System for maintaining body canal patency

• US 8,506,647 B2
• Filed: 02/14/2002
• Issued: 08/13/2013
• Est. Priority Date: 02/14/2002
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Rao, Doreen S., Rioux, Robert F.
• Primary Examiner(s): MCEVOY, THOMAS M
• Application Number:
  US10/075,144
• Publication Number:
  US 20030153970A1
• Time in Patent Office: 4,198 Days
• Field of Search: 623/23.64, 623/23.66, 623/23.7, 623/1.15, 623/1.16, 623/23.65, 604/907, 606/108, 606/191, 24/33, 24/31.3, 24/491, 24/56, 24/58, 63/4, 63/38, 63/12, 63/13, 704/57, 59/80, 59/82, 59/84, 59/93, 59/95, D84/99, D11/13
• US Class Current: 623/23.65
• 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: A61M 27/008 pre-shaped, for use in the urethral or ureteral tract

Abstract

A device is provided for insertion and implantation in a patient'"'"'s bodily canals or vessels such as the ureter. The device includes interconnected loops that form a flexible structure that may span the length of a bodily canal. The device may include retaining elements at both or either ends. Further according to the present invention, there is provided a stylet for delivering the device to the desired body canal. The device minimizes contact with the lining of the bodily canal while retaining the patency of the canal. The device also is adjustable in length and shape. It is particularly useful for maintaining the tortousness of a body canal.

Claims

1. A device for treating a body canal, comprising:

a medical device that includes;

a proximal end-piece positioned at a proximal-most end of said medical device, a first portion of the proximal end-piece defining an opening configured to receive at least a portion of an insertion device;

a distal end-piece positioned at a distal end of said medical device, the end-pieces being spheres; and

an elongated body portion disposed between said proximal end-piece and said distal end-piece, said body portion comprising a plurality of interconnected loops directly connected to a second potion of the proximal end-piece and to the distal end-piece and configured to fit within said body canal, each of said loops comprising a member defining at least one opening, the member of each loop passing through at least one opening of another loop to form said plurality of interconnected loops, and wherein the elongated body portion further comprises a substantially cylindrical non-loop segment having a distal end surface and a proximal end surface, the distal end surface being directly connected to a first loop of the interconnected loops and the proximal end surface being directly connected to a second loop of said interconnected loops, wherein the non-loop segment is a single continuous structure, a diameter of at least one of the end-pieces being larger than a diameter of any component of the elongated body;

the substantially cylindrical non-loop segment having an undulating outer surface extending from a distal end of the substantially cylindrical non-loop segment to a proximal end of the substantially cylindrical non-loop segment.

2. The device of claim 1 wherein said plurality of interconnected loops comprises discrete loops.

3. The device of claim 1 wherein at least one of said loops is substantially oval.

4. The device of claim 1 wherein at least one of said loops is substantially circular.

5. The device of claim 1 wherein at least one of said loops is substantially rectangular.

6. The device of claim 1 wherein said member of at least one of said loops comprises a substantially circular cross-section.

7. The device of claim 1 wherein at least one of said members defines a closed loop.

8. The device of claim 1 wherein at least one of said members defines an open loop comprising two ends.

9. The device of claim 8 further comprising a gap between said open loop ends, the largest dimension of said gap being no greater than the diameter of an adjacent loop member.

10. The device of claim 1 wherein at least one of said members is hollow.

11. The device of claim 1 wherein said members are biodegradable.

12. The device of claim 1 further comprising a drug releasable from said device.

13. The device of claim 12, further comprising a plug for releasing said drug.

14. The of claim 12 wherein said device further comprises a coating disposed on at least a portion of said device, said coating releasing said drug in a solution.

15. The device of claim 1, wherein at least one of said end-pieces comprises a cross-sectional area larger than a cross-sectional area of said body portion.

16. The device of claim 1, wherein the substantially cylindrical non-loop segment defines a longitudinal axis, a radial center of the substantially cylindrical non-loop segment extends along the longitudinal axis, the first loop of the interconnected loops and the second loop of the interconnected loops extend along the longitudinal axis.

17. The device of claim 1, wherein the medical device includes a removal member extending from a portion of the medical device.

18. A device for treating a body canal, comprising:

a medical device that includes;

a proximal end-piece positioned at a proximal-most end of said medical device, a first portion of the proximal end-piece defining an opening configured to receive at least a portion of an insertion device;

a distal end-piece positioned at a distal-most end of said medical device; and

an elongated body portion disposed between said proximal end-piece and said distal end piece, said body portion comprising a plurality of interconnected loops directly connected to a second portion of the proximal end-piece and to the distal end-piece and configured to fit within said body canal, each of said loops comprising a member defining at least one opening, the member of each loop passing through at least one opening of another loop to form said plurality of interconnected loops, the elongated body portion further comprising a substantially cylindrical non-loop segment having a proximal end surface and a distal end surface, the proximal end surface being directly connected to a first loop of the interconnected loops and the distal end surface being directly connected to a second loop of said interconnected loops, wherein the non-loop segment is a single continuous structure, a diameter of at least one of the end-pieces being larger than a diameter of any component of the elongated body, and the end pieces being spherical in shape;

the substantially cylindrical non-loop segment having an undulating outer surface extending from a distal end of the substantially cylindrical non loop segment to a proximal end of the substantially cylindrical non-loop segment.

19. The device of claim 18, wherein at least one of the end-pieces is configured to hold a respective end of the device at a specific anatomical location.

20. The device of claim 19, wherein the specific anatomical location includes one of a renal pelvis, a urinary bladder, or a blood vessel.

21. The device of claim 18, further including a proximal loop member joined to the proximal end-piece and a distal loop member joined to the distal end-piece.

22. The device of claim 21, wherein the proximal loop member and the distal loop member are joined to the proximal end-piece and the distal end-piece, respectively, by one of welding, soldering, or adhesive.

23. The device of claim 18 wherein said member of at least one of said loops comprises a substantially circular cross-section.

24. The device of claim 18 wherein at least one of said members comprises a closed loop.

25. The device of claim 18, wherein the non-loop segment is made of a compressible material.

26. The device of claim 18, wherein the substantially cylindrical non-loop segment defines a longitudinal axis, a radial center of the substantially cylindrical non-loop segment extends along the longitudinal axis, the first loop of the interconnected loops and the second loop of the interconnected loops extend along the longitudinal axis.

27. The device of claim 18, wherein the medical device includes a removal member extending from a portion of the medical device.

28. A device for treating a body canal, comprising:

a medical device that includes;

a proximal end-piece positioned at a proximal-most end of said medical device, a first portion of the proximal end-piece defining an opening configured to receive at least a portion of an insertion device;

a distal end-piece positioned at a distal end of said medical device, the end-pieces having a spherical shape; and

an elongated body portion disposed between said proximal end-piece and said distal end-piece, said body portion comprising a plurality of interconnected loops directly connected to a second portion of the proximal end-piece and to the distal end-piece and configured to fit within said body canal, each of said loops comprising a member defining at least one opening, the member of each loop passing through at least one opening of an adjacent loop to form said plurality of interconnected loops, the elongate body portion further comprising a substantially cylindrical non-loop segment comprising a first end directly connected to a first loop of the interconnected loops and a second end directly connected to a second loop of said interconnected loops, wherein the non-loop segment is a single continuous structure, a diameter of at least one of the end-pieces being larger than a diameter of any component of the elongated body, and wherein adjacent interconnected loops are moveable along each of an X, Y, and Z orthogonal axis relative to each other at least during deployment of the medical device in the body canal, the substantially cylindrical non-loop segment defines a longitudinal axis, a radial center of the substantially cylindrical non-loop segment extends along the longitudinal axis, the first loop of the interconnected loops and the second loop of the interconnected loops extend along the longitudinal axis;

the substantially cylindrical non-loop segment having an undulating outer surface extending from a distal end of the substantially cylindrical non-loop segment to a proximal end of the substantially cylindrical non-loop segment.

29. The device of claim 28, wherein each of the plurality of interconnected loops is configured to move within the confines of the opening of an adjacent loop.

30. The device of claim 28, wherein the interconnected loops are configured to permit fluid to pass through each at least one opening.

31. The device of claim 28, wherein an axial length of the body portion is adjustable.

32. The device of claim 28 wherein said member of at least one of said loops comprises a substantially circular cross-section.

33. The device of claim 28 wherein at least one of said members comprises a closed loop.

34. The device of claim 28, wherein the medical device includes a removal member extending from a portion of the medical device.

35. A device for treating a body canal, comprising:

a medical device that includes;

a proximal end-piece positioned at a proximal-most end of said medical device, a first portion of the proximal end-piece defining an opening configured to receive at least a portion of an insertion device;

a distal end-piece positioned at a distal-most end of said medical device, the end-pieces being spherical in shape; and

an elongated body portion disposed between said proximal end-piece and said distal end-piece, said body portion comprising a plurality of interconnected loops directly connected to a second portion of the proximal end-piece and to the distal end-piece and configured to fit within said body canal, each of said loops comprising a member defining at least one opening, the member of each loop passing through at least one opening of another loop to form said plurality of interconnected loops, and wherein the elongated body portion further comprises a non-loop segment having a distal end surface and a proximal end surface, the distal end surface being directly connected to a first loop of the interconnected loops and the proximal end surface being directly connected to a second loop of said interconnected loops, wherein the non-loop segment is a single continuous structure, a cross-sectional diameter of at least one of the end-pieces being greater than a cross-sectional diameter of any component of the elongated body;

the non-loop segment having an undulating outer surface extending from a distal end of the non-loop segment to a proximal end of the non-loop segment.

36. The device of claim 35 wherein the member of at least one of said loops comprises a substantially circular cross-section.

37. The device of claim 35 wherein at least one of the members comprises a closed loop.

38. The device of claim 35, wherein the non-loop segment defines a longitudinal axis, a radial center of the non-loop segment extends along the longitudinal axis, the first loop of the interconnected loops and the second loop of the interconnected loops extend along the longitudinal axis.

39. The device of claim 35, wherein the medical device includes a removal member extending from a portion of the medical device.

40. A device for treating a body canal, comprising:

a medical device that includes;

a proximal end-piece positioned at a proximal end of said medical device, a first portion of the proximal end-piece defining an opening configured to receive at least a portion of an insertion device, the proximal end-piece being spherical;

a distal end-piece positioned at a distal end of said medical device, the distal end-piece being spherical; and

an elongated body portion disposed between said proximal end-piece and said distal end-piece, said body portion comprising a plurality of interconnected loops directly connected to a second portion of the proximal end-piece and to the distal end-piece and configured to fit within said body canal, each of said loops comprising a member defining at least one opening, the member of each loop being biodegradable and passing through at least one opening of another loop to form said plurality of interconnected loops, and wherein the elongated body portion further comprises a substantially cylindrical non-loop segment connected to at least one of said interconnected loops comprising a first end directly connected to a first loop of the interconnected loops and a second end directly connected to a second loop of said interconnected loops, wherein the non-loop segment is a single continuous structure, a diameter of at least one of the end-pieces being larger than a diameter of any component of the elongated body, the substantially cylindrical non-loop segment defines a longitudinal axis, a radial center of the substantially cylindrical non-loop segment extends along the longitudinal axis, the first loop of the interconnected loops and the second loop of the interconnected loops extend along the longitudinal axis;

the substantially cylindrical non-loop segment having an undulating outer surface extending from a distal end of the substantially cylindrical non-loop segment to a proximal end of the substantially cylindrical non-loop segment.

41. The device of claim 40, wherein the medical device includes a removal member extending from a portion of the medical device.

42. A device for treating a body canal, comprising:

a medical device that includes;

a proximal end-piece positioned at a proximal-most end of said medical device, a first portion of the proximal end-piece defining an opening configured to receive at least a portion of an insertion device;

a distal end-piece positioned at a distal end of said medical device, the end-pieces having a spherical shape; and

an elongated body portion disposed between said proximal end-piece and said distal end-piece, said body portion comprising a plurality of interconnected loops directly connected to a second portion of the proximal end-piece and to the distal end-piece and configured to fit within said body canal, each of said loops comprising a member defining at least one opening, the member of each loop passing through at least one opening of another loop to form said plurality of interconnected loops, and wherein the elongated body portion further comprises a substantially cylindrical non-loop segment made of a compressible material and connected to at least one of said interconnected loops comprising a first end directly connected to a first loop of the interconnected loops and a second end directly connected to a second loop of said interconnected loops, wherein the non-loop segment is a single continuous structure, a diameter of at least one of the end-pieces being larger than a diameter of any component of the elongated body, the substantially cylindrical non-loop segment defines a longitudinal axis, a radial center of the substantially cylindrical non-loop segment extends along the longitudinal axis, the first loop of the interconnected loops and the second loop of the interconnected loops extend along the longitudinal axis;

the substantially cylindrical non-loop segment having an undulating outer surface extending from a distal end of the substantially cylindrical non-loop segment to a proximal end of the substantially cylindrical non-loop segment.

43. The device of claim 42, wherein the medical device includes a removal member extending from a portion of the medical device.

44. A device for treating a body canal, comprising:

a medical device that includes;

a proximal end-piece positioned at a proximal-most end of said medical device, a first portion of the proximal end-piece defining an opening configured to receive at least a portion of an insertion device;

a distal end-piece positioned at a distal end of said medical device, the end-pieces having a spherical shape; and

an elongated body portion disposed between said proximal end-piece and said distal end-piece, said body portion comprising a plurality of interconnected loops directly connected to a second portion of the proximal end-piece and the to distal end-piece and configured to fit within said body canal, each of said loops comprising a member defining at least one opening, the member of each loop passing through at least one opening of an adjacent loop to form said plurality of interconnected loops, the elongate body portion further comprising a substantially cylindrical non-loop segment made of a compressible material and comprising a proximal end surface and a distal end surface, the distal end surface being directly connected to a first loop of the interconnected loops and the proximal end surface being directly connected to a second loop of said interconnected loops, wherein the non-loop segment is a single continuous structure, a diameter of at least one of the end-pieces being larger than a diameter of any component of the elongated body, and wherein adjacent interconnected loops are moveable along each of an X, Y, and Z orthogonal axis relative to each other at least during deployment of the medical device in the body canal;

the non-loop segment having an undulating outer surface extending from a distal end of the non-loop segment to a proximal end of the non-loop segment.

45. The device of claim 44, wherein the substantially cylindrical non-loop segment defines a longitudinal axis, a radial center of the substantially cylindrical non-loop segment extends along the longitudinal axis, the first loop of the interconnected loops and the second loop of the interconnected loops extend along the longitudinal axis.

46. The device of claim 44, wherein the medical device includes a removal member extending from a portion of the medical device.

47. A device for treating a body canal, comprising:

a medical device that includes;

a proximal end-piece positioned at a proximal-most end of said medical device, a first portion of the proximal end-piece defining an opening configured to receive at least a portion of an insertion device;

a distal end-piece positioned at a distal end of said medical device, the end-pieces being spheres; and

an elongated body portion disposed between said proximal end-piece and said distal end-piece, said body portion comprising a plurality of interconnected loops directly connected to a second portion of the proximal end-piece and to the distal end-piece and configured to fit within said body canal, each of said loops comprising a member defining at least one opening, the member of each loop being biodegradable and passing through at least one opening of another loop to form said plurality of interconnected loops, and wherein the elongated body portion further comprises a substantially cylindrical non-loop segment connected to at least one of said interconnected loops comprising a first end directly connected to a first loop of the interconnected loops and a second end directly connected to a second loop of said interconnected loops, wherein the non-loop segment is a single continuous structure, a diameter of at least one of the end-pieces being larger than a diameter of any component of the elongated body, the substantially cylindrical non-loop segment defines a longitudinal axis, a radial center of the substantially cylindrical non-loop segment extends along the longitudinal axis, the first loop of the interconnected loops and the second loop of the interconnected loops extend along the longitudinal axis;

the substantially cylindrical non-loop segment having an undulating outer surface extending from a distal end of the substantially cylindrical non-loop segment to a proximal end of the substantially cylindrical non-loop segment.

48. The device of claim 47, wherein the medical device includes a removal member extending from a portion of the medical device.