WO2016091956A1

WO2016091956A1 - Application device

Info

Publication number: WO2016091956A1
Application number: PCT/EP2015/079134
Authority: WO
Inventors: Christina Zimmer
Original assignee: twistid GmbH & Co. KG
Priority date: 2014-12-09
Filing date: 2015-12-09
Publication date: 2016-06-16
Also published as: DE102014118261A1

Abstract

The invention relates to an application device (1) for the light-based finding of a peripheral vein, and the subsequent execution of a venipuncture in the region of a skin surface (4) of a patient, comprising at least one light source (2) and a catheter holder (6) for holding a catheter (2), wherein a support surface (7) is provided for supporting the application device (1) on the skin surface (4), and at least one part (8) of a transmission surface (9) for transmitting the light beams (10) generated by the light source (5) into a tissue located under the skin surface (4) is arranged in the region of the support surface (7). The invention also relates to a catheter application assembly, a catheter assembly and a carrier element having a catheter holder, as well as a single-use protective sleeve for a carrier element.

Description

applicator

The present invention relates to an application device for light-based finding of a peripheral vein and then performing a venipuncture in the region of a skin surface of a patient according to the preamble of claim I, a catheter application assembly according to claim 20. A catheter assembly according to claim 21, a support member according to claim 22 and a disposable protective cover according to claim 23.

Peripheral venipuncture is commonly referred to as piercing with a stylet, the needle for placing a catheter, a peripheral vein for collection of blood or for administration of infusions or medicaments in liquid form.

Every year, more than 1.4 billion venous punctures are performed. About one third of the venipuncture attempts fail in the first puncture attempt, so that one or more further puncture attempts must be made. An entry should be placed after a maximum of three puncture attempts and within two minutes.

Often finding a suitable vein is difficult, especially in children, the elderly, obese people, or people with heavily pigmented skin. Application devices have already been developed for this problem, which are intended to simplify finding a suitable vein.

EP 1 764 031 A1 discloses a transilluminating device which produces orange light in the wavelength range between 580 nm and 620 nm in order to visualize veins in the tissue directly on the skin surface of a patient. After finding a suitable vein, the catheter containing the stylet must be freehanded for venipuncture to the vein with one hand. The one-handed and hands-free placement of the catheter can lead to incorrect punctures or even to stitches at an inappropriate angle to the skin surface. The prior art further discloses a device having an ultrasound detector device and a vessel positioner device connected thereto and guided in a groove. Although veins based on the Doppler effect can be detected by means of the ultrasound detector device, the reflected sound waves must be evaluated and made visible by means of an evaluation device. After burring a vein, the vascular puncture device may be delivered along the groove at a fixed angle to the tissue below the skin surface. However, in order to perform a venipuncture, it is recommended to pierce the vein at an initially steep angle to the skin surface and flatten the angle to the skin surface after piercing so as not to puncture the vein completely. The guide in a groove does not allow this procedure easily. To change the angle, the vascular puncture device must always be carried along or rotated altogether.

Malpositions are not only pain for the patient and stress for the attending physician or nurse. On the contrary, delays in providing access can lead to a deterioration in health status or mortal danger. On the part of the patient, the risk of infection increases as well as the risk of further complications due to malpositions. On the part of the attending physician or nursing staff, the treatment time is extended, which is associated with rising costs.

Finding a peripheral vein and then performing venipuncture are difficult and often failures in many situations in doctors' offices or hospitals, especially in emergency situations. The present invention is accordingly based on the problem. an application device with which a venipuncture on a peripheral vein is feasible to design and further develop such that a venipuncture can be performed easily and safely in the first attempt.

The above problem is solved in an application device having the features of the preamble of claim 1 by the features of the characterizing part of claim 1. What is essential is the recognition that a support surface for supporting the application device is provided on the skin surface and that in the region of the support surface at least part of a transfer surface for transferring the light rays generated by a light source is disposed in a tissue located below the skin surface. By using light beams can be dispensed with a complex evaluation.

Preference is given to using light rays in the visible range, so that it is readily possible to find veins with the eye. Therefore, a suitable vein can be visualized in the area of the support surface so that the stylet of a catheter can then be safely inserted into the tissue under the skin surface. The preferred embodiments of the application device according to claims 2 to 7 describe advantageous structural embodiments of the application device according to the invention, including the flexibility of a part of a support element. Thus, the application device can also have a carrier element in addition to a housing. In addition, in a preferred embodiment according to claim 8, an optical deflecting element serves to redirect the light beams generated in a light source and to transmit them specifically into the tissue under the skin surface.

The light pipe is described in claims 9 and 10. Here, fiber optic cables or the like for light conduction are proposed. Likewise, the carrier element can be designed to be light-conducting as such.

A preferred embodiment according to claims 1 1 and 12, a guide for the catheter as a longitudinal guide along a catheter longitudinal axis provided.

Preferably, according to claims 13 and 14 for separating the catheter from the application device after a successful venipuncture, an optionally adjustable removal opening is provided on the end region of the carrier element. In order to avoid wastage in a preferred embodiment according to claim 15, a vapor deposition in the form of a mirror coating on the side facing away from the skin surface of the support element is provided. Locking means for receiving the carrier element or a catheter holder. in which a catheter is latched, are described in the embodiments according to claims 16 and 17. The preferred embodiments of the light sources used are described in claims 18 and 19.

Furthermore, according to claims 20 to 22 a catheter application arrangement, a catheter arrangement with a carrier element and a carrier element as such are claimed. For a carrier element, which can be used multiple times, is furthermore according to claims 23 and 24, a disposable protective cover, which can be attached to perform a venipuncture on the support surface of the support element. proposed.

Further details, features, objects and advantages of the present invention will be explained in more detail below with reference to the drawing of preferred embodiment examples. In the drawing shows:

Fig. 1 exploded view of an application device according to the invention;

Fig. 2a, b, the use of the application device of FIG. 1 on the

Skin surface of a patient;

3a, b each show an embodiment of a carrier element for the application device according to Fig. 1 and Fig. 2a.b.

4a, b, a third exemplary embodiment of a proposed carrier element with a deflecting element;

5a, b, a fourth embodiment of a proposed carrier element with a light source; and

FIGS. 6a, b, c show the use of a proposed application device for the light-based finding of a peripheral vein and the other concluding a venipuncture in the area of a skin surface of a patient,

1 shows an exploded view of a proposed application device I, in which a catheter 2 with stylet 3 is inserted.

The proposed application device 1 for light-based finding of a peripheral vein and subsequent performance of a venipuncture in the region of a skin surface 4 of a patient has at least one light source 5 and a catheter receptacle 6 for receiving a catheter 2. The proposed application device 1 is characterized in that a support surface 7 for supporting the application device 1 is provided on the skin surface 4 and that in the region of the support surface 7 at least a portion 8 of a transfer surface 9 for transmitting the light beams 10 generated by the light source 10 in a tissue located below the skin surface 4 is arranged therein. Here, the application device 1 comprises the support surface 7 and the transfer surface 9. The catheter 2 preferably comprises the stylet 3.

In the application device 1, the transfer surface 9 preferably provides a part of the support surface 7. It may also correspond to the transfer surface 9 of the support surface 7, which in particular touches the skin surface 4. In order to avoid that a part of the transfer surface 9 pushes tissue before finding a suitable vein, the support surface 7 or the transfer surface 9 may be angled like a runner, i. projecting from the skin surface 4.

Is preferred. in that the application device 1 comprises the carrier element 13 and that the carrier element 13 comprises the supporting surface 7.

The application device 1 has a housing 1 1, which comprises a carrier element receptacle 12 for receiving a carrier element 13. The carrier element 13 preferably has the catheter receptacle 6. In this, a catheter 2 may be included, see, for example, according to the figures 1, 2. Alternatively, the housing 1 1, the catheter holder 6 have. According to a preferred variant, the at least one light source 5 is arranged on the carrier element 13. According to an alternative variant, the at least one light source 5 is arranged on the housing 1 1.

Preferably, the catheter receptacle 6 is arranged to the support surface 7 such that when supporting the application device I on the support surface 7 of the stylet 3 of the catheter 2 is aligned for venipuncture in a predetermined angular range to the Flautoberfläche 4. Figures 6a, b, c show the process of performing a venipuncture, with the stylet aligned at three different angles to the skin surface 4 which are in the predetermined angular range. According to FIG. 6 a, the catheter 2 is arranged on the carrier element receptacle 12 of the carrier element 13. The stylet 3 stands to the skin surface 4 at a relatively shallow angle. To locate a suitable vein, the stylet 3 is moved away from the skin surface 4 with the application device 1 as a whole (FIG. 6 a).

It is preferred that the carrier element 13, which is preferably one-piece or two-piece. in the support of the application device] for changing and in particular for increasing the angle of the stylet 3 to the skin surface 4 is at least partially bendable. Such a bendable section 14 supports the course of a correct venipuncture. For when finding a suitable vein, it is advantageous if the stylet 3 is arranged at a distance from the skin surface 4, as shown in Fig. 6a. As soon as a suitable vein has been found, the stylet 3 assumes an angle β, for example greater than 30 °, for piercing the found vein to the skin surface 4, as shown in FIG. 6b. The bendable portion 14 allows the transfer of the catheter 2 and thus of the stylet 3 from a small angle to a larger such angle with respect to the skin surface 4. The support member 13 is by its geometry and elasticity the above angular range in which the position of the Mandrins 3 to the skin surface 4 can be changed before. For the transfer of the stylet 3 in the larger compared to the initial position angle ß, which here is greater than 30 °, the bendable portion 14 of the support member 13, which preferably serves a waveform. Groove shape or the like. The bendable portion 14 is elastically deformable, so that the stylet 3 can be converted into a larger angle to the skin surface 4. If now the application device 1 overall, possibly only slightly, is moved in the direction according to the orientation of the stylet 3, the stylet 3 can puncture the vein. The catheter 2 penetrates equally into the vein.

The carrier element 13 preferably has the transfer surface 9. which, based on the skin surface 4, that is, the plane defined by the skin surface 4, is arranged circumferentially to the stylet 3. In the region of the transfer surface 9, the carrier element 13 is preferably formed with an arcuate or rectangular surface or the like. The transfer surface 9 may be formed planar or with angled surface 15 or the like. The angled surface 15, which, like a runner, is bent away from the skin surface 4 avoids that tissue is compressed during venipuncture and leads to discomfort of the patient.

In the region of the transfer surface 9, at least one optical deflecting element 16 is preferably provided for deflecting the light beams 10 into the tissue located below the skin surface 4; in particular, the at least one deflecting element 16 is arranged at a distance from the at least one light source 5. The deflection element 16 serves for the targeted alignment of the generated light beams 10 in the direction of the skin surface 4 of a patient. In the area of the transfer surface 9, a crosshair 17 is preferably provided for locating and / or locating the vein to be punctured. Preferably, the reticle 17 comprises one or more deflecting elements 16. Alternatively, the reticule 17 may be formed as a non-deflecting light mark.

It is preferred that the carrier element 13 is arranged for guiding the light beams 10 generated by the light source 5 up to the transfer surface 9. In particular, the carrier element 13 essentially consist of a light-conducting material. Alternatively or additionally, the carrier element 13 may have a separate optical waveguide arrangement, in particular an optical waveguide cable or the like. When using optical fiber cables, for example, they can be mounted in or on the carrier element 13 by injection molding. When using a plurality of optical fiber cables, these can be arranged next to one another and / or one another on the carrier element 13. The at least one light source 5 is preferably arranged at a distance from the transfer surface 9. In order to enable the transmission of the light beams 10, the carrier element 13 preferably comprises at least one Lichteinkoppelstelle 18. Preferably, each light source 5 couples the light 10 generated in at least one Lichteinkoppelstelle 18, so that the generated light 10 to the transfer surface 9, in particular as low loss, directed becomes. In Fig. 4, such a Lichteinkoppelstelle 18 is shown. The Lichteinkoppelstelle 18 can be included in the Trägerelementaufhahine 12.

The at least one light source 5 is supplied with energy via an accumulator. The accumulator is preferably arranged in the housing 1 1 and is in particular inductively rechargeable. For this purpose, the housing 1 1 is stored, for example, after removal of the carrier element 13 or with your carrier element 13 in a charging station. The charging station (not shown) may for example be connected to the firelighter in a vehicle, so that the application device 1 is also suitable for mobile use. as for use in hospitals or medical practices.

After the stylet 3 has pierced the found vein, the angle of the stylet 3 is flattened again to prevent further puncture of the vein (Figure 6c). In addition, the catheter 2 is pushed into the vein at the lowest possible angle to the skin surface 4, where the catheter is to remain. The flattening of the catheter 2 and the withdrawal of the mantrin 3 are shown in FIG. 6c (see the arrows in FIGS. 6b and 6c). To move the catheter 2 into the vein, the catheter 2 is moved along a guide 19. For this purpose, the application device I or in particular the carrier element 13 preferably has a guide 19, in particular a guide opening. for guiding the catheter 2 accommodated by the carrier element 13. This guide 19 may in particular be subject to play.

The guide 19 is preferably designed as a longitudinal guide along a catheter longitudinal axis 20. This catheter longitudinal axis 20 is defined as an imaginary extension of the Madrid 3 (see Fig. 1), or laid through the stylet 3, as this initializes the venepuncture. In particular, the guide 19 extends from the catheter receptacle 6 to an end region of the carrier element 13, preferential way to the transfer surface 9. However, the guide 19 may also have any other shape, which is suitable for guiding the catheter 2.

The end region of the application device 1, in particular of the carrier element 13, preferably has a removal opening 21 for separating the catheter 2 from the carrier element (13). In this case, the guide 19 preferably passes into the removal opening 21 and the removal opening 21 is dimensioned for passing the catheter 2, in particular for carrying out a port 22 of the catheter 2. According to the exemplary embodiment according to FIG. 3b, the carrier element 13 is adjustable, in particular expandable, at least in the region of the removal opening 21 for separating the catheter 2 from the carrier element 13. On the support member 13, a joint element 29 is preferably provided for spreading, which supports the spreading when compressing the webs of the support member 13.

In order to avoid scattering losses, the carrier element 13 has a vapor deposition 23 in the region of the transfer surface 9 on a side facing away from the skin surface 4. wherein the support member 13 may be particularly mirrored. As a result, the generated light beams 10 are additionally deflected in the direction of the skin surface 4 and the entry of light beams 10 in the eye of the performing venipuncture personnel is reduced.

Preferably, the carrier element exception 12 for latching the carrier element 13 on a locking means 24, in which the Trägereleinent 13 engages. The latching means 24 can be actuated via a Entrastungselement, in particular a push button, so that a unlatching is initiated.

The catheter receptacle 6 is preferably designed for latching and in particular for clipping in the catheter 2. In particular, the catheter holder 6 is arranged on the housing 11 or on the carrier element 13. FIG. 3a, for example, shows a carrier element 13 with a catheter receptacle 6 for clipping in the catheter 2. This allows a quick assembly of the application device I with a catheter 2, so that the conditions for a sterile work are fulfilled. Another aspect of the present invention relates to a disposable protective cover 25 for the sterile use of a support element 13 of the proposed application device I, wherein the disposable protective cover 25 for venipuncture on the support surface 7 can be attached. A corresponding exemplary embodiment is shown in FIG. 5 c. In this case, the carrier element 13 can be used several times. Here it is then conceivable to form the carrier element 13 in one piece with the housing 1 1 to form a one-piece application device 1. A two-part application device I with carrier element 13 and housing 1 1 is also possible. The disposable protective cover 25 is preferably translucent for the light beams 10 generated by the light source 5.

The application device 1 preferably has at least two light sources 5. Preferably, the at least two light sources 5 are arranged to generate light beams 10 or different wavelengths.

The at least one light source 5 preferably has at least one LED 26, preferably for generating light beams 10 of a wavelength between 580 nm and 620 nm. A light source 5 may comprise one or more LEDs 26. In addition, other light sources 5 can be used. which generate light beams 10 in the or another relevant wavelength range. Alternatively or additionally, it may be provided that the light intensity and / or the color mixture of the light beams 10 generated is or are adjustable. A proposed catheter application arrangement with a proposed application device I and a catheter 2, which is arranged in the catheter receiving 6, for example, in Fig. 1, 2 and Fig. 6 is shown.

A proposed catheter arrangement with a carrier element 13, which comprises a catheter receptacle 6 for receiving the catheter 2, for a proposed application device 1 and a catheter 2, which is arranged in the catheter receptacle 6, is shown in FIG. 3a.

Advantageous embodiments of the proposed carrier element 13 for a proposed application device 1 with a Katheteraufhahme 6 for the recording of the catheter 2, can be taken from the drawing, in particular Figs. 3, 4 and 5.

FIGS. 4a and b show schematically the operation of the at least one deflection element 16. The light rays 10 are diffracted at the surfaces of the deflection elements 16, i. deflected and directed towards the skin surface 4. In Fig. 4a, the coupling-in points 18 for the light beams 10 of the light source 5 are given as round light guides, which are embedded by an injection molding process in a plastic or silicone support member i 3.

In Fig. 5 a and 5b, a support member 13 is shown, in which the at least one light source 5 is arranged in the carrier element 13. In particular, the at least one light source 5 comprises a plurality of LEDs 26 in the region of the support surface 7. Here, for example, so-called surface mounted device LEDs (SMD) may be used, which may be mounted on a so-called flex conductor 27 (also called flexible printed circuit board). Preferably, the flex conductor 27 is arranged in the carrier element 13. The flex conductor 27 has contacts 28 which enable electronic contacting to a supply source (not shown) of electrical energy and to the light source S.

Claims

claims

1. Application device (I) for light-based finding of a peripheral vein and subsequent performance of a venipuncture in the region of a skin surface (4) of a patient with at least one light source (5) and a catheter receptacle (6) for receiving a catheter (2),

characterized,

a support surface (7) is provided for supporting the application device (1) on the skin surface (4) and in that at least a part (8) of a transfer surface (9) for transferring the light emitted by the light source (5) is provided in the region of the support surface (7) ) light rays (10) is arranged in a below the skin surface (4) located tissue inside.

2. Application device (1) according to claim 1, characterized in that the transfer surface (9) provides a part of the support surface (7) or that the transfer surface (9) of the support surface (7).

3. Application device (L) according to any one of the preceding claims, characterized in that the application device (1) comprises a housing (1 1), which comprises a carrier element receptacle (12) for receiving a carrier element (13). preferably, that the carrier element (13) or the housing (1 1) the Katheteraufhahme (6).

4. Application device (I) according to claim 3, characterized in that the at least one light source (S) is arranged on the carrier element (13) and / or that the at least one light source (5) on the housing (1 1) is arranged ,

5. Application device (1) according to any one of the preceding claims, character- ized in that the catheter receptacle (6) to the support surface (7) is arranged such that when supporting the application device (1) on the support surface (7) a stylet (3) of the catheter (2) is aligned for venipuncture in a predetermined angular range to the skin surface (4).

6. Application device (I) according to claim 3, characterized in that the application device (I) comprises the carrier element (13) and that the carrier element (13) comprises the support surface (7), preferably, that the carrier element (13) when supporting the application device (I) to change. in particular for enlarging, the angle of the stylet (3) to the skin surface (4) is at least partially bendable.

7. Application device (1) according to claim 5, characterized in that the Trägerelemcnt (13) has the transfer surface (9), which is arranged with respect to the skin surface (4) circumferentially to the stylet (3).

8. Application device (1) according to any one of the preceding claims, characterized in that in the region of the transfer surface (9) at least one optical deflecting element (16) for deflecting the light beams (10) in the below the skin surface (4) located tissue is provided. in particular, that the at least one deflecting element (16) is arranged at a distance from the at least one light source (5).

9. Application device (1) according to claim 3 or 6, characterized marked. in that the carrier element (13) is arranged to guide the light beams (10) generated by the light source (5) to the transfer surface (9), in particular that the carrier element (13) substantially consists of a light-conducting material and / or that the carrier element (13) has a separate optical fiber arrangement, in particular, a fiber optic cable.

10. Application device (1) according to claim 3, 6 or 9, characterized in that the carrier element (13) comprises at least one Lichteinkoppelstelle (18), preferably that each light source (5) the generated light beams (10) in at least one Lichteinkoppelstelle (18 ).

1 1. Application device (1) according to any one of claims 3, 6, 9 or 10, characterized in that the carrier element (13), a guide (19), in particular a guide opening. for guiding a catheter (2) accommodated by the carrier element (13) after the venipuncture.

12. Application device (1) according to claim II, characterized in that the guide (19) is designed as Längsfuhrung along the catheter longitudinal axis (20), in particular that the guide (19) from the catheter receiving (6) to an end of the Carrier element (13). in particular to the transfer surface (9) extends.

13. Application device (I) according to claim 12, characterized in that the end region of the carrier element (13), a Entnahmöffhung (21) for separating the catheter (2) from the carrier element (13), preferably, wherein the guide (19 ), in particular the guide opening, into the removal opening (21) and the removal opening (21) for passage through the catheter (2), in particular for passage through a port (22) of the catheter (2), is dimensioned.

14. Application device (1) according to any one of claims 3, 6, 9 or 10 to

13, characterized in that the carrier element (13) at least in the region of the removal opening (21) for separating the catheter (2) of the support element (13) adjustable, in particular spreadable, is

15. Application device (1) according to any one of claims 3, 6, 9 or 10 to

14, characterized in that the carrier element (13) in the region of the transfer surface (9) on a side facing away from the skin surface (4) has a vapor deposition (23), in particular is mirrored, to avoid scattering losses.

16. Application device (1) according to any one of the preceding claims, characterized in that the Trägerelementaufhahme (12) for engaging the carrier element (13) has a latching means (24).

17. Application device (1) according to one of the preceding claims, characterized in that the catheter holder (6) is adapted for latching, in particular for clipping, the catheter (2).

18. Application device (I) according to one of the preceding claims, characterized in that the application device (1) at least two Light sources (5). preferably for generating light beams (10) of identical or different wavelength.

19. Application device (I) according to any one of the preceding claims, characterized in that the at least one light source (S) at least one LED (26), preferably, for generating light beams (10) has a wavelength between 580 nm and 620 nm., more preferably, that the light intensity and / or the color mixture of the generated light beams (10) is adjustable or are.

20. Kathether application arrangement with an application device (1) according to one of claims I to 19 and a catheter (2), which is arranged in the catheter Aufhahme (6).

21 catheter assembly with a carrier element (13). which comprises a catheter receptacle (6) for receiving a catheter (2), an applicator device (1) according to any one of claims 1 to 19 and a catheter (2) which is arranged in the catheter receptacle (6).

22 carrier element (13) for an application device (I) according to one of claims 1 to 19 with the Katheteraufhahme (6) for receiving the catheter (2).

23 disposable protective sheath (25) for the sterile use of a support element (13) of an application device (1) according to one of claims 1 to 19, characterized in that the disposable protective sheath (25) for a venipuncture to the support surface (7). attachable.

24. Disposable protective cover (25) according to claim 23, characterized in that the disposable protective cover (25), in particular, for the of the light source (5) generated light beams (10) is translucent.