Medical devices having layer(s) of stretchable adhesive, and method of use

Abstract

Medical devices having a layer(s) of stretchable adhesive, and a method of use thereof are described.

Description

[0001] MEDICAL DEVICES HAVING LAYER(S) OF STRETCHABLE ADHESIVE, AND METHOD OF USE

[0002] BACKGROUND

[0003] In a traditional bandage, an adhesive-backed anchoring member(s) is used to adhere the bandage over a wound or incision to minimize sun exposure, dirt and bacteria ingress, and in some cases apply a wound or incision treatment, such as an antimicrobial solution. In these cases, the adhesive-backed anchoring member(s) might be made of stretchable and flexible material, and the exact tension of the adhesive-backed anchoring member(s) is not crucial and may vary.

[0004] A traditional bandage may be contrasted with a medical device for closing a wound or incision. Such a medical device may include first and second adhesive-backed anchoring members for adhesion to the patient’s skin proximate to opposing edges of the wound or incision. Thereafter, the anchoring members are drawn toward each other to close the wound or incision.

[0005] The first and second adhesive-backed anchoring members of a medical device for closing a wound or incision may have a rigidity sufficient to maintain tension and position of the first and second adhesive-backed anchoring members with respect to the wound or incision edges to promote optimal healing and minimal scarring.

[0006] In some instances, use of adhesive in combination with the rigidity of an adhesive-backed anchoring member can lead to blistering of skin at the outer edges of the anchoring member, delamination of the layers of the medical device, and / or de-adhesion of the anchoring member from the skin. These failures can often occur when the adhesive-backed anchoring member is adhered to a region of skin where variable skin tension (e.g., due to stretching and flexion) is found, such as near a joint or other areas of articulation, such as the knee, neck, fingers and hands, feet and ankles, faces, and so on.

[0007] When these more rigid and less flexible devices are placed in areas that experience variations in skin stretching, blisters or other skin irritation or discomfort may occur, especially at the outer edges of adhesive pads anchoring the device to the patient’s skin.

[0008] Consider a long knee incision positioned longitudinally down the leg for knee replacement surgery. It is medically necessary to move the knee joint after surgery. The first and second adhesive-backed anchoring members for closing the incision may be adhered along regions of the skin stretching and relaxing to accommodate the knee’s motions. While the medical device is applying closing forces to hold the edges of the incision closed, the skin may stretch (in this case) along the axis of the incision as the knee bends and relaxes.

[0009] In some medical devices, adhesives on the adhesive-backed anchoring member(s) in contact with the skin may be generally thin and applied as a film of continuous thickness. The adhesive itself may nominally be selected to adhere to the medical device with greater force than to the skin, thus allowing removal of the device from the skin without leaving behind the adhesive. The strength and thinness of the adhesive may be such that any stretchability of the adhesive itself is a non-factor to the overall performance of the adhesive and the likelihood of blistering and other complications.

[0010] SUMMARY

[0011] A first aspect of the present disclosure relates to a medical device for closing a wound or incision, comprising: first and second adhesive-backed anchoring members for adhering to skin of a patient, wherein: the first and second adhesive-backed anchoring members each comprise a wound edge for positioning proximate to the wound or incision, the first adhesive-backed anchoring member comprises a continuous layer of adhesive, a cross-section of the continuous layer of adhesive has a variable thickness, and the continuous layer of adhesive is thickest at one or more edges of the first adhesive-backed anchoring member.

[0012] In at least some embodiments of the first aspect, the continuous layer of adhesive comprises a thickest cross-sectional portion along an entirety of the one or more edges.

[0013] In at least some embodiments of the first aspect, the first adhesive-backed anchoring member further comprises an edge opposite the wound edge; the continuous layer of adhesive comprises a thickest cross-sectional portion at the edge opposite the wound edge; and the crosssection of the continuous layer of adhesive decreases in thickness when moving from the edge opposite the wound edge and toward the wound edge.

[0014] In at least some embodiments of the first aspect, the thickest cross-sectional portion extends along an entirety of the edge opposite the wound edge.

[0015] In at least some embodiments of the first aspect, the continuous layer of adhesive comprises a thinnest cross-sectional portion at the wound edge. In at least some embodiments of the first aspect, the thinnest cross-sectional portion extends along an entirety of the wound edge.

[0016] In at least some embodiments of the first aspect, the continuous layer of adhesive comprises one or more thickest cross-sectional portions and a thinnest cross-sectional portion; and the cross-section of the continuous layer of adhesive transitions from the one or more thickest cross-sectional portions to the thinnest cross-sectional portion at a constant rate.

[0017] In at least some embodiments of the first aspect, the continuous layer of adhesive comprises one or more thickest cross-sectional portions and a thinnest cross-sectional portion; and the cross-section of the continuous layer of adhesive transitions from the one or more thickest cross-sectional portions to the thinnest cross-sectional portion at a non-constant rate.

[0018] In at least some embodiments of the first aspect, the continuous layer of adhesive comprises a thickest cross-sectional portion configured to maintain adherence to skin up to a skin stretching of 25%.

[0019] In at least some embodiments of the first aspect, the continuous layer of adhesive comprises a thinnest cross-sectional portion located between two thickest cross-sectional portions.

[0020] In at least some embodiments of the first aspect, the continuous layer of adhesive comprises a thickest cross-sectional portion located between two thinnest cross-sectional portions.

[0021] In at least some embodiments of the first aspect, the cross-section of the continuous layer of adhesive comprises: a first thinnest cross-sectional portion between first and second thickest cross-sectional portions; and a second thinnest cross-sectional portion between the second thickest cross-sectional portion and a third thickest cross-sectional portion.

[0022] In at least some embodiments of the first aspect, the first adhesive-backed anchoring member further comprises a second continuous layer of adhesive having a variable thickness.

[0023] In at least some embodiments of the first aspect, the continuous layer of adhesive and the second continuous layer of adhesive are spaced apart.

[0024] In at least some embodiments of the first aspect, the cross-section of the continuous layer of adhesive comprises a thinnest cross-sectional portion that does not extend to any edge of the first adhesive-backed anchoring member. In at least some embodiments of the first aspect, the first adhesive-backed anchoring member further comprises an edge opposite the wound edge, and third and fourth edges extending between the wound edge and the edge opposite the wound edge; and a thickness of the cross-section of the continuous layer of adhesive decreases as it moves away from the edge opposite the wound edge, the third edge, and the fourth edge.

[0025] In at least some embodiments of the first aspect, the continuous layer of adhesive is tackified acrylic adhesive, pressure-sensitive tackified acrylic adhesive, non-tackified acrylic adhesive, acrylate adhesive, pressure-sensitive acrylate adhesive, natural rubber adhesive, synthetic rubber adhesive, silicone adhesive, heat-activated adhesive, pressure-sensitive silicone adhesive, transparent adhesive, rubber / acrylic adhesive, or a combination thereof.

[0026] In at least some embodiments of the first aspect, the continuous layer of adhesive is capable of stretching up to five times its unstretched length before de-adhering from the skin of the patient.

[0027] In at least some embodiments of the first aspect, the first adhesive-backed anchoring member is made of a substantially inelastic material.

[0028] In at least some embodiments of the first aspect, the substantially inelastic material is a substantially inelastic polymeric material.

[0029] In at least some embodiments of the first aspect, the substantially inelastic material is polyurethane, polyester, polyethylene, or a combination thereof.

[0030] A second aspect of the present disclosure relates to a medical device for closing a wound or incision, comprising: first and second adhesive-backed anchoring members for adhering to skin of a patient, wherein: the first and second adhesive-backed anchoring members each comprise a wound edge for positioning proximate to the wound or incision, the first adhesive- backed anchoring member comprises a continuous layer of adhesive, and the continuous layer of adhesive comprises a stretchable adhesive portion at an edge of the first adhesive-backed anchoring member.

[0031] In at least some embodiments of the second aspect, the stretchable adhesive portion extends along an entirety of the edge.

[0032] In at least some embodiments of the second aspect, the first adhesive-backed anchoring member further comprises an edge opposite the wound edge; and the stretchable adhesive portion is at the edge opposite the wound edge. In at least some embodiments of the second aspect, the stretchable adhesive portion extends along an entirety of the edge opposite the wound edge.

[0033] In at least some embodiments of the second aspect, the continuous layer of adhesive comprises a non-stretchable adhesive portion at the wound edge.

[0034] In at least some embodiments of the second aspect, the non-stretchable adhesive portion extends along an entirety of the wound edge.

[0035] In at least some embodiments of the second aspect, the stretchable adhesive portion is configured to maintain adherence to skin up to a skin stretching of 25%.

[0036] In at least some embodiments of the second aspect, the continuous layer of adhesive comprises a non-stretchable adhesive portion located between two stretchable adhesive portions.

[0037] In at least some embodiments of the second aspect, the continuous layer of adhesive comprises the stretchable adhesive portion located between two non-stretchable adhesive portions.

[0038] In at least some embodiments of the second aspect, the continuous layer of adhesive comprises: a first non-stretchable adhesive portion between first and second stretchable adhesive portions; and a second non-stretchable adhesive portion between the second stretchable adhesive portion and a third stretchable adhesive portion.

[0039] In at least some embodiments of the second aspect, the first adhesive-backed anchoring member further comprises a second continuous layer of adhesive having at least one stretchable adhesive portion.

[0040] In at least some embodiments of the second aspect, the continuous layer of adhesive and the second continuous layer of adhesive are spaced apart.

[0041] In at least some embodiments of the second aspect, the continuous layer of adhesive comprises a non-stretchable adhesive portion that does not extend to any edge of the first adhesive-backed anchoring member.

[0042] In at least some embodiments of the second aspect, the first adhesive-backed anchoring member further comprises an edge opposite the wound edge, and third and fourth edges extending between the wound edge and the edge opposite the wound edge; and the continuous layer of adhesive comprises: a first stretchable adhesive portion located at the edge opposite the wound edge, a second stretchable adhesive portion located at the third edge, and a third stretchable adhesive portion located at the fourth edge. In at least some embodiments of the second aspect, the stretchable adhesive portion is a 3D printable tissue adhesive, a blood-repelling hydrophobic matrix adhesive, a direct ink writing adhesive, or a combination thereof.

[0043] In at least some embodiments of the second aspect, the continuous layer of adhesive comprises a non- stretchable adhesive portion made of tackified acrylic adhesive, pressuresensitive tackified acrylic adhesive, non-tackified acrylic adhesive, acrylate adhesive, pressuresensitive acrylate adhesive, natural rubber adhesive, synthetic rubber adhesive, silicone adhesive, heat-activated adhesive, pressure-sensitive silicone adhesive, transparent adhesive, rubber / acrylic adhesive, or a combination thereof.

[0044] In at least some embodiments of the second aspect, the stretchable adhesive portion is capable of stretching up to five times its unstretched length before de-adhering from the skin of the patient.

[0045] In at least some embodiments of the second aspect, the first adhesive-backed anchoring member is made of a substantially inelastic material.

[0046] In at least some embodiments of the second aspect, the substantially inelastic material is a substantially inelastic polymeric material.

[0047] In at least some embodiments of the second aspect, the substantially inelastic material is polyurethane, polyester, polyethylene, or a combination thereof.

[0048] A third aspect of the present disclosure relates to a method for closing a wound or incision, comprising: providing a medical device of the first aspect of second aspect; applying the medical device to skin of a patient proximate the wound or incision; and after applying the medical device, closing the wound or incision by moving the first and second adhesive-backed members towards each other.

[0049] BRIEF DESCRIPTION OF DRAWINGS

[0050] For a more complete understanding of the present disclosure, reference is now made to the following description taken in conjunction with the accompanying drawings.

[0051] Figure 1 is a top view of an interlaced medical device showing slit- or slice-type discontinuities in adhesive-backed anchoring members.

[0052] Figure 2 is a bottom projection view of an interlaced medical device including release liners. Figure 3 is a perspective view of an interlaced medical device showing a first adhesive- backed anchoring member protected by a first release liner and a second release liner. A second adhesive-backed anchoring member is shown with a mirror image release liner configuration including a first release liner and a second release liner.

[0053] Figure 4a is a perspective view of an example wherein a common release liner is shared between two components of a medical device.

[0054] Figure 4b is a perspective view of an example wherein a crease is provided in a common release liner shared between two components of a medical device.

[0055] Figure 4c is a perspective view of an example wherein a frangible line is provided in a common release liner shared between two components of a medical device.

[0056] Figure 5 is a cross-section view of an adhesive-backed anchoring member having a continuous layer of variable thickness adhesive adhered to skin.

[0057] Figure 6 is a perspective view of the adhesive-backed anchoring member of Figure 5.

[0058] Figure 7 is a cross-section view of the adhesive-backed anchoring member of Figure 5 when the skin to which it is adhered is stretched.

[0059] Figure 8 is a cross-section view of an adhesive-backed anchoring member having a continuous layer of variable thickness adhesive.

[0060] Figure 9 is a cross-section view of an adhesive-backed anchoring member having a continuous layer of variable thickness adhesive.

[0061] Figure 10 is a cross-section view of an adhesive-backed anchoring member having a continuous layer of variable thickness adhesive.

[0062] Figure 11 is a cross-section view of an adhesive-backed anchoring member having multiple continuous layers of variable thickness adhesive adhered to skin.

[0063] Figure 12 is a perspective view of the adhesive-backed anchoring member of Figure 11.

[0064] Figure 13 is a cross-section view of the adhesive-backed anchoring member of Figure 12 when the skin to which it is adhered is stretched.

[0065] Figure 14 is a bottom planar view of an adhesive-backed anchoring member having a layer of adhesive with a non-stretchable portion located between first and second stretchable portions. Figure 15 is a bottom planar view of an adhesive-backed anchoring member having a layer of adhesive with a non-stretchable portion and a stretchable portion positioned at the edge opposite the wound edge the adhesive-backed anchoring member.

[0066] Figure 16 is a bottom planar view of an adhesive-backed anchoring member having a layer of adhesive with a stretchable portion located between first and second non-stretchable portions.

[0067] Figure 17 is a bottom planar view of an adhesive-backed anchoring member having a layer of adhesive including a first non-stretchable portion positioned between first and second stretchable portions, and a second non-stretchable portion positioned between the second and a third stretchable portion.

[0068] Figure 18 is a bottom planar view of an adhesive-backed anchoring member having a layer of adhesive including a first stretchable portion located at an edge opposite a wound edge of the adhesive-backed anchoring member, a second stretchable portion located at a third edge extending between the wound edge and the edge opposite thereto, a third stretchable portion located at a fourth edge extending between the wound edge and the edge opposite thereto, and a non-stretchable portion located at the wound edge.

[0069] Figure 19 is a bottom planar view of an adhesive-backed anchoring member having a layer of adhesive including a first stretchable portion located at a third edge extending between a wound edge and an edge opposite thereto, a second stretchable portion located at a fourth edge extending between a wound edge and an edge opposite thereto, a non-stretchable portion located at and extending between the wound edge and the edge opposite thereto.

[0070] Figure 20 is a process flow diagram illustrating a method for closing a wound or incision.

[0071] DETAILED DESCRIPTION

[0072] A medical device, for closing a wound or incision, may include at least two adhesive- backed anchoring members for adhesion to skin on either side of the wound or incision. The skin may need to stretch along the wound or incision (e.g., say the flexing of a knee, with the wound or incision being over the kneecap). If the medical device is too rigid, the skin would be unable to stretch where the adhesive-backed anchoring members are adhered. As a result, the skin not adhered to the adhesive-backed anchoring members would be required to stretch an extra amount so that an average stretching is achieved. This additional stretching may be painful and may lead to blistering in the transitional region at the edges of adhesive-backed anchoring members.

[0073] In some instances, several medical devices may be placed along the wound or incision, with small gaps between each medical device to accommodate skin stretching. Assuming the skin above and below the wound or incision is already in tension, the skin between the medical devices would have to stretch significantly, and potentially painfully, increasing the likelihood of the medical device de-adhering from the skin.

[0074] Assume strain gages were placed on the skin. One would see the skin adhered to the adhesive-backed anchoring members experience a static amount of straining (essentially nonchanging strain) from that observed at the time of the adhesive-backed anchoring members were adhered to the skin. But strain gages placed on the skin outside the edges of the adhesive-backed anchoring members would experience well over the average strain. That is because this skin would need to stretch additionally to accommodate the skin that is adhered to the adhesive- backed anchoring members and unable to stretch. Such can lead to painful stretching and blistering around the edges of the adhesive-backed anchoring members.

[0075] The present disclosure provides, among other things, a medical device for closing a wound or incision, where the medical device has at least one adhesive-backed anchoring members having a layer(s) of stretchable adhesive for adhering to a patient’s skin. In some embodiments, the layer(s) of stretchable adhesive may be applied to one or more anchoring members of the medical device. The layer(s) of stretchable adhesive can stretch significantly without de-adhering from the patient’s skin, in conjunction with spreading out tension on the adhesive-backed anchoring member(s) to minimize the risk of blistering, skin irritation, or having the medical device peel away from the patient’s skin.

[0076] In some embodiments, a layer of adhesive may obtain its stretchability from the layer of adhesive being continuous and having a variable thickness. In other embodiments, the layer of adhesive may obtain its stretchability due to the composition of the layer of adhesive. In yet other embodiments, a layer of adhesive may obtain a portion of its stretchability from the portion being of variable thickness and another portion of its stretchability from the portions composition.

[0077] A medical device and layer(s) of adhesive of the present disclosure may have some or all of the features described herein below. Medical Devices

[0078] A medical device of the present disclosure may include at least two opposing adhesive- backed anchoring members that are movable with respect to each other and designed for placement with respect to opposing edges of a wound or incision (i.e., designed for adhesion to patient skin proximate to opposing edges of a wound or incision) such that drawing the adhesive- backed anchoring members toward each other closes the wound or incision. An example of such a medical device 100 is illustrated in Figure 1.

[0079] The medical device 100 includes a first component including a first adhesive-backed anchoring member 102 having a “wound” or “incision” edge 104 for placement at a desired location with respect to an edge of a wound or incision 106. The first component also includes one or more first elongated connectors 108 extending from the first adhesive-backed anchoring member 102 and a first pulling element 110 joined to the one or more first elongated connectors 108 and adapted for translation of the first adhesive-backed anchoring member 102 toward the wound or incision 106.

[0080] The medical device 100 also includes a second component including a second adhesive- backed anchoring member 112 having a “wound” or “incision” edge 114 for placement at a desired location with respect to another edge of the wound or incision 106. The second component also includes one or more second elongated connectors 116 extending from the second adhesive-backed anchoring member 1 12 and a second pulling element 118 joined to the one or more second elongated connectors 116 and adapted for translation of the second adhesive- backed anchoring member 112 toward the wound or incision 106.

[0081] The medical device 100 includes means for attaching the one or more first elongated connectors 108 to the second adhesive-backed anchoring member 112 thereby forming an attached portion and a bridging portion for each attached first elongated connector 108. The medical device 100 also includes means for attaching the one or more second elongated connectors 116 to the first adhesive-backed anchoring member 102 thereby forming an attached portion and a bridging portion for each attached second elongated connector 116. Interlaced and Keyhole Embodiments

[0082] Embodiments of the medical device 100 can be interlaced or non-interlaced. Interlaced embodiments are those where both the first and second components comprise two or more elongated connectors, where the first and second elongated connectors of the first component are attached to a single pulling element and the first and second elongated connectors of the second component are attached to another single pulling element. Further, an elongated connector from one of the two components passes through the void formed between the two elongated connectors of the other component. When assembled in this manner, the first and second components are linked and cannot be separated without cutting or breaking at least one of the two components. A simple analogy to such an interlaced device is a pair of interlocking rings.

[0083] One of skill in the art will recognize that more complex interlaced embodiments can be produced where, referring to a first component, interlacing extends to two or more adjacent voids formed by three or more adjacent elongated connectors. Examples of such embodiments are provided in the disclosures of U.S. Patent Nos. 6,329,564; 6,831,205; 6,822,133; 7,511,185; 8,636,763; 7,414,168; 7,332,641; 7,354,446; 8,636,763; 7,838,718; 7,414,168; and 7,563,941, the disclosures of which are incorporated herein by reference in their entireties.

[0084] Interlaced embodiments can be produced in a variety of ways. Consider, for example, the simplest embodiment to which the analogy to interlocking rings has been made. To produce such an interlaced structure, the first and second components can be die cut as monolithic elements. One of the two components can then be cut, interlaced with the uncut component, and the cut can then be repaired, for example, with adhesive or some other appropriate means. As an alternative method for producing the simplest interlaced embodiment, one component can be die cut monolithically, and the second component can be die cut with an element, or a portion of an element missing. For example, the second component could be die cut with one of the two required elongated connectors being absent. The missing second elongated connector could be provided as a separate die cut element, complete with adhesive. Following interlacing of the first component with the partial second component, the interlaced structure could be completed by attaching the separately supplied missing elongated connector.

[0085] A non-interlaced, alternative design may be referred to as a “key-hole” design. In this design, for example, the two components of the medical device 100 are separately produced. In a preferred method, they are produced through a die cut process as monolithic components. Each of the two monolithic components comprise an adhesive-backed anchoring member, elongated connector(s), and a pulling element. The elongated connector(s) of the first component are centrally located in the assembled and applied device. The elongated connectors of the second component are spaced apart thereby creating a void, or “key-hole” through which the pulling element and elongated connector(s) of the first element are inserted. Following insertion and rotation of the first and second components into a common plane, the two components are mated in a “key-hole” arrangement and the medical device is in condition for use.

[0086] In some embodiments, the adhesive-backed anchoring members 102 / 112, elongated connectors 108 / 116, and pulling elements 110 / 118 are produced from a substantially inelastic material. In some embodiments, the adhesive-backed anchoring members 102 / 112, elongated connectors 108 / 116, and pulling elements 110 / 118 are produced from a substantially inelastic polymeric material (e.g., polyurethane, polyester, polyethylene, or a combination thereof). Alternatively, they may be produced from an elastic material which is reinforced with an inelastic structural component thereby rendering the medical device substantially inelastic. For example, such inelastic materials may include monofilament polymeric line or mesh. Such reinforced polymers are referred to herein as polymeric composites. A reinforcing, inelastic structural material is referred to in the art as “scrim.” Scrim may be a woven textile or polymer, a non-woven polymer, or any other structural material that acts to stabilize the substrate. In some embodiments, the scrim reinforced substrate may have a high degree of permeability (e.g., 1,000 to 8,000 liters / sec / m2).

[0087] Additionally, non-reinforced polymers exhibiting a degree of elasticity (e.g., polyurethane or polyester) may be used in the production of the adhesive-backed anchoring members 102 / 112 for embodiments in which the adhesive-backed anchoring members 102 / 112 and elongated connectors 108 / 116 are produced separately, and subsequently attached to one another (i.e., non-monolithic embodiments). An example polymer for the production of the adhesive-backed anchoring members 102 / 112 is polyurethane having a thickness of 3-12 mils. Such a polymer is breathable and exhibits a degree of flexibility. If a non-reinforced elastic polymer is used to produce an adhesive-backed anchoring member 102 / 112, it may be preferable to reinforce the top surface of the wound edge 104 / 114 with an inelastic element so that the wound edge 104 / 114 remains substantially straight across the incision site during the closure process. Such an element is referred to herein as a “wound edge bar.” One skilled in the art will recognize that a wide range of inelastic polymers, or even metals, can be utilized in the production of a wound edge bar for the purpose of providing rigidity to the wound edge. Vapor permeable polymeric materials that satisfy the other requirements for use in the manufacturing of the medical device 100 may offer improved comfort. Transparent stock may be preferred so that the healing process and the entire wound site can be monitored easily. Therefore, at least the first and second adhesive-backed anchoring members 102 / 112 are produced from transparent stock in some embodiments. As an alternative design choice, colored or opaque stock may be used in the production of at least the first and second adhesive-backed anchoring members 102 / 112 when circumstances (e.g., cost considerations) dictate or permit.

[0088] Sheet Stock

[0089] In some embodiments, the adhesive-backed anchoring members 102 / 112, elongated connectors 108 / 116, and pulling elements 110 / 118 are produced from sheets or rolls of polymeric material or polymeric composite material (e.g., polyurethane or polyester). The sheet or roll stock is sometimes referred to as “film” as the thickness in some embodiments ranges from about 0.5 mil to about 5 mil and may vary depending upon application. Die cutting these elements from polymeric sheet stock to provide two monolithic components (i.e., having no seams or joints) which, when assembled / packaged comprise the medical device 100, is a particularly cost-effective approach to manufacturing. Die cutting can be combined with other assembly steps, for example, in connection with the production of interlaced embodiments as discussed elsewhere herein. Laser and ultrasonic trimming devices are also examples of equipment that can be used to cut the components of the medical device 100. The sheet stock may be perforated to allow for the exchange of air with the skin beneath the medical device 100.

[0090] Adhesives

[0091] The adhesives selected for use in connection with the medical device 100 may meet a number of requirements. First, adhesive which is to contact the patient’s skin may be selected to minimize the potential for adverse reaction by the skin. That is, the adhesive selected may be hypoallergenic. Additionally, all adhesives, whether or not they are intended to contact the skin, should provide a secure hold for a period of time sufficient for the healing process to progress to the point where removal of the medical device 100 is appropriate. An adhesive hold period of about 7-10 days is generally suitable.

[0092] Adhesive is a preferred means of attaching one or more elongated connectors 108 / 116 to an adhesive-backed anchoring member 102 / 112. In one embodiment, adhesive is applied to at least a portion of the bottom surface of the elongated connectors 108 / 116 for attaching the elongated connectors 108 / 116 of one of the two components to the applied adhesive-backed anchoring member 102 / 112 of the other component. Alternatively or additionally, adhesive may be applied to a portion of the top surfaces of the first and second adhesive-backed anchoring members 102 / 112. Release liners may be used to protect applied adhesives prior to application of the medical device 100.

[0093] Example adhesives include, but are not limited to, tackified acrylic adhesive, pressuresensitive tackified acrylic adhesive, non-tackified acrylic adhesive, acrylate adhesive, pressuresensitive acrylate adhesive, natural rubber adhesive, synthetic rubber adhesive, silicone adhesive (repositionable or not), heat-activated adhesive, pressure-sensitive silicone adhesive, transparent adhesive, rubber / acrylic adhesive, or a combination thereof

[0094] Elongated Connectors

[0095] The elongated connectors 108 / 116 have two parts or portions, an attached portion and a bridging portion. The attached portion of the elongated connectors 108 / 116, as the name indicates, is that portion which is attached to the adhesive-backed anchoring member 102 / 1 12 of the opposing component following application of the medical device 100 to the patient’s skin. The bridging portion is the portion of the elongated connector 108 / 116 which spans over the wound or incision. In some embodiments, the bottom surface of the bridging portion contains less adhesive than the attached portion. In some embodiments, the entire bridging portion is free of adhesive or, alternately, has adhesive but this is blocked with another film (kill layer) to render the adhesive in the bridging portion nonfunctional.

[0096] The dimension of the elongated connectors 108 / 116 may be strap-like in that their width is substantially greater than their thickness. Since the point of attachment between the first and second adhesive-backed anchoring members 102 / 112 is between the underside / backside of attached portions of elongated connectors 108 / 116 with the top surface of the adhesive-backed anchoring members 102 / 112, maximizing the area of contact will result in a more secure closure of the medical device 100 because the area of adhesive contact is maximized. Thus, from the standpoint of security of closure, wider attached portions are preferred. However, as the width of all the elongated connectors 108 / 116 is increased, the distance between elongated connectors 108 / 116 necessarily is decreased.

[0097] As was stated in U.S. Pat. No. 6,329,564, the disclosure of which is incorporated herein by reference: There is no absolute minimum which can be stated with respect to spacing between elongated connectors 108 or 116. Preferred ranges may be stated as a percentage of device length (i.e., the dimension of the medical device generally parallel the wound or incision). For example, a spacing of between about 5% to about 10% of the medical device length is an example of an appropriate range.

[0098] This spacing provides substantial adhesive contact between attached portions of elongated connectors 108 / 116 with the adhesive-backed anchoring members 102 / 112. When the wound or incision is closed, the bridging portions of the one or more first elongated connectors 108 and the bridging portions of the one or more second elongated connectors 116 may be aligned with one another over the closed wound or incision. In some embodiments, the average width of the bridging portions is less than the average width of the attached portions of the elongated connectors 108 / 116. Average width is determined by measuring from the outer perimeters of the bridging portions and the outer perimeters of the attached portions.

[0099] This difference in width in the bridging portion relative to the attached portion affords advantages. Consider, for example, a device designed for maximum security. In such a device, the elongated connectors would be placed as close as possible, while still providing for a minimum acceptable degree of adjustment range. If the bridging area were narrowed in such a device, the net effect would be an increase in exposed area over the wound or incision (which is desirable for application of medicines, removal of exudates, etc.), as well as an increase in the range of adjustment (narrowing the width of the elongated connectors in the bridging portion effectively increases the distance between adjacent bridging portions).

[0100] Considering the device discussed in the preceding paragraph, holding the width of bridging portion constant, while increasing the width of the attached portions provides for greater security as the area of adhesive contact is effectively increased. It will be recognized by one skilled in the art that hybrid configurations (i.e., devices having narrowed bridging portions and widened attached portions relative to uniform width devices) represent embodiments of the present disclosure.

[0101] The elongated connectors 108 / 116 may be viewed as strap-like in their dimensions. In some embodiments, a portion of the elongated connectors 108 / 116 is cut away to increase the unobstructed surface area over the wound or incision. This tends to facilitate drainage of exudates and application of medication. This cut-out may be best produced during the die cut process. U.S. Pat. No. 6,329,564, the disclosure of which is incorporated herein by reference, depicts cut-outs, for example, in FIG. 3. The shape of the cut-out is not critical. What is important is that the structural integrity of the elongated connectors 108 / 116 is not compromised by the introduction of the cut-outs.

[0102] Pulling Elements

[0103] Embodiments of the present disclosure include pulling elements 110 / 118 which are attached to elongated connectors 108 / 116, or to extensions of elongated connectors 108 / 116. Extensions of elongated connectors 108 / 116 could themselves be considered pulling elements in embodiments in which only one elongated connector is associated with a component. By definition, the attached portion of an elongated connector 108 / 116 attaches to the adhesive- backed anchoring member 102 / 112 of another component of the medical device 100. Extensions of an elongated connector 108 / 116 may extend the length of the elongated connector 108 / 116 for ease of application, and may be generally removed following the application process. Perforations or scoring may be provided to facilitate their removal. For embodiments in which the number of elongated connectors 108 / 116 associated with an adhesive-backed anchoring member 102 / 112 is greater than one, a pulling element 110 / 118 may be useful for joining the elongated connectors 108 / 116 or extensions thereof to enable a user to easily apply a pulling force to more than one elongated connector 108 / 116.

[0104] Removal of the pulling elements 110 / 118 minimizes the footprint of the applied medical device 100. This decrease in the overall size of the medical device 100 reduces the chance that a portion of the medical device 100 may be caught, for example, on clothing or a pillow. Such an occurrence could tend to pull the applied medical device 100 away from the skin thereby causing the wound or incision to open. Minimizing the overall footprint of the applied medical device 100 also tends to provide for a more comfortable fit. Eversion Edges

[0105] In some embodiments, the wound edges 104 / 114, of the first and second adhesive-backed anchoring members 102 / 112, are adapted to evert (or raise) skin edges to promote wound / incision healing. It is known in the art that everting, raising, or mounding of the skin edges at the wound or incision site prevents wound inversion. One way in which this can be accomplished is to provide a bend at the wound edge 104 / 114. The bend may be angled or arcuate. The adhesive on the lower portion of the adhesive-backed anchoring members 102 / 112 is also applied to the wound edge portion. When attached to the skin this eversion edge tends to lift the edges of the skin at the point of closure contact, thereby promoting wound or incision healing.

[0106] Coding

[0107] To minimize confusion for new users of the medical device 100, the pulling elements 110 / 118 and adhesive-backed anchoring members 102 / 112 may be coded to enable user distinction. Thus, for example, the coding may comprise an observable geometric distinction between the shape of the pulling elements 110 / 118 and the shape of the adhesive-backed anchoring members 102 / 112. In some embodiments, such coding may comprise printed indicia to enable user distinction between the components. Colors may also be used to provide this distinguishing function.

[0108] Lateral Translation Element

[0109] In instances of the present disclosure, both the first and second adhesive-backed anchoring members 102 / 112 comprise one or more first elongated connectors attached to a single first pulling element. In other instances, one of the first or the second adhesive-backed anchoring members, but not both, comprise one or more lateral translation elements. In these embodiments, one of the first or second adhesive-backed anchoring components comprises one or more lateral translation elements, and the other adhesive-backed anchoring component comprises a plurality of lateral translation elements, each comprising one or more elongated connectors attached to a single pulling element. Each lateral translation element is selected from the group consisting of: a) a single elongated connector and a single pulling element; and b) a plurality of elongated connectors and a single pulling element.

[0110] Alternative Stock

[0111] The embodiments of the medical device 100 discussed above comprise first and second components which are monolithic in nature. That is, the first component (which includes the anchoring member 102 and one or more elongated connectors 108) is produced from a single sheet of stock material without joints or seams. The same statement applies to the second component. In an alternative embodiment, the first and second components are not monolithic in nature. This alternative embodiment is based on the recognition that the desired physical properties of the anchoring members 102 / 112 and the elongated connectors 108 / 116 are not, in every instance, identical. For example, a degree of elasticity is a desirable feature in an anchoring member 102 / 112 when applied, for example, to an area such as a joint. An anchoring member 102 / 112 produced from a film having a degree of elasticity is less likely to release prematurely than an anchoring member 102 / 112 produced from a substantially inelastic material when applied to such an area. Elasticity may be a property to be avoided when producing elongated connectors 108 / 116. Stretching of elongated connectors 108 / 116 may allow premature opening of a wound or incision.

[0112] In embodiments in which the first and second components are not monolithic, the anchoring members 102 / 112 may be produced from stock having a degree of elasticity. The elongated connectors 108 / 116 may be produced separately from stock which is substantially inelastic. The one or more first elongated connectors 108 are then attached (e.g., with adhesive) to the first anchoring member 102 to produce a first component. A second component is similarly constructed. As discussed elsewhere, a wound edge bar may be attached to reinforce the wound edge, particularly in embodiments wherein the sheet stock employed has a degree of elasticity.

[0113] It is not a requirement that elongated connectors and anchoring members of non- monolithic components be produced from different stock material. It may be desirable, for example, to create an overlap in a portion of the elongated connectors (e.g., the bridging portion) in order to provide for additional strength. Thus, double thickness in the bridging area may be provided by producing a monolithic anchoring member including a portion of a connecting member. A separately produced elongated connector is then attached, in an overlapping manner, to the monolithic anchoring member. This creates a first component which is double-thick in the bridging portion for additional strength and further eliminates stretching.

[0114] Reinforcing Elements

[0115] It may be desirable to reinforce the wound edge portion of the anchoring member 102 / 112 with another layer of less flexible stock. This “wound edge bar” would provide better translation of the force applied by the elongated connectors 108 / 116 uniformly along the entire wound edge 104 / 114. Similarly, it may be desirable to reinforce the optional pulling element 110 / 118, or a portion thereof, with another layer of less flexible stock. This “pull bar” would be useful in applying uniform tension from the pulling element 110 / 118 to all elongated connectors 108 / 116, as the medical device 100 is positioned for closure. This feature would become more important in embodiments of the medical device 100 intended to close long wounds or incisions where there might be up to four or more elongated connectors 108 / 116 to be pulled and secured to each adhesive-backed anchoring member 102 / 112.

[0116] Elastic Tension Indicators

[0117] The medical device 100 may optionally include an elastic tension indicator element. The purpose of the tension indicator element is to provide a visual indication that a desired tension has been reached while applying the medical device 100. For example, materials are known in the art which change color when a predetermined tension is applied. Similarly, other graphic representations may be used for this purpose. For example, a rectangular graphic representation may be applied to an elastic tension indicator element. As this tension indicator is stretched, the graphic representation of the rectangle stretches. This element may be designed such that the desired tension is indicated when the original rectangular representation is stretched to the point where it closely approximates a geometric square.

[0118] It may be desirable that this elastic tension indicator element be removable with the pulling elements 110 / 118 following application of the medical device 100. At a minimum, the elastic tension indicator element should be positioned in the medical device 100 such that when the medical device 100 is applied, it is not possible for the elastic element to continue to stretch and release the desired tension previously established.

[0119] Transderrnal Drug Delivery

[0120] The medical device 100 can be optionally adapted for transderrnal drug delivery. As is known in the art, a drug is deliverable transdermally through the skin. For such an application, a drug-containing patch is secured to at least one of the adhesive-backed anchoring members 102 / 112 in such a way that the drug can be delivered through the skin. Given the fact that there will be no adhesive contact between the skin and the adhesive-backed anchoring member 102 / 112 in the area of the drug delivery patch, it may be necessary to increase the size of the anchoring member 102 / 112 to secure the medical device 100 in such a transderrnal drug delivery embodiment. Transderrnal drug delivery is well known in the art and a review of the background is not necessary to enable one of skill in the art to make and use the present disclosure.

[0121] Embedded Infection Indicators

[0122] Embedded infection indicators can be incorporated to provide for a wound closure device that can, for example, change color as an indication of the presence of unwanted bacteria. One technology utilizes the release of a fluorescent dye from nanocapsules, the release being triggered by toxins secreted by the unwanted bacteria.

[0123] Discontinuities in Adhesive-Backed Anchoring Members

[0124] The adhesive-backed anchoring members 102 / 112 may be characterized by the presence of one or more discontinuities in the polymeric film allowing for the release of sweat from beneath the adhesive-backed anchoring members 102 / 112. The use of an inherently breathable polymeric film (i.e., a polymeric film, that without any mechanical manipulation, allows for the exchange of air with the skin beneath the adhesive-backed anchoring members 102 / 112) for the production of the adhesive-backed anchoring members 102 / 112 may not allow for the release of sweat.

[0125] Certain mechanical manipulation of an inherently breathable polymeric film that does not allow for the release of sweat will permit sweat to pass from the skin beneath the medical device 100. The same can be said for mechanical manipulation of a polymeric film that is not inherently breathable.

[0126] The introduction of discontinuities that do allow for the release of sweat from beneath the adhesive-backed anchoring members 102 / 112 addresses the problem of adhesion loss. There is variability in the size, number, and distribution of active sweat glands in humans. For example, according to one expert estimate, the palm of the hand has about 370 sweat glands per cm2. By comparison, the back of the hand has about 200; the forehead has about 175; the breast, abdomen, and forearm have about 155; and the leg and back have about 60-80 (all expressed in sweat glands per cm2). Given this sweat gland distribution pattern, one skilled in the art will recognize that discontinuities should be introduced broadly, across the area of the adhesive- backed anchoring members 102 / 112, to be most effective in addressing the problem of adhesion loss.

[0127] Discontinuities can be introduced into the polymeric material used to produce the adhesive-backed anchoring members 102 / 112 in a variety of ways. It is not a requirement that all discontinuities introduced into a particular adhesive-backed anchoring member be homogenous or uniform. Die cutting technology is a method for the introduction of discontinuities. Die cutting is a process involving the use of a die to shear a web or webs of low-strength materials such as polymeric sheet materials. For example, a needle or pin die could be used to introduce hundreds, or even thousands of small, round discontinuities into the first and second adhesive-backed anchoring members 102 / 1 12 through a perforation process. Perforation, as used herein, refers to a process wherein a discrete piercing element, such as a pin in an array of pins assembled on a die, penetrates a material leaving no excess material on either side (e.g., entry or exit side). Whether penetration by a particular piercing element leaves excess material on one side or another (e.g., deformation of material on the exit side) depends not solely on the piercing element, but also the material being pierced (in this case a polymeric sheet material). For example, a larger gauge piercing element, the size of a small nail, for example, may create exit deformation in some polymeric sheet stocks that would not be useful for the introduction of discontinuities consistent with the present disclosure. The shape of a piercing element need not be round. There are no geometric restrictions on the shape of a piercing element.

[0128] For the introduction of larger discontinuities, like those produced by piercing a polymeric material with a small nail, a punch process may be more appropriate. A punch, as used herein, is contrasted from a perforation by the requirement that material is removed in a punch process. For example, a punch die of a particular diameter would punch, or remove, a chad from the polymeric material. Such loose chads are removed in a variety of ways in a die cutting process including, for example, inclusion of an adhesive web to capture cut chads, or a vacuum process. Punches will tend to be visible to a user inspecting the applied medical device 100 whereas slits, slices, and perforations are practically invisible to the unaided eye.

[0129] In addition to perforation or punching, as described above, cutting (e.g., die cutting) can be used to introduce one or more slits (or slices) 120 into the adhesive-backed anchoring members 102 / 112. Again, in view of the sweat gland distribution discussed above, a plurality of slits 120 may be preferred.

[0130] One of skill in the art will recognize that a certain amount of routine experimentation may be required to optimize discontinuity size, shape, and distribution. Certainly, larger gauge perforations, punches, or slits will allow for the transfer of sweat from the skin beneath the medical device 100. Certain smaller gauge perforations, produced for example using a pin die as discussed above, may allow for vapor transfer but not sweat transfer. It is a matter of routine experimentation to determine discontinuity parameters that will allow for sweat transfer. Optimal discontinuity design for one specific polymer sheet backed with one specific adhesive, may not work well using a different polymer sheet and / or different adhesive. A particularly soft or gummy adhesive, for example, may function in a self-healing role by flowing in to fill perforations when such perforations are introduced with a particularly small diameter piercing element.

[0131] It will also be recognized by one of skill in the art that punch-type discontinuities will tend to remove skin contact surface area (and adhesive) from an adhesive-backed anchoring member 102 / 112. For this reason, larger punch-type discontinuities (e.g., paper punch size discontinuities, or larger) may not be favored, at least for applications requiring high adhesion characteristics.

[0132] For a variety of reasons, slits or slices introduced into the adhesive-backed anchoring members may be preferred. For one, like perforations, slits or slices do not remove material from the adhesive-backed anchoring members 102 / 112 and, therefore, the adhesive-backed anchoring members 102 / 112 retain their full surface area and adhesive content following the introduction of the slits or slices. Slits or slices can be straight or curvilinear and the slits or slices can be relatively long (e.g. running the length or width of an adhesive-backed anchoring member 102 / 112) or generally short in length. Furthermore, under flexion, a slit or slice will tend to open up. This tendency serves at least two purposes that represent advantages in the context of the medical device 100. First, the “opening up” of a slit or slice under flexion enables relative unimpeded transfer of sweat from the surface of the skin beneath the adhesive-backed anchoring member 102 / 112 to the external environment. Second, the “opening up” of the slit or slice tends to allow the adhesive-backed surfaces adjacent to the slit or slice to remain in good adherence with the skin. The presence of the slit or slice tends to reduce peel or shear forces that tend to result in poor adherence characteristics. When introduced, in embodiments of slices that are relatively long the effect can be the creation of a plurality of adhering subdomains in the adhesive-backed anchoring member 102 / 112.

[0133] In some instances, the slits 120 are introduced into each adhesive-backed anchoring member 102 / 112 in a direction generally perpendicular to the wound edge 104 / 114 of the adhesive-backed anchoring member 102 / 112. The slits 120 may be positioned so that they will fall between elongated connectors 108 / 116. Slits oriented in this way tend to allow a particular adhesive-backed anchoring member 102 / 112 to be viewed as a unit having a number of adhering subdomains, with the adhering subdomains being divided by the introduced slits. The adhered medical device 100 opens in an accordion-like manner under flexion. The adhering subdomains can actually separate from one another over time thereby creating independent subdomains.

[0134] Mechanical manipulation of the type described above can provide for “elastic-like” properties in non-elastic materials. Although the mechanical manipulation does not change the non-elastic characteristic of the particular material, the introduction of voids or discontinuities can allow for movement in dimensions where no movement would be possible absent the voids or discontinuities.

[0135] While the length of the slits 120 can be variable, as can the number of slits between elongated connectors 108 / 116, it may be beneficial that one end of the slits 120 closely approach the wound edge 104 / 114. It may also be beneficial that the other end of the slits 120 closely approach the edge generally opposite wound edge 104 / 114. The reason for the stated preference as to the length of the slits 120 is that the combined shear strength of two individual segments of polymeric material exceeds that of an otherwise identical single polymeric segment construct having equal area as compared to the two individual segments combined. The effective separation of adhesive-backed anchoring member 102 / 112 into individual segments (also referred to as adhering subdomains), as shown in Figure 1 will provide for enhanced shear strength as compared to the adhesive-backed anchoring member 102 / 112, lacking the slits 120.

[0136] It was stated above that it may be beneficial that one end of the slits 120 closely approach the wound edge 104 / 114. The integrity of the wound edge 104 / 114 should be maintained during the application process. Therefore, prior to application, the slits 120 should not extend all the way to the wound edge 104 / 114, thereby severing the wound edge 104 / 114. In another instance of the present disclosure, the slits 120 may terminate near the wound edge 104 / 114, and perforations may be introduced extending the slits 120 all the way to wound edge 104 / 114. The perforations will not separate during the application process and the integrity of the wound edge 104 / 114 will be maintained. However, in the weeks following application, due to flexion and stretching, the perforations may break at the wound edge 104 / 114 thereby allowing adhering subdomains of the adhesive-backed anchoring member 102 / 112 to operate more independently.

[0137] At the edge of the adhesive-backed anchoring member 102 / 112 generally opposite the wound edge 104 / 114, the slits 120 may be extended to the edge by perforation, as discussed above in connection with perforations approaching the wound edge 104 / 114. Furthermore, the integrity of the edge, generally opposite wound edge 104 / 114, is not as critical as the integrity of wound edge 104 / 114. Hence, the slits 120 may be introduced in the manufacturing process to sever the edge of the adhesive-backed anchoring member 102 / 112 generally opposite wound edge 104 / 1 14.

[0138] Release Liners

[0139] The adhesive-backed surfaces of the medical device 100 may be protected (e.g., from contamination and oxidation) by the application of release liners during the manufacturing process. In some instances, multiple release liners, or release liner systems, may be used to protect a single, uninterrupted, adhesive-backed surface. A plurality of release liners may be positioned on each adhesive-backed anchoring member 102 / 112. In some embodiments, a first release liner, which protects the wound edge portion of an anchoring member, is removed first during the application process. In this way, the wound edge 104 / 114 can be adhered to the skin while leaving a protected portion of the adhesive-backed anchoring member 102 / 112 which can be held without the medical device 100 adhering to the fingers of the user. Once the wound edge has been applied, the second release liner can be removed to fully secure the adhesive-backed anchoring member 102 / 112. Illustrative release liner stock includes paper, cardboard, or polymeric sheet stock. To minimize confusion for new users of the medical device 100, the release liners may also be coded. Release liner colors or printed indicia on the release liner are examples of coding enabling a user to readily identify the order of release liner removal.

[0140] Figure 2 is a bottom projection view of the medical device 100 showing adhesive-backed surfaces, of the adhesive-backed anchoring members 102 / 112, being protected by first release liners 202 and second release liners 204, and third release liners 203 (shown in cross-hatching).

[0141] The medical device may include a third release liner 203a adhered to the elongated connectors 108, with the third release liner 203a having a tab portion that extends along the first pulling element 110 and which the user may pull on to remove the third release liner 203a. Likewise, a third release liner 203b may be adhered to the elongated connectors 116, with the third release liner 203b having a tab portion that extends along the second pulling element 118 and which the user may pull on to remove the third release liner 203b.

[0142] Figure 3 is a perspective view of the medical device 100 showing the first adhesive- backed anchoring member 102 protected by the first release liner 202a and second release liner 204a. The second adhesive-backed anchoring member 112 is shown with a mirror image release liner configuration including a first release liner 202b and second release liner 204b.

[0143] Each of the release liners 202a and 204a as shown in Figure 3 include an adhered portion (or protecting portion) in contact with and protecting an adhesive backed portion of first adhesive-backed anchoring member 102. Each of release liners 202b and 204b as shown in Figure 3 include an adhered portion (or protecting portion) in contact with and protecting an adhesive backed portion of second adhesive-backed anchoring member 112. In Figure 3, the adhered portion of the first release liner 202a has been assigned reference numeral 302a and the adhered portion of the second release liner 204a has been assigned reference numeral 304a. Similarly, the adhered portion of the first release liner 202b has been assigned reference numeral 302b and the adhered portion of the second release liner 204b has been assigned reference numeral 304b.

[0144] Each of the release liners shown in Figure 3 (202a, 204a, 202b, and 204b) also include an unadhered tab portion that extends beyond the adhesive-backed surfaces and facilitates removal of the associated release liner during application of the medical device 100. In Figure 3, the unadhered tab portion of first release liner 202a has been assigned reference numeral 306a and the unadhered tab portion of second release liner 204a has been assigned reference numeral 308a. Similarly, the unadhered tab portion of first release liner 202b has been assigned reference numeral 306b and the unadhered tab portion of second release liner 204b has been assigned reference numeral 308b.

[0145] Tabs, or tab portions as used herein, can refer to tabs which are continuous with the associated release liner. In other words, they are produced from the same sheet stock, typically in a die cut process. Alternatively, a tab can be produced from separate stock material and attached to the release liner that it is associated with, using adhesive, for example.

[0146] As shown in Figure 3, the first adhesive-backed anchoring member 102 has a boundary axis 310a that is parallel with the wound edge 104. Similarly, the second adhesive-backed anchoring member 112 has a boundary axis 310b that is parallel with the wound edge 114. Figure 3 also shows that the first adhesive-backed anchoring member 102 has a boundary axis 312a that is parallel with the wound edge 104. Similarly, the second adhesive-backed anchoring member 112 has a boundary axis 312b that is parallel with the wound edge 114. Each boundary axis (310a, 310b, 312a, and 312b) defines a boundary of the adhered portion of an individual release liner. More specifically, the boundary defined by each boundary axis is an internal boundary (i.e., a boundary internal to either the first or the second adhesive-backed anchoring member). To be specific, boundary axis 310a defines an internal boundary on the first adhesive- backed anchoring member 102 that is protected by the adhered portion 302a of the first release liner 202a. Boundary axis 312a defines an internal boundary on the first adhesive-backed anchoring member 102 that is protected by adhered portion 304a of the second release liner 204a. Boundary axis 310b defines an internal boundary on the second adhesive-backed anchoring member 112 that is protected by adhered portion 302b of the first release liner 202b. Finally, boundary axis 312b defines an internal boundary on the second adhesive-backed anchoring member 112 that is protected by adhered portion 304b of the second release liner 204b.

[0147] As already mentioned, the boundary axes are parallel to a wound edge. Boundary axes 310a and 312a are parallel to the wound edge 104, and boundary axes 310b and 312b are parallel to the wound edge 114. Furthermore, because the entire adhesive-backed surface of each adhesive-backed anchoring member is completely protected by the pair of release liners, the two boundary axes associated with each adhesive-backed anchoring member must be adjacent (because the entire adhesive-backed portion of each adhesive-backed anchoring member is protected).

[0148] In use and referring to Figure 3, the first release liners 202a and 202b may be removed and the medical device 100 subsequently applied to the skin. Once applied, the second release liners 204a and 204b may be removed so the remainder of the adhesive-backed anchoring members 102 and 112 can be adhered to the patient’s skin.

[0149] Figure 4a shows diagrammatically an alternative instance of the present disclosure wherein a common release liner 402 (shown in stippling) is shared between the two components of the medical device 100. In particular, Figure 4a is a diagrammatic representation showing the first adhesive-backed anchoring member 102 protected by a first adhered portion 404a (crosshatching) of common release liner 402, and second release liner 204a. The adhesive-backed portion of second adhesive-backed anchoring member 112 is protected by a second adhered portion 404b (cross-hatching) of common release liner 402, and second release liner 204b. Common release liner 402 is provided with a first tab 406a and a second tab 406b. As depicted in the instance shown in Figure 4a, tabs 406a and 406b are analogous to tabs 306a and 306b as discussed above in connection with Figure 3. The transition from second adhered portions 404a and 404b of common release liner 402, to tabs 406a and 406b, respectively, are marked by a fold (not numbered).

[0150] In use and referring to Figure 4a, the common release liner 402 may be removed and the medical device 100 subsequently applied to the skin. Once applied, the second release liners 204a and 204b may be removed so the remainder of the adhesive-backed anchoring members 102 and 112 can be adhered to the patient’s skin.

[0151] Alternative instances including a common release liner 402 divided into two zones are shown diagrammatically in Figures 4b and 4c. The purpose of introducing two zones into the two-zone instances is to enable a user to more easily apply the medical device 100.

[0152] Referring to Figure 4b, a crease 408 is provided in common release liner 402. Following removal of first adhered portion 404a from first adhesive-backed anchoring member 102, common release liner folds, or is folded along crease 408. Crease 408 provides a convenient feature for a user to “fold away” the loose tail of common release liner 402 while applying the adhesive portion of first adhesive-backed anchoring member 102 exposed by removal of first adhered portion 404a. Depending upon the depth of crease 408, the feature may enable a user to tear off a portion of the loose tail of common release liner along the crease, rather than merely folding it back. Crease 408 is located in a central region of common release liner 402 located between adhered portions 404a and 404b.

[0153] Referring to Figure 4c, a frangible line 410 is provided in common release liner 402. Following removal of first adhered portion 404a from first adhesive-backed anchoring member 102, the loose tail portion is removed by fracturing common release liner 402 along frangible line 410. Frangible line 410 provides a convenient feature enabling a user to remove the loose tail of common release liner 402 while applying the adhesive portion of first adhesive-backed anchoring member 102 exposed by removal of first adhered portion 404a. Frangible line 410 is located in a central region of common release liner 402 located between adhered portions 404a and 404b.

[0154] Adhesive Lavers of Variable Thickness

[0155] With reference to Figures 5 and 6, one or more of the adhesive-backed anchoring members 102 / 112 may include a continuous layer of adhesive 508 having a variable thickness. The variable thickness may exist when the adhesive backed-anchoring member 102 / 112 and adhesive 508 are viewed in cross-section, and more particularly when the cross-section is taken (substantially) perpendicular to a plane extending (substantially) parallel to or (substantially) along the adhesive-backed anchoring member 102 / 112 and skin 502 to which it is (to be) adhered.

[0156] The continuous layer of adhesive 508 is not intended to be limited to any particular adhesive composition unless specifically noted herein. For example, the continuous layer of adhesive 508 could be tackified acrylic adhesive, pressure-sensitive tackified acrylic adhesive, non-tackified acrylic adhesive, acrylate adhesive, pressure-sensitive acrylate adhesive, natural rubber adhesive, synthetic rubber adhesive, silicone adhesive (repositionable or not), heat- activated adhesive, pressure-sensitive silicone adhesive, transparent adhesive, rubber / acrylic adhesive, or a combination thereof.

[0157] As illustrated in Figures 5 and 6, the cross-section of the continuous layer of adhesive 508 may be thickest at one or more edges (e.g., the first edge 504, second edge 506, and / or one or more other edges) of the adhesive-backed anchoring member 102 / 112. As further illustrated in Figures 5 and 6, the cross-section of the continuous layer of adhesive 508 may be thickest along the entirety of the one or more edges of the adhesive-backed anchoring member 102 / 112. In other words, the continuous layer of adhesive 508 may include one or more thickest cross- sectional portions that are linear, positioned at one or more corresponding edges of the adhesive- backed anchoring member 102 / 112, and extend along (the entirety of) the one or more corresponding edges.

[0158] The continuous layer of adhesive 508 may include a thinnest cross-sectional portion located between the two thickest cross-sectional portions. In some embodiments, the thinnest and two thickest cross-sectional portions may be linear and extend along a common plane. As illustrated in Figure 1, the adhesive-backed anchoring member 102 / 112 may include a wound edge 104 / 114, an edge opposite the wound edge 104 / 114, and third and fourth edges extending between the wound edge 104 / 114 and the edge opposite the wound edge 104 / 114. In some embodiments, the two thickest cross-sectional portions may be positioned at the third and fourth edges. In some embodiments, the two thickest cross-sectional portions may extend along (the entirety of) the third and fourth edges.

[0159] As illustrated in Figure 7, when the skin 502 (after the continuous layer of adhesive 508 of variable thickness is adhered thereto) is stretched outwardly away from the adhesive-backed anchoring member 102 / 112, the thickest cross-sectional portion(s) (e.g., located at one or more edges of the adhesive-backed anchoring member 102 / 112) of the continuous layer of adhesive 508 stretches with the skin 502 and “flattens out” or “lays down.” This minimizes the likelihood of blistering of the skin 502 at the edges of the adhesive-backed anchoring member 102 / 112, delamination of the layers of the medical device 100, and / or de-adhesion of the adhesive-backed anchoring member 102 / 112 from the skin 502.

[0160] In some embodiments, the variable thickness of the continuous layer of adhesive 508 and / or the composition of the adhesive 508 may be configured such that the thickest portion(s) of the continuous layer of adhesive 508 (when viewed in cross-section in an unstretched orientation) may stretch to a point where it has a thickness (substantially) equal to that of the thinnest portion of the continuous layer of adhesive 508 (when viewed in cross-section in the unstretched orientation). Put other way, the variable thickness of the continuous layer of adhesive 508 and / or the composition of the adhesive 508 may be configured such that the continuous layer of adhesive 508 may stretch to a point of having a (substantially) uniform thickness (substantially) equal to that of the thinnest portion of the adhesive 508 (when viewed in cross-section in the unstretched orientation).

[0161] As illustrated Figures 5 and 6, the adhesive-backed anchoring member 102 / 112 and continuous layer of adhesive 508 may be manufactured such that the adhesive-backed anchoring member 102 / 112 is arcuate and the continuous layer of adhesive 508 is applied to a convex surface of the anchoring member 102 / 112 such that the surface of the continuous layer of adhesive 508 to be applied to the skin 502 is (substantially) planar. Consequently and as illustrated in Figure 7, when the skin 502 and as a result the continuous layer of adhesive 508 are stretched, the adhesive-backed anchoring member 102 / 112 may transition from arcuate to (substantially) planar. In other embodiments (such as those illustrated in Figures 8-10 discussed below), the adhesive-backed anchoring member 102 / 112 and continuous layer of adhesive 508 may be manufactured such that the adhesive-backed anchoring member 102 / 112 is (substantially) planar and the continuous layer of adhesive 508 is applied to a (substantially) planar surface of the anchoring member 102 / 112 such that the surface of the continuous layer of adhesive 508 to be applied to the skin 502 is arcuate or otherwise pitched. Either of the above manufacturing configurations result in the continuous layer of adhesive 508 having a crosssection of variable thickness.

[0162] In use, it may be desirable to not facilitate stretching of skin at one or more edges of the first and / or second adhesive backed anchoring members 102 / 112. For example, in use the first and second adhesive-backed anchoring members 102 / 1 12 may be rigidly attached to each other (using the first and second elongated connectors 108 / 116) to maintain a set distance between the first and second adhesive-backed anchoring members 102 and 112 and thus keep the wound or incision closed. In this context, it may not be beneficial to have a thickest cross-sectional portion of the continuous layer of adhesive located at the wound edge 104 / 114 of the first and / or second adhesive-backed anchoring member 102 / 112, as such may assist in unwanted stretching of skin at the edges of the wound or incision.

[0163] In view of the foregoing and as illustrated in Figure 8, the adhesive-backed anchoring member 102 / 112 may have a continuous layer of adhesive 800 including a thickest cross- sectional portion positioned at the edge (e.g., the first edge 504 in Figure 8) of the adhesive- backed anchoring member 102 / 112 opposite the wound edge 104 / 114 (e.g., the second edge 506 in Figure 8). The cross-section of the continuous layer of adhesive 800 decreases in thickness when moving from away from the thickest cross-sectional portion (i.e., away from the edge opposite the wound edge 104 / 114).

[0164] In some embodiments, the continuous layer of adhesive 800 may be configured such that the thinnest cross-sectional portion thereof is positioned at an edge (e.g., the second edge 506 in Figure 8) of the adhesive-backed anchoring member 102 / 112. In some embodiments, the thinnest cross-sectional portion may be positioned at the wound edge 104 / 114 of the adhesive-backed anchoring member 102 / 112.

[0165] In some embodiments, the continuous layer of adhesive 800 may be configured such that the thinnest cross-sectional portion thereof is positioned at the wound edge 104 / 114, a thickest cross-sectional portion thereof is positioned at the edge opposite the wound edge 104 / 114, and the cross-section of the continuous layer of adhesive 800 decreases in thickness when moving from the thickest cross-sectional portion to the thinnest cross-sectional portion (i.e., from the edge opposite the wound edge 104 / 114 and to the wound edge 104 / 114). Such a configuration enables the continuous layer of adhesive 800 to maintain adherence to skin as it stretches away from the wound or incision while also maintaining closure of the wound or incision. In other words, the thickest cross-sectional portion of the continuous layer of adhesive 800 can stretch to accommodate skin stretching while the wound edge 104 / 114 of the adhesive-backed anchoring member 102 / 112 remains stationary with respect to the wound or incision and without facilitating undesired opening of the wound or incision.

[0166] In some embodiments of the adhesive-backed anchoring member 102 / 112 of Figure 8, the thickest cross-sectional portion of the continuous layer of adhesive 800 may extend along the entirety of the first edge 504 (e.g., the edge opposite the wound edge 104 / 114). Moreover, in some embodiments of the adhesive-backed anchoring member 102 / 112 of Figure 8, the thinnest cross-sectional portion of the continuous layer of adhesive 800 may extend along the entirety of the second edge 506 (e.g., the wound edge 104 / 114).

[0167] With reference to Figure 9, in some embodiments the adhesive-backed anchoring member 102 / 112 may have a continuous layer of adhesive 900 including a thickest cross- sectional portion positioned between two thinnest cross-sectional portions. In some embodiments, the two thinnest cross-sectional portions may be positioned at edges (e.g., the wound edge 104 / 114 and the edge opposite the wound edge) of the adhesive-backed anchoring member 102 / 112. In some embodiments, the two thinnest cross-sectional portions may extend along (the entirety of) the edges. In some embodiments the thickest cross-sectional portion may be linear and extend along (the entirety of) the adhesive-backed anchoring member 102 / 112.

[0168] With reference to Figure 10, in some embodiments the adhesive-backed anchoring member 102 / 112 may have a continuous layer of adhesive 1000 including a first thinnest cross- sectional portion positioned between first and second thickest cross-sectional portions, and a second thinnest cross-sectional portion positioned between the second and a third thickest cross- sectional portion. In some embodiments, two of the thickest cross-sectional portions may be positioned at edges of the adhesive-backed anchoring member 102 / 112. In some embodiments, the two thickest cross-sectional portions may extend along (the entirety of) the edges. In some embodiments the first and second thinnest and thickest cross-sectional portions may be linear and extend along a common plane. In some embodiments the first and second thinnest and thickest cross-sectional portions may be linear and extend along (the entirety of) the adhesive- backed anchoring member 102 / 112.

[0169] As illustrated in Figure 1, the adhesive-backed anchoring member 102 / 112 may include a wound edge 104 / 114, an edge opposite the wound edge 104 / 114, and third and fourth edges extending between the wound edge 104 / 114 and the edge opposite the wound edge 104 / 114. In some embodiments, the adhesive-backed anchoring member 102 / 112 may have a continuous layer of adhesive where the thickness of the cross-section of the continuous layer of adhesive decreases as it moves away from the edge opposite the wound edge 104 / 114, the third edge, and the fourth edge. In other words, the continuous layer of adhesive may have a first thickest cross- sectional portion located at (and optionally extending along) the edge opposite the wound edge 104 / 114, a second thickest cross-sectional portion located at (and optionally extending along) the third edge, and a third thickest cross-sectional portion located at (and optionally extending along) the fourth edge, but the continuous layer of adhesive may not have a fourth thickest cross- sectional portion located at (and optionally extending along) the wound edge 104 / 114.

[0170] In other embodiments, the adhesive-backed anchoring member 102 / 112 may have a continuous layer of adhesive where the thickness of the cross-section of the continuous layer of adhesive decreases as it moves away from the third edge and the fourth edge. In other words, the continuous layer of adhesive may have a first thickest cross-sectional portion located at (and optionally extending along) the third edge and a second thickest cross-sectional portion located at (and optionally extending along) the fourth edge, but the continuous layer of adhesive may not have third thickest cross-section portion located at (and optionally extending along) the edge opposite the wound edge 104 / 114 or a fourth thickest cross-sectional portion located at (and optionally extending along) the wound edge 104 / 114.

[0171] In some embodiments, the adhesive-backed anchoring member 102 / 112 may have a continuous layer of adhesive including one or more thinnest cross-sectional portions and none of the one or more thinnest cross-sectional portions may extend to any edge of the adhesive-backed anchoring member 102 / 112. In other words, the one or more thinnest cross-sectional portions may be surrounded by thicker cross-sectional areas (but not necessarily thickest cross-sectional areas) of the continuous layer of adhesive.

[0172] In some embodiments, a continuous layer of adhesive described herein may include a thickest cross-sectional portion configured to (based on one or more of its thickness, length, and / or composition) maintain adherence to skin up to a skin stretching of 25%. For example, the thickest cross-sectional portion may be configured to maintain adherence to skin up to a skin stretching of up to 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, 24%, or 25%. For example, given an adhesive that can stretch to x% strain without de-adhering from the skin or adhesive-backed anchoring member 102 / 112, the change in thickness of the adhesive along the direction of skin stretching in the region where variable thickness adhesive is placed may be represented as:

[0173] (strained skin lenqth)-(device edqe length) „ . ,

[0174] - - - Equation 1 adhesive strain limit

[0175] Using Equation 1 and as an example, if the skin is to be able to stretch 25% (i.e., 1.25x original length) in 1 cm (10mm) and the adhesive can stretch 400% strain (i.e., 5x its original length), then the adhesive could be configured to be12 5 7n7n 10 771771= 0.5mmthicker at the edge than at the area(s) from the edge where the adhesive is of nominal thickness. As another example, if the skin is to be able to stretch 25% (i.e., 1.25x original length) in 1 cm (10mm) and the adhesive can stretch 300% strain (i.e., 4x its original length), then the adhesive could be configured to be12,5771771 10 mm> Q 525 mm thicker at the edge than at the area(s) from the

[0176] 4 edge where the adhesive is of nominal thickness.

[0177] In some embodiments, a continuous layer of adhesive described herein may include a thickest cross-sectional portion configured to (based on one or more of its thickness, length, and / or composition) maintain adherence to skin undergoing at least 10% stretching. In some embodiments, a continuous layer of adhesive described herein may include a thickest cross-sectional portion configured to (based on one or more of its thickness, length, and / or composition) stretch up to 5 times its unstretched length before de-adhering from skin. For example, the thickest cross-sectional portion may be configured to stretch up to 2 times, 3 times, 4 times, or 5 times its unstretched length before de-adhering from skin.

[0178] In some embodiments, the cross-section of a continuous layer of adhesive described herein may (prior to being applied to skin) transition from one or more thickest cross-sectional portions thereof to a thinnest cross-sectional portion thereof at a constant rate (e.g., slope). In other embodiments, the cross-section of a continuous layer of adhesive described herein may (prior to being applied to the skin) transition from one or more thickest cross-sectional portions thereof to a thinnest cross-sectional portion thereof at a non-constant rate (e.g., exponentially). The type and magnitude of rate change used may depend on various factors such as manufacturing ease, desired stretchability of the continuous layer of adhesive, and / or other factors that will be apparent to those skilled in the art.

[0179] In some embodiments, the singular adhesive-backed anchoring member 102 / 112 may include more than one (e.g., at least first and second) continuous layers of adhesive. For example, the adhesive-backed anchoring member 102 / 112 may include first and second continuous layers of adhesive, where each layer is independently selected to have one or more of the variable thickness cross-section aspects noted herein; first, second, and third continuous layers of adhesive, where each layer is independently configured to have one or more of the variable thickness cross-section aspects noted herein, and so on.

[0180] In some embodiments, adjacent continuous layers of adhesive may be spaced apart on the adhesive-backed anchoring member 102 / 112. In other embodiments, adjacent continuous layers of adhesive may abut one another.

[0181] As used herein, “independently selected” means the multiple components being referenced can be the same or have one or more different characteristics. In the context of continuous layers of adhesive, this means the different continuous layers of adhesive can be the same or different with respect to one or more of size, shape, number of thickest cross-sectional portions, number of thinnest cross-sectional portions, thickness of the thickest cross-sectional portion(s), thickness of the thinnest cross-sectional portion(s), size (e.g., length and width) of the thickest cross-sectional portion(s), size (e.g., length and width) of the thinnest cross-sectional portion(s), variable thickness nature (e.g., constant change of thickness, exponential change of thickness, etc.), etc.

[0182] With reference to Figures 11 and 12, when the adhesive-backed anchoring member 102 / 112 is configured with more than one continuous layer of variable thickness adhesive, the adhesive-backed anchoring member 102 / 112 may include one or more extension portions 1100. The number of extension portions 1100 is configurable. The adhesive-backed anchoring component 102 / 112 is not to be limited to having two extension portions 1100 as illustrated in Figures 11 and 12.

[0183] As illustrated in Figures 11 and 12, the one or more extension portions 1100 may be manufactured to be arcuated. While the one or more extension portions 1100 are illustrated to project way from the continuous layers of variable thickness adhesive, in some embodiments one or more of the one or more extension portions 1100 may be manufactured to project toward the continuous layers of variable thickness adhesive.

[0184] As illustrated in Figure 13, when the skin 502 (after the adhesive-backed anchoring member 102 / 112 is adhered thereto) is stretched outwardly away from the adhesive-backed anchoring member 102 / 112, the thickest cross-sectional portion(s) of the continuous layers of adhesive stretches with the skin 502 and “flattens out” or “lays down.” Likewise, the one or more extension portions 1100 flatten out and lay down. This minimizes the likelihood of blistering of the skin 502 at the edges of the adhesive-backed anchoring member 102 / 112, delamination of the layers of the medical device 100, and / or de-adhesion of the adhesive-backed anchoring member 102 / 112 from the skin 502.

[0185] In some embodiments of the adhesive-backed anchoring member 102 / 112 including multiple continuous layers of adhesive and one or more extension portions 1100, the compositions of the one or more extension portions 1100 and the adhesives may be configured such that the one or more extension portions 1100 fully flatten out / lay down prior to the thickest cross-sectional portions of the multiple continuous layers of adhesive flattening out / laying down. In other embodiments, the compositions of the one or more extension portions 1100 and the adhesives may be configured such that the thickest cross-sectional portions of the multiple continuous layers of adhesive fully flatten out / lay down prior to the one or more extension portions 1100 flattening out / laying down. In yet other embodiments, the one or more extension portions 1100 and thickest cross-sectional portions of the multiple continuous layers of adhesive may be configured to flatten out / lay down at least partially in parallel.

[0186] The separate continuous layers of variable thickness adhesive are shown for clarity with a noticeable gap in Figures 11-12. In reality, the extension portions 1100 may be flattened enough as packaged (and optionally as held together by an applicator card, not shown) to bring the continuous layers of variable thickness adhesive adjacent to each other, as shown where the skin has been stretched in Figure 13.

[0187] Stretchable Adhesive Layers of (Substantially) Uniform Thickness

[0188] In some embodiments, one or more of the adhesive-backed anchoring members 102 and 112 may include a layer of stretchable adhesive having a (substantially) uniform thickness. The layer of stretchable adhesive may be entirely stretchable, or one or more portions (but not the entirety) of the layer of adhesive may be stretchable. The one or more stretchable portions may be independently selected, meaning they can be the same or different with respect to one or more of size, shape, and composition.

[0189] Whether the entirety or one or more portions of the layer of adhesive is stretchable is configurable and will depend on the composition of the layer of adhesive. For example, the entire layer of adhesive may be made of one or more stretchable adhesives, resulting in the entire layer of the adhesive being stretchable. As another example, one or more portions (but not the entirety) of the layer of adhesive may be made of one or more stretchable adhesives while the layer of adhesive also includes at least one portion made of one or more non-stretchable adhesives.

[0190] It will be appreciated that a “non-stretchable portion” of the layer of adhesive may have some level of stretchability, but such stretchability may be substantially lower than that of a “stretchable portion.”

[0191] In embodiments where one or more portions (but not the entirety of) the layer of adhesive is stretchable, the stretchable portion(s) of the layer of adhesive may be located at (and optionally extend along) one or more edges of the adhesive-backed anchoring member 102 / 112. In some embodiments, the stretchable portion(s) may extend along the entirety of the one or more edges of the adhesive-backed anchoring member 102 / 112. In other words, the one or more stretchable portions may be linear, positioned at one or more corresponding edges of the adhesive-backed anchoring member 102 / 112, and extend along (the entirety of) the one or more corresponding edges.

[0192] In some embodiments and with reference to Figure 14, the layer of adhesive may include a non-stretchable portion 1402 located between first and second stretchable portions 1404a and 1404b. In some embodiments, the non-stretchable portion 1402, first stretchable portion 1404a, and second stretchable portion 1404b may be linear and extend along a common plane. For example and with reference to Figure 1, the adhesive-backed anchoring member 102 / 112 may include a wound edge 104 / 114, an edge opposite the wound edge 104 / 114, and third and fourth edges extending between the wound edge 104 / 114 and the edge opposite the wound edge 104 / 114. In some embodiments, the first and second stretchable portions 1404a and 1404b may be positioned at the third and fourth edges. In some embodiments, the first and second stretchable portions 1404a and 1404b may extend along (the entirety of) the third and fourth edges.

[0193] As noted herein above, in use it may be desirable to not facilitate stretching of skin at one or more edges of the first and / or second adhesive backed anchoring members 102 / 112. For example, in use the first and second adhesive-backed anchoring members 102 / 112 may be rigidly attached to each other (using the first and second elongated connectors 108 / 116) to maintain a set distance between the first and second adhesive-backed anchoring members 102 and 112 and thus keep the wound or incision closed. In this context, it may not be beneficial to have a stretchable portion of the adhesive layer located at the wound edge 104 / 114 of the first and / or second adhesive-backed anchoring member 102 / 112, as such may assist in unwanted stretching of skin at the edges of the wound or incision.

[0194] In view of the foregoing and with reference to Figure 15, the adhesive-backed anchoring member 102 / 112 may have a layer of adhesive including a stretchable portion 1404 positioned at the edge 1502 of the adhesive-backed anchoring member 102 / 112 opposite the wound edge 104 / 114. Such a configuration enables the layer of adhesive to maintain adherence to skin as it stretches away from the wound or incision while also maintaining closure of the wound or incision. In other words, the stretchable portion 1404 of the layer of adhesive can stretch to accommodate skin stretching while the wound edge 104 / 114 of the adhesive-backed anchoring member 102 / 112 remains stationary with respect to the wound or incision and without facilitating undesired opening of the wound or incision. In some embodiments, the stretchable portion 1404 of the layer of adhesive may extend along the entirety of the edge 1502 opposite the wound edge 104 / 114. Moreover, in some embodiments the non-stretchable portion 1402 of the layer of adhesive may extend along the entirety of the wound edge 104 / 114.

[0195] In some embodiments and with reference to Figure 16, the adhesive-backed anchoring member 102 / 112 may have a layer of adhesive including a stretchable portion 1404 positioned between first and second non-stretchable portions 1402a and 1402b. In some embodiments, the first and second non-stretchable portions 1402a and 1402b may be positioned at edges (e.g., the wound edge 104 / 114 and the edge opposite the wound edge) of the adhesive-backed anchoring member 102 / 112. In some embodiments, the first and second non-stretchable portions 1402a and 1402b may extend along (the entirety of) the edges. In some embodiments the stretchable portion 1404 may be linear and extend along (the entirety of) the adhesive-backed anchoring member 102 / 112.

[0196] In some embodiments and with reference to Figure 17, the adhesive-backed anchoring member 102 / 112 may have a layer of adhesive including a first non-stretchable portion 1402a positioned between first and second stretchable portions 1404a and 1404b, and a second non- stretchable portion 1402b positioned between the second stretchable portion 1404b and a third stretchable portion 1404c. In some embodiments, the first and third stretchable portions 1404a and 1404c may be positioned at edges of the adhesive-backed anchoring member 102 / 112. In some embodiments, the first and third stretchable portions 1404a and 1404c may extend along (the entirety of) the edges. In some embodiments the portions of the layer of adhesive may be linear and extend along a common plane. In some embodiments the portions may be linear and extend along (the entirety of) the adhesive-backed anchoring member 102 / 112.

[0197] As discussed above, the adhesive-backed anchoring member 102 / 112 may include a wound edge 104 / 114, an edge 1502 opposite the wound edge 104 / 114, and third and fourth edges extending between the wound edge 104 / 114 and the edge 1502 opposite the wound edge 104 / 114. In some embodiments and with reference to Figure 18, the layer of adhesive may have a first stretchable portion 1404a located at (and optionally extending along) the edge 1502 opposite the wound edge 104 / 114, a second stretchable portion 1404b located at (and optionally extending along) the third edge, a third stretchable portion 1404c located at (and optionally extending along) the fourth edge, and a non-stretchable portion 14021 ocated at (and optionally extending along) the wound edge 104 / 114. In some embodiments, the second and third stretchable portions 1404b and 1404c may extend all the way to the wound edge 104 / 114 and the first non-stretchable portion 1402 may not extend along an entirety of the wound edge 104 / 114. (as illustrated in Figure 18). In other embodiments, the second and third stretchable portions 1404b and 1404c may extend part way to the wound edge 104 / 114 and the first non-stretchable portion 1402 may extend along an entirety of the wound edge 104 / 114.

[0198] In some embodiments and with reference to Figure 19, the layer of adhesive may have a first stretchable portion 1404a located at (and optionally extending along) the third edge, a second stretchable portion 1404b located at (and optionally extending along) the fourth edge, a non-stretchable portion 1402 located at and extending between the wound edge 104 / 114 and the edge 1502 opposite the wound edge 104 / 114.

[0199] In some embodiments, the layer of adhesive may include one or more non-stretchable portions and none of the one or more non-stretchable portions may extend to any edge of the adhesive-backed anchoring member 102 / 112. In other words, the one or more non-stretchable portions may be surrounded by stretchable portions of the layer of adhesive.

[0200] In some embodiments, the layer of adhesive may include a stretchable portion configured to (based on its size and / or composition) maintain adherence to skin up to a skin stretching of 25%. For example, the stretchable portion may be configured to maintain adherence to skin up to a skin stretching of up to 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, 24%, or 25%.

[0201] In some embodiments, the layer of adhesive may include a stretchable portion configured to (based on its size and / or composition) maintain adherence to skin undergoing at least 10% stretching.

[0202] In some embodiments, the layer of adhesive may include a stretchable portion configured to (based on its size and / or composition) stretch up to 5 times its unstretched length before deadhering from skin. For example, the stretchable portion may be configured to stretch up to 2 times, 3 times, 4 times, or 5 times its unstretched length before de-adhering from skin.

[0203] In some embodiments, the singular adhesive-backed anchoring member 102 / 112 may include more than one (e.g., at least first and second) layers of adhesive. For example, the adhesive-backed anchoring member 102 / 112 may include first and second continuous layers of adhesive, where each layer is independently selected to have one or more of the stretchable portions noted herein; first, second, and third layers of adhesive, where each layer is independently configured to have one or more of the stretchable portions noted herein, and so on.

[0204] In some embodiments, adjacent layers of adhesive may be spaced apart on the adhesive- backed anchoring member 102 / 112. In other embodiments, adjacent layers of adhesive may abut one another.

[0205] In the context of layers of adhesives having stretchable portions, “independently selected” means the different layers of adhesive can be the same or different with respect to one or more of size, shape, number of stretchable portions, number of non-stretchable portions, shape of the stretchable portion(s), shape of the non-stretchable portion(s), size (e.g., length and width) of the stretchable portion(s), size (e.g., length and width) of the stretchable portion(s), etc.

[0206] The adhesive-backed anchoring member 102 / 112, having more than one layer of adhesive each having one or more stretchable portions, may be configured as illustrated in Figures 11 and 12. That is, the adhesive-backed anchoring member 102 / 112 may include the one or more extension portions 1100, with the number being configurable

[0207] In some embodiments of the adhesive-backed anchoring member 102 / 112 including multiple layers of adhesive (each including one or more stretchable portions) and one or more extension portions 1100, the compositions of the one or more extension portions 1100 and the adhesives may be configured such that the one or more extension portions 1100 fully flatten out / lay down prior to the stretchable portions of the multiple layers of adhesive fully stretching. In other embodiments, the compositions of the one or more extension portions 1100 and the adhesives may be configured such that the stretchable portions of the multiple layers of adhesive fully stretch prior to the one or more extension portions 1100 flattening out / laying down. In yet other embodiments, the one or more extension portions 1100 and stretchable portions of the multiple layers of adhesive may be configured to flatten out / lay down / stretch at least partially in parallel.

[0208] By way of example and not limitation, a non-stretchable portion of a layer of adhesive may be tackified acrylic adhesive, pressure-sensitive tackified acrylic adhesive, non-tackified acrylic adhesive, acrylate adhesive, pressure-sensitive acrylate adhesive, natural rubber adhesive, synthetic rubber adhesive, silicone adhesive, heat-activated adhesive, pressure-sensitive silicone adhesive, transparent adhesive, rubber / acrylic adhesive, or a combination thereof. By way of example and not limitation, a stretchable portion of a layer of adhesive may be a 3D printable tissue adhesive (such as that described in Wu, S.J. et al., “A 3D printable tissue adhesive”, Nat Commun 15, 1215 (2024), https: / / doi.org / 10.1038 / s41467-024-45 I47~9, which is incorporated herein by reference is its entirety), a blood-repelling hydrophobic matrix adhesive, a direct ink writing adhesive, or a combination thereof.

[0209] Method of Closing a Wound or Incision

[0210] The present disclosure also provides a method 2000 for closing a wound or incision. The method 900 includes providing (step 2002) the medical device 100.

[0211] After providing the medical device 100, the method 2000 may proceed with applying (step 2004) the medical device 100 to the patient’s skin. In other words, the method may include adhering the first and second adhesive-backed anchoring members 102 and 112 to areas of the patient’s skin corresponding to opposing edges of the wound or incision. In the event the medical device 100 has one or more release liners, applying the medical device 100 may include removing one or more of the release liner(s) from the medical device 100 prior to application.

[0212] After the medical device 100 is applied to the patient’s skin, the method 2000 may include closing (step 2006) the wound or incision using the medical device 100 (i.e., by moving / drawing the first and second adhesive-backed anchoring members 102 and 112 towards each other.

[0213] Further Definitions and Construction of Terms

[0214] The titles, headings, and subheadings provided herein should not be interpreted as limiting the various aspects of the disclosure. Accordingly, the terms defined herein are more fully defined by reference to the specification in its entirety. All references cited herein are incorporated by reference in their entirety.

[0215] Unless otherwise defined, scientific and technical terms used herein shall have the meanings that are commonly understood by those of ordinary skill in the art. Further, unless otherwise required by context, singular terms shall include pluralities, and plural terms shall include the singular. In this application, the use of “or” means “and / or” unless stated otherwise. In the context of a multiple dependent claim, the use of “or” refers back to more than one preceding independent or dependent claim in the alternative only.

[0216] It is further noted that, as used in this specification and the appended claims, the singular forms “a,” “an,” and “the,” and any singular use of any word, include plural referents unless expressly and unequivocally limited to one referent.

[0217] As used herein, the term “about,” means approximately. When the term “about” is used in conjunction with a numerical range, it modifies that range by extending the boundaries above and below the numerical values set forth. Illustratively, the use of the term “about” indicates that values slightly outside the cited values (i.e., plus or minus 0.1% to 10%), which are also effective and safe are included in the value. Numerical ranges recited herein by endpoints include all numbers and fractions subsumed within that range (e g. 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.90, 4, and 5).

[0218] As used herein, the terms “comprising” (and any form of comprising, such as “comprise,” “comprises,” and “comprised”), “having” (and any form of having, such as “have” and “has”), “including” (and any form of including, such as “includes” and “include”), and “containing” (and any form of containing, such as “contains” and “contain”) are inclusive or open-ended and do not exclude additional, un-recited elements or method steps. Additionally, a term that is used in conjunction with the term “comprising” is also understood to be able to be used in conjunction with the term “consisting of’ or “consisting essentially of.”

[0219] Method steps described in this disclosure can be performed in any order unless otherwise indicated or otherwise clearly contradicted by context.

[0220] For the avoidance of doubt, insofar as is practicable any embodiment of a given aspect of the present disclosure may occur in combination with any other embodiment of the same aspect of the present disclosure. In addition, insofar as is practicable it is to be understood that any preferred or optional embodiment of any aspect of the present disclosure should also be considered as a preferred or optional embodiment of any other aspect of the present disclosure.

Claims

CLAIMSWHAT IS CLAIMED IS:

1. A medical device for closing a wound or incision, comprising: first and second adhesive-backed anchoring members for adhering to skin of a patient, wherein: the first and second adhesive-backed anchoring members each comprise a wound edge for positioning proximate to the wound or incision, the first adhesive-backed anchoring member comprises a continuous layer of adhesive, a cross-section of the continuous layer of adhesive has a variable thickness, and the continuous layer of adhesive is thickest at one or more edges of the first adhesive-backed anchoring member.

2. The medical device of claim 1, wherein the continuous layer of adhesive comprises a thickest cross-sectional portion along an entirety of the one or more edges.

3. The medical device of claim 1, wherein: the first adhesive-backed anchoring member further comprises an edge opposite the wound edge; the continuous layer of adhesive comprises a thickest cross-sectional portion at the edge opposite the wound edge; and the cross-section of the continuous layer of adhesive decreases in thickness when moving from the edge opposite the wound edge and toward the wound edge.

4. The medical device of claim 3, wherein the thickest cross-sectional portion extends along an entirety of the edge opposite the wound edge.

5. The medical device of claim 3, wherein the continuous layer of adhesive comprises a thinnest cross-sectional portion at the wound edge.

6. The medical device of claim 5, wherein the thinnest cross-sectional portion extends along an entirety of the wound edge.

7. The medical device of claim 1, wherein: the continuous layer of adhesive comprises one or more thickest cross-sectional portions and a thinnest cross-sectional portion; and the cross-section of the continuous layer of adhesive transitions from the one or more thickest cross-sectional portions to the thinnest cross-sectional portion at a constant rate.

8. The medical device of claim 1, wherein: the continuous layer of adhesive comprises one or more thickest cross-sectional portions and a thinnest cross-sectional portion; and the cross-section of the continuous layer of adhesive transitions from the one or more thickest cross-sectional portions to the thinnest cross-sectional portion at a non-constant rate.

9. The medical device of claim 1, wherein the continuous layer of adhesive comprises a thickest cross-sectional portion configured to maintain adherence to skin up to a skin stretching of 25%.

10. The medical device of claim 1, wherein the continuous layer of adhesive comprises a thinnest cross-sectional portion located between two thickest cross-sectional portions.

11. The medical device of claim 1, wherein the continuous layer of adhesive comprises a thickest cross-sectional portion located between two thinnest cross-sectional portions.

12. The medical device of claim 1, wherein the cross-section of the continuous layer of adhesive comprises: a first thinnest cross-sectional portion between first and second thickest cross-sectional portions; and a second thinnest cross-sectional portion between the second thickest cross-sectional portion and a third thickest cross-sectional portion.

13. The medical device of claim 1, wherein the first adhesive-backed anchoring member further comprises a second continuous layer of adhesive having a variable thickness.

14. The medical device of claim 13, wherein the continuous layer of adhesive and the second continuous layer of adhesive are spaced apart.

15. The medical device of claim 1, wherein the cross-section of the continuous layer of adhesive comprises a thinnest cross-sectional portion that does not extend to any edge of the first adhesive-backed anchoring member.

16. The medical device of claim 1, wherein: the first adhesive-backed anchoring member further comprises an edge opposite the wound edge, and third and fourth edges extending between the wound edge and the edge opposite the wound edge; and a thickness of the cross-section of the continuous layer of adhesive decreases as it moves away from the edge opposite the wound edge, the third edge, and the fourth edge.

17. The medical device of claim 1, wherein the continuous layer of adhesive is tackified acrylic adhesive, pressure-sensitive tackified acrylic adhesive, non-tackified acrylic adhesive, acrylate adhesive, pressure-sensitive acrylate adhesive, natural rubber adhesive, synthetic rubber adhesive, silicone adhesive, heat-activated adhesive, pressure-sensitive silicone adhesive, transparent adhesive, rubber / acrylic adhesive, or a combination thereof.

18. The medical device of claim 1, wherein the continuous layer of adhesive is capable of stretching up to five times its unstretched length before de-adhering from the skin of the patient.

19. The medical device of claim 1, wherein the first adhesive-backed anchoring member is made of a substantially inelastic material.

20. The medical device of claim 19, wherein the substantially inelastic material is a substantially inelastic polymeric material.

21. The medical device of claim 20, wherein the substantially inelastic material is polyurethane, polyester, polyethylene, or a combination thereof.

22. A medical device for closing a wound or incision, comprising: first and second adhesive-backed anchoring members for adhering to skin of a patient, wherein: the first and second adhesive-backed anchoring members each comprise a wound edge for positioning proximate to the wound or incision, the first adhesive-backed anchoring member comprises a continuous layer of adhesive, and the continuous layer of adhesive comprises a stretchable adhesive portion at an edge of the first adhesive-backed anchoring member.

23. The medical device of claim 22, wherein the stretchable adhesive portion extends along an entirety of the edge.

24. The medical device of claim 22, wherein: the first adhesive-backed anchoring member further comprises an edge opposite the wound edge; and the stretchable adhesive portion is at the edge opposite the wound edge.

25. The medical device of claim 24, wherein the stretchable adhesive portion extends along an entirety of the edge opposite the wound edge.

26. The medical device of claim 24, wherein the continuous layer of adhesive comprises a non-stretchable adhesive portion at the wound edge.

27. The medical device of claim 26, wherein the non-stretchable adhesive portion extends along an entirety of the wound edge.

28. The medical device of claim 22, wherein the stretchable adhesive portion is configured to maintain adherence to skin up to a skin stretching of 25%.

29. The medical device of claim 22, wherein the continuous layer of adhesive comprises a non-stretchable adhesive portion located between two stretchable adhesive portions.

30. The medical device of claim 22, wherein the continuous layer of adhesive comprises the stretchable adhesive portion located between two non-stretchable adhesive portions.

31. The medical device of claim 22, wherein the continuous layer of adhesive comprises: a first non-stretchable adhesive portion between first and second stretchable adhesive portions; and a second non-stretchable adhesive portion between the second stretchable adhesive portion and a third stretchable adhesive portion.

32. The medical device of claim 22, wherein the first adhesive-backed anchoring member further comprises a second continuous layer of adhesive having at least one stretchable adhesive portion.

33. The medical device of claim 32, wherein the continuous layer of adhesive and the second continuous layer of adhesive are spaced apart.

34. The medical device of claim 22, wherein the continuous layer of adhesive comprises a non-stretchable adhesive portion that does not extend to any edge of the first adhesive-backed anchoring member.

35. The medical device of claim 22, wherein: the first adhesive-backed anchoring member further comprises an edge opposite the wound edge, and third and fourth edges extending between the wound edge and the edge opposite the wound edge; and the continuous layer of adhesive comprises: a first stretchable adhesive portion located at the edge opposite the wound edge, a second stretchable adhesive portion located at the third edge, and a third stretchable adhesive portion located at the fourth edge.

36. The medical device of claim 22, wherein the stretchable adhesive portion is a 3D printable tissue adhesive, a blood-repelling hydrophobic matrix adhesive, a direct ink writing adhesive, or a combination thereof.

37. The medical device of claim 22, wherein the continuous layer of adhesive comprises a non-stretchable adhesive portion made of tackified acrylic adhesive, pressure-sensitive tackified acrylic adhesive, non-tackified acrylic adhesive, acrylate adhesive, pressure-sensitive acrylate adhesive, natural rubber adhesive, synthetic rubber adhesive, silicone adhesive, heat-activated adhesive, pressure-sensitive silicone adhesive, transparent adhesive, rubber / acrylic adhesive, or a combination thereof.

38. The medical device of claim 22, wherein the stretchable adhesive portion is capable of stretching up to five times its unstretched length before de-adhering from the skin of the patient.

39. The medical device of claim 22, wherein the first adhesive-backed anchoring member is made of a substantially inelastic material.

40. The medical device of claim 39, wherein the substantially inelastic material is a substantially inelastic polymeric material.

41. The medical device of claim 40, wherein the substantially inelastic material is polyurethane, polyester, polyethylene, or a combination thereof.

42. A method for closing a wound or incision, comprising: providing the medical device of claim 1 or claim 22; applying the medical device to skin of a patient proximate the wound or incision; and after applying the medical device, closing the wound or incision by moving the first and second adhesive-backed members towards each other.

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