EP1948032A1 - Systeme externe de fermeture des vaisseaux a fermeture automatique comportant une aiguille integree presentant un grand lumen - Google Patents

Systeme externe de fermeture des vaisseaux a fermeture automatique comportant une aiguille integree presentant un grand lumen

Info

Publication number
EP1948032A1
EP1948032A1 EP06817711A EP06817711A EP1948032A1 EP 1948032 A1 EP1948032 A1 EP 1948032A1 EP 06817711 A EP06817711 A EP 06817711A EP 06817711 A EP06817711 A EP 06817711A EP 1948032 A1 EP1948032 A1 EP 1948032A1
Authority
EP
European Patent Office
Prior art keywords
closure
self
integrated
closing external
external vessel
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.)
Withdrawn
Application number
EP06817711A
Other languages
German (de)
English (en)
Inventor
Ernst-Diethelm Harren
March Ulrich Lehmann
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.)
Inova Medical AG
Original Assignee
Inova Medical AG
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Inova Medical AG filed Critical Inova Medical AG
Publication of EP1948032A1 publication Critical patent/EP1948032A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0612—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/08—Wound clamps or clips, i.e. not or only partly penetrating the tissue ; Devices for bringing together the edges of a wound
    • A61B17/085—Wound clamps or clips, i.e. not or only partly penetrating the tissue ; Devices for bringing together the edges of a wound with adhesive layer

Definitions

  • the invention relates to a self-closing external vascular closure with integratedforlumiger needle for puncturing vessels in the human or animal body, with flexible wings for fixation on the body, according to claim 1.
  • the invention relates in particular to a further development in connection with large-sized needles, one with a
  • the flexible wings which are also usually attached to the connecting part, mainly serve to facilitate the one hand, the leadership of the cannula during insertion, on the other hand, as mentioned but also to the safe and easy fixation after the puncture on the human or animal body by means To allow adhesive tapes.
  • large-lumen needle as a collective term for related parts, namely a large-lumen cannula, a connecting part and a protective cap for the cannula, in the sense of a limitation to the essential, but without the (usually existing) connection hose, used.
  • Fistula Needle Model No. F16AS from Gambro. It also shows the previously described design and is available in the sizes G14 to G17 and with connection tube lengths of 15 cm or 30 cm. In this model, the flexible wings are arranged rotatably relative to the connecting part.
  • Nipro's so-called "safetouch fistula needle” This needle has a slidable protective cover, which in turn is provided with said flexible wings, the flexible wings also being either fixed or rotatable movable part serves to protect against accidents.
  • the object of the invention is therefore to provide a device with a large-lumen needle for puncturing vessels in the human or animal body, with which to be performed after puncturing hemostasis is facilitated.
  • the inventive self-closing external vascular closure with integrated large-lumen needle for puncturing vessels in the human or animal body has flexible wings for fixation on the body by means of an adhesive bond.
  • the self-closing external vessel closure has a pressure chamber, a closure part, a closure element and a pressure wall part.
  • the large-lumen needle has a cannula integrated with a connecting part, which is provided with an attachable protective cap for protection against accidents.
  • An inventively designed self-closing external vascular closure with integrated large-lumen needle has the advantage that the flexible wings not only facilitate the guidance of the cannula during insertion and allow a secure and easy fixation of the large-lumen needle on the body after puncture, but that parts of the device, namely the self-closing external vessel closure with the pressure chamber, the closure part, the closure element and the pressure wall part, after pulling out of the cannula can remain at the point of puncture and no other and separate means must be used for hemostasis.
  • a further advantage is that the connecting part with the cannula integrated therein, or a protective part movably mounted in this area, no longer has to have flexible wings and can therefore be manufactured more simply and less expensively.
  • hemostasis in the solution according to the invention takes place by means of autologous blood, because, after withdrawing the cannula from the puncture channel, the blood flowing into the pressure chamber builds up a counterpressure and thus stops the bleeding. That this is so, is due to the fact that the closure element has self-closing properties.
  • the closure element has self-closing properties.
  • FIG. 1 shows a cross section through a self-closing external vessel closure with integratedforlumiger needle (before use), and
  • Fig. 2 is a plan view of the remaining after the removal of the cannula on the puncture site external vessel closure from the side of the closure element.
  • FIG. 1 shows a cross section through a self-closing external vessel closure 1 with integrated large-lumen needle before its use.
  • the needle has a connecting part 2 with a cannula 3 integrated therein.
  • a flexible connection tube 4 is attached or attachable.
  • the flexible connection hose is usually relatively short and in addition provided with a slidable on the hose and resilient configured Abdrückelement and a removable closure.
  • the latter are not shown in the figures, since the AnschluBsschlauch and the aforementioned accessories are not the subject of the invention.
  • the closure element 6 has self-closing properties and is arranged in the part of the pressure chamber 8 facing away from the body and substantially adjacent to the connection part.
  • the closure element 6 may also be designed spherical segment-like or lenticular, round or elliptical.
  • the closure part 5 and the pressure wall part 7 are connected to each other by means of a technical adhesive layer 9, wherein the adhesive layer 9 is missing in the region of the closure element 6, so that there can form the mentioned pressure chamber.
  • a technical adhesive layer 9 On a lower side U, which is intended for skin contact, there is a medical skin adhesive layer 10.
  • both the closure part 5 and the pressure wall part 7 and the technical adhesive layer 9 and the medical skin adhesive layer 10 are preferably transparent.
  • the technical adhesive layer 9 does not need to have skin-specific properties because it can not come into contact with the skin at all.
  • the adhesive layer 9 which in the simplest case only consists of an adhesive (as mentioned above also referred to as a technical adhesive, ie an adhesive without skin-adhesive-specific properties), a carrier film (not shown), the adhesive on both sides is provided.
  • a technical adhesive ie an adhesive without skin-adhesive-specific properties
  • a carrier film not shown
  • the adhesive on both sides is provided.
  • Such a structure of the adhesive layer 9 can be chosen to simplify the production in the sense that the adhesive layer can also be designed as a / supplier part 'for the production of self-closing external vessel closures.
  • the medical skin adhesive layer 10 is intended for contact with the human or animal skin and can therefore also have, for example, antiseptic, antiallergic or analgesic properties due to added active ingredients.
  • the medical skin adhesive layer 10 is in turn still covered with a peelable protective film 11, while the protruding from the self-closing external vessel closure 1 portion of the cannula 3 is covered by a likewise peelable protective cap 12.
  • the protective film 11 and the protective cap 12 are connected to one another in such a way that both can be pulled off together from the large-lumen needle.
  • Parts of the closure part 5, the pressure-wall part 7 and the protective film 11, which form flexible wings 13, are designed as laterally projecting and opposite extensions.
  • Anlique Anlagenn 14 are provided, which may be, for example, non-adhesive areas.
  • FIG. 2 shows a plan view of the vessel closure 1 remaining after the removal of the cannula 3 on the puncture site from the side of the closure element 6.
  • the self-closing external vessel closure 1 and the large-lumen needle are thus integrated into one another according to the invention.
  • suitable material combinations must be selected. That's how it works
  • Closing element 6 and the closure part 5 preferably made of silicone, because in silicone because of the extraordinarily high restoring force after pulling out of the cannula of the puncture automatically closes again, so that no blood can ausfHessen.
  • the pressure-wall part 7 is preferably likewise made of a soft material which adapts well to the skin topography and, although it has a high but lower elasticity than the material of the closure element 6.
  • an approximately 25 microns thick polyurethane film is preferably used, but other materials such as polyester or polypropylene films can be used.
  • the material of the pressure wall part serves to limit and stabilize the silicone layer in the areal extent, but on the other hand it must also be stretchable enough to allow the pressure chamber to form when it fills with blood after retraction of the cannula 3.
  • other material combinations known and suitable to the person skilled in the art may also be considered.
  • the blood vessel intended for puncturing is localized.
  • the protective film 11 connected to the protective cap 3 is pulled off by pulling off the protective cap 12. As a result, the protective film 11 separates from the medical skin adhesive layer 10 and the cannula 3 is exposed.
  • the flexible wings 13 are by means of the Anacrylamide silkn 14 to the rear (toward the
  • the needle (including connection tube 4) is aligned with the puncture. This alignment involves rotating the needle until the beveled tip of the cannula 3 is brought into the desired orientation.
  • the self-closing external vessel closure 1 is adhered to the skin of the patient by means of the medical skin adhesive layer 10. There are no further fasteners needed because the
  • Vessel closure and in particular by the holding force of the closure element 6 is kept stable in the desired position.
  • the cannula 3 is pulled out, the protective cap 12 and the protective film 11 is pushed back on the cannula 3 for safety reasons (risk of injury), but the self-closing external vessel closure 1 remains glued on.
  • the self-closing external vessel closure 1 remains glued on.
  • the pressure chamber 8 expands and fills with blood until, by means of the resulting pressure body (the expanding pressure chamber) has built up a back pressure, the
  • the closure element 6 also ensures that the pressure body inwardly, ie in the direction of the punctured blood vessel, ausformt, and thus also achieves the desired hemostatic effect.
  • the self-closing external vessel closure 1 can be used as a pushing-off aid by applying pressure to the closure element 6, either by the staff or by the patient himself, if he is able to do so.
  • a field of application for self-closing external vascular occlusions 1 according to the invention with integrated large-lumen needles are, in addition to the applications described, for example, also fistula needles, as are used, for example, in dialyses for puncturing inserted shunts. Further developments of the present invention, for example in the field of accident prevention, are of course also possible.
  • the large-lumen needle could be designed so that in a similar manner as in the Nipro safetouch fistula needle after use of the cannula, a protective sleeve over the same, or even by the process of pulling out of the cannula from the closure element automatically a protective sleeve is pulled over the cannula.

Abstract

L’invention concerne un système externe de fermeture des vaisseaux (1) à fermeture automatique comportant une aiguille intégrée présentant un grand lumen destinée à réaliser une ponction dans des vaisseaux corporels humains ou animaux, ledit système comprenant une chambre sous pression (8), une partie de fermeture (5), un élément de fermeture (6) et une paroi de pression (7), ainsi qu’un châssis souple (13) destiné à être fixé au corps. L’aiguille présentant un grand lumen comporte une canule (3) intégrée au moyen d’une pièce d’assemblage (2) et un bout renforcé (12) pouvant être placé sur la canule (3). La canule (3) passe au travers de l’élément de fermeture (6) et la paroi de pression (7). Le bout renforcé (12) pouvant être placé sur la canule (3) est associé à un film de protection (11), de manière à ce que le film de protection (11) et le bout renforcé (12) soient montés de manière retirable sur une couche adhésive cutanée (10) médicale placée sur la paroi de pression (7). Le châssis souple (13) est constitué de la partie de fermeture (5), de la paroi de pression (7) et de la feuille de protection (11). Cette aiguille présentant un grand lumen a l’avantage de faciliter l’hémostase après la ponction.
EP06817711A 2005-11-15 2006-11-09 Systeme externe de fermeture des vaisseaux a fermeture automatique comportant une aiguille integree presentant un grand lumen Withdrawn EP1948032A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CH18322005 2005-11-15
PCT/CH2006/000632 WO2007056879A1 (fr) 2005-11-15 2006-11-09 Systeme externe de fermeture des vaisseaux a fermeture automatique comportant une aiguille integree presentant un grand lumen

Publications (1)

Publication Number Publication Date
EP1948032A1 true EP1948032A1 (fr) 2008-07-30

Family

ID=36636482

Family Applications (1)

Application Number Title Priority Date Filing Date
EP06817711A Withdrawn EP1948032A1 (fr) 2005-11-15 2006-11-09 Systeme externe de fermeture des vaisseaux a fermeture automatique comportant une aiguille integree presentant un grand lumen

Country Status (5)

Country Link
US (1) US20090299293A1 (fr)
EP (1) EP1948032A1 (fr)
JP (1) JP2009515673A (fr)
CN (1) CN101309649A (fr)
WO (1) WO2007056879A1 (fr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10940263B2 (en) 2013-03-04 2021-03-09 Becton, Dickinson And Company Single step removal of cannula guard and adhesive liner in medical device

Family Cites Families (21)

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Publication number Priority date Publication date Assignee Title
US3856020A (en) * 1973-09-17 1974-12-24 S Kovac Trocar-catheter assembly
CA1272423A (fr) * 1986-02-25 1990-08-07 Peter C. Lord Trousse a injection sous-cutanee avec canule souple et methode de fabrication
US5236421A (en) * 1986-05-28 1993-08-17 Lts Lohmann Therapie-Systeme Gmbh & Co. Kg Fixing system for fastening catheters, cannulas or the like to the skin surface and process for the sterile fastening thereof
US5015228A (en) * 1989-06-05 1991-05-14 Eastman Kodak Company Sterilizing dressing device and method for skin puncture
US5545143A (en) * 1993-01-21 1996-08-13 T. S. I. Medical Device for subcutaneous medication delivery
US5342319A (en) * 1993-08-17 1994-08-30 Watson Robert L Transdermal injection appliance
US5496264A (en) * 1993-08-17 1996-03-05 Watson; Robert L. Hemostatic transdermal injection appliance
JP3717952B2 (ja) * 1994-04-01 2005-11-16 ミネソタ マイニング アンド マニュファクチャリング カンパニー 医療用粘着剤及びこれを有する医療用ドレッシング材
DE4447557C2 (de) * 1994-08-18 1997-10-23 Harren Ernst Diethelm Punktionsverschluß
DE4429230C2 (de) * 1994-08-18 1996-09-19 Harren Ernst Diethelm Punktionsverschluß
WO1997006734A1 (fr) * 1995-08-17 1997-02-27 Macropharm Gesellschaft Für Pharmazeutische Und Diagnostische Präparate Gmbh Pansement occlusif a pression
US5738641A (en) * 1996-07-31 1998-04-14 Watson; Robert L. Blood withdrawal patch
US5728071A (en) * 1996-09-09 1998-03-17 Watson; Robert L. Injection patch
ATE237999T1 (de) * 1996-11-16 2003-05-15 Cap Inc Dichter punktionsverschluss
US6036721A (en) * 1996-11-16 2000-03-14 Cap Incorporated Puncture closure
DE19726386A1 (de) * 1996-11-16 1998-05-20 Harren Ernst Diethelm Dichter Punktionsverschluß
US20040068290A1 (en) * 2002-03-27 2004-04-08 Datascope Investment Corp. Device and method for compressing wounds
US7338465B2 (en) * 2002-07-02 2008-03-04 Patton Medical Devices, Lp Infusion device and method thereof
US7309326B2 (en) * 2003-11-18 2007-12-18 Icu Medical, Inc. Infusion set
US8017826B2 (en) * 2004-09-16 2011-09-13 Dsu Medical Corporation Injection and hemostasis site
US20070293888A1 (en) * 2004-10-20 2007-12-20 Ernst-Diethelm Harren Self-Closing External Vascular Closure

Non-Patent Citations (1)

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Title
See references of WO2007056879A1 *

Also Published As

Publication number Publication date
JP2009515673A (ja) 2009-04-16
WO2007056879A1 (fr) 2007-05-24
US20090299293A1 (en) 2009-12-03
CN101309649A (zh) 2008-11-19

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