Prosthesis intended for the treatment of a natural lumen or tract, in particular an endo-urethral prosthesis

• US 5,766,209 A
• Filed: 08/15/1995
• Issued: 06/16/1998
• Est. Priority Date: 02/19/1993
• Status: Expired due to Term

• Current Assignee: Marian A. Devonec
• Original Assignee: Marian A. Devonec
• Inventors: Devonec, Marian A.
• Primary Examiner(s): Weiss, John G.
• Assistant Examiner(s): SNOW, BRUCE EDWARD
• Application Number:
  US08/501,140
• Time in Patent Office: 1,036 Days
• Field of Search: 623/11, 623/12, 623/1, 604/8-9, 604/93, 604/164, 604/212, 606/108-191, 606/153, 606/198
• US Class Current: 604/8
• 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 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body

Abstract

Prosthesis (8) intended for the treatment of a natural lumen (1) or tract of a human or animal body through which a flow is effected on either side of a sphincter (5), said prosthesis comprising a tubular element (9, 11), in particular of cylindrical shape, which is sufficiently flexible to conform to said natural lumen, but sufficiently rigid to maintain an artificial passage in said lumen, and is intended to be placed in said natural lumen, the wall of said tube comprising a relatively smooth and soft biocompatible material, such as a silicone rubber, at least in its outer part, characterized in that said prosthesis comprises two tubular elements (9, 11), such as are defined in the preamble of the present claim, which are intended to be arranged in said lumen (1) on either side, respectively, of the sphincter (5), and are attached to each other by a flexible and deformable connection means (10) which is intended to be held in the orifice of the sphincter (5), and each said tubular element having an external cross section which is substantially constant from one end to the other of said element.

Claims

1. A prosthesis adapted to be inserted and contained in a biological lumen or tract, comprising:

first and second tubular elements that are locatable on either side of a sphincter surrounding the lumen or tract, wherein the first and second tubular elements comprise at least a substantially smooth outer layer of a biocompatible material which is sufficiently flexible to conform to the lumen or tract and sufficiently rigid to maintain an artificial passage through the lumen or tract against a force that tends to obstruct the lumen or tract; and

a connecting element comprising a first end that is connected to the first tubular element, a second end that is connected to the second tubular element, and a flexible middle portion joining the first and second ends that is locatable in the sphincter, wherein the middle portion can be moved by the sphincter to allow the sphincter to close naturally and thereby close the lumen or tract, and wherein abutment of the first and second tubular elements against the sphincter can substantially maintain position of the prosthesis in the lumen or tract.

2. The prosthesis according to claim 1, wherein the connecting element comprises a flexible sleeve.

3. The prosthesis according to claim 2, wherein the connecting element assumes a closed configuration upon contraction of the sphincter wherein fluid flow through the connecting element is prevented, and a flow configuration upon relaxation of the sphincter wherein fluid flow through the connecting element is possible.

4. The prosthesis according to claim 3, wherein the connecting element assumes an hourglass shape when in the closed configuration.

5. The prosthesis according to claim 3, wherein the connecting element assumes a cylindrical shape when in the flow configuration.

6. The prosthesis according to claim 3, wherein the first and second tubular elements and the connecting element form a conduit having a substantially constant inner diameter when the connecting element is in the flow configuration.

7. The prosthesis according to claim 1, wherein a thickness of a wall of the middle portion of the connecting element is smaller than a thickness of walls of the first and second tubular elements.

8. The prosthesis according to claim 1, wherein apertures are formed in at least the middle portion of the connecting element.

9. The prosthesis according to claim 1, wherein the connecting element comprises at least one strip of material, and wherein first and second ends of each at least one strip of material are connected to the first and second tubular elements, respectively.

10. The prosthesis according to claim 9, wherein the at least one strip of material comprises a thread.

11. The prosthesis according to claim 9, wherein the at least one strip of material comprises a plurality of strips of material, and wherein the plurality of strips of material are radially inwardly movable.

12. The prosthesis according to claim 1, wherein at least one of the first and second tubular elements includes a reinforcing element.

13. The prosthesis according to claim 12, wherein the reinforcing element comprises a coil of material embedded in a wall of the at least one tubular element.

14. The prosthesis according to claim 1, wherein a plurality of apertures are distributed along a length of at least one of the first and second tubular elements.

15. The prosthesis according to claim 1, wherein a plurality of undulations are distributed along an outer wall of at least one of the first and second tubular elements.

16. The prosthesis according to claim 1, wherein an end of at least one of the first and second tubular elements opposite the connecting element is closed and has a convex shape, and wherein at least one aperture is formed in a wall of the at least one tubular element adjacent the closed end.

17. The prosthesis according to claim 1, wherein a removal thread is attached to an end of at least one of the first and second tubular elements opposite the connecting element.

18. The prosthesis according to claim 1, wherein an external diameter of the first tubular element is greater than an external diameter of the second tubular element.

19. The prosthesis according to claim 1, wherein an external surface of at least one of the first and second tubular elements is coated with a therapeutic substance.

20. An assembly for treating a biological lumen or tract, comprising:

a prosthesis according to claim 16;

a semi-rigid cylindrical mandrel having a first end with an outer diameter that is adapted to pass inside an inner diameter of the prosthesis to engage the prosthesis, and wherein a second, opposite end of the mandrel has an outer limit stop; and

a rigid and hollow cylindrical pusher having inner and outer diameters, the inner diameter allowing the mandrel to pass inside the pusher, wherein the pusher acts as a spacer between the engaged prosthesis and the outer limit stop.

21. An assembly according to claim 20, wherein the mandrel is hollow and includes an aperture that aligns with the at least one aperture adjacent the closed end of the prosthesis when the mandrel engages the prosthesis.

22. A method of treating an obstruction of a biological lumen or tract that passes through a sphincter using the prosthesis of claim 19, wherein the obstruction is due to an external force that tends to close the lumen or tract, and wherein the prosthesis is located in the biological lumen or tract such that the first and second tubular members are located on either side of the sphincter and the connecting element extends through the sphincter, comprising the steps of:

supporting an interior of the lumen or tract at the obstruction with a smooth walled portion of at least one of the first and second tubular elements so that the biological lumen or tract is open despite the external force that tends to close the lumen or tract; and

allowing the sphincter to contract to block fluid flow through the lumen or tract, and to relax to permit fluid flow through the lumen or tract.