CA2271882C - Tight puncture seal - Google Patents

Tight puncture seal Download PDF

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Publication number
CA2271882C
CA2271882C CA002271882A CA2271882A CA2271882C CA 2271882 C CA2271882 C CA 2271882C CA 002271882 A CA002271882 A CA 002271882A CA 2271882 A CA2271882 A CA 2271882A CA 2271882 C CA2271882 C CA 2271882C
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CA
Canada
Prior art keywords
puncture closure
closure according
arterial puncture
retaining wall
pressure
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Fee Related
Application number
CA002271882A
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French (fr)
Other versions
CA2271882A1 (en
Inventor
Ernst-Diethelm Harren
Christian Bangert
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
CAP Inc Panama
Original Assignee
CAP Inc Panama
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Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=26031367&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2271882(C) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority claimed from DE19726386A external-priority patent/DE19726386A1/en
Application filed by CAP Inc Panama filed Critical CAP Inc Panama
Publication of CA2271882A1 publication Critical patent/CA2271882A1/en
Application granted granted Critical
Publication of CA2271882C publication Critical patent/CA2271882C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/08Wound clamps or clips, i.e. not or only partly penetrating the tissue ; Devices for bringing together the edges of a wound
    • A61B17/085Wound clamps or clips, i.e. not or only partly penetrating the tissue ; Devices for bringing together the edges of a wound with adhesive layer
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F13/02Adhesive plasters or dressings
    • A61F13/0203Adhesive plasters or dressings having a fluid handling member
    • A61F13/0213Adhesive plasters or dressings having a fluid handling member the fluid handling member being a layer of hydrocoloid, gel forming material
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F13/02Adhesive plasters or dressings
    • A61F13/0203Adhesive plasters or dressings having a fluid handling member
    • A61F13/0226Adhesive plasters or dressings having a fluid handling member characterised by the support layer
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00535Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00637Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for sealing trocar wounds through abdominal wall
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00646Type of implements
    • A61B2017/00659Type of implements located only on one side of the opening
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F2013/00361Plasters
    • A61F2013/00365Plasters use
    • A61F2013/00412Plasters use for use with needles, tubes or catheters
    • A61F2013/00417Plasters use for use with needles, tubes or catheters pierced by needle
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F2013/00361Plasters
    • A61F2013/00365Plasters use
    • A61F2013/00463Plasters use haemostatic
    • A61F2013/00468Plasters use haemostatic applying local pressure

Abstract

An arterial puncture closure is provided for closing a punctured blood vesse l in a human or animal body by means of the blood of the human or the animal. The arterial puncture closure includes a pressure chamber which is configured to be fastened onto the body in the vicinity of the puncture. The pressure chamber is further configured to be loaded with excess pressure. A part of the pressure chamber which is opposite to the bod y is provided with a retaining wall. A closing element of at least 1 mm thickness, is provided, the closing element being made of material having an elastic restoring force. Th e closing element is arranged in an area of the retaining wall in which puncture by th e cannula is planned.

Description

TIGHT PUNCTURE SEAL
TECHNICAL FIELD
The present invention relates to an arterial puncture closure for closing a punctured blood vessel in a human or animal body by means of his own blood.
BACKGROUND ART
DE-44 29 230, WO 96/05774 or WO 97/06735 (published later) describe puncture closures for closing a punctured blood vessel. The pressure chamber of these puncture closures is filled with the blood running out of the blood vessel until the pressure in the pressure chamber equals the blood pressure in the blood vessel, so that a balance of pressure between the blood vessel and the pressure chamber is achieved. This balance of pressure stops the bleeding. The puncture closure disclosed in DE-44 29 230 or in WO
96105774 has a nearly rigid retaining wall that is provided on their underside with an easily extensible pressure wall, preferably made of latex.
Before starting the therapeutic or diagnostic intervention the puncture closure is stuck onto the human or animal body in the area where the blood vessel will be punctured.
Then, the cannula of the injection, the catheter or the like is pierced through the pressure chamber, particularly through the retaining wall and through the pressure wall, before it pierces the skin and the tissue of the patient to reach the blood vessel aimed at. Now, the required therapeutic step may be taken.
In order to avoid the risk of punching out of the retaining wall particles of material when piercing it with the cannula, it has been suggested to provide the retaining and/or the pressure wall with preformed openings. This has not proved practicable, since the blood may run out of these preformed openings, weakening the adhesive layers of the puncture closure so that the blood may run out without control.
When the treatment is over, the cannula is taken out of the body of the patient and of the puncture closure, whereas the puncture closure keeps sticking on the body. Then, the opening in the retaining wall is closed by a closing bracket equipped with glue and is arranged on the retaining wall. (See DE 44 29 230, WO 96/05774 or WO
97/06735.) Single blood drops may ooze out of the pressure chamber and/or of the cannula before the closing bracket has sealed the opening. These blood drops are unhygienic and represent a risk of infection for the caring staff. These blood drops may also weaken the glue so much that the closing bracket can no longer be stuck in a pressure-sealed way onto the retaining wall.
DESCRIPTION OF THE INVENTION
An object of a broad aspect of the present invention is to provide a puncture closure whose pressure chamber may securely be closed once the cannula has been withdrawn.
One broad aspect of the present invention provides an arterial puncture closure for closing a punctured blood vessel in a human or animal body by a cannula by means of the blood of the human or animal. The arterial puncture closure includes a pressure chamber which is configured to be fastened onto the body in the vicinity of the puncture. The pressure chamber is further configured to be loaded with excess pressure, a part of said pressure chamber which is opposite to said body being provided with a retaining wall. A
closing element of at least 1 mm thickness, is provided, the closing element being made of material having an elastic restoring force. The closing element is arranged in an area of the retaining wall in which puncture by the cannula is planned.
A puncture closure made according to a broad aspect of the present invention has the advantage that the cannula pushes the material apart with elastic restoring force or is displacing it, when entering the closing element, thereby, avoiding in a secure manner, the punching out of material particles. When the material is pushed apart, the energy involved is stored in the material with elastic restoring force, so that the material is reintegrating its original position once the cannula has been withdrawn, thus closing the opening made by the puncture of the cannula (memory effect).
The material pushed apart by the cannula securely seals the place of puncture and protects it during the intervention against environmental influences since the material with the elastic restoring force always sits close to the cannula, because of this restoring force.
In one preferred embodiment, the closing element is designed as a spherical segment or as a lens and is arranged, more particularly glued, onto the retaining wall, thereby advantageously reinforcing the retaining wall.
As already explained in DE 44 29 230 or WO 96105774, an advantageous puncture closure has a retaining wall that is substantially-non-extensible or that is rigid in order to prevent the pressure chamber from expanding away from the body of the patient.
This substantially-non-extensible retaining wall enables the pressure chamber to expand mainly towards the body, and the tissue lying between the puncture closure and the blood vessel is compressed so that the blood cannot run into the tissue.
By reinforcing the retaining wall by means of a closing element according to a broad aspect of the present invention arranged on the retaining wall, it is possible to make the retaining wall, just like the pressure wall, of an extensible material.
The extensible retaining wall becomes inflexible by the closing element fastened onto it so that the pressure chamber can not expand significantly away from the body. The fact that the retaining wall and the pressure wall are made of the same extensible material has the advantage that the retaining wall and the pressure wall may be welded (e.g., by thermo-welding or by ultrasonically-welding) together in alignment. Thus a puncture closure manufactured according to this broad aspect of the present invention may be produced at low cost, and the walls of the pressure chamber, joined together in a flow of material, can securely withstand the blood pressure prevailing in human and animal bodies.
A puncture closure with a retaining wall and an extensible pressure wall of polyetherurethane having the same thickness and provided with a closing element arranged on the retaining wall has proved to have a sufficient extension towards the body when used under pressure. It may still be of advantage to make the retaining wall thicker than the pressure wall, since this measure further restrains the extension of the retaining wall.
The closing element may be covered by an outer layer which is substantially-non-extensible or rigid, and preferably is made of polyester or polyetherurethane.
The advantage thereof is that it is more difficult for the retaining wall to extend away from the body, particularly when the outer layer extends beyond the area which is assigned to the cannula puncture. The thus achieved sandwich-like structure of retaining wall - closure element - outer layer reliably prevents the retaining wall from extending too far away from the body.
Another advantage of the outer layer is that it protects the closing element against dirt and/or damage.
In one preferred embodiment of an aspect of the present invention, the outer layer is glued onto the particularly lens-shaped closing element with pressure or pretension so that the closure element is under a certain pressure or pretension. The restoring effect of the material with elastic restoring force of which the closing element is made is reinforced by this measure since, due to the prevailing pressure alone, the closing element already aims at closing the puncture opening made by the cannula as soon as it is withdrawn from the puncture closure. In order to reinforce this effect more, the outer layer is advantageously made of a substantially-non-extensible material as, for example, of a polyester foil or of a foil on polyester basis. The pressure built up on the closing element is thus maintained.
The outer layer extends up to the edge of the puncture closure or even beyond.
This has the advantage that the puncture closure may be easily seized with a finger since it has thus as a whole a palpable stability for the user. Another advantage thereof is that an adherend that extends beyond the edge of the pressure chamber may be used to fasten the puncture closure on the skin of the patient.
In another preferred embodiment of an aspect of the present invention, the puncture closure is air permeable, at least partially and preferably in the area outside the pressure chamber. Thus, the puncture closure stuck on the skin advantageously leaks sweat or other vapours so that no moisture accumulates underneath the puncture closure that might attack the glue and so that the puncture closure does not incommodate the patient.
By another broad aspect of the present invention, the arterial puncture closure, further includes an outer layer which is arranged on said closing element. The outer layer is made of a material which is substantially-rigid and has a thickness of between 10 ~m and 100 ~cm. The arterial puncture closure may also include an outer layer which is configured to extend beyond the area in which the puncture by the cannula is planned.
In a particularly preferred embodiment, the retaining wall and the pressure wall are made of the same extensible material, and the retaining wall is thicker than the pressure wall. Due to the difference in thickness the retaining wall and the pressure wall have different capacities of extension. This difference in extension between the retaining wall and the pressure wall has proved to be sufficient to guide the forces occasioned by the pressure within the pressure chamber onto the tissue so that the puncture opening closes.
This is particularly true when the retaining wall and the pressure wall are made of an extensible polyetherurethane foil, a polyurethane foil or a polypropylene foil. The retaining wall has a thickness of 30 ~m up to 300 ,um and the pressure wall has a thickness of 5 ,um to 100 Vim. When the puncture closure is used for dialysis, the retaining wall has a thickness preferably of 40 ,um and the pressure wall a thickness preferably of 25 ~cm.
When used in cardiology, the retaining wall of the puncture closure has a thickness preferably of 100 ~cm and the pressure wall a thickness preferably of 60 ~cm.
When polyetherurethane is used, no particles are punched out by the cannula that could get into the blood stream.
A retaining wall and a pressure wall made of polyetherurethane, polyurethane, polyether or polypropylene also has the advantage that these materials are air permeable and transparent, so that such a puncture closure is agreeable to wear on the skin and that the place of puncture on the body of the patient remains visible, even when the puncture closure is stuck. This preferred puncture closure is, for example, used for hemodialysis on dialysis patients.
In an alternative embodiment of the puncture closure according to a broad aspect of the present invention, the whole retaining wall is made of a material having an elastic restoring force. The retaining wall either has a uniform thickness or is provided in the puncture area with a corresponding swelling. The pressure wall stuck on the underside of such a retaining wall is extensible as compared to the retaining wall.
The material used for a retaining wall made of elastic material as well as for the closing element should be thick enough so that the opening made by the cannula may be closed again. Corresponding tests with a closing element made of silicone showed that a material thickness of approximately 4 mm is sufficient reliably to close an opening made by a cannula of an outer diameter of 1.8 mm as they are used for hemodialysis.
When using the puncture closure according to an aspect of the present invention in cardiology, far larger opening diameters are made so that the thickness of material should advantageously be of up to 25 mm.
Since the blood pressure in the arteries fluctuates between a peak value and a minimum value depending on the pulse (e.g. between two pulse beats), a certain amount of blood runs out of the pressure chamber as soon as the pressure in the artery momentarily sinks due to the constant pressure built up in the pressure chamber. In order to avoid this, the pressure wall should advantageously be made of a layer having a thickness of 0.2 mm to 3 mm, preferably of 0.5 mm to 1 mm and being made of a material with elastic restoring force. Another possibility is to arrange a closing layer having a thickness of 0.2 mm to 3 mm, preferably of 0.5 mm to 1 mm and made of a material with elastic restoring force inside the pressure chamber on the pressure wall.
In both cases, the blood runs out of the blood vessel into the pressure chamber and first keeps the opening open, since the restoring force of the material is not big enough completely to close the opening. When a certain pressure has built up in the pressure chamber, the closing element or the pressure wall are partially compressed so that, together with the restoring force of the material, the opening in the pressure wall is now closed. The closing layer or pressure wall functioning as a one-way valve shortens the time needed for the pressure chamber to get filled so that, within a very short period of time, a higher maximum pressure may be achieved in the pressure chamber. These two features improve the efficiency of the puncture closure according to a broad aspect of the present invention.
In another preferred embodiment of an aspect of the present invention the retaining wall is made of a material with elastic restoring force that is reinforced by inelastic fibres.
These inelastic fibres may be long fibres arranged crosswise or they may constitute a net, for example.
The advantage thereof is that the retaining wall may be manufactured and more particularly cast together with the closure element made of caoutchouc, rubber, latex, hydrogel, (fluid) silicone, polymer plastic or the like so as to form one integral piece, but that, due to the unelastic fibres, is hardly extensible so that the pressure building up in the pressure chamber only causes the pressure wall but not the retaining wall to extend.
In still another preferred embodiment of an aspect of the present invention, the retaining wall and the pressure wall are glued together with a silicone glue or with a synthetic caoutchouc. Retaining wall and pressure wall are particularly glued together when the retaining wall and the pressure wall are made of different materials.
The problem hereby is that the glue layer is very much exposed to stripping due to the diac-like strain so that it is not able to provide a strong enough adhesive force. When using silicone glue or a synthetic caoutchouc, and more particularly when the glue layer is 0.1 mm to 1 mm thick, the line load is transmitted into a surface load via the thickness of the layer so that the glue may now much more easily control the occurnng forces and keep together the two walls.
Since the bonding emulsion in the vicinity of the puncture opening only has a sealing function and no force, a bonding emulsion is applied in the central area of the pressure chamber of a preferred embodiment, the bonding emulsion having less adhesive strength than the other bonding emulsion. The central area of the pressure chamber may also be kept free of glue. This has the advantage that the puncture closure may be withdrawn more easily from the patient's body, without the closed puncture being strained by strong forces.
DESCRIPTION OF FIGURES
In the accompanying drawings:
Fig. 1 shows a sectional side view of a puncture closure according to an embodiment of an aspect of the present invention with integrated drug carrier;
Fig. 2 shows a sectional side view of a puncture closure according to an embodiment of an aspect of the present invention with an outer layer;
Fig. 3 shows a sectional side view of a puncture closure according to an embodiment of an aspect of the present invention with a lengthened outer layer;
Fig. 4 shows a sectional side view of a puncture closure according to an embodiment of an aspect of the present invention with a closing layer integrated in the pressure chamber;
Fig. 5 shows a sectional side view of a puncture closure according to an embodiment of an aspect of the present invention with a closure element integrated in the retaining wall.
The different figures of the drawing show parts of the subject matter according to broad aspects of the present invention in superproportional enlargements in order to better show its structure.
AT LEAST ONE MODE FOR CARRYING OUT THE INVENTION
The four different embodiments shown in Figures 1 to 4 all have the same core structure, since all these puncture closures 10, 20, 30, 40 are provided with a retaining wall 11, 21, 31, 41 that is only slightly extensible and that is made of a polyetherurethane foil of 40 ,um thickness. The retaining wall is welded in alignment with a pressure wall 12, 22, 32, 42 made of a polyetherurethan foil of 25 ,um thickness so that a pressure chamber 13, 23, 33, 43 is provided between the retaining wall 11, 21, 31, 41 and the pressure wall 12, 22, 32, 42 that receives the blood running out of the blood vessel. The side of the puncture closure 10, 20, 30, 40 facing the body is provided with a skin-tolerated, bio-compatible glue 14, 24, 34, 44 preferably on an acrylate or silicone basis, by means of which the puncture closure 10, 20, 30, 40 may be fastened onto the skin of a patient. In order for the glue layer to remain movable and operative it has to be provided with a protective foil that is not shown here.
A closing element 15, 25, 35, 45 is glued or vulcanized onto the retaining wall 11, 21, 31, 41, more particularly on its upper side, i.e., on the side of the puncture closure 10, 20, 30, 40 that is opposite to the body. The closing element 15, 25, 35, 45 is preferably arranged in the centre on top of the corresponding pressure chamber 13, 23, 33, 43. This closing element 15, 25, 35, 45 is made of silicone and reinforces on one hand the retaining wall 11, 21, 31, 41 while on the other hand, it closes the opening made by the insertion of the cannula after the cannula (not shown) has been withdrawn. In the embodiments shown in Figures 1 to 4, the closing element 15, 25, 35, 45 has the shape of a segment of a circle, i.e., the lower side of the closing element 15, 25, 35, 45 is planar and its upper side is bent.
In other words, the closing element 15, 25, 35, 45 has the shape of a split lens.
This basic version of a puncture closure according to a broad aspect of the present invention has a retaining wall 11, 21, 31, 41 and a pressure wall 12, 22, 32, 42 made of the same material, but the retaining wall 11, 21, 31, 41 is thicker so that it is less extensible than the pressure wall 12, 22, 32, 42. This easy-to-extend polyetherurethane is reinforced in the area of the planned cannula insertion and beyond it by the spherical segment-shaped closing element 15, 25, 35, 45 made of silicone so that the retaining wall 11, 21, 31, 41 only extends slightly when the pressure chamber 13, 23, 33, 43 is filled.
Thus, the main expansion of the pressure chamber 13, 23, 33, 43 is occurnng via the pressure wall 1 2, 22, 32, 42 in direction of the body of the patient so that under no circumstances can the blood escape into the tissue, since the tissue is compressed.
By using similar materials for the pressure wall 12, 22, 32, 42 and for the retaining wall 11, 21, 31, 41, these two walls may easily be bonded together. Thus, a tight enough pressure chamber 13, 23, 33, 43 may be manufactured at low cost.

In the embodiment of the puncture closure 10 according to a broad aspect of the present invention and shown in Figure 1, a drug carrier 16 made of gauze or of a tissue matrix is integrated in the pressure wall 12. The drug Garner 16 may be soaked with a hematostatic for a faster blood coagulation or with another drug.
In the embodiment shown in Figure 2, the puncture closure 20 is provided on its upper side with an outer layer 27 made of a 40 ,um thick polyester foil that completely covers the closing element 25. The outer layer 27 sits so close to the closing element 25 that the closing element is at least slightly compressed. The outer layer 27 is glued due to the glueing effect of the silicone of the closing element 25. This pressure exerted onto the closing element 25 reinforces the restoring force of the silicone, since now, additional exterior forces are acting onto the opening made by the cannula in order to close it. This effect is still reinforced by the fact that, when the pressure chamber 27 is filled, the closing element 25 on the retaining wall 21 is compressed tangentially to the retaining wall. Thus, the pressure exerted onto the closing element 25 to close the puncture is still further increased.
In the embodiment shown in Figure 3, the outer layer 37 is much larger than the closing element 35 itself and extends beyond the edge of the retaining wall 31, so that the outer layer 37 projects clearly beyond the retaining wall 31. In the projecting area of the outer layer 37, a glue 34 is provided on the side facing the body so that the puncture closure 30 may reliably be fastened onto the body of the patient.
In the embodiment shown in Figure 4, a closing layer 48 made of a material with an elastic restoring force, preferably of silicone, is integrated in the pressure chamber 43 of the puncture closure 40. The closing layer 48 is located on the inner side of the pressure wall 42 and is arranged in the area in which the insertion of the cannula is planned. This closing layer 48 acts like a one-way valve and hinders the blood from running out of the pressure chamber 43 during the momentary drop of pressure in the blood vessel.
Figure 5 shows an alternative embodiment of a puncture closure 50 according to a broad aspect of the present invention. Here, the retaining wall S 1 is made of a thick layer of (natural) caoutchouc, latex or silicone. On its underside, an easily extensible pressure wall 52 is stuck that is made of a 25 ,um thick polyetherurethan foil so that a pressure chamber 53 is provided between the retaining wall S 1 and the pressure wall 52. In this embodiment too, the underside of the puncture closure 50 is coated with the above mentioned glue 54.
In an alternative embodiment, the outer layer may be made, just as the retaining wall, of (natural) caoutchouc, latex or silicone. As opposed to the retaining wall 51, the pressure wall 52 is then only given a thickness of 0.5 mm.
All puncture closures 10, 20, 30, 40, 50 described above are used for example in dialysis or in cardiology. When used in dialysis, the puncture closure according to a broad aspect of the present invention is inserted on the forearm in the area of the shunt, whereas in cardiology, the puncture closure according to a broad aspect of the present invention is inserted on the thigh in the area of the femoral artery. When used in dialysis, the cannulas regularly used have a diameter of 1.8 mm, so that a closing element having a thickness of mm is sufficient to close the opening made by the cannula after completion of the intervention. In cardiology, the cannulas and/or catheters inserted into the blood vessel are much thicker and reach diameters of up to 5 mm, so that here, depending on the case, the closing element has to have a thickness of up to 25 mm in order to be able reliably to close the opening.
In an alternative embodiment (not shown), the puncture closure has a retaining wall and a pressure wall, both of them being made of a 150 ,um thick polyetherurethan or incision foil. These two 150 ,um thick foils may be bonded or vulcanized together several times or in alignment, so that a strong connection between the foils is achieved. That connection is so strong that it may withstand the pressure forces occurnng in the pressure chamber when the puncture closure is used in cardiology.
All puncture closures 10, 20, 30, 40, 50 are transparent, in order to keep the blood vessel to be punctured at least approximately visible.
All the elements described in this application and made of a material with an elastic restoring force are at least partially made of rubber, natural caoutchouc, synthetic caoutchouc, latex, silicone, liquid silicone, hydrogel, polymer plastic or of a combination of some of the above mentioned materials.

List of numerals 10, 20, 30, puncture closure 40, 50 11, 21, 31, retaining wall 41, 51 12, 22, 32, pressure wall 42, 52 13, 23, 33, pressure chamber 43, 53 14, 24, 34, glue 44, 54 15, 25, 35, closing element 16 drug carrier 27, 37, 47 outer layer 48 closing layer

Claims (31)

CLAIMS:
1. Arterial puncture closure for closing a punctured blood vessel in a human or animal body by a cannula by means of the blood of said human or animal, said arterial puncture closure comprising:
a pressure chamber which is configured to be fastened onto said body in the vicinity of said puncture, said pressure chamber being further configured to be loaded with excess pressure, a part of said pressure chamber which is opposite to said body being provided with a retaining wall; and a closing element of at least 1 mm thickness, said closing element being made of material having an elastic restoring force, said closing element being arranged in an area of said retaining wall in which puncture by said cannula is planned.
2. The arterial puncture closure according to claim 1, wherein:
said closing element is made of a material having an elastic restoring force;
and said closing element is at least partially made of natural caoutchouc, synthetic caoutchouc, rubber, latex, silicone, liquid silicone, hydrogel, polymeric plastic or a combination thereof.
3. The arterial puncture closure according to claim 1 or 2, wherein said closing element is arranged on said retaining wall.
4. The arterial puncture closure according to claim 3, wherein said element is glued onto said retaining wall.
5. The arterial puncture closure according to any one of claims 1 to 4, wherein, said closing element comprises a spherical segment.
6. The arterial puncture closure according to any one of claims 1 to 5, further comprising:
an outer layer which is arranged on said closing element; and wherein:
said outer layer is made of a material which is substantially-rigid and has a thickness of between 10 µm and 100 µm.
7. The arterial puncture closure according to claim 6, wherein said outer layer is made of polyester or polyetherurethane.
8. The arterial puncture closure according to claim 6 or claim 7, wherein, said outer layer is configured to extend beyond the area in which the puncture by the cannula is planned.
9. The arterial puncture closure according to claim 6, claim 7 or claim 8, wherein said outer layer is fastened onto said puncture closure in such a way that said closing element is constantly under pressure or pretension.
10. The arterial puncture closure according to any one of claims 1 to 9, wherein said pressure chamber further comprises an extensible pressure wall in its area facing said puncture opening.
11. The arterial puncture closure according to claim 10, wherein said retaining wall and said extensible pressure wall are each made of the same extensible material.
12. The arterial puncture closure according to claim 11, wherein said retaining wall is thicker than said extensible pressure wall.
13. The arterial puncture closure according to claim 10, claim 11 or claim 12, wherein said retaining wall is welded in alignment with said extensible pressure wall.
14. The arterial puncture closure according to claim 13, wherein said retaining wall is thermo-welded in alignment with said extensible pressure wall.
15. The arterial puncture closure according to claim 13, wherein said retaining wall is ultrasonically-welded in alignment with said extensible pressure wall.
16. The arterial puncture closure according to any one of claims 10 to 15, wherein said retaining wall is made of a foil of polyetherurethane, polyether or polypropylene, having a thickness of between 30 µm and 100 µm.
17. The arterial puncture closure according to claim 16, wherein the thickness of said foil is 40 µm.
18. The arterial puncture closure according to any one of claims 10 to 17, wherein said pressure wall is made of a foil of polyetherurethane, polyether or polypropylene having a thickness of between 5 µm and 50 µm.
19. The arterial puncture closure according to claim 18, wherein the thickness of said foil is 25 µm.
20. The arterial puncture closure according to any one of claims 10 to 19, further comprising a closing layer made of a material with elastic restoring force and having a thickness of between 0.2 mm to 3 mm which is arranged on the inner side of said extensible pressure wall in the area in which the puncture by the cannula is planned.
21. The arterial puncture closure according to claim 20, wherein said closing layer has a thickness of between 0.5 mm to 1 mm.
22. The arterial puncture closure according to any one of claims 10 to 21, wherein said retaining wall is made of a layer of caoutchouc, latex or silicone having a thickness of between 1 mm and 25 mm.
23. The arterial puncture closure according to claim 22, wherein the thickness of said extensible retaining wall is between 5 mm to 10 mm.
24. The arterial puncture closure according to any one of claims 10 to 23, wherein said extensible pressure wall is made of a layer of caoutchouc, latex or silicone having a thickness of between 0.2 mm and 3 mm.
25. The arterial puncture closure according to claim 24, wherein the thickness of said extensible pressure wall is between 0.5 mm and 1 mm.
26. The arterial puncture closure according to any one of claims 22 to 25, wherein said retaining wall is reinforced by fibres which are inserted in the material of said retaining wall.
27. The arterial puncture closure according to any one of claim 22 to 26, wherein said extensible pressure wall is reinforced by fibres which are inserted in the material of said extensible pressure wall.
28. The arterial puncture closure according to any one of claims 1 to 27, wherein said puncture closure is at least partially air-breathable.
29. The arterial puncture closure according to claim 28, wherein said puncture closure is at least partially air-breathable in the area outside said pressure chamber.
30. The arterial puncture closure according to any one of claims 1 to 29, wherein said puncture closure is transparent, at least in the area where said puncture by said cannula is planned.
31. The arterial puncture closure according to claim 30, wherein said puncture closure is transparent in the whole area of said pressure chamber.
CA002271882A 1996-11-16 1997-11-17 Tight puncture seal Expired - Fee Related CA2271882C (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
DE19647496.5 1996-11-16
DE19647496 1996-11-16
DE19726386A DE19726386A1 (en) 1996-11-16 1997-06-21 Tight puncture closure
DE19726386.0 1997-06-21
PCT/DE1997/002684 WO1998022027A1 (en) 1996-11-16 1997-11-17 Tight puncture seal

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CA2271882A1 CA2271882A1 (en) 1998-05-28
CA2271882C true CA2271882C (en) 2005-02-08

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CN (1) CN1142744C (en)
AT (1) ATE237999T1 (en)
AU (1) AU719167B2 (en)
BR (1) BR9713360A (en)
CA (1) CA2271882C (en)
DE (1) DE19781295B4 (en)
ES (1) ES2191867T3 (en)
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WO (1) WO1998022027A1 (en)

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CA2271882A1 (en) 1998-05-28
EP0955901A1 (en) 1999-11-17
AU719167B2 (en) 2000-05-04
JP2001502956A (en) 2001-03-06
RU2207814C2 (en) 2003-07-10
DE19781295B4 (en) 2006-06-22
CN1142744C (en) 2004-03-24
WO1998022027A1 (en) 1998-05-28
CN1237886A (en) 1999-12-08
DE19781295D2 (en) 1999-12-16
EP0955901B1 (en) 2003-04-23
ATE237999T1 (en) 2003-05-15
BR9713360A (en) 2000-01-25
AU5308198A (en) 1998-06-10
JP3318715B2 (en) 2002-08-26
ES2191867T3 (en) 2003-09-16

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