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WO1998013087A2 - Accessoire pour injection sans aiguille - Google Patents

Accessoire pour injection sans aiguille Download PDF

Info

Publication number
WO1998013087A2
WO1998013087A2 PCT/GB1997/002626 GB9702626W WO9813087A2 WO 1998013087 A2 WO1998013087 A2 WO 1998013087A2 GB 9702626 W GB9702626 W GB 9702626W WO 9813087 A2 WO9813087 A2 WO 9813087A2
Authority
WO
WIPO (PCT)
Prior art keywords
injection
location
skin
injector
member according
Prior art date
Application number
PCT/GB1997/002626
Other languages
English (en)
Other versions
WO1998013087A3 (fr
Inventor
Terence Edward Weston
Douglas Arthur Emmott
Original Assignee
Weston Medical Limited
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
Priority claimed from GBGB9620184.3A external-priority patent/GB9620184D0/en
Priority claimed from GBGB9620270.0A external-priority patent/GB9620270D0/en
Application filed by Weston Medical Limited filed Critical Weston Medical Limited
Priority to AU43914/97A priority Critical patent/AU4391497A/en
Publication of WO1998013087A2 publication Critical patent/WO1998013087A2/fr
Publication of WO1998013087A3 publication Critical patent/WO1998013087A3/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/00051—Accessories for dressings
    • A61F13/00063—Accessories for dressings comprising medicaments or additives, e.g. odor control, PH control, debriding, antimicrobic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/02—Adhesive bandages or dressings
    • A61F13/0203—Adhesive bandages or dressings with fluid retention members
    • A61F13/0206—Adhesive bandages or dressings with fluid retention members with absorbent fibrous layers, e.g. woven or non-woven absorbent pads or island dressings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/02—Adhesive bandages or dressings
    • A61F13/0203—Adhesive bandages or dressings with fluid retention members
    • A61F13/0226—Adhesive bandages or dressings with fluid retention members characterised by the support layer
    • 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
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/30—Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules

Definitions

  • This invention relates to an accessory for use in the needleless injection of a stream of injectate through the skin of a subject.
  • Needleless injectors are used as an alternative to needle-type hypodermic syringes for delivering liquid drugs and medicaments directly through the patient's skin and into the tissues without using a hollow needle.
  • Such injectors consist of a piston pump driven by a spring or pressurised gas, which ejects the liquid drug or medicament through a small discharge orifice at a sufficient rate and pressure to pierce the skin and enter the tissues through the hole thus formed.
  • Such injectors have been known for over fifty years, and, until recently, multi- dose injectors were a common device for vaccinating large numbers of people economically.
  • multi-dose injectors could pick up infectious body fluid from one patient and transfer it to the next. This occurred as the result of the nozzle and its surrounding structure touching the skin: either infectious fluid already on the skin or a slight reflux of infectious blood through the injection hole in the skin would be sufficient to contaminate the nozzle. Consequently, multi-dose injectors are now hardly used except in veterinary applications.
  • injectors have the lowest cost per dose of any parenteral delivery system, and there have been attempts recently to provide injectors which have the drug delivered from a disposable capsule attached manually to the injector.
  • injectors which have the drug delivered from a disposable capsule attached manually to the injector.
  • such methods can be inconvenient, and they certainly add to the cost.
  • a member for use in needleless injection of a stream of injectate through the skin of a subject said member being suitable for placing in contact with the skin during injection and being piercable by the stream of injectate when delivered thereto at pressure such that after passage through the member it is at a pressure suitable for passage through the skin.
  • the member is preferably in the form of a self adhesive patch formed of a thin plastics material. Needleless injectors may be designed to have ample power to pierce such a patch without detriment to the injection efficiency.
  • the patch material is substantially self-sealing immediately after the injection, i.e. the hole produced in the patch by the injection has a tendency to close up and prevent reflux of injectate and/or blood.
  • the patch material may be coated or impregnated with a disinfectant, anti-bacterial material, or other an ti- infection material.
  • the advantage of the injection patch is that each patient's skin is covered before contact with the injector nozzle, and there is thus no contamination of the nozzle.
  • the patch material closes the wound to prevent oozing of the fluid.
  • the patch may include an absorbent layer, or the patch material itself may be absorbent, so as to further reduce the chance of contaminating the injector nozzle.
  • the patch is left in place for a short time until the injectate has dispersed somewhat within the tissues. This has the added advantage that scratching of the infection site is prevented whilst the patch is in place. This is similar to the recommended practice of holding a sterile swab in place after any type of injection.
  • the patches may be applied by the patients or by an assistant, or automatically by a device attached to the injector. If the patches are applied some minutes prior to the injection, the outer surface is preferably protected from contamination by a tamper-evident film, which is removed immediately before the injection.
  • the patches may be releasably pre-assembled onto a carrier strip, and protected by a further strip or individual cover, the whole being sterilised.
  • An alternative to using individual patches is to use a continuous strip of material which may be automatically indexed past the nozzle to protect it for each injection. This, however, does not have the advantage of continuing the protection of the injection site for a short time after the injection.
  • Figure 1 is a perspective view showing a member in the form of a patch
  • Figure 2 is a diagrammatic representation of a continuous strip of patches
  • Figure 3 is a perspective view of a needleless injector fitted with a cartridge for feeding patches automatically;
  • Figure 4 is a cross-section through the cartridge of Figure 3, and showing also part of the needleless injector of Figure 3 prior to firing;
  • Figure 5 is a view corresponding to Figure 4 but showing the injector as it is fired.
  • patch 1 comprises a flexible, skin-protecting film
  • the film 2 preferably formed of a suitable plastics material such as polyethylene or a self- sealing material sold under the Trade Mark PARAFILM.
  • the film 2 has a surface
  • the surface of the skin-contacting film 2 which is on the other side of the film to the surface 3 is coated with a layer of adhesive 5, which in turn may be protected by a removable release film 6.
  • the adhesive 5 is selected to be suitable to be adhered to the patient's skin. Often there is a small reverse flow of medicament after an injection, and to allow for this the skin-contacting film 2 may be absorbent and antibacterial (or anti-infection in some other way), or may have a layer of material thereon which is absorbent and anti-infection.
  • the colour of the protective film 4 is different to that of the skin- contacting film 2, or it is visually distinguishable in some other way, for example by giving it a pattern, e.g. of stripes, to enable immediate recognition that the film has been removed and the sterile surface is exposed.
  • the patch is used by removing the release film and sticking the patch to the patient's injection site. Immediately before the injection is given, the protective film
  • the injector nozzle is pressed against the skin-contacting film 3 and the injectate is fired through that film and through the adhesive layer 5.
  • the film 3 and the adhesive layer 5 are integrated with one another to a sufficient extent to ensure that there is no possibility of small pieces of film 3 or adhesive 5 being torn away and injected into the patient.
  • Figure 3 shows a multi dose injector 7 with a cartridge 8 removably attached to the injection end thereof, so as to enable a plurality of injections to be given successively, each through a respective patch applied automatically to the skin of the patient.
  • the injector 7 has an injection nozzle 7a (see Figures 4 and 5).
  • the cartridge 8 is shown in more detail in Figure 4.
  • the cartridge 8 comprises a housing 9 within which a carrier strip 10 having a plurality of patches 1 thereon is wound up on a reel 11.
  • the cartridge 8 has a yoke 12 by means of which it is removably attached to the front end of the injector 7.
  • the barrel 13 of the injector is fixedly mounted in a passageway 14 formed in the yoke 12.
  • a compression spring 15 surrounds the barrel 13 and bears against the yoke 12 at one end and, at the other end, against an abutment 16 fixedly mounted with the casing 9.
  • the yoke 12 is free to slide within a collar 17 which forms an extension from the main body of the casing 9.
  • the carrier strip 10, with the patches 1 carried thereon, is wound on a spool 11.
  • the free end of the strip is threaded over support rollers 18 which are positioned either side of an opening 19 in the front of the casing.
  • the strip passes over a drive wheel 20 and through a nip formed between the drive wheel 20 and a pinch roller 21.
  • the latter keeps the strip in fric onal contact with the surface of the drive wheel, so that when the drive wheel rotates in the direction of the arrow R, by the means described below, the carrier strip is pulled from the spool.
  • the strip exits the cartridge through an opening 22.
  • the drive wheel 15 has a toothed wheel 23 mounted coaxially thereon for rotation therewith.
  • a pawl 24 is urged into engagement with the toothed wheel 23 by a compression spring 25, and a rack 26, pivotally mounted on the yoke 12, is also urged into contact with the toothed wheel 23, this time by means of a tension spring 27 acting between the rack and the yoke.
  • the front of the cartridge 8 is placed on the patient's skin 28, with the opening 19 opposite the intended injection site.
  • the injector 7 is pushed towards the patient's skin 28 in the direction of the arrow F, which causes the yoke 12 to move in the same direction, from the position shown in Figure 4 to that shown in Figure 5.
  • the nozzle 7a of the injector 7 presses against the patch located opposite the opening 19, which is thereby pressed onto'the skin 28, and the injector is operated at this point and the injectate is fired through the patch and into the patient's tissues.
  • the pawl 24 prevents movement of the drive wheel 20. It is greatly preferred that the injector should operate automatically on reaching the optimum skin contact force, and an injector which operates in this manner is described in PCT published application WO 93/03779, to which attention is directed for further details.
  • the patch becomes detached from the carrier strip 10 as a result of the above- described operation, and remains adhered to the patient's skin after removal of the injector nozzle 7a, thus providing short-term protection for the wound, and containing any reflux of injectate.
  • spring 15 returns the cartridge 8 to the position shown in Figure 4, and the rack 26 indexes the drive wheel 20 in the direction of arrow R to move the next patch into position for application.
  • FIG 2 is a diagram showing the structure of an embodiment of carrier strip 10, with patches 1 , for use in the device described above.
  • the carrier strip comprises a film 30, with a release film 31 on one face thereof, to prevent the patch adhesive 5 (see below) from sticking to the film 30 when the strip is rolled up, and adhesive 32 on the opposite face.
  • the patches are secured to the strip by means of the adhesive 32.
  • Each patch 1 comprises a skin-contacting film 2 and adhesive 5, as in the case of the patches shown in Figure 1 , and on the face adjacent the carrier strip 10 each patch has a release film 33 to enable it to detach itself readily from the carrier strip after injection.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Dermatology (AREA)
  • Medical Informatics (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Medicinal Preparation (AREA)

Abstract

L'invention concerne une pastille adhésive, ou une pièce continue de matériau, qui permet d'injecter sans aiguille un flux de produit dans la peau d'un sujet. Dans le cas de la pastille, on colle celle-ci sur la peau du sujet avant l'injection et on fait l'injection au travers de la pastille, qui est percée par le flux du produit injecté. Après l'injection, la pastille reste temporairement collée sur la peau, de façon à la protéger.
PCT/GB1997/002626 1996-09-27 1997-09-26 Accessoire pour injection sans aiguille WO1998013087A2 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU43914/97A AU4391497A (en) 1996-09-27 1997-09-26 Needleless injector accessory

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
GBGB9620184.3A GB9620184D0 (en) 1996-09-27 1996-09-27 Needleless injector accessory
GB9620184.3 1996-09-27
GBGB9620270.0A GB9620270D0 (en) 1996-09-30 1996-09-30 Needleless injector accessory
GB9620270.0 1996-09-30

Publications (2)

Publication Number Publication Date
WO1998013087A2 true WO1998013087A2 (fr) 1998-04-02
WO1998013087A3 WO1998013087A3 (fr) 1998-05-07

Family

ID=26310117

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB1997/002626 WO1998013087A2 (fr) 1996-09-27 1997-09-26 Accessoire pour injection sans aiguille

Country Status (2)

Country Link
AU (1) AU4391497A (fr)
WO (1) WO1998013087A2 (fr)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001026717A1 (fr) * 1999-10-11 2001-04-19 Needleless Ventures, Inc. Protecteur universel contre les infections pour injecteurs sans aiguille
WO2003028797A1 (fr) * 2001-09-28 2003-04-10 Hewlett-Packard Company Systeme d'administration cutanee
WO2007071485A1 (fr) * 2005-12-20 2007-06-28 Novo Nordisk A/S Appareil de rétention cutanée pour une unité médicale d’injection sans aiguille
JP2009525094A (ja) * 2006-01-31 2009-07-09 ノボ・ノルデイスク・エー／エス 事前充填式医療用ジェット注射装置のシール

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1993003779A1 (fr) 1991-08-23 1993-03-04 Weston Medical Limited Injecteur sans aiguille

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2764934A (en) * 1952-06-21 1956-10-02 Kaplan Irving Combined printing device and tape applicator
US3745083A (en) * 1971-02-04 1973-07-10 Kelly T Apparatus for visually marking an article with characters over an opaque background covering
FR2625438A1 (fr) * 1988-01-05 1989-07-07 Cediat Mediffusion Ensemble en kit destine a pratiquer des injections de medicaments ou (et) des prelevements biologiques et/ou pathologiques
DE3838061A1 (de) * 1988-11-10 1990-05-23 Holzer Walter Sterile selbstklebefolie fuer die medizinische eingriffsvorbereitung
CA2116645A1 (fr) * 1993-03-01 1994-09-02 Peter George Sperinck Methode de fabrication d'un pansement adhesif
AU7009994A (en) * 1993-08-11 1995-02-28 Michael John Smith Improvements in and relating to dressings

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1993003779A1 (fr) 1991-08-23 1993-03-04 Weston Medical Limited Injecteur sans aiguille

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001026717A1 (fr) * 1999-10-11 2001-04-19 Needleless Ventures, Inc. Protecteur universel contre les infections pour injecteurs sans aiguille
WO2003028797A1 (fr) * 2001-09-28 2003-04-10 Hewlett-Packard Company Systeme d'administration cutanee
US6723077B2 (en) 2001-09-28 2004-04-20 Hewlett-Packard Development Company, L.P. Cutaneous administration system
US7544190B2 (en) 2001-09-28 2009-06-09 Hewlett-Packard Development Company, L.P. Cutaneous administration system
WO2007071485A1 (fr) * 2005-12-20 2007-06-28 Novo Nordisk A/S Appareil de rétention cutanée pour une unité médicale d’injection sans aiguille
JP2009519798A (ja) * 2005-12-20 2009-05-21 ノボ・ノルデイスク・エー／エス 医療用ジェット式注射ユニットのための皮膚保持装置
US8652095B2 (en) 2005-12-20 2014-02-18 Novo Nordisk A/S Skin retention device for a medical jet injection kit
JP2009525094A (ja) * 2006-01-31 2009-07-09 ノボ・ノルデイスク・エー／エス 事前充填式医療用ジェット注射装置のシール
US8920365B2 (en) 2006-01-31 2014-12-30 Novo Nordisk A/S Seal for a prefilled medical jet injection device

Also Published As

Publication number Publication date
WO1998013087A3 (fr) 1998-05-07
AU4391497A (en) 1998-04-17

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