DEVICE FOR THE TREATMENT OF STRESS URINARY INCONTINENCE

Abstract

A needle (16) for deploying a suture is provided. The needle (16) has a feeding end (11) with an aperture (19) for receiving the suture and a pointed end (3) for creating an incision. The needle (16) extends between the feeding end (11) and the pointed end (3). The needle (16) also has a second aperture (18) and an interior channel (5) extending between the first aperture (19) and the second aperture (18) for transporting the suture from the first aperture (19) to the second aperture (18). A kit for deploying sutures includes at least one suture, at least one needle (16) and at least one pusher (12). The pusher (12) pushes the suture through the interior channel (5) of the needle (16) and out of the second aperture (18).

Claims

1. A needle for deploying a suture, the needle comprising: a feeding end comprising a first aperture for receiving the suture; a pointed end for creating an incision, wherein the needle extends between the feeding end and the pointed end; a second aperture proximal to and spaced from the pointed end; and an interior channel extending between the first aperture and the second aperture for transporting the suture from the first aperture to the second aperture.

2. The needle as claimed in claim 1, wherein the pointed end comprises a bevel.

3. The needle as claimed in claim 1, wherein the second aperture extends through a wall of the needle.

4. (canceled)

5. The needle as claimed in claim 1, wherein the needle comprises markings indicating the side of the needle in which the second aperture is formed.

6. The needle as claimed in claim 1, wherein the particular distance is based on the thickness of a target human or animal tissue and/or the angle at which the end of the suture exits from the second aperture into the target tissue.

7. The needle as claimed in claim 1, wherein a portion of the needle between the pointed end and the second aperture is closed.

8. The needle as claimed in claim 1, wherein a portion of the needle between the pointed end and the second aperture is solid.

9. The needle as claimed in claim 1, wherein the interior channel comprises a deflection surface arranged to deflect a suture toward the second aperture when the suture is incident on the deflection surface.

10. The needle as claimed in claim 9, wherein the deflection surface is on a side of the second aperture proximal to the pointed end of the needle.

11. The needle as claimed in claim 9, wherein the deflection surface comprises one side of the wall of the interior channel, which optionally forms a curve toward an edge of the second aperture proximal to the pointed end of the needle.

12. The needle as claimed in claim 1, wherein the needle comprises a material that is visible through fluoroscopic imaging and/or CT imaging.

13. (canceled)

14. The needle as claimed in claim 1, wherein the needle is arranged to receive a pusher for pushing the suture through the interior channel of the needle and out of the second aperture.

15. A kit for deploying sutures, comprising: at least one suture; at least one needle according to claim 1; and at least one pusher, arranged to push the suture through the interior channel of the needle and out of the second aperture.

16. The kit as claimed in claim 15, wherein the at least one suture is a T-bar suture.

17. The kit as claimed in claim 16, wherein each suture comprises a footplate portion and a thread portion.

18. (canceled)

19. The kit as claimed in claim 15, comprising a member for inserting into an orifice of the human or animal body, wherein the member is arranged to support the pointed end of the needle in a target human or animal tissue and wherein the member is cylindrical with a tapered end.

20. (canceled)

21. The kit as claimed in claim 15, wherein the suture comprises a free end and the kit comprises an anchoring device for securing the free end of each suture under tension at an anchoring point.

22. The kit as claimed in claim 15, further comprising a tunnelling device for pulling the thread portion or free end of each suture through tissue to an anchoring point.

23-25. (canceled)

26. A method for the treatment of stress urinary incontinence, the method comprising: inserting the needle of claim 1, into a female human or animal body; advancing the needle until the pointed end reaches a periurethral anterior vaginal wall tissue; transporting the suture through the interior channel of the needle until the end of the suture exits the needle through the second aperture and the suture is retained in the periurethral anterior vaginal wall tissue; removing the needle from the female human or animal body; and securing the suture, under tension such that a pubourethral ligament is reinforced.

27. A method for the treatment of stress urinary incontinence, the method comprising: transporting a T-bar suture into a periurethral anterior vaginal wall tissue of a female human or animal body such that the T-bar suture is retained in the periurethral anterior vaginal wall tissue; and securing the T-bar suture, under tension such that a pubourethral ligament is reinforced.

Description

[0089] One or more non-limiting examples will now be described, by way of example only, and with reference to the accompanying figures in which:

[0090] FIG. 1 schematically shows a longitudinal cross-section of a needle embodying the invention;

[0091] FIG. 2 schematically shows the needle of FIG. 1 in the plane of the aperture;

[0092] FIG. 3 shows a T-bar suture for use with the needle shown in FIGS. 1 and 2;

[0093] FIGS. 4A and 4B show in more detail a variant of the feeding end of the needle and a pusher;

[0094] FIGS. 5A and 5B show schematically a longitudinal cross-section of the delivery of the T-bar suture of FIG. 3 through and out of the needle of FIG. 1;

[0095] FIG. 6 shows schematically a procedure using the needle of FIG. 1;

[0096] FIG. 7 shows schematically a variant of the procedure shown in FIG. 6;

[0097] FIG. 8 shows schematically a later stage of the procedure compared to FIGS. 6 and 7;

[0098] FIG. 9A shows schematically a first method of securing the free end of each suture together with a common crimp;

[0099] FIG. 9B shows schematically the final position of the secured sutures according to the method of FIG. 9A;

[0100] FIG. 10A shows schematically a second method of securing the free end of each suture separately with a dedicated crimp for each suture; and

[0101] FIG. 10B shows schematically the final position of the secured sutures according to the method of FIG. 10A.

[0102] FIG. 1 shows a longitudinal cross-section of a needle according to an embodiment of the present invention. The stainless steel needle 16 has an interior channel 5 that extends between a first aperture 19 at a feeding/handling end 11, through the needle to a second aperture (side-hole) 18. The side-hole 18 is spaced from the pointed end 3 of the needle. The distance 4 between the pointed end 3 of the needle 16 and the side-hole is set to suit the intended procedure, such that the final position of the side-hole 18 reaches a certain depth in the target human or animal tissue, or a certain distance from a particular part of the body, when the needle 16 is inserted into a human or animal body. The embodiment in FIG. 1 shows one side wall of the an interior channel 5 of the needle 16 (the side furthest from the side-hole 18) having a surface 14 that curves toward the side-hole 18.

[0103] In FIG. 2, an alternate view of the needle is shown. The schematic shows the needle in a plane facing the side-hole 18. The pointed end 3 of the needle 16 and uppermost point of the aperture 18 are separated by a particular distance 4. The side-hole 18 is sized and shaped such that a suitable suture can be delivered from the needle 16, exiting through the side-hole 18.

[0104] Although the needle 16 is suitable for deploying any type of suitable suture, one preferred type of suture 7 is shown in FIG. 3. The T-bar suture 7, shown in FIG. 3, comprises a rigid bar 6, herein referred to as the footplate. From the centre of the footplate 6, i.e. from the middle of the longitudinal axis of the bar 6, extends a thread 8. The T-bar suture 7 is designed to anchor into soft tissue such that when tension is applied to the thread 8, the footplate does not slip or move.

[0105] In FIG. 4A a full view of the needle 16 and a pusher 12 is shown. The pusher 12 is sized and shaped so that it fits within the interior channel 5 of the needle 16. The length is such that when fully inserted into the needle 16, the end of the pusher 12 reaches the aperture 18 situated towards the pointed end 3 of the needle 16. In this embodiment, the pusher 12 is a stiff thin rod made of stainless steel with a flat disc at one end, having a diameter larger than the diameter of the rod portion. The disc shape 10 at the end of the pusher 12 is advantageous as it helps to disperse the pressure on the practitioner's hand as the rod 12 is pushed through the needle 16.

[0106] In the embodiment shown in FIG. 4A, the needle 16 has a feeding/handling end 17, where a suture 7 and the pusher 12 are introduced into the interior channel 5 through a first aperture 19. Similarly to the embodiment shown in FIG. 1, the needle has a pointed end 3 for inserting into the human or animal body. Proximal to but spaced away from the pointed end 3, is a second aperture (side hole) 18 out of which the suture 7 can be pushed.

[0107] As shown in FIG. 4A, the feeding end 11 has a receiving portion 17 arranged to receive a suture 7 into the first aperture 19 of the needle 16. The receiving portion 17 surrounds the needle body at the feeding end 11 and has a conical shape having a narrower end and a wider end. The narrower end is oriented in the direction of the pointed end 3 of the needle 16, with a wider base at the feeding end 11. The wider base has a lip that extends out into a larger disc shape. The receiving portion 17 helps to improve the ergonomics of the needle. Here, the receiving portion 17 helps to introduce the suture 7 and/or pusher 12 into the interior channel via the first aperture 19 at the feeding end 11, and helps a user to handle the needle 16.

[0108] FIG. 4B shows an alternate view of the pusher 12 and the needle 16, looking from the handling/feeding end 11 of the needle 16 towards the pointed end 3 of the needle 16, such that the tip of the rod portion of the pusher 12 and pointed end of the needle 16 are directed into the page. The view in FIG. 4B thus faces the disc shaped end 10 of the pushing rod and the handling/feeding end 11 of the needle 16. The distal end of the receiving portion 17 at the handling/feeding end 11 of the needle 16 takes the shape of a disc with a small hole or aperture 19 arranged to receive a suture 7 and the pushing rod 12.

[0109] FIG. 5A shows the needle 16 of FIG. 1 in use, in combination with the suture 7 of FIG. 3 and the pushing rod 12 of FIG. 4A.

[0110] The suture deployment apparatus 2 comprises the needle 16, a T-bar suture 7 and a pushing rod 12. The deployment takes place once the needle 16 has been inserted, such that the side-hole 19 is situated within the target tissue of a human or animal body, as will be described in more detail below.

[0111] In operation, first the T-bar suture 7 is placed in the interior channel 5 of the needle 16. The flexibility of the thread 8 allows the suture 7 to bend so that the longitudinal axis of the footplate 6 aligns with the longitudinal axis of the needle 16. The suture 7 is inserted into the first aperture 19 of the needle 16, followed by the pusher 12 which is then gradually fed through the interior channel 5 of the needle 16.

[0112] As can be seen in FIG. 5A, the interior channel 5 is sized and shaped to receive both the thread 8 of the suture 7 and the pushing rod 12, side by side within the interior channel 5. The cross-sectional area of the interior channel 5 is sized to be spacious enough such that the pushing rod 12 and thread 8 can align without getting stuck, but tight enough that the pushing rod 12 is always situated behind the footplate 6 of the suture 7, and does not slip over the footplate 6.

[0113] As the pusher 12 pushes the suture 7 through the interior channel 5, the footplate 6 approaches the curved surface 14 which directs the footplate 6 out of the second aperture (side-hole) 18.

[0114] The step of the process where the footplate 6 of the T-bar suture 7 exits from the side-hole 18 is shown in FIG. 5B.

[0115] The pushing rod 12 is pushed through the needle 16 such that the tip of the pushing rod 12 (distal from the handling/feeding end 10) reaches the side-hole 18. The T-bar suture 7 is shown exiting the side-hole 18 at an angle to the longitudinal axis of the needle 16. The curved surface 14 results in smooth delivery of the suture 7, reducing the likelihood of the suture 7 snagging or stopping when the suture 7 is exiting the aperture 18.

[0116] Having the second aperture 18 at the side of the needle 16, in combination the curved surface 14, causes the T-bar suture 7 to be deployed into the soft tissue substantially perpendicular to the longitudinal axis of the needle 16. This is advantageous as the footplate 6 can be anchored better into the target tissue when the footplate 6 is angled such that the longitudinal axis of the footplate 6 is approximately perpendicular to the direction the thread 8 will be pulled. When the suture 7 is secured under tension, and the thread 8 is pulled, it is less likely to move around in or slip through the target tissue than other types of suture.

[0117] In FIG. 5B it can be seen that, owing to the topology of the apparatus 2, the suture 7 is deployed at a specified distance 4 from the pointed end 3.

[0118] The apparatus 2 could be used for a variety of procedures that may involve depositing a suture 7 into the soft tissue of an animal or human body. However, in a preferred embodiment, the apparatus 2 is used for the treatment of stress urinary incontinence in females. The procedure for treating stress urinary incontinence will 35 be described with reference to FIGS. 6, 7, 8, 9A, 9B, 10A, and 10B.

[0119] The procedure described is similar to laparoscopic colposuspension, however, the apparatus 2 enables the treatment to be completed more efficiently, using only local anaesthetic. The procedure described may be more minimally invasive and less morbid in comparison with existing treatments for SUI. It is envisaged that the procedure described will make treatment easier to perform such that a larger number of practitioners (including radiologists and surgeons), not essentially trained in laparoscopic surgeries, are able to perform minimally invasive SUI treatments.

[0120] FIGS. 6-10B show cross-sectional views of a human female pelvis in the transverse plane. The patient undergoing the treatment is lying down on their back. The view shown in FIGS. 6-10B is similar to what would be viewed by a practitioner from a screen displaying a real-time CT image. This procedure may be combined with fluoroscopic and CT facilities to help the practitioner guide the needle 16 to the correct part of the body.

[0121] In FIGS. 6-8 the urethra 20 and vaginal wall 22 are depicted schematically. The target tissue, in this case, is the periurethral tissue of the vaginal wall 22. FIGS. 6-8 show various steps of the procedure according to an embodiment of the invention.

[0122] FIG. 6 shows that the needle 16 has been inserted at an approximately 45 angle to the floor, directed at one side of the vaginal wall 22. In this example, the needle 16 is advanced under fluoroscopic imaging through the obturator foramen; however, other approaches may be used (e.g. inferior to the pubic bone or through the pubis symphysis).

[0123] Before the needle is inserted, a 6-8 French (1 French= mm) urinary catheter may be used to fill the bladder with a dilute contrast agent (then a concentrated contrast agent (3 ml)) to show the catheter tubing better under fluoroscopy. The practitioner may then manipulate the image intensifier with appropriate craniocaudal, right anterior oblique (RAO) and/or left anterior oblique (LAO) tilt, until a clear path can be seen (not overlaid by bony or vascular structures) and the catheter in the mid-urethra can be seen on a viewing screen. The practitioner then centres the display and may also use laser crosshairs to mark the incision/puncture area. The local anaesthetic would then be infiltrated in-line with the laser crosshairs with a spinal needle down to the vaginal wall 22 to the ipsilateral side of the urethra (not pictured). Ultrasound imaging may also be used during the procedure to ensure that important soft tissue structures such as blood vessels and nerves are not in line with the path of the needle.

[0124] To insert the needle 16 into the position shown in FIG. 6, a small skin incision is made at the desired puncture site. The skin incision is to be used for burying sutures at the end of the procedure. The flat disc surface at the feeding end of the needle 16 may be useful for allowing laser crosshairs to be seen clearly, which may help with the alignment of the central interior channel 19 perpendicular to the surface of the image intensifier (i.e. along the line of sight, so that the needle appears as just a dot on the image). The needle 16 is fed throughunder fluoroscopyuntil the pointed end 3 reaches the anterior wall of the vagina 22 adjacent to the urethra 20 and just below the bladder.

[0125] The needle 16 may pass through the obturator foramen to reach this position or via other approaches mentioned above. Digital vaginal examination may be performed synchronously to ensure that the vaginal wall is not traversed. The needle 16 should pass close to the periosteum where there is strong ligamentous tissue for suture 7 fixation. The target tissue (where the sutures are to be placed), in this procedure, is the periurethral anterior vaginal wall tissue.

[0126] FIG. 7 shows a variation to the procedure shown in FIG. 6, in which a solid object 24, in the form of a smooth plastic cylinder 24, which has been inserted into the patient's vagina. The pointed end 3 of the needle 16 is inserted into the tissue until it comes into contact with the solid object. Then, while the needle 16 is being pressed against the solid object 24, the T-bar suture 7 is deployed. This ensures that the suture 7 is placed accurately at the desired distance defined by the spacing 4 between the pointed end 3 and the second aperture 18. The presence of the solid object 24, also prevents the needle 16 traversing the vaginal wall 22.

[0127] The suture 7 is pushed down through the needle 16, with a pushing rod 12 pushing the suture 7 through the interior channel 5 of the needle 16 until the footplate 6 of the suture 7 exits the second aperture 18 and is retained in the periurethral anterior vaginal wall tissue, as illustrated in FIGS. 5A and 5B. One or more sutures 7 may be placed at a time on each side. The angle of deployment may be altered between sutures by rotating the body of the needle 16 (and hence the second aperture 18).

[0128] The needle 16 and pusher 12 are then removed, leaving the suture 7 in position in the tissue, and the process is repeated on the other side, with another suture 7 deployed in the vaginal wall 22, entering through the groin again but on the other side of the body. FIG. 8 shows the sutures 7 in place after the needle 16 and pusher 12 are removed. Only two T-bar sutures 7 have been placed into the vaginal wall 22 in this example, however, this process could be repeated a number of times.

[0129] Turning back to FIG. 4A, the feeding end of the needle 16 has arrow markings which indicate the side of the needle 16 having the second aperture 18, which is the side that the suture 7 will exit from. This may be helpful, for example, if the procedure involves depositing one suture 7 toward the head, and then rotating the needle 180 in situ before depositing another suture 7 toward the feet. This head-to-toe positioning would be preferable as it would lessen the likelihood of damaging the urethra 20. The arrow markings 17 allow the practitioner to know in which direction the suture 7 will be deployed, which is especially helpful when deploying two or more sutures 7 in succession.

[0130] FIGS. 9A-10B show two methods of securing the free end 8 of the suture 7 under tension, once it has been deployed as shown in FIGS. 6-8. This step of the process provides the urethra 20 with support, similarly to colposuspension, which may ameliorate the symptoms of SUI.

[0131] In FIG. 9A, a securing device (crimp) 26 is used to secure the threads 8 of both of the sutures 7. Here, in the trans-obturator approach, the sutures 7 are secured under tension in the same area in front of the pubis symphysis and held together by a shared crimp 26. The suture threads 8 are brought to the midline position using a tunnelling tool. The crimp 26 could be any material, but in this example the crimp is made of stainless steel.

[0132] An alternative approach of the needle would be inferior to the pubic bone (not pictured). This approach may require a shorter needle inserted at a narrower angle and helps to reduce the risk of injury to the femoral vessels/nerves.

[0133] In FIG. 9A, a common crimp 26 is used to secure the threads 8 of both of the sutures 7. The crimp 26 could be any material, but in this embodiment the crimp is made of stainless steel. The suture threads 8 are directed to the midline position using a tunnelling tool, and are brought out of the body through the same incision. FIG. 9B shows the crimp 26 in its final position. At this point the T-bar sutures 7 are secured around the pubic bone under tension, thus keeping the vaginal wall in place and providing support to the urethra 20.

[0134] FIGS. 10A and 10B show a variation of the superficial securing method shown in FIGS. 9A and 9B.

[0135] In FIG. 10A a first crimp 28 and a second crimp 28 are used to respectively secure each of the threads 8 of the sutures 7. Two crimps are needed for this method but they are likely to be the same type of crimp and may be identical to the crimp from FIGS. 9A and 9B, or made of a plug of absorbable material (e.g. collagen) that can only advance along the thread towards the T-bar and is restrained from slipping back in the opposite direction. The suture threads 8 are held in position by each crimp 28.

[0136] The same incision that was made for the needle is used for the crimps. In this case, tunnelling to the midline is not necessary. FIG. 10B shows the final position of the sutures according to the second method of superficially securing the sutures 7 under tension. Similarly to FIG. 9B, the sutures 7 are secured under tension, thus keeping the vaginal wall 22 in place and providing support to the urethra 20.

[0137] An absorbable material may be used for the footplate 6 of the suture. The formation of natural scar tissue related to suture absorption would then cause the urethra to be supported, having lasting positive effects after the footplate 6 is absorbed. To achieve this, the footplate 6 could be made from a bio-absorbable polymere.g. a 50:50 blend of lactide and glycolide polymers. Additionally, the crimp 26, 28 may be made from a bio-absorbable material. The treatment may involve a completely absorbable system, such that the SUI treatment does not leave permanent synthetic material behind in the body. If the suture 7 is entirely absorbable, scar tissue would form along the whole suture tract and effectively replace the whole system (T-bar, suture, crimp).

[0138] While the invention has been described in detail in connection with only a limited number of embodiments, it should be readily understood that the invention is not limited to such disclosed embodiments. Rather, the invention can be modified to incorporate any number of variations, alterations, substitutions or equivalent arrangements not heretofore described, but which are commensurate with the scope of the invention. Additionally, while various embodiments of the invention have been described, it is to be understood that aspects of the invention may include only some of the described embodiments. Accordingly, the invention is not to be seen as limited by the foregoing description, but is only limited by the scope of the appended claims.