WO2007034393A2

WO2007034393A2 - Medical device adhesive backing having a multi-piece support

Info

Publication number: WO2007034393A2
Application number: PCT/IB2006/053321
Authority: WO
Inventors: Thomas Solosko
Original assignee: Koninklijke Philips Electronics N.V.
Priority date: 2005-09-20
Filing date: 2006-09-15
Publication date: 2007-03-29
Also published as: WO2007034393A3; EP1962753A2; JP2009508561A

Abstract

An adhesive backing for a medical device has a conformable film backing (204) having an adhesive side and an opposite non -adhesive side, a multi-piece support (209) disposed on the non -adhesive side of the film backing, and a release liner (208) disposed on the adhesive side of the film backing.

Description

MEDICAL DEVICE ADHES IVE BACKING HAVING A MULTI-PIECE

SUPPORT

[001] 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.

[002] Thin films, such as polyurethane films in thicknesses of below 0.001 inch to

0.003 inch thick and thin polyurethane foams fr om 0.005 inch to 0.015 inch thick, backed with medical grade pressure sensitive adhesives, are effective materials for skin applications such as wound care bandages, patches used to hold bags or devices onto the skin, and other applications for medical adh esive backings. Figure 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.

[003] The same thin and flexible properties of these films which make them ideal candidates for skin applications also create challenges in handling and applying them to the skin. Without additional support, they wrinkle, fold and curl upon themselves once they are removed from their release liners.

[004] To increase their handleability and manageability away from the release liner, several current patch designs have added 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. During the patch manufacturing process, 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.

[005] U.S. Patent No. 5,531,855 entitled "Carrier Delivered Dressing and Method of

Manufacture," describes an example of a frame design in detail. Several methods of non-permanently bonding the carrier material or frame to the film including coating and heatsealing is described therein. There are challenges with manufacturing and handling a full -window-style frame. For example, during manufacturing, if the window is kiss - cut into the material, it must subsequently be removed, either during manufacturing or by the user. This requires another manufacturing step, adding cost to the process. For another example, once the patch is on the skin, removing a full frame can be challenging because there is no accessible end or edge to begin the frame -peeling process. A frame having a slit addresses this problem to some degree. That is, a slit in the frame does provide the user with an end to more easily grasp and start the frame removal process. However, providing a slit in the frame does not solve the manufacturing issues with removal of the inner window section.

[006] 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.

[007] 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. [008] In the drawings:

[009] Figure 1 is a schematic representation of a patient wearing a medical device with an adhesive backing.

[010] Figure 2 is an exploded isometric diagram of an adhesive backing and support according to an embodiment of the present invention.

[011] 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.

[012] 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.

[013] 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.

[014] 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.

[015] Figure 7 is a plan view of an adhesive backing and support for a medical device according to another embodiment of the present invention.

[016] Figure 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. As previous discussed, 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. In a constructed embodiment 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.

[017] 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.

[018] A multi -piece support 209 is formed on the non -adhesive second side 206. The multi -piece support 209, as shown in Figure 2, 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. In the particular embodiment of the adhesive backing 200 shown in Figure 2, edges 240 proximate the spaces 234, 236 are rounded to facilitate removal of the pieces 210, 212. In alternative embodiments, however, 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.

[019] The pieces 210, 212 can be similarly sized and shaped, or as shown in Figure 2, can be differently sized and/or shaped. In Figure 2, 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. For example, where greater support is desired, 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.

[020] Also shown in Figure 2 is optional tab 220. In the example shown in Figure 2, 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. Although only one tab 220 is shown in Figure 2, additional tabs 220 can be provided on the adhesive first side 205 as well. For example, 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.

[021] 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. Although not shown in Figure 2, 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.

[022] In one example of the invention, 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. 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.

[023] 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). As shown in Figure 3A, 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. In Figure 3B 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. In Figure 3C, 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.

[024] In various examples, the shape of the interior region 250 is designed to facilita te the "strip -style" carrier removal from the interior region 250. For example, the shape of the interior region 250 can be designed so that no sharp corners or "cove -like" cuts are used. Additionally, 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. In addition, all internal edges can be designed to facilitate internal carrier stripping. For example, 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.

[025] 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.

[026] The adhesive backing 400 includes a film backing 404 and a multi -piece support

409 disposed on a non -adhesive side ("face -up" in Figure 4) and a release liner (not shown) disposed on an adhesive side. 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. The spaces 434, 436 allow a user to grasp an end of the pieces 410, 412 and remove it from the non -adhesive side once the film backing 404 has been applied to the skin of the patient. In the particular example of the adhesive backing 400 shown in Figure 4, 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.

[027] 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. As previously discussed with respect to tab 2 20 (Figure 2), 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.

[028] 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. In contrast to the embodiment of the adhesive backing 400 shown in Figures 5A, 5B, and 5C, 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.

[029] Figure 7 illustrates an adhesive backing 700 according to another example of the invention. Although similar to the tri -lobe shape of the adhesive backing 400 (Figure 4), 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. Additionally, in an embodiment where the multi -piece support 709 is formed from a carrier of the film backing 704 and the adhesive backing 700 is manufactured using a strip -style carrier removal, the edges 740 further facilitate removal of a carrier material from an interior region 750 during manufacturing. As with the adhesive backing 400, the adhesive backing 700 may be advantageous in applications where electrodes positioned in the lobes are to be attached to a patient.

[030] Although the examples of medical use adhesive backings described herein with reference to Figures 2-7 illustrate multi -piece supports having two separate pieces, other examples not specifically discussed herein have a greate r number of pieces. The plurality of pieces can be position along a peripheral edge of the adhesive backing, or in alternative examples, include sections positioned in an interior region as well.

[031] From the foregoing it will be appreciated that, although specific examples of the invention have been described herein for purposes of illustration, various modifications may be made without deviating from the spirit and scope of the invention. Accordingly, the invention is not limited except as by the appended claims.

Claims

WHAT IS CLAIMED IS:

1. A medical device which is to be attached to the body for sensing a bodily function and having an adhesive backing comprising: a conformable film backing having 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.

2. The apparatus of claim 1 wherein the multi -piece support is removable.

3. The apparatus of claim 2 wherein the multi -piece support comprises a multi-piece support formed from a kraft paper carrier of the conformable film backing.

4. The apparatus of claim 3 wherein the kraft paper is coated with a silicone release agent.

5. The apparatus of claim 2 wherein the multi -piece support comprises a multi-piece support formed from a polymer film.

6. The apparatus of claim 5 wherein the polymer film is coated with a silicone release agent.

7. The apparatus of claim 5 wherein the polymer film comprises at least one of polyethylene, polypropylene, and polyester.

8. The apparatus of claim 2 wherein the film backing has a perimeter and wherein the multi -piece support comprises a plurality of separate pieces positioned along the perimeter of the film backing.

9. The apparatus of claim 8 wherein the plurality of separate pieces comprise at least one piece having a peripheral edge shaped to correspond with a portion of the perimeter.

10. The apparatus of claim 8 wherein an interior region of the film backing that is defined by the perimeter is exposed.

11. The apparatus of claim 8 wherein the multi -piece support further comprises at least one separate piece positioned in an interior region of the film backing that is defined by the perimeter.

12. The apparatus of claim 2 wherein the mul ti-piece support comprises a plurality of separate pieces having rounded corners.

13. The apparatus of claim 2, further comprising at least one tab positioned along a peripheral edge of the film backing.

14. The apparatus of claim 13 wherein the tab positioned along the peripheral edge of the film backing is located on the adhesive side.

15. The apparatus of claim 14 wherein the tab is removable from the adhesive side.

16. The apparatus of claim 13 wherein the tab is positioned on the adhesive side corresponding to a space between first and second separate pieces of the multi -piece support.

17. The apparatus of claim 13 wherein the tab is attached to first and second separate pieces of the multi -piece support.

18. A method for forming an adhesive backing for a medical d evice which is to be attached to the body for sensing a bodily function comprising: providing a film backing having a carrier on a non -adhesive side and a release liner on an adhesive side, the non -adhesive and adhesive sides on opposite sides of the film backing; cutting the carrier to provide removable and residual portions of the carrier; removing the removable portion of the carrier; and cutting the adhesive film backing to a shape having a peripheral edge thereby forming a support for the adhesive film backing from the residual portion of the carrier, the support having a plurality of non -adjoining sections.

19. The method of claim 18 wherein removing the removable portion of the carrier comprises removing removable portions of the carrier from two or more adhesive backings as a contiguous piece of the carrier.

20. The method of claim 18 wherein cutting the carrier, removing the removable portion of the carrier, and cutting the adhesive film backing to a shape provides a plurality of non -adjoining sections positioned along the peripheral edge of the shape.

21. The method of claim 20 wherein at least one of the plurality of non - adjoining sections positioned along the peripheral edge of the shape is cut to have a peripheral edge corresponding with the peripher al edge of the shape.

22. The method of claim 20 wherein cutting the carrier, removing the removable portion of the carrier, and cutting the adhesive film backing to a shape exposes an interior region of the film backing.

23. The method of claim 20 wherein cut ting the carrier, removing the removable portion of the carrier, and cutting the adhesive film backing to a shape further provides a non -adjoining section positioned in an interior region of the film backing.

24. The method of claim 18 wherein cutting the ca rrier, removing the removable portion of the carrier, and cutting the adhesive film backing to a shape provides a plurality of non -adjoining sections having rounded corners.

25. The method of claim 18, further comprising providing at least one tab positioned along a peripheral edge of the film backing.

26. The method of claim 25 wherein providing at least one tab comprises providing the tab on the adhesive side.

27. The method of claim 26 wherein the tab on the adhesive side is removable.

28. The method of claim 26 wherein the tab is positioned on the adhesive side corresponding to a space between first and second sections of the plurality of non - adjoining sections. The method of claim 25 wherein the tab is attached to first and second sections of the plurality of non-adjoining sections.