Polymeric implant delivery system

• US 8,372,133 B2
• Filed: 10/05/2009
• Issued: 02/12/2013
• Est. Priority Date: 10/05/2009
• Status: Active Grant

• Current Assignee: Lyra Therapeutics, Inc.
• Original Assignee: 480 Biomedical, Inc.
• Inventors: Douk, Nareak, Busold, Rany, Core, Lee, Ho, Kicherl, Le, My
• Primary Examiner(s): Houston, Elizabeth
• Application Number:
  US12/573,687
• Publication Number:
  US 20110082464A1
• Time in Patent Office: 1,226 Days
• Field of Search: 623/1.11, 623/1.12, 623/903, 606/108, 606/159, 606/198, 606/200, 606/213, 606/151, 606/215, 606/194, 128/831, 128/843
• US Class Current: 623/1.12
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• 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 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 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• 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 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2230/0054 V-shaped

Abstract

Delivery systems for a polymeric tubular implant, kits that include such delivery systems, and methods of treating patients by implanting tubular implants using the delivery systems. The delivery systems include an inner shaft, an expandable member slidably disposed about the inner shaft and configured to receive the tubular implant, and a tubular outer shaft disposed about the inner shaft.

Claims

1. A delivery system for the placement of a tubular implant within a patient, comprising:

a tubular implant having a first diameter when in an unstressed configuration and a second diameter less than the first diameter when in a compressed configuration; and

a delivery device, comprising;

an inner shaft comprising a distal end configured for insertion into a patient and a proximal end configured to remain outside of the patient when the distal end is inserted into the patient, at least a portion of said inner shaft having a diameter less than the first diameter of the tubular implant when the tubular implant is in an unstressed configuration;

a first expandable member slidably disposed about said inner shaft, said first expandable member comprising an open distal end having a cross-sectional dimension greater than the first diameter of the tubular implant the open distal end of said first expandable member configured for placement therein of at least a portion of the tubular implant when in an unstressed configuration, said first expandable member comprising a proximal end having a cross-sectional dimension less than the first diameter of the tubular implant when the tubular implant is in an unstressed configuration;

a second expandable member affixed to said inner shaft said second expandable member comprising an open distal end; and

a tubular outer shaft slidably disposed about said inner shaft, said tubular outer shaft having a distal end and a proximal end, wherein the diameter of said tubular outer shaft at its distal end is less than a cross-sectional dimension of said first expandable member at the distal end of said first expandable member, and the diameter of said tubular outer shaft at its distal end is greater than a cross-sectional dimension of said first expandable member at the proximal end of said first expandable member;

wherein the tubular implant is removably disposed between the inner shaft and the tubular outer shaft and between the first and second expandable members;

wherein each of the first and second expandable members consists of a material selected from the group consisting of mesh material and woven material.

2. The delivery system of claim 1, further comprising a polymeric tip connected to the distal end of said inner shaft.

3. The delivery system of claim 1, further comprising a tubular middle shaft slidably disposed about said inner shaft and located between said inner shaft and said tubular outer shaft.

4. The delivery system of claim 3, wherein the proximal end of said first expandable member is connected to said tubular middle shaft.

5. The delivery system of claim 4, wherein said first expandable member is connected to said tubular middle shaft with an adhesive.

6. The delivery system of claim 1, wherein said first expandable member is funnel-shaped when expanded.

7. The delivery system of claim 1, wherein said open distal end of said second expandable member has a cross-sectional dimension greater than the first diameter of the tubular implant when the tubular implant is in an unstressed configuration, and said second expandable member has a proximal end having a cross-sectional dimension less than the first diameter of the tubular implant when the tubular implant is in an unstressed configuration, said second expandable member being configured to be at least partially placed inside of the tubular implant.

8. The delivery system of claim 1, wherein said inner shaft comprises an enlarged diameter portion, the enlarged diameter portion being located proximal to the second expandable member and the distal end of said inner shaft and distal to the first expandable member.

9. The delivery system of claim 1, further comprising a funnel removably attached to the distal end of said tubular outer shaft.

10. A kit comprising the delivery system of claim 1.

11. A delivery system for a tubular, the delivery system comprising:

an inner shaft comprising a distal end configured for insertion into a patient and a proximal end configured to remain outside of the patient when the distal end is inserted into the patient, at least a portion of said inner shaft having a diameter less than the first diameter of the tubular implant when the tubular implant is in an unstressed configuration;

a soft tip disposed at a distal-most end of the inner shaft;

a tubular middle shaft slidably disposed about said inner shaft, said tubular middle shaft comprising a distal end and a proximal end;

a first expandable member connected to the distal end of said tubular middle shaft, said first expandable member comprising an open distal end having a cross-sectional dimension greater than the first diameter of the tubular implant when the tubular implant is in an unstressed configuration, the open distal end of said first expandable member configured for placement therein of at least a portion of the tubular implant when in an unstressed configuration, said first expandable member comprising a proximal end having a cross-sectional dimension less than the first diameter of the tubular implant when the tubular implant is in an unstressed configuration;

a second expandable member affixed to said inner shaft said second expandable member comprising an open distal end;

a tubular outer shaft slidably disposed about said inner shaft, said tubular outer shaft having a distal end and a proximal end, wherein the diameter of said tubular outer shaft at its distal end is less than a cross-sectional dimension of said first expandable member at the distal end of said first expandable member, and the diameter of said tubular outer shaft at its distal end is greater than a cross-sectional dimension of said first expandable member at the proximal end of said first expandable member; and

a tubular implant having a first diameter when the implant is in an unstressed configuration and a second diameter less than the first diameter when the implant is in a compressed configuration, wherein said tubular implant is removably disposed between the inner shaft and the tubular outer shaft and between the first and second expandable members.