WO2007034393A2 - Element de fixation adhesif pour dispositif medical, comportant un support en plusieurs parties - Google Patents

Element de fixation adhesif pour dispositif medical, comportant un support en plusieurs parties Download PDF

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Publication number
WO2007034393A2
WO2007034393A2 PCT/IB2006/053321 IB2006053321W WO2007034393A2 WO 2007034393 A2 WO2007034393 A2 WO 2007034393A2 IB 2006053321 W IB2006053321 W IB 2006053321W WO 2007034393 A2 WO2007034393 A2 WO 2007034393A2
Authority
WO
WIPO (PCT)
Prior art keywords
adhesive
carrier
film backing
backing
tab
Prior art date
Application number
PCT/IB2006/053321
Other languages
English (en)
Other versions
WO2007034393A3 (fr
Inventor
Thomas Solosko
Original Assignee
Koninklijke Philips Electronics N.V.
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 Koninklijke Philips Electronics N.V. filed Critical Koninklijke Philips Electronics N.V.
Priority to EP06821094A priority Critical patent/EP1962753A2/fr
Priority to JP2008530723A priority patent/JP2009508561A/ja
Publication of WO2007034393A2 publication Critical patent/WO2007034393A2/fr
Publication of WO2007034393A3 publication Critical patent/WO2007034393A3/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
    • A61F13/02—Adhesive plasters or dressings
    • A61F13/023—Adhesive plasters or dressings wound covering film layers without a fluid handling layer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/683—Means for maintaining contact with the body
    • A61B5/6832—Means for maintaining contact with the body using adhesives
    • A61B5/6833—Adhesive patches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
    • A61B5/28—Bioelectric electrodes therefor specially adapted for particular uses for electrocardiography [ECG]
    • A61B5/282—Holders for multiple electrodes

Definitions

  • This invention relates generally to medical devices with pressure sensitive adhesive backings for attachment to the body of a patient, and more particularly, to a medical device with an adhesive backing having a multi -piece support provided for handling and to facilitate application of the backing.
  • Thin films such as polyurethane films in thicknesses of below 0.001 inch to
  • FIG. 1 illustrates a medical use backing 106 applied to the skin of a patient 102. Since the films have higher moisture vapor transmission rates (MVTR), they allow body moisture to pass from the skin through to the outside of the patch. Also, because these films do not let outside moisture into the patch, they help to minimize skin irritation by maintaining a dry skin surface. In addition, due to their thin, flexible nature, these films stretch and contract with the skin, remaining vir tually unnoticeable to the user as he or she moves, bends and stretches.
  • MVTR moisture vapor transmission rates
  • a frame to the top, non -adhesive surface of the thin film.
  • This frame material is formed from the carrier.
  • the carrier is normally a 0.002 inch to 0.005 inch thick release liner upon which the film is cast and cured.
  • a window is "kiss -cut" through this liner to the top surface of the film and removed, leaving a thick outside border.
  • This border, or frame supports the film and allows it to be easily handled without bending or wrinkling as it is later removed from the release liner and a pplied to the skin. Once on the skin, the frame is carefully lifted away from the top surface of the film leaving only the film behind.
  • One aspect of the invention provides an adhesive backing for a medica 1 device having a conformable film backing with an adhesive side and an opposite non -adhesive side, a multi -piece support disposed on the non -adhesive side of the film backing, and a release liner disposed on the adhesive side of the film backing.
  • Another aspect of the invention provides a method for forming the medical use backing.
  • Another aspect of the invention provides a method for forming an adhesive backing for a medical device which is to be attached to the body to detect a bodily function.
  • a film backing having a carrier on a non -adhesive side and a release liner on an opposite adhesive side is provided.
  • the carrier is cut to provide removable and residual portions of the carrier and the removable portion of the carrier is removed.
  • the adhesive film backing is cut to a shape thereby forming a support for the adhesive film backing from the residual portion of the carrier.
  • the support is formed from a plurality of non -adjoining sections.
  • Figure 1 is a schematic representation of a patient wearing a medical device with an adhesive backing.
  • Figure 2 is an exploded isometric diagram of an adhesive backing and support according to an embodiment of the present invention.
  • Figures 3 A, 3B, and 3C are schematic representations of different steps of a manufacturing process for the support of the adhesive backing of Figure 2.
  • Figure 4 is a plan view of an adhesive backing and support for a medical device according to another embodiment of th e present invention.
  • Figures 5A and 5B are plan views of an adhesive backing and support for a medical device according to another embodiment of the present invention.
  • Figure 5C is an exploded isometric view of the adhesive backing of Figures 5 A and 5B.
  • Figures 6A and 6B are plan views of an adhesive backing and support for a medical device according to another embodiment of the present invention.
  • Figure 6C is an exploded isometric view of the adhesive backing of Figures 6 A and 6B.
  • Figure 7 is a plan view of an adhesive backing and support for a medical device according to another embodiment of the present invention.
  • FIG. 2 illustrates an adhesive backing 200 for a medical device according to an example of the present invention.
  • a film backing 204 has a first side 205 that is adhesive and a second opposite side 206 that is non -adhesive.
  • the film backing 204 can be made from a thin polyurethane film or foam backed with medical grade pressure sensitive adhesive. Typical thicknesses are in the range below 0.001 inch to 0.003 inch thick for film and 0.005 inch to 0.015 inch thick for foam. Due to the thin, flexible nature of the material, the film backing 204 can stretch and contract with the skin, remaining virtually unnoticeable to the patient during movement.
  • the film backing can be used in various medical applications, ranging from wound care bandages and patches to securing medical sensing devices onto the skin of a patient.
  • th e medical device is a cardiac sensor which is attached to the chest of a patient as in Figure 1 and senses heart signals such as an ECG signal.
  • the film backing 204 is semi -permeable to allow body moisture to pass from the skin (on the first side 205) thr ough to the outside (on the second side 206) of the film backing 204, but does no let outside moisture through, thereby helping to minimize skin irritation by maintaining a dry skin surface.
  • a release liner 208 on which the film backing 204 is cast and cured during manufacturing, covers the adhesive of the first side 205 until it is removed when the film backing 204 is applied to a patient.
  • a multi -piece support 209 is formed on the non -adhesive second side 206.
  • the multi -piece support 209 includes separate, non -adjoining pieces 210, 212 that are spaced apart by spaces 234, 236.
  • the pieces 210 and 212 have shapes that correspond to a peripheral edge 230 of the film backing 204 and provide an interior region 250.
  • the multi -piece support 209 provides support for the film backing 204 after the release liner 208 has been removed to facilitate application to the patient. After applying the film backing 204 to the patient, the pieces 210, 212 can be removed.
  • the spaces 234, 236 allow a user to grasp an end of the pieces 210, 212 and remove them from the non -adhesive second side 206 once the film backing 204 has been applied to the skin of the patient.
  • edges 240 proximate the spaces 234, 236 are rounded to facilitate removal of the pieces 210, 212.
  • the particular shape of the edges of the pieces 210, 212 can be different.
  • the material from which the pieces 210, 212 are fo rmed can also be coated with a release agent, such as silicone, to further facilitate removal.
  • the pieces 210, 212 can be similarly sized and shaped, or as shown in Figure 2, can be differently sized and/or shaped.
  • the piece 210 is larger t han the piece 212, which can be used as an indicator of orientation of the adhesive backing 200 during application.
  • the spaces 234, 236 can be designed so that sufficient support is provided during application of the adhesive backing 200 to the patient's skin.
  • the adhesive backing 200 can be manufactured with smaller spaces 234, 236.
  • the widths of the pieces 210, 212 can also be adjusted as well. Although greater support will be provided by having smaller spaces 234, 236, it may be more difficult to form the multi -piece support 209 during manufacture, as will be discussed in more detail below.
  • the spacing can also be adjusted according to the type of material used for the pieces 234, 236, designing a multi-piece support with smaller spaces 234, 236 when using more resilient materials that are less likely to tear during manufacturing of the adhesive backing 200.
  • tab 220 Also shown in Figure 2 is optional tab 220.
  • the tab 220 is positioned on the adhesive first side 205 relative to the pieces 212, 210 on the non-adhesive second side 206 to extend across the space 234, thereby providing additional rigidity to the adhesive backing 200 when the release liner 208 is removed.
  • additional tabs 220 can be provided on the adhesive first side 205 as well.
  • two tabs 220 can be positioned on the adhesive first side 205 so that a first tab 220 extends across the space 234 and a second tab 220 extends across the space 236.
  • a tab 220 can alternatively or additionally be positioned elsewhere on the adhesive first side 205.
  • Such a tab 220 can be used to assist in removal of the release liner 208 by covering a region of the adhesive first side 205 along the peripheral edge 230 where the release liner 208 is not directly attached and provide a starting location from which the release liner 208 can be peeled away.
  • the tab 220 can also provide a non -adhesive region on the adhesive first side 205 where the adhesive backing 200 can be held during application after the release liner 208 has been removed.
  • the tab 220 can be a permanent, semi -permanent, or removable portion affixed to the adhesive first side 205 of the film backing 204. In the re movable case, the tab 220 is typically removed after a greater portion of the film backing 204 is already attached to the patient's skin, and following removal of the tab 220, the remaining portion of the film backing 204 can be attached.
  • An optional tab 224 is also shown in Figure 2.
  • the tab 224 is attached to the pieces 210, 212 of the multi -piece support 209. As shown in Figure 2, the tab 224 bridges the space 236 and increases rigidity of the multi -piece support 209.
  • a tab can be alternatively or additionally attached to the pieces 210, 212 to bridge the space 234. The tab 224 is removed with the multi -piece support.
  • the multi -piece support 209 is formed from a kraft paper carrier provided on the second side 206 of the film backing 204 during manufacturing. Where the carrier of the film backing 204 is used for the multi -piece support 209, the carrier is cut and removed to form the interior region 250 and the spaces 234, 236. The carrier, the film backing 204, and the release liner 208 are then cut to shape. In the embodiment shown in Figure 2, the shape of the adhesive backing 200 is generally rectangular, although other shapes can be formed as well. Other materials can be used fo r the multi -piece support 209 as well. These materials include polymer films, such as polyethylene (LDPE or HDPE), polypropylene, and polyester.
  • LDPE polyethylene
  • HDPE polypropylene
  • the pieces 210, 212 of the multi -piece support 209 can also be non -permanently bonded to the non-adhesive second side 206 using conventional processes known to those in the art, for example, using a pressure -sensitive adhesive, coating, or heatsealing.
  • Figures 3A-3C illustrate a process of forming adhesive backings 200 for a medical device from a roll of film b acking material 300 having a carrier (shown in Figures 3A-3C in Crosshatch).
  • the carrier has been cut along lines 310, 312.
  • a conventional kiss -cutting process, or other cutting process, can be used for cutting through the carrier without cutting the film backing 300.
  • the cut carrier material has been removed from the roll of film backing material 300 to form the interior region 250 and the spaces 234, 236 for a plurality of adhesive backings 200.
  • the film backing 204 is exposed as a result.
  • the internal carrier material can be removed as a single strip, with the carrier material cut for spaces 234, 236 connecting the internal carriers of adjacent adhesive backings 200.
  • the individual adhesive backings 200 are cut from the roll of film backing material 300 to a desired shape.
  • the pieces 210, 212 of the multi -piece support 209 are formed from the remaining carrier material.
  • the shape of the interior region 250 is designed to facilita te the "strip -style" carrier removal from the interior region 250.
  • the shape of the interior region 250 can be designed so that no sharp corners or "cove -like" cuts are used.
  • large radii can be placed on the edges 240 of each s upport piece. The large radii allow the internal carrier to peel cleanly and easily away from the outer carrier piece, through the inside and back to the outside of each adhesive backing 200.
  • all internal edges can be designed to facilitate internal carrier stripping.
  • near -vertical or near -horizontal edges near the spaces 234, 236 can be designed with a slight angle to minimize the chance of the catching and tearing the carrier as it is reaches those edges while being removed.
  • Other techniques and designs for facilitating removal of the carrier material can be used as well.
  • Figure 4 illustrates a plan view of an adhesive backing 400 for a medical device according to another example of the invention.
  • the adhesive backing 400 h as a generally tri-lobe shape.
  • the shape of the adhesive backing 400 may be advantageous in applications where circular electrodes positioned in the lobes are to be attached to a patient.
  • the adhesive backing 400 includes a film backing 404 and a multi -piece support
  • the multi -piece support 409 includes separate, non-adjoining pieces 410, 412 that are spaced apart by spaces 434, 436.
  • the pieces 410 and 412 have shapes that correspond to a peripheral edge 430 of the film backing 404 and provide an interior region 450.
  • the multi -piece support 409 provides support for the film backing 404 after the release liner has been removed when ap plying the adhesive backing 400 to the patient's skin. After applying the film backing 404 to the patient, the pieces 410, 412 can be removed.
  • edges 440 proximate the spaces 434, 436 are rounded to facilitate removal of the pieces 410, 412.
  • Additional Iy in an example where the multi -piece support 409 is formed from a carrier of the film backing 404 and the adhesive backing 400 is manufactured using a "strip -style" carrier removal, near- horizontal (as oriented in Figure 4) edges 460, 464 are designed w ith a 3 -degree angle to reduce tearing during removal of carrier material from the interior region 450 during manufacturing.
  • Figures 5 A and 5B illustrate an alternative example of the adhesive backing 400.
  • Figure 5A illustrates the non -adhesive side of the film backing 404 and the multi -piece support 409 having pieces 410, 412.
  • Figure 5B illustrates the adhesive side of the film backing 404 (release liner not shown) having tabs 420 and 421 disposed thereon.
  • the tabs 420 and 421 cover portions of the adhesive side to facilitate removal of the release liner as well as provide locations at which the adhesive backing 400 can be handled without touching the adhesive after removal of the release line r.
  • the tabs 420 and 421 are also positioned on the adhesive side of the film backing 404 to extend across the gaps 436 and 434, respectively, to increase rigidity of the multi -piece support 409.
  • the tabs 420, 421 are shaped to conform to a portion of the peripheral edge 430 to which the respective tab abuts.
  • Figure 5C illustrates the position of the tabs 420, 421 on the adhesive side of the film backing 404 relative to the pieces 410, 412 and the spaces 436, 434.
  • Figures 6A and 6B illustrate an alterna tive example of the adhesive backing 400.
  • Figure 6A illustrates the non -adhesive side of the film backing 404 and the multi -piece support 409 having pieces 410, 412. Tabs 424, 425 are shown attached to the pieces 410, 412 bridging spaces 436, 434, respec tively. The tabs 424 and 425 are provided to increase rigidity of the multi -piece support 409.
  • Figure 6B illustrates the adhesive side of the film backing 404 (release liner not shown).
  • Figure 6C illustrates the position of the tabs 424, 425 relative to the pieces 410, 412 and the spaces 436, 434.
  • the embodiment of the adhesive backing 400 shown in Figures 6 A, 6B, and 6C uses tabs 424, 425 attached to the pieces 4 10, 412 disposed on the non -adhesive side of the film backing 404.
  • Figure 7 illustrates an adhesive backing 700 according to another example of the invention.
  • the adhesive backing 700 uses a multi -piece support 709 having an "upper" piece 710 and “lower” piece 712 (as oriented in Figure 7) that are separated by spaces 734, 736.
  • the edges 740 of the pieces 710, 712 adjacent the spaces 734, 736 are shaped to facilitate removal of the pieces 710, 712 after application to the patient's skin.
  • the edges 740 further facilitate removal of a carrier material from an interior region 750 during manufacturing.
  • the adhesive backing 700 may be advantageous in applications where electrodes positioned in the lobes are to be attached to a patient.

Abstract

L'invention concerne un élément de fixation adhésif pour un dispositif médical, composé d'une pellicule de fixation souple comportant une face adhésive et une face opposée non adhésive, un support en plusieurs parties disposé sur la face non adhésive de la pellicule de fixation, et une feuille de protection détachable disposée sur la partie adhésive de la pellicule de fixation.
PCT/IB2006/053321 2005-09-20 2006-09-15 Element de fixation adhesif pour dispositif medical, comportant un support en plusieurs parties WO2007034393A2 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
EP06821094A EP1962753A2 (fr) 2005-09-20 2006-09-15 Element de fixation adhesif pour dispositif medical, comportant un support en plusieurs parties
JP2008530723A JP2009508561A (ja) 2005-09-20 2006-09-15 複数要素支持体を有する医療装置の接着裏地

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US71888005P 2005-09-20 2005-09-20
US60/718,880 2005-09-20

Publications (2)

Publication Number Publication Date
WO2007034393A2 true WO2007034393A2 (fr) 2007-03-29
WO2007034393A3 WO2007034393A3 (fr) 2009-03-12

Family

ID=37889215

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2006/053321 WO2007034393A2 (fr) 2005-09-20 2006-09-15 Element de fixation adhesif pour dispositif medical, comportant un support en plusieurs parties

Country Status (3)

Country Link
EP (1) EP1962753A2 (fr)
JP (1) JP2009508561A (fr)
WO (1) WO2007034393A2 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018067758A1 (fr) * 2016-10-07 2018-04-12 3M Innovative Properties Company Pansement adaptable et système d'administration
US10456497B2 (en) 2014-09-10 2019-10-29 C. R. Bard, Inc. Protective dressing for skin-placed medical device

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5531855A (en) * 1993-03-22 1996-07-02 Minnesota Mining And Manufacturing Company Carrier delivered dressing and method of manufacture
WO1997025012A1 (fr) * 1996-01-12 1997-07-17 Smith & Nephew Plc Pansement

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5531855A (en) * 1993-03-22 1996-07-02 Minnesota Mining And Manufacturing Company Carrier delivered dressing and method of manufacture
WO1997025012A1 (fr) * 1996-01-12 1997-07-17 Smith & Nephew Plc Pansement

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10456497B2 (en) 2014-09-10 2019-10-29 C. R. Bard, Inc. Protective dressing for skin-placed medical device
WO2018067758A1 (fr) * 2016-10-07 2018-04-12 3M Innovative Properties Company Pansement adaptable et système d'administration
CN109789039A (zh) * 2016-10-07 2019-05-21 3M创新有限公司 可适形伤口敷料和递送系统
US11246761B2 (en) 2016-10-07 2022-02-15 3M Innovative Properties Company Conformable wound dressing and delivery system
CN109789039B (zh) * 2016-10-07 2022-03-22 3M创新有限公司 可适形伤口敷料和递送系统

Also Published As

Publication number Publication date
WO2007034393A3 (fr) 2009-03-12
JP2009508561A (ja) 2009-03-05
EP1962753A2 (fr) 2008-09-03

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