WO2010048965A1

WO2010048965A1 - A sheat device for insertion in the anal canal of a body

Info

Publication number: WO2010048965A1
Application number: PCT/DK2009/050287
Authority: WO
Inventors: Søren HERN
Original assignee: Contura A/S
Priority date: 2008-10-31
Filing date: 2009-10-30
Publication date: 2010-05-06
Also published as: AR077161A1

Abstract

A sheath device (1) for insertion into an anal canal of a patient, the sheath device comprising an elongate tubular member (10) having a first longitudinal axis (A1) and comprising a distal end (11) and a proximal end (12); an internal guide (20) for guiding an obturator (220), said internal guide extending from an opening at said proximal end (12) to an opening at said distal end (11); a needle guide (30) for guiding a needle, the needle guide (30) extending at least partly along the tubular member (10); and - a coupling member (40) for attaching said tubular member (10) to an optic (120), said coupling member (40) having a second longitudinal axis (A2), the coupling member comprising a distally facing part (41); a proximal end (42); wherein said distally facing part (41) and said proximal end (12) of the tubular member (10) are adapted for attaching said coupling member (40) to said tubular member (10), the tubular member 10 being rotatable relative to the coupling member (40) when attached; and wherein said proximal end (42) is adapted for detachably attaching the coupling member (40) to an optic (120), the coupling member (40) and the optic (120) being in a locked state against rotation and displacement along longitudinal axis (A2) with respect to each other when attached.

Description

A SHEATH DEVICE FOR INSERTION IN THE ANAL CANAL OF A BODY

The present invention relates to a sheath device for insertion in the anal canal (canalis analis) for the purpose of examining and treating patients suffering from diseases therein. More specifically, the invention relates to a sheath device for use in treatment of patients suffering from anal incontinence by injection of a bulking agent for obtaining a restricted fecal/flatus passageway in the anal canal.

Background of the invention

Anal incontinence disease is a widespread medical problem for many people, and several kinds of medical and surgical treatment are developed and used for curing these people. For example different ways of anal sphincter surgical repair are used to improve the function of the sphincter, artificial anal sphincter devices can be implanted in the patient for preventing fecal/flatus leakage or a bulking agent can be injected into the tissue surrounding the anal canal for restricting the fecal passageway. The present invention is preferably used in connection with the latter method of injecting a bulking agent.

The outer layer of the anal canal is covered mostly with mucosal tissue. The mucosal tissue prevents a sufficient sterilisation of the area. Hence, there is an increased risk of infections when inserting or injecting any material through the anal mucosa. Therefore, surgeons today preferably inject a bulking agent from the outside/tissue side, and not via the anal canal in order to minimise the risk of injury and infections. However, it may be difficult to determine the exact position to place a bulk in the anal canal without ultrasound control, and such surgical procedure are complicated, comprehensive and usually requires that the patient is anaesthetised.

Furthermore, it is important for surgeons in medical practise, whether it is for the purpose of examination or for surgical procedures, to easily inspect and/or interact with the patient's organs and cavities in order to obtain the most successful and comfortable procedure for the patients, which is not the case with present methods. Devices cumbersome to handle or manipulate may result in unsuccessful surgical procedures, misdiagnoses and, particularly in the case where the patient is not anaesthetised, great discomfort to the patient.

There is a need in the art for a device which, when attached to an optical device, allows for manipulation of the primary working element, namely the elements contacting with the patient, e.g. a needle, whilst allowing other elements, e.g. a light source, typically connected to fixed units in the operating theatre, to remain immobile. This allows for the surgeon to simply manipulate the primary working element whilst at once being visually aware of the interaction between the element inserted into the patient and the patient's interior, and being free from concerning himself with other cumbersome but necessary attachments to the sheath device.

Object of the invention

An object of the present invention is to provide a device for use in treatment of the anal canal via anus.

It is a further object of the present invention to provide a device for use in treatment of the anal canal via anus, which minimises or even eliminates the risk of injuring the anal canal and in particular the rectum with the surgical instruments during examination and treatment.

It is a further object of the present invention to provide a device for use in treatment of the anal canal via anus, which eases the way of reaching the correct position to be treated.

It is a further object of the present invention to provide a less painful and faster method of examining and treating patients suffering from disorders in the anal canal.

It is a further object of the invention to provide a cost effective sheath device.

It is a further object of the present invention to provide an alternative to the prior art

Also, it may be seen as an object of the present invention to provide a sheath that solves the above mentioned problems of the prior art.

Summary of the invention

Thus, the above described object and several other objects are intended to be obtained in a first aspect of the invention by providing a sheath device for insertion into an anal canal of a patient, the sheath device comprising an elongate tubular member having a first longitudinal axis and comprising o a distal end and a proximal end; o an internal guide for guiding an obturator, said internal guide extending from an opening at said proximal end to an opening at said distal end; o a needle guide for guiding a needle, the needle guide extending at least partly along the tubular member; and

- a coupling member for attaching said tubular member to an optic, said coupling member having a second longitudinal axis, the coupling member comprising o a distally facing part; o a proximal end; wherein said distally facing part and said proximal end of the tubular member are adapted for attaching said coupling member to said tubular member, the tubular member being rotatable relative to the coupling member when attached; and wherein said proximal end is adapted for detachably attaching the coupling member to an optic, the coupling member and the optic being in a locked state against rotation and displacement along longitudinal axis with respect to each other when attached.

The invention is particularly, but not exclusively, advantageous for obtaining a sheath device that is suitable for an endoscopic device, such as a needle or cannula, which, when said sheath device is mounted onto any optical device, allows for the surgeon to examine or manipulate within an orifice of the body, whilst easily manipulating the endoscopic device. The sheath device allows for delivery by means of an agent to the target organ or tissue at variable positions whilst maintaining a fixed position of the optical device or fluid inlet/outlet device.

The sheath device allows anoscopic treatments to be conducted by a single person. No assistant is needed, since the tubular part may be rotated together with the cannula/needle using one hand and the optic/camera may be operated/kept in position using the other hand. Prior art anoscopes/rectoscopes have 30 cm long handles since these need to be secured to a fixed point such as an operating table or an assistant needs to be able to aid.

Advantageous embodiment are described in dependent claims 2-26.

These and other aspects of the invention will be apparent from and elucidated with reference to the embodiments described hereinafter.

Throughout this document the terms "comprising" or "comprises" do not exclude other possible elements or steps. Also, the mentioning of references such as "a" or "an" etc. should not be construed as excluding a plurality.

The term sheath device is used throughout the application. The sheath device according to the invention may advantageously be used in combination with an optic to form an anoscope, and also as a rectoscope. Anoscopes are usually rigid, approximately 5-8 cm in length by approximately 2 cm in diameter, and formed as a metal or plastic tube inserted per rectum to examine the anorectal mucosa. Rectoscopes are sometimes also referred to as proctoscopes, i.e. a speculum or tubular instrument with illumination in the form of a a light source/light guide, and for inspecting the rectum.

Brief description of the drawings The sheath device according to the invention will now be described in more detail with reference to the accompanying figures. The figures show one way of implementing the present invention and is not to be construed as being limiting to other possible embodiments falling within the scope of the attached claim set.

- Fig. 1, in a partially sectioned and partly exploded view, shows a sheath device according to an embodiment of the invention, and an optic;

Fig. 2A, in an exploded perspective view, shows parts of a tubular member of a sheath device according to another embodiment of the invention, and an obturator;

Fig. 2B and 2C show the sheath device and the obturator of Fig. 2A in an assemble state, and from a distal viewpoint and a proximal viewpoint, respectively;

Figs. 2D-2G shows the sheath device and obturator assembly of Figs. 2B and 2C in a front view (from distal viewpoint), a side view, a rear view (from proximal viewpoint) and a top view, respectively;

Fig. 3A, in a perspective view and from a distal viewpoint, shows a sheath device with a tubular member as in Figs. 2A-G with a coupling member and assembled with an optic.

Figure 3B, in an exploded perspective view, shows an inner and an outer part of a tubular member, and a coupling member of the sheath device of Fig. 3A;

- Fig. 3C , in a perspective view, shows the sheath device of Fig. 3B in an assembled state and with the coupling member attached to the tubular member;

Fig. 3D, in a perspective view, shows a sheath device assembled with an optic, as in Fig 3A, but from a proximal viewpoint.

Figs. 4A-C shows the assembled sheath device shown in Fig. 3C in a front view (distal viewpoint), a side view, and a rear view (proximal viewpoint), respectively; Figs. 5 A-C show the sheath device of Fig. 4 with an optic attached to the coupling member, and in a front view (distal viewpoint), a side view, and a rear view (proximal viewpoint), respectively;

- Fig. 6A shows a top view of a sheath device of Fig. 4

Fig. 6B shows a cross sectional view of the device in Fig. 6A, the cross section taken along, section B-B in Fig. 6A;

- Fig. 7A shows details of a snap connection between a proximal end of a tubular member and a distally facing part of a coupling member according to an embodiment of the invention;

Fig 7B shows a front view, i.e. from a distal viewpoint, of a coupling member of the sheath device in fig 7A;

Fig. 8 show a sheath device according to another aspect of the invention, an obturator inserted in a tubular member of the sheath device;

- Fig. 9 shows a tubular member of the sheath device, shown in Fig 8;

Fig.10 shows a coupling member of the sheath device coupled to an optic;

Fig.11 shows a tubular member and a coupling member of the sheath device in a separated state;

Fig 12 shows a tubular member a coupling member of the sheath device and an optic in an assembled state;

- Fig.13 shows a tubular member and an obturator of the sheath device in a separated state;

Fig. 14 shows a distal end of a tubular member of the sheath device in one embodiment; and

Fig. 15 shows a distal end of a tubular member of the sheath device in another embodiment.

Embodiments of the invention In Fig. 1 is shown one embodiment of a sheath device 1 according to the invention. The sheath device 1 is adapted for insertion into an anal canal of a patient. The sheath device 1 comprises a tubular member 10 and a coupling member 40. The tubular member 10 has an elongate shape and is preferably cylindrical. However, the tubular member 10 may in other embodiments have other elongate shapes. The tubular member 10 has a first longitudinal axis, Al, and comprises a distal end 11 that during use is inserted into a patient and a proximal end 12 opposite to the distal end 11 with respect to said axis, A2, that, during use, is intended to be external to the patient in order for a medical staff member to operate the sheath device.

An internal guide 20 is provided in the tubular member 10. The internal guide 20 is intended for guiding an obturator 220 e.g. as shown in Fig. 2. The internal guide 20 is also intended for receiving a lens part 130 of an optic 120, and protecting the lens part 130 from contact with body tissues of a patient during use of the sheath device 1, as described in further detail below, and e.g. as shown in Fig 3A. The internal guide extends from a proximal opening 12b at the proximal end 12 to a distal opening lib at said distal end 11.

Also formed in the tubular member 10 is a needle guide 30 in the form of a channel, the width or diameter of which is adapted for guiding a hollow needle needle/cannula (not shown). The needle guide 30 extends at least partly along the tubular member 10, between the distal end 11 and partly towards the proximal end 12 of the tubular member 10, e.g. such as is shown in the figures. It may however in other embodiments (not shown) extend all the way to the proximal end.

The coupling member 40 is adapted for attachment to said tubular member 10 when the obturator 220 is removed from the internal guide 20. The coupling member 40 is further adapted for attachment to an optic 120, such that the coupling member provides an intermediate part between the tubular member 10 and the optic 120.

The coupling member 40, as shown in the Figures is preferably an elongate, hollow member, preferably of cylindrical shape, and having a second longitudinal axis, A2. The coupling member 40 comprises a distally facing part 41 and a proximal end 42 opposite to the distally facing part 41 with respect to said axis, A2.

The distally facing part 41 and said proximal end 12 of the tubular member 10 are adapted for attaching said coupling member 40 to said tubular member 10, such that the tubular member 10 is rotatable relative to the coupling member 40 when the two are attached to each other. The proximal end 42 of the coupling member 40 is adapted for attaching the coupling member 40 to an optic 120, such that the coupling member 40 and the optic 120 are in a state, locked against rotation with respect to each other, when the two are attached . Preferably, proximal end 42 of the coupling member 40 is also adapted for attaching the 5 coupling member 40 to an optic 120, such that the coupling member 40 and the optic 120 are in a state locked against coaxial displacement along longitudinal axis, A2 with respect to each other, when the two are attached. The connection between the proximal end 42 of the coupling member 40 and the optic 120 is preferably of a nature such that the coupling member may be detached from the optic 120 after use. Thus the coupling member 40 is 10 preferably detachably attachable to the optic 120.

The connection provided between the tubular member 10 and the coupling member 40 is preferably such that the tubular member 10 is freely rotatable with respect to the coupling member 40, when the two are attached. The tubular member 10 and the coupling member

15 40 are formed such that the longitudinal axis, A2, of the coupling member 40 and the longitudinal axis, Al, of the tubular member 10 are coinciding upon attachment of coupling member 40 to tubular member 10, such that the tubular member 10 is rotatable with respect to the coupling member 40 about a common axis that is thus coaxial with Al and A2. Examples of such arrangements are described below in relation to Fig. 7. Thus, the

20 connection means provided between the two members 10, 40 must allow such rotation. Thus, only the cooperating connection means on the two parts may be cylindrical, and the cross sectional shape of the tubular member 10 and the coupling member 40 may be other than shape than circular, e.g. oval. However, in order to provide the least amount of discomfort for the patient during the insertion of the sheath device 1, at least the tubular

25 member is preferably of a generally circular or oval outer cross sectional shape.

As is shown in the figures, the needle guide 30 is separate or isolated from internal guide 20. Preferably, the needle guide is formed in a sidewall of the tubular member 10. The needle guide 30 has an outlet 31 that is arranged in a perimeter 15 of the distal end 11 30 opening lib of said tubular member 10.

The distal end 11 of the tubular member 10 of the sheath device 1 may, as shown in the figures, be skewed such that a perimeter 15 of the distal end 11 opening lib forms an angle different from perpendicular to said first longitudinal axis Al. Preferably, the distal 35 end 11 is skewed such that the distal most portion 11a of the tubular member 10 is provided generally where the above mentioned needle guide outlet 31 is situated. Thereby, and as may be appreciated from e.g. Fig. 3A, the outlet 31 and the needle/cannula tip (not shown) may be seen via the optic 120 when the optic is attached to the sheath device, such that the distalmost end 131 of a lens part 130 of the optic is positioned within the internal guide 20 of the tubular member.

In other embodiments (not shown), the distal end of the tubular member 10 of the sheath device 1 may be formed such that a perimeter 15 of the distal end 11 opening lib forms an angle essentially perpendicular to said first longitudinal axis Al.

The tubular member 10 may be provided with a mark formed at the distal end 11 of the tubular member 10 on an inner side of the member, such that the mark is visible from a position inside the tubular member 10, such as through an optic 120, when the optic 120 is attached to the sheath device 1. The mark may be a line painted on or otherwise provided, e.g. etched or notched, in the inner surface of the tubular member 10. However, preferably and as shown in the figures, the mark is formed as a notch 19 in a perimeter 15 of the distal end 11 opening lib of the tubular member 10. The outlet 31 of the needle guide 30 is preferably provided at said notch 19, and as shown in the figures, at the bottom - most proximal part of the notch 19. The notch 19 allows the mucosal tissue of the anal canal to drop into the notch. Thereby the tissue at the site where the injection is intended will be at the right position for the needle/cannula exiting the outlet 31 of the needle guide 30.

The tubular member 10 may, as shown in the figures, be provided with a skirt 16. The skirt 16 broaden towards the proximal end 12 of said tubular member 10, i.e. an outer wall or wall surface diverges from the axis A2 . The skirt 16 preferably extends around the entire perimeter of the tubular member towards the proximal end 12 of said tubular member 10. The skirt 16 allow for a spreading of the tissue external of the anal canal. Further, the skirt 16 allows for an easier manipulation (e.g. turning) of the tubular member, when inserted into a patient. Further, the skirt may serve as a stop, when inserting the tubular member in the anal opening of a patient.

However, in embodiment not shown, the skirt 16 may further be provided with a handle. Such a handle may be a tap or the like formed in laterally extension of and on the skirt. However, in the embodiment shown, a handle is preferably formed as one or more indentations 60, and preferably two opposite indentations 60, in said skirt 16.

An inlet 32 for the needle guide 30 may be formed at a proximally facing edge 16a of the skirt 16, and preferably the inlet 32 is formed between the outer surface of the proximal end 12 of the tubular member 10 and an inner or inwardly facing surface of the skirt 16. The inlet 32 for the needle guide 30 may advantageously be formed in an angle of 5-30°, such as 10-20° with respect to said fist longitudinal axis, Al, of the tubular member. Thereby, easier access to the needle guide 30is provided for the user of the sheath device 1 when the needle/cannula is to be inserted in the sheath device 1. Also, the angled 5 insertion allows for more space to handle an optic 120 at the proximal end the coupling member 40 when an optic 120 is attached.

The tubular member 10 has a portion 13 extending proximally beyond a proximally facing edge 16a of said skirt 16. The portion 13 is preferably provided such that the proximal end 10 12 of said tubular 10 member extends 1V2-6 cm, such as 2-5 cm, such as 3-4 cm proximally beyond the proximally facing edge 16a of said skirt 16.

A lens guide 43 is preferably formed in the coupling member 40 said lens guide 43 being adapted for receiving, guiding and supporting a distally extending lens part 130 of said

15 optic 120. The lens guide may in an embodiment (not shown) be a proper dimensioning (to cooperate with the outer surface of distally extending lens part 130) of an aperture formed in the proximal end 42 of the coupling member 40. However, as may be appreciated from Fig. 3B and Fig. 6B the lens guide 43 may additionally or optionally be formed in a distally protruding part 44 of the coupling member 40, the protruding part 44

20 extending distally relative to said distally facing part 41 of the coupling member 40. The lens guide 43 may provide support over the entire length of the guide, i.e. be provided as a channel through the protruding part 44, or it may as shown in the embodiment shown in Fig. 6B be provided as a narrowing at the distal end 46 of the channel constituting the guide 43.

25

The coupling member 40 is, in preferred embodiments, adapted to allow a positioning of a distally extending lens part 130 of an optic 120 centrally within said tubular member 10 with respect the inner walls of the tubular member 10 as seen in a cross section of the tubular member 10 perpendicular to said longitudinal axis, Al, when said tubular member

30 10 is connected to said coupling member 40. Thereby, the lens may be provided such that a medical staff person has a view of the internal side of the anal canal from a central position, and with the needle guide outlet 31 being positional by rotation of the tubular member 10 relative to this viewpoint, thus allowing precise injection of a bulking agent at a number of injection sites in the entire circumference of the anal canal.

35

As may be appreciated from Fig. 3A, the coupling member 40 and the tubular member 10 are preferably further adapted or dimensioned so as to allow a positioning of a distal end 131 of a distally extending lens part 130 of the optic 120 immediately proximal to the distal end 11 of the tubular member 10, when said tubular member 10 is connected to said coupling member 40. A length of the coupling member 40 and a length of the tubular member 10 are adapted to a length of a distally extending lens part 130 of the optic 120, such that distal end 131 of the lens part 130 is positioned 1-10 mm, such as 3-8 such as 5 mm proximal to a distalmost part 11a of the distal end 11 of the tubular member 10.

As shown in Figs. 2-6, the tubular member 10 of the sheath device 1 may be formed as an assembly of an inner part 10a and an outer part 10b. With such an assembly of the tubular member 10, the needle guide 30 may be formed between the inner and the outer part 10a, 10b. Preferably, the needle guide 30 may be formed with parallel lateral protrusions, at least partly along the inner or the outer part 10a, 10b. In other embodiments, cooperating parts on the inner and outer parts 10a, 10b, e.g. in the shape of elongate lateral protrusions and/or elongate grooves make up the channel providing the needle guide 30.

In embodiments where the tubular member 10 is provided in two parts 10a, 10b, as well as in embodiments where this is not the case, a funnel 35 may be provided at the inlet 32 of the needle guide 30 in order to allow guidance of the needle/cannula into the needle guide 30.

The skirt 16 may be formed integral with the outer part 10b. The notch 19 may be formed in the distalmost end of the outer part 10b.

The invention also concerns a sheath device 1 further comprising an obturator 210 mountable in said internal guide 20, when the coupling member 40 is detached from the tubular member 10. Preferably, the obturator 220 and the tubular member 10 are adapted to allow a distalmost end 221 of the obturator 220 to extend distally of said distal end 11 of said tubular member 10 to form a closed and generally smooth distal end of the sheath device 1. The distal end 11 of the tubular member 10 of the sheath device 1 is further formed such that it forms a generally smooth transition between the outer surface of the tubular member 10 and the outer surface of the tip 221 of the obturator 220, when the obturator is inserted in the tubular member 10.

In an embodiment, the connection between the tubular member 10 and the coupling member 40, is provided as a snap lock connection such that once the coupling member 40 is attached to the tubular member it cannot be removed, whereby re-use of the sheat device may be prevented. The snap lock connection may, as shown in Figs. 7A and B be provided by a rim 17 on the proximal end 12 of the tubular member 10 cooperating with a number of taps 47 on the distally facing part 41 of the coupling member 40. In embodiments, a flexibility in the taps 47 may be provided by a set of small openings 48 on the coupling member 40.

In another aspect of the invention and as shown in Figs. 8-15, the sheath device 1, may 5 comprise comprises a tubular member 10 and a coupling member 40. In this aspect of the invention, the coupling member 40 cooperates with an internal guide 20 of the tubular member 10. The tubular member 10 has an elongate shape and is preferably cylindrical. However, the tubular member 10 may in other embodiments have other elongate shapes. The tubular member 10 has a first longitudinal axis, Al, and comprises a distal end 11 that 10 during use is inserted into a patient and a proximal end 12 opposite to the distal end 11 with respect to said axis, A2, that, during use, is intended to be external to the patient in order for a medical staff member to operate the sheath device.

An internal guide 20 is provided in the tubular member 10. The internal guide 20 is 15 adapted for guiding an obturator 220. The internal guide 20 is also adapted for receiving coupling member 40. The internal guide 20 extends from a proximal opening 12b at the proximal end 12 to a distal opening lib at said distal end 11.

The coupling member 40 is adapted for receiving and guiding a lens part 130 of an optic 20 120, and protecting the lens part 130 from contact with body tissues of a patient during use of the sheath device 1, as described in further detail below.

Also formed in the tubular member 10 is at least one needle guide 30 in the form of a channel, the width or diameter of which is adapted for guiding a hollow needle

25 needle/cannula (not shown). The needle guide 30 extends at least partly along the tubular member 10, between the distal end 11 and partly towards the proximal end 12 of the tubular member 10. It may however, as in the embodiments shown, extend all the way to the proximal end 12 of the tubular member 10 to and through a tubular protrusion 36, the tubular protrusion 36 extending proximally from the tubular member 10.

30

In other embodiments, there is two, three, four or five, such needle guides formed in the tubular member 10.

The coupling member 40 is adapted for attachment to said tubular member 10, when the 35 obturator 220 is removed from the internal guide 20. The coupling member 40 is further adapted for attachment to an optic 120, such that the coupling member provides an intermediate part between the tubular member 10 and the optic 120. The coupling member 40, as shown in the Figures 8-15, is preferably an elongate, hollow member, and having a second longitudinal axis, A2. The coupling member 40 comprises a distal end 41' and a proximal end 42 opposite to the distal end 41 with respect to said axis, A2. 5

The outer surface 45 of the coupling member 40 and the internal guide 20 of the tubular member 10 are adapted for attaching said coupling member 40 to said tubular member 10, such that the tubular member 10 is prevented from rotation relative to the coupling member 40 when the two are attached to each other.

10

The proximal end 42 of the coupling member 40 is adapted for attaching the coupling member 40 to an optic 120, such that the coupling member 40 and the optic 120 are in a state, locked against against coaxial displacement along longitudinal axis, A2 with respect to each other, when the two are attached.

15

The proximal end 42 of the coupling member 40 may further be adapted for attaching the coupling member 40 to an optic 120, such that rotation between the coupling member 40 and the optic 120 is possible, when the two are attached. The connection between the proximal end 42 of the coupling member 40 and the optic 120

20 is preferably of a nature such that the coupling member may be detached from the optic 120 after use. Thus the coupling member 40 is preferably detachably attachable to the optic 120.

The connection provided between the coupling member 40 (and thereby the the tubular 25 member 10) and the optic 120 is preferably such that the coupling member 40 is freely rotatable with respect to the optic 120, when the two are attached.

The tubular member 10 and the coupling member 40 are formed such that the longitudinal axis, A2, of the coupling member 40 and the longitudinal axis, Al, of the tubular member 30 10 are coinciding upon attachment of coupling member 40 to tubular member 10

The connection means provided between the two members coupling member 40 and the optic 120 may be provided on a proximally extending tubular protrusion 49. Either the rotation may be provided in the connection with the optic 120. Or the connection with the 35 optic may be fixed against rotation, and the rotation may be provide between the protrusion 47 and the proximal end 42 of the coupling member 40.

The needle guide 30 is separate or isolated from internal guide 20. Preferably, the needle guide is formed in a sidewall of the tubular member 10. Preferably, the needle guide 30 is formed in a thickening of the material of the sidewall, such that an inwardly extending elongate bulge 37 is formed in the internal guide 20. The bulge or bulges 37 in the internal guide cooperated with grooves 225 on the outside of an obturator 220, when the obturator is attached, and with grooves 70 on the coupling member 40.

The needle guide 30 has an outlet 31 that is arranged in a perimeter 15 of the distal end 11 opening lib of said tubular member 10.

The distal end 11 of the tubular member 10 of the sheath device 1 may, as shown in the figures be slotted such that one or more slots 18 are provided in the distal end 41' of the tubular member 10. The slots 18 are separated from each other by leaves 75.The transition between slots and leaves is preferably smooth. The slots 18 are provided generally where the above mentioned needle guide outlet 31 are situated.

Thereby, and as may be appreciated from e.g. Fig. 10, the outlet 31 and the needle/cannula tip (not shown) or at least tissue that has dropped into the slot may be seen via the optic 120, when the optic is attached to the sheath device, such that the distal most end 131 of a lens part 130 of the optic is positioned within the internal guide 20 of the tubular member, and the sheath device 1 is inserted into the anal canal of a patient.

Further,tThe tubular member 10 may be provided with a mark formed at the distal end 11 of the tubular member 10 on an inner side of the member, such that the mark is visible from a position inside the tubular member 10, such as through an optic 120, when the optic 120 is attached to the sheath device 1. The mark may be a line painted on or otherwise provided, e.g. etched or notched, in the inner surface of the tubular member 10. However, in this aspect the slots 18 will provide means for orientation in themselves, and thus function as a mark.

The tubular member 10 may be provided with a skirt 16. The skirt 16 broaden towards the proximal end 12 of said tubular member 10, i.e. an outer wall or wall surface diverges from the axis A2 . The skirt 16 preferably extends around the entire perimeter of the tubular member towards the proximal end 12 of said tubular member 10. The skirt 16 allow for a spreading of the tissue external of the anal canal. Further, the skirt 16 allows for an easier manipulation (e.g. turning) of the tubular member 10, when inserted into a patient. Further, the skirt may serve as a stop, when inserting the tubular member in the anal opening of a patient. However, in embodiments not shown, the skirt 16 may further be provided with a handle. Such a handle may be a tap or the like formed in laterally extension of and on the skirt. However, in the embodiment shown, a handle is preferably formed as one or more indentations 60, and preferably two opposite indentations 60, in said skirt 16.

An inlet 32 for the needle guide 30 may be formed at a proximally facing edge 16a of the skirt 16. As in the first aspect of the invention, the inlet 32 may be formed between the outer surface of the proximal end 12 of the tubular member 10 and an inner or inwardly facing surface of the skirt 16. The inlet 32 for the needle guide 30 may in such embodiements advantageously be formed in an angle of 5-30°, such as 10-20° with respect to said fist longitudinal axis, Al, of the tubular member. Thereby, easier access to the needle guide 30is provided for the user of the sheath device 1 when the needle/cannula is to be inserted in the sheath device 1. Also, the angled insertion allows for more space to handle an optic 120 at the proximal end the coupling member 40 when an optic 120 is attached.

However, as shown in Figs. 8-15, the inlet 32 may alternatively be formed in protrusion 36.

A lens guide may be formed in the coupling member 40 said lens guide being adapted for receiving, guiding and supporting a distally extending lens part 130 of said optic 120. The lens guide may in an embodiment (not shown) be a proper dimensioning (to cooperate with the outer surface of distally extending lens part 130) of an aperture formed in the proximal end 42 of the coupling member 40.

The coupling member 40 is, in preferred embodiments, adapted to allow a positioning of a distally extending lens part 130 of an optic 120 centrally within said tubular member 10 with respect the inner walls of the tubular member 10 as seen in a cross section of the tubular member 10 perpendicular to said longitudinal axis, Al, A2 when said tubular member 10 is connected to said coupling member 40. Thereby, the lens may be provided such that a medical staff person has a view of the internal side of the anal canal from a central position, and with the needle guide outlet 31 being positional by rotation of the optic relative to this viewpoint, thus allowing precise injection of a bulking agent at a number of injection sites in the entire circumference of the anal canal. In embodiments where there are two or more needle guides the needle may be removed needle guides and inserted into another one between the individual injections of bulking material, and thus the rotation of the tubular member 10 may be limited or avoided.

As may be appreciated from Fig. 10, the coupling member 40 and the tubular member 10 are preferably further adapted or dimensioned so as to allow a positioning of a distal end 131 of a distally extending lens part 130 of the optic 120 immediately proximal to the distal end 11 of the tubular member 10, when said tubular member 10 is connected to said coupling member 40. A length of the coupling member 40 and a length of the tubular member 10 are adapted to a length of a distally extending lens part 130 of the optic 120, such that distal end 131 of the lens part 130 is positioned 1-10 mm, such as 3-8 such as 5 mm proximal to a bottom or most proximal part of the slot 18.

The skirt 16 may be formed integral with the tubular member 10 such that the skirt forms the proximal end 42 of the tubular member 10.

This aspect of the invention also concerns a sheath device 1 further comprising an obturator 210 mountable in said internal guide 20, when the coupling member 40 is detached from the tubular member 10. Preferably, the obturator 220 and the tubular member 10 are adapted to allow a distalmost end 221 of the obturator 220 to extend distally of said distal end 11 of said tubular member 10 to form a closed and generally smooth distal end of the sheath device 1. The distal end 11 of the tubular member 10 of the sheath device 1 is further formed such that it forms a generally smooth transition between the outer surface of the tubular member 10 and the outer surface of the tip 221 of the obturator 220, when the obturator is inserted in the tubular member 10.

In an embodiment, the connection between the tubular member 10 and the coupling member 40, is provided as a snap lock connection such that once the coupling member 40 is attached to the tubular member it cannot be removed, whereby re-use of the sheath device 1 may be prevented.

Either of the tubular member 10, the coupling member 40 and the obturator 220 may be formed in a plastic material, e.g. polycarbonate which will make the part appear clear (see through) or in polypropylene (unclear).

The sheath device 1 according to the above described aspects and embodiments of the invention may be used in the following way. The tubular member 10, with the obturator 220 attached in the internal guide 20, is introduced into a body cavity of a patient, such as the anal canal. When inserted, the obturator 220 is removed from the tubular member 10, which is left in the body cavity. Then, the coupling member 40 is attached to the tubular member 10 and the optic 110, or the coupling member is attached to the optic 110 and then to the tubular member 10. The optic 110 is preferably of a type having a light entrance 126 and an ocular 125 (or connection means to a camera/display system). Through the optic 110 a medically trained person may visually locate desirable injection sites for injecting a bulking agent. A hollow needle/cannula is then introduced via the needle guide 30 and inserted through the tissue in front of the needle guide outlet 131. When an injection has been made, the needle may be retracted slightly, and the tubular member may be turned to reposition the needle guide outlet 131 at the next desired injection site.

In embodiments where there are two or more needle guides the needle may be removed needle guides and inserted into another one between the individual injections of bulking material, and thus the rotation of the tubular member 10 may be limited or avoided.

Although the present invention has been described in connection with the specified aspects and embodiments, it should not be construed as being in any way limited to the presented examples. The scope of the present invention is set out by the accompanying claim set. The use of reference signs in the claims with respect to elements indicated in the figures shall also not be construed as limiting the scope of the invention. Furthermore, individual features mentioned in different claims, may possibly be advantageously combined, and the mentioning of these features in different claims does not exclude that a combination of features is not possible and advantageous.

Claims

1. A sheath device (1) for insertion into an anal canal of a patient, the sheath device comprising an elongate tubular member (10) having a first longitudinal axis (Al) and comprising o a distal end (11) and a proximal end (12); o an internal guide (20) for guiding at least an obturator (220), said internal guide extending from an opening at said proximal end (12) to an opening at said distal end (11); o a needle guide (30) for guiding a needle, the needle guide (30) extending at least partly along the tubular member (10); and

- a coupling member (40) for attaching said tubular member (10) to an optic (120), said coupling member (40) having a second longitudinal axis (A2), the coupling member comprising o a distally facing part (41); o a proximal end (42);

wherein said distally facing part (41) and said proximal end (12) of the tubular member

(10) are adapted for attaching said coupling member (40) to said tubular member (10), the tubular member (10) being rotatable relative to the coupling member (40) when attached; and

wherein said proximal end (42) is adapted for detachably attaching the coupling member (40) to an optic (120), the coupling member (40) and the optic (120) being in a locked state against rotation and displacement along longitudinal axis (A2) with respect to each other when attached.

2. A sheath device (1) according to claim 1, wherein the longitudinal axis (A2) of said coupling member (40) and the longitudinal axis (Al) of said tubular member (10) are coinciding upon attachment of coupling member (40) to tubular member (10), such that the tubular member (10) is rotatable with respect to the coupling member (40) about a common axis, coaxial with (Al) and (A2).

3. A sheath device (1) according to claim 1 or 2, wherein said needle guide (30) has an outlet (31) in a perimeter (15) of the distal end (11) opening of said tubular member (10).

4. A sheath device (1) according to any one of the preceding claims wherein the distal end

(11) of the tubular member is skewed such that a perimeter (15) of the distal end (11) opening forms an angle different from perpendicular to said first longitudinal axis (Al).

5. A sheath device (1) according to any one of the preceding claims wherein the tubular member (10), has a mark at the distal end (11), the mark being visible from a position inside the tubular member (10).

5

6. A sheath device (1) according to claim 5, wherein said mark is a notch (19) in a perimeter (15) of the distal end (11) opening of the tubular member (10).

7. A sheath device (1) according to claim 6, wherein said needle guide (30) has an outlet 10 (31) at said notch (19).

8. A sheath device (1) according to any one of the preceding claims wherein said tubular member (10) has a skirt (16), said skirt (16) diverging from the axis Al towards the proximal end (12) of said tubular member (10).

15

9. A sheath device (1) according to claim 8 wherein said skirt (16) comprises handle.

10. A sheath device (1) according to claim 9 wherein said handle is formed as one or more indentations (60) in said skirt (16).

20

11. A sheath device (1) according to any one of claims 8-10 having an inlet (32) for said needle guide (30) at a proximally facing edge (16a) of said skirt (16).

12. A sheath device (1) according to any one of claims 8-11, having an inlet (32) for said 25 needle guide (30) between said tubular member (10) and said skirt (16).

13. A sheath device (1) according to any one of the preceding claims wherein an inlet (32) for said needle guide (30) is formed in an angle of 5-30°, such as 10-20° with respect to said fist longitudinal axis (Al) of said tubular member (10).

30

14. A sheath device (1) according to any one of the claims 8-13, wherein the tubular member (10) has a portion (13) extending proximally beyond a proximally facing edge (16a) of said skirt (16).

35 15. A sheath device (1) according to claim 14, wherein the proximal end (12) of said tubular (10) member extends 1V2-6 cm, such as 2-5 cm, such as 3-4 cm proximally beyond the proximally facing edge (16a) of said skirt (16).

16. A sheath device (1) according to any one of the preceding claims, wherein a lens guide (43) is formed in the coupling member (40) said lens guide (43) being adapted for receiving, guiding and supporting a distally extending lens part (130) of said optic (120).

5 17. A sheath device (1) according to claim 16, wherein said lens guide (43) is formed in a protruding part (44) extending distally relative to said distally facing part (41) of the coupling member (40).

18. A sheath device (1) according to any one of the preceding claims, wherein the coupling 10 member (40) is adapted to allow a positioning of a distally extending lens part (130) of an optic (120) centrally within said tubular member (10) with respect to a cross section of the tubular member (10) perpendicular to said longitudinal axis (Al), when said tubular member (10) is connected to said coupling member (40).

15 19. A sheath device (1) according to any one of the preceding claims, wherein the coupling member (40) and the tubular member (10) are adapted to allow a positioning of a distal end (131) of a distally extending lens part (130) of the optic (120) immediately proximal to the distal end (11) of the tubular member (10), when said tubular member (10) is connected to said coupling member (40).

20

20. A sheath device (1) according to claim 19, wherein a length of the coupling member (40) and a length of the tubular member (10) are adapted to a length of a distally extending lens part (130) of the optic (120), such that distal end (131) of the lens part (130) is positioned 1-10 mm, such as 3-8 such as 5 mm proximal to a distalmost part

25 (Ha) of the distal end (11) of the tubular member (10).

21. A sheath device (1) according to any one of the preceding claims, wherein the tubular member (10) is formed as an assembly of an inner part (10a) and an outer part (10b).

30 22. A sheath device (1) according to claim 21, wherein the needle guide 30 is at least partly formed in a lateral protrusion (33) on the inner part (10a).

23. A sheath device (1) according to claim 21 or 22, wherein the skirt (16) is formed integral with the outer part (10b).

35

24. A sheath device (1) according to any one of claims 20-22 wherein the notch (19) is formed in the distalmost end of the outer part (10b).

25. A sheath device (1) according to any one of the preceding claims further comprising an obturator (220) mountable in said internal guide (20), when the coupling member (40) is detached from the tubular member (10).

5 26. A sheath device (1) according to claim 25, wherein the obturator (220) and the tubular member (10) is adapted to allow a distalmost end (221) of the obturator (220) to extend distally of said distal end (11) of said tubular member (10) to form a closed and generally smooth distal end of the sheath device (1).

10 27. A sheath device (1) for insertion into an anal canal of a patient, the sheath device comprising

- an elongate tubular member (10) having a first longitudinal axis (Al) and comprising o a distal end (11) and a proximal end (12);

15 o an internal guide (20) for guiding at least an obturator (220) and a coupling member (40), said internal guide extending from an opening at said proximal end (12) to an opening at said distal end (11); o a needle guide (30) for guiding a needle, the needle guide (30) extending at least partly along the tubular member (10); and

20 - a coupling member (40) for attaching said tubular member (10) to an optic (120), said coupling member (40) having a second longitudinal axis (A2), the coupling member comprising an external surface (45) o an external surface (45) o distal end (41'); and 25 o a proximal end (42);

wherein said external surface (45) and said internal guide (20) are adapted for attaching said coupling member (40) to said tubular member (10); and

30 wherein said proximal end (42) is adapted for detachably attaching the coupling member (40) to an optic (120).

28. A sheath device (1) for insertion into an anal canal of a patient, the sheath device comprising

35 - an elongate tubular member (10) having a first longitudinal axis (Al) and comprising o a distal end (11) and a proximal end (12); o an internal guide (20) for guiding at least an obturator (220) and a coupling member (40), said internal guide extending from an opening at said proximal end (12) to an opening at said distal end (11); o a needle guide (30) for guiding a needle, the needle guide (30) extending at least partly along the tubular member (10); and a coupling member (40) for attaching said tubular member (10) to an optic (120), said coupling member (40) having a second longitudinal axis (A2), the coupling member comprising an external surface (45)

wherein said coupling member (40) and said tubular member (10) are adapted for attaching to each other,

wherein a proximal end (42) of said coupling member (40) is further adapted for detachably attaching the coupling member (40) to an optic (120), and

wherein the distal end 11 of the tubular member (10) is provided with interchanging slots (18) and leaves (75).