Male urethral stent device

• US 7,527,651 B2
• Filed: 08/15/2006
• Issued: 05/05/2009
• Est. Priority Date: 10/22/2002
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Gellman, Barry N.
• Primary Examiner(s): SWEET, THOMAS
• Application Number:
  US11/504,884
• Publication Number:
  US 20060276909A1
• Time in Patent Office: 994 Days
• Field of Search: 623/1.12, 623/1.15, 623/23.66, 623/23.69, 623/23.7, 623/23.75, 623/1.22, 604/8, 606/108, 606/198
• US Class Current: 623/23.66
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• CPC Class Codes: A61F 2002/047 Urethrae
• CPC Class Codes: A61F 2002/828 Means for connecting a plurality of stents allowing flexibility of the whole structure
• CPC Class Codes: A61F 2210/0004 bioabsorbable

Abstract

A stent for treatment of a body lumen through which a flow is effected on either side of a sphincter, said stent comprising one or more windings and having an inner core substantially covered by an outer core and including a first segment, a second segment, and a connecting member disposed between the segments. When the stent is positioned within a patient'"'"'s urinary system, the first segment and second segments are located on either side of the external sphincter to inhibit migration of the stent while not interfering with the normal functioning of the sphincter. The outer coating comprises an absorbable material that provides temporary structural support to the stent. After absorption of substantially all the outer coating of the stent, the remaining relatively compliant inner core facilitates easy removal by the patient by pulling a portion of the stent that extends outside the patient'"'"'s body for this purpose.

Claims

1. A medical device for use within a body lumen of a patient, the device comprising:

a stent comprising;

a first anchoring segment defining a first passageway, the first anchoring segment disposed on the proximal side of the external sphincter when the stent is placed within the body of the patient;

a second anchoring segment defining a second passageway, the second anchoring segment disposed on the distal side of the external sphincter when the stent is placed within the body of the patient;

a substantially straight connecting segment extending through the external sphincter when the stent is placed within the body of the patient, the connecting segment disposed between and coupling together the first anchoring segment and the second anchoring segment;

and

a removal segment continuing and extending from the stent and disposed within at least one of the first passageway and the second passageway.

2. The medical device of claim 1 wherein at least one of the first anchoring segment and the second anchoring segment comprises a coil having a plurality of windings.

3. The medical device of claim 1 wherein the first anchoring segment comprises a coil having a plurality of windings and the second anchoring segment comprises a coil having a plurality of windings and the windings of the first anchoring segment and the second anchoring segment are sized and configured to progressively uncoil upon application of a continuous tensile force to the removal segment.

4. The medical device of claim 1 wherein the removal segment is attached to the first anchoring segment.

5. The medical device of claim 1 wherein at least one of at least a portion of the first anchoring segment, the second anchoring segment, and the connecting segment further comprises a bio-absorbable outer coating that substantially absorbs into the body lumen.

6. The medical device of claim 5 wherein at least one of the first anchoring segment, the second anchoring segment, and the connecting segment further comprises an inner core and the outer coating covers at least a portion of the inner core.

7. The medical device of claim 6 wherein the inner core comprises a biocompatible material.

8. The medical device of claim 5 wherein the outer coating loses structural integrity during hydration.

9. The medical device of claim 5 wherein the outer coating is a polyimid.

10. The medical device of claim 5 wherein the outer coating is absorbed into the lumen of a patient at a predetermined degradation rate.

11. The medical device of claim 5 wherein the outer coating is selected from the group consisting of polyglycolic acid, polylactic acid, or a polymer.

12. The medical device of claim 5 wherein the outer coating further comprises a pharmaceutical.

13. The medical device of claim 1 wherein the first anchoring segment, second anchoring segment and connecting segment are of unitary construction.

14. The medical device of claim 1 wherein at least one of the first anchoring segment and the second anchoring segment comprises a cross-sectional shape selected from the group consisting of circular, elliptical, rectangular, square, and triangular.

15. The medical device of claim 1 wherein a proximal end of the first anchoring segment and a distal end of the second anchoring segment include one or more hooks to permit connection to a delivery system.

16. The medical device of claim 15 further comprising a delivery system, the delivery system comprising:

a rotatable element including a first end, a second end, and a first connection arm hingedly coupled to the first end; and

a second element including a first end, a second end, and a second connection arm disposed on the first end, the second element comprising a lumen sized to receive the rotatable element.

17. The medical device of claim 16 wherein the rotatable element is positioned inside the lumen of the second element, the first end of the rotatable element is disposed proximal to the first end of the second element, and the second end of the rotatable element is disposed proximal to the second end of the second element.

18. The delivery system of claim 16 wherein the first connection arm further comprises an opening adapted to receive the one or more hooks and the second connection arm further comprises an opening adapted to receive the one or more hooks.

19. A medical device for use within a body lumen of a patient, the device comprising:

a stent comprising;

a first anchoring segment defining a first lumen, the first anchoring segment disposed on the proximal side of the external sphincter when the stent is placed within the urethra of the patient;

a second anchoring segment defining a second lumen, the second anchoring segment disposed on the distal side of the external sphincter when the stent is placed within the urethra of the patient;

at least one of the first anchoring segment and the second anchoring segment comprising a coil having a plurality of windings;

a substantially straight connecting segment extending through the external sphincter when the stent is placed within the urethra of the patient, the connecting segment disposed between and coupling together the first anchoring segment and the second anchoring segment;

and

a removal segment continuing and extending from the stent and including a distal portion disposed outside the body of the patient when the at least one of the first anchoring segment and the second anchoring segment comprising a coil is placed within the urethra of the patient.

20. The medical device of claim 19 wherein the first anchoring segment comprises a coil having a plurality of windings and the second anchoring segment comprises a coil having a plurality of windings and the windings of the first anchoring segment and the second anchoring segment are sized and configured to progressively uncoil upon application of a continuous tensile force to the removal segment.

21. The medical device of claim 19 wherein the removal segment is attached to the first anchoring segment.

22. The medical device of claim 19 wherein at least one of at least a portion of the first anchoring segment, the second anchoring segment, and the connecting segment further comprises a bio-absorbable outer coating that substantially absorbs into the body lumen.

23. The medical device of claim 19 wherein the first anchoring segment, second anchoring segment and connecting segment are of unitary construction.

24. The medical device of claim 19 wherein at least one of the first anchoring segment and the second anchoring segment comprises a cross-sectional shape selected from the group consisting of circular, elliptical, rectangular, square, and triangular.

25. The medical device of claim 19 wherein a proximal end of the first anchoring segment and a distal end of the second anchoring segment include one or more hooks to permit connection to a delivery system.

26. A medical device for use within a body lumen of a patient, the device comprising:

a stent comprising;

a first coil having a plurality of windings defining a first passageway, the first coil disposed on the proximal side of the external sphincter when the stent is placed within the body of the patient;

a second coil having a plurality of windings defining a second passageway, the second coil disposed on the distal side of the external sphincter when the stent is placed within the body of the patient;

a substantially straight connecting segment extending through the external sphincter when the stent is placed within the body of the patient, the connecting segment disposed between and coupling together the first and the second coils; and

a removal segment continuing and extending from the stent.

27. The medical device of claim 26 wherein the removal segment is disposed within at least one of the first passageway and the second passageway.

28. The medical device of claim 26 wherein the first coil and the second coil are sized and configured to progressively uncoil upon application of a continuous tensile force to the removal segment.

29. The medical device of claim 26 wherein the removal segment is attached to the first coil.

30. The medical device of claim 26 wherein at least one of at least a portion of the first coil, the second coil, and the connecting segment further comprises a bio-absorbable outer coating that substantially absorbs into the body lumen.

31. The medical device of claim 30 wherein at least one of the first coil, the second coil, and the connecting segment further comprises an inner core and the outer coating covers at least a portion of the inner core.

32. The medical device of claim 31 wherein the inner core comprises a biocompatible material.

33. The medical device of claim 30 wherein the outer coating loses structural integrity during hydration.

34. The medical device of claim 26 wherein a proximal end of the first coil and a distal end of the second coil include one or more hooks to permit connection to a delivery system.