WO2008061386A1

WO2008061386A1 - Puncture seal

Info

Publication number: WO2008061386A1
Application number: PCT/CH2007/000578
Authority: WO
Inventors: Ernst-Diethelm Harren; Jan Stanek
Original assignee: Serumwerk Bernburg Ag
Priority date: 2006-11-20
Filing date: 2007-11-19
Publication date: 2008-05-29

Abstract

The invention relates to a puncture seal with an adhesive (3) for connection to a body (1), wherein the puncture seal, during use, forms a pressure chamber (5) for receiving endogenous blood, the pressure chamber (5) is arranged between an elastic cover element (4) and body (1), and the pressure chamber (5) is at least partially enclosed at the sides by the adhesive (3), characterized in that a means (6a) for forming a counterpressure chamber (6) is arranged in the elastic cover element (4), the counterpressure chamber is connected, during use, to the pressure chamber (5) such that the counterpressure chamber (6) can be filled with blood during use, and the counterpressure chamber (6) has at least one counterpressure surface (8) oriented in such a way that, when the counterpressure chamber (6) is filled with blood, a compressive force component acts in the direction of the body (1) and/or the adhesive layer (3).

Description

Puncture closure

The invention relates to a puncture closure for closing a blood vessel, in particular for closing an artery after the puncture during a dialysis.

Such articles are e.g. from EP 955 901 Bl. For closing an arterial blood vessel having a puncture opening in the human or animal body by means of autologous blood, a pressure chamber that can be acted upon by overpressure and fastened to the body in the region of the puncture opening is provided. The pressure chamber has in its region facing away from the body a retaining wall and a closure element, wherein the closure element consists of a material with elastic .Rückstellkraft and is mounted in a provided for the insertion of a cannula region of the retaining wall.

In the known puncture closure, there is the problem that a cover element, usually formed as a silicone element, must be fixed by means of a double-sided adhesive with the interposition of a film on the skin. A double-sided adhesive tape has a relatively inelastic polyester film which is coated on both sides with adhesive. Usually it will be on the skin side

Skin adhesive and on the other side an industrial adhesive used for connection with the silicone part. A force acts on this double-sided adhesive from the substantially cylindrically shaped pressure chamber, so that a film can come off the double-sided adhesive tape.

Likewise, it may come after pulling out of the puncture needle dripping through the puncture channel.

It is the object of the present invention to avoid this disadvantage.

Confirmation head © By a means for forming a back pressure chamber and / or a back pressure chamber in the elastic cover the possibility is created to develop a force that counteracts the detachment forces. The backpressure chamber is connected to the pressure chamber via an opening, for example, so that the backpressure chamber can be filled with blood during use, wherein the backpressure chamber has at least one counterpressure surface which is oriented so that when the backpressure chamber is filled with blood there is a pressure force component in the direction of the body and / or the adhesive layer shows .. ".

It is advantageous if the counter-pressure chamber is frusto-conical or cylindrical. These shapes are easy to make. It is also advantageous if "the pressure chamber and / or. ■ '^' -: ■ ^■ • '•• ^{■ *} • ^• ' counter-pressure chamber are rotationally symmetrical. It is particularly advantageous if the center axes of the pressure chamber and the back pressure chamber are formed perpendicular or inclined to the surface of the body.

Further, it is advantageous if the means for forming a counter-pressure chamber are formed as incisions or recesses which expand under the inflowing blood pressure and then form a counter-pressure chamber.

It is also advantageous to design the upper middle part of the elastic covering element of the puncture closure in particular. Likewise, a lens having a particular configuration can be applied to the elastic covering element. The special design is through

Sections on the inside of the upper part of the elastic cover member or the applied lens achieved. ^' This increases the restoring force of the material used, resulting in a more reliable closing of the puncture channel after pulling out the puncture needle. The advantage comes especially to bear, if the material for. the covering or its central part and the lens preferably has a low Shore hardness, namely a hardness less than 20 Shore, ^■ less than 15 Shore. As a predestined material for these purposes, a silicone material in question.

Further, it is advantageous to provide a membrane with a very high, restoring force in the cavity below the .Linse or the cover. After removing the puncture needle, the puncture channel shifts between

Membrane and lens or cover, whereby a dripping blood is also largely avoided. As material for the membrane silicones come into question. , ,. ^'

The geometry of the membrane can be made flat, but also concave or convex curved. The surface of the membrane may be rough, non-adhesive or smooth and adhesive. The geometric design depends on the external forces acting on the puncture closure. The inwardly directed side of the lens or the covering element of the puncture closure is shaped congruent to the configuration of the inserted membrane. The surface -can be flat, flat but also concave or convexly curved to match the membrane used. The arrangement of the membrane, in the back pressure chamber can be carried out loose, floating, continuous or biased.

The invention will be explained in more detail below with reference to the figures of the drawings of several embodiments. Show it:

1 shows a first embodiment of a puncture closure according to the invention;

1 a shows a modification of the first embodiment of the puncture closure according to the invention; FIG. 2 shows a second embodiment of the puncture closure according to the invention; FIG.

FIG. 2a shows a modification of the second embodiment of the puncture closure according to the invention; FIG.

3 shows a third embodiment of the puncture closure according to the invention;

Fig. 4, a fourth embodiment of the puncture closure according to the invention;

5 shows a fifth embodiment of the puncture closure according to the invention; '.. ^''■'"■ . ^" •. - ^'' :. ^{• •} ^{• • • • • • • •} ^•

6 shows a sixth embodiment of the puncture closure according to the invention;

7 shows a seventh embodiment of the puncture closure according to the invention;

8 shows an eighth embodiment of the puncture ^{closure according to} the invention;

9 shows a ninth embodiment of the puncture closure according to the invention;

10 shows a tenth embodiment of the puncture closure according to the invention with a puncture aid;

Fig. 11 is a known embodiment of a

Puncture device;

FIG. 12 shows a further embodiment of the puncture closure according to the invention; FIG. FIG. 13 shows a further embodiment of the puncture closure according to the invention; FIG.

Fig. 13a, b, c further embodiments of the. puncture closure according to the invention,

Fig. 14 shows an embodiment of the invention

Puncture closure without double adhesive

Tape;

Fig. 15 shows an embodiment of the invention

Puncture closure with a bubble-shaped pressure chamber;

Fig. 16a, b, c Description of the effect of a

Embodiment with a Dichtlipppe;

Fig. 17 shows an embodiment of the invention

Puncture closure with an attached lens on the cover;

Figv 18a, b, c embodiments of the invention

Puncture closure with cuts on the outside of the attached lens;

Fig. 19 shows an embodiment of the invention

Puncture closure with an additional membrane in the back pressure chamber;

Fig. 20a, b embodiments of the invention

Puncture closure without or with a roughening of the inside of the cover.

In Fig. 1, a first embodiment of the present invention is shown in a sectional view. On the body 1, an elastic film 2 is arranged, on which the double-sided adhesive 3 (here a double-sided Adhesive tape) is arranged. The double-sided adhesive 3 connects the _. elastic film 2 with the elastic covering element, here a silicone element 4th

The silicone element 4 with an upwardly bulging lens and the elastic film 2 are in the intended use of. pierce a cannula, not shown here. The puncture takes place in a region in which no double-sided adhesive 3 is arranged. This area fills up after the puncture of a blood vessel in the body 1 with blood and serves as a pressure chamber 5. The pressure chamber is substantially cylindrical. The elastic silicone member 4 exerts a pressure opposite to the blood pressure in the pressure chamber 5

The particular embodiment according to the embodiment of the invention contributes to the fact that the pressure in the pressure chamber 5 does not lead to separation phenomena of the adhesive 3. For this purpose, a back pressure chamber 6 is arranged in the silicone element 4, which is connected to the pressure chamber 5 via an opening 7. When used as intended, the Gegendruekkammer 6 fills as well as the pressure chamber 5 with blood.

Unlike the known closure elements thus the Abdeckelemeήt 4 (here silicone element) is not made of a solid material, but internally structured.

The back pressure chamber 6 is formed so that it has a counter-pressure surface 8, whose normal 9 when pressurized a force component which points in the direction of the body 1 (and thus in the direction of the adhesive 3). This force component of the hydrostatic pressure in the backpressure chamber 6 compresses the underlying layers. The tensile forces acting on the adhesive 4 (due to the blood pressure in the pressure chamber 5) are thus at least partially compensated. In the present example, the pressure chamber 5 must withstand an internal pressure up to 0.5 bar. In a conventional design with a pressure chamber with a diameter of 18 mm -from the layers begin already at 0.3 bar ..within \ _ ^{• ■} solve (peeling) so that the tightness after. 40..bis 50 seconds is lost. At rising

Ambient temperatures ^' decreases the bond strength in addition enormously. A comparable embodiment, according to the present invention shown in FIG. 1 even withstands an internal pressure of 0.6 bar for a long time. ;. , ^■ . :

In the embodiment according to FIG. 1, the counter-pressure chamber 6 is designed as a truncated cone standing on the tip,. wherein the oblique conical sides of the counter-pressure surface. , 8 represent. There is an undercut inside the ^• . Silicone element before, but in the face of; elastic material of the silicone element 4 can be produced easily.

The counter-pressure surface 8 is inclined up to 30 ° relative to the surface of the body 1 ^■ here. The opening 7 of the .. Back pressure chamber β has a diameter of 10 mm, which widens in the direction away from the body 1 to 14 mm. ^■ the length of the counter-pressure surface 8 is 2 mm. In principle, of course, other dimensions are possible, which can be adapted to the respective application purposes.

The embodiment of the back pressure chamber 6 according to FIG. 1 has a smooth counterpressure surface 8. By corresponding structuring (eg) of the counter-pressure surface 8, the surface can be purposefully enlarged, so that the desired force component finds more attack surface. , , ^• .

In Fig. Ia of the basic structure of the first embodiment ^{^} sForm of FIG. 1 is shown taking place here the connection between the puncture closure and the body 1 through an adhesive 3 in the form of an applied • adhesive layer. Otherwise, can for. this form of execution refers to • the description of the. Fig. 1 to be referred.

Also, the backpressure chamber 6 can be cylindrical according to FIG. 2 be formed ..

The . Mit.telach.se the .Druckkammer .5 and the back pressure chamber. 6 ^' Are, here "formed perpendicular to the Körperoberf.

Basically, the central axis but also obliquely, to. Be arranged body surface, which would facilitate the puncture of the blood vessel.

Analogous to, variant according to Fig. 1a / is shown in FIG. 2a shows an embodiment according to FIG. 2, in which instead of a double-sided adhesive tape, an adhesive layer -3 is provided. Otherwise, the description of FIGS.

2 reference. be genpmmen. , , , ,

In Fig. FIGS. 3 to 9 each show schematic sectional views through various embodiments. Da.bei are the .Abdeckelemente, 4, pressure chambers 5 and 6 back pressure chambers in each case circular in shape, so das.s when gluing - ^: the, Punkt.ionsvers.chlusses .keine particular direction must be observed must. , , , , .,. _, , -

In FIG. 3 _: a third embodiment is shown, wherein in this representation, as well as in the illustrations according to FIG. 4 to FIG. 9, the puncture closure is shown in each case in a non-use position, ie the back pressure chamber 6 is not deployed shown. When used as intended, the Gegendruckkkammer 6 fills with blood, so. a pressure can be exerted on the surface of the body 1 (here below the puncture closure, not shown) via the counterpressure surfaces 8. Also, in Figs. 3 to 9, an adhesive layer

3 schematically shown, for example, as a double-sided Tape or a simple coating with a. Glue can be executed.

In Fig. 3, the elastic cover member 4 on the body 1 side facing a cylindrical Ausnehrtvung as a pressure chamber 5 on. At the upper circumference of the cylindrical pressure chamber 5 an incision 6a is arranged in a ring parallel to the surface of the body 1. During the intended use of this notch 6 ^"serves as means for forming the back-pressure chamber 6. The blood that flows out of the not shown here, the body 1 from the bottom up in the pressure chamber 5, penetrates into the notch 6a. Thus, in a defined ^' , a back pressure chamber 6 are formed on the upper periphery of the pressure chamber 5. the lower surface of • ^■ -. ^■■■■ incision 6a forms 8. during proper use .the counter-pressure surface..

4, a modification of the third embodiment is shown, in which the incision 6a is not introduced parallel to the body 1, but at an angle of approximately 45 °. Otherwise, the construction and the function correspond to the third embodiment. ^{• ■}

As in the embodiments according to FIGS. 3 and 4, in FIG. 5, the counter-pressure chamber 6 before the intended

Use not fully developed. Rather, the elastic cover 4 has an L-shaped annular recess 6a on the body 1 zugewanden side (ie in Fig. 5 below). When used as intended, the blood flows into the L-shaped recess 6a and expands it, so that class a back pressure chamber 6 is formed. In the horizontal part of the L-shaped notch 6a, the counterpressure surface S forms below. As with the embodiments of Figs. 3 and 4, the recess 6a is a means for forming the back pressure chamber 6. Fig. 6 shows a sixth embodiment of the puncture closure according to the invention, in which, similar to the fifth embodiment (FIG _. 'intended use no back pressure chamber 6 is present. Rather, a ring-shaped manner is arranged ^'notch 6a is used as means for forming a back-pressure chamber 6 as well. ^'The cut 6 is effected here approx. inclined at 45 ° relative to the surface of the body 1. Thus, as an incision 6a, an annular inclined surface is inserted from below into the elastic cover member 4. Of the. Notch 6a thus has the shape of a truncated cone.

In the in Fig. From 7 is illustrated guide form, when used in substantially ^■ ^"the ^'same build-up, as examples of ^{• ■} ^■ _ in. ^• • Fig. .6 From illustrated guide form. In contrast .to a recess 6a is here a recess 6b annular and inclined introduced into the elastic cover element 4. the recess 6b forms an annular gap into which the blood may flow during the intended use. If there is sufficient blood flowed, the recess 6 ^~ b is extended. thus, the recess 6b is at the beginning Part of the pressure chamber 5, later it is a means for forming ^■ - the back pressure chamber. 6

In the eighth embodiment of FIG. 8, the seventh embodiment is shown in FIG. 7 modified to the effect that the recess 6b is widened toward the middle. This creates a larger space for the absorption of the blood.

In the embodiments according to FIG. 3 to 8 was the _. the

Body 1 facing side always substantially smooth, d. H . No part of the puncture fastener protruded downwards.

An advantageous ninth embodiment of the invention (FIG. 9) provides an annular, inclined recess 6b whose transition region to the body is a kind of thin lip 40 (Sealing lip) is formed. Otherwise, the structure of the ninth Ausführungsfαrm corresponds to the eighth embodiment.

The sealing lip 40 protrudes ^' ringf örming down out. If the .Punktionsverschluss placed in the intended use on the surface of the body 1, this lip 40 serves the improved seal. Especially in long-term dialysis patients, there are inflamed, enlarged veins, which are very strong. Lifting the skin .. The thin, particularly elastic sealing lips 40, in use, nestle snugly against this surface shape and prevent blood from escaping in the transition areas. This is illustrated eg in connection with FIG. 16B ^' .

Even if the. Sealing lip 40 is shown only in connection with FIG. 9, such lips can in principle be formed on the back pressure chambers 6 or pressure chambers 5 of all ■ forms of execution of the invention to develop an improved Di cht effect. , ,

In the embodiments according to FIGS. 3 to 9, a punctation closure is shown, which comprises a means 6a; 6b for forming a back pressure chamber 6 and / or a back pressure chamber 6 has. The imple mentation forms according to FIG. 3, 4, 5, 6 have before use as intended no back pressure chamber 6, but only a means 6a for forming the back pressure chamber. 6

7 to 9 have Ausneh.mungen 6b, which initially already form a back pressure chamber 6, but also constitute a means for forming a ^* back pressure chamber 6 during use as intended.

In Fig. 10, an embodiment of the inventive he punctual puncture closure is shown schematically, which has an auxiliary line 11 as a puncture aid. The auxiliary line 11 ^• .is here as an annular line. arranged the spherical part of the elastic cover 4. The puncture should, as shown in Fig. 10, take place so that the angle between the puncture needle 20 and the surface of the body 5 is not more than 30 °. In the case of a puncture with a larger angle, there is a risk that blood will enter the puncture channel in the elastic covering means 4 as a result of the bevelled puncture needle when the puncture needle is withdrawn.

10th

In Fig. il is the known per se execution of a puncture closure shown. The puncture closure is connected to the skin by means of a skin adhesive 20. The skin adhesive is on its upper side with a -PUR film 21 -

15 connected. Compared with other components of the bond is. the PUR film 21 (for example, referred to as elastic film in Fig. 1) is relatively elastic. On the PUR film 21 is. above a double-sided adhesive tape 22 is arranged, which has a carrier tape 23 coated on both sides. The

20 carrier tape 23 is relatively inelastic. The difference in elasticity 'between the different components of the puncture closure can -führen- to wrinkles, ■ can cause a ^• fceilweises peeling (peeling). This could leak blood from the puncture closure. Other disadvantages

25 of this article were described in the introduction.

In Fig. 12 is a further embodiment of the embodiment of the present invention punctation closure shown. With the

Skin is a skin glue 20 connected. Over the skin adhesive 20

30 is a PUR film 21 angeordet, on which in turn a ^' double-sided adhesive tape 22 is arranged which connects to the "silicone part" The carrier tape 23 of the double-sided adhesive tape 22 has a similar elasticity as the cover member 4. Thus, the partial

35 Removal of the puncture closure from the skin of the patient avoided. In the Fig. 12 is analogous to FIG. 1 shows a pressure chamber 5, at the periphery of a Counter-pressure surface is arranged, which seals the substantially cylindrical pressure chamber 5 in use against the environment. In use, blood flows into the pressure chamber 5. • •

FIG. 13 shows a development of the embodiment of the invention in which the double-sided adhesive tape 22 is dispensed with. The PUR film 21 is coated on both sides with adhesive, wherein skin adhesive 20 is applied to the skin side, on the side facing away from the skin, an adhesive 24 is applied for connecting the PUR film 21 with the elastic cover member 4 made of silicone. Here, the region 30 below the pressure chamber 5 remains free of the adhesive 24 not to impair ^■ around the puncture.

Analogous adhesive arrangements, as in FIG. 13, ie without double-sided adhesive tape 21, can basically be used in all embodiments of the invention. ^'

In Fig. 13a, a further embodiment of the invention is shown. As in FIG. 13, the double-sided adhesive tape 22 is dispensed with. As carrier tape 23 'for the Kl ^_"boar. 20, 24, a film is used whose modulus of elasticity is similar to the modulus of elasticity of the cover. 4 Contrary to the usual. Choice of materials for the carrier tape 23 which is a little elastic material, a high elasticity is desired, so that the carrier tape 23 can follow all movements of the elastic cover element 4. This prevents separation of the puncture closure.

In Fig. 13b is still another Auführungsform the _. Invention shown. As in FIG. 13, the double-sided adhesive tape 22 is dispensed with. As a carrier tape 23 for the adhesive 20, 24, in turn, a film is used, for. B. PUR film whose modulus of elasticity of the ^' modulus of elasticity of Covering element 4 is similar. Contrary to the embodiment in Fig. 13a, the carrier tape 23 is not punched over the entire region 30 of the back pressure chamber 6. Thus, the hole in the carrier tape 23 is substantially smaller than the diameter of the back pressure chamber 6. As a result, the detachment of the ■ puncture closure is even more reduced.

Another variant is shown in Fig. 13c. As in FIG. 13, the double-sided adhesive tape 22 is dispensed with. In contrast to the embodiment in Fig. 13, both

Skin adhesive 20 or adhesive 24 applied over the entire surface of the carrier tape 23. Also with this variant. a good hold of the puncture closure according to the invention on the skin of the patient is achieved.

As stated several times, this variant of the bond in all embodiments of the invention may ^•. be used.

In Fig. 14 is another embodiment of the invention. represented, in the ^' on the PUR film is completely omitted, ie. the skin adhesive 20 provides the connection between the elastic covering element 4 and the skin not shown here. Analogous adhesive arrangement, as in FIG. 14, ie. Only with a skin adhesive 20 can basically be applied to all

Embodiments of the invention, in particular according to FIGS. 1 to 9 are used.

In Fig. 15, another embodiment of the invention is shown, the connection with the skin by skin adhesive ^■ 20 takes place. In principle, however, the other bonds can also be used. In contrast to the other embodiments, the pressure chamber 5 is closed to the environment before use, ie, a bubble is introduced into the elastic cover element 5. During the puncture of this bladder (analogously, for example, FIG. 10), the bladder is also punctured at the lower area. Around the puncture lies Thus, a relatively thin-walled area of silicone ago. Due to the puncture, not shown here, blood enters the pressure chamber 5 ^" , wherein the area lying laterally around the puncture forms a surface on which a pressure force of the blood acts, thus forming a counterpressure surface 8. Within the pressure chamber 5 Thus, the backpressure chamber 6 itself forms, that is, the pressure chamber 5 and the backpressure chamber 6 are located in the former bladder 16. The pressure chamber 5 can also be regarded as a means for generating a backpressure chamber 6.

In connection with FIGS. 16 a, 16 b and 16 c, the particular advantages of the sealing lip 40 will be described. In Fig. 16a, an elastic Abedeckelement 4 is shown schematically on a large vein 50: The pressure chamber 5 and. the back pressure chamber 6 correspond in some of the execution ^'form of FIG. 8. It can be seen that the sealing effect can be improved in such a situation, when the sealing lips of FIG. 16b (see embodiment according to Fig. 9) are used. In Fig. 16c is a perspective view is shown.

In Fig. 17 is a development of the invention

Puncture closure shown. In the area of the auxiliary line 11 of the elastic covering element 4, as described in FIG. 10, a lens 11 is additionally applied. The lens 11 is made of a silicone material having a hardness of less than 20 Shore, preferably less than 15 Shore. It has been found that in the case of materials with this low Shore hardness, only a narrow cutting band is produced after pulling out the injection needle .20 in the lens 11. As a result, a dripping of the blood is greatly reduced, and also reduces the dripping time.

The lens 11 can in principle be molded onto all embodiments of the puncture closure according to the invention, in order to achieve an improved sealing effect in the puncture channel. In FIGS. 18 a, b, c, further developments of the embodiment shown in FIG. 17 are shown. shown puncture closure shown. The additional lens has in the middle of its cover member: side facing a cut 13 in a cross shape or more adjacent sections 13 in one direction. The lens is shown here without the actual puncture closure. The measures provided for on the outside of the lens 11 cuts 13 help that during insertion and. Pulling out the puncture needle only a minimal

Tensile stress or distortion of the lens 11 occurs in the branch channel.

This effect is also achieved when puncture closures without an additional lens 11 are used. In these cases, in the area of the auxiliary line 10 on the

Inside the cover 4, the cuts provided. Also, this particular configuration can at all

Embodiments of the puncture closure according to the invention are provided.

In Fig. 19 is a further development of the will - ^'puncture closure shown. In the counter-pressure chamber 6, an additional membrane 14 made of a material with a very high restoring force or VerschlieSfähigkeit after piercing with a puncture needle 25 is provided. By building up pressure in the back pressure chamber 6 after withdrawal of the puncture needle ^"25, the diaphragm 14 is pressed upwards against the cover member 4. This leads to displacement of the branch duct in the membrane 14 relative to the cover member. 4 and thus further to a Component that reduces dripping and reduces dripping time.

The membrane 14 can be classified in the back pressure chamber 6 loosely, floating, positive or biased. Likewise, the most diverse geometric shapes, as straight, curved, concave or convex conceivable. In this case, the cover element 4 facing side of the membrane 14 should have the congruent shape to the inside of the cover 4 ^' . According to the classification in the back pressure chamber 6, the cover 4 to the pointing

Surface of the membrane 14 rough, so non-adhesive or smooth running for a good adhesion.

Of course, the use of a membrane 14 can in principle be provided in all puncture closures according to the invention.

For a good bond, ie bonding, of the cover 4 with the elastic film 2, it is necessary that the surfaces are smooth. On the other hand, care must be taken that the surface of the elastic film 2 does not adhere to the covering element 4 in the region of the counter-pressure chamber 6 or even sticks to the covering element 4, as shown in FIG. 20a. Bonding would lead to no pressure build-up in the backpressure chamber 6 when pulling out the puncture needle 25. As a result, the puncture closure is peeled off the skin and blood escapes under the puncture closure.

It is therefore advantageous if the cover 4 in the region of the back pressure chamber 6 has a sufficient roughness 12, as shown in Fig. 20b. The roughness depth can be generated by eroding, blasting, engraving, etching and others. The roughness depth is preferably greater than 1.6 μm. The inside of the cover 4 can not only, as noted in the drawing, curved, but also all other shapes, such as flat shapes have. The roughening 12 of the cover 4 can be provided in principle in all variants of the puncture closure according to the invention. I body. 2 elastic film

3 adhesive layer, double-sided adhesive tape 4 cover element, silicone leraent

5 pressure chamber

6 back pressure chamber

6a incision as a means for forming a

Back pressure chamber 6b recess as means for forming a back pressure chamber

7 Opening the backpressure chamber .8 Backpressure surface

9. Normal on pressurization of the counter chamber 10 auxiliary line for puncture

II lens

12 roughening.

13 patterns

14 membrane 20 skin glue

21 PUR film

^■ 22 Double-sided adhesive tape

23 carrier tape of the double-sided adhesive tape

24 glue 25 puncture needle

30 area free of glue

40 lip, sealing lip

50 vein

Claims

claims

1. puncture closure with an adhesive (3) for connection 'with a body (1), wherein the

Puncture closure in use forms a pressure chamber (5) for receiving endogenous blood, wherein the pressure chamber (5) between an elastic Abdeckelement-. (4) and. Body (1) is arranged, the pressure chamber (5) is at least partially laterally surrounded by the adhesive (3),

characterized in that

in the elastic covering element (4) a means (6a) for forming "a back pressure chamber (6) and / or a Gegendrückkammer- (6) is arranged, wherein the back pressure chamber (G) in use with the pressure chamber (5) is connected, so that the backpressure chamber (5) can be filled with blood during use, the backpressure chamber (6) having at least one counterpressure surface (8) oriented in such a way as to fill the backpressure chamber (8)

Back pressure chamber (6) with blood a compressive force component towards the body (1) and / or the adhesive layer (3) shows.

2. puncture closure according to claim 1, characterized in that the counter-pressure chamber (6) is frustoconical or cylindrical in use ..

3. puncture closure according to claim 1 or 2, characterized in that the means (6 a) for forming the counter-pressure chamber (6) at least partially a recess ^' or a recess (6 b) in the elastic cover member (4).

4. puncture closure according to claim 3, characterized in that the incision (6 a) or the recess (6 b) has a closed curve, in particular a circular or annular shape.

5. puncture closure according to claim 3 or 4, characterized in that the incision (6 a) or Ausnehπvung .. (6 b) extend at a shallow angle to the surface of the body (1).

6. puncture closure according to at least one of the preceding claims, characterized in that the. Adhesive (3) as an adhesive layer, in particular a double-sided adhesive tape (22) is formed or a double-sided adhesive tape (22).

7. puncture closure according to at least one of the preceding claims, characterized in that the counter-pressure chamber (6) in particular in use via a. Opening is connected to the pressure chamber (5) or in use part of the pressure chamber (5).

8. puncture closure according to at least one of the preceding claims, characterized in that .The pressure chamber (5) and / or the back pressure chamber (6) rotationally symmetrical or formed as a bubble -sind.

9. puncture closure according to claim 8, characterized in that the central axes of the pressure chamber (5) and the counter-pressure chamber (6) are formed perpendicular or inclined to the surface of the body (1).

10. puncture closure according to at least one of the preceding claims, characterized in that on and on the elastic cover (4) has a visual and / or., Sensible annular marking (10) is arranged as an auxiliary line for a puncture.

11. puncture closure according to at least one of the preceding claims, characterized in that the Back pressure chamber (6) and / or the pressure chamber (5) at least partially sealing lips (40).

12. puncture closure after at least one of

5 preceding claims, characterized in that, a region (30) for the puncture is free of adhesive material (20).

13. puncture closure after at least one of

10 preceding claims, characterized in that the components of an adhesive bond (20, 22, 23) and the elastic film (2), in particular a PUR film, have substantially the same Elastitziät.

i5

14. puncture closure according to at least one of the preceding claims, characterized in that, the carrier tape (23) for the adhesive (20, 24), an elastic film, same elasticity as the cover member (4). ^■

20 ^•

15. puncture closure according to claim 14, characterized in that an area (30) ^• f-for the puncture free of carrier tape (23).

25 16 .. puncture closure according to claim 14, characterized in that the carrier tape (23) is not punched over the entire region (30) of the back pressure chamber (6).

30 17. puncture closure according to claim 14, characterized ^' , that the skin adhesive (20) and the adhesive (24) are applied to the entire surface of the carrier tape (23).

35 18. puncture closure according to at least one of the preceding claims, characterized in that the Upper part of the elastic covering element (4) in the region of the annular marking (10) is designed as a lens (11).

19. puncture closure according to at least one of ^' - preceding claims, characterized in that on the elastic cover (4) in the region of the annular marking (10) a lens (11) is applied.

20. puncture closure according to at least one of the preceding claims, characterized in that the.

Lens (11) consists of a material having a hardness of less than 20 Shore preferably less than 15 Shore.

21. puncture closure according to at least one of the preceding claims, characterized in that the - lens (11) has on its inside a section (13) in a cross shape.

22. puncture closure according to at least one of claims 1 to 18, characterized in that the lens (11) on its inner side a plurality of adjacent pointing in the same direction cuts (13); ^{• '} . ^{• ■ •} .

23. puncture closure according to at least one of the preceding claims, characterized in that in the back pressure chamber (6) an additional membrane (14) is provided with high restoring force.

24. puncture closure according to claim 2.3, characterized in that the membrane (14) is arranged loosely, floating, positive or biased in the counter-pressure chamber (S).

25. puncture closure according to claim 23 or 24, characterized in that the membrane (14) is designed in a variety of geometric shapes.

26. puncture closure according to claim 25, characterized in that the membrane (14) is straight, curved, concave or convex.

27. puncture closure according to claim 23 to 26, characterized in that the membrane (14) has a rough or a smooth surface.

.28. Puncture closure according to at least one of the preceding claims, characterized in that the cover element (4) in the region of. Back pressure chamber (6) has a certain roughness (12).

• 29th Puncture closure according to claim 28, characterized,. , characterized in that the roughness (12) by eroding, ^• blasting, engraving, etching, etc. is obtained.