WO2007023305A1

WO2007023305A1 - Speculum

Info

Publication number: WO2007023305A1
Application number: PCT/GB2006/003203
Authority: WO
Inventors: Mark Dagleish; Philip Steele
Original assignee: Moredun Research Institute
Priority date: 2005-08-26
Filing date: 2006-08-25
Publication date: 2007-03-01
Also published as: GB2443771A; GB0803985D0; GB0517610D0; GB2443771B

Abstract

The present invention relates to devices for insertion into body passages. In particular, the present invention provides a device for facilitating access to a surface or particular location of a body passage for the purposes of, for example, sampling or examining the tissue of the body passage.

Description

SPECULUM

FIELD OF THE INVENTION

The present invention relates to devices for insertion into body passages. In particular, the present invention provides a device for facilitating access to a surface of a body passage.

BACKGROUND OF THE INVENTION

Tissue biopsies or samples of substances such as blood, faeces, urine, saliva, mucus or the like, are often useful in facilitating the detection or diagnosis of disease. For example, samples or biopsies can be probed for the presence of particular micro- organisms, antibodies, nucleic acid sequences or evidence of disease.

Frequently, a sample or biopsy of a particular tissue type, structure or substance is required in order to carry out a diagnostic test. Obtaining such samples may require a minor surgical procedure, and, where the subject is an animal, a general anaesthetic may be required. In other cases, obtaining the appropriate sample can be a time consuming process requiring a number of trained personnel.

In addition to the above it is often important not to contaminate the sample during the collection process. Where samples are obtained from, for example the rectum, contamination either with faecal material or cells from other tissue types may occur rendering the sample useless. The increased incidence of new variant Creutzfeldt- Jakob Disease (vC JD) in humans has been linked to animal encephalopathies such as bovine spongiform Encephalopathy (BSE). As such the public awareness of other animal encephalopathies has increased and there is mounting pressure to remove diseased animals from the human food chain. Scrapie in sheep is possibly the most common of the spongiform encephalopathies both in the UK and throughout the world and, although not directly associated with the occurrence of vCJD, it is thought to play a role in the development of BSE.

As such there is a considerable drive to advance research into scrapie and one of the primary objectives is the development of a diagnostic/screening test capable of detecting infected animals prior to the development of clinical signs. Such a test would enable flocks of sheep to be screened to identify "scrapie-free" animals.

One possible basis for such a test is the identification of the disease associated marker PrP in experimentally and naturally infected sheep. This disease marker is detectable in a specific tissue located within the rectum of the sheep known as the recto-anal mucosal associated lymphoid tissue (RAMALT).

While the rectum of the sheep is relatively accessible, sampling of the correct area of RAMALT is vitally important. As described above, the equipment and personnel required to obtain suitable samples are often expensive and the process can be time consuming. It is among the objects of the present invention to provide a device that mitigates and/or obviates problems associated with the prior art.

It is a further object of the present invention to provide a device for facilitating the obtaining of a sample of RAMALT.

SUMMARY OF THE INVENTION According to a first aspect of the present invention there is provided, a device for facilitating access to a surface of a body passage, said device comprising: a member adapted for at least partial location within a body passage, said member defining a cavity, a wall of said member comprising an aperture for accessing a location within said body passage; wherein in use, said cavity and said aperture are accessed via an opening defined by the member.

In use, the device separates and/or supports the various surfaces comprising the body passage, and permits access to, or isolates, for the purpose of sampling, viewing, inspection, diagnosis and/or the execution of surgical procedures, a particular region or portion, of a surface of a body passage.

It is to be understood that the terms "sampling" or "sample" may be taken to mean, for example, a biopsy of a particular tissue type or structure, for example a tumour or polyp, or may be taken to mean a swab or scraping of either a tissue, a structure or a substance, for example, mucus, faeces, saliva, blood or the like.

Furthermore the term "body passage" may be taken to relate to internal body passages such as the rectum, colon or vagina. In addition "a surface of a body passage" may be taken to mean the surfaces, walls or linings comprising the body passage. For example the device of the present invention may be used to obtain samples of rectal or colonic tissue, or samples of the faecal contents or the mucus lining the mucosal membranes of such body passages.

Preferably, the member adapted to be at least partially located within a body passage comprises a leading end, a middle portion and a trailing end. Preferably the leading end and the middle portion are adapted to be located within a body passage while the trailing end is adapted to remain outside the body passage and may abut the opening to the body passage. It should be noted that the leading end and the middle portion of the member will, hereinafter, be referred to as the "insertion portion" of the device. Preferably, the insertion portion defines a longitudinal axis and in one embodiment, the insertion portion may define an elongate body having a main, longitudinal axis.

Advantageously, the insertion portion of the device may comprise an elongate body of any cross-section and in one embodiment, the insertion portion may have a uniform cross-sectional profile. Alternatively, the cross-sectional profile of the insertion portion may vary along the longitudinal axis of the insertion portion.

Advantageously, the insertion portion may be adapted so as to cause a body passage to expand in a particular manner or direction. Beneficially, and by way of example, a device for rectal insertion, may have a substantially circular or ovoid cross-section.

In use therefore, the insertion portion of the device may result in the uniform expansion of part of a body passage. Alternatively however, the insertion portion may result in the variable expansion of part of a body passage. Preferably, the leading end of the insertion portion is adapted to facilitate entry of the device into a body passage. Preferably also, and particularly when the device is being inserted, the leading end is adapted to affect the gradual separation of a surface or surfaces of the body passage. Advantageously, the leading end of the device may define a tapering protrusion. Advantageously therefore, and in one embodiment of the present invention, the cross-sectional area of the region of the leading end adjacent the middle portion of the member, may be greater than the cross-sectional area of the terminal portion of the leading end.

Advantageously, the leading end of the insertion portion may define, for example, a pyramidal, frusto-pyramidal, truncated pyramid, conical, frusto-conical or truncated-cone shape. Alternatively, the leading end of the insertion portion may define a segment or truncated segment of a sphere, for example a domed shape, truncated domed shape, hemisphere or truncated hemisphere.

Preferably, the leading end of the insertion portion defines a segment of a sphere, for example a hemisphere. Alternatively, the leading end of the device may comprise a protrusion emanating from an edge of the middle portion of the member and extending towards the central longitudinal axis of the elongate member.

In use, the leading end of the insertion portion may easily be guided into a body passage. Furthermore, as the insertion portion is introduced to the body passage, the leading end of the insertion portion affects the gradual separation of the surfaces comprising said passage. In this way, damage or trauma to the surfaces of a body passage is minimised as there is no sudden expansion of the body passage as the device is inserted. Furthermore, as a result of the gradual expansion of the body passage, the discomfort experienced by the animal or subject into which the device is inserted, is reduced.

The insertion portion of the device comprises the cavity. Advantageously, the cavity may extend substantially along all or part of the longitudinal axis of the insertion portion. Preferably, and in one embodiment of the present invention, the cavity extends substantially parallel to the longitudinal axis of the insertion portion and terminates short of the leading end of the insertion portion.

Preferably, a wall of the member defines an aperture longitudinally extending through part of the insertion portion of the device. Preferably, in use, the aperture defined by a wall of the member permits access to a surface of a body passage. In one embodiment, the aperture permits access to a specific portion, surface or part of a body passage. Advantageously a wall or walls of the member may define a plurality of apertures each permitting, in use, a particular surface or surfaces of a body passage to be isolated or accessed.

Advantageously, the aperture defined by a wall of the member may be positioned such that, in use, a particular tissue type, structure or substance within a body passage may be selectively accessed. For example a device for use in the rectal passage of ruminants may define an aperture in a wall of the member that, in use, isolates or permits access to a specific tissue, for example, the recto-anal mucosal associated lymphoid tissue (RAMALT).

Preferably, the member adapted to be at least partially inserted into a body passage of an organism, further comprises a trailing end. Preferably a portion of the trailing end is adapted to be located outside the body passage. Preferably also, the trailing end of the member further defines an opening permitting access to both the cavity defined by the insertion portion, and the aperture defined by a wall of the member. Advantageously, the device of the present invention may be formed from a metal, metal alloy, polymeric or reinforced composite material. For example the device may be formed from a metal such as titanium, surgical steel, stainless steel or aluminium or any other suitable metal. Alternatively, the device may be formed from a polymeric material such as a plastics material, for example polypropylene, polycarbonate or polyethylene or an elastomeric material such as rubber, latex rubber, silicone or the like. The device may also be formed from a reinforced composite material such as a fibre-reinforced composite, laminated composite, particulate composite or the like. Preferably, the device is formed from a resilient polymeric material, for example a plastics material. Preferably the features of the device are integrally formed such that the device comprises a single component which may considerably lower the cost of manufacturing the device. Alternatively however, it should be understood that certain features may be separately formed and subsequently added or joined by adhesive bonding, screwing, bolting, riveting, welding or the like.

Alternatively, the device of the present invention may be formed from a combination of the abovementioned materials. Beneficially, the device may comprise resilient portions, for example, the device may comprise a resilient insertion portion.

Additionally, or alternatively, the device may comprise rigid portions, for example the device may comprise a rigid insertion portion and/or a rigid leading end.

Advantageously the device may comprise a rigid material surrounded or substantially enveloped by a less rigid or resilient material. Furthermore the device may comprise a portion formed of a material of low friction, such as a silicone material, such that, it is easy to insert into a body passage. Preferably the leading end is formed of a low friction material.

In a preferred embodiment of the present invention, the device comprises a material or combination of materials such that the device is substantially resilient. Preferably therefore, the device comprises a resilient plastics material.

Preferably, the device comprises a material suitable for sterilisation either by heat (wet or dry), chemical or irradiation means.

Advantageously, the device may be recycled such that, once cleaned and sterilised, it may be re-used. Alternatively, the device may be a "use once" device such that, after use, the device is discarded.

Advantageously, the material or materials comprising the device may be coloured by some means, for example the addition of a dye or the use of a pre- coloured material such as a coloured plastic. For example, the device may comprise a material, the colour of which contrasts with the colour of the walls, surfaces, linings or tissues comprising the body passage. By way of example, the device may be yellow or green in colour such that, in use, the surface or surfaces of the body passage into which the device is inserted, may easily be distinguished from the device.

Preferably, once inserted into a body passage the device is retained within the body passage. Advantageously, the trailing portion of the device may be adapted to be located within a body passage. Alternatively, a portion of the trailing end of the device may be adapted to remain outside the body passage and a portion of the trailing portion may be adapted to be located inside the body passage. Such an arrangement may result in a device which is "self-retaining". By way of an example, were the device is to be inserted into, for example, the rectum, a device in which at least a portion of the trailing end is adapted to be located within the body passage, may be located within the rectum such that the sphincter muscle surrounding the opening of the rectum may contract around the trailing end of the device (or a portion thereof) causing it to be retained within the rectum until it is removed by the user. In one embodiment a part of the trailing end is cut away to permit a portion of the trailing end to be located inside the body passage. Preferably, a portion of the trailing end opposite the aperture through which a location in the body passage is accessed, is cut away. Advantageously, the cut away portion of the trailing end defines an area which, in use, is occupied by the tissues that comprise the body passage. Such an arrangement facilitates the retention of the device within the body passage. More particularly, once inserted, the tissues comprising, the body passage move to occupy the area defined by the cut away portion of the trailing end. The co-operation between the cut-away portion of the trailing end and the tissues of the body passage ensures the device is retained within the body passage.

In a second aspect of the present invention there is provided a device for facilitating access to the surface of a body passage, said device comprising: a member comprising an insertion portion adapted for location within a body passage, said insertion portion defining a cavity, a wall of said member defining an aperture for accessing said body passage; and a trailing end, a portion of which is adapted for location outside a body passage, said portion further comprising a means for facilitating user operation and/or control of the device.

Advantageously, the trailing end may define a means for allowing the device to be held, operated and/or controlled by a user. Said means may facilitate the ability of the user to operate and/or control the device, both before and after insertion into or location within a body passage. In instances where the subject is, for example lying in an awkward/incorrect position or moving, such means may permit the user to correctly orientate the device before insertion. In this way accidental damage to the body passage may be avoided. Furthermore if the device is incorrectly inserted, the provision of means facilitating user operation and/or control, may allow easy adjustment of the device to correctly orientate it within the body passage. Beneficially, the means for facilitating user operation and/or control of the device may comprise a handle, lug or other protrusion which extends from the trailing end of the device.

In one embodiment, the trailing end of the device may define a lug or handle.

Alternatively, the trailing end may define a plurality of lugs or handles. Preferably, the trailing end of the device defines two lugs or handles, and in one embodiment of the present invention, the lugs or handles may extend either side of the trailing end of the device.

The handles may extend from the trailing end in a plane lying perpendicular to the central longitudinal axis of the insertion portion. Advantageously, the lugs or handles may comprise a textured . or profiled surface to improve a user's grip on the device when in use. Furthermore, when wearing gloves or other protective wear, a profiled or textured surface would enhance the user's ability to "feel" and/or control the device.

The device may be dimensioned and configured so as to facilitate sampling of the RAMALT. For example, the aperture through which a user may access the RAMALT may be a particular size, shape or located in a specific position, such that when the device is inserted, only the RAMALT is exposed. Furthermore, when the device is inserted into the body passage, the lugs may be configured so as to abut the opening of the body passage and prevent further insertion of the device. Accordingly, the aperture for accessing the body passage may be positioned relative to the lugs such that, when the lugs abut the opening of the body passage, the RAMALT is exposed. Such an arrangement is advantageous as accurate sampling of the RAMALT could be achieved by merely inserting the device until the lugs abut the opening of the body passage and prevent further insertion. In one embodiment the aperture for accessing the body passage is positioned approximately about 20mm to about 55mm from the trailing end of the device. Preferably the aperture for accessing the body passage is positioned about 30mm to about 50mm from the trailing end and more preferably from about 40mm to about 45mm, from the trailing end of the device. Alternatively, the aperture for accessing the body passage may extend to about 20 to about 55mm from the trailing end of the device. Preferably, the aperture for sampling the body passage may extend to about 30mm to about 50mm and more preferably about 40mm to about 45mm from the trailing end.

Advantageously the portion of the trailing end adapted to be located outside the body passage, may lie in a plane perpendicular to the longitudinal axis of the insertion member.

Alternatively, the longitudinal axis of the insertion portion may be offset from said plane. Preferably, the longitudinal axis of the insertion portion is offset from the plane in which the portion of the trailing end adapted to remain outside the body

passage, lies, by about 1 ° to about 10°, preferably 2° to 8° more preferably 3° to 6°.

In use the plane in which the portion of the trailing end adapted to be located outside the body passage lies, is orientated such that it is substantially parallel to the outside surface of the body passage into which the device is to be inserted and, in this way, the insertion portion of the device enters, or is located within, the body passage such that the longitudinal axis of the insertion portion is offset from the longitudinal axis of the terminal portion of the rectum.

It is to be understood that the longitudinal axis of the "terminal portion of the rectum" of an organism, for example a four legged animal, is to be regarded as lying substantially parallel to the ground when the organism is stood normally. In the case of bipedal organisms for example, humans, the longitudinal axis of the terminal portion of the rectum may be regarded as substantially perpendicular to the ground when the organism is stood normally.

Preferably the lugs or handles of the device extend in a plane substantially parallel to the plane in which the portion of the trailing end adapted to be located outside the body passage, lies. In this way a user may easily ensure that the plane of the portion of the trailing end adapted to be located outside the body passage is substantially parallel to the outside surface of the body passage, by aligning the plane in which the handles or lugs extend, to be substantially parallel with said outside surface. Advantageously, the longitudinal axis of the insertion portion may be offset such that a surface of a body passage is caused to distend and/or expand more than an opposing surface. Thus, if, for example, the longitudinal axis of the insertion member is offset such that, in situ, the insertion portion points up towards the dorsal surface of the subject, the upper surface of the body passage may distend and/or expand by an amount greater than that of the lower surface. Conversely, if the longitudinal axis of the insertion member is offset such that, in situ, the insertion portion points down towards the ventral surface of the subject, the lower surface of the body passage may distend and/or expand by an amount greater than that of the upper surface. Alternatively, if the longitudinal axis of the insertion member is perpendicular to the plane in which the lugs or handles extend and or the plane in which the portion of the trailing end adapted to be located outside the body passage, lies, the surfaces, for example the upper surface and the lower surface, of the body passage may distend by an equal amount.

In use, and when the longitudinal axis of the insertion portion of the device is offset from the longitudinal axis of the body passage, access to a particular surface or structure may be greatly facilitated.

An arrangement, such as that described above, permits a larger portion of the aperture defined by a wall of the member to be visible through the opening defined by the trailing end of the device. As such, access to a surface of the body passage is greatly facilitated and specific tissue or structure types may easily be observed. In a third aspect of the present invention there is provided a method of obtaining a sample from a body passage, said method comprising the steps of; locating the device of the first aspect of the present invention in a body passage; and obtaining a sample of a tissue or other structure.

In a fourth aspect of the present invention there is provided a device for facilitating access to the recto-anal mucosal associated lymphoid tissue (RAMALT) of a ruminant, said device comprising; a member comprising an insertion portion, having a longitudinal axis, adapted to be located within the rectum of a ruminant; said insertion portion defining a cavity, a wall of said cavity defining an aperture for accessing the RAMALT of said ruminant; and a trailing end, a portion of which is adapted to be located outside the rectum of the ruminant, and further comprising at least one handle for facilitating user operation and/or control of the device;

Wherein, in use the cavity and aperture are accessed via an opening defined by the trailing end and at least one handle extends from the trailing end in a plane offset from the plane lying normal to a longitudinal axis of the insertion portion.

In a fifth aspect of the present invention, there is provided a kit for facilitating the retrieval of a sample from a body passage, said kit comprising; a device in accordance with the first aspect of the present invention and one or more of the following; advantageously the kit may further comprise an implement for obtaining a sample. For example, the kit may comprise a swab, scalpel, forceps, glass or plastic slide or other suitable implement for obtaining a sample. Advantageously the kit may comprise receptacles for storing samples of, for example, tissue.

Advantageously the kit may further comprise solutions for storing the sample such as osmotically balanced buffers, enzyme inhibitors such as protease inhibitors, DNase or RNase inhibitors to preserve cejl structure and/or prevent damage to proteins, nucleic acids and the like. Additionally, or alternatively, the kit may also comprise substances such as cryopreservants to prepare samples for long term cold storage and a lubricant or lubricants to assist the user with inserting the device into a body passage. Additionally or alternatively, the device may be provided in a sealed packet or other receptacle. In this way the device may be kept sterile before use and also may be pre-coated with a lubricant such that once the packet or receptacle containing the device has been opened, the device may immediately be inserted into the body passage.

In a sixth aspect of the present invention, there is provided a device for facilitating access to a surface of a body passage, substantially as described in the description and the drawings. BRIEF DESCRIPTION OF THE FIGURES

The present invention will now be further described with reference to the following figures which show: Figure 1 is an end view of the trailing end of a device in accordance with a preferred embodiment of the present invention.

Figure 2 is a longitudinal view of the underside of the device of figure 1.

Figure 3 is a side view of the device shown in Figures 1 and 2.

Figure 4 shows the device of Figures 1, 2 and 3 located within a body passage. Figure 5 is a longitudinal view of the underside of a device in accordance with a further embodiment of the present invention.

Figure 6 is a side view of the device shown in Figure 5.

Figure 7shows the device of Figures 5 and 6 located within a body passage. DETAILED DESCRIPTION

Figure 1 shows a device, generally designated 10, for facilitating access to a surface of a body passage, in accordance with one embodiment of the present invention. The device comprises a member 12 adapted to be at least partially located within a body passage and defines a cavity 14. A wall of the member 12, defines an aperture 16 for accessing a surface, wall or lining of said body passage. The cavity 14 and the aperture 16 defined by a wall of the member 12, are accessed, in use, by an opening 18. The embodiment shown in figure 1 further comprises means, 20, for facilitating user operation and/or control of the device. In the embodiment shown, the means 20, take the form of lugs 21a and 21b which extend wither side of the member 12.

Turning now to figure 2, the member 12 of the device 10, is more clearly shown to comprise a leading end 22, a middle portion 24 and a trailing end 26, a portion of which 26a, is, in use, located outside the body passage. The aperture 16, defined by a wall of the member 12, extends longitudinally through the wall of the member 12. When in use, the aperture 16 and the cavity 14 are accessed by the opening 18, defined by the trailing end 26 of the device 10.

Figure 3 shows a side view of the device 10 also shown in Figures 1 and 2. In this particular figure the means 20 for facilitating user operation and/or control of the device 10 extend from the trailing end 26, and in plane a - a' offset from the longitudinal axis b-b' of the member 12. Figure 4 shows the device 10 of Figures 1, 2 and 3 in use, and located within a body passage 28 of an animal. The body passage 28 comprises a wall or lining 30 which forms an upper, 30a and lower, 30b, surface of the body passage 28. In use, the member 12 is partly located within the body passage 28 such that a portion (26a) of the trailing end 26 is located outside the body passage 28. As such the means 20 for facilitating user operation and/or control of the device 10, are also located outside the body passage 28. The means 20 for facilitating user operation and/or control of the device 10 extend from the trailing end 26, and in a plane a-a' which is offset from the longitudinal axis b-b' of the member 12. As a result, in situ, the member 12 points up towards the dorsal surface of the subject causing the upper surface 30a of the body passage 28 to distend and/or expand by an amount greater than that of the lower surface 30b.

In this way the user, represented by the numeral 32 in this Figure, is able to see more of the aperture 16 through the opening 18 of the device 10. Consequently the user 32 may easily access the wall or lining 30 of the body passage 28.

Figures 5 and 6 show a device generally designated 40, in accordance with a further embodiment of the present invention. Features in common with those shown in Figures 1-4 have been designated the same reference numerals. As with the device shown in Figures 1-4, this particular embodiment also facilitates access to a surface of a body passage. The device of Figures 5 and 6, differs from that shown in Figures 1-4 by way of modifications made to the trailing end 26 and the means for user operation and/or control of the device 20 which in this embodiment take the form of lugs 21a and 21b. Specifically, a part of the trailing end 26 has been cut away such that a portion of the trailing end 26b may be located inside the body passage and a portion of the trailing end 26a may remain outside the body passage. In use, the cut away part of the trailing end 26 allows the sphincter muscles of the rectum to contract around a portion of the trailing end 26 to retain the device within the body passage. As stated above, the lugs 21a and 21b differ from those shown in Figures 1-4; the differences are best shown in Figure 6. Specifically, lugs 21a and 21b lie in a plane perpendicular to the central longitudinal axis (b-b') of the insertion member 12.

Figure 7 shows the device 40 of Figures 5 and 6, located within the body passage 28 also shown in Figure 4. The body passage 28 comprises a wall or lining 30 which forms an upper 30a and lower 30b surface of the body passage 28. In use, the member 12 is partly located in the body passage 28 such that a portion (26a) of the trailing end 26 is located outside the body passage 28. The lugs 21a and 21b of the device 40 extend from the portion of the trailing end 26 located outside the body passage and abut the entrance to the body passage 28a. A part (26b) of the trailing end 26 is cut away such that a portion of the trailing end 26 is located within the body passage 28. The void 27 defined by the cut-away part of the trailing end is occupied by a portion of the tissue comprising the body passage 28. The engagement of a portion of the tissue comprising the body passage 28 with the void 27 assists in retaining the device within the body passage.

Various modifications may be made to the foregoing within the scope of the present invention. For example, the means for user operation and/or control of the device may extend from the trailing end of the device in a plane which lies perpendicular to the longitudinal axis of the member.

Claims

Claims:

1. A device for facilitating access to a surface of a body passage, said device comprising: a member adapted for at least partial location within a body passage, said member defining a cavity, a wall of said member defining an aperture for accessing said body passage; wherein in use, said cavity and said aperture are accessed via an opening defined by the member

2. The device of claim 1 , wherein the member adapted to be at least partially located within a body passage comprises a leading end, a middle portion and a trailing end.

3. The device of claim 2, wherein the leading end and the middle portion are adapted to be located within a body passage while the trailing end is adapted to remain outside the body passage.

4. The device of claims 2-3, wherein the leading end of the device defines a tapering protrusion.

5. The device of claim 4, wherein the leading end of the device defines a segment of a sphere.

6. The device of claims 2-5, wherein the leading end and the middle portion define an insertion portion.

7. The device of claim 6, wherein the insertion portion defines an elongate body having a main, longitudinal axis.

8. The device of claim 7, wherein the insertion portion has a uniform cross- sectional profile.

9. The device of claim 7, wherein the cross-sectional profile of the insertion portion varies along the longitudinal axis.

10. The device of claims 7-9, wherein the cavity extends substantially along all or part of the longitudinal axis of the insertion portion.

11. The device of claims 6- 10, wherein a wall of the member defines an aperture longitudinally extending through part of the insertion portion of the device.

12. The device of claims 6-10, wherein a wall or walls of the member define a plurality of apertures

13. The device of claim 11 or 12, wherein the aperture or apertures defined by the wall or walls of the member permit(s) access to a surface of a body passage.

14. The device of claims 11, 12 or 13, wherein the aperture(s) are positioned such that, in use, a particular tissue type, structure or substance within a body passage may be selectively accessed

15. The device of claim 14, wherein the aperture(s) isolates or permits access to recto-anal mucosal associated lymphoid tissue (RAMALT).

16. The device of any preceding claim, wherein the trailing end is adapted to be located outside the body passage.

17. The device of claim 16, wherein the trailing end defines an opening permitting access to the cavity and the aperture or apertures defined by a wall or walls of the member.

18. The device of any preceding claim, wherein the device is manufactured from a metal, metal alloy, polymeric or reinforced composite material.

19. The device of claim 18, wherein the polymeric material is a plastics material or an elastomeric material.

20. The device of claim 18, wherein the device is manufactured from a combination of materials.

21. The device of claim 20, wherein the leading end is manufactured of a low friction material.

22. The device of any preceding claim, wherein the device is integrally formed.

23. The device of any preceding claim, wherein the device is coloured by some means. _ . . .

24. The device of claim 23, wherein the colour of the device contrasts with the colour of the walls, surfaces, linings or tissues comprising the body passage.

25. The device of any preceding claim, wherein once inserted into a body passage, the device is retained within the body passage.

26. The device of claim 25, wherein a portion of the trailing end is adapted to remain outside the body passage and a portion of the trailing portion is adapted to be located inside the body passage.

27. The device of claim 26, wherein a part of the trailing end is cut away to permit a portion of the trailing end to be located inside the body passage.

28. The device of claim 27, wherein the part of the trailing end that is cut away defines a void which, in use, is occupied by a portion of the tissues that comprise the body passage, such that the device is retained within the body passage.

29. The device of claim 26, wherein the portion of the trailing end adapted to be located outside the body passage, lies in a plane perpendicular to the longitudinal axis of the insertion member

30. The device of claim 28, wherein the longitudinal_. axis of the insertion portion is offset from the plane in which the portion of the trailing end adapted to remain outside the body passage, lies.

31. The device of claim 30, wherein the longitudinal axis of the insertion portion

is offset by about 1° to about 10°, preferably 2° to 8° more preferably 3° to 6°.

32. The device of claim 26, wherein the portion of the trailing end adapted for location outside a body passage, comprises a means for facilitating user operation and/or control of the device.

33. The device of claim 32, wherein said means comprises at least one handle, lug or other protrusion extending from the trailing end of the device.

34. The device of claim 33, wherein the at least one handle extends from the trailing end in a plane lying perpendicular to the central longitudinal axis of the insertion portion.

35. The device of claims 32 and 33, wherein said means comprises a textured or profiled surface to improve a user's grip on the device when in use.

36. The device of claim 33, wherein the at least one handle or lug extends in a plane substantially parallel to the plane in which the portion of the trailing end adapted to be located outside the body passage, lies.

37. A method of obtaining a sample from a body passage, said method comprising the steps of; locating the device of claim 1 in a body passage; and obtaining a sample of a tissue or other structure.

38. A device for facilitating access to the recto-anal mucosal associated lymphoid tissue (RAMALT) of a ruminant, said device comprising; a member comprising an insertion portion, having a longitudinal axis, adapted to be located within the rectum of a ruminant; said insertion portion defining a cavity, a wall of said cavity defining an aperture for accessing the RAMALT of said ruminant; and a trailing end, a portion of which is adapted to be located outside the rectum of the ruminant, and further comprising at least one handle for facilitating user operation and/or control of the device;

39. A kit for facilitating the retrieval of a sample from a body passage, said kit comprising; (i) a device according to claim 1 or 35 and one or more of the following; (ii) one or more implements for obtaining a sample or samples;

(iii) receptacles for storing the sample or samples;

(iv) solutions for storing the sample(s);

(v) cryopreservants to prepare samples for long term cold storage; and

(vi) a lubricant.

40. A device for facilitating access to a surface of a body passage, substantially as described in the description and the drawings.