63, further comprising maintaining a proximal tension applied to the tubular member after retraction is ceased, thereby preventing any substantial slack from returning into the tubular member.
65. The method of claim 62, wherein the distal portion comprises a material allowing observation of the lumen within the distal portion, wherein the tubular member comprises a substantially opaque or translucent portion proximal to the distal portion, and wherein the prosthesis is initially disposed entirely within the substantially opaque or translucent portion until the tubular member is retracted.
66. The method of claim 65, wherein retraction of the tubular member is ceased when at least a portion of the prosthesis is observed entering the distal portion.
67. The method of claim 62, wherein the delivery apparatus further comprises a bumper member slidably disposed within the lumen adjacent the prosthesis, and wherein the retracting step comprises retracting the tubular member relative to the bumper member, the bumper member for preventing axial displacement of the prosthesis while the tubular member is retracted.
CA002422722A 2000-09-18 2001-09-17 Apparatus for delivering endoluminal prostheses and methods of making and using them Expired - Fee Related CA2422722C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US09/664,970 US6945989B1 (en) 2000-09-18 2000-09-18 Apparatus for delivering endoluminal prostheses and methods of making and using them
US09/664,970 2000-09-18
PCT/US2001/029166 WO2002022053A2 (en) 2000-09-18 2001-09-17 Apparatus for delivering endoluminal prostheses and methods of making and using them

Publications (2)

Publication Number Publication Date
CA2422722A1 true CA2422722A1 (en) 2002-03-21
CA2422722C CA2422722C (en) 2010-03-09

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CA002422722A Expired - Fee Related CA2422722C (en) 2000-09-18 2001-09-17 Apparatus for delivering endoluminal prostheses and methods of making and using them

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US (2) US6945989B1 (en)
EP (1) EP1318769B1 (en)
JP (1) JP4874502B2 (en)
AT (1) ATE422860T1 (en)
CA (1) CA2422722C (en)
DE (1) DE60137698D1 (en)
ES (1) ES2320737T3 (en)
WO (1) WO2002022053A2 (en)

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