Implant for the closing of defect openings in the body of a human or animal and a system for the placement of such an implant

• US 7,097,653 B2
• Filed: 01/03/2001
• Issued: 08/29/2006
• Est. Priority Date: 01/04/2000
• Status: Expired due to Fees

• Current Assignee: Pfm Medical AG
• Original Assignee: Pfm Produkte Fur Die Medizin Aktiengesellschaft
• Inventors: Freudenthal, Franz, Siegner, Georg
• Primary Examiner(s): Woo, Julian W.
• Application Number:
  US10/169,655
• Publication Number:
  US 20030171774A1
• Time in Patent Office: 2,064 Days
• Field of Search: 606/213, 606/215, 606/216, 606/217, 606/151, 606/200, 606/198, 606/113, 623/1.11, 600/585
• US Class Current: 606/213
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00597 Implements comprising a membrane
• CPC Class Codes: A61B 2017/00606 Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61B 2017/00619 Locking means for locking the implement in expanded state

Abstract

An implant for the closing of defect openings in the body of a human or animal is proposed, with a load-bearing structure which, in a first operating state (primary form), has a great ratio of length to transverse extent along an axis (9) and, at least in a further operating state (secondary form), has a much smaller ratio of length to transverse extent along the axis (9), the load-bearing structure (1) being capable of being reversibly transformed from the secondary form into the primary form by exertion of a force against elastic material forces, the secondary form assuming approximately the form of a double disc with a proximal disc element (7) and a distal disc element (6) for receiving the surroundings of the defect opening between the disc elements, and the load-bearing structure (1) being formed essentially in one piece without joining connections, and a placement system.

Claims

1. An implant for the closing of defect openings in the body of a human or animal comprising a load-bearing structure which, in a primary form, has a great ratio of length to transverse extent along an axis and, in a secondary form, has a much smaller ratio of length to transverse extent along the axis, the load-bearing structure being capable of being reversibly transformed from the secondary form into the primary form by exertion of a force against elastic material forces, the secondary form assuming approximately the form of a double disc with a proximal disc element and a distal disc element for receiving the surroundings of the defect opening between the disc elements, and the load-bearing structure being formed essentially in one piece without joining connections by a tube slit over part of its length including the middle of the tube.

2. An implant as recited in claim 1 wherein the tube consists of a metallic shape-memory material.

3. An implant for the closing of defect openings in the body of a human or animal comprising a load-bearing structure which, in a primary form, has a great ratio of length to transverse extent along an axis and, in a secondary form, has a much smaller ratio of length to transverse extent along the axis, the load-bearing structure being capable of being reversibly transformed from the secondary form into the primary form by exertion of a force against elastic material forces, the secondary form assuming approximately the form of a double disc with a proximal disc element and a distal disc element for receiving the surroundings of the defect opening between the disc elements, and the load-bearing structure being formed essentially in one piece without joining connections by a tube slit over part of its length wherein strips are formed along the slit part of the length along the tube, with the width of the strips varying along the slit part of the tube.

4. An implant for the closing of defect openings in the body of a human or animal comprising a load-bearing structure which, in a primary form, has a great ratio of length to transverse extent along an axis and, in a secondary form, has a much smaller ratio of length to transverse extent along the axis, the load-bearing structure being capable of being reversibly transformed from the secondary form into the primary form by exertion of a force against elastic material forces, the secondary form assuming approximately the form of a double disc with a proximal disc element and a distal disc element for receiving the surroundings of the defect opening between the disc elements, and the load-bearing structure being formed essentially in one piece without joining connections by a tube slit over part of its length wherein strips are formed along the slit part of the length along the tube, with holes being formed in the strips, at least partly along the slit part of the tube.

5. An implant as recited in claim 4 wherein one or more membranes are fastened to at least some of the holes in the strips at least for covering the proximal disc element in the secondary form of the implant.

6. An implant as recited in claim 5 wherein said one or more membranes are formed by a stringing of metallic wire or yarn, and when assuming the secondary form in a helix arrangement.

7. An implant for the closing of defect openings in the body of a human or animal comprising a load-bearing structure which, in a primary form, has a great ratio of length to transverse extent along an axis and, in a secondary form, has a much smaller ratio of length to transverse extent along the axis, the load-bearing structure being capable of being reversibly transformed from the secondary form into the primary form by exertion of a force against elastic material forces, the secondary form assuming approximately the form of a double disc with a proximal disc element and a distal disc element for receiving the surroundings of the defect opening between the disc elements, and the load-bearing structure being formed essentially in one piece without joining connections by a tube slit over part of its length wherein strips are formed along the slit part of the length along the tube, with the ships arranged spirally with respect to the axis of the implant, at least over part of their length.

8. An implant for the closing of defect openings in the body of a human or animal comprising a load-bearing structure which, in a primary form, has a great ratio of length to transverse extent along an axis and, in a secondary form, has a much smaller ratio of length to transverse extent along the axis, the load-bearing structure being capable of being reversibly transformed from the secondary form into the primary form by exertion of a force against elastic material forces, the secondary form assuming approximately the form of a double disc with a proximal disc element and a distal disc element for receiving the surroundings of the defect opening between the disc elements, and the load-bearing structure being formed essentially in one piece without joining connections by a tube slit over part of its length wherein strips are formed between curved contoured slits along part of the length of the tube.

9. An implant as recited in claim 8 wherein mutually facing curved contours of respectively neighbouring strips are formed in such a way as to be mirror-inverted in relation to one another, at least along part of their length.

10. An implant as recited in claim 8 wherein mutually facing curved contours of respectively neighboring strips formed in such a way as to be complementary to one another, at least along part of their length.

11. An implant for the closing of defect openings in the body of a human or animal comprising a load-bearing structure which, in a primary form, has a great ratio of length to transverse extent along an axis and, in a secondary form, has a much smaller ratio of length to transverse extent along the axis, the load-bearing structure being capable of being reversibly transformed from the secondary form into the primary form by exertion of a force against elastic material forces, the secondary form assuming approximately the form of a double disc with a proximal disc element and a distal disc element for receiving the surroundings of the defect opening between the disc elements, and the load-bearing structure being formed essentially in one piece without joining connections wherein the load-bearing structure has a variable rigidity along part of its length, the rigidity being less in particular in the proximal disc element is formed than in the region in which the distal disc element is formed.

12. An implant as recited in claim 11 wherein in the surface of the load-bearing structure is etched and/or electrochemically polished in the region of reduced rigidity.

13. An implant as recited in claim 11 wherein strips are formed along a slit part of the length along the tube with a strip in the secondary form describing along the axis from the proximal end of the implant an arc which is open in the direction of the axis and is adjoined towards the distal end in opposed curvature by a loop.

14. An implant for the closing of defect openings in the body of a human or animal comprising a load-bearing structure which, in a primary form, has a great ratio of length to transverse extent along an axis and, in a secondary form, has a much smaller ratio of length to transverse extent along the axis, the load-bearing structure being capable of being reversibly transformed from the secondary form into the primary form by exertion of a force against elastic material forces, the secondary form assuming approximately the form of a double disc with a proximal disc element and a distal disc element for receiving the surroundings of the defect opening between the disc elements, and the load-bearing structure being formed essentially in one piece without joining connections wherein strips are formed along a slit part of the length along the tube with a strip in the secondary form describing along the axis from the proximal end of the implant an arc which is open in the direction of the axis and is adjoined towards the distal end in opposed curvature by a loop.

15. An implant for the closing of defect openings in the body of a human or animal comprising a load-bearing structure which, in a primary form, has a great ratio of length to transverse extent along an axis and, in a secondary form, has a much smaller ratio of length to transverse extent along the axis, the load-bearing structure being capable of being reversibly transformed from the secondary form into the primary form by exertion of a force against elastic material forces, the secondary form assuming approximately the form of a double disc with a proximal disc element and a distal disc element for receiving the surroundings of the defect opening between the disc elements, and the load-bearing structure being formed essentially in one piece without joining connections wherein the load-bearing structure has at its proximal end and its distal cad in each case at least one through-hole, which are arranged approximately in line with one another and approximately on the axis, and the hole at the distal end having a smaller diameter than the hole at the proximal end.

16. An implant according to claim 15 wherein the distal end and/or the proximal end of the implant are configured to allow, when implanted, proper grasping by a snare type probe for removal of the implant.

17. An implant for the closing of defect openings in the body of a human or animal comprising a load-bearing structure which, in a primary form, has a great ratio of length to transverse extent along an axis and, in a secondary form, has a much smaller ratio of length to transverse extent along the axis, the load-bearing structure being capable of being reversibly transformed from the secondary form into the primary form by exertion of a force against elastic material forces, the secondary form assuming approximately the form of a double disc with a proximal disc element and a distal disc element for receiving the surroundings of the defect opening between the disc elements, and the load-bearing structure being formed essentially from a one piece structure without joining connections wherein the load-bearing structure has at its proximal end at least one eyelet for the fastening of holding elements of a placement system.

18. An implant for the closing of defect openings in the body of a human or animal comprising a load-bearing structure which, in a primary form, has a great ratio of length to transverse extent along an axis and, in a secondary form, has a much smaller ratio of length to transverse extent along the axis, the load-bearing structure being capable of being reversibly transformed from the secondary form into the primary form by exertion of a force against elastic material forces, the secondary form assuming approximately the form of a double disc with a proximal disc element and a distal disc clement for receiving the surroundings of the defect opening between the disc elements, and the load-bearing structure being formed essentially in one piece without joining connections including a placement system having a stretching element and a holding wire, the stretching element serving for interacting with a distal end of an implant and the holding wire serving for interacting with a proximal end of an implant, the implant being capable of being transformed from a primary form into a secondary form and vice versa by relative movement of the holding wire in relation to the stretching element, while the stretching element interacts with the distal end of the implant.

19. An implant as recited in claim 18 wherein the stretching element is formed by a stretching cannula, and which furthermore has a guiding wire led through the stretching cannula, and a holding wire, with the implant being capable of being transformed from a primary form into a secondary form and vice versa by relative movement of the holding wire in relation to the stretching cannula along the guiding wire.

20. An implant as recited in claim 18 wherein the stretching element is intended to interact with a loss-preventing means provided at the distal end of an implant, preventing unintentional separation of the implant from the stretching element.

21. An implant according to claim 18 wherein the stretching element is formed by a section of a guiding wire having a larger cross sectional dimension than the remainder of the guiding wire.

22. An implant for the closing of defect openings in the body of a human or animal comprising a load-bearing structure which, in a primary form, has a great ratio of length to transverse extent along an axis and, in a secondary form, has a much smaller ratio of length to transverse extent along the axis, the load-bearing structure being capable of being reversibly transformed from the secondary form into the primary form by exertion of a force against elastic material forces, the secondary form assuming approximately the form of a double disc with a proximal disc element and a distal disc element for receiving the surroundings of the defect opening between the disc elements, and the load-bearing structure being formed essentially in one piece without joining connections including a placement system having a stretching element and at least one holding wire, the stretching element serving for interacting with an end of an implant, the implant being capable of being transformed from a primary form into a secondary form and vice versa, and which furthermore has at least one guiding wire led in general through the implant and the guiding wire is led through a loop formed in the holding wire, wherein the guiding wire is led over a part of the length of the implant over the outer circumference of the same and the holding wire serving for interacting with the guiding wire so that the implant is secured to the placement system unless the guiding wire or the holding wire is removed, preventing unintentional separation of the implant from the placement system.

23. A placement system for an implant with a distal end and a proximal end comprising:

(a) a stretching element for interacting with the distal end of the implant; and

(b) a holding wire for interacting with the proximal end of the implant whereby relative movement of the holding wire in relation to the stretching element causes the implant to transform from a primary form to a secondary form and then reverse from a secondary form to the primary form, wherein the stretching element is a stretching cannula and has a guide wire led through the stretching cannula.

24. A placement system for an implant as recited in claim 23 wherein the stretching element interacts with a loss preventing means for preventing unintentional separation of the implant, the loss preventing means is provided at the distal end of an implant.

25. A placement system for an implant as recited in claim 23 wherein the stretching element is formed by a section of a guiding wire having a larger cross sectional dimension than the remainder of the guiding wire.

26. A placement system for an implant that is capable of being transformed from a primary form into a secondary form and reversing from a secondary form into a primary form comprising:

(a) a stretching element configured for interacting with an end of an implant;

(b) a holding wire having a loop configured for interacting with another end of the implant; and

(c) a guiding wire through the loop in the holding wire and extending from the stretching element, wherein the stretching element is formed by a section of the guiding wire having a larger cross-sectional dimension than the remainder of the guiding wire.

27. A method for using an implant as a vascular filter comprising:

(a) providing an implant having a load-bearing structure which, in a primary form, has a great ratio of length to transverse extent along an axis and, in a secondary form, has a much smaller ratio of length to transverse extent along the axis, the load-bearing structure being capable of being reversibly transformed from the secondary form into the primary form by exertion of a force against elastic material forces, the secondary form assuming approximately the form of a double disc with a proximal disc element and a distal disc element for receiving the surroundings of a defect opening between the disc elements, and the load-bearing structure being formed essentially from a one piece structure without joining connections;

(b) inserting the implant into a vascular vessel; and

(c) forming an elongated net with the implant to capture particles.

28. A method as recited in claim 27 wherein the load-bearing element has at its proximal end and its distal end a through-hole, in which each hole is arranged approximately in line wit the other through hole and approximately on the axis, and the hole at the distal end having a smaller diameter than the hole at the proximal end.

29. A vascular filter comprising a load-bearing structure which, in a primary form, has a great ratio of length to transverse extent along an axis and, in a secondary form, has a much nailer ratio of length to transverse extent along the axis, the load-bearing structure being capable of being reversibly transformed from the secondary form into the primary form by exertion of a force against elastic material forces, the secondary form assuming approximately the form of double discs with a proximal disc element and a distal disc element for receiving the surroundings of a defect opening between the disc elements, and the load-bearing structure being formed essentially from a one piece structure without joining connections, wherein the load-bearing structure has at its proximal end and its distal end in each case at least one through-hole, which are arranged approximately in line with one another and approximately on the axis, and the hole at the distal end having a smaller diameter than the hole at the proximal end.

30. A vascular filter as recited in claim 29 wherein the diameter of the secondary form is limited by the diameter of a vascular vessel.