Surgical method, kit of parts, and implant

• US 9,017,380 B2
• Filed: 03/30/2007
• Issued: 04/28/2015
• Est. Priority Date: 04/03/2006
• Status: Active Grant

• Current Assignee: Woodwelding AG
• Original Assignee: Woodwelding AG
• Inventors: Mayer, Jrg, Weber, Urs, Knecht, Thomas, Seiler, Philipp, Rast, Christopher, Aeschlimann, Marcel, Torriani, Laurent, Mller, Andrea
• Primary Examiner(s): BATES, DAVID W
• Application Number:
  US11/694,249
• Publication Number:
  US 20070265704A1
• Time in Patent Office: 2,951 Days
• Field of Search: 623/17.12, 606/75, 606/285, 606/151, 606/232
• US Class Current: 606/232
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0642 for bones, e.g. for osteosynthesis or connecting tendon to bone
• CPC Class Codes: A61B 17/68 Internal fixation devices , including fasteners and spinal fixators, even if a part thereof projects from the skin bone staples A61B17/0642
• CPC Class Codes: A61B 17/8085 with pliable or malleable elements or having a mesh-like structure, e.g. small strips A61B17/8071, A61B17/8076 take precedence
• CPC Class Codes: A61B 17/8605 Heads, i.e. proximal ends projecting from bone
• CPC Class Codes: A61B 2017/06057 Double-armed sutures, i.e. sutures having a needle attached to each end
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2/0811 Fixation devices for tendons or ligaments
• CPC Class Codes: A61F 2002/0835 with deformation of anchor parts, e.g. expansion of dowel by set screw
• CPC Class Codes: A61F 2002/0858 Fixation of tendon or ligament between anchor and bone, e.g. interference screws, wedges
• CPC Class Codes: A61F 2002/0888 Anchor in or on a blind hole or on the bone surface without formation of a tunnel
• CPC Class Codes: A61F 2002/30065 thermoplastic, i.e. softening or fusing when heated, and hardening and becoming rigid again when cooled
• CPC Class Codes: A61F 2002/30579 with mechanically expandable devices, e.g. fixation devices
• CPC Class Codes: A61F 2002/4683 by applying ultrasonic vibrations
• CPC Class Codes: A61F 2210/0071 thermoplastic
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes

Abstract

A surgical method is provided, the method including the steps of: providing an artificial or allograft flexible planar structure; providing an implant, the implant including material liquefiable by mechanical oscillation, exposing a surface region of hard tissue or hard tissue substitute material; positioning the implant on an exposed area of the hard tissue or hard tissue substitute material; and fastening the implant to the hard tissue or hard tissue substitute material by impinging the proximal end of the implant with mechanical oscillation and simultaneously pressing the implant against the hard tissue or hard tissue substitute material while the distal end of the implant protrudes into a cavity of the hard tissue or hard tissue substitute material and regions of the liquefiable material are in contact with the hard tissue or hard tissue substitute material, and thereby liquefying at least a portion of the liquefiable material, and letting the liquefiable material resolidify.

Claims

1. A surgical method comprising the steps of:

providing a structure, said structure being a textile, porous suturing fabric;

providing an implant, said implant comprising a proximal end, a distal end and a surface region, wherein

(A) there is solid material that is liquefiable by mechanical movement at the surface region of the implant, or

(B) the implant further comprises

(i) a hollow space that is at least partially filled by solid material that is liquefiable by mechanical movement, and

(ii) a plurality of channels between the hollow space and the surface region of the implant that allow liquefied material in the hollow space to reach the surface region of the implant when mechanical movement is applied to the solid material that is liquefiable by mechanical movement;

exposing a surface region of hard tissue or hard tissue substitute material;

positioning the structure relative to the exposed surface region of hard tissue or hard tissue substitute material;

manufacturing an opening in the structure positioned relative to the exposed surface region of hard tissue or hard tissue substitute material and causing the implant to reach through the opening and to contact the hard tissue or hard tissue substitute material;

fastening the implant to the hard tissue or hard tissue substitute material by;

impinging the proximal end of the implant with mechanical movement and simultaneously pressing the implant against the hard tissue or hard tissue substitute material while the distal end of the implant protrudes into the hard tissue or hard tissue substitute material such that at least a portion of the solid material becomes liquefied material and said liquefied material makes contact with the hard tissue or hard tissue substitute material and thereby causes at least a portion of the liquefied material to penetrate at least one of (i) unevenness, (ii) pores and (iii) artificially made retention structures of the hard tissue or hard tissue substitute material; and

letting the liquefied material resolidify to cause an interlocking of the implant and the hard tissue or hard tissue substitute material;

fastening the structure to the implant

before impinging the proximal end of the implant by mechanical movement,

while impinging the proximal end of the implant by mechanical movement, or

after impinging the proximal end of the implant by mechanical movement; and

suturing a flexible element to the suturing fabric after the implant has been fastened to the hard tissue or hard tissue substitute material.

2. The method of claim 1, wherein a plurality of implants is provided, each implant comprising a proximal end, a distal end and a surface region, wherein

(A) there is solid material that is liquefiable by mechanical movement at the surface region of the implant, or

(B) the implant further comprises

(i) a hollow space that is at least partially filled by solid material that is liquefiable by mechanical movement, and

(ii) at least one channel between the hollow space and the surface that allow liquefied material in the hollow space to reach the surface region of the implant when mechanical movement is applied to the solid material that is liquefiable by mechanical movement,

wherein each one of said plurality of implants is fastened to the hard tissue or hard tissue substitute material, and

wherein the structure is fastened to each one of said plurality of implants

before impinging the proximal end of the implant by mechanical movement

while impinging the proximal end of the implant by mechanical movement, or

after impinging the proximal end of the implant by mechanical movement.

3. The method of claim 1, wherein fastening the structure to the implant includes liquefying, by mechanical movement, the solid material of the implant that is liquefiable by mechanical movement while the implant is in contact with the structure, and thereby forming a intimate connection between portions of the implant and of the structure.

4. The method of claim 3, wherein the step of fastening the structure to the implant includes causing the liquefied material of the implant to penetrate at least one of pores and of spaces of the structure and further includes letting the liquefied material to resolidify thereafter.

5. The method of claim 3, wherein the step of fastening the structure to the implant includes causing the liquefied material of the implant to weld to liquefied material of the structure.

6. The method of claim 1, wherein the structure is fastened to the implant ex situ before exposing the surface region of the hard tissue or hard tissue substitute material.

7. The method of claim 1, wherein fastening the structure to the implant includes letting the implant protrude through the opening manufactured in the structure.

8. The method of claim 7, wherein the implant further comprises a tip towering towards the proximal end, and wherein fastening the structure to the implant is done after impinging the implant by mechanical movement and comprises piercing the structure by the tip by applying the structure to the hard tissue or hard tissue substitute material and thereafter deforming the tip so as to affix the structure on the hard tissue or hard tissue substitute material.

9. The method of claim 8, wherein the tip is deformed by means of applying mechanical movement, and wherein material of the tip is liquefied by the mechanical movement and penetrates at least one of pores and of spaces of the structure.

10. The method of claim 7, wherein the implant is chosen to comprise a head-like or a claw-like structure and wherein after insertion of the implant said head-like or claw-like structure abuts to the structure.

11. The method of claim 1, wherein during the step of fastening the implant to the hard tissue, a force is applied to the implant in a direction towards the proximal end of the implant.

12. The method of claim 11, wherein by said force the implant is pressed against the structure.

13. The method of claim 1, wherein during the step of fastening the implant to the hard tissue, a force is applied to the structure in a direction toward the distal end of the implant, whereby the structure is pressed against the implant.

14. The method according to claim 1, wherein the step of manufacturing the opening comprises piercing the structure by the implant.

15. The method of claim 1, wherein the structure comprises pores, wherein either

the solid material that is liquefiable by mechanical movement at the surface region of the implant is in contact with the structure during the step of impinging, or

the implant further comprises a second surface region, and there is solid material that is liquefiable by mechanical movement at the second surface region of the implant that is in contact with the structure during the step of impinging, and

wherein the step of impinging causes liquefied material to infiltrate the pores to form, after re-solidification, an anchoring of the implant also in the structure.

16. The method according to claim 1, wherein the flexible element is a ligament or a tendon.

17. The method according to claim 1, wherein the structure is provided with growth factors and acts as a release system for the growth factors.