WO2008052251A1

WO2008052251A1 - Anchoring device and its implementation

Info

Publication number: WO2008052251A1
Application number: PCT/AU2007/001635
Authority: WO
Inventors: Margaret Skilling
Original assignee: Kvinno Centre Pty Ltd
Priority date: 2006-10-30
Filing date: 2007-10-26
Publication date: 2008-05-08

Abstract

A tissue anchor (50) formed of a material which is compatible for location in human and/or animal muscle and/or ligament tissue, the anchor (50) comprising a base (51), a side (52) extending from adjacent each end of the base (51), and prongs (53) each extending substantially inwardly from a side (52), wherein the base (51), sides (52) and prongs (53) generally define a receiving portion (54) therebetween for receiving a filamentary element (60) and muscle and/or tissue, and wherein the anchor (50) can be reshaped such that the prongs (53) are moved substantially toward each other for engaging tissue and retaining the filamentary element (60) against the tissue.

Description

"Anchoring Device and Its Implementation"

This invention relates to an anchor which can be used in surgical procedures on both humans and animals.

Background Art

The invention has application to a wide variety of surgical procedures and one such procedure relates to a method of resolving female incontinence, which involves insertion of a filament which is to be fixed to the ligamentous tissue to either side of the vagina in order to reconstitute the ligamentary support for the urethra and/or vaginal wall. In the past such filaments have either been fixed to the pubic bone or alternatively the rectus abdominous muscle or left "tension free" in that muscle.

The inventor's husband, Dr. Peter Petros, is the principal author of an article entitled "Role of the Pelvic Floor in Bladder Neck Opening and Closure II: Vagina" which appeared in the International Urogynecology Journal (1997) 8:69-73. In that article it was identified the "connective tissue laxity in the vagina or its supporting ligaments is the prime cause of symptoms of stress, urgency and abnormal emptying". As a result in the case of a lax vagina, at least some of the muscular activity which is applied to maintain continence is taken up in resolving the vaginal laxity rather than control of the urethra. Therefore in rectifying the problem it is desirable to establish a situation in which the relationship between the existing muscular and ligamentory support can be re-established

In PCT/AU2003/001036 (WO 2004/017845), Dr. Petros described posterior vaginal wall repair, an anchor device and its implementation. The disclosure in WO 2004/017845 is fully incorporated herein by reference.

Disclosure of the Invention

The present invention provides a tissue anchor formed of a material which is compatible for location in human and/or animal muscle and/or ligament tissue, the anchor comprising a base, a side extending from adjacent each end of the base, and prongs each extending substantially inwardly from a side, wherein the base, sides and prongs generally define a receiving portion therebetween for receiving a filamentary element and tissue, and wherein the anchor can be reshaped such that the prongs are moved substantially toward each other for engaging tissue and retaining the filamentary element.

Preferably, the prongs are pointed and generally extend toward each other. The base in one embodiment includes end sections and a curved mid-portion therebetween which substantially extends into the receiving portion, wherein moving the mid-portion relative to the end sections reshapes the anchor. The mid-portion preferably includes a peak located at a distance from the end sections and connected thereto by angled portions. The anchor is preferably substantially symmetrical about the peak and is formed of a suitable stainless steel, polymeric material or biodegradable material.

In another embodiment, the mid-portion includes a generally pointed peak. In this embodiment, movement of the anchor sides and/or base end sections relative to the mid-portion reshapes the anchor.

The present invention also provides a cartridge having a cradle portion, a channel being formed in the cradle portion for receiving and retaining the anchor thereon. The cradle portion is preferably substantially U-shaped and includes end portions and a bottom portion generally defining a receiving space therebetween. The channel preferably extends from an end portion, along the bottom portion and to the other end portion. The channel is preferably dimensioned to receive and retain the anchor therein by friction fit or via protrusions formed in the channel.

The cartridge preferably includes a base portion configured for attachment to an insertion appliance. The base portion preferably includes an attachment recess for receiving a portion of the insertion appliance for retaining the cartridge thereon. The base portion also preferably includes a central aperture extending therethough to allow an actuator of the insertion appliance to extend therethrough. The central aperture preferably extends into the channel.

The present invention also provides an insertion appliance for connection with the cartridge, the insertion appliance having an actuator for engaging the anchor for reshaping same. The insertion appliance preferably includes a handle supporting a tubular body, the actuator extending through the tubular body from the handle and past a distal end of the tubular body. The actuator is preferably provided with a hook at its distal end for engaging the anchor. The handle preferably includes a lever operatively coupled to the actuator such that actuation of the lever moves the actuator hook toward the tubular body distal end. The insertion appliance is preferably adapted to provide for incremental retraction movement of the actuator hook with actuations of the lever. The handle preferably includes a release to release the hook back to its original unretracted position.

In another embodiment, the appliance includes a first actuator for reshaping the anchor, and a second actuator for disengaging the anchor from the cartridge.

In the preferred embodiment, the cartridge is supplied with the anchor loaded therein. The channel is preferably dimensioned such that the prongs are substantially aligned with the distal ends of the cartridge end portions. The anchor loaded cartridge is preferably supplied with a length of filamentary element received in the anchor receiving portion.

The preferred assembly includes two anchor loaded cartridges having a length of the filamentary element received in the anchor receiving portions.

The invention will be more fully understood in the light of the following description of several specific embodiments

Brief Description of the Drawings

The description is made with reference to the accompanying drawings of which:

Figure 1 is an isometric view of an assembly according to the preferred embodiment of the present invention, the assembly including an insertion tool, a cartridge, an anchor and a length of filamentary element supported by the anchor;

Figure 2 is an enlarged isometric view of the end of the insertion tool supporting the cartridge, anchor and filamentary element, with some parts shown in phantom for clarity; - A -

Figure 3 is an isometric view of a cross-section of Figure 2 along the longitudinal direction thereof;

Figure 4 is an isometric view of a cross-section of Figure 2 along the lateral direction thereof;

Figure 5 is an isometric view of an assembly according to an alternative embodiment of the present invention, the assembly including an insertion tool, a cartridge, an anchor and a length of filamentary element supported by the anchor;

Figure 6 is an enlarged isometric view of the end of the insertion tool supporting the cartridge, anchor and filamentary element of the alternative embodiment of Figure 5;

Figure 7 is an isometric view of a cross-section of Figure 6 along the longitudinal direction thereof;

Figure 8 corresponds to Figure 7 with some parts shown in phantom for illustration purposes;

Figure 9 shows the compression of tissue into a lump by externally applied forceps;

Figure 10 shows a modification embodiment of the cartridge of Figure 2 or Figure 6; and

Figure 11 schematically shows the embodiment of figure 10 in use.

Detailed Description of Specific Embodiments

The anchor 50 of the preferred embodiment provides a means of attaching a filamentary element 60 into muscle and/or ligamentary tissue, similar to the anchor described in WO 2004/017845. The anchor 50 comprises a staple which is able to engage the tissue whereby once it is so engaged the anchor 50 is retained in position. The anchor 50 is able to receive and support a filamentary element 60 whereby the filamentary element 60 can slide therethrough until the anchor 50 fully engages the tissue. The aim of the embodiment is to incorporate into the fascial tissue, which is located above and below the vaginal wall, a supporting filamentary element 60 which is supported at either end from either the recto-vaginal ligaments or the arcus tendineus (A.T.F.P.) ligaments located to each side of the vagina.

The procedure involves forming a longitudinal incision in the anterior and/or posterior vaginal wall. This results in the creation of a pair of flaps of fascial tissue to each side of the longitudinal incision. One or more lengths of filamentary element 60 are then fixed to each of either the recto-vaginal ligaments or the arcus tendineus (A.T.F.P.) ligaments which are located to each side of the vagina. The fixing of each length of filament 60 is effected through a pair of the anchors 50 of the form described below which receive the length of filamentary element 60.

The spacing between the anchors 50 on the length of filamentary element 60 can be reduced by fixing one anchor 50 in position in tissue, thereby also retaining the anchor 50 in position on the filamentary element, and then causing the filamentary element to be drawn through the other anchor 50 until the desired spacing is achieved, and then fixing the second anchor 50 in position, thereby retaining the second anchor 50 in position on the filamentary element 60. The spacing between the anchors 50 on the filamentary element 60 cannot be increased.

The anchors 50 on each length of filamentary element 60 are embedded into the recto-vaginal ligaments to each side of the vagina. The length of the filament 60 between the ligaments is reduced to introduce a degree of tension into the filamentary element 60 between the ligaments. The flaps of fascial tissue are then resutured into place. With the healing of the incisions the filamentary element 60 becomes embodied into the fascial tissue on the anterior and posterior sides of the vaginal walls to provide reinforcement and support for that fascial tissue.

The tensioning of the filamentary element 60 on its location in position between the recto-vaginal ligaments or the arcus tendineus (A.T.F.P.) ligaments enables the filamentary element 60 to be precisely and sufficiently tightened to bring the fascia towards the mid-line and in so doing serves to repair any hernia. This serves to restore support for the vaginal wall and to facilitate the desired transmission of the muscle contraction to effect opening and closure of the urethra and anus without the muscle having initially to take up the laxity that previously existed in the connection between the fascial tissue and the recto-vaginal ligaments.

The description below is directed to an anchor 50 which can be utilised in association with a filamentary element 60 to enable the fixing and location of the filamentary element 60 into a patient as described above.

The filamentary element 60 which is used comprises a tape which is formed of a knitted or woven material where the material once located in the body will facilitate the growth of scar-like tissue upon it

Figures 1 to 4 show an assembly 10 comprising an insertion appliance 20, which supports a cartridge 40, which supports an anchor 50, which receives a filamentary element 60.

The insertion appliance 20 comprises a handle 22 supporting a proximal end 23 of a tubular body 24. An internal bore 25 of the tubular body 24 slidably supports an actuator 26 which extends from the handle 22 and past a distal end 27 of the tubular body 24. The actuator 26 is provided with a hook 28 at its distal end which is spaced from the tubular body distal end 27. The handle 22 includes a lever 29 operatively coupled to the actuator 26 such that actuation of the lever 29 moves the actuator hook 28 toward the tubular body distal end 27 (the hook 28 is retracted toward the distal end 27). The insertion appliance 20 can be adapted to provide for incremental movement of the actuator hook 28 such that one actuation of the lever 29 retracts the hook 28 a certain distance and subsequent actuations of the lever 29 then causes the hook 28 to be further retracted. The handle 22 can include a release and/or biasing means (not shown) to release the hook 28 back to its original unretracted position as shown in the drawings.

The cartridge 40 includes a base portion 41 and a cradle portion 42. The base portion 41 includes a circular attachment recess 43 for receiving the tubular body distal end 27 and retaining the cartridge 40 thereon. The base portion 41 also includes a central aperture 44 extending therethough concentric with the recess 43 and dimensioned to allow the actuator 26 to extend therethrough when the cartridge 40 is attached to the tubular body 24. The cradle portion 42 is substantially U-shaped with the bottom portion elongated and includes end portions 45 and a bottom portion 46. A continuous channel 47 extends from an internal surface of an end portion 45, along the bottom portion 46 and to an internal surface of the other end portion 45. The channel 47 is dimensioned to receive and retain an anchor 50 therein, for example by friction fit or via small protrusions, until the anchor 50 engages a tissue as will be explained below. The bottom portion 46 and end portions 45 generally define a receiving space 48 therebetween. The base portion aperture 44 extends into the channel 47. A space 49 is provided within the cradle portion 42 for receiving the actuator hook 28 when the hook 28 is retracted in use.

The anchor 50 according to the embodiment generally comprises a staple having a base 51, sides 52 each extending from an end of the base 51 , and prongs 53 each extending substantially inwardly from a side 52. The base 51 , sides 52 and prongs 53 generally define a receiving portion 54 therebetween for receiving the filamentary element 60. The base 51 includes end sections 58 and a curved mid- portion 55 substantially extending into the receiving portion 54. The mid-portion 55 includes a peak 56 located at a distance from the end sections 58 and connected thereto by angled portions 57. The anchor 50 is substantially symmetrical about the peak 56 and is formed of a suitable stainless steel, polymeric material or biodegradable material.

In the preferred embodiment, the cartridge 40 is supplied with the anchor 50 received (loaded) therein as shown in the drawings. In this loaded position, the anchor 50 is held within the cartridge channel 47 with the anchor receiving portion 54 substantially aligned with the cartridge receiving space 48. The channel 47 is dimensioned such that the prongs 53 are substantially aligned with the distal (top) ends of the cartridge end portions 45. The anchor loaded cartridge 40 can also be supplied with the filamentary element 60 received in the anchor receiving portion 54, or the filamentary element 60 can be inserted therein when required.

In use, the anchor loaded cartridge 40 is mounted onto the tubular body distal end 27 by the circular recess 43 receiving the distal end 27. The actuator 26 extends through the cartridge aperture 44 and the actuator hook 28 engages the anchor peak 56. The top of the hook 28 can include a taper such that when the anchor loaded cartridge 40 is mounted, the tapered portion of the hook 28 first engages the anchor mid-portion 55 to move the hook 28 laterally outwardly, with the hook 28 returning to its substantially central position thereafter to engage the anchor peak 56. Alternatively or additionally, the insertion appliance 20 can have a second lever or a button (not shown) for moving the actuator 26 laterally outwardly for engagement with the anchor peak 56 when the cartridge 40 is being mounted. The same lever or button can also be used to move the actuator 26 laterally outwardly for disengagement with the anchor base 51 when required.

It can be seen that when the actuator hook 28 is retracted via the lever 29, the hook 28 will engage the anchor peak 56 to move the peak 56 toward the tubular body distal end 27. Effectively, the anchor peak 56 is moved relative to the anchor end sections 58. This action will substantially straighten the base angled portions 57 which will effectively move the prongs 53 toward each other, which in use will cause the prongs 53 to engage tissue material. The anchor 50 is thus reshaped.

Two anchor loaded cartridges 40 are used with a length of the filamentary element 60 being received in the anchor receiving portions 54. In use, the insertion appliance 20 is used to insert the first anchor loaded cartridge 40 into the body cavity through an opening in the body wall such that the distal ends of the cartridge end portions 45 are located against the surface of a layer of muscle tissue. With the application of an axial pushing force on the tubular body 24, tissue material will be received in the anchor receiving portion 54. With actuation of the lever 29, the first anchor 50 is caused to engage the tissue at the first location to become lodged therein.

As described above, the insertion appliance 20 can be adapted to provide for incremental movement of the actuator hook 28 such that the corresponding engagement of tissue with the anchor 50 is also incremental. For example, one actuation of the lever 29 can cause the anchor 50 to initially engage tissue and still allow the filamentary element 60 to pass through its receiving portion 54. Subsequent actuations of the lever 29 can then cause the anchor prongs 53 to be further embedded into the tissue to maintain the anchor 50 in position in the tissue and also fix the position of the anchor 50 relative to the filamentary element 60.

Once the first anchor 50 is firmly in position, the actuator hook 28 is disengaged from the anchor base 51 and the insertion appliance 20 with the cartridge 40 mounted thereon is withdrawn. This removes the anchor 50 from the cartridge 40 to leave the anchor 50 and filamentary element 60 in place. The unloaded first cartridge 40 is removed and the second anchor loaded cartridge 40 is then mounted onto the insertion appliance 20 with the filamentary element 60 received in the second anchor 50. The second anchor 50 is then initially fixed to a second tissue position in a similar manner using the insertion appliance 20 such that the second anchor 50 will allow the filamentary element 60 to pass through its receiving portion 54. The filamentary element 60 is then pulled to reduce the length of filamentary element 60 between the first and second anchors 50. This also reduces the distance between the tissue locations and tensions the filamentary element 60. When the desired tissue spacing is achieved, the handle lever 29 is further actuated to fix the second anchor 50 in position and maintain the anchor positions on the filamentary element 60.

Where the filamentary element 60 is used to provide a sling-like support between two anchors 50 supported in the recto-vaginal ligaments as described above, the tensioning applied to the filamentary element 60 is such as to restore the normal tension which is expected at the site to enable the muscular action which is available to be used to control the urethra.

Throughout the specification, unless the context requires otherwise, the word "comprise" or variations such as "comprises" or "comprising", will be understood to imply the inclusion of a stated integer or group of integers but not the exclusion of any other integer or group of integers.

It should be appreciated that the scope of the invention need not be limited to the particular scope of the embodiment described above and in particular is not restricted to the particular example of application of the embodiment described above. Modifications can be made to the described embodiment. For example, the anchor peak can be made to be substantially flat or can include an aperture for engagement with the actuator hook. Also, the connection between the actuator hook and the actuator can include a fracture point which has a predetermined calibrated point of weakness. The fracture point will be designed to break when a particular tensile force load is exceeded, which will be slightly over the force required to cause the anchor to engage tissue and be retained therein. The actuator and anchor provides the force and motion required to cause the anchor to engage the tissue and affix the filamentary element, whereafter further actuation of the lever will cause the fracture point to break such that the actuator can be disengaged from the anchor and retracted from the operation site. In such an embodiment the hook can be replaced by a wire loop which will be pre- engaged with the anchor.

The anchor sides and prongs can also be dimensioned to extend further than the cradle end portions when the anchor is loaded onto the cradle. Also, the handle can be adapted to require only one actuation of the lever for permanent fixing of the anchors into tissue. In this case, pulling the filamentary element relative to the second anchor is performed when the second anchor is being axially forced into tissue, with the lever being actuated once the desired filamentary element length between the anchors is achieved.

Other clinical uses of the present invention aside from the above described application include Stress Incontinence, Posterior Sling, Uterine Prolapse, Vaginal Vault Prolapse and Perinea Body Repair.

Figures 5 to 8 show an alternative assembly 110 comprising an insertion appliance 120, which supports a cartridge 140, which supports an anchor 150, which receives a filamentary element 160. The parts of the assembly 110 are substantially similar as those for assembly 10 described above.

The insertion appliance 120 comprises a handle 122 supporting a proximal end 123 of a tubular body 124. An internal bore 125 of the tubular body 124 slidably supports a first tubular actuator 126a, within which is supported a second actuator 126b. The first and second actuators 126a and 126b both extend from the handle 122, with the first actuator 126a extending to a distal end 127 of the tubular body 124, and the second actuator 126b extending further past the distal end 127. The distal end of the second actuator 126b is provided with a spike 128 between two flat portions 131.

The handle 122 includes a lever 129 operatively coupled to the first and second actuators 126a and 126b such that a first actuation of the lever 129 moves only the first actuator 126a upwardly (i.e. away from the tubular body distal end 127) and a second actuation of the lever 129 moves only the second actuator 126b upwardly, which will be explained further below. In this specification, the terms "upwardly", "top" and "upper" are referred to in the orientation of the device as shown in the drawings.

The cartridge 140 includes a base portion 141 and a cradle portion 142. The base portion 141 includes a central aperture 144 for receiving the tubular body distal end 127 and retaining the cartridge 140 thereon. The cradle portion 142 includes two end walls 145, a bottom portion 146 and two side walls 170 which are shorter than the end walls 145, which together define an internal space 171 therewithin.

Within the space 171 , two movable substantially L-shaped horns 143 are located, each horn 143 having a vertical portion 173 adjacent a respective end wall 145, and a horizontal portion 175 adjacent the cradle portion bottom portion 146. The horizontal portions 175 are dimensioned to be engaged by the first actuator 126a in use, with the second actuator 126b extending between the horns 143.

Also within the space 171 , a stationary saddle 177 is disposed between the two L- shaped horns 143, with the second actuator 126b extending through an aperture in the saddle 177. The saddle 177 supportingly engages the horn vertical portions 173. The saddle also has top inner surfaces 178 for supporting the second actuator flat portions 131 and top outer surfaces 179 for supporting the anchor 150. Two spaced protrusions 180 are located in the side walls 170 for retaining the anchor 150 as further explained below.

The side walls 170 being shorter than the end walls 145 provides a receiving space 182 in the distal end of the cartridge 140. Channels 184 are formed in the internal surfaces of the end walls 145 for supporting sides 152 of the anchor 150.

The bottom portion of the anchor 150 are supported by portions of the horns 143, saddle 177 and second actuator 126b, which together form a substantially continuous support surface for the anchor base 151.

The anchor 150 according to the embodiment generally comprises a staple having a base 151 , sides 152 each extending from an end of the base 151 , and prongs 153 each generally inwardly directed from a side 152. The base 151 , sides 152 and prongs 153 generally define a receiving portion 154 therebetween for receiving the filamentary element 160. The base 151 includes generally flat end sections 158 and a curved mid-portion 155 substantially extending into the receiving portion 154. The mid-portion 155 includes a substantially pointed peak 156 located at a distance from the end sections 158 and connected thereto by angled portions 157. The second actuator spike 128 and flat portions 131 are shaped to correspond to the lower surface of the anchor 150. The anchor 150 is substantially symmetrical about the peak 156 and is formed of a suitable stainless steel, polymeric material or biodegradable material.

In the preferred embodiment, the cartridge 140 is supplied with the anchor 150 received (loaded) therein as shown in the drawings. In this loaded position, the anchor 150 is held within the cartridge 140 with the anchor receiving portion 154 substantially aligned with the cartridge receiving space 182. The protrusions 180 engage the upper surfaces of the anchor flat end sections 158 to retain the anchor 150 in the cartridge 140. The prongs 153 are substantially aligned with the distal (top) ends of the cartridge end walls 145 and the peak 156 is substantially aligned with the distal ends of the side walls 170.

In use, the anchor loaded cartridge 140 is mounted onto the tubular body distal end 127 by the central aperture 144 receiving the distal end 27. The distal end of the second actuator 126b can be adapted to be inserted into the cartridge 140 to be placed in position as shown in the drawings. Alternatively, the loaded cartridge assembly can include the second actuator 126b extending through the base portion central aperture 144. In this embodiment, the proximal end of the second actuator 126b is inserted through the first actuator 126a to be engaged by the handle 122. A first actuation of the lever 29 will move the first actuator 126a upwardly which in turn will moves the horns 143 upwardly. The protrusions 180 will retain the anchor 150 within the cartridge 140 and thus, this movement of the horns 143 will reshape the anchor 150 and force the anchor prongs 153 to move substantially inwardly toward each other for engaging tissue. The inward movement of the anchor prongs 153 will form a channel for guiding the filamentary element 160 therethrough. A second actuation of the lever 129 will move the second actuator 126b upwardly which will move the anchor 150 over the protrusions 180 to dislodge the anchor 150 from the cartridge 140. The pointed anchor peak 156 will then engage the filamentary element 160 to lock it in place in the tissue.

Use of the assembly 120 is similar to that of the assembly 20 described above. Two anchor loaded cartridges 140 are used with a length of the filamentary element 160 being received in the anchor receiving portions 154. At the first tissue location, a first actuation of the lever 129 causes the first anchor 150 to engage the tissue and a second actuation fixes the filamentary element 160 at the first location. At the second location, a first actuation of the lever 129 causes the second anchor 150 to engage the tissue. The tension in the filamentary element 160 is then adjusted and a second actuation of the lever 129 fixes the filamentary element 160 at the second location.

The insertion appliance 120 can be adapted to provide for incremental movement of the first actuator 126a such that the corresponding engagement of tissue with the anchor 150 is also incremental. This can be a desired feature to ensure that the anchor 150 sufficiently engages the tissue prior to actuation of the second actuator 126b. The appliance 120 in this embodiment can include a switch for selecting actuation between the first and second actuators 126a and 126b as required.

Figure 9 to 11 show how the invention is used for flat tissue. As shown in Figure 9, flat or substantially flat tissue 190 is 'pinched' using external forceps 192 to form a bump or lump 194 in the tissue 190. Figure 10 shows a modified embodiment of a cartridge 200 which includes spikes 202 at the distal face thereof. In use, as shown in Figure 11 , the spikes 202 are used to engage opposite sides of the formed lump 194 such that the staple 50 or 150 can be inserted into the tissue as described above.

Claims

ClaimsThe claims defining the invention are as follows:

1. A tissue anchor formed of a material which is compatible for location in human and/or animal muscle and/or ligament tissue, the anchor comprising a base, a side extending from adjacent each end of the base, and prongs each extending substantially inwardly from a side, wherein the base, sides and prongs generally define a receiving portion therebetween for receiving a filamentary element and muscle and/or tissue, and wherein the anchor can be reshaped such that the prongs are moved substantially toward each other for engaging tissue and retaining the filamentary element against the tissue.

2. The tissue anchor of claim 1 wherein the prongs are pointed and generally extend toward each other.

3. The tissue anchor of claim 1 or 2 wherein the base includes end sections and a curved mid-portion therebetween which substantially extends into the receiving portion, wherein moving the mid-portion relative to the end sections reshapes the anchor.

4. The tissue anchor of claim 3 wherein the mid-portion includes a peak located at a distance from the end sections and connected thereto by angled portions.

5. The tissue anchor of claim 4 wherein the anchor is substantially symmetrical about the peak.

6. The tissue anchor of claim 3, 4 or 5 wherein the mid-portion includes a generally pointed peak and movement of the anchor sides and/or base end sections relative to the mid-portion reshapes the anchor.

7. The tissue anchor of any one of claims 1 to 6 wherein the anchor is formed of a suitable stainless steel, polymeric material or biodegradable material.

8. An assembly comprising the tissue anchor of any one of claims 1 to 7 and a cartridge having a cradle portion, a channel being formed in the cradle portion for receiving and retaining the tissue anchor thereon.

9. The assembly of claim 8 wherein the cradle portion is substantially U-shaped and includes end portions and a bottom portion generally defining a receiving space therebetween, wherein the channel extends from an end portion, along the bottom portion and to the other end portion.

10. The assembly of claim 9 wherein the channel is dimensioned such that in use the prongs are substantially aligned with distal ends of the end portions.

11. The assembly of claim 9 or 10 wherein distal faces of the end portions include at least one spike thereon.

12. The assembly of any one of claims 8 to 11 wherein the channel is dimensioned to receive and retain the anchor therein by friction fit or via protrusions formed in the channel.

13. The assembly of any one of claims 8 to 12 wherein the cartridge includes a base portion configured for attachment to an insertion appliance.

14. The assembly of claim 13 wherein the base portion includes an attachment recess for receiving a portion of the insertion appliance for retaining the cartridge thereon.

15. The assembly of claim 13 or 14 wherein the base portion includes a central aperture extending therethough to allow an actuator of the insertion appliance to extend therethrough.

16. The assembly of claim 15 wherein the central aperture extends into the channel.

17. The assembly of any one of claims 8 to 16 further including an insertion appliance for connection with the cartridge, the insertion appliance having an actuator for engaging the anchor for reshaping same.

18. The assembly of claim 17 wherein the actuator is provided with a hook at its distal end for engaging the anchor.

19. The assembly of claim 17 or 18 wherein the insertion appliance includes a handle supporting a tubular body, the actuator extending through the tubular body from the handle and past a distal end of the tubular body.

20. The assembly of claim 19 wherein the handle includes a lever operatively coupled to the actuator such that actuation of the lever moves the actuator hook toward the tubular body distal end.

21. The assembly of claim 20 wherein the insertion appliance is adapted to provide for incremental retraction movement of the actuator hook with actuations of the lever.

22. The assembly of any one of claims 17 to 21 wherein the appliance includes a first actuator for reshaping the anchor, and a second actuator for disengaging the anchor from the cartridge.

23. A tissue anchor substantially as herein described with reference to the accompanying drawings.

24. An assembly comprising a tissue anchor and a cartridge substantially as herein described with reference to the accompanying drawings.

25. An assembly comprising a tissue anchor, a cartridge and an insertion appliance substantially as herein described with reference to the accompanying drawings.