Devices and methods for treating a fistula
AssigneeMillennium Pharmaceuticals, Inc.
InventorsVincent Ling, Sachiko Imaichi, Matthew Phaneuf, Nathaniel Long, Rayan Kassab, Daniel Leffler
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Abstract
Described herein are devices used for treating a fistula, along with methods of treatment thereof, and methods of manufacturing the device.
Claims38
A device for implantation into a fistula tract within a subject, wherein the fistula tract has a primary opening in a wall of a bodily structure and a tract extending from the primary opening, the device comprising:
- a unitary body configured to fill at least a portion of the fistula tract, wherein the body comprises:
- an enlarged portion located at a first end of the body;
- and
- a tube-like structure extending from an area proximate the enlarged portion and terminating at a second end of the body, wherein the enlarged portion has a cross-sectional dimension equal to or greater than a cross-sectional dimension of the tube-like structure relative to a longitudinal axis of the body.
4-9. (canceled)
12-24. (canceled)
27-35. (canceled)
37-39. (canceled)
A device for implantation into a fistula tract within a subject, wherein the fistula tract has a primary opening in a wall of a bodily structure and a tract extending from the primary opening, the device comprising:
- a body configured to fill at least a portion of the fistula tract and at least partially formed from an electrospun nanofibrous polymer, wherein the body comprises:
- an enlarged portion located at a first end of the body;
- and
- a tube-like structure extending from the enlarged portion and terminating at a second end of the body, wherein the enlarged portion has a cross-sectional dimension equal to or greater than a cross-sectional dimension of the tube-like structure relative to a longitudinal axis of the body.
42-64. (canceled)
67-72. (canceled)
A method of manufacturing a device for implantation into a tract within a subject such as a fistula, which has a primary opening in a wall of a bodily structure and a tract extending from the primary opening, the method comprising:
- preparing a polymeric solution;
- loading the solution into an electrospinning unit;
- perfusing said polymeric solution at a defined rate into an injection needle port that has a defined voltage applied to the needle;
- collecting the resulting nanofibers emanating from the needle port onto a rotating collector in the form of a mandrel having a fluted portion to create a unitary tube-like electro-spun body with a fluted portion;
- performing a post-treatment process, such as vacuum heating or solvent extraction, to remove residual solvent;
- removing the electro-spun body from the mandrel;
- manipulating the fluted portion by pulling the fluted end downward to form an enlarged portion relative to the rest of the body, wherein the enlarged portion has a cross-sectional dimension larger than a cross-section dimension of the rest of the body;
- flattening the rest of the body to form a substantially planar structure extending from the elongate portion;
- splitting the planar structure along a longitudinal axis of the body to form a plurality of elongate members;
- and
- forming a neck region between the enlarged portion and the elongate members by sealing a portion of the tube-like body proximate to the enlarged portion, wherein the neck region has a cross-sectional dimension less that the cross-sectional dimensions of the enlarged portion and the rest of the body.
76-80. (canceled)
82-91. (canceled)
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103-108. (canceled)
110-111. (canceled)
Dependencies are inferred from the claim text.