Wound closure device

[0002] This application is a continuation of application Ser. No. 08/858,015, filed May 16, 1997, now U.S. Pat. No. 5,960,795 which is a continuation-in-part of application Ser. No. 08/544,146, filed Oct. 17, 1995, now U.S. Pat. No. 5,630,430 dated May 20, 1997, which is a continuation-in-part of application Ser. No. 08/278,575, filed Jul. 20, 1994, now U.S. Pat. No. 5,497,788 dated Mar. 12, 1996, which is a continuation of application Ser. No. 08/092,594 filed Jul. 16, 1993, now abandoned.

[0003] This invention relates generally to devices for covering wounds, lacerations, incisions, inserted medical devices and the like. More particularly, but not by way of limitation, this invention relates to an improved device having one or more adhesive layers for covering wounds, lacerations, incisions, and inserted medical devices that can be easily applied by a person wearing surgical gloves and the like.

[0004] The use of film dressing is well known for the purpose of covering wounds. Usually, such wounds are relatively small or are located in a position where there is little or no distension of the skin as a result of movement by the injured person. Wounds, incisions, lacerations, insertion of medical devices, and any related skin traumas wherein there is a separation or penetration of a patient's skin are interchangeable terms as used herein.

[0005] An example of a transparent film dressing is given by Robert W. McCracken, et. al., in U.S. Pat. No. 4,614,183, issued Sep. 30, 1986. The device is often difficult to apply when the user is wearing surgical gloves.

[0006] Another example of a transparent film dressing, which also includes a wound closure feature is embodied in a device sold under the trade name “Steri-Strip”, Laparoscopic Wound Closure System featuring “Tegaderm” Transparent Dressing and made by the Medical-Surgical Division of 3M Health Care, and related to U.S. Pat. No. 3,645,835. When using this dressing, it appears that a narrow closure member is removed, or partially removed, from a release treated paper backing and applied to close the wound. It is then necessary to remove a very thin transparent film that is separate from the closure member and apply this film to cover the area of the trauma. While this device may effectively cover the wound, it is often difficult to apply when wearing gloves.

[0007] In accordance with teachings of the present invention, an improved wound covering device is provided to substantially reduce or eliminate shortcomings previously associated with such wound covering devices.

[0008] The terms “viewing member” and “cover dressing” are used interchangeably and the terms “closure member” and “handle member” are used interchangeably throughout this specification.

[0009] According to one aspect of the present invention a wound covering device for covering and sealing at least a portion of a patient's wound includes an elongated handle member and a cover dressing which is releasably secured to the handle member by a first adhesive layer. The first adhesive layer may be used to secure the cover dressing to an area of skin adjacent to a patient's wound when the cover dressing is disposed in an overlying relation to the wound. The wound covering device further including a flexible hinge member having a width that is approximately coextensive with a portion of the wound to be covered. The flexible hinge member further having a first portion disposed on the cover dressing and a second portion disposed on the handle member. The first portion of the flexible hinge member preferably affixed to the cover dressing by a second adhesive layer. The wound covering device still further including a third adhesive layer disposed on a side of the flexible hinge member remote from the cover dressing for securing the flexible hinge member to the patient's skin adjacent to the wound.

[0010] According to another aspect of the present invention, a wound covering device may include a transparent portion in the handle member for facilitating alignment of the wound covering device relative to at least a portion of the wound to be covered.

[0011] According to yet another aspect of the present invention, a wound covering device includes a primary dressing disposed on the second portion of the hinge member.

[0012] For a more complete understanding of the present invention, and the advantages thereof, reference is now made to the following written description taken in conjunction with the accompanying drawings in which like reference numbers indicate like features, and wherein:

[0013] FIG. 1A is a top view of a wound covering device constructed in accordance with teachings of the present invention;

[0014] FIG. 1B is a sectional view of the wound covering device of FIG. 1A taken generally along line B—B of FIG. 1A;

[0015] FIG. 1C is an exploded view of the wound closure device of FIG. 1A;

[0016] FIG. 2A is a top view of a wound covering device showing the associated handle member disposed over a wound;

[0017] FIG. 2B is a top view of another embodiment of a wound covering device showing the associated handle member disposed over a wound;

[0018] FIG. 2C is a top view of yet another embodiment of a wound covering device showing the associated handle member disposed over a wound;

[0019] FIG. 3 is a top view of a wound covering device showing the associated handle member having an alignment pattern;

[0020] FIGS. 4A-4D are schematic drawings showing an exemplary method of applying a wound covering device according to teachings of the present invention;

[0021] FIG. 5A is a top view of another embodiment of a wound covering device according to the teachings of the present invention;

[0022] FIG. 5B is a drawing in section of the wound covering device shown in FIG. 5A taken generally along the line B—B;

[0023] FIG. 6 is a schematic drawing showing a top view of a modified version of the wound covering device shown in FIG. 5A;

[0024] FIGS. 7A-7C are schematic drawings showing plan views of various embodiments of a wound covering device constructed according to teachings of the present invention;

[0025] FIG. 8 is a schematic drawing showing a top view of still another embodiment of a wound covering device constructed according to teachings of the present invention; and

[0026] FIGS. 9A-9D are schematic drawings showing an exemplary method of applying a wound covering device according to teachings of the present invention.

[0027] FIG. 10 is a plan view of another embodiment of an incision closure device constructed in accordance with the teachings of the present invention;

[0028] FIG. 20 is a cross-sectional view of the incision closure device of FIG. 10 taken generally along the line 2—2 of FIG. 10;

[0029] FIG. 30 is a cross-sectional view of the incision closure device of FIG. 10 positioned adjacent to an incision with a bottom protective member removed;

[0030] FIG. 40 is a top view of a portion of FIG. 30 showing to closure member disposed over the incision;

[0031] FIG. 50 is a view similar to FIG. 40, but showing the incision closed;

[0032] FIG. 60 is a view similar to FIG. 30, but showing the incision closed and having the top protective member removed also;

[0033] FIG. 70 is a view similar to FIG. 50, but showing the viewing member folded over the closure member and encompassing the incision in the skin;

[0034] FIG. 80 is a view taken generally along the line 808 of FIG. 70;

[0035] FIG. 90 is a plan view of a modified form of incision closing device that is also constructed in accordance with the teachings of the invention; and

[0036] FIG. 100 is a plan view of another modified form of incision closing device that is also constructed in accordance with the teachings of the invention.

[0037] The preferred embodiments of the present invention and its advantages are best understood by referring to FIGS. 1-100 of the drawings, like numerals being used for like and corresponding parts of the various drawings. It will be understood that the thicknesses of the layers of materials and other dimensions in the drawings have been greatly exaggerated for purposes of illustration.

[0038] FIGS. 1A-1C show various views of a wound covering device 10. Wound covering device 10 includes elongated handle member 12, which has first side 14 and second side 16. Wound covering device 10 further includes cover dressing 18 having first side 20 and second side 22. First adhesive layer 24 may be disposed on first side 22 of cover dressing 18 such that adhesive layer 24 resides between first side 22 of cover dressing 18 and first side 14 of handle member 12. Wound covering device 10 may also include flexible hinge member 26 having first side 28 and second side 30. Hinge member 26 preferably has a width that is approximately coextensive with a portion of the wound to be covered by wound covering device 10. Hinge member 26 may further include first portion 32 and second portion 34. Second adhesive layer 36 may be disposed on second side 30 of flexible hinge member 26. For the embodiment shown in FIGS. 1B and 1C, second adhesive layer 36 extends over second side 30 of first portion 32 and second portion 34. For some applications, second adhesive layer 36 may only be disposed on second side 30 corresponding with first portion 32.

[0039] Third adhesive layer 38 may further be disposed on first side 28 of hinge member 26. First portion 32 of hinge member 26 is disposed on cover dressing 18 such that second adhesive layer 36 resides between cover dressing 18 nd hinge member 26. Second portion 34 of hinge member 26 is disposed on first side 14 of handle member 12. Second adhesive layer 36 may or may not reside between first portion 32 of hinge member 26 and side 14 of handle member 12. Protective member 40 may be disposed on third adhesive layer 38. Protective member 40 may extend beyond first portion 32 of hinge member 26 to over some or all of first side 20 of cover dressing 18. Similarly, protective member 40 may extend beyond second portion 34 of hinge member 26 to cover some or all of first side 14 of handle member 12.

[0040] Handle member 12 preferably includes an enlarged portion 17 that is at least coextensive with cover dressing 18 so as to prevent undesired exposure of first adhesive layer 24. Provided a portion of handle member 12 is at least coextensive with first adhesive layer 24, handle member 12 may take any size and shape appropriate for a particular application. Handle member 12 may be transparent or opaque, and may be formed from a variety of materials, such a paper, polyester, polyethylene or laminates of these materials. In addition, handle member 12 may be silicon coated on first side 14 to facilitate easy release from cover dressing 18.

[0041] First adhesive layer 24 operates to adhere second side 22 of cover dressing 18 to a patient's sin surrounding a wound. To accomplish this objective, first adhesive layer 24 may, but need not be coextensive with second side 22 of cover dressing 18. First adhesive layer 24 may occupy any area of cover dressing 18 suitable to create an adequate bond between cover dressing 18 and the skin surrounding the wound. For example, first adhesive layer 24 may be located in a relatively narrow band around the periphery of cover dressing 18. To assist in the healing process, adhesive layer 24 may be impregnated with a variety of medicinal agents, such as antimicrobial compounds, antifungal compounds and/or antibacterial compounds. First adhesive layer 24 further operates to releasably attach first side of handle member 12 to second side 22 of cover dressing 18. A release coating may be applied to first side 14 of handle member 12 so that handle member 12 can be readily separated from cover dressing 18 despite the presence of adhesive layer 24.

[0042] Cover dressing 18 operates to cover at least a portion of the wound to be covered. Where cover dressing 18 is coextensive with or larger than the wound to be covered, cover dressing may be used to cover the entire wound. In cases where cover dressing 18 is smaller than the area to be covered, multiple wound covering devices may be used to cover the entire wound. Cover dressing 18 may be fashioned in any shape, size and configuration appropriate to specific applications.

[0043] When disposed in an overlying relation to the wound, cover dressing 18 preferably forms a barrier around the portion of the wound covered. This barrier may prevent external contaminants from entering the wound site, and may also prevent wound exudates from leaking from the wound site. Cover dressing 18 may be transparent or opaque. Utilizing a transparent cover dressing is advantageous in that is facilitates observation of the wound throughout the healing process. Cover dressing 18 may be formed form a variety of materials, such as polyethylene, polyurethane, polypropylene, polyester, woven or non-woven substrates or dydrogel. Depending on the application, cover dressing 18 may comprise a hydrophobic material or a hydrophilic material. To further assist the healing process, cover dressing 18 may be loaded with one or more medicinal agents, such as antimicrobial compounds, antifungal compounds, and/or antibiotic compounds.

[0044] Hinge member 26 operates to secure wound covering device 10 to a selected location or locations adjacent to a patient's wound. Hinge member 26 preferably has a width that is approximately coextensive with the portion of the wound to be covered by a cover dressing 18. It should be noted that hinge member 26 need not be exactly coextensive with the portion of the wound to be covered. Hinge member 26 may be somewhat smaller or larger than the portion of the wound to be covered without departing from the spirit of the invention. In addition, hinge member 26 may be any length. In some applications a primary dressing (not shown) may be affixed to hinge member 26 and subsequently aligned over a portion of the wound to be covered. Details of affixing and utilizing a primary dressing are described below. Hinge member 26 may be transparent or opaque and may be formed from a variety of materials including polyethylene, polyurethane, polyester, woven substrates, non-woven substrates, hydrogel or foam. To further assist in the healing process, hinge member 26 may be loaded with one or more medicinal agents, such as antimicrobial compounds, antifungal compounds, and/or an antibiotic compound. Details of the function of hinge member 26 are described below.

[0045] Second adhesive layer 36 serves to connect first side 20 or cover dressing 18 with second side 30 of first portion 32 of hinge member 26. Second adhesive layer 36 may be disposed on first side 20 of cover dressing 18, or on second side 30 of first portion 32 of hinge member 26. Second adhesive layer 36 may occupy any portion of first side 20 of cover dressing 18 or second side 30 of first portion 32 of hinge member 26 suitable to create a bond between the two structures. Second adhesive layer 36 may, but need not reside between handle member 12 and second side 30 of second portion 34 of hinge member 26.

[0046] Third adhesive layer 38 may cover both first portion 32 and second portion 34 of first side 28 of hinge member 26. Third adhesive layer 38 serves to bond first side 28 of hinge member 26 to a selected area of skin adjacent to a patient's wound. Third adhesive layer 38 may occupy any area of first side 28 of hinge member 26 suitable to create an effective bond between first side 28 of hinge member 26 and the selected area of the patient's skin adjacent to a wound. To assist in the healing process, third adhesive layer 38 may be impregnated with a variety of medicinal agents, such as antimicrobial compounds, antifungal compounds and/or antibacterial compounds.

[0047] It should be observed that when then caregiver peels handle member 12 away from second portion 34 of hinge member 26, any adhesive residing between handle member 12 and second portion 34 of hinge member 26 may tend cause hinge member 26 to be peeled away from the patient's skin. To ensure that hinge member 26 is not removed from the patient's skin when handle member 12 is peeled away, it may be advantageous to leave part of second side 30 of second portion 34 of hinge member 26 free from adhesive. For example, an area of second side 30 of second portion 34 of hinge member 26 remote from cover dressing 18 may be left free from second adhesive layer 36. In this way, third adhesive layer 38 may form a primary bond between hinge member 26 and the patient's skin, while second adhesive layer 36 forms a weaker secondary bond between handle member 12 and second portion 34 of hinge member 26. The caregiver may then peel handle member 12 away from second portion 34 of hinge member 26 without removing hinge member 26 from the patient's skin adjacent to the wound.

[0048] Protective member 40 is preferably releasably attached to hinge member 26 by third adhesive layer 38. A release coating may be applied to the side of protective member 40 adjacent to third adhesive layer 38 so that protective member 40 can be easily separated from hinge member 26 despite the presence of third adhesive layer 38. Protective member 40 is at least coextensive with third adhesive layer 38 so as to prevent undesired exposure of third adhesive layer 38 prior to its application to a patient's skin. Provided that protective member 40 is at least coextensive with third adhesive layer 38, it may take any size and shape. Protective layer 40 may be advantageously fashioned to have dimensions different from those of handle member 12 so that protective member 40 can be readily removed from hinge member 26 when wound covering device 10 is to be applied to the patient's skin adjacent to the wound. Protective member 40 may be formed from a variety of materials, such as paper, polyester, polyethylene, or laminates of these materials.

[0049] FIGS. 2A-2C illustrate various embodiments of wound covering devices 110, 210 and 310, respectively, as well as a method of aligning the wound covering device over a wound according to teachings of the present invention. FIGS. 2A-2C illustrate that elongated handle members 112, 212 and 312 may take a variety of shapes and sizes. In one embodiment (FIG. 2A) handle member 112 may cover an area smaller than a portion of wound 50 to be covered. In such a case, a care giver may align wound covering device 110 by placing handle member 112 in a position approximately over the center of the portion of wound 50 to be covered. In another embodiment (FIG. 2B) handle member 212 may include viewing portion 260. Viewing portion 260 may comprise any portion, or all of handle member 212. In one embodiment, viewing portion 260 includes the entirety of handle member 212, which may be formed from a substantially transparent material to facilitate observation of wound 50 during alignment of wound covering device 210. In another embodiment, viewing portion 260 may comprise only a part of handle member 212. In such a case, viewing portion 260 may comprise a substantially transparent portion of an otherwise opaque handle member. In still another embodiment, viewing portion 260 may consist of an excised portion of handle member 212 through which all or part of wound 50 is visible. Handle member 212 may be die cut to any shape to form viewing portion 260.

[0050] FIG. 2C illustrates still another embodiment in which handle member 312 includes viewing portion 360 which has been die cut to suit a particular application. In this case, handle member 312 may include a first prong 313 and a second prong 315. Prongs 313 and 315 may be die cut to any size, shape or configuration suitable to a particular application. The configuration of handle member 312 may be useful in applications such as where a large dressing requires two hands to deliver the dressing to the wound site.

[0051] FIG. 3 illustrates a wound covering device 410 in which elongated handle member 412 includes alignment pattern 470 for aiding in placement of wound covering device 410 over wound 50. Although alignment pattern 470 is shown as three parallel lines, it should be noted that alignment pattern 470 could be any desired pattern helpful in aiding the care giver to align wound covering device 410 over wound 50. For example, alignment pattern 470 may be a single line, several offset lines, a centering point or a grid pattern. In addition to aiding the care giver in positioning wound covering device 410 over wound 50, alignment pattern 470 may be used to align wound covering device 410 over a medical device, such as a catheter or intravenous tube extending from the patient's skin.

[0052] FIGS. 4A-4D illustrate a method of applying a wound covering device 10 according to the teachings of the present invention. A care giver 5 begins the method of applying wound covering device 10 by removing wound covering device 10 from a sterile package (not shown). Upon removing wound covering device from its packaging, there is no live adhesive exposed. Caregiver 5 proceeds by grasping handle member 12 and cover dressing 18, and removing protective member 40 to expose adhesive layer 38. Because there is no adhesive on the side 16 of handle member 12 or side 20 of cover dressing 18, caregiver 5 may grasp wound covering device 10 without sticking to it. Caregiver 5 may dispose of protective member 40 adjacent 38 removed before application to skin in 4B (as in 1B), or alternatively, may sketch or write notes on protective member 40 and retain it for future reference.

[0053] Caregiver 5 may next align handle member 12 over a wound 50 to be covered (FIG. 4A). Caregiver 5 may be aided in aligning the handle member by viewing portion 260 or 360 and/or alignment pattern 470 (FIGS. 2B, 2C, and 3). If the wound covering device is used to cover and/or secure a medical device extending from a patient's skin, the caregiver will begin by aligning the medical device with an alignment pattern on the handle member. In that type of application, the present invention provides an advantage of enabling the caregiver to apply the wound covering device with one hand while holding the medical device secure with the other.

[0054] Once wound covering device 10 is properly aligned, caregiver 5 may apply pressure across area 1—1 to affix hinge member 26 to a patient's skin 19 adjacent to the portion of the wound to be covered. This causes wound covering device 10 to be affixed to the patient's skin in a location selected by caregiver 5. Caregiver 5 may next grasp handle member 12 at an area 21 remote from cover member 18, and peel handle member 12 away from hinge member 26 until cover dressing 18 is encountered (FIG. 4B). Upon encountering cover dressing 18, caregiver 5 peels handle member 12 away from cover dressing 18, drawing cover dressing over wound 50 (FIG. 4C). Caregiver 5 continues to peel handle member 12 from cover dressing 18 until cover dressing 18 overlies the wound and handle member 12 separates from cover dressing 18. Once handle member 12 has separated from cover dressing 18, caregiver 5 may write notes, such as the date of the application of wound covering device 10, on handle member 12, and retain handle member 12 in the patient's records for future reference. Additionally, caregiver 5 may sketch the outline of wound 50 on handle member 12 to make a record of the extent of the wound for future reference.

[0055] Once cover dressing 18 is disposed in an overlying relationship to wound 50, caregiver 5 may apply pressure to cover member 18 to affix it securely to the skin surrounding wound 50 (FIG. 4D). Cover member 18 forms a barrier around wound 50. This barrier may prevent external contaminants from entering the wound site, and may also prevent wound exudates from leaking from the wound site. In the case of application of wound covering device 10 to a medical device extending from the patient's skin, cover dressing 18 secures the position of the medical device and forms a similar barrier around the medical device.

[0056] FIGS. 5A and 5B show a top view and a cross-sectional view, respectively, of another embodiment of a wound covering device according to the teachings of the present invention. Wound covering device 510 is structurally similar to wound covering device 10 shown in FIGS. 1A-1C. Wound covering device 510 includes handle member 512, which is similar in structure and function to handle member 12 of FIGS. 1A-1C. Like handle member 412 shown in FIG. 3, handle member 512 may include an alignment pattern 570 for aiding in the alignment of wound covering device 510 over a wound. Alignment pattern 570 may be a variety of patterns, such as a single line, a set of parallel lines, a centering point or a grid pattern. Wound covering device 510 further includes a cover dressing 518 disposed on handle member 512. Cover dressing 518 is similar in structure and function to cover dressing 18 of FIGS. 1A-1C. A first adhesive layer 524, which is disposed on cover dressing 518, is similar in structure and function to adhesive layer 24 in FIGS. 1A-1C.

[0057] Wound covering device 510 further includes a flexible hinge member 526 having a first side 528 and a second side 530. Hinge member may further include a first portion 532 and a second portion 534. First portion 532 of hinge member 526 is disposed on cover dressing 518. A second adhesive layer 536 may reside between first portion 532 of hinge member 526 and cover dressing 518. Adhesive layer 536 may be disposed on cover dressing 18 or second side 530 of first portion 532 of hinge member 526. Adhesive layer 536 may occupy any portion of cover dressing 518 or first portion 532 of hinge member 56 suitable to create a bond between the two structures. Second portion 534 of hinge member 526 may be disposed on handle member 512. Adhesive layer 536 may or may not reside between handle member 512 and second portion 534 of hinge member 526. As previously described in reference to wound covering device 10, it may be advantageous to leave a part of second portion 534 of hinge member 526 free from second adhesive layer 536, thus avoiding separation of hinge member 526 from the patient's skin when handle member 512 is removed. First portion 532 of hinge member 526 is similar in structure and function to first portion 32 of hinge member 26 in FIGS. 1A-1C. Second portion 534 of hinge member 526 may be elongated to support a primary dressing 580 disposed on first side 528 of second portion 534 of hinge member 526. Wound covering device 510 may include primary dressing 580. If wound covering device 510 does not already include primary dressing 580, a caregiver may affix a primary dressing to hinge member 526.

[0058] A third adhesive layer 538 is disposed on at least a portion of hinge member 526 on first side 28 of hinge member 526 remote from handle member 512. Adhesive layer 538 serves to bond the side of hinge member 526 remove from handle member 52 to an area of skin adjacent to patient's wound. Adhesive layer 538 may occupy any area of the side of hinge member 526 remote from handle member 512 suitable to create an effective bond between hinge member 526 and an area of the patient's skin adjacent to a wound. Adhesive layer 538 may further function to adhere primary dressing 580 to first side 528 of second portion 534 of hinge member 526. Alternatively, primary dressing 580 may include its own adhesive layer (not shown) facilitating a bond between primary dressing 580 and first side 528 of second portion 534 of hinge member 526. Second portion 534 of hinge member 526 and adhesive layer 538 may extend beyond the perimeters of primary dressing 580. In this way, primary dressing 580 may be disposed on a patient's wound and secured in place by affixing hinge member 526 on the patient's skin adjacent to the wound on either side of the wound.

[0059] Primary dressing 580 may be formed from a variety of materials including foam, hydrogel, hydrocolloid, silicon, woven substrates, non-woven substrates or alginate. Depending on the application, primary dressing 580 may be hydrophobic or hydrophilic. Similarly, depending on the application, primary dressing 580 may be loaded with medicinal agents such as antimicrobial compounds, antifungal compounds and/or antibacterial compounds to reduce the risk of infection.

[0060] A protective member 540 may be releasably attached to hinge member 526 by adhesive layer 538. A release coating may be applied to the side of protective member 540, adjacent to adhesive layer 538 so that protective member 540 can be easily separated from hinge member 526 despite the presence of adhesive layer 538. Protective member 540 is at least co-extensive with adhesive layer 538 so as to prevent undesired exposure of adhesive layer 538 prior to its application to a patient's skin. Provided that protective member 540 is at least co-extensive with adhesive layer 538, it may take any size, shape and configuration. Protective layer 540 may be advantageously fashioned to have dimensions different from those of handle member 512, so that protective member 540 can be readily removed from hinge member 526 when the device is to be applied to the patient's skin adjacent to the wound. Protective member 40 may be formed from a variety of materials, such as paper, polyester, polyethylene or laminates of these materials, Caregiver may sketch or write notes on protective member 40 and retain protective member 540 for future reference.

[0061] FIG. 6 shows a top view of another embodiment of a wound covering device 610 according to the teachings of the present invention. Although all the components are not shown in FIG. 6, the wound covering device 610 includes the same structural components as did the device 510 described in detail hereinbefore. The modification of FIG. 6, as compared to the wound covering device 510, resides in a change to the configuration of hinge member 526 and a primary dressing 680. While hinge member 526 and primary dressing 580 extend to meet the perimeter of handle member 512, the perimeters of hinge member 626 and primary dressing 680 have been excised, or kiss-cut, to form a dry edge 682 around a portion of the perimeters of hinge member 626 and primary dressing 680. Dry edge 682 protects against cold flow causing live adhesive to flow beyond the perimeters of handle member 512 and protective member 540. Because there is an adhesive layer between hinge member 626 and primary dressing 680, pressure applied to primary dressing 580 during shipping or handling may force the adhesive layer between the two to flow beyond the perimeters of these structures. The resulting live adhesive could cause difficulties if it were to contact packaging materials around wound covering device 610. Further, such live adhesive reduces an advantage of this invention; providing a wound covering device which is easy to apply, even when a caregiver is wearing Latex glove. By excising a portion of the perimeters of hinge member 626 and primary dressing 680, dry edge 682 may be formed. Dry edge 682 becomes a protective area, guarding against cold flow of adhesive from the perimeters of hinge member 626 and primary dressing 680.

[0062] FIGS. 7A-7C illustrate various embodiments of wound covering devices according to teachings of the present invention. As shown, the hinge member, primary dressing and cover dressing may assume a variety of shapes, sizes and configurations depending on the application. The primary dressing may be any size relative to the hinge member. The cover dressing will generally be larger than the primary dressing to facilitate covering both the wound and the primary dressing and creating a seal around the portion of the wound to be covered.

[0063] FIG. 7A shows wound covering device 710 having hinge member 726, cover dressing 712 and primary dressing 714. Cover dressing 712 exhibits an octagonal shape and primary dressing 714 is rectangular. This configuration may be useful in a variety of applications. FIG. 7B shows a wound covering device 720 having a hinge member 723, an elliptical cover dressing 722 and a circular primary dressing 724. Wound covering device 720 may be advantageously applied to specific applications, such as covering pressure sores on a patient's hip, ankle, shoulder, elbow or heel. FIG. 7C illustrates a wound covering device 730 having hinge member 733, cover dressing 732 and primary dressing 734. Both cover dressing 732 and a primary dressing 734 exhibit a triangular shape. This configuration may be useful, for example, in an application to pressure sores in the sacral-coccyx area.

[0064] FIG. 8 illustrates another embodiment of a wound covering device 810 in which a primary dressing 880 includes a first fenestration 882. Wound covering device 810 further includes a hinge member 884 having a second fenestration 886 corresponding to first fenestration 882 in primary dressing 880. Fenestration 882 and 886 facilitate placement of wound covering device 810 over a medical device such as a catheter or intravenous device extending from a patient's skin. In such applications, wound covering device 810 may serve to secure the medical device as well as to seal the skin around the medical device preventing moisture from escaping. Details of the application of wound covering device 810 to a medical device extending from a patient's skin are described below.

[0065] FIGS. 9A-9D show a method of applying a wound covering device according to the teachings of the present invention. A caregiver 5 begins the method of applying wound covering device 510 by removing wound covering device 510 from a sterile package (not shown). Upon removing wound covering device from its packaging, there is no live adhesive exposed. Caregiver 5 proceeds by grasping handle member 512 and cover dressing 518, and removing protective member 540 to expose adhesive layer 538 and primary dressing 580. Because there is no adhesive on the side of cover dressing 518 being grasped, wound covering device 510 will not stick to caregiver 5. Caregiver 5 may either dispose of protective member 540 or sketch or write notes on protective member 540 and retain it for future reference.

[0066] If wound covering device 510 does not already include a primary dressing, caregiver 5 may affix primary dressing 580 to first side 528 of second portion 534 of hinge member 526. Caregiver 5 may next align primary dressing 580 over a wound 50 to be covered (FIG. 9A). If wound covering device 810 (FIG. 8) is used to cover and/or secure a medical device extending from a patient's skin, the caregiver will begin by aligning the medical device with fenestration 882 and 886 in primary dressing 880 and hinge member 884, respectively (FIG. 8). In that application, wound covering device 810 provides an advantage of enabling the caregiver to apply wound covering device 810 with one hand while holding the medical device secure with the other.

[0067] Once wound covering device 510 is properly aligned, caregiver 5 may apply pressure across area 3—3 to affix first portion 532 of hinge member 526 to a patient's skin 90 adjacent to the wound to be covered. Depending on the configuration of the wound covering device, caregiver 5 may or may not apply pressure over an area 4—4 to affix second portion 534 of hinge member 526 to an area of skin 95 adjacent to wound 50.

[0068] Once hinge member 26 has been affixed to the patient's skin adjacent to wound 50, caregiver 5 may grasp handle member 512 at an area remote from cover member 518, and peel handle member 512 away from hinge member 526 until cover dressing 518 is encountered (FIG. 9B). Upon encountering cover dressing 518, caregiver 5 peels handle member 512 away from cover dressing 518, drawing cover dressing 518 over wound 50 and primary dressing 580 (FIG. 9C). Caregiver 5 continues to peel handle member 512 from cover dressing 518 until cover dressing 518 overlies primary dressing 580 and handle member 512 separates from cover dressing 518. Caregiver 5 may write notes or sketch on handle member 512, and retain handle member 512 in the patient's records for future reference. Once cover dressing 518 is disposed in an overlying relationship to primary dressing 580, caregiver 5 may apply pressure to cover member 518 to affix cover member 518 securely to the skin surrounding wound 50 (FIG. 9D). Cover member 518 forms a barrier around primary dressing 580 and wound 50. This barrier may prevent external contaminants from entering the wound site, and may also prevent wound exudates from leaking from the wound site.

[0069] The following disclosure contains the specification and figures from application Ser. No. 08/544,146, U.S. Pat. No. 5,630,430. The present application is a continuation of the Ser. No. 08/858,015 application, which claims priority to the '146 application and incorporates the '146 application by reference in its entirety therein.

[0070] A wound closure device constructed in accordance with the present invention includes an elongated closure member; an adhesive on a side of the closure member arranged to be located adjacent to the laceration; an enlarged, substantially transparent, viewing member having one end attached to an adjacent end of the closure member; and an adhesive on a side of the viewing member remote from the closure member for securing the viewing member to the skin adjacent to the laceration when the viewing member is disposed in overlying relation to the closure member.

[0071] As previously noted, the terms “wound”, “incision”, “laceration” and any similar or related trauma resulting in separation of the skin are interchangeable with respect to each other for purposes of defining and claiming the present invention.

[0072] The preferred embodiments of the present invention and its advantages are best understood by referring to FIGS. 10-100 of the drawings, like numerals being used for like and corresponding parts of the various drawings.

[0073] It will be understood that the thicknesses of the layers of materials and other dimensions in the drawing have been greatly exaggerated for purposes of illustration. Further, directions, such as top and bottom refer to the location of the various members in the drawing and, in general, also to their positions relative to a patient. “Top” refers to a location remote from the patient, while “bottom” refers to a location adjacent to the patient.

[0074] Referring to the drawings and to FIGS. 10 and 20 in particular, shown therein and generally designated by the reference character 100, is an incision closure device. The incision closure device 100 includes an elongated closure member 120 having top and bottom adhesive layers 140 and 160 thereon. The closure member is sometimes referred to as a suture strip. The bottom layer of adhesive 160, that is, the layer that will be disposed adjacent to the patient (See FIGS. 30 and 60), must be one that will cause the closure member 120 to adhere to the patient. For some applications, the closure member 120 may be constructed from a material that is transparent or at least translucent so that an incision or wound 170 can be viewed through the closure member 120 during application of the closure device 100 to the patient. For many applications, the closure member 120 is preferably formed from opaque material.

[0075] It should also be noted that the closure member is relatively narrow as compared to the length of the wound 170 (See FIGS. 40, 50, and 70). Usually, the closure member 120 will be substantially more narrow than the width of the wound 170 so that the wound can be viewed reasonably well even if the wound 170 cannot be seen through the member 120.

[0076] The closure device 100 also includes a viewing member 180 that is constructed from a transparent material such as polyurethane film. The viewing member 180 has one end 190 adhered to one end 215 of the closure member 120 forming a single member. An adhesive layer 200 is disposed on the top surface of the viewing member 180 for purposes that will become more apparent as the description proceeds. Preferably, the adhesive layer 200 completely covers the top surface of viewing member 180. Alternatively, adhesive layer 200 may be located in a relatively narrow band around the periphery of the viewing member 180 as shown in dash lines in FIG. 10 rather than fully coating the member 18.

[0077] The viewing member 180 is enlarged as compared to the closure member 120. It has a length that is about equal to that of the member 120, but has a width that is substantially larger than the width of the member 120. Preferably, the width of the viewing member 180 is not less than twice the width of the closure member 120. Manifestly, the object of having the large width is to cover the wound 170. If wound 170 is very long it will most likely be sutured and the closure device 100 not used. However, closure devices 100 can be used by spacing several of them along the length of the wound. In any event, the width of the viewing member 180 is preferably not less than twice the width of the closure member 120.

[0078] The top protective member 220 and the viewing member 180 have been partially cut away so that the various superimposed members can be better shown in FIG. 10.

[0079] A first or top protective member 220 is located on top of the closure member 120 and on top of the viewing member 180 and is releasably attached thereto by the adhesive layers 140 and 200. A release coating is applied to the side of the member 220 adjacent to the adhesive layers 140 and 200 so the member 220 can be easily separated from the members 120 and 180 despite the presence of the adhesive layers 140 and 200.

[0080] The top protective member 220 is substantially coextensive with the members 120 and 180. However, to enable the member 220 to be easily removed even by a person wearing surgical gloves, the member 220 has a tab portion or end 240 that extends slightly past the closure member 120. The end 240 may be bent or turned slightly upwardly away from the patient to which the device 100 is being applied further facilitating the grasping of the end 240 by a person wear gloves.

[0081] A second or bottom protective member 265 is located below the closure member 120 and below the viewing member 180 and is releasably attached thereto by the adhesive layer 160. The member 265 is not attached to the viewing member 180 since no adhesive is present on the bottom side of the viewing member 180. A release coating is applied to the side of the member 265 adjacent to the adhesive layer 160 so the member 265 can be easily separated from the member 120 despite the presence of the adhesive layer 160. End 240 of top protective member 220 may also be bent or otherwise offset from member 265 to further facilitate grasping end 240 by a person wearing gloves. For some application, it may not be necessary to “bend” end 240.

[0082] The bottom protective member 265 is substantially coextensive with the members 120 and 180 and with the top protective member 220. However, to enable the member 265 to be easily removed even by a person wearing surgical gloves, the member 265 has a tab portion or end 280 adjacent to the lower side of the viewing member 180 that may be bent or turned slightly outwardly from the viewing member 180 to offset member 280 from viewing member 180 to further facilitate the grasping of the end 280 by a person wearing gloves. Other techniques in addition to bending may be satisfactorily used to offset member 280 from viewing member 180.

[0083] Both of the protective member 220 and 265 may be constructed from materials such as paper, polyester, polypropylene, and polyethylene. It is preferred that the top protective layer 220 be constructed from a material that is transparent which permits a full view of the wound 170 when using the device 100 to close the wound.

[0084] When the closure device 100 is removed from a sterile package (not shown), the device 100 is configured as described in detail hereinbefore and as shown in FIGS. 10 and 20. The bottom protective member 265 is removed by grasping the offset end or tab portion 280 and pulling the member 265 away from the remainder of the device 100. The offset end 28 enables a use wearing gloves to easily grasp and remove the member 265 which is coated with a release coating as previously described. The bottom protective member 265 is then discarded leaving the device 10 in the configuration shown in FIG. 30.

[0085] After removing the bottom protective member 240, the left end of the closure member 120 (as oriented in the drawing) is pressed onto the skin of the patient adjacent to the wound 170 as shown in FIG. 30. The adhesive layer 160 is in contact with the skin sticking the closure member 120 to the skin adjacent to the left side of wound 170 as shown in FIGS. 30 and 40. The wound 170 is open at this time.

[0086] There is no adhesive on the bottom side of the enlarged viewing member 180 so that the viewing member can be grasped in the fingers of the person applying the device 100 without the device sticking to the user. The user holds the closure member 120 out of contact with the skin on the right side of the wound 170 and exerts a force on the skin on the left side of the wound 170 by pulling to the right on the viewing member 180. The user then pushes on the skin on the right side of the wound 170 toward the skin on the left side of the wound 170 until the edges or sides of the wound 170 are in juxtaposition with the wound 170 closed.

[0087] When this has been accomplished, the closure member 120 is pressed against the skin on the right side of the wound 170 placing the adhesive layer 160 in contact with the skin on the right side of the wound 170. The adhesive layer 160 sticks the closure member 120 to the skin and holds the wound 170 in the closed condition as shown in FIGS. 50 and 60.

[0088] It is important to note that during this process, the ends of the wound 170 are visible to the person applying the device 100 on both sides of the closure member 120 even if the closure member is not constructed from a transparent material. Such visibility enables the user to more efficiently and effectively apply the device 10 to place the wound 170 in the closed condition.

[0089] The offset end or tab portion 240 on the top protective member 220 is grasped and a pull exerted thereon separating the protective member 220 from the closure member 120 and the viewing member 180, exposing the adhesive layer 140 on the closure member 120 and the adhesive layer 200 on the viewing member 180. The member 220 can be easily grasped by a user wearing gloves due to the configuration of the end 240 on the closure member 120 and the member 220 can be separated easily from the viewing member 180 due to the release coating on the member 220.

[0090] When the protective member 220 has been removed, the user continues to pull the viewing member 180 over the closure member 120 and over the wound 170 as shown in FIGS. 70 and 80. The adhesive layer 200 on the viewing member 180 sticks the member 180 to the patient's skin enclosing the wound 170 to aid in maintaining the sterility of the wound. The wound can still be viewed since the viewing member 180 is constructed from a transparent material. The viewing member 180 is further adhered to the closure member 120 due to the adhesive layer 14 on the closure member 120.

[0091] Referring to FIG. 90, a modified form of a closure device that is also constructed in accordance with the invention is indicated generally by the reference character 910. Although all the components are not shown in FIG. 90, the wound or incision closure device 910 includes the same structural components as did the device 100 which was described in detail hereinbefore. As shown in FIG. 90, the device 910 includes a relatively narrow closure member 912, an enlarged top protective member 922, and an enlarged viewing member 918. (The protective member 922 is partially cut away to show the viewing member 918.)

[0092] The modification of FIG. 90, as compared to the closure device 100 resides in the change to the configuration of the viewing member 918. While the viewing member 180 has a generally hexagonal shape, the viewing member 918 is generally circular. The closure device 910 is used in the same manner as previously described in detail with respect to the closure device 100.

[0093] Referring to FIG. 100, a modified form of closure device that is also constructed in accordance with the invention is indicated generally by reference character 811. Although all the components are not shown in FIG. 100, the device 811 includes the same structural components as did the device 100 which was described in detail hereinbefore. As shown in FIG. 100, the wound or incision closure device 811 includes a relatively narrow closure member 812, an enlarged top protective member 822, and an enlarged viewing member 818. (The member 822 is partially cut away to show the viewing member 818.)

[0094] The modification of FIG. 100 resides in the change to the configuration of the viewing member 818 as compared to the viewing member 180 of the closure device 100. While the viewing member 180 has a generally hexagonal shape and the viewing member 918 has a generally circular shape, the viewing member 818 is generally elliptical. The closure device 811 is used in the same manner as previously described in detail with respect to the closure device 100.

[0095] The various configurations of the closure devices 100, 910, and 811 illustrate that the present invention allows varying the configuration the viewing member as desired for specific applications while still providing a sufficiently large tab portion to be easily grasped by a person wearing surgical gloves while applying the device to close the wound. The viewing member is preferably large enough to completely enclose the wound to aid in preventing infection by sealing the area around the wound to maintain the sterility of the wound.

[0096] It will be appreciated from the foregoing detailed description that a device constructed in accordance with the invention provides a closure device that is not only effective to close a wound or the like, but one that can be easily used by a person wearing surgical gloves because of the arrangement of the bent or offset ends of the protective members.

[0097] Further, the closure device constructed in accordance with the invention is simple to use and because of its unitary construction is not susceptible to having components thereof lost while applying the device rendering it ineffective or totally unusable. This feature of the invention results from the use of adhesives to assemble the various components of the device into the unitary structure received by the user when the closure device is removed from it packaging (not shown) for use.

[0098] Although the present invention and its advantages have been described in detail, it should be understood that various changes, substitutions, and alterations can be made therein without departing from the spirit and scope of the invention as defined in the following claims.