Title of Invention

"SURGICAL INSTRUMENT AND METHOD FOR TREATING URINARY CONTINENCE"

Abstract

Surgical instrument for treating female urinary incontinence, comprising: - ashank (10) having a handle (11) at one end and a curved portion (21) at the other end, said portion being intended to be passed into the body via vagina, - a tape to be implanted into the body as a loop around the urethra characterised by - two curved needle-like elements (21 A, 21B). each connected at one end thereof to one end of said tape (26) and - means on said shank and each of said elements for exchangeable connection of the said needle like elements one at a time to the shank at the other end thereof to form at said other an extension of the shank as a curved end portion thereof to extend from the inside surface of the vaginal wall over the back of the pubic bone to the outside of the abdominal wall.

Full Text

The invention relates to a surgical instrument for treating female urinary incontinence, i.e. incapacity of controlling the discharge of urine. Urinary incontinence may be caused by a defect function in the tissue or ligaments connecting the vaginal wall with the pelvic muscles and pubic bone. US-A-5 112 344 describes a method for treating female urinary incontinence without the necessity of opening the abdomen, which would require hospital care for may be four days. IN this method a tape is looped around the muscle tissue of the abdomen to either side of urethra to be implanted into the soft tissue between the vaginal wall and the abdominal wall extending into vagina. The tape is left in the body in order that fibrous tissue shall develop around the tape, said scar tissue functioning as a supporting ligament in the soft tissue. The tape is removed from the body when such scar tissue has developed, which take about two months. A surgical instrument of special construction is also proposed for use with this method, comprising a shank having a handle at one end thereof anxl a curved portion at the other end thereof said portion being intended to be passed into the body via the vagina. The result obtained by such surgery is not always satisfactory due to the fact that fibrous tissue will not develop sufficiently since the soft tissue between the vaginal wall and the abdominal wall is in bad condition. The object of the invention is to provide improved and simplified surgery with a considerably improved prognosis with regard to restoration of the urinary continence, and for this purpose the invention provides a surgical instrument for treating female urinary incontinence, comprising: a shank (10) having a handle (11) at one end and a curved portion (21) at the other end, said portion being intended to be passed into the body via vagina, a tape to be implanted into the body as a loop around the urethra characterised by two curved needle-like elements (21 A, 21B), each connected at one end thereof to one end of said tape (26) and means on said shank and each of said elements for exchangeable connection of the said needle like elements one at a time to the shank at the other end thereof to form at said other an extension of the shank as a curved end portion thereof to extend from the inside surface of the vaginal wall over the back of the pubic bone to the outside of the abdominal wall. The invention also provides a method for treatment of female urinary incontinence in accordance with claim 29. Also in this method a tape is passed into the tissue etween he vaginal wall and the abdominal wall but the tape is left permanendy in the body co provide itself, as an artificial ligament, the reinforcement of the tissue required in order to restore the urinary continence, and/or to provide said reinforcement by the development of fibrous tissue. The invention will be explained in more detail with reference to the accompanying drawings which disclose embodiments of the surgical instrument according to the inventions as well as several surgical steps when practising the method of the invention using aid surgical instrument. In the accompanying drawings Fig. 1 is a side view of the surgical instrument in one embodiment thereof, Fig. 2 is a plan view of the surgical instrument, Fig. 3 is an enlarged fragmentary axial cross Sectional view of a coupling of the instrument for attaching an exchangeable part thereof, Fig. 4 to 10 illustrate diagrammatically several surgical steps of the method according to the invention, Fig. 11 in the same ways illustrates the final steps of the method, Fig. 12, is a side view of the surgical instrument in a second, preferred embodiment thereof. Fig. 13 is a plan view of the surgical instrument disclosed in Fig. 12 FIG. 14 is an exploded side view of one of the needles and tape and shrinkage hose to be connected witn said needle, FIG. 15 is a side view of the needle in FIG. 14 with the tape connected therewith, FIG. 16 is an enlarged fragmentary axial cross sectional view of a modified coupling of the instrument for connecting exchangeable needles of the kind shown in FIGS 14 and 15, and FIG. 17 is a side view of two needles and a tape interconnecting said needles. The surgical instrument of FIGS 1 to 3 comprises a cylindrical tubulary shank 10 having at one end thereof a handle 11 which forms two in opposite directions in a common plane projecting wings 12 and an opening 13. At the other end of the shank there is a socket 14 which is partly passed onto the shank and is soldered or brazed to the shank, a portion of the socket projecting from the shank at said other end thereof. A cylindrical shaft 15 is rotatably mounted in the shank and can be rotated manually by means of a knob 16 axially knurled at the outside surface thereof, which is mounted to one end of the shaft and is received by opening 13. The other end of the shaft forms a cylindrical portion 17 of smaller outside diameter than the shaft, which joins a portion 18 having external threads, a smooth end portion 19 of further reduced diameter joining the threaded portion 18, end portion 19 forming a guide pin at said other end of the shaft. Portions 18 and 19 are received in the portion of socket 14 projecting from the shank, and also a shoulder 20 projecting from the shank is received in said portion. The surgical instrument as described so far is intended to be used several times and therefore should consist of a material which can be sterilized by autoclaving, e.g. of stainless steel. The surgical instrument also includes an exchangeable and disposable element 21 which will be termed needle. It is attached to the shank at a straight portion 21' at one end of the needle and extends over substantially a quarter of a circle to the other, free end thereof in order to follow substantially the profile of the pubis between the vagina and the abdominal wall. The needle has circular cross section and has a smooth, preferably polished outside surface. It tapers slightly towards the free end thereof where the needle forms a point 22 by being conical or, as shown, faceted but it can als be blunt-ended and have a transversely cut end. The practical use of the surgical instrument so far has shown that the conical shape of the point is preferred. The disposable needle shall be made either of a tissue compatible plastics, such as polycarbonate, or of steel or a similar material. For attachment of needle 21 to shank 10 the needle has at said one end thereof where the needle forms said straight portion 21' to be received in socket 14, an axial blind hole extending from the end surface said hole having a threaded portion 23 and inwardly thereof a narrower, cylindrical portion 24. Guide pin 19 is dimensioned to be guidingly received by said latter portion when the threaded portion 18 for attaching needle 21 to the rest of the surgical instrument is screwed into threaded portion 23 of the blind hole by rotating shaft 15 by manual rotation of knob 16, the end surfaces of the shank and the needle being pressed against each other. The needle should be oriented in a predetermined rotational position in relation to the shank; it should project at right angles to the plane of handle 16, and this rotational position is secured by shoulder 20 on the shank being received in a mating recess 25 in the outside surface of the needle. Portion 23 of needle 21 instead of being threaded can be dimensioned such that the threaded portion 18 of shaft 15 cuts a thread in the material of the needle when being screwed thereinto. When the two parts of the surgical instrument are screwed together in the manner described they form a rigid unit which can be controlled with great precision at handle 11 when it is used for surgery by applying the method of the invention. When the method according to the invention is practised two needles 21A and 21B of the embodiment described shall be connected one at each end of a tape 26, FIG. 4. The tape end can be glued to the needle but the connection can be effected also by the tape being passed through an eye 27, FIG. 3, in the needle adjacent the end attached to the shank or by the tape end being connected by ultrasonic welding to the needle or being baked into the plastics material of the needle at injection molding thereof. When the surgery for implanting the tape shall start one needle 21A is attached to shank 10, the other needle 21B hanging loosely in tape 26 as shown in FIG. 4. In FIGS. 4 to 11 the relevant parts of the female lower abdomen is disclosed diagrammatically, the vagina being designated 28, the urinary bladder 29, the urethra 30, the pubic bone 31, and the abdominal wall 32. The first step of the surgery for implanting tape 26 is disclosed in FIG. 4 and comprises penetration of the vaginal wall by needle 21A an incision having first been made in said wall, and also penetration of the soft tissue at one side of urethra 30, the needle then according to FIG. 5.being passed close to the back of the pubic bone 31 and then through the abdominal wall above the pubic bone. An incision can be done through the abdominal wall for the passage of the needle therethrough but if the needle is pointed it may be sufficient to let the needle penetrate into the abdominal wall from the inside thereof and to make a registering incision in the abdominal wall on the outside thereof. The shank of the instrument is now disconnected from needle 21A, FIG. 6, by rotating shaft 15 at knob 16 so that the threaded portion 18 of the shaft is unscrewed from the threaded portion 23 in needle 21A said needle then being withdrawn from the abdominal wall by means of forceps and tape 26 being pulled into and through the tissue as illustrated in FIG. 7. The other needle 21B is now attached to the shank, FIG. 8, and is passed through the incision in the vaginal wall to pass through the soft tissue at the other side of urethra 30. Needle 21B is passed through the abdominal wall, FIG. 9, and then, after having been disconnected from the shank, is withdrawn from the abdominal wall, FIG. 10, all in the same way as in the earlier procedure with needle 21A. Tape 26 is now located at each side of urethra 30 as shown in FIG. 10 and is tightened with the tape forming a loop around urethra and located between urethra and the vaginal wall, FIG. 11. The surplus of the tape at the outside of the abdominal wall is cut off. Then, the tape is left as an implant in the body to form an artificial ligament and providing the support for urethra as required in order to restore the urinary continence. In the embodiment of FIGS 12 to 17 the end portion 14' of socket 14 is flattened from opposite sides so that the cross section of said end portion is non-circular, and the straight portion 21' of needle 21 at the end to be attached to shank 10 is cylindrical but has milled flat faces 21" over that part of said portion 21', extending from the adjacent end of the needle, which shall be received by socket portion 14'. The predetermined rotational position of the needle in relation to the shank at right angles to the plane of handle 11 is secured by the non-circular shape of socket portion 14' and the end portion of the needle having the flat faces 21", which fits into socket portion 14'. The end portion of the needle having the flat faces 21" joins the body of the needle over a conical portion 33, which tapers towards a shoulder 33' . In the preferred embodiment the tape comprises a mesh or netting forming openings of the order of 1 mm. in order that fibroblasts shall be able to grow into the tape for anchoring of the tape in surrounding tissue. A suitable material for the tape is PROLENE , a knitted polypropylene mesh having a thickness of 0,7 mm manufactured by Ethicon, Inc., Sommerville, New Jersey, USA. This material is approved by FDA in USA for implantation into the human body. Another kind of tape which may be used in the method according to the invention can be knitted or woven more closely than the tape mentioned above and can be of such material that the tape after a shorter or longer period will be completely resorbed. By the development of fibroblast proliferation stimulated by the tape the reinforcement of the tissue required in order to restore the urinary continence will be obtained. The material of the tape can be coated with a fibroblast stimulating substance, e.g. an enamel matrix derivative. The netting (tape) preferably has a width of approximately 10 mm and is enclosed in a thin polyethylene sheath 34 which in flattened condition has substantially the same width as the tape although a difference in width is shown in FIG 14 in order to make the provision of the sheath more clear. The length of the netting should be approximately 400 mm. The netting and the sheath may be interconnected by means of two rows 35 of stiching as shown although this is not necessary. The end portion of the sheath is attached to the conical portion 33 of the needle by means of a shrink hose 36 of rubber which extends from the shoulder 33' over the conical portion 33 and partly over the cylindrical end portion 21' of the needle. The shrink hose is substantially flush with the surface of the needle at the shoulder. By this arrangement the netting is securely attached to the needle but if desired the connection can be supplemented by gluing the sheath to portion 33. The purpose of sheath 34 is above all to facilitate the insertion of the netting in the manner described above i e when the netting is pulled at the ends thereof from the vaginal wall to the abdominal skin and to avoid that rough edges of the netting irritate or damage the body tissues. When the tape has been positioned in the correct position as a sling around the urethra the polyethylene sheath shall be removed, and in order to facilitate the removal the sheath can be perforated at the longitudinal center thereof as indicated by a dot-and-dash line 37 in FIG. 17, so that the two halves of the sheath can be withdrawn from the body by pulling at the respective outer ends thereof the halves being separated at the perforation under the influence of the pulling force. As an alternative the sheath can be made in two halves which overlap each other without being interconnected at the longitudinal center of the netting. The purpose of the polyethylene sheath is also to protect the netting during attachment to the needles and during handling before and during insertion into the body. The longitudinal center of the tape and sheath should be indicated by a visible colour mark 38, FIG. 17 so that the surgeon readily can see when the netting is symmetrically located with reference to urethra during the surgery. We claim: 1. Surgical instrument for treating female urinary incontinence, comprising: a shank (10) having a handle (11) at one end and a curved portion (21) at the other end, said portion being intended to be passed into the body via vagina, a tape to be implanted into the body as a loop around the urethra characterised by two curved needle-like elements (21A, 21B), each connected at one end thereof to one end of said tape (26) and means on said shank and each of said elements for exchangeable connection of the said needle like elements one at a time to the shank at the other end thereof to form at said other an extension of the shank as a curved end portion thereof to extend from the inside surface of the vaginal wall over the back of the pubic bone to the outside of the abdominal wall. 2. Surgical instrument as claimed in claim 1 wherein said shank (10) has a screw coupling means (18, 23) for attachment of the element (21A, 21B) to said shank. 3. Surgical instrument as claimed in claim 2 wherein said screw coupling means comprises a shaft (15) rotatably mounted in the said shank (10) and having an operating knob (16) at one end of the shaft, said knob being available at the handle end of the shank, and a threaded portion (18) at the other end of the shaft for screw engagement with the element (21 A, 21B). 4. Surgical instrument as claimed in claims 1 to 3 wherein said shaft (10) has a sleeve portion (14) at said other end thereof to receive therein an end portion of the needle-like element (21 A, 21B) at said one end of the element. Surgical instrument as claimed in any of the claims 1 to 4 wherein the handle (11) comprises two wings (12) projecting diametrically from the shank (10). Surgical instrument as claimed in claim 5 wherein said shank (10) and the needle-like elements (21A, 21B) have mutually cooperating means (20, 25) for positioning the respective elements on the shank (10) at right angles to the plane of the wings (12). Surgical Instrument as claimed in any of claims 1 to 6 wherein said shank (10) consists of a material that can be autoclaved, the needle-like elements (21 A, 21B) being intended for a single use and include plastics material & stainless steel. Surgical instrument as claimed in claim 7 wherein the tape (26) is attached to the associated element (21A, 21B) by the tape ends being glued or welded to the elements, or being baked into the plastics material of the elements, or being mechanically clamped to the elements. Surgical instrument as claimed in claim 7 wherein the tape ends are passed through an eye (27) in the needle like element (21 A, 21B). Surgical instrument as claimed in any of the claims 1 to 9 wherein the needle-like elements are curved over substantially a quarter of a circle. Surgical Instrument as claimed in any of the claims 1 to 10 wherein the elements (21A, 21B) taper towards the other, free end thereof. Surgical Instrument as claimed in claim 11 wherein said other end is pointed. Surgical Instrument as claimed in claim 11 wherein said other end is blunt. 14. Surgical Instrument as claimed in claims 1 to 13 wherein the tape (26) is perforated for growth of fibroblasts there-into. 15. Surgical Instrument as claimed in claim 14 wherein the tape is coated with a fibroblast stimulating material. 16. Surgical instrument as claimed in claim 15 wherein that the tape (26) is made of polypropylene. 17. Surgical instrument as claimed in any one of claims 14 to 16 wherein that the tape (26) comprises a netting. 18. Surgical Instrument as claimed in any of claims 15 to 17, wherein the tape (26) is enclosed by a thin plastic sheath (34). 19. Surgical Instrument as claimed in claim 18 wherein the sheath (34) is made of polyethylene. 20. Surgical instrument as claimed in claim 18 or 19 wherein the sheath (34) has a perforation line at the longitudinal centre thereof or comprises two halves having adjacent ends overlapping each other. 21. Surgical instrument as claimed in any of claims 17 to 20 wherein the needle-like element (21) comprises a non-circular end portion (21') fitting into a non-circular socket (14') at said other end of the shank (10). 22. Surgical instrument as claimed in claim 21 wherein the said end portion (21) of the needle-like element (21) joins the rest of the element by a conical portion (32) tapering towards a shoulder (33) on the needle-like element. 23. Surgical Instrument as claimed in claim 22 wherein the netting (26) and the sheath (34) are connected to the needle-like element (21) at said conical portion (32). 24. Surgical Instrument as claimed in claim 23 wherein the netting (26) and the sheath (34) at the site of attachment thereof are covered by a shrink hose (36). 25. Surgical Instrument as claimed in claim 24 wherein one end of the shrink hose (36) abuts the shoulder (33') and is substantially flush with the surface of the needle-like element at said shoulder. 26. Surgical instrument as claimed in any of the claims 17 to 25, wherein the netting (26) and the sheath (34) project from the shrink hose (36) at the other end thereof. 27. Surgical instrument as claimed in any of claims 17 to 25, wherein a visible marking (38) is provided on the sheath (34) at the longitudinal centre thereof. 28. Surgical instrument substantially as herein described with reference to the accompanying drawings

Documents:

202-del-1996-abstract.pdf

202-del-1996-assignment.pdf

202-del-1996-claims.pdf

202-del-1996-complete specification (granted).pdf

202-del-1996-correspondence-others.pdf

202-del-1996-correspondence-po.pdf

202-del-1996-description (complete).pdf

202-del-1996-drawings.pdf

202-del-1996-form-1.pdf

202-del-1996-form-10.pdf

202-del-1996-form-13.pdf

202-del-1996-form-2.pdf

202-del-1996-form-3.pdf

202-del-1996-form-6.pdf

202-del-1996-form-9.pdf

202-del-1996-pa.pdf

202-del-1996-pct-210.pdf

202-del-1996-petition-124.pdf

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