WO2011105899A1

WO2011105899A1 - Guard device for an intravenous body

Info

Publication number: WO2011105899A1
Application number: PCT/NL2011/050129
Authority: WO
Inventors: Marleen Johanna Jacoba Van Leengoed
Original assignee: Iq+ Investments N.V.
Priority date: 2010-02-26
Filing date: 2011-02-23
Publication date: 2011-09-01
Also published as: EP2539010A1; NL2004309C2

Abstract

A guard device (10,20) for an intravenous body (42) for use around a percutaneous infusion port in a peripheral body part comprises a hollow, substantially form-retaining guard body (10) open on at least one side which is intended and adapted to receive the intravenous body thereunder. The guard body (10) comprises at least a first shell part (11) and a second shell part ( 12) which are connected for adjustment relative to each other. The two shell parts (11,12) can thus be adjusted to different angles relative to each other so as to optimally match the natural anatomy of the body part.

Description

Guard device for an intravenous body

The present invention relates to a guard device for an intravenous body for use around a percutaneous infusion port in a peripheral body part, comprising a substantially form- retaining guard body which comprises a cavity bounded by wall parts and open on at least one side for receiving the intravenous body therein, and which can at least be provided with fastening means for fixing the guard body relative to the body part.

What is particularly involved here to guarding of an intravenous infusion needle or catheter around the percutaneous infusion port where it has been introduced into a blood vessel for the purpose of a medical treatment of a patient. Intravenous infusions are applied on large scale for therapeutic administering of an infusion liquid directly into a vein of a patient, such as for instance a salt solution having, if necessary, an indicated pharmaceutical dissolved therein. The medical treatments involved are of diverse nature. In order to insert an infusion a location is preferably chosen where a vein lies just below the skin. At the position of such a superficial vein a venipuncture is realized percutaneously using an infusion needle, after which the same infusion needle or an infusion catheter is introduced intravenously into the relevant vein via the infusion port and stabilized by being fixed on the skin using tape.

The human or animal body has a number of suitable venipuncture sites. These are particularly peripheral locations on the skull and the upper and lower extremities. In addition, there are suitable central venipuncture sites which provide access to the vena cava. In the upper extremities, or the arms, suitable venipuncture sites are situated at the position of the cephalic, medial basilic and medial antecubital veins in the forearm and moreover on the dorsal side of the hand where, normally speaking, branches of the cephalic and basilic veins and of the dorsal venous arch are punctured. In addition, the lower extremities, or the legs, provide suitable locations for a venipuncture, particularly in the foot. A large number of factors are involved in the choice of a determined venipuncture location, such as the age and condition of the patient and the type of infusion liquid which has to be introduced. In an adult the best venipuncture locations are, in order of preference, the forearm and hand, the upper arm and the antecubital fossa. In the case of children a cranial vein can be used because it is normally readily accessible, although recourse is often had, as in adults, to the forearm and hand. Needles and catheters of different type are applied for intravenous infusions. Formerly a hollow needle used for the percutaneous puncture of the vein was then also used to introduce the infusion liquid. Current practice however is to administer the infusion liquid via a catheter which has been introduced intravenously using a separate needle which is then withdrawn. Roughly two main types of catheter are used here, i.e. so- called over-the-needle catheters and through-the-needle catheters. An older type of infusion needle as well as a modern infusion catheter ends proximally in a connecting block with tap, usually referred to as hub, having proximally a tapering hollow shaft onto which a flexible infusion line can be placed. It is important that such a line, which as a rule is fixed on the shaft only by elastic clamping, does not detach therefrom since in that case infusion liquid is lost and the patient can be seriously affected as a result.

In addition, there is a danger of an unintended longitudinal dislocation of the infusion needle or catheter relative to the host vein. Not only can the needle or catheter in an extreme case then exit the vein, this also results in undesirable intra-luminal displacements, whereby the vascular wall can be irritated or even perforated, with bleeding as a result. In the case of prolonged irritation an inflammation of the vascular wall (phlebitis) can moreover occur, whereby the vascular wall can become porous. In both cases infusion liquid will infiltrate into the surrounding tissue instead of into the blood vessel, whereby the surrounding tissue will swell, the infusion therapy will not have the intended effect and other complications can occur.

It is therefore of great importance to prevent such an undesirable infusion dislocation by guarding and sufficiently fixing the infusion needle or catheter around the infusion port. Although not exclusively so, this is particularly important in the case of children and babies, who may be expected to display no or only very little discipline and attention in this respect. A simple, and therefore generally applied method for stabilizing the coupling between the hub and the feed conduit and preventing the needle or catheter unintentionally moving from its position, makes use of a fixation with adhesive tape on the skin. The adhesive power of the applied adhesive tape does however decrease in the course of time, particularly under the influence of transpiration, whereby an adequate fixation is no longer guaranteed. Even though the venipuncture location is taped but otherwise unprotected, the catheter or needle with hub can moreover still easily catch on something in the case of too wild a movement with the relevant body part and be undesirably detached or accidentally pulled loose. In order to protect the infusion port with an intravenous infusion therein, the American patent USP 5,167,240 describes a known guard device of the type referred to in the preamble. This known device essentially comprises a hollow guard cover which supports on the skin around the infusion port with the needle or catheter thereunder, and is attached to the skin using adhesive tape. The guard cover is given a transparent form in order to allow a visual inspection of the infusion port without having to remove the cover.

The known guard cover is intended specifically in combination with an infusion which has been inserted on the dorsal hand side. Owing to the specific form and dimensions this same device is less suitable for other venipuncture sites. For such other positions it will therefore be necessary to have recourse to a similar device designed specifically for the purpose; this is particularly the case for bridging a bending joint such as an elbow or ankle, for which the flat known device is unsuitable. And although the known device provides per se for an adequate dorsal protection of the percutaneous infusion port and an area around it, the device provides no resistance, or hardly any, to a palmar flexion of the wrist, whereby an undesirable dislocation of the needle or catheter can still occur. Nor does the dorsal hand side, in small children and babies provides sufficient surface area for an adequate adhesion of this known device, whereby it is not sufficiently suitable for younger patients.

The present invention has for its object, among others, to provide a guard device for an intravenous hollow body, such as an intravenous needle or catheter, which obviates to at least significant extent one or more of these drawbacks.

In order to achieve the stated object a guard device of the type described in the preamble has the feature according to the invention that the wall parts comprise at least a first shell part and a second shell part which are connected for adjustment relative to each other, wherein respective central axes of said shell parts enclose a first angle in a first relative position and a second angle differing from the first angle in a second relative position. By adjusting said shell parts relative to each other the device can thus be adapted and modified to the specific body part where the device has to be applied. It is therefore not necessary to have a separate guard device available for each body part.

The guard body can, if desired, be mounted on a rigid splint body provided for this purpose on an opposite side of the body part instead of directly on the skin. In addition to a mounting base for the guard body, which thereby need not be adhered directly to the body part itself, such a splint body enhances fixation and stabilization of the body part. By fixing the body part to the splint body and because the guard body is in turn mounted on the splint body, the guard cover is ipso facto fixed relative to the body part with the percutaneous infusion port therein. Since no direct adhesion to the body part is required here, the available surface thereon is not relevant, so that the device according to the invention is also suitable for (small) children and babies, and the body part is moreover thus given relief. Not only does this latter contribute toward the wearing comfort and acceptance of the patient, an undesirable pressure point on the skin is moreover hereby avoided, this enhancing an undisturbed subcutaneous blood circulation and preventing decubitus.

In a particular embodiment the guard device according to the invention is characterized in that the first and second shell parts can be adjusted in stepwise manner between the first position and the second position, and comprise fixation means which are able and adapted to fix the two shell parts in at least one intermediate position between the first position and the second position. As well as being fixable in the first and second position, the two shell parts can thus also be fixed in stepwise manner in one or more intermediate positions relative to each other. The compound guard body thus nevertheless forms a relatively rigid whole after being locked in one of these positions, this enhancing stabilization of the body part The device can here be adapted to and match a natural anatomy of the body part to at least a great extent by choosing a suitable position.

The shell parts of the guard body can be embodied adjustably relative to each other in various ways, for instance be axially slidable in or out along an arc. A particular embodiment of the guard device according to the invention has in this respect the feature that the first shell part and the second shell part are mutually connected for pivoting around a shared pivot axis, in particular via at least a point hinge or film hinge. The use of such a film hinge in particular allows the manufacture of the two parts in a joint production step without subsequent mutual assembly being necessary.

In a preferred embodiment the guard device according to the invention has the feature that a first of the two shell parts is pivotable inside a second of the two shell parts. There will thus always be an overlap of the two shell parts irrespective of the position in which they are placed relative to each other, whereby an adequate protection of the infusion port remains guaranteed.

In order to provide a stepwise locking option of the two shell parts pivoting inside each other, a further particular embodiment of the guard device according to the invention is characterized in that the two shell parts are provided on mutually facing main surfaces with fixation means able and adapted to lock both parts relative to each other in successive positions. This particular embodiment according to the invention is more particularly characterized in that the fixation means comprise at least one cavity in the one main surface and at least one protrusion which can penetrate therein and which extends from the other main surface, wherein at least one of the protrusion and the cavity forms part of a series of respective successive protrusions and cavities on the relevant main surface. By adjusting the two shell parts relative to each other the protrusion will snap into the successive cavities, or vice versa, so as to thus lock the whole in the position corresponding therewith. Such a snap cavity can lie inside an opening in a wall of the shell part or extend from a recess which has been arranged over only a part of a wall thickness thereof.

For an increased wearer comfort and an optimal protection a further particular embodiment of the guard device according to the invention has the feature that the two shell parts are shaped at least substantially in accordance with a natural anatomy of the body part on a side directed toward the body part. A further contribution is made hereto by a further particular embodiment of the guard device according to the invention, characterized in that the shell parts are provided on a base with a compressible layer, in particular one comprising a skin-friendly textile and/or a foam. Such a compressible layer provides for a comfortable pressure distribution and thereby reduction in pressure on the body part, and moreover an optimal fitting thereto.

A further preferred embodiment of the guard device according to the invention has the feature here that the compressible layer extends integrally from a flexible basic body to which the guard body is attached, which basic body comprises connecting means for connection to the body part. A particular embodiment of the guard device according to the invention is characterized here in that the connecting means comprise attaching straps which extend laterally from the basic body and are provided with closing means for connection to an opposite side of the basic body while enclosing the body part. The device thus essentially comprises two parts, i.e. the adjustable guard body and the basic body, wherein the guard body provides for an adjustable protection of the infusion port and the basic body provides wearer comfort in addition to connecting means to the body part. Particularly when use is made here of attaching straps intended to close round the body part, the amount of space available on the body part is less critical and an adequate fastening can nevertheless be ensured, so that the guard device is also particularly suitable for small children and even babies.

During use the intravenous body is not infrequently coupled to an infusion line with which an infusion liquid is continuously introduced intravenously. To enable simple accommodation of such a line a further particular embodiment of the guard device according to the invention has the feature that the guard body comprises infusion tube guide means. In a further particular embodiment the guard device according to the invention is characterized here in that the infusion tube guide means provide an infusion tube fixation, and more particularly a pull relief for an infusion tube. In addition to an adequate guiding and fixing of the infusion line, the infusion guide means also provide in the latter case for a pull relief, whereby irritation and even perforation of the vascular wall as a result of unintended dislocation of an applied intravenous body is avoided.

In order to allow a brief visual inspection of the infusion port, a further particular embodiment of the guard device according to the invention has the feature that the first and the second shell parts are formed from a plastic, in particular a translucent plastic from a group of polypropylene and polycarbonate. In the latter case the guard body need not be removed each time for such an inspection. Plastic in any case has the additional advantage that the guard body can be manufactured therefrom at a relatively low cost price in series production. Suitable techniques for this purpose are injection moulding and vacuum forming, or optionally other (thermo)forming techniques with which the guard body can be realized at least for the most part in one production step.

Although the device according to the invention can in principle be utilized at diverse locations on the human or animal body by adjusting the shell parts as required, the device can if desired be provided in a number of sizes in order to fit the actual dimensions of the body part, which will often be a reflection of an age and/or height of the user.

The invention will be further elucidated hereinbelow on the basis of two exemplary embodiments and an associated drawing. In the drawing:

figure 1 is a top view of a first embodiment of a guard device according to the invention; figure 2 is a front view of the guard device of figure 1 ;

figure 3 shows a longitudinal section through the guard device of figure 1 ;

figures 4A-D show the device of figure 3 in successive positions;

figure 5 is a top view of a basic body of a second embodiment of a guard device according to the invention;

figure 6 is a top view of a guard body of a second embodiment of a guard device according to the invention; and

figure 7 is a top view of a second embodiment of a guard device according to the invention in assembled state;

figure 8 is a top view of an infusion needle with infusion tube; and

figure 9 shows the guard device of figure 7 as applied with the infusion needle of figure 8.

The figures are otherwise purely schematic and not drawn to scale. For the sake of clarity some dimensions in particular may be exaggerated to a greater or lesser extent. Corresponding parts are designated as far as possible in the figures with the same reference numeral.

A first exemplary embodiment of a guard device according to the invention is shown in figures 1-3, respectively in top view, front view and longitudinal section. The device comprises a substantially form-retaining guard body 10 with two shell parts 11,12, which are mutually connected and are herein adjustable relative to each other. Shell parts 11, 12 are formed together as monolithic injection-moulded part, see figure 3, from polycarbonate, polypropylene or another suitable transparent plastic. The two shell parts 11,12 bound a cavity 15 located thereunder which provides space for an infusion needle which penetrates into a peripheral body part, usually a blood vessel, via a percutaneous infusion port. A flat intermediate part 13 is embodied with a smaller wall thickness or other weakening, whereby this part serves as film hinge. Use can otherwise also be made instead of a point hinge between the two shell parts 11 ,12, the respective components of which can in that case also be formed integrally on shell parts 11 , 12 or can extend integrally therefrom. Owing to film hinge 13 the two shell parts 11,12 can be pivoted in stepwise manner through a large angle relative to each other about a pivot axis 3. In mutually facing main surfaces the shell parts 11,12 here comprise fixation means in the form of a protrusion 80 on second shell part 12 and a series of cavities in openings 81-85 in the wall of first shell part 11. First shell part 11 pivots about pivot axis 13 into second shell part 12, see also figures 4A-4D, whereby protrusion 80 will snap successively into openings 81-85 in stepwise manner. In each such end or intermediate position the two shell parts 11,12 are locked relative to each other so that a highly form-retaining whole is obtained. Respective central axes 1,2 through a bottom surface of the two shell parts 11,12 will thus enclose a different angle a in each case, as shown by way of illustration in figures 4A-4D. The guard body, although substantially form-retaining, can nevertheless thus be adapted to a natural anatomy of a body part and can thereby be applied to different body parts, and even to bridge a joint such as an elbow or ankle, wherein the adjustability of the two parts 11,12 relative to each other enhances an effective connection at both longitudinal outer ends to the relevant body part. An opening 16 is provided laterally in second shell part 12 so as to nevertheless ensure a sufficient ventilation under the guard body under such conditions. Both the first shell part 11 and second shell part 12 are provided with a flat flanged edge 21 ,22 on a base thereof. The guard body can hereby be attached directly to the body part, for instance by means of adhesive tape. A compressible layer (not shown) can optionally be applied here under the flanged edge, which layer brings about a certain pressure distribution and reduction.

An alternative exemplary embodiment of a guard device according to the invention is shown in figure 5 and further. Use is made here of a guard body 10, see figure 6, which is substantially the same as that of figures 1-4, but a separate basic body 30 of a flexible textile is applied thereunder which may or may not, as in this embodiment, be filled with a thin foam layer. The textile is breathing and of a skin-friendly nature, while perforations are provided in the foam layer to allow a sufficient transport of air and vapour to and from a skin to be received thereunder. Guard body 11,12 is durably attached to the basic body with flanged edges 21 ,22, see figure 7, for instance by means of adhesive or thermo-welding (sealing). Situated inside the basic body is an opening 35 corresponding to cavity 15 of the guard body. Owing to the flexible character of the basic body it does not impede the mutual adjustability of the two shell parts 1 ,12 relative to each other. These can thereby take up different positions relative to each other. Provided on basic body 30 are connecting means in the form of a first and second closing strap 31,32, which extend on respectively the left side and the right side from basic body 30. At their free outer end the closing straps 31,32 are provided with closing means such as an attaching surface such as an adhesive layer or a velcro tape.

Using closing straps 31 ,32 the guard device can be strapped round a body part and fixed relative thereto in exceptionally practical manner. Use is preferably made here of reclosable closing means so that the whole can for instance be removed during washing or showering and then re-placed. Closing straps 31 ,32 of unequal length are

advantageously applied on the left and right-hand side of basic body 30 so that the closure will not come to lie under but to the side of the body part. This facilitates arranging and/or opening of the closure. In this embodiment basic body 30 comprises a skin-friendly, hypo-allergenic breathing textile or non-woven filled with a hypo-allergenic breathing plastic foam, and has a pleasant feel even in the case of more prolonged use. Recesses 34 provided for this purpose in the basic body form infusion guide means for an infusion tube 40, while provided on either side on second shell part 12 of guard body 10 are resilient tongues 25 under which the infusion tube 40,50, normally having a valve coupling 41 provided thereon, can be placed and fixedly clamped, see also figures 8 and 9. An infusion needle 42 which is introduced percutaneously into a blood vessel is provided on an outer end of infusion tube 40. The guard device thus provides for a fixation 23 and guide 34 of infusion tube 40 with valve coupling 41, this also providing a pull relief in that the coupling 41 comes up against clamp 23. Infusion needle 42 is thus protected particularly effectively from an unintended dislocation. Although the invention has been further elucidated on the basis of only several exemplary embodiments, it will be apparent that the invention is by no means limited thereto. On the contrary, many variations and embodiments are still possible within the scope of the invention for a person with ordinary skill in the art.

Use is thus made in the shown exemplary embodiment of a film hinge connection between the two shell parts of the guard body, but a satisfactory releasable mutual coupling can also be realized instead by means of a point hinge or a co-axial adjustability of the two parts along an arc.

The stated materials are given solely by way of example, without precluding that other materials are also suitable for the different components of the device according to the invention.

Finally, the use of velcro tape within the scope of the invention is exceptionally practical as fixing closing strap, although such a strap can also be embodied with press- studs, a (semi-permanent) glue layer or other closing means in order to provide comparable utility.

Claims

1. Guard device for an intravenous body for use around a percutaneous infusion port in a peripheral body part, comprising a substantially form-retaining guard body which comprises a cavity bounded by wall parts and open on at least one side for receiving the intravenous body therein, and which can at least be provided with fastening means for fixing the guard body relative to the body part, characterized in that the wall parts comprise at least a first shell part and a second shell part which are connected for adjustment relative to each other, wherein respective central axes of said shell parts enclose a first angle in a first relative position and a second angle differing from the first angle in a second relative position.

2. Guard device as claimed in claim 1, characterized in that the first and second shell parts can be adjusted in stepwise manner between the first position and the second position, and comprise fixation means which are able and adapted to fix the two shell parts in at least one intermediate position between the first position and the second position.

3. Guard device as claimed in claim 1 or 2, characterized in that the first shell part and the second shell part are mutually connected for pivoting around a shared pivot axis, in particular via at least a point hinge or film hinge.

4. Guard device as claimed in claim 3, characterized in that a first of the two shell parts is pivotable inside a second of the two shell parts.

5. Guard device as claimed in claim 4, characterized in that the two shell parts are provided on mutually facing main surfaces with fixation means able and adapted to lock both parts relative to each other in successive positions.

6. Guard device as claimed in claim 5, characterized in that the fixation means comprise at least one cavity in the one main surface and at least one protrusion which can penetrate therein and which extends from the other main surface, wherein at least one of the protrusion and the cavity forms part of a series of respective successive protrusions and cavities on the relevant main surface.

7. Guard device as claimed in one or more of the foregoing claims, characterized in that the two shell parts are shaped at least substantially in accordance with a natural anatomy of the body part on a side directed toward the body part.

8. Guard device as claimed in one or more of the foregoing claims, characterized in that the shell parts are provided on a base with a compressible layer, in particular one comprising a skin-friendly textile and/or a foam.

9. Guard device as claimed in claim 8, characterized in that the compressible layer extends integrally from a flexible basic body to which the guard body is attached, which basic body comprises connecting means for connection to the body part.

10. Guard device as claimed in claim 9, characterized in that the connecting means comprise attaching straps which extend laterally from the basic body and are provided with closing means for connection to an opposite side of the basic body while enclosing the body part.

11. Guard device as claimed in one or more of the foregoing claims, characterized in that the first and the second shell parts are formed from a plastic, in particular a translucent plastic from a group of polypropylene and polycarbonate.

12. Guard device as claimed in one or more of the foregoing claims, characterized in that the guard body comprises infusion tube guide means.

13. Guard device as claimed in claim 12, characterized in that the infusion tube guide means provide an infusion tube fixation, and more particularly a pull relief for an infusion tube.