GB2402070A

GB2402070A - Fluid transfer device

Info

Publication number: GB2402070A
Application number: GB0312370A
Authority: GB
Inventors: Leonard John Rodgers
Original assignee: Individual
Current assignee: Individual
Priority date: 2003-05-30
Filing date: 2003-05-30
Publication date: 2004-12-01
Also published as: GB0312370D0

Abstract

A fluid transfer device 10 which is locatable in a cavity, such as a urethra, in a human body 12, to transfer fluid to and from the body 12, comprises an insertion member 14 for insertion into the cavity in the body. The insertion member 14, which is desirably of unitary construction, includes a fluid transfer passage 16 for transferring fluid into the body 12 and a fluid evacuation passage 18 to enable removal of fluid from the body. In a preferred embodiment, the fluid evacuation passage 18 is in the form of a catheter receiving passage (26, Fig. 3) which is adapted to receive a conventional catheter 11, for example a urinary catheter, which is operable to evacuate fluid from the human body.

Description

1 2402070 \ Fluid Transfer Devices The present invention relates to fluid

transfer devices, and particularly but not exclusively to fluid transfer devices and/or systems for transferring fluid to and from a human body. The invention also relates to catheters, and more particularly but not exclusively to urinary catheters.

Catheters generally comprise a hollow flexible tube for insertion into a cavity in a human body to allow evacuation of fluid from the body. A urinary catheter is used to evacuate urine from the bladder, usually when normal urine output cannot be maintained, which may for example occur following surgery or due to an enlarged prostate gland.

A conventional urinary catheter includes proximal and distal ends and is inserted into a urethra such that the proximal end lies outside the human body and the distal end extends through the urethra into the bladder. A central fluid evacuation passage is provided for draining urine from the bladder into a bag or container attached to the proximal end. An inflatable balloon may also be provided towards the distal end of the catheter to secure the catheter in position in the urethra. An inflation passage is provided to enable inflation and deflation of the balloon from the proximal end.

It may be desirable to transfer fluid into the human body whilst the urinary catheter is in position in the urethra. This may be achieved by locating a further catheter, of smaller external diameter than the urinary catheter, in the urethra adjacent the urinary catheter to extend a short distance into the urethra. The further catheter has a passage for transferring fluid into the body at a location between the outside of the urinary catheter and the urethra. The fluid then travels along a path between the outside of the urinary catheter and the urethra into the bladder.

Insertion of a further catheter alongside a urinary catheter can create cavities which enable fluid being transferred via the further catheter to flow back out of the urethra. Furthermore, insertion of the further catheter causes localized stretching of the urethra which can be painful and may result in damage to the urethra.

According to a first aspect of the present invention, there is provided a fluid transfer device for transferring fluid to and from a human body, the device comprising an insertion member for insertion into the body, the insertion member including a fluid transfer passage for transferring fluid into the body and a fluid evacuation passage for removing fluid from the body.

The insertion member may be a unitary member. The insertion member may be elongate and have proximal and distal ends. The fluid evacuation passage may extend longitudinally through the insertion member between the proximal and distal ends. The fluid evacuation passage may extend centrally through the insertion member.

The fluid transfer passage may extend through the insertion member adjacent to the fluid evacuation passage. The fluid transfer passage may include a fluid inlet for transferring fluid into the insertion member. The fluid transfer passage may include at least one fluid outlet for transferring fluid from the fluid transfer passage into the human body.

The fluid transfer passage may be arranged to transfer fluid into the body at a first location. The fluid transfer passage may be arranged to cause the fluid to travel from said first location to a second location within the body.

The fluid evacuation passage may be arranged to remove fluid from the body at said second location. The fluid to be removed may comprise a proportion of the fluid transferred into the body. The fluid to be removed may comprise a combination of the fluid transferred to the body and another fluid already present in the body.

In a first embodiment of the invention, the fluid evacuation passage may comprise a catheter receiving passage for receiving a catheter to enable removal of fluid from the body.

According to a second aspect of the present invention, there is provided a fluid transfer device for transferring fluid to and from a human body, the device comprising an insertion member for insertion into the body, the insertion member including a fluid transfer passage for transferring fluid into the body and a catheter receiving passage for receiving a catheter to enable removal of fluid from the body. \

The insertion member may be tubular and have proximal and distal ends. The catheter receiving passage may extend through the insertion member between the proximal and distal ends. The insertion member may be tapered at its distal end which may define a generally conical portion for facilitating insertion into the body.

The insertion member may include a base portion and side walls extending from the base portion to define the catheter receiving passage. The insertion member may be substantially U-shaped, and may include inwardly directed projections to securely locate the insertion member in use on a catheter. The insertion member may include a closure member to secure the insertion member in use on a catheter.

The insertion member may comprise first and second portions locatable in use around a catheter. The first and second portions may be substantially semi-cylindrical such that when assembled, the portions define the catheter receiving passage. One or more securing members may be provided to secure the first and second portions in use on a catheter.

The insertion member may include an annular region and at least part of the fluid transfer passage may extend through said region. The fluid transfer passage may include a first passage section and a second passage section, each having a diameter. The diameter of the first passage section may be greater than the diameter of the second passage section. The first passage section may include a fluid inlet for transferring fluid into the fluid transfer passage. The second passage section may include a fluid outlet for transferring said fluid into the body.

The insertion member may have an inner surface and may include a fluid transfer groove extending along at least part of the inner surface to transfer fluid from the fluid transfer passage into the body. The fluid transfer groove may extend along the inner surface of the conical portion. The fluid transfer groove may be configured to accelerate fluid flow therethrough into the body. The fluid transfer groove may be tapered.

The fluid transfer passage may be arranged so that, in use, fluid is delivered into the body between the body and a catheter. The fluid transfer passage may be arranged so that the fluid travels into the body along a path between the body and the catheter.

In a second embodiment of the invention, the insertion member may comprise a catheter.

According to a third aspect of the present invention, there is provided a catheter comprising a fluid transfer passage for transferring fluid into a human body and a fluid evacuation passage for removing fluid from the body.

The catheter may be tubular and have proximal and distal ends. The fluid evacuation passage may extend longitudinally through the catheter between the proximal and distal ends. The catheter may have an inner and an outer wall defining an annular region therebetween. The fluid transfer passage may extend longitudinally through the annular region adjacent to the fluid evacuation passage.

The fluid transfer passage may extend from the proximal end partway along the catheter towards the distal end. The fluid transfer passage may include a fluid inlet at said proximal end. The fluid transfer passage may include a fluid outlet. The fluid outlet may comprise an outlet passage extending from the fluid transfer passage through the outer wall of the catheter. A plurality of said fluid outlets may be provided.

The or each fluid outlet may be arranged so that, in use, fluid is delivered into the body between the body and the catheter. The fluid transfer passage may be arranged so that the fluid travels into the body along a path between the body and the catheter.

The catheter may be a urinary catheter.

According to a fourth aspect of the present invention, there is provided a fluid transfer system for transferring fluid to and from a human body, the system comprising a catheter locatable, in use, within the body for removing fluid from the body, and a fluid transfer device comprising an insertion member for insertion into the body, the insertion member including a fluid transfer passage for transferring fluid into the body and a catheter receiving passage for receiving the catheter.

The fluid transfer device may be as described above.

According to a fifth aspect of the present invention, there is provided a method of transferring fluid to and from a body, the method comprising: locating in the body a fluid transfer device comprising an insertion member, the insertion member including a fluid transfer passage and a fluid evacuation passage; transferring fluid into the body via the fluid transfer passage; removing fluid from the body via the fluid evacuation passage.

The method may be used to transfer fluid to and from a human body and the locating step may include inserting the insertion member into the human body. The locating step may include inserting the insertion member into a urethra.

The method may include the use of a fluid transfer device as described above.

Embodiments of the present invention will now be described by way of example only and with reference to the accompanying drawings, in which: Fig. 1 is a diagrammatic cross-sectional side view of a fluid transfer device according to the invention located in a human body; Fig. 2 is a diagrammatic side view of a first fluid transfer device according to the first embodiment of the invention; Fig. 3 is a cross-sectional side view of the device of Fig. 2; Fig. 4 is a view from one end of the device of Fig. 2; Fig. 5 is a view from one end of a modified device of Fig. 2; Fig. 6 is a diagrammatic side view of a second fluid transfer device according to the first embodiment of the invention; Fig. 7 is a cross- sectional side view of the device of Fig. 6; Fig. 8 is a cross-sectional view along A-A of Fig. 6; Fig. 9 is a cross-sectional view along B-B of Fig. 6; Fig. 10 is a cross-sectional side view of part of a fluid transfer device according to the second embodiment of the invention; Fig. 1 1 is a view from one end of the device of Fig. 10; and Fig. 12 is a diagrammatic cross-sectional side view of a fluid transfer device located on a catheter.

Fig. 1 shows generally a fluid transfer device 10 located in a cavity, such as a urethra, in a human body 12. The device 10 comprises a unitary insertion member 14 for insertion into the body 12, and the insertion member 14 includes a fluid transfer passage 16 for transferring fluid into the body 12 and a fluid evacuation passage 18 to enable removal of fluid from the body 12.

In more detail, Figs. 2 to 5 illustrate a first fluid transfer device 10 according to a first embodiment of the invention. The insertion member 14 is substantially tubular and includes a proximal end 20 which lies outside the body 12 in use and a distal end 22 which is tapered to provide a generally conical portion 24 for insertion into the body 12.

The fluid evacuation passage 18 is in the form of a catheter receiving passage 26 which is adapted to receive a conventional catheter 11, for example a urinary catheter. The passage 26 extends longitudinally through the insertion member 14 between the proximal and distal ends 20, 22. The insertion member 14 is substantially U-shaped and includes a base portion 28 and side walls 30 extending from the base portion 28 to define the catheter receiving passage 26. As best seen in Fig. 4, the side walls 30 include inwardly directed projections 32 which enable the insertion member 14 to be snap-fitted and securely located in use on a catheter 11.

Fig. 5 illustrates a modified version of the device 10 in which a closure member 34 is slidably locatable in a correspondingly shaped recess 36 which extends longitudinally through the insertion member 14. When the closure member 34 is in place, the device 10 cannot be removed from a catheter.

With this arrangement, the projections 32 are optional.

Referring in particular to Fig. 3, the insertion member 14 includes an annular region 37 and the fluid transfer passage 16 extends through this region 37 between the proximal and distal ends 20, 22 adjacent to the catheter receiving passage 26. In the embodiment shown, the inner and outer walls of the annular region 37 are not co-axial. The fluid transfer passage 16 1 5 includes a first passage section 38 which extends from the proximal end 20 through annular region 37 substantially parallel to the catheter receiving passage 26. A second passage section 40 of smaller diameter than the first passage section 38 extends through the annular region 37 into the conical portion 24 and has a fluid outlet 42 which extends into the tapered region of the catheter receiving passage 26. The first passage section 38 includes a fluid inlet 44 to enable injection of fluid into the fluid transfer passage 16. A connection device 46 is provided to enable the connection of a fluid supply arrangement. A fluid transfer groove 48 extends along at least part of an inner surface of the conical portion 24 to enable transfer of fluid from the outlet 42 into the body 12. The fluid transfer groove 48 is tapered such that it accelerates fluid flowing from the fluid outlet 42 into the body 12.

Figs. 6 to 9 illustrate a second fluid transfer device 50 according to the first embodiment of the invention in which corresponding elements are given corresponding reference numerals.

The device 50 comprises first and second portions 52, 54 both of which are substantially semi-cylindrical such that when assembled, they form a cylindrical housing 56 with the catheter receiving passage 26 extending therethrough between the proximal and distal ends 20, 22. Securing members in the form of resilient C-shaped clips 58 are locatable in use around the first and second portions 52, 54 to secure them together and thereby securely retain the housing 56 in use on a catheter. As best seen in 1 5 Fig. 9, location means such as a projection 59 and corresponding recess 59a are provided to facilitate alignment of the first and second portions 52, 54 Referring in particular to Fig. 7, the fluid transfer passage 16 extends radially through the first portion 52 from an outer surface into the catheter receiving passage 26. A fluid transfer groove 60 extends along the inner surface of the first portion 52 from the fluid transfer passage 16 towards the conical portion 24.

Figs. 10 and 11 show part of a fluid transfer device 70 according to the second embodiment of the invention in which corresponding elements are given corresponding reference numerals. The insertion member 14 comprises a modified urinary catheter 72 having a longitudinally extending fluid evacuation passage 18. The catheter 72 is substantially cylindrical and includes inner and outer walls 74, 76 defining therebetween an annular region 78. An inflation passage 80 extends through the annular region 78 between proximal and distal ends of the catheter 72. Water is injected via the passage to inflate a balloon (not shown) at the distal end of the catheter 72 to securely locate it in position in a urethra.

JO The fluid transfer passage 16 extends through the annular region 78 adjacent the fluid evacuation passage 18. The fluid transfer passage 16 extends from the proximal end of the catheter 72 part way along the catheter 72 through the annular region 78 and includes at least one fluid outlet 82 extending through the outer wall 76. The fluid outlet 82 is arranged so that fluid injected into the fluid transfer passage 16 exits the passage 16 at a first location in the body remote from the distal end of the catheter 72.

Fig. 12 shows a fluid transfer system in which a fluid transfer device 90 is permanently located for slideable movement on a catheter 11 located in a human body 12. The device 90 is substantially tubular and includes a fluid transfer passage 16 which extends radially at the proximal end 20 of the device 90 into an annular fluid transfer cavity 94. A sealing arrangement in the form of an annular seal 96 prevents escape of fluid from the proximal end of the device 10 and causes fluid introduced via passage 16 to travel along a path between the device 90 and the catheter 92 from the proximal end 20 towards the distal end 22 such that the fluid exits the device 90 at the conical portion 24 where it is injected into the body.

The fluid transfer device according to the invention is used to inject fluid into the body at a location between the body and a catheter located in the body. The fluid transferred into the body using the device then travels into the body along a path between the body and the catheter.

The device 10, 50 of Figs. 1 to 9 is used to inject fluid into the body as follows. Firstly, a conventional catheter 11 such as a urinary catheter, is located in the body 12, for example in the urethra. This enables the evacuation of fluid, such as urine, from the body. If and when it is desired to transfer a fluid into the body 12, the fluid transfer device 10, 50 is located on the catheter 11 such that the catheter 11 is received within the catheter receiving passage 26 of the insertion member 14. The insertion member 14 is then moved along the catheter 11 and the conical portion 24 inserted into an opening, such as the tip of the urethra, in the body 12. When the fluid transfer device 10, 50 is in its operating position, fluid is injected via the fluid inlet 44 into the fluid transfer passage 16. The fluid travels through the passage 16, and exits the device 10,50 at a location between the catheter 11 and the body 12. By virtue of capillary action, the fluid then travels along a path between the body 12 and the catheter 11 into the body. For example, when the catheter 11 is a urinary catheter located in the urethra, fluid travels along a path between the outside of the catheter 11 and the urethra into or towards the bladder.

The fluid transfer device 70 shown in Figs. 10 and 11 is used in a similar manner except that the device 70 does not require the prior insertion of a conventional catheter 11. The device 70 is inserted into the body 12 in the same way as a conventional catheter 11. When the device 70 is in position, fluid may be evacuated from the body along the fluid evacuation passage 18 as with a conventional catheter. When it is desired to transfer fluid into the body 12, fluid supply means are connected to the fluid inlet (not shown in Figs. 10 and 11) of the fluid transfer passage 16 and fluid is injected into the passage 16. The fluid travels along the passage and exits via the fluid outlet 82. The fluid then travels along a path between the outer wall 76 of the catheter 72 and the body 12 into the body 12 by virtue of capillary action.

The fluid transfer device 90 shown in Fig. 12 is used in a similar manner to the device shown in Figs. 1 to 9. The device 90 is however permanently located on the catheter 92 and the conical portion 24 is selectively inserted into the body 12 only when it is desired to transfer fluid into the body. When such fluid transfer into the body is not required, the device 90 is moved along the catheter 92 away from the body such that the conical portion 24 is removed from the opening in the body 12. It is envisaged that this arrangement would be particularly suitable for use by persons who are permanently catheterized.

The fluid transfer device according to the invention is formed of plastics material and may be used to introduce a number of different fluids into the body for a number of different purposes. For example, radio opaque fluids may be transferred into the body using the device to enable capture of x-ray images of internal body organs, for example the bladder. The device may be used to transfer sterile fluids into the body which may subsequently be evacuated from the body for the purposes of laboratory analysis, fluids to treat an enlarged prostate gland before surgery or instead of surgery, fluids suitable for removing accretions which may build up due to leakage of urine between the catheter and the urethra, fluids suitable for separating adhesions between the catheter and urethra or lubricant to facilitate insertion or removal of the catheter. It should however be appreciated that these are merely examples of fluids which may be transferred into the body using the fluid transfer device according to the invention, and that the transfer of any fluid or fluid like substance (for example, gel) into the body is within the scope of the present invention.

The fluid transfer device according to the invention provides a complete seal between the insertion member and the body and enables transfer of fluid into the body without creating cavities or escape routes for the fluid. The device also provides for even deformation of the body into which it is inserted

and is less painful than prior art arrangements.

Although embodiments of the present invention have been described in the preceding paragraphs with reference to various examples, it should be appreciated that various modifications to the examples may be made without departing from the scope of the invention as defined in the claims. For example, the device may have a configuration other than that shown in the drawings. The connection device 46 may be formed integrally with the insertion member 14. The insertion member 14 and closure member 34 of the device of Figs. 2 to 5 and the first and second sections 52, 54 and clips 58 the device of Figs. 6 to 9 may be connected by flexible cord or the like to facilitate assembly on a catheter and to ensure the components do not become separated prior to use of the device. The device may comprise a material other than plastics material. The device may be used to transfer fluid or any fluid like substance to and from any cavity in a human body.

Whilst endeavouring in the foregoing specification to draw attention to those features of the invention believed to be of particular importance, it should be understood that the Applicant claims protection in respect of any patentable feature or combination of features hereinbefore referred to and/or shown in the drawings, whether or not particular emphasis has been placed thereon.

Claims

Claims 1. A fluid transfer device for transferring fluid to and from a

human body, the device comprising an insertion member for insertion into the body, the insertion member including a fluid transfer passage for transferring fluid into the body and a fluid evacuation passage for removing fluid from the body.
2. A device according to claim 1, wherein the insertion member is a unitary member.
3. A device according to claim 1 or claim 2, wherein the insertion member is elongate and has proximal and distal ends.
4. A device according to claim 3, wherein the fluid evacuation passage extends longitudinally through the insertion member between the proximal and distal ends.
5. A device according to any of the preceding claims, wherein the fluid evacuation passage extends centrally through the insertion member.
6. A device according to any of the preceding claims, wherein the fluid transfer passage extends through the insertion member adjacent to the fluid evacuation passage. l
7. A device according to any of the preceding claims, wherein the fluid transfer passage includes a fluid inlet for transferring fluid into the insertion member.
8. A device according to any of the preceding claims, wherein the fluid transfer passage includes at least one fluid outlet for transferring fluid from the fluid transfer passage into the human body.
9. A device according to any of the preceding claims, wherein the fluid transfer passage is arranged to transfer fluid into the body at a first location.
10. A device according to claim 9, wherein the fluid transfer passage is arranged to cause the fluid to travel from said first location to a second location within the body.
1 1. A device according to claim 10, wherein the fluid evacuation passage is arranged to remove fluid from the body at said second location.
12. A device according to any of the preceding claims, wherein the fluid to be removed comprises a proportion of the fluid transferred into the body.
13. A device according to any of the preceding claims, wherein the fluid to be removed comprises a combination of the fluid transferred to the body and another fluid already present in the body.
14. A device according to any of the preceding claims, wherein the fluid evacuation passage comprises a catheter receiving passage for receiving a catheter to enable removal of fluid from the body.
15. A device according to claim 14, wherein the insertion member is tubular and has proximal and distal ends.
16. A device according to claim 15, wherein the catheter receiving passage extends through the insertion member between the proximal and distal ends.
17. A device according to claim 15 or claim 16, wherein the insertion member is tapered at its distal end to define a generally conical portion for facilitating insertion into the body.
18. A device according to any of claims 14 to 17, wherein the insertion member includes a base portion and side walls extending from the base portion to define the catheter receiving passage.
19. A device according to any of claims 14 to 18, wherein the insertion member is substantially U-shaped and includes inwardly directed projections to securely locate the insertion member in use on a catheter.
20. A device according to any of claims 14 to 19, wherein the insertion member includes a closure member to secure the insertion member in use on a catheter. l
21. A device according to any of claims 14 to 17, wherein the insertion member comprises first and second portions locatable in use around a catheter.
22. A device according to claim 21, wherein the first and second portions are substantially semi-cylindrical such that when assembled, the portions define the catheter receiving passage.

JO
23. A device according to claim 21 or claim 22, wherein one or more securing members are provided to secure the first and second portions in use on a catheter.
24. A device according to any of claims 14 to 23, wherein the insertion member includes an annular region and at least part of the fluid transfer passage extends through said region.
25. A device according to any of claims 14 to 24, wherein the fluid transfer passage includes a first passage section and a second passage section, each having a diameter.
26. A device according to claim 25, wherein the diameter of the first passage section is greater than the diameter of the second passage section.
27. A device according to claim 25 or claim 26, wherein the first passage section includes a fluid inlet for transferring fluid into the fluid transfer passage.
28. A device according to any of claims 25 to 27, wherein the second passage section includes a fluid outlet for transferring said fluid into the body.
29. A device according to any of claims 14 to 28, wherein the insertion member has an inner surface and includes a fluid transfer groove extending JO along at least part of the inner surface to transfer fluid from the fluid transfer passage into the body.
30. A device according to claim 29, wherein the fluid transfer groove extends along the inner surface of the conical portion.
31. A device according to claim 29 or claim 30, wherein the fluid transfer groove is configured to accelerate fluid flow therethrough into the body.
32. A device according to any of claims 29 to 31, wherein the fluid transfer groove is tapered.
33. A device according to any of claims 14 to 32, wherein the fluid transfer passage is arranged so that, in use, fluid is delivered into the body between the body and a catheter.
34. A device according to any of claims 14 to 33, wherein fluid transfer passage is arranged so that the fluid travels into the body along a path between the body and a catheter.
35. A device according to any of claims 1 to 13, wherein the insertion member comprises a catheter.
36. A device according to claim 35, wherein the catheter is tubular and has proximal and distal ends.
37. A device according to claim 36, wherein the fluid evacuation passage extends longitudinally through the catheter between the proximal and distal ends.
38. A device according to any of claims 35 to 37, wherein the catheter has an inner and an outer wall defining an annular region therebetween.
39. A device according to claim 38, wherein the fluid transfer passage extends longitudinally through the annular region adjacent to the fluid evacuation passage.
40. A device according to any of claims 36 to 39, wherein the fluid transfer passage extends from the proximal end partway along the catheter towards the distal end.
41. A device according to any of claims 36 to 40, wherein the fluid transfer passage includes a fluid inlet at said proximal end.
42. A device according to any of claims 35 to 41, wherein the fluid transfer passage includes a fluid outlet.
43. A device according to claim 42 when dependent on claim 38, wherein the fluid outlet comprises an outlet passage extending from the fluid transfer passage through the outer wall of the catheter.
44. A device according to claim 42 or claim 43, wherein a plurality of said fluid outlets is provided.
45. A device according to any of claims 42 to 44, wherein the or each fluid outlet is arranged so that, in use, fluid is delivered into the body between the body and the catheter.
46. A device according to any of claims 35 to 45, wherein the fluid transfer passage is arranged so that the fluid travels into the body along a path between the body and the catheter.
47. A device according to any of claims 35 to 46, wherein the catheter is a urinary catheter.
48. A fluid transfer system for transferring fluid to and from a human body, the system comprising a catheter locatable, in use, within the body for removing fluid from the body, and a fluid transfer device comprising an insertion member for insertion into the body, the insertion member including a fluid transfer passage for transferring fluid into the body and a catheter receiving passage for receiving the catheter.
49. A fluid transfer system according to claim 48, wherein the fluid transfer device is according to any of claims 14 to 34.
50. A third transfer device substantially as hereinbefore described with reference to the accompanying drawings.
51. A fluid transfer system substantially as hereinbefore described with reference to the accompanying drawings.
52. Any novel subject matter or combination including novel subject matter disclosed herein, whether or not within the scope of or relating to the same invention as any of the preceding claims.