POLYMERIC IMPLANT DELIVERY SYSTEM

• US 20130066295A1
• Filed: 09/07/2012
• Published: 03/14/2013
• 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, Robinson, Timothy Walter, Kostanski, Sarah, Shia, Benedict, Brightbill, Jerry
• Granted Patent: US 9,198,783 B2
• Time in Patent Office: Days
• US Class Current: 604/500
• 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 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• 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 2002/826 more than one stent being applied sequentially
• 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 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 method of treating a patient, comprising:

providing a tubular implant and a delivery catheter adapted to engage with the tubular implant;

engaging the tubular implant with the delivery catheter;

inserting at least a portion of the delivery catheter into a body of the patient; and

disengaging the tubular implant and the delivery catheter, thereby implanting the tubular implant within the body of the patient,

wherein the implant is disengaged after fewer than 24 hours have elapsed from the engagement of the tubular implant with the catheter.

2. The method of claim 1, wherein

(a) the tubular implant is moveable between an unstressed configuration characterized by a first diameter and a compressed configuration characterized by a second diameter less than the first diameter,

(b) engaging the tubular implant with the delivery device includes moving the tubular implant from the unstressed configuration to the compressed configuration;

and

(c) disengaging the tubular implant and the delivery catheter includes moving the tubular implant from the compressed configuration to the unstressed configuration.

3. The method of claim 2, wherein

(a) the delivery catheter includes:

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; and

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 or equal to than the first diameter, the open distal end of said first expandable member configured for placement therein of at least a portion of the polymeric tubular implant in the unstressed configuration, said first expandable member comprising a proximal end having a cross-sectional dimension less than the first diameter; and

(b) engaging the tubular implant and the delivery catheter includes;

advancing the tubular implant over the inner shaft;

positioning at least a portion of the tubular implant within the open distal end of the first expandable member; and

compressing the first expandable member, thereby moving at least a portion of the tubular implant from the unstressed configuration to the compressed configuration.

4. The method of claim 3, wherein

(a) the delivery catheter includes 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

(b) compressing the first expandable member includes advancing the tubular outer shaft in a distal direction over the first expandable member and the tubular implant.

5. The method of claim 4, further comprising step of retracting the first expandable member in a proximal direction away from the tubular implant after advancing the tubular outer shaft in a distal direction over the tubular implant.

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

7. The method of claim 6, wherein the proximal end of said first expandable member is connected to said tubular middle shaft.

8. The method of claim 7, wherein said first expandable member is connected to said tubular middle shaft with an adhesive.

9. The method of claim 3, wherein the delivery catheter includes a second expandable member, said second expandable member being affixed to said inner shaft, wherein said second expandable member comprises an open distal end having a cross-sectional dimension greater than a diameter of the polymeric tubular implant when the polymeric tubular implant is in an unstressed configuration, and a proximal end having a cross-sectional dimension less than a diameter of the polymeric tubular implant when the polymeric tubular implant is in an unstressed configuration, said second expandable member being configured to be at least partially placed inside of the polymeric tubular implant.

10. The delivery system of claim 3, wherein

(a) the inner shaft comprises an enlarged diameter portion located proximal to the distal end of the inner shaft;

and

(b) advancing the tubular implant over the inner shaft includes positioning at least a portion of the tubular implant over the enlarged diameter portion.

11. The delivery system of claim 3, wherein

(a) the inner shaft comprises a rententive cushion;

and

(b) advancing the tubular implant over the inner shaft includes positioning at least a portion of the tubular implant over the retentive cushion.

12. The method of claim 1, wherein providing a tubular implant includes providing a loading aid containing the tubular implant in an unstressed configuration.

13. A method of treating a patient, comprising the steps of:

providing 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;

providing a delivery device, comprising;

an inner shaft comprising a distal end and a proximal end, wherein at least a portion of said inner shaft has a diameter less than the first diameter of the tubular implant;

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 and a proximal end having a cross-sectional dimension less than the first diameter of the tubular implant; and

a tubular outer shaft slidably disposed about said inner shaft, said tubular outer shaft having a distal end and a proximal end and an inner diameter less than the first diameter of the tubular implant;

advancing the tubular implant over the distal end of the inner shaft and the cushion;

advancing first expandable member distally so that at least a portion of the tubular implant is located within the distal end of the first expandable member;

advancing the distal end of the tubular outer shaft over the first expandable member and the tubular implant, thereby compressing the tubular implant and loading it between the inner shaft and the outer shaft;

withdrawing the first flexible member such that no portion of the tubular implant is located within the first flexible member;

inserting the distal end of the inner shaft including the first expandable member and the tubular implant into a patient; and

withdrawing the distal end of the outer shaft to expose the cylindrical implant, thereby permitting the cylindrical implant to relax away from the inner cylindrical member.

14. The method of claim 14, wherein the portion of the inner shaft of the delivery device having a diameter less than the first diameter of the tubular implant includes a compressible cushion.

15. The method of claim 14, wherein the step of providing a tubular implant includes providing a loading aid containing the tubular implant in an unstressed configuration.