GB2561843A

GB2561843A - An improved catheter assembly

Info

Publication number: GB2561843A
Application number: GB1706473.4A
Authority: GB
Inventors: Mclellan Steven
Original assignee: OPTIMUM MEDICAL SOLUTIONS Ltd
Current assignee: OPTIMUM MEDICAL SOLUTIONS Ltd
Priority date: 2017-04-24
Filing date: 2017-04-24
Publication date: 2018-10-31
Anticipated expiration: 2037-04-24
Also published as: GB201706473D0; GB2561843B

Abstract

A catheter assembly 10 comprising a main body 100 having a first opening 110, a second opening 120 and a cavity 130 defined therebetween configured to receive a lubricant 140. A catheter tube 220 extends through the first opening 110, the cavity 130 and the second opening 120. A seal 160 configured to fluidly seal the second opening 120 when the catheter tube 220 is extended through the second opening 120. The main body comprises one or more alignment portions 170 configured to radially constrain the catheter tube 220 when it is received by the cavity 130. The alignment portions 170 extend radially inwardly from an internal surface of the main body 100. The assembly may also comprise a catheter grip 210 which may fluidly seal the first opening 110. The alignment portions 170 may be discontinuous along the axial length of the cavity 130. The lubricant 140 may comprise a gel. A container 300 may hermetically seal at least a portion of the catheter tube 220. The container 300 may be flexible and may comprise a foil. The seal 160 may comprise a flexible or elastomeric material.

Description

(54) Title of the Invention: An improved catheter assembly Abstract Title: An Improved Catheter Assembly (57) A catheter assembly 10 comprising a main body 100 having a first opening 110, a second opening 120 and a cavity 130 defined therebetween configured to receive a lubricant 140. A catheter tube 220 extends through the first opening 110, the cavity 130 and the second opening 120. A seal 160 configured to fluidly seal the second opening 120 when the catheter tube 220 is extended through the second opening 120. The main body comprises one or more alignment portions 170 configured to radially constrain the catheter tube 220 when it is received by the cavity 130. The alignment portions 170 extend radially inwardly from an internal surface of the main body 100. The assembly may also comprise a catheter grip 210 which may fluidly seal the first opening 110. The alignment portions 170 may be discontinuous along the axial length of the cavity 130. The lubricant 140 may comprise a gel. A container 300 may hermetically seal at least a portion of the catheter tube 220. The container 300 may be flexible and may comprise a foil. The seal 160 may comprise a flexible or elastomeric material.

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An Improved Catheter Assembly [0001] This invention relates to an improved catheter assembly. Particularly, this invention relates to a catheter assembly comprising means for providing an improved distribution of lubricant around a catheter tube upon removal from the catheter assembly.

BACKGROUND [0002] Intermittent self-catheterisation (ISC) is used to treat bladders that do not empty fully. ISC involves the insertion of a catheter directly into the bladder via the urethra, and is a procedure which a user can do at home. Complete bladder emptying prevents residues or urine remaining and will reduce the amount of times a person needs to urinate. This not only protects the bladder but also reduces the risk of leakage, urinary tract infections and other complications. ISC catheters are typically disposable and the procedure can be repeated multiple times a day with a new ISC catheter.

[0003] Certain prior art ISC catheters may be lubricated before use to facilitate insertion of the catheter and improve the comfort for the user. It is known to provide a catheter assembly that applies lubricant to the catheter as the catheter is removed from a sterile package. Commonly, however, in many known devices, the lubricant may be applied unevenly around the catheter. Consequently, the catheter may have areas which not sufficiently lubricated and this may cause discomfort when inserting the catheter, or render the catheter less effective.

[0004] It is an object of certain embodiments of the present invention to address certain disadvantages associated with the prior art.

BRIEF SUMMARY OF THE DISCLOSURE [0005] In accordance with the present invention there is provided a catheter assembly comprising a main body having a first opening, a second opening and a cavity defined therebetween configured to receive a lubricant; a catheter tube extending through the first opening, the cavity and the second opening; and a seal configured to fluidly seal the second opening when the catheter tube is extended through the second opening. The main body comprises one or more alignment portions configured to radially constrain the catheter tube when the catheter tube is received by the cavity, and wherein the alignment portions extend radially inwardly from an internal surface of the main body.

[0006] In certain embodiments, the catheter assembly may comprise a catheter grip connected to the catheter tube. The catheter grip may be configured to selectively fluidly seal the first opening.

[0007] In certain embodiments, each of the one or more alignment portions may extend along at least a portion of the axial length of the cavity of the main body. Each of the one or more alignment portions may be discontinuous along the axial length of the cavity of the main body.

[0008] In certain embodiments, each of the one or more alignment portions may extend from the first opening towards the second opening.

[0009] In certain embodiments, the catheter assembly may comprise at least two alignment portions. For example, the catheter assembly may comprise three alignment portions. The alignment portions may be equally circumferentially spaced about an internal surface of the main body.

[0010] In certain embodiments, each of the one or more alignment portions may extend the same distance radially inwardly.

[0011] In certain embodiments, the catheter assembly may comprise a lubricant sealingly contained within the cavity when the catheter tube is received through the second opening and the first opening is sealed by the catheter grip. The lubricant may comprise a lubricating gel.

[0012] In certain embodiments, the catheter assembly may comprise a container configured to hermetically seal at least a portion of the catheter tube. The main body may be attached to the container, such that the container at least partially encloses the main body and the catheter extends from the main body to within the hermetically sealed container. The container may comprise a flexible material. For example, the container may comprise a foil material.

[0013] In certain embodiments, the seal may comprise a flexible material. For example, the seal may comprise an elastomeric material.

[0014] In an embodiment of the present invention, there is provided a main body having a first opening, a second opening and a cavity defined therebetween to receive a lubricant. The main body comprises one or more alignment portions configured to radially constrain a catheter tube when the catheter tube is received by the cavity, wherein the alignment portions extend radially inwardly from an internal surface of the main body.

BRIEF DESCRIPTION OF THE DRAWINGS [0015] Embodiments of the invention are further described hereinafter with reference to the accompanying drawings, in which:

Figure 1 shows a schematic sectional view of a catheter assembly in accordance with an embodiment of the present invention;

Figure 2 shows a schematic sectional view of a main body of the catheter assembly of Figure 1; and

Figure 3 shows a schematic top view of a first opening of the main body of Figure 2.

DETAILED DESCRIPTION [0016] A catheter assembly 10 in accordance with an embodiment of the present invention is shown schematically in Figure 1. The schematic shown in Figure 1 is a sectional view ofthe catheter assembly 10. The catheter assembly 10 includes a main body 100 having a central axis 101, and a catheter 200. The catheter assembly 10 is shown in an assembled configuration wherein the catheter 200 is received by and connected to the main body 100, and a longitudinal axis of the catheter 200 is co-axial with the central axis 101 of the main body 100.

[0017] The main body 100 includes a first opening 110, a second opening 120, and a cavity 130 defined therebetween. Adjacent the first opening 110 is a connecting portion 150 of the main body 100 configured to connect with the catheter 200. The cavity 130 contains a lubricant 140 for improving the usability of the catheter 200 once the catheter 200 is removed from the main body 100 and inserted into a user. In one embodiment, the lubricant 140 comprises a lubricating gel. In other embodiments, the lubricant may comprise any liquid or gel suitable for lubricating a catheter.

[0018] The catheter 200 includes a catheter grip 210 and a catheter tube 220, wherein the catheter grip 210 is attached to the catheter tube 220. The catheter tube 220 includes an open end 221 and two openings 223 towards an end opposite the open end 221.The catheter grip 210 is fluidly connected to the catheter tube 220 so that when the catheter tube 220 is inserted into a bladder, fluid may pass through the openings 223 of the catheter tube 220, through the catheter tube 220, through the open end 221 of the catheter tube 220, and through the catheter grip 210. The catheter grip 210 has a funnel-shaped end to aid in directing expelled fluid from a bladder into a basin or container to be disposed of.

[0019] The catheter tube 220 is received by the main body 100 such that the catheter tube 220 extends through the first opening 110, the cavity 130 and the second opening 120 of the main body 100. When the catheter assembly 10 is in the assembled configuration, a portion 222 of the catheter tube 220 extends out of the second opening 120 and away from the main body 100.

[0020] The catheter grip 210 is configured to connect to the connecting portion 150 ofthe main body 100 to fluidly seal the first opening 110 of the main body 100 in the assembled configuration. When the catheter grip 210 fluidly seals the first opening 110, the lubricant 140 contained within the cavity 130 is substantially prevented from exiting the cavity 130 through the first opening 110.

[0021] In other embodiments, the first opening 110 of the main body 100 may be sealed by means other than the catheter grip 210. For example, the catheter assembly 10 may comprise a removable seal configured to seal the first opening.

[0022] In the embodiment shown in Figures 1 to 3, the catheter grip 220 may be screwed into a thread of the connecting portion 150 of the main body. In certain embodiments, the catheter grip 210 may connect to the connecting portion 150 by an interference fit, a threaded fit or any other suitable means of securing the catheter grip 210 relative to the connecting portion 150.

[0023] The first opening 110 and the second opening 120 are each configured to be of a greater diameter than the catheter tube 220, so that the catheter tube 220 may pass through the first opening 110 and/or the second opening 120 without colliding with walls of either the first opening 110 or the second opening 120.

[0024] The catheter assembly 10 includes a seal 160 configured to effectively reduce the diameter of the second opening 120 to one that is smaller than the diameter of the catheter tube 220. In the embodiment shown in Figure 1, the seal 160 seals around the outside of the main body 100 adjacent the second opening 120. The seal 160 comprises a flexible material so that, when the seal 160 is positioned adjacent the second opening 120 and the catheter tube 220 extends through the second opening 120, the seal 160 deforms around the catheter tube 220 to fluidly seal against the catheter tube 220. In one embodiment, the seal 160 comprises an elastomeric material. In other embodiments, the seal 160 may comprise any suitable material which may deform around the catheter tube 220 to fluidly seal the second opening 120, e.g. silicon or rubber. When the catheter tube 220 extends through the second opening 120, and the seal 160 is positioned adjacent the second opening 120, the lubricant 140 contained within the cavity 130 is substantially prevented from exiting the cavity 130 through the second opening 120.

[0025] Thus, when the catheter grip 210 is connected to the connecting portion 150 of the main body 100, the catheter tube 220 extends through the first opening 110 and the second opening 120, and the seal 160 is positioned adjacent the second opening 120, the lubricant 140 is fluidly sealed within the cavity 130 between the first opening 110 and the second opening 120. As such, the portion 222 of the catheter tube 220 extending out from the second opening 120 away from the main body 100 is not exposed to the lubricant 140, and a portion

224 of the catheter tube 220 within the cavity 130 of the main body 100 is in contact with the lubricant 140.

[0026] The catheter assembly 10 may include a bag (not shown) configured to hermetically seal around the catheter tube 220 when the catheter tube 220 is received by the main body 100. The bag may be vacuum or heat sealed around a portion of the main body 100 so that when the catheter tube 220 extends through the first opening 110 and the second opening 120, the portion 222 of the catheter tube 220 extending out of the second opening 120 is sealed within the bag. The advantage of hermetically sealing the catheter tube 220 is that the catheter tube 220 remains sterile until it is removed from the main body 100 for use. This reduces the risk of contamination of the catheter tube 220 during transportation or handling of the catheter assembly 10 prior to use. The bag may comprise a foil material. In other embodiments, the bag may comprise a plastics material.

[0027] Indeed, in other embodiments, the catheter tube 220 may be kept sterile by any suitable means so long as the catheter tube 220 remains sterile before use. For example, the catheter tube 220 may be encased in a container other than a bag, or the entire catheter assembly 10 may be sealed in a bag or another container. The bag or other container may comprise flexible and/or rigid materials (e.g. foil). In the arrangement shown in Figure 1, the catheter tube 220 is encased by a tubular container 300.

[0028] In Figure 1, the catheter assembly 10 is shown in an assembled pre-use configuration. The method of assembling the catheter assembly 10 is described below. Firstly, the catheter grip 210 is attached to the catheter tube 220 to form the catheter 200. The catheter 200 is inserted into the main body 100 so that the catheter tube 220 extends through the first opening 110, the cavity 130 and the second opening 120, and the portion 222 of the catheter tube 220 extends out of the second opening 120 away from the main body 100. A cover (not shown) may be fitted over the catheter grip 210. The catheter grip 210 is connected to the main body 100 to fluidly seal the first opening 110 of the main body 100. The subassembly is then positioned so that the second opening 120 is facing substantially vertically upwards. The cavity 130 of the main body 100 is filled with lubricant 140 by a filling device (not shown), wherein the catheter grip 210 prevents the lubricant 140 from exiting via the first opening 110. Once the cavity 130 contains a sufficient volume of lubricant 140, the filling device is removed from the cavity 130. The seal 160 is positioned over the portion 222 of the catheter tube 220 and then slid down the catheter tube 220 and fixed to the main body 100 so as to form a fluid seal around the second opening 120, and thus fluidly seal the lubricant 140 within the cavity 130. The sub-assembly may then be positioned within the tubular container 300 (or other container, e.g. a bag). In embodiments in which the container is a bag, the bag may be vacuum or heat sealed to the main body 100 to hermetically seal the catheter tube 220 within the bag. In certain embodiments, the bag may also be enclosed around the catheter grip 210.

[0029] In the assembled pre-use configuration, the catheter assembly 10 is ready for a user to disconnect the catheter grip 210 from the connecting portion 150 of the main body 100, and subsequently remove the catheter tube 220 from the main body 100. In use, removal of the catheter tube 220 through the main body results in the portion 222 of the catheter tube 220 passing through the second opening 120, the cavity 130, and the first opening 110 of the main body 100. As such, when lubricant 140 is contained within the cavity 130, the portion 222 of the catheter tube 220 passes through the volume of lubricant 140 as the catheter 200 is removed from the main body 100. In doing so, the portion 222 of the catheter tube 220 becomes lubricated and is consequently ready for insertion into the user’s bladder.

[0030] In certain embodiments, the catheter grip 210 may be connected to the catheter tube 220 by any suitable means so long as removal of the catheter grip 210 causes removal of the catheter tube 220, and the catheter grip 210 is fluidly connected to the catheter tube 220. For example, the catheter grip 210 and the catheter tube 220 may be formed monolithically.

[0031] Figure 2 is a schematic sectional view of the main body 100 of the catheter assembly 10. The main body 100 comprises alignment portions 170 configured to control the amount and distribution of the lubricant 140 that is applied to the catheter tube 220 as it is withdrawn from the main body 100. The alignment portions 170 may be in the form of axial ribs as shown in the illustrated embodiment. The alignment portions 170 radially constrain the catheter tube 220 when the catheter tube 220 is axially aligned with the alignment portions 170. In the embodiment shown in the Figures, the main body 100 comprises a first alignment portion 170a, a second alignment portion 170b and a third alignment portion 170c. In the illustrated embodiment, the alignment portions 170 are proximate the first opening 110.

[0032] Figure 3 is a schematic top view of the first opening 110 of the main body 100. In Figure 3, it is clearly shown that the three alignment portions 170a, 170b, 170c are equally spaced about a circumference of an internal surface of the main body 100. Thus, in a circumferential direction, the separation between the first alignment portion 170a and the second alignment portion 170b is 120deg, the separation between the second alignment portion 170b and the third alignment portion 170c is 120deg, and the separation between the third alignment portion 170c and the first alignment portion 170a is 120deg.

[0033] Each alignment portion 170a, 170b, 170c extends the same distance radially inwardly from the internal surface of the main body 100 so as to extend within the cavity 130. As such, in a position within the cavity 130 where one or more of the alignment portions 170a, 170b,

170c is located, the effective diameter of the cavity 130 at that position is reduced. The effective diameter determined by the alignment portions 170a, 170b, 170c is greater than or equal to the diameter of the catheter tube 220. As such, the possibility that the alignment portions 170a, 170b, 170c constrict the catheter tube 220 is reduced. The effective diameter of the alignment portions 170 may be less than or substantially equal to the diameter of any of the first opening 110, the cavity 130 and the second opening 120.

[0034] In certain embodiments, each alignment portion 170a, 170b, 170c extends the same distance along the axial direction 101 ofthe main body 100 relative to others ofthe alignment portions 170. The alignment portions 170 are discontinuous along the axial length ofthe cavity 130 of the main body 100 to permit areas of the cavity 130 where the catheter tube 220 may be exposed to the lubricant 140 without circumferential obstruction from the alignment portions 170. In the embodiment shown in Figures 1 to 3, the alignment portions 170a, 170b, 170c extend from near the first opening 110 towards the second opening 120. Thus, there is an axial separation between the alignment portions 170 and the first opening 110 which effectively determines a first volume 131 of lubricant 140. There is an axial separation between the alignment portions 170 and the second opening 120 which effectively determines a second volume 132 of lubricant 140. Therefore, upon removal of the catheter tube 220 from the main body 100, the initially unlubricated portion 222 of the catheter tube 220 may pass through the second volume 132 and the first volume 131 respectively before and after moving axially past the alignment portions 170, permitting application of lubricant 140 from the cavity 130 uninterrupted by the alignment portions 170.

[0035] Each alignment portion 170a, 170b, 170c is configured to contact a relatively small portion of the circumference of the outer surface of the catheter tube 220 when the catheter tube 220 is received between the alignment portions 170. Consequently, the risk that the alignment portions 170 may prevent a significant amount of lubricant 140 from being applied to the catheter tube 220 as it is removed from the main body 100 is advantageously reduced.

[0036] During removal of the catheter tube 220 from the main body 100, it is desired that the force used to remove the catheter tube 220 is in alignment with the axis 101 of the main body 100 to ensure that the catheter tube 220 does not collide with any wall of the cavity 130, the first opening 110 or the second opening 120, which may result in an uneven coating of lubricant 140.

[0037] In the present invention, when the catheter tube 220 is axially aligned with the alignment portions 170, the alignment portions 170 radially constrain the catheter tube 220 so that the catheter tube 220 is substantially centred along the axis 101 of the main body 100. Thus, upon removal of the catheter tube 220 from the main body 100, the outer surface of the catheter tube 220 is substantially equidistant from the inner surface of the first opening 110.

As a consequence of the catheter tube 220 exiting the first opening 110 centred along the axis of the main body 100, the risk that the catheter tube 220 may scrape against the first opening 110 due to a deviation in removal angle relative to the central axis 101 is advantageously reduced.

[0038] Indeed, a deviation in the angle at which the catheter tube 220 is removed from the main body 100 may result in the catheter tube 220 bending about one or more of the alignment portions 170. Effectively, the alignment portions 170 may act as a fulcrum for the catheter tube 220, rather than the first opening 110 acting as a fulcrum in prior art packages.

In such a situation, the circumferential extent of the alignment portions 170 about the catheter tube 220 is low enough to avoid a significant amount of lubricant 140 being removed from the catheter tube 220 even if the catheter tube 220 were to scrape along the alignment portions 170 due to a deviation in removal angle relative to the axis 101 of the main body 100.

[0039] As the alignment portions 170 are configured to remove little or no lubricant 140 from the catheter tube 220 as it is removed, the catheter tube 220 may advantageously be removed from the main body 100 at an inclined angle relative to the central axis 101 of the main body 100 whilst maintaining an even distribution of lubricant 140 about the outer surface of the catheter tube 220.

[0040] As such, a deviation in the direction of removal force relative to the axis of the main body 100 may have little or no negative effect on the amount and distribution of lubricant 140 coated onto the catheter tube 220. Advantageously, this may improve the usability, comfort and reliability of the catheter assembly 10 when compared to prior art catheter packages.

[0041] In certain embodiments, there may be one, two, or more than three alignment portions, so long as the alignment portions radially constrain the catheter tube to centre the catheter tube along the axis of the main body.

[0042] In certain embodiments, there may be one or more sets of alignment portions in series along the axial length of the main body. Axial gaps may be present between each set of alignment portions so as to provide a space for lubricant to be contained within the cavity unobstructed by the alignment portions.

[0043] In certain embodiments, the alignment portions may extend at least partially helically around the internal surface of the main body. Preferably, the alignment portions cause the removal of little or substantially no lubricant from the catheter tube upon removal of the catheter tube from the main body.

[0044] In certain embodiments, the alignment portions may not be equally spaced around the internal circumference of the main body.

[0045] In certain embodiments, the alignment portions may extend to one or both of the first opening and the second opening.

[0046] In certain embodiments, each alignment portion may have a different axial extent along the main body relative to another of the alignment portions, so long as the alignment portions may axially centre the catheter tube.

[0047] In certain embodiments, each alignment portion may have a different circumferential extent around the circumference of the cavity of the main body.

[0048] In certain embodiments, each alignment portion may contact a different circumferential extent about the circumference of the catheter tube relative to another of the adjacent portions, when the catheter tube is adjacent to the alignment portions.

[0049] In certain embodiments, one or more alignment portions may have a different radial extent to another of the one or more alignment portions, so long as the alignment portions may axially centre the catheter tube.

[0050] Throughout the description and claims of this specification, the words “comprise” and “contain” and variations of them mean “including but not limited to”, and they are not intended to (and do not) exclude other moieties, additives, components, integers or steps. Throughout the description and claims of this specification, the singular encompasses the plural unless the context otherwise requires. In particular, where the indefinite article is used, the specification is to be understood as contemplating plurality as well as singularity, unless the context requires otherwise.

[0051] Features, integers, characteristics, compounds, chemical moieties or groups described in conjunction with a particular aspect, embodiment or example ofthe invention are to be understood to be applicable to any other aspect, embodiment or example described herein unless incompatible therewith. All of the features disclosed in this specification (including any accompanying claims, abstract and drawings), and/or all of the steps of any method or process so disclosed, may be combined in any combination, except combinations where at least some of such features and/or steps are mutually exclusive. The invention is not restricted to the details of any foregoing embodiments. The invention extends to any novel one, or any novel combination, ofthe features disclosed in this specification (including any accompanying claims, abstract and drawings), or to any novel one, or any novel combination, of the steps of any method or process so disclosed.

[0052] The reader's attention is directed to all papers and documents which are filed concurrently with or previous to this specification in connection with this application and which are open to public inspection with this specification, and the contents of all such papers and documents are incorporated herein by reference.

Claims

1. A catheter assembly, comprising:

a main body having a first opening, a second opening and a cavity defined therebetween configured to receive a lubricant;

a catheter tube extending through the first opening, the cavity and the second opening; and a seal configured to fluidly seal the second opening when the catheter tube is extended through the second opening;

wherein the main body comprises one or more alignment portions configured to radially constrain the catheter tube when the catheter tube is received by the cavity, and wherein the alignment portions extend radially inwardly from an internal surface of the main body.

2. A catheter assembly according to claim 1, further comprising a catheter grip connected to the catheter tube.

3. A catheter assembly according to claim 2, wherein the catheter grip is configured to selectively fluidly seal the first opening.

4. A catheter assembly according to any preceding claim, wherein each of the one or more alignment portions extend along at least a portion of the axial length of the cavity of the main body.

5. A catheter assembly according to claim 4, wherein each of the one or more alignment portions is discontinuous along the axial length of the cavity of the main body.

6. A catheter assembly according to any preceding claim, wherein each of the one or more alignment portions extends from the first opening towards the second opening.

7. A catheter assembly according to any preceding claim, wherein the one or more alignment portions comprises at least two alignment portions.

8. A catheter assembly according to any preceding claim, wherein the one or more alignment portions comprises three alignment portions.

9. A catheter assembly according to claims 7 or 8, wherein the alignment portions are equally circumferentially spaced about an internal surface of the main body.

10. A catheter assembly according to any preceding claim, wherein each of the one or more alignment portions extends the same distance radially inwardly.

11. A catheter assembly according to any preceding claim, further comprising a lubricant sealingly contained within the cavity when the catheter tube is received through the second opening.

12. A catheter assembly according to claim 11, when dependent on claim 2, wherein the first opening is sealed by the catheter grip.

13. A catheter assembly according to claim 11, wherein the lubricant comprises a lubricating gel.

14. A catheter assembly according to any preceding claim, further comprising a container configured to hermetically seal at least a portion of the catheter tube.

15. A catheter assembly according to claim 14, wherein the main body is attached to the container, such that the container at least partially encloses the main body and the catheter extends from the main body to within the hermetically sealed container.

16. A catheter assembly according to claim 14 or 15, wherein the container comprises a flexible material.

17. A catheter assembly according to claim 16, wherein the flexible material comprises a foil.

18. A catheter assembly according to any preceding claim, wherein the seal comprises a flexible material.

19. A catheter assembly according to claim 18, wherein the seal comprises an elastomeric material.

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