Catheter insertion aid

Abstract

An insertion aid for catheter manipulation is disclosed. The insertion aid can be used for urinary catheters, such as hydrophilic urinary catheters for intermittent use. The insertion aid includes first and second plate-like arms arranged overlying each other and with a separation distance there between. The insertion aid also includes a resilient hinge connecting adjacent marginal edges of the plate-like arms together. At least one of the plate-like arms includes a groove on its clamping inner surface for holding a catheter shaft. The groove extends at least partly in the same direction as, and essentially parallel to, the resilient hinge, and is arranged at a distance both from the resilient hinge and from the marginal edge of the plate-like arm. Corresponding catheter set and catheter assembly are also disclosed.

Claims

1. An insertion aid for catheter manipulation, comprising first and second plate-like arms arranged overlying each other and with a separation distance therebetween, and a resilient hinge connecting adjacent marginal edges of said plate-like arms together, wherein at least one of said plate-like arms is provided with a groove on a clamping inner surface thereof for holding a catheter shaft, the groove extending at least partly in the same direction as, and substantially parallel to, said resilient hinge, and distantly arranged from both the resilient hinge and from the marginal edge of said plate-like arm, the groove arranged between the resilient hinge and the marginal edge, and wherein the resilient hinge is arranged to exert a clamping force onto a catheter arranged in the insertion aid when in an unbiased state.

2. The insertion aid of claim 1, wherein the groove is arranged closer to the resilient hinge than to the marginal edge of said plate-like arm being opposite to said resilient hinge.

3. The insertion aid of claim 2, wherein a distance between the groove and the resilient hinge is 25% to 75% of a distance between the groove and the marginal edge of said plate-like arm being opposite to said resilient hinge.

4. The insertion aid of claim 2, wherein a distance between the groove and the resilient hinge is 30% to 70% of a distance between the groove and the marginal edge of said plate-like arm being opposite to said resilient hinge.

5. The insertion aid of claim 2, wherein a distance between the groove and the resilient hinge is 40% to 60% of a distance between the groove and the marginal edge of said plate-like arm being opposite to said resilient hinge.

6. The insertion aid of claim 1, wherein both of said plate-like arms are provided with the groove on a clamping inner surface thereof for holding the catheter shaft, the grooves being arranged overlying each other.

7. The insertion aid of claim 1, wherein the insertion aid includes has a length dimension in the direction of the resilient hinge which is longer than the width dimension perpendicular to the resilient hinge.

8. The insertion aid of claim 1, wherein the insertion aid includes has a length dimension in the direction of the resilient hinge which is at least 50% longer than the width dimension perpendicular to the resilient hinge.

9. The insertion aid of claim 1, wherein the insertion aid includes has a length dimension in the direction of the resilient hinge which is at least 100% longer than the width dimension perpendicular to the resilient hinge.

10. The insertion aid of claim 1, wherein the insertion aid is elongated in the direction of the groove, having a length that is in the range of 4 to 10 cm.

11. The insertion aid of claim 1, wherein the insertion aid is elongated in the direction of the groove, having a length is in the range of 5 to 9 cm.

12. The insertion aid of claim 1, wherein the insertion aid is elongated in the direction of the groove, having a length is in the range of 6 to 8 cm.

13. The insertion aid of claim 1, wherein the groove and the resilient hinge extend along straight, parallel lines.

14. The insertion aid of claim 1, wherein the plate-like arms are curved or bent away from each other along at least part of the marginal edge.

15. The insertion aid of claim 1, wherein the plate-like arm includes a slanted or beveled internal surface in the vicinity of the ends of the groove.

16. The insertion aid of claim 1, wherein at least one of the plate-like arms is provided with protrusions on an external surface thereof.

17. The insertion aid of claim 16, wherein each of the protrusions extend in a direction perpendicular to the groove.

18. The insertion aid of claim 1, wherein each of the plate-like arms is provided with a protrusion on an external surface thereof.

19. The insertion aid of claim 1, wherein at least one of the plate-like arms is provided with protrusions on an internal surface thereof.

20. The insertion aid of claim 19, wherein each of the protrusions extend in a direction perpendicular to the groove.

21. The insertion aid of claim 1, wherein each of the plate-like arms is provided with protrusions on an internal surface thereof.

22. The insertion aid of claim 1, wherein the insertion aid is formed as a clip, wherein the plate-like arms form a receiving mouth at the ends opposite to the resilient hinge.

23. The insertion aid of claim 1, wherein the insertion aid is monolithic and is formed from a material comprising a plastics material.

24. The insertion aid of claim 23, wherein the insertion aid is formed from a material that includes a thermoplastic and/or thermosetting plastic material.

25. The insertion aid of claim 23, wherein the insertion aid is formed from a material that includes a thermoplastic elastomer.

26. The insertion aid of claim 1, wherein the resilient hinge is provided with at least one cavity or opening arranged between the plate-like arms.

27. A catheter set comprising a catheter and the insertion aid of claim 1, wherein the catheter comprises a forward insertion part and a rearward connector part, wherein, in a storage position, the insertion aid is arranged over the connector part of the catheter so that the insertion aid detachably connects the insertion aid to the catheter.

28. The catheter set of claim 27, wherein the catheter is a hydrophilic catheter, and wherein the forward insertion part is at least partly provided with a hydrophilic material exhibiting low-friction surface properties when wetted.

29. The catheter set of claim 27, wherein the catheter is a urinary catheter.

30. The catheter set of claim 29, wherein the catheter is a urinary catheter for intermittent use.

31. The catheter set of claim 27, wherein the insertion aid is more rigid than the catheter shaft.

32. A catheter assembly comprising a catheter set of claim 27 and a package enclosing said catheter set.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) For exemplifying purposes, the disclosed technology will be described in closer detail in the following with reference to embodiments thereof illustrated in the attached drawings, wherein:

(2) FIG. 1 is a side view in perspective of an insertion aid according to an embodiment of the present disclosed technology;

(3) FIG. 2 is a side view in perspective of an insertion aid according to a second embodiment of the present disclosed technology;

(4) FIG. 3 is a side view in perspective of an insertion aid according to a third embodiment of the present disclosed technology;

(5) FIG. 4 is a side view in perspective of an insertion aid according to a fourth embodiment of the present disclosed technology;

(6) FIGS. 5a and 5b are a perspective side view and top view, respectively, of an insertion aid according to a fifth embodiment of the present disclosed technology;

(7) FIG. 6 is a side view in perspective of an insertion aid according to a sixth embodiment of the present disclosed technology;

(8) FIG. 7 is a side view in perspective of an insertion aid according to a seventh embodiment of the present disclosed technology;

(9) FIG. 8 is a side view in perspective of an insertion aid according to an eighth embodiment of the present disclosed technology; and

(10) FIG. 9 is a side view in perspective of the insertion aid of FIG. 1 when being arranged on a catheter in a use position.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

(11) In the following detailed description, preferred embodiments of the disclosed technology will be described. However, it is to be understood that features of the different embodiments are exchangeable between the embodiments and may be combined in different ways. It may also be noted that, for the sake of clarity, the dimensions of certain components illustrated in the drawings may differ from the corresponding dimensions in real-life implementations. Even though in the following description, numerous specific details are set forth to provide a more thorough understanding of the disclosed technology, it will be apparent to one skilled in the art that the disclosed technology may be practiced without these specific details. In other instances, well known constructions or functions are not described in detail, so as not to obscure the disclosed technology.

(12) The following discussion is in particular concerned with an insertion aid for use with hydrophilic urinary catheters for intermittent use. However, the disclosed technology can also be used in relation to other types of urinary catheters, or other types of catheters in general.

(13) An insertion aid according to an exemplary embodiment will first be discussed with reference to FIG. 1. The insertion aid 1 comprises first and second plate-like arms 11 arranged overlying each other and with a separation distance there between. The arms are connected together at one longitudinal side through a resilient hinge 12, thus connecting adjacent marginal edges of the plate-like arms together. Further, at least one of the plate-like arms 11 is provided with a groove 13. In this example, both arms are provided with such grooves 13, wherein the grooves are arranged overlying each other, at the same distance from the hinge 12. The grooves 13 extend at least partly in the same direction as, and preferably essentially parallel to, the resilient hinge 12, and are arranged at a distance both from the resilient hinge and from the marginal edges 14 of the plate-like arm being opposite to the resilient hinge 12. The grooves are provided on a clamping inner surface of the arms, for holding a catheter shaft, as will be discussed in more detail in the following.

(14) The grooves may be centrally arranged, at the same or about the same distance from both the resilient hinge 12 and the marginal edges 14. The grooves may alternatively be arranged closer to the marginal edges 14. However, preferably, the grooves are, as also shown in FIG. 1, arranged closer to the resilient hinge 12 than to the marginal edges 14. For example, the distance between the groove and the resilient hinge 12 may be 25-75% of the distance between groove and the marginal edge 14, such as 30-70%, or such as 40-60%.

(15) The insertion aid may be elongate, and preferably has a length extension in the direction of the resilient hinge which is longer than the width extension perpendicular to the resilient hinge, and preferably at least 50% longer, and most preferably at least 100% longer. The length is preferably in the range of 4-10 cm, and preferably 5-9 cm, and most preferably 6-8 cm. Thus, the length is preferably about the same as the width of a palm.

(16) The marginal edges 14 of the arms being arranged opposite to the resilient hinge 12 forms an insertion opening, allowing the insertion aid to be assembled onto a catheter, by pushing the insertion aid laterally over the catheter shaft. To facilitate this, the arms 11 may be arranged to enlarge the opening. In the example of FIG. 1, the arms are outwardly slightly curved, so that the marginal edges 14 are to some extent directed away from each other. Hereby, an enlarged opening is formed, facilitating arrangement of the insertion aid over the catheter, both during production and during subsequent use.

(17) The resilient hinge allows arms to be moved towards each other when a compression force is applied to the arms, and also is resilient so that the arms are moved back again when the compression force is released. In the illustrative example of FIG. 1, the resilient hinge is formed as an outwardly curved sidewall, extending between the arms.

(18) However, the resilient hinge 12′ may also be arranged as a relatively flat side wall, as illustrated in the embodiment of FIG. 2.

(19) In the embodiment of FIG. 2, the enlarged opening formed by the marginal edges 14 is also not formed by providing a curvature in the arms. Instead, the arms are here essentially flat in the vicinity of the marginal edges 14, but angled in relation to each other, so that the distance between the arms gradually increases from the grooves and in the direction towards the marginal edges 14.

(20) Still further, the side wall of the resilient hinge may also be provided with at least one cavity or opening arranged between the plate-like arms, in order to increase flexibility and reduce material costs. Such an embodiment is illustrated in FIG. 3, where four cut-out openings 15 are formed in the resilient hinge 12″, here being provided as a flat sidewall. However, more or fewer openings may also be used, and may also have other shapes than rectangular, such as circular, oval or the like. Further, instead of openings extending through the entire wall thickness, as in the illustrative example of FIG. 3, cavities of less depth may be used, such as holes, grooves or the like, penetrating only through part of the sidewall thickness.

(21) In the embodiment of FIG. 3, an example is further provided of an insertion aid which does not form an enlarged opening opposite to the resilient hinge. Instead, the arms are here essentially parallel to each other from the grooves 13 to the marginal edges 14.

(22) Various arrangements may also be provided to facilitate application of compression forces to the arms to bring them closer towards each other. One such example is provided in the embodiment of FIG. 4, in which the marginal edges 14′ are provided with centrally arranged and outwardly protruding tab areas. Hereby, an increased gripping area is provided. The tab areas shown in FIG. 4 are formed as rounded tongues extending out from the plate-like arms, and monolithically integrated with the plate-like arms. However, the protruding tab areas may alternatively be formed as separate parts, fixedly attached to the plate-like arms by e.g. welding, adhesion or the like. Further, it is also possible to have the protruding tab areas extending in a forward and/or backward direction, so that the tab areas at least partly extend past the marginal edge(s) of the plate-like arms in the length direction. The tab areas may hereby be e.g. in the shape of a mushroom, extending past the marginal edges in both direction, or in the shape of a hook, extending past the marginal edge in only one direction.

(23) In the embodiments discussed so far, the distance between the arms is essentially constant when seen in any longitudinal cross section extending parallel to the resilient hinge. However, it is also possible to provide a varying distance between the arms along one or several such cross-sections. For example, it is possible to provide the plate-like arms with a slanted or beveled internal surface in the vicinity of the ends of the grooves. This makes the edges smoother, thereby minimizing the risk of damaging the catheter when the insertion aid is moved along the catheter shaft. Such an embodiment is shown in FIGS. 5a and 5b, where the arms in the vicinity of the marginal edges 16 of the arms directed perpendicular to the resilient hinge are curved outwardly, so that the marginal edges 16 are to some extent directed away from each other. Hereby, enlarged openings are formed at the lateral sides of the insertion aid. Such enlarged openings may be applied only to the lateral sides, and not to the longitudinal side opposite to the resilient hinge. However, in the illustrative example of FIG. 5, the longitudinal side is also provided with an enlarged opening, formed by outwardly curved arms, in the same way as discussed previously in relation to FIG. 1.

(24) In the embodiment of FIG. 6, the insertion aid has been provided with rounded corners. Further, protrusions have been provided on the external sides of the plate-like arms 11. More specifically, a number of protrusion lines 17 have been provided distributed centrally on the arms, and each extending in a direction generally perpendicular to the groove and the resilient hinge. In addition a protrusion line 18 running along the outer edges of the arms is provided. Due to these protrusions, gripping of the plate-like arms, for holding and manipulating the insertion aid, and for applying the clamping force, is facilitated. However, many other types of protrusions may be used in addition or instead of these protrusions. For example, point like protrusions and corrugations may be used. Other means for facilitating gripping may also be used, such as providing an increased surface texture, e.g. in the form of embossment and perforations.

(25) The protrusion line 18 need not extend over all marginal edges of the two arms, as in the example of FIG. 6. Instead, one or several shorter protrusion line(s) may be arranged at or close to the edges. One such embodiment is illustrated in FIG. 7, in which the protrusion line 18 only extends over a lateral marginal edge, and a short distance into the longitudinal marginal edge.

(26) Further, instead of, or in addition, to forming an enlarged longitudinal opening by providing curved and/or angled plate-like arms, as discussed in the foregoing in relation to FIGS. 1 and 2, such an enlarged opening may be formed by beveled surfaces forming tapering ends towards the longitudinal marginal ends. Such an embodiment is also illustrated in FIG. 7. Hereby, the thickness of the plate-like arms gradually decreases towards the longitudinal marginal edges 14, thereby providing an enlarged opening. This tapering may extend over almost the entire plate-like arms from the grooves to the marginal edges 14. However, alternatively, the tapering may be provided on only a limited part of the arms being closest to the marginal edges. Such an embodiment is illustrated in FIG. 8.

(27) Further, in the embodiment of FIG. 8, the distance between the grooves and the resilient hinge has been limited, so that the grooves are arranged very close to the resilient hinge.

(28) Protrusions or the like (not shown) may also be provided on one or several of the internal surfaces of the plate-like arms, and preferably on internal surfaces of both said plate-like arms. Such protrusions may e.g. extend in a direction perpendicular to the groove. Hereby, the friction between the catheter and the insertion aid is increased, thereby limiting the clamping force necessary to maintain the catheter in position during maneuvering and the like. The protrusions may be formed as protrusion lines, but may alternatively be formed by point like protrusions and the like. Further, similar effects may be obtained by corrugations, by providing an increased surface texture, e.g. in the form of embossment and perforations, and the like.

(29) The insertion aid may be formed by many different types of plastic materials, and in various ways. It may be formed by two or more different materials, e.g. one material for forming the resilient hinge, and another material for forming the plate-like arms. However, preferably, the entire insertion aid is formed by one and the same material. Preferably, the insertion aid is formed as a monolithic piece. Further, the plastic material is preferably a thermoplastic and/or thermosetting plastic material, and most preferably a thermoplastic elastomer. In one embodiment, the tubular insertion aid may be made of thermoplastic elastomer, such as the commercially available Dryflex® or LDPE. However, other materials are also feasible. For example, the material may be one or several of: a polymer material, such as polyurethanes, thermoplastic rubbers, polyvinylchloride, other vinyl polymers, polyesters, polyether block amid, polypropene, polyethen polyamide and styren-ethen/butadiene-styren co-polymer, polyacrylates and polysiloxanes.

(30) The insertion aid may be formed by injection molding. However, other manufacturing methods may also be employed. For example, the insertion aid may be formed by extrusion. In particular, embodiments where the lateral cross-section is essentially uniform along the length of the insertion aid are well-suited for extrusion, such as the embodiments discussed above in relation to FIGS. 1, 2 and 8.

(31) The insertion aid may be provided as a separate component, e.g. arranged in a sterile package. However, preferably the insertion aid is arranged in a package together with the catheter. In this case, the insertion aid be arranged loosely within the package. However, preferably, the insertion aid is assembled on the catheter already during manufacture.

(32) The catheter is preferably a hydrophilic catheter, having a hydrophilic exterior surface exhibiting a low-friction when wetted. The package may also comprise a wetting liquid, either in contact with the catheter, thereby maintaining the hydrophilic surface wetted and activated during storage, or in a separate compartment, to be released prior to use for activation of the catheter.

(33) The resilient hinge may be arranged to exert a clamping force onto a catheter arranged in the insertion aid when in an unbiased state. Hereby, the insertion aid will apply a certain, limited clamping force on the catheter also when no additional clamping force is applied. Hereby, the insertion aid will stay in place over the catheter at all times, unless it is deliberately moved by the user. This facilitates use, since the user may release insertion aid during use, without the risk of the insertion aid falling down and the like. It also facilitates manufacturing, since the insertion aid can hereby be arranged on the catheter already during manufacturing, and then remain in place during packaging, sterilization, handling, storage, etc. It will also remain in place during activation and preparation for use, e.g. when the catheter is removed from its package.

(34) The insertion aid may also comprise inward protrusions or recessions which may be engaged with a recession or protrusion or the like in the catheter and/or catheter connector, thereby securely connecting the insertion aid to the catheter. Such a connection may form a weak mechanical interlocking, which maintains the insertion aid in an intended stored position. At the same time, disassembling of the insertion aid is simple, since the insertion aid can easily be pulled out of this weakly locked state, thereby allowing clean and safe maneuvering of insertion aid over the catheter during insertion into the intended human cavity. Further, the insertion aid will always be kept securely in place before it is removed and used as an insertion aid.

(35) The insertion aid is preferably arranged overlying or adjacent the connector of the catheter. Thus, if the user does not need an insertion aid for manipulation of the catheter, the insertion aid can be allowed to remain in its non-released state during the entire use. Even in this way of using the catheter, where the insertion aid remains non-detached, the insertion aid is to advantage, since it hereby provides an enlarged gripping portion for the catheter, which makes insertion and withdrawal of the catheter easier, especially for users with reduced dexterity.

(36) Pre-arrangement of the insertion aid on the catheter can be done with high speed automated manufacturing. The insertion aid can be mounted from the side, i.e. in a lateral direction seen from the catheter. Consequently, the need for pulling the insertion aid over the length of the catheter is avoided, which facilitates automated manufacturing.

(37) Upon use, the insertion aid may be loosened from its storage position, if pre-arranged on the catheter, or alternatively be assembled over the catheter, if arranged separated from the catheter during storage.

(38) A catheter with an insertion aid arranged thereon is illustrated in FIG. 9. The catheter 2 comprises a forward insertion part 20 and a rearward connector part 21. The connector part may form a waist (not shown) having a cross-sectional dimension of lower extension than the surrounding portions of the connector part. In a preferred embodiment, the connector part 21 comprises a funnel shaped rearward end, tapering in a direction towards the insertion end of the catheter. However, other configurations of the rearward connector part 21 are also feasible, such as a cylindrical outer surface being provided with an indentation or similar waist, or other types of a non-circular circumference.

(39) The forward insertion part 20 preferably comprises an elongate shaft with an insertion end. The insertion end is preferably provided with one or several drainage openings, in fluid communication with an internal lumen of the catheter.

(40) The catheter may be of any size suitable for catheterization. For use by female users the elongate shaft preferably has a length in the range of 5-20 cm, such as in the size of 15 cm. For male users, the elongate shaft preferably has a length in the range 18-45 cm, such as in the size of 40 cm.

(41) In order to further facilitate insertion of the catheter, the elongate shaft may comprise a hydrophilic material at the surface, said hydrophilic material providing a low-friction character to the catheter surface when wetted. For example, the elongate shaft can be made essentially entirely of a hydrophilic material. Alternatively, the elongate shaft may be provided with a hydrophilic surface coating.

(42) The hydrophilic material may e.g. be polyvinyl pyrrolidone (PVP), but many other types of hydrophilic coatings are known in the art, and may be used in the context of the present disclosed technology. The hydrophilic coating provides a low-friction character to the catheter when wetted, thereby facilitating insertion of the catheter into the urethra, and reducing the risk of pain etc.

(43) After arrangement of the insertion aid on the catheter shaft, as shown in FIG. 9, the insertion aid 1 is usable as an insertion aid for maneuvering the catheter 2 during insertion into the human cavity. In this position, the insertion aid 1 may be moved along the length of the elongate shaft, when no compression force is applied, and firmly fixate the catheter when a compression force is applied, thereby facilitating contamination free handling of the catheter, which reduces the risk of urinary tract infections and the like. Clamping can easily be obtained by pressing the plate-like arms towards each other. This can be made by pressing the plate-like arms together by use of two fingers, by means of pressing one or several fingers towards the palm, by use of two hands, by pressing on only one of the plate-like arms while the other is in contact with another part of the body or an external structure, and the like. Thus, the insertion aid provides numerous simple handling possibilities, which is particularly useful for users having reduced dexterity.

(44) In this use position, the catheter 2 is positioned within the groove(s) of the insertion aid 1, so that the catheter is maintained in a correct position during operation, avoiding the risk of the catheter inadvertently falling out or being misplaced.

(45) Due to the resilience, the insertion aid will apply a pressure on the enlarged rearward part (the connector) of the catheter, and it may consequently be held in place solely by friction. The user may choose not to use the insertion aid, and in such a case, the insertion aid will remain in its place, attached to connector, during the entire catheterization. If the user decides to use the insertion aid, the clip is easily pulled down from its attached position, and is then easily movable along the catheter shaft.

(46) A method for producing a catheter assembly of this type includes: Assembling a insertion aid of the above-discussed type on a catheter. Arranging the catheter and, optionally a wetting fluid or a wetting fluid container, in a package. Closing the package. Sterilizing the package, including its content.

(47) The disclosed technology has now been disclosed with reference to specific exemplary embodiments. However, it will be acknowledged by the skilled addressee that several modifications are possible. For example, various types of gripping means and the like may be provided, to facilitate gripping, various forms of ridges, surface texture or the like may be applied to the interior surface to increase friction, etc. Further, the insertion aid may be used for other types of catheters, e.g. catheters having differently designed connector ends, and the catheter set may also be arranged in many different forms of catheter assemblies.

(48) The above-discussed and other obvious modifications must be considered to be within the scope of the disclosed technology. It should be noted that the above-mentioned embodiments illustrate rather than limit the disclosed technology, and that those skilled in the art will be able to design many alternative embodiments without departing from the scope of the appended claims. In the claims, any reference signs placed between parentheses shall not be construed as limiting to the claim. The word “comprising” does not exclude the presence of other elements or steps than those listed in the claim. The word “a” or “an” preceding an element does not exclude the presence of a plurality of such elements.