Spiral implant for organ pathways

• US 5,536,274 A
• Filed: 10/01/1993
• Issued: 07/16/1996
• Est. Priority Date: 02/15/1991
• Status: Expired due to Term

• Current Assignee: Pfm Produkte Fur Die Medizin
• Original Assignee: Pfm Produkterfur Die Medizin
• Inventors: Neuss, Malte
• Primary Examiner(s): BRITTINGHAM, DEBRA
• Application Number:
  US08/098,303
• Time in Patent Office: 1,019 Days
• Field of Search: 600/36, 606/108, 606/194, 606/195, 606/198, 623/1, 623/12
• US Class Current: 623/1.22
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12145 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61F 2/0004 Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

Spiral implant for organ pathways, in particular for blood vessels, which is formed from a primary spiral made of metal or a primary tube made of an elastic synthetic material whose anterior end is closed and whose cross-section at a distance of 0.5 to 2 mm from the other end of the primary spiral or primary tube is modified for a distance of 0.01 to 10 mm in order to make it possible to reposition the implant. The force required to displace the primary shape on the guide wire serving as an insertion aid amounts to 0.5N to 10N. The invention describes an implant (1) which can be used in vascular surgery or vascular radiology in order to achieve selective blood vessel occlusion. Insertion of the implant (1) into a blood vessel is brought about by means of an insertion catheter (16), with the implant being held in a rectilinear shape by a guide wire (14) slid therein. After the implant has reached the correct position in the organ pathway (18) it assumes a pre-formed spiral shape on the withdrawal of the insertion wire from inside it, thereby ensuring fixation of the implant in the organ pathway.

Claims

1. An implant for insertion into a vessel of an organ comprising an elongated tubular conduit having anterior and posterior ends, said conduit defining a lumen having an inner surface and an outer surface defining internal and external diameters, respectively, said conduit being made from a material having restitutory forces;

and

said interior end being closed and a posterior region at the posterior end having means forming a clamping seat sized to engage a guide wire having an anterior end; and

said implant having a distended first configuration when said guide wire is inserted within the tubular conduit and a second configuration when said guide wire is removed from the tubular conduit, said second configuration being effected by the restitutory forces of the material,

wherein said means forming the clamping seat is a radial constriction of the internal diameter beginning about 0.5 mm to 2 mm from said posterior end and extending to a length of about 0.1 mm to 10 mm.

2. An implant as defined in claim 1, wherein the conduit consists of a primary spiral made of metal.

3. An implant as defined in claim 2, wherein the primary spiral has a diameter and is made of wire having a wire diameter of from 0.06 to 0.6 mm, and wherein the diameter of the primary spiral is from 0.2 to 3 mm.

4. An implant as defined in claim 2, wherein the cross-section of at least one to several turns of the primary spiral is modified by constricting the diameter of the primary spiral.

5. An implant as defined in claim 2, wherein the primary spiral is wound from a wire having a cross-section chosen from the group consisting of round, oval and rectangular.

6. An implant as defined in claim 2, wherein the force required to displace the conduit and to overcome the clamping force exercised by the clamping seat on the guide wire is 0.5N to 10N.

7. An implant as defined in claim 6, wherein the guide wire is provided, at its anterior end or in the vicinity of this end, either with an annular groove or with a circumferential beading.

8. An implant as defined in claim 2, wherein the cross-section of at least one to several turns of the primary spiral is modified by flattening the primary spiral so that it assumes an oval cross-section.

9. An implant as defined in claim 1, wherein the conduit consists of a primary tube, having a diameter, made of elastic synthetic material.

10. An implant as defined in claim 9, wherein the primary tube has a wall with a thickness of from 0.08 mm to 0.8 mm and the diameter of the primary tube is from 0.3 to 3 mm.

11. An implant as defined in claim 9, wherein the cross-section of the primary tube is modified by constricting the diameter of a portion of the primary tube.

12. An implant as defined in to claim 9, wherein the cross-section of the primary tube is modified by forming a portion of the primary tube with an oval cross-section having a reduced diameter in one direction as compared with the diameter of the remainder of the primary tube.

13. An implant as defined in claim 1, wherein the conduit is 10 to 500 mm long.

14. An implant as defined in claim 1, wherein the second configuration of the conduit has a form chosen from the group consisting of a cylinder, a cone, a double cone with larger diameters at the ends, a cylinder in which turns of the second configuration having different diameters alternate, a double helix which is connected by a cylindrical section, a double rosette, and the form of several horizontal figures of eight.

15. An implant as defined in claim 14, wherein the double cone, double helix and double rosette have inner and outer turns, said inner turns being composed of a primary spiral having a round wire cross-section, and said outer turns being composed of a primary spiral having an enlarged wire cross-section chosen from the group consisting of round, oval and rectangular.

16. A process for positioning the implant defined in claim 1 in an organ pathway by means of the steps:

a) advancement of an insertion catheter, in whose inner lumen the implant is located in the distended first configuration on the guide wire, inside the organ pathway into the vicinity of the site where the implant is to be located,

b) displacement of the guide wire, with the implant located on it in the distended first configuration, to the intended site for the implant'"'"'s location,

c) formation of the second configuration of the implant by withdrawing the guide wire or by pushing forward a stripping element,

d) further withdrawal of the catheter and of the guide wire, or pushing forward of the stripping element, until only the anterior end of the guide wire is held in the clamping seat in the posterior region of the conduit,

e) correction of the position of the implant, or, withdrawal of the implant into the catheter,

f) stripping-off of the implant from the guide wire at the site intended for it in the organ pathway using the stripping element.