Medical device accessory

Abstract

A cover for fitting over the distal end of a shaft of a medical device is provided. The cover comprises: a tubular body with a first end, a second end, inner and outer circumferential surfaces, a longitudinal axis and at least one outwardly extending projecting element; and a plurality of guide members pivotally attached to the second end of tubular body and movable between a first position in which the guide members converge towards the longitudinal axis in a direction from the second end of the tubular body towards the first end of the tubular body, and a second position in which the guide members are parallel to the longitudinal axis.

Description

[0001] MEDICAL DEVICE ACCESSORY

[0002] Field

[0003] The present disclosure relates to an accessory for use with a medical device, such as an endoscope.

[0004] Background

[0005] US 2019 / 0183328 A1 describes a cover for the shaft of a medical scoping device, in particular for fitting over the distal tip of an endoscope. The cover is a tubular member with proximal and distal ends and inner and outer circumferential surfaces. Axially extending ribs may be provided on the inner and outer circumferential surfaces. A plurality of projecting elements is provided on the outer surface of the cover which in use extend radially outwardly from the cover. These can pull back or flatten folds of body tissue to facilitate the inspection of a body cavity or carrying out other medical procedures with the medical scoping device. This type of cover is formed of a plastic material and forms a friction fit on the shaft of the medical device.

[0006] To improve efficiency, there is a need for accessories which are quick and easy for medical personnel to fit to a shaft of a medical device.

[0007] US 2018 / 0153380 A1 discloses, according to its abstract, an endoscopic sleeve which includes a tubular member from which extend spaced projecting elements.

[0008] Summary

[0009] The present disclosure provides a cover for fitting over the distal end of a shaft of a medical device. The cover comprising: a tubular body with a first end, a second end, inner and outer circumferential surfaces, a longitudinal axis and at least one outwardly extending projecting element; and a plurality of guide members pivotally attached to the second end of tubular body and movable between a first position in which the guide members converge towards the longitudinal axis in a direction from the second end of the tubular body towards the first end of the tubular body, and a second position in which the guide members are parallel to the longitudinal axis.

[0010] Each guide member may comprise an elongate body with a first end and a second end, and wherein each guide member is pivotally attached to the tubular body between the first

[0011] 15988255.JCP2.JCP2 end and the second end of the elongate body such that, in the first position, the first end of the elongate body projects inwardly of the tubular body and the second end of the elongate body projects outwardly of the tubular body.

[0012] The elongate body may taper from a central region towards the first end thereof and towards the second end thereof.

[0013] The tubular body may further comprise a plurality of recesses in the second end, and each recess receives the first end of a respective guide member in the second position.

[0014] The tubular body may further comprise a stiffening rib around the periphery of each recess.

[0015] In the second position, a radially inner surface of each guide member may be aligned with the inner circumferential surface of the tubular body.

[0016] In the second position, the radially inner surface of each guide member may be co-planar with the inner circumferential surface of the tubular body.

[0017] Each guide member may be pivotally attached to the second end of tubular body by a pair of flexible connecting pieces.

[0018] The guide members may be formed of a harder material than the rest of the cover.

[0019] The cover may further comprise a flexible tether connected between the first end of each guide member and the tubular body.

[0020] Each tether may be configured to extend straight between a respective guide member and the tubular body in the first position and to bend outwardly in the second position.

[0021] Each tether may be formed with weakened regions to facilitate bending.

[0022] Each guide member may be for centring the shaft relative to the tubular body.

[0023] A method for fitting the cover to the distal end of a shaft of a medical device is provided, with the guide members in the first position. The method comprises: bringing the distal end

[0024] 15988255.JCP2.JCP2 of a shaft of a medical device into contact with the guide members to centre the shaft relative to the tubular body; and inserting the shaft into the tubular body from the second end towards the first end thereby causing the guide members to pivot into the second position.

[0025] Brief Description of the Drawings

[0026] The present disclosure refers, by way of example only, to the accompanying drawings in which:

[0027] Figure 1 is a side view of one embodiment of accessory;

[0028] Figure 2 is a plan view of the accessory of Figure 1 ;

[0029] Figure 3 shows a cross section of the accessory of Figure 1 along the line AA; Figure 4 shows an enlarged detail view of area C of the accessory of Figure 1 ; Figures 5a and 5b show side views during insertion of a shaft into the accessory of Figure 1 ;

[0030] Figures 6 is a side view of a second embodiment of accessory;

[0031] Figure 7 is a plan view of the accessory of Figure 6;

[0032] Figure 8 shows a cross section of the accessory of Figure 7 along the line BB; Figure 9 shows an enlarged detail view of area D of the accessory of Figure 6; Figure 10 is a side view of a third embodiment of accessory;

[0033] Figure 11 is a plan view of the accessory of Figure 10;

[0034] Figure 12 shows a cross section along the line FF and an enlarged detail view of area J of the accessory of Figure 10;

[0035] Figure 13 shows an enlarged detail view of area G of the accessory of Figure 10;

[0036] Figures 14a and 14b show side views during insertion of a shaft into the accessory of Figure 10; and

[0037] Figure 15 shows a cross section of the accessory of Figure 10 along the line HH and an enlarged detail view of area I when a shaft is inserted.

[0038] Detailed Description

[0039] As shown in Figures 1 to 5, a first embodiment of an accessory 10 for a medical device comprises a cover for fitting over the distal end of a shaft 70 of the medical device. The cover comprises a tubular body 12 with first and second ends 14, 16, an outer circumferential surface 18, an inner circumferential surface 20 and a longitudinal axis 22. The tubular body 12 is open at its first and second ends 14, 16. The accessory 10 also comprises one or more projecting elements 24 projecting radially outwardly, as described further below. The accessory 10 further comprises a plurality of pivotable guide members 26, as also described below.

[0040] In use, the accessory 10 is fitted over the distal end of a shaft 70 of a medical device such as an endoscope, as shown in Figures 5a and 5b and described further below. The first end 14 is located at the distal-most end of the shaft 70. The second end 16 is located proximally on the shaft 70.

[0041] The accessory 10 is preferably formed from a flexible, resilient material, such as a plastic or other polymer. This material forms the exterior surface of the tubular body 12, including the outer and inner circumferential surfaces 18, 20. The flexible, resilient material protects the shaft 70 and may enhance the grip of the tubular body 12 on the shaft 70. The tubular body 12 may also be textured or shaped, for example with ribs on the outer and / or inner circumferential surfaces 18, 20. In this example, a plurality of axially extending ribs 28 are formed on the outer circumferential surface 18.

[0042] The annular projecting element 24 may be located at or near to the first end 14 and may comprise a plurality of arms projecting radially outwardly from the tubular body 12. The arms may be identical to each other and equally spaced around the tubular body 12, but other configurations are also possible. Connecting webs (not shown) may join adjacent arms to one another. Alternatively, the projecting element 24 may comprise an annular collar extending around the circumference of the tubular body 12.

[0043] In all embodiments, the projecting element 24 may be made a resilient polymer material, such as a silicone. The projecting element 24 therefore has some stiffness and is self- supporting so that it maintains its shape, while allowing some flexing as it contacts body tissue when in use.

[0044] The plurality of pivotable guide members 26 may be located at or near to the second end 16 of the tubular body 12. In this embodiment, four guide members 26 are provided, which are equally spaced about the circumference of the tubular body 12. However, fewer or more guide members 26 may be provided and the spacing between them may be varied.

[0045] Each guide member 26 comprises a generally cuboid elongate body, having a first end 30, and a second end 32, as best seen in Figure 3. Figure 3 shows the accessory 10 in side view, along with a cross section of the accessory 10 along the line AA. In a first position, each guide member 26 lies at an angle to the longitudinal axis 22, with the first end 30 projecting inwardly towards the longitudinal axis 22 and towards the first end 14 of the tubular body 12. In other words, the guide members 26 converge towards the longitudinal axis 22, in a direction from the second end 16 of the tubular body 12 towards the first end 14 of the tubular body 12.

[0046] Each guide member 26 is attached to the tubular body 12 by a pivot 34, which may be a central region of each guide member 26, between its first and second ends 30, 32. That is, each guide member 26 may be pivotably attached to the tubular body 12. In other words, each guide member 26 may be separate from the tubular body 12 and / or not integral / unitary therewith.

[0047] The pivot 34 allows each guide member 26 to move into a second position in which it lies substantially parallel to the longitudinal axis 22 as shown in Figure 5b. The tubular body 12 may be provided with a recess 36 (or gap) adjacent to each guide member 26 to receive the first end 30 of the guide member 26 when it moves into its second position. Thus, the first end 30 of the guide member 26 is lowermost (with respect to the orientation shown in Figure 1) and is directed towards the first end 14 of the tubular body 12, the second end 32 of the guide member 26 is uppermost and extends upwardly beyond the second end 16 of the tubular body 12. A radially inner surface 27 of each guide member 26 may be aligned with the inner circumferential surface 20 of the tubular body 12 when in the second position.

[0048] In this context, reference to the radially inner surface 27 of the guide member 26 being aligned with the inner circumferential surface 20 of the tubular body 12 can effectively mean that the two are substantially co-planar. In other words, the radially inner surface 27 of the guide member 26 may be spaced substantially the same distance from the longitudinal axis 22 as the inner circumferential surface 20. Particularly, this may be true for a mid-point of the inner surface 27 of the guide member 26 in a circumferential direction of the tubular body 12. This could be compared to a point on the inner circumferential surface 20 at the same circumferential position, but offset in the longitudinal direction from the guide member 26. It is appreciated that the inner surface 27 of the guide member 26 may be straight (or curve at a different diameter to the tubular body 12), and hence may vary slightly from this strict definition where the tubular body 12 curves.

[0049] In other words, in the second position the guide members 26 may not substantially extend radially inwardly of the inner circumferential surface 20.

[0050] The tubular body 12 may have an enlarged rim 38 around the second end 16 as shown in Figure 4. Figure 4 shows the section C of the accessory 10 in detail, for example this detail may be at a scale of 2:1 . The pivot 34 may comprise a narrow connecting piece 40 joining each side of each guide member 26 to an adjacent section of the rim 38 across the mouth of the recess 36. The connecting pieces 40 are sufficiently thin and flexible that they allow the guide member 26 to pivot. The tubular body 12, guide members 26, rim 38 and connecting pieces 40 may all be integrally formed in one piece and configured such that in a relaxed, non-twisted state of the connecting pieces 40, each guide member 26 assumes the first, angled position. However, the various components may be separate and assembled together. When the guide members 26 move to the second position, the connecting pieces 40 are twisted and in tension. Thus, the connecting pieces 40 tend to bias the guide members 26 back towards the first position.

[0051] In use, the guide members 26 are initially in the first, angled position. A shaft 70 of a medical device may be inserted into the tubular body 12 from the second end 16 as shown in Figures 5a and 5b. The distal end of the shaft 70 is brought into contact with the radially inner surfaces 27 of the guide members 26. The guide members 26 therefore act as guides to centre the shaft 70 relative to the tubular body 12. This facilitates smooth insertion of the shaft 70 and prevents the shaft 70 from pressing down more on one side of the tubular body 12 and distorting it. As the shaft 70 is moved further into the tubular body 12, it pushes against the guide members 26, causing them to pivot into the second position as shown in Figure 5b so that they lie adjacent to the outer surface of the shaft 70, parallel to the longitudinal axis 22. Thus, the guide members 26 may help to grip the shaft 70 and assume a low profile against the shaft 70 so that they do not impede subsequent functioning of the shaft 70 and accessory 10.

[0052] The shaft 70 is normally inserted until its distal end is level with the first end 14 of the tubular body 12. In this state, the accessory 10 grips the shaft 70 and is ready for use. The medical device may then be inserted into a patient’s body. Normally when examining the colon, for example, the shaft 70 of the medical device is advanced relatively quickly to the furthest point requiring examination and then gradually withdrawn more slowly, with most of the visual examination carried out during the withdrawal. As the shaft 70 is gradually withdrawn, the projecting elements 24 act to gently pull back and flatten folds of tissue, to allow a clearer view of and access to the body tissues. At the end of the procedure the shaft 70 is completely withdrawn from the patient’s body. The accessory 10 can then be removed from the shaft 70 and disposed of.

[0053] As noted above, the accessory 10 may be formed from a flexible, resilient material, such as a plastic or other polymer. The hardness of the material may be between 50 and 100 Shore A. The entire accessory 10 may be formed from the same material, or a combination of different materials. For example, the guide members 26 may be formed from a material which is slightly harder than the rest of the accessory 10, to better guide the centring and insertion of the shaft 70.

[0054] A second embodiment of accessory 10 is shown in Figures 6 to 9. Figure 8 shows the second embodiment of the accessory 10 in side view, along with a cross section of the second embodiment of the accessory 10 along the line BB. Figure 9 shows the section D of the second embodiment of the accessory 10 in detail, for example this detail may be at a scale of 2:1 . The features of the second embodiment are generally the same as those of the first embodiment and therefore like reference numerals are shown. However, the pivot 34 has a different configuration. In this case, the rim 38 around the second end 16 of the tubular body 12 is substantially continuous and merges into the guide members 26 so that there are no narrower connecting pieces 40 as in the first embodiment. The dimensions of the rim 38 are chosen such that, in the region across the mouth of the recess 36, it is weaker and more flexible than the guide members 26 and it is therefore able to twist and act as a pivot for the guide members 26 as described above.

[0055] A third embodiment of accessory 10 is shown in Figures 10 to 15. Again, the features of the third embodiment are generally the same as those of the first embodiment and like reference numerals are used. However, there are certain differences in the configuration of the guide members 26 and pivot 34. As mentioned above, in the previous embodiments the guide members 26 are a substantially cuboid shape. In the third embodiment, the outward facing side 42 of each guide member 26 is convex so that a middle portion of the guide member 26, where it joins the pivot 34, is thicker and the guide member 26 tapers towards the first and second ends 30, 32. This strengthens the guide member 26 in the region of the pivot 34 but also provides a smooth outward profile when in use on a shaft 70.

[0056] The tubular body 12 may be provided with a stiffening rib 44 which is generally Y-shaped. The rib 44 comprises an axially extending stem 46 below each recess 36, and a pair of arms 48 which extend either side of each recess 36. Each pivot 34 comprises a thin wall portion 50 extending across the mouth of the recess 36, between one arm 48 and side of the adjacent guide member 26. The dimensions of the thin wall portion 50 are chosen such that it is weaker and more flexible than the guide members 26 and is able to pivot and twist, allowing pivoting of the guide member 26 as described above.

[0057] In addition, a flexible tether 52 is provided between the first end 30 of the guide member 26 and the tubular body 12. Figure 12 shows the third embodiment of the accessory 10 in side view, along with a cross section of the third embodiment of the accessory 10 along the line FF. Figure 12 also shows the section J of the third embodiment of the accessory 10 in detail, for example this detail may be at a scale of 2:1 . As shown in Figure 12, in the first position when the guide member 26 is angled relative to the longitudinal axis 22 of the tubular body 12, the tether 52 is pulled out straight. This limits how far the guide member 26 is able to pivot and prevents the second end 32 of the guide member 26 moving any further away from the longitudinal axis 22. As the guide member 26 pivots to the second position, the tether 52 is configured to bend outwardly and becomes folded-up between the guide member 26 and the tubular body 12 as shown in Figure 15. The tether 52 may be provided with one or more weakened portions in order to facilitate it bending into the desired configuration. The tether 52 thus prevents the guide member 26 from pivoting the wrong way during insertion of the shaft 70.

[0058] Figure 13 shows the section G of the third embodiment of the accessory 10 in detail, for example this detail may be at a scale of 2:1 .

[0059] Figure 15 shows the third embodiment of the accessory 10 in side view, along with a cross section of the third embodiment of the accessory 10 along the line HH. Figure 12 also shows the section I of the third embodiment of the accessory 10 in detail, for example this detail may be at a scale of 2:1 For both the second and third embodiments, the process of centring and inserting the shaft 70 is the same as described above with respect to the first embodiment. The guide members 26 are initially in the first, angled position and act as guides to centre the shaft 70 as it is brought into contact with them. As the shaft 70 is inserted, the guide members 26 pivot into the second position and lie adjacent to the outer surface of the shaft 70, parallel to the longitudinal axis 22.

[0060] It will be appreciated that the features of the various embodiments may be combined and interchanged as required. For example, the convex outward facing surface 42 on the guide members 26, the Y-shaped rib 44 and / or the tether 52, could also be provided in the accessories of the first and second embodiments. Similarly, the narrow connecting pieces 40 of the first embodiment, could also be provided in the second and third embodiments and so on.

[0061] Thus, the present disclosure provides an improved accessory 10 for the shaft 70 of a medical device. The accessory 10 simplifies smooth insertion of the shaft 70 into the tubular body 12, to increase efficiency during use.

[0062] As noted above, in this disclosure the term “medical device” may refer to an endoscope, but this term is also intended to refer to any device suitable for insertion into a biological cavity or lumen in order to carry out visualisation thereof and / or treatment. Accordingly, the term “medical device” is intended to encompass any or all of endoscopes, gastroscopes, colonoscopes, enteroscopes, sigmoidoscopes, panendoscopes, but this list is non- exhaustive. Endoscopy involves inspecting the inside of a body lumen or cavity and includes procedures known as arthroscopy, cystoscopy, gastroscopy, uteroscopy and colonoscopy. Enteroscopy involves examination of the small intestine including the duodenum, jejunum and ileum. Such devices are elongate flexible probes which may be inserted into the body directly or via a cannula or other guide device. Medical devices can also include rigid surgical endoscopes or endotherapy devices such as biopsy forceps and polypectomy snares. The cover of the present disclosure may be used in conjunction with all of the aforementioned types of medical device.

Claims

CLAIMS:1 . A cover for fitting over the distal end of a shaft of a medical device, the cover comprising: a tubular body with a first end, a second end, inner and outer circumferential surfaces, a longitudinal axis and at least one outwardly extending projecting element; and a plurality of guide members pivotally attached to the second end of tubular body and movable between a first position in which the guide members converge towards the longitudinal axis in a direction from the second end of the tubular body towards the first end of the tubular body, and a second position in which the guide members are parallel to the longitudinal axis.

2. The cover as claimed in claim 1 , wherein each guide member comprises an elongate body with a first end and a second end, and wherein each guide member is pivotally attached to the tubular body between the first end and the second end of the elongate body such that, in the first position, the first end of the elongate body projects inwardly of the tubular body and the second end of the elongate body projects outwardly of the tubular body.

3. The cover as claimed in claim 2, wherein the elongate body tapers from a central region towards the first end thereof and towards the second end thereof.

4. The cover as claimed in claim 2 or claim 3, wherein the tubular body further comprises a plurality of recesses in the second end, and each recess receives the first end of a respective guide member in the second position.

5. The cover as claimed in claim 4, wherein the tubular body further comprises a stiffening rib around the periphery of each recess.

6. The cover as claimed in any preceding claim, wherein in the second position, a radially inner surface of each guide member is aligned with the inner circumferential surface of the tubular body.

7. The cover as claimed in claim 6, wherein in the second position, the radially inner surface of each guide member is co-planar with the inner circumferential surface of the tubular body.

8. The cover as claimed in any preceding claim, wherein each guide member is pivotally attached to the second end of tubular body by a pair of flexible connecting pieces.

9. The cover as claimed in any preceding claim, wherein the guide members are formed of a harder material than the rest of the cover.

10. The cover as claimed in any preceding claim, further comprising a flexible tether connected between the first end of each guide member and the tubular body.11 . The cover as claimed in claim 10, wherein each tether is configured to extend straight between a respective guide member and the tubular body in the first position and to bend outwardly in the second position.

12. The cover as claimed in claim 11 , wherein each tether is formed with weakened regions to facilitate bending.

13. The cover as claimed in any preceding claim, wherein each guide member is for centring the shaft relative to the tubular body.

14. A method for fitting a cover as claimed in any preceding claim to the distal end of a shaft of a medical device, wherein, with the guide members in the first position, the method comprises: bringing the distal end of a shaft of a medical device into contact with the guide members to centre the shaft relative to the tubular body; and inserting the shaft into the tubular body from the second end towards the first end thereby causing the guide members to pivot into the second position.

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