Surgical prosthesis-forming device used to implant an organ support in a mammal

• US 7,229,404 B2
• Filed: 08/27/2003
• Issued: 06/12/2007
• Est. Priority Date: 08/30/2002
• Status: Active Grant

• Current Assignee: Analytic Biosurgical Solutions- ABISS
• Original Assignee: Bernard Bouffier
• Inventors: Bouffier, Bernard
• Primary Examiner(s): Marmor, II; Charles A.
• Assistant Examiner(s): Hopkins; Christine D.
• Application Number:
  US10/524,861
• Publication Number:
  US 20050261547A1
• Time in Patent Office: 1,385 Days
• Field of Search: 600/29, 600/30, 600/37, 600/121, 600/149
• US Class Current: 600/30
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/06109 Big needles, either gripped by hand or connectable to a handle
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61F 2/0045 Support slings

Abstract

The invention concerns a surgical device forming a surgical prosthesis.

This device is characterized in that it contains at least one first sling (20), at least one first traction component (30), and at least one first fixation or anchoring system (40), designed to work in concert with at least said first traction component (30), which includes a cage-forming device (42), the upper end (43) of which is fitted with a sliding component (46) which makes it easier to pull on the traction component (30) which acts on the sling (20), so that said pulling effects translation of one end of the sling (20).

The device is preferably intended for the treatment of urinary incontinence in female mammals, in particular the human female.

Claims

1. A surgical device forming a surgical prosthesis, designed to provide support to a physiological, mammalian organ that can be supported, comprising:

a) at least one first support component to provide support comprising a sling, with a first end and a second end designed to exert a supporting action on said physiological mammalian organ requiring support;

said sling being made at least partially of a substantially inextensible but flexible and deformable material;

b) at least one first traction component, which can be connected at least temporarily with at least one end of said sling support component, made of a substantially inextensible material enabling to pull on the sling support component and maintain same in place in a position providing said support;

c) at least one first anchoring system, designed to cooperate with at least said first traction component, to fix said sling support component and keep same in the correct position;

said first anchoring system comprising a cage-forming device with an upper end and a lower end, the upper end being fitted with a sliding component wherein the sliding component of the anchoring system is configured to act as a pulley, around which the traction component can slide or translate to pull on one end of the sling to provide support to said organ and keep said organ in support position,

wherein the upper end and the lower end of the cage-forming device of the anchoring system are joined to one another by a series of lateral bridging arms made of a substantially inextensible but flexible and deformable material being long enough to induce a kinking at the vicinity of their mid-point by pulling on the traction component to allow a so-called umbrella-type positioning with a broad surface of fixation or anchoring of the anchoring system.

2. The device of claim 1, wherein the lower end of the anchoring system is configured to be inserted on or attached to a mammalian substrate which is relatively resistant to tearing.

3. The device of claim 1, wherein the traction component is in the form of a traction wire, having a first end and a second end, comprising a ring or loop at one of said first end and of said second end;

the other of said first end and of said second end of the wire, named free end, cooperating with said ring or loop to create a lasso-like loop device to facilitate pulling on the sling.

4. The device of claim 1, wherein a single anchoring system is provided designed to simultaneously pull both ends of the sling.

5. The device of claim 1, wherein the first anchoring system joined to a first end of the sling component is configured to allow fixation at a predetermined, set position, while the second end of the sling is joined to a second anchoring system, thereby allowing displacement of the second end of the sling in order to exert a traction force on the mammalian organ as required.

6. The device of claim 1, wherein the cage-forming device comprises at its upper end a hollow, tubular component having a first end which is designed to be joined to or continuous with said upper end of the cage and, at the same time, to form the sliding component by presenting a surface which forms the pulley around which the traction wire is designed to slide.

7. The device of claim 6, wherein said end of the tubular component has a hole which is substantially coaxial with the hollow tubular component.

8. The device of claim 1, wherein the lower part of at least the first anchoring system or of each anchoring system comprises an annular part defining a central hole through which can be passed the first traction component or each traction component.

9. The device of claim 8, wherein said central hole is designed to accommodate the needle of a trocar.

10. The device of claim 1, wherein the sling is in the shape of a strip having a main part which is located between its ends consisting essentially of a fabric or meshwork created from two or more wires made of a substantially inextensible but flexible material.

11. The device of claim 10, wherein the material of the wires comprising the fabric of the strip is an organic polymer which is compatible with implantation in mammalian tissue.

12. The device of claim 11, wherein the organic material is selected from the group consisting of polyethylene, polypropylene and nylon.

13. The device of claim 1, wherein the second inextensible traction component includes or is constituted of an inextensible traction wire made of an inextensible organic material which is compatible with long-term implantation in mammalian tissue.

14. Traction component of the surgical device forming a surgical prosthesis as defined in claim 1, wherein said traction component is made of a substantially filiform inextensible material, and is connectable at least temporarily with at least one end of the sling to allow the pulling of said sling and keep same in a position providing said support.

15. Fixation or anchoring system of the surgical device forming a surgical prosthesis as defined in claim 1, wherein said anchoring system comprises a cage-forming device with an upper end and a lower end, the upper end being fitted with a sliding component for pulling on the traction component which acts on the sling, in order to effect the translation of one end of the sling in order to provide support to said organ or keep said organ in position.

16. Fixation and anchoring kit comprising at least one surgical device forming a surgical prosthesis as defined in claim 1, together with an introducer instrument, in the form of a penetrating trocar, with a protective sheath for the fixation or anchoring system mounted in a compact way or folded back between the penetrating trocar and the sheath, and joined to said sheath at least in the direction of penetration, said sheath comprising a system to prevent retrocession of the fixation system in place between the trocar and the sheath.

17. A method to provide support for an a physiological mammalian organ which requires support, comprising:

a) performing local anesthesia administered close to the organ requiring support;

b) performing incision, and dissection of the tissue opposite and on either side of said physiological mammalian organ requiring support to create an opening;

c) inserting through said opening at least one first elongated support component or sling with a first end and a second end designed to exert a supporting action on said physiological mammalian organ requiring support;

said first elongated component being made at least partially of a substantially inextensible but flexible and deformable material; and

then an introducer penetrating trocar instrument having a protective sheath and containing at least a first anchoring system designed to cooperate with at least one traction component, into the opening created by said incision and dissection of the tissues on one side and behind the organ requiring support, and after reaching said mammalian substrate which is relatively resistant to tearing, withdrawal of the protective sheath;

d) withdrawing the penetrating trocar;

e) simultaneous pulling on both ends of the filiform traction component to install the anchoring system in the correct place and open or deploy it;

f) repeating preceding steps c), d) and e) on the other side of the organ in order to introduce a second anchoring system, preferably identical to the first;

g) passing one end of the traction component of the first anchoring system in a means of joining in one first end of the first elongated sling then into the sliding component of the other end of the filiform traction component, to create a lasso-like loop, and a first pulling movement on the end or free part of the traction component for preliminary positioning;

h) repeating the same procedure as in the preceding steps for the second anchoring system on the other side of the organ requiring support, thereby preliminarily positioning the elongated sling near the organ in question;

i) simultaneous pulling on both ends or free parts respectively of the first traction component and of the second traction component until there is tension being exerted on the first elongated sling in the correct position in contact with said organ to provide the desired support for said organ;

j) joining of the free ends respectively of the first filiform component and the end of the second filiform component in the appropriate position, this joining of said end being carried out at such a position that the organ being supported is not compromised in any way;

k) closing of the incision with a suitable surgical closing means;

wherein the first anchoring system is designed to fix said first elongated support component and keep same in the correct position;

said first anchoring system comprises a cage-forming device with an upper end and a lower end, the upper end being fitted with a sliding component, which enables to pull on the traction component, which acts on the elongated support component, to effect through said pulling the translation of one end of the elongated support component to provide support to said organ and keep said organ in support position;

wherein said traction component can be connected at least temporarily with at least one end of said first elongated support component and is made of a substantially inextensible material enabling to pull on the first elongated support component and maintain same in the place in a position providing said support;

wherein the upper end and the lower end of the cage-forming device of the anchoring system are joined to one another by a series of lateral bridging arms made of a substantially inextensible but flexible and deformable material, said arms being long enough to induce a kinking at the vicinity of their mid-point by pulling on the traction component to allow a so-called umbrella-type positioning with a broad surface of fixation or anchoring of the anchoring system.

18. The method of claim 17, which is performed to correct incontinence in female mammals.

19. The method of claim 17, wherein the organ to be supported is the urethra.

20. The method of claim 17, wherein at least one anchoring system is inserted on tissue of the wall of the pelvic cavity.