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WO2024110860A1 - Dispositif d'étalement d'adhésif cutané topique - Google Patents

Dispositif d'étalement d'adhésif cutané topique Download PDF

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Publication number
WO2024110860A1
WO2024110860A1 PCT/IB2023/061727 IB2023061727W WO2024110860A1 WO 2024110860 A1 WO2024110860 A1 WO 2024110860A1 IB 2023061727 W IB2023061727 W IB 2023061727W WO 2024110860 A1 WO2024110860 A1 WO 2024110860A1
Authority
WO
WIPO (PCT)
Prior art keywords
body portion
flexural
adhesive
proximal
topical skin
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/IB2023/061727
Other languages
English (en)
Inventor
Jason T. Perkins
Grant S. MILLER
Doug Souls
Robert A. Rousseau
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Cilag GmbH International
Original Assignee
Cilag GmbH International
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US18/490,875 external-priority patent/US12533132B2/en
Application filed by Cilag GmbH International filed Critical Cilag GmbH International
Priority to KR1020257020679A priority Critical patent/KR20250112845A/ko
Priority to JP2025529812A priority patent/JP2025538547A/ja
Priority to EP23813080.1A priority patent/EP4622560A1/fr
Priority to CN202380080515.4A priority patent/CN120239589A/zh
Priority to AU2023386025A priority patent/AU2023386025A1/en
Publication of WO2024110860A1 publication Critical patent/WO2024110860A1/fr
Priority to MX2025005950A priority patent/MX2025005950A/es
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00491—Surgical glue applicators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00491—Surgical glue applicators
    • A61B2017/00495—Surgical glue applicators for two-component glue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00831—Material properties
    • A61B2017/0084—Material properties low friction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00831—Material properties
    • A61B2017/00862—Material properties elastic or resilient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00831—Material properties
    • A61B2017/00951—Material properties adhesive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/02—Adhesive bandages or dressings
    • A61F13/023—Adhesive bandages or dressings wound covering film layers without a fluid retention layer

Definitions

  • a wound closure system (also referred to as a skin closure system) may be used at the conclusion of a surgical procedure on a patient to close a wound (e.g., a surgical incision) that was formed in the patient’s skin for accessing a target anatomical structure.
  • wound closure systems may include components such as sutures, substrates, and/or liquid topical skin adhesives that are applied by a surgeon to approximate the edges of the wound and, in some cases, form a stable and protective layer over the wound that promotes efficient healing.
  • one or more components of the applied wound closure system may be absorbed by the patient during the healing process. Following healing of the wound, remaining components of the wound closure system may be removed from the skin by a surgeon, and/or they may automatically separate from the skin such that they may be discarded by the patient.
  • FIG. 1 depicts a perspective view of an example of a wound closure system that includes a wound closure device, an adhesive applicator, and an adhesive spreader;
  • FIG. 2 depicts a disassembled perspective view of the wound closure device of FIG. 1, showing a mesh layer, a pressure sensitive adhesive layer, and a removable backing layer;
  • FIG. 3 A depicts a perspective view of the wound closure device of FIG. 1 aligned longitudinally with a wound in the skin of a patient, showing a central section of the backing layer having been removed;
  • FIG. 3B depicts a perspective view of the wound closure device of FIG. 1 applied to the patient’s skin over the wound to approximate the edges of the wound
  • FIG. 3C depicts a perspective view of the wound closure device of FIG. 1 applied to the patient’s skin over the wound, showing remaining sections of the backing layer having been removed so the wound closure device is fully adhered to the skin;
  • FIG. 3D depicts a perspective view of the wound closure device of FIG. 1 applied to the patient’s skin over the wound, showing application of a liquid topical skin adhesive onto the mesh layer with the adhesive applicator;
  • FIG. 3E depicts a perspective view of the wound closure device of FIG. 1 applied to the patient’s skin over the wound, showing the adhesive spreader positioned against the patient at the start of an adhesive spreading stroke for spreading the applied topical skin adhesive over and through the wound closure device;
  • FIG. 3F depicts a perspective view of the wound closure device of FIG. 1 applied to the patient’s skin over the wound, showing the adhesive spreader during a subsequent portion of the adhesive spreading stroke;
  • FIG. 4 depicts a perspective view of the adhesive spreader of FIG. 1;
  • FIG. 5 depicts a top plan view of the adhesive spreader of FIG. 1;
  • FIG. 6 depicts a side elevational view of the adhesive spreader of FIG. 1;
  • FIG. 7A depicts a side sectional view of the adhesive spreader of FIG. 1, taken along line
  • FIG. 7B depicts a side sectional view of the adhesive spreader of FIG. 1, taken along line
  • FIG. 8 depicts an end sectional view of the adhesive spreader of FIG. 1, taken along line
  • FIG. 9 depicts an end sectional view of the adhesive spreader of FIG. 1, taken along line
  • FIG. 10 depicts a plan view of the distal body portion of the adhesive spreader of FIG. 1, showing a spreading tip of the adhesive spreader conforming to a convexly curved skin surface;
  • FIG. 11 depicts a plan view of the distal body portion of the adhesive spreader of FIG. 1, showing the spreading tip conforming to a convexly and concavely curved skin surface;
  • FIG. 12 depicts an end sectional view of another illustrative adhesive spreader configured for use with the wound closure system of FIG. 1 ;
  • FIG. 13 depicts an end sectional view of another illustrative adhesive spreader configured for use with the wound closure system of FIG. 1 ;
  • FIG. 14 depicts an end sectional view of another illustrative adhesive spreader configured for use with the wound closure system of FIG. 1 ;
  • FIG. 15 depicts a perspective view of another illustrative adhesive spreader configured for use with the wound closure system of FIG. 1;
  • FIG. 16 depicts a perspective view of another illustrative adhesive spreader configured for use with the wound closure system of FIG. 1.
  • proximal and distal are defined herein relative to a human or robotic operator of the surgical instrument.
  • proximal refers the position of an element closer to the human or robotic operator of the surgical instrument and further away from the surgical end effector of the surgical instrument.
  • distal refers to the position of an element closer to the surgical end effector of the surgical instrument and further away from the human or robotic operator of the surgical instrument.
  • spatial terms such as “side,” “upwardly,” and “downwardly” also are used herein for reference to relative positions and directions. Such terms are used below with reference to views as illustrated for clarity and are not intended to limit the invention described herein.
  • FIG. 1 shows an example of a wound closure system (10) that includes a wound closure device (20) (also referred to as a patch) configured to be applied to a patient’s wound (W), an adhesive applicator (40) configured to apply a topical skin adhesive (54) (see FIG. 3D) to the applied wound closure device (20), and an adhesive spreader (60) configured to spread the applied topical skin adhesive (54) onto and through wound closure device (20).
  • a wound closure device (20) also referred to as a patch
  • an adhesive applicator 40
  • a topical skin adhesive see FIG. 3D
  • an adhesive spreader 60
  • wound closure device (20) of the present version has an elongate, generally rectangular shape and a triple layer construction. More specifically, wound closure device (20) includes a layer of substrate in the form of a textile mesh (22), a layer of pressure sensitive adhesive (24) formed as a continuous or non-continuous coating along the lower skin-facing side of mesh (22), and a layer of backing (26) removably applied to the lower side of pressure sensitive adhesive (24).
  • wound closure device as used herein encompasses wound closure device (20) both with and without backing (26), which may be removed and discarded during application of wound closure device (20) to a patient, as described in greater detail below.
  • Mesh (22) is configured to retain a liquid topical skin adhesive and may be formed of polyethylene (PET) or any other suitable surgical textile material.
  • Pressure sensitive adhesive (24) is configured to enable wound closure device (20) to self-adhere to a patient’s skin in response to a pressure being applied to the upper side of mesh (22) during its application by a surgeon.
  • Backing (26) serves to protect pressure sensitive adhesive (24) before application of wound closure device (20) to the patient.
  • backing (26) includes elongate arrays of perforations that extend longitudinally and define an elongate central backing section (28) and a pair of elongate side backing sections (30). Though each backing section (28, 30) is shown as generally rectangular in the present version, backing sections (28, 30) may be of various alternative shapes, sizes, and quantities in other versions.
  • adhesive applicator (40) includes an applicator body (42), a plunger unit (44) slidably received within an open proximal end of applicator body (42), and a static mixer (46) secured to a distal end of applicator body (42).
  • Applicator body (42) includes a pair of barrels (48) arranged side by side, where each barrel (48) houses a respective part of a two- part liquid topical skin adhesive.
  • Plunger unit (44) includes a pair of plungers (50) that are arranged side by side and are interconnected at their proximal ends by a bridge (52).
  • Each plunger (50) is actuatable distally through a respective barrel (48) of applicator body (42) to force the corresponding liquid adhesive part distally into static mixer (46).
  • Static mixer (46) is configured to receive the first and second adhesive parts and direct them around and through a series of static baffles and passages (not shown) that mix the two adhesive parts together into a homogenous liquid adhesive (54) that is then dispensed through an open distal end of static mixer (46), as shown in FIG. 3D described below.
  • liquid topical skin adhesive (54) is in the form of a silicone- based topical skin adhesive that is configured to cure on skin at body temperature in less than two minutes. Once cured, topical skin adhesive (54) remains elastomeric such that a given section of cured adhesive (54) is configured to stretch up to 160% of its cured length and then fully recover to the cured length. Accordingly, wound closure system (10) may be particularly effective for use on actuatable body parts of a patient such as a knee, wrist, elbow, or other joint, for example. [00037] As also shown in FIG.
  • adhesive spreader (60) of the present version has a monolithic body that includes a proximal body portion (62) configured to be gripped by a user, a distal body portion (64) that terminates at a tip configured to spread applied topical skin adhesive (54), and an intermediate flexural body portion (66) that interconnects the proximal and distal body portions (62, 64).
  • Flexural body portion (66) is configured to elastically deform so that distal body portion (64) angularly deflects relative to proximal body portion (62) to promote effective spreading of topical skin adhesive (54) along wound closure device (20) with a suitable normal force within a predetermined range, as described in greater detail below.
  • FIGS. 3A-3D show an example of wound closure system (10) being used to close a wound (W) formed in the skin (S) of a patient.
  • wound (W) may be at least partially closed with one or more sutures, for example at deeper portions of wound (W), prior to use of wound closure system (10).
  • wound closure device (20) may be trimmed by a surgeon to any suitable shape as desired.
  • central backing section (28) is removed from wound closure device (20) to expose a central window of mesh (22) and pressure sensitive adhesive (24), and an imaginary centerline of wound closure device (20) is aligned longitudinally with the edges of wound (W).
  • Wound closure device (20) is then applied to the patient skin (S) over wound (W) and the surgeon applies pressure to the central portion of mesh (22) to force pressure sensitive adhesive (24) to adhere to the skin (S), thus fixing the edges of wound (W) relative to one another.
  • the edges of wound (W) may be held in an approximated state by the surgeon.
  • the central portion of wound closure device (20) may be applied in a laterally alternating manner to approximate the edges of wound (W) during application.
  • wound closure device (20) is configured to hold the edges of wound (W) in an approximated state following this initial step of application. Once the surgeon is satisfied with the position of wound closure device (20) relative to wound (W), the surgeon may then remove the remaining two side backing sections (30) to adhere the reminder of wound closure device (20) to skin (S).
  • adhesive applicator (40) is then used to apply a pattern of topical skin adhesive (54) to the upper side of mesh (22) of the applied wound closure device (20). While adhesive applicator (40) is shown applying a linear bead of topical skin adhesive (54) in the present version, it will be appreciated that various other patterns of topical skin adhesive (54) may be applied in other versions, such as a T-shaped pattern or a wave-shaped pattern as disclosed in U.S. Pat. App. No. 17/991,992, entitled “Application of Topical Skin Adhesive to Surgical Mesh,” filed November 22, 2022, the disclosure of which is incorporated by reference herein, in its entirety.
  • adhesive spreader (60) is then used to spread the applied topical skin adhesive (54) uniformly over wound closure device (20) to force the topical skin adhesive (54) through the layers of mesh (22) and pressure sensitive adhesive (24) and directly against wound (W) and the surrounding skin (S).
  • the layers of mesh (22) and pressure sensitive adhesive (24) may be at least partially permeable to permit forced passage of topical skin adhesive (54) therethrough.
  • flexural body portion (66) of adhesive spreader (60) may be in a non-deformed state when adhesive spreader (60) is first positioned against wound closure device (20) at the beginning of an adhesive spreading stroke.
  • flexural body portion (66) As adhesive spreader (60) is dragged longitudinally along wound closure device (20), the input force exerted by the user may cause flexural body portion (66) to elastically deform such that distal body portion (64) angularly deflects relative to proximal body portion (62), as shown in FIG. 3F.
  • the degree of deformation of flexural body portion (66) may be directly related to the viscosity of topical skin adhesive (54).
  • a greater viscosity may require that the user exert a greater input force through proximal body portion (62) to effectively spread topical skin adhesive (54) over and through wound closure device (20), such that the flexural body portion (66) deforms a relatively greater amount.
  • a lesser viscosity may require a lesser input force such that the flexural body portion (66) deforms less or not at all.
  • topical skin adhesive (54) may also be spread over adjacent portions of skin (S) not covered by wound closure device (20) to ensure that an entirety of mesh (22) is embedded with topical skin adhesive (54).
  • topical skin adhesive (54) may be spread onto at least 1 cm of skin (S) about the entire outer perimeter of the applied wound closure device (20).
  • any topical skin adhesive (54) on skin (S) beyond the perimeter of device (20) may then be wiped away with sterile gauze, for example.
  • a quantity of topical skin adhesive (54) may be applied between the edges of wound (W) before wound closure device (20) is applied to the skin (S).
  • wound closure device (20) cures within and over wound closure device (20) to form a composite microbial barrier over wound (W) that maintains a protective environment that promotes efficient healing.
  • wound closure device (20) may be removed from the skin (S) manually (e.g., by a surgeon) or it may automatically separate from the skin (S) such that it may be discarded by the patient.
  • Wound closure system (10) may be further configured and operable in accordance with at least some of the teachings of U.S. Pat. No. 11,712,229, entitled “Systems, Devices and Methods for Dispensing and Curing Silicone Based Topical Skin Adhesives,” issued August 1, 2023, the disclosure of which is incorporated by reference herein, in its entirety; U.S. Pat. No. 11,518,604, entitled “Systems, Methods and Devices for Aerosol Spraying of Silicone Based Topical Skin Adhesives for Sealing Wounds,” issued December 6, 2022, the disclosure of which is incorporated by reference herein, in its entirety; U.S. Pat. No.
  • adhesive spreader (60) of the present version has a monolithic body defined by proximal body portion (62), distal body portion (64), and flexural body portion (66) in combination.
  • this monolithic body has a variable buckling strength along its lateral width and is configured to elastically deform at flexural body portion (66) and at its distal end to ensure consistent application of a normal force of a predetermined, appropriate range to topical skin adhesive (54) and wound closure device (20) during use.
  • adhesive spreader (60) is configured to ensure that a topical skin adhesive, such as topical skin adhesive (54), is driven sufficiently through wound closure device (20) to contact and bond with skin (S) without transmitting excessive normal force that could dislodge wound closure device (20) from skin (S).
  • a topical skin adhesive such as topical skin adhesive (54)
  • the monolithic body of adhesive spreader (60) extends longitudinally between a rounded proximal end at which proximal body portion (62) terminates proximally, and a squared distal end defined by a spreading tip (68) at which distal body portion (64) terminates distally.
  • Adhesive spreader (60) has a lateral width measured between opposed lateral sides (70), and a thickness measured between opposed working sides (72).
  • Adhesive spreader (60) is symmetric about a first midplane (Pl) that bisects the monolithic body along its lateral width, and is also symmetric about a second midplane (P2) that bisects the monolithic body along its thickness, where the first and second midplanes (Pl, P2) intersect along a longitudinal axis (A) of adhesive spreader (60). Accordingly, adhesive spreader (60) may be used in various orientations interchangeably.
  • proximal body portion (62) and distal body portion (64) has a generally elongate oval-shaped cross-section that has a generally constant thickness through proximal body portion (62) and tapers in thickness distally through distal body portion (64) toward spreading tip (68), which defines a minimum thickness of adhesive spreader (60) and thus has a lesser rigidity than the proximal remainder of adhesive spreader (60).
  • spreading tip (68) may be configured to elastically deflect before and at a faster rate than flexural body portion (66) when pressed against an application surface.
  • Cross-sectional shapes and elastic deflection characteristics of spreading tip (68) and flexural body portion (66) are described in greater detail below.
  • proximal body portion (62) on each working side (72) of adhesive spreader (60) includes a finger well (74) that is located just proximal to flexural body portion (66) and is recessed inwardly with a concave curvature.
  • Each finger well (74) is sized and shaped to receive one or more fingers, such as a thumb, of a user to promote effective griping of proximal body portion (62).
  • a plurality of surface gripping features in the form of raised nubs (76) are arranged on each working side (72) of proximal body portion (62) within finger wells (74) and on at least a proximal half of proximal body portion (62).
  • Raised nubs (76) are configured to further promote effective gripping of proximal body portion (62) in the presence of fluids, such bodily fluids or saline, that might otherwise make proximal body portion (62) slippery during a surgical procedure, or when the user grasps proximal body portion (62) with gloved fingers.
  • Proximal body portion (62) on each working side (72) also includes a recessed area (78) proximal to finger well (74) that may include visual indicia (not shown), such as product branding, though it will be appreciated that recessed areas (78) are merely optional.
  • distal body portion (64) tapers distally toward spreading tip (68) and includes on each working side (72) an alignment indicator (80) positioned along the longitudinal axis (A) of adhesive spreader (60).
  • each alignment indicator (80) is shown in the form of a triangular recess, though alignment indicators (80) may be of various other configurations may be employed in other versions.
  • adhesive spreader (60) is oriented relative to wound (W) and wound closure device (20) such that the distal tips of alignment indicators (80) are aligned with the longitudinal centerline of wound (W) and wound closure device (20), and this alignment is maintained as adhesive spreader (60) is pulled in a stroke longitudinally across wound closure device (20).
  • spreading tip (68) extends transversely to the longitudinal axis (A) of adhesive spreader (60) and it includes a central planar surface (82) on each working side (72). Additionally, adhesive spreader (60) may be sized such that spreading tip (68) is slightly wider than wound closure device (20) so that spreading tip (68) may span the full width of wound closure device (20) and partially onto skin (S) on each side of wound closure device (20) during use.
  • wound closure device (20) may be approximately 4 cm wide and adhesive spreader (60) may be approximately 4.5 cm wide, including at spreading tip (68).
  • flexural body portion (66) on each working side (72) of adhesive spreader (60) includes a void feature shown in the form of a wedge-shaped channel (84).
  • void refers to an absence of material.
  • Each wedge-shaped channel (84) is centered on the longitudinal axis (A) of adhesive spreader (60) and has a length that is equal to approximately 80% of the lateral width of adhesive spreader (60).
  • each wedge-shaped channel (84) has a proximal surface (86) that is generally perpendicular to first midplane (Pl), and a distal surface (88) that is obliquely angled relative to first midplane (Pl).
  • Proximal and distal surfaces (86, 88) of each wedge-shaped channel (84) define an outwardly opening angle (0) of approximately 20°.
  • wedge-shaped channels (84) cooperate to provide a central web portion of flexural body portion (66) with a lesser rigidity than proximal body portion (62) such that flexural body portion (66) is configured to elastically deform so that distal body portion (64) angularly deflects relative to proximal body portion (62) when spreading tip (68) is pressed against an application surface by a user. More specifically, in response to a user input force, distal body portion (64) is configured to pivotably hinge relative to proximal body portion (62) about a transverse hinge axis defined by flexural body portion (66) that extends along first midplane (Pl) and orthogonally intersects second midplane (P2).
  • Distal body portion (64) may deflect in a first direction by a maximum deflection angle (0) as shown in FIG. 7A, and also in an opposite second direction by maximum deflection angle (0) as shown in FIG. 7B.
  • proximal and distal surfaces (86, 88) of the wedge-shaped channel (84) in the direction of deflection contact one another and thus act as mechanical stops to inhibit further deflection of distal body portion (64) in that direction.
  • distal body portion (64) may resilient snap back to its relaxed state shown in FIG. 6 in which proximal and distal body portions (62, 64) extend coaxially along the longitudinal axis (A), centered about first midplane (Pl).
  • proximal body portion (62) grips proximal body portion (62) and positions spreading tip (68) in contact with an application surface, such as mesh (22) of wound closure device (20) and/or skin (S).
  • an application surface such as mesh (22) of wound closure device (20) and/or skin (S).
  • the user leans adhesive spreader (60) so that its longitudinal axis (A) defined by proximal body portion (62) defines a lean angle relative to the application surface of approximately 45° to approximately 60°, as shown in FIGS. 3E-3F.
  • the user then applies a downward force through proximal body portion (62) in a direction normal to the application surface while dragging adhesive spreader (60) across the application surface such that proximal body portion (62) leads distal body portion (64).
  • the applied force creates a moment about spreading tip (68) that may be sufficient to cause flexural body portion (66) to elastically deform, due to its reduced thickness, such that distal body portion (64) angularly deflects relative to proximal body portion (62) in a hinge-like manner .
  • This elastic deformation of flexural body portion (66) may result in spreading tip (68) exerting a normal force against the application surface and the topical skin adhesive that is approximately 1.5 Ibf to approximately 5 Ibf when proximal body portion (62) is oriented within the lean angle range noted above.
  • proximal body portion (62) is oriented at lean angles greater than 60°, then the moment generated at spreading tip (68) progressively decreases resulting in less deformation of flexural body portion (66) such that the user-applied force is transmitted more directly through spreading tip (68) to the application surface. For instance, if proximal body portion (62) is oriented at a lean angle of 90° such that proximal body portion (62) is perpendicular to the application surface, then spreading tip (68) may exert a normal force of up to approximately 10 Ibf.
  • flexural body portion (66) enables a user to employ enhanced control and precession when spreading topical skin adhesive (54) over wound closure device (20).
  • adhesive spreader (60) is configured to spread topical skin adhesive (54) effectively over and through wound closure device (20) with a suitable normal force that may fall within the predetermined range noted above, depending on the viscosity of topical skin adhesive (54) and how adhesive spreader (60) is manipulated by the user.
  • flexural body portion (66) may operate to limit the normal force when spreading topical adhesives of relatively lower viscosity and may operate to ensure a predetermined minimum normal force when spreading topical skin adhesives of relatively higher viscosity.
  • adhesive spreader (60) enables it to apply the normal force consistently over wound closure device (20) to create a film of topical skin adhesive (54) having a uniform film thickness, such as approximately 0.5 mm.
  • Adhesive spreader (60) may also facilitate creation of film edges with a tapered thickness that help minimize the risk of the cured adhesive catching onto the patient’s clothing or other articles positioned against the patient’s skin (S).
  • each of flexural body portion (66) and spreading tip (68) has a non-uniform thickness, and thus a non-uniform rigidity and buckling strength, along the lateral width of adhesive spreader (60). More specifically, the thickness and buckling strength of flexural body portion (66) increases from the second midplane (P2) in orthogonal directions toward lateral sides (70), where a maximum thickness and buckling strength of flexural body portion (66) is defined at each longitudinal end of wedge-shaped channels (84) adjacent to lateral sides (70).
  • flexural body portion (66) has a minimum rigidity and buckling strength along the second midplane (P2) and a maximum rigidity and buckling strength along lateral sides (70). Accordingly, these regions of maximum buckling strength along lateral sides (70) function as structural beam-like features.
  • spreading tip (68) exhibits an inverse configuration from flexural body portion (66) regarding thickness and buckling strength. More specifically, the thickness and buckling strength of spreading tip (68) decreases from the second midplane (P2) in orthogonal directions toward lateral sides (70), where a maximum thickness of flexural body portion (66) is defined at the second midplane (P2). Accordingly, spreading tip (68) has a maximum rigidity and buckling strength along the second midplane (P2) and a minimum rigidity and buckling strength along lateral sides (70).
  • flexural body portion (66) and spreading tip (68) enable adhesive spreader (60) to elastically deform axially along longitudinal axis (A) so that spreading tip (68) may conform to various types of contoured application surfaces.
  • FIG. 10 shows spreading tip (68) conforming to a convex application surface (90)
  • FIG. 11 shows spreading tip (68) conforming to an undulating application surface (92) having both convex and concave portions.
  • Such application surfaces (90, 92) may be representative of patient body joints such as a knee, wrist, or elbow, for example.
  • adhesive spreader (60) may be formed of an elastomeric material having a hardness of approximately 50 Shore A to approximately 70 Shore A, such as approximately 60 Shore A, where the elastomeric material is non-reactive with topical skin adhesive (54), wound closure device (20), and skin (S).
  • adhesive spreader (60) may comprise a silicone rubber, and may be formed by injection molding.
  • two or more portions of adhesive spreader (60) may be formed of different materials, where at least flexural body portion (66) and spreading tip (68) are formed of elastomeric materials.
  • all or least a distal portion of adhesive spreader (60) may be at least at least partially transparent to enable visualization through adhesive spreader (60) while spreading a topical adhesive and promote alignment of alignment indicators (80) with the wound (W).
  • an adhesive spreader that includes a flexural body portion having a void feature other than wedge-shaped channels (84), where the void feature provides the flexural body portion with a buckling strength that varies along a lateral width of the adhesive spreader, and where the void feature promotes elastic deformation of the flexural body portion to enable a distal body portion of the spreader to angularly deflect relative to a proximal body portion to regulate a normal force applied by the spreader to the application surface.
  • FIGS. 12-16 show illustrative alternative adhesive spreaders (100, 120) configured in such a manner, where adhesive spreaders (100, 120) are similar to adhesive spreader (60) except as otherwise described below.
  • FIG. 12 shows an alternative adhesive spreader (100) that includes a proximal body portion (102) similar to proximal body portion (62), a distal body portion (not shown) similar to distal body portion (64), a unique flexural body portion (106), a pair of lateral sides (108), and a pair of working sides (110).
  • Flexural body portion (106) includes a void feature in the form of a pair of wedge-shaped channels (112) that are opposed from one another about first midplane (Pl) (see FIGS. 4 and 6). Each channel (112) has a root (114) that extends concavely relative to first midplane (Pl).
  • FIG. 13 shows another alternative adhesive spreader (120) that includes a proximal body portion (122) similar to proximal body portion (62), a distal body portion (not shown) similar to distal body portion (64), a unique flexural body portion (126), a pair of lateral sides (128), and a pair of working sides (130).
  • Flexural body portion (126) includes a void feature in the form of a pair of wedge-shaped openings (132) that are opposed from one another about first midplane (Pl) (see FIGS. 4 and 6).
  • Wedge-shaped openings (132) are similar to wedge-shaped channels (84, 112) but communicate with one another to define a central opening (134) (also referred to as a window) that extends fully through the central portion of flexural body portion (126) and longitudinally along first midplane (Pl), such that central opening (134) opens to each working side (130).
  • a thickness and buckling strength of flexural body portion (106) increases in a direction away from second midplane (P2) toward lateral sides (128).
  • flexural body portion (126) has a minimum buckling strength at second midplane (P2) and along the length of central opening (124), and a maximum buckling strength at the lateral ends of wedge-shaped openings (132).
  • FIG. 14 shows another alternative adhesive spreader (140) that includes a proximal body portion (142) similar to proximal body portion (62), a distal body portion (not shown) similar to distal body portion (64), a unique flexural body portion (146), a pair of lateral sides (148), and a pair of working sides (150).
  • Flexural body portion (146) includes a void feature in the form a plurality of recesses (152, 154, 156, 158) formed in working sides (150), where recesses (152, 154, 156, 158) are arranged symmetrically about second midplane (P2) and are separated from one another by a respective web of material.
  • a central recess (152) is centered laterally on second midplane (P2) and opens through the second working side (150) and is closed along the first working side (150).
  • a first intermediate recess (154) is disposed on each lateral side of central recess (152) and opens through the first working side (150) and is closed along the second working side (150).
  • a second intermediate recess (156) is disposed laterally outwardly of each first intermediate recess (154) and likewise opens through the second working side (150) and is closed along the first working side (150).
  • an internal volume of recesses (152, 154, 156, 158) decreases in a direction away from second midplane (P2), where central recess (152) has the greatest internal volume of recesses (152, 154, 156, 158) and each outer recess (158) has a minimum internal volume of recesses (152, 154, 156, 158).
  • the web of material that separates outer recesses (158) from second intermediate recesses (156) is thicker than the web of material that separates first and second intermediate recesses (154 156). Accordingly, the buckling strength of flexural body portion (146) increases in a direction away from second midplane (P2), with a minimum buckling strength at second midplane (P2) and a maximum buckling strength at lateral sides (148).
  • FIG. 15 shows another alternative adhesive spreader (160) that includes a proximal body portion (162) similar to proximal body portion (62), a distal body portion (164) similar to distal body portion (64), a unique flexural body portion (166), a pair of lateral sides (168), and a pair of working sides (170).
  • Flexural body portion (166) of the present example includes a first void feature in the form of a pair of wedge-shaped channels (172), and a second void feature in the form of an array of angled slits (174) that are formed between the lateral ends of wedge-shaped channels (172) and the lateral sides (168) of adhesive spreader (160).
  • Angled slits (174) extend fully through the thickness of adhesive spreader (160) and are arranged in pairs, where each pair defines an arrow or chevron-like shape having an apex oriented toward a respective lateral side (168). Additionally, angled slits (174) have a progressively larger opening size in a direction advancing from the lateral sides (168) toward the second midplane (P2) that bisects adhesive spreader (160) along its thickness. Accordingly, a buckling strength of flexural body portion (166) decreases in a direction toward the second midplane (P2) from lateral sides (168).
  • FIG. 16 shows another alternative adhesive spreader (180) that includes a proximal body portion (182) similar to proximal body portion (62), a distal body portion (184) similar to distal body portion (64), a unique flexural body portion (186), a pair of lateral sides (188), and a pair of working sides (190).
  • Flexural body portion (186) of the present example includes a void feature in the form of an array of bores (192) that extend fully through the thickness of adhesive spreader (180) along a linear path that extends transversely to the longitudinal axis of adhesive spreader (180) and parallel to the second midplane (P2).
  • bores (192) are formed symmetrically about the second midplane (P2), and the average diameter and density of bores (192) increases in a direction toward the second midplane (P2). Accordingly, a buckling strength of flexural body portion (186) decreases in a direction toward the second midplane (P2). [00065] IV. Examples of Combinations
  • An apparatus comprising: (a) a proximal body portion configured to be gripped by a user; (b) a distal body portion that terminates distally at a spreading tip configured to spread a topical skin adhesive along an application surface; and (c) a flexural body portion that interconnects the proximal and distal body portions to define a monolithic body, wherein in response to an input force applied by a user to the proximal body portion when the spreading tip is positioned against the application surface, the flexural body portion is configured to at least one of: (i) buckle non-uniformly along a lateral width of the apparatus, or (ii) elastically deform so that the distal body portion angularly deflects relative to the proximal body portion to thereby limit to a predetermined range a resultant normal force exerted by the spreading tip on the topical skin adhesive along the application surface.
  • Example 1 The apparatus of Example 1, wherein the monolithic body comprises an elastomeric material having a hardness of approximately 50 Shore A to approximately 70 Shore A.
  • Example any of the preceding Examples, wherein the elastomeric material comprises a silicone rubber.
  • Example 5 The apparatus of Example 5, wherein the void feature includes a pair of wedge- shaped channels arranged on opposing sides of the monolithic body, wherein each of the wedge- shaped channels extends transversely to a longitudinal axis of the apparatus.
  • each of the wedge-shaped channels has first and second opposed surfaces that define an angle of approximately 20°.
  • each of the flexural body portion and the spreading tip has a non-uniform thickness along a lateral width of the monolithic body such that a buckling strength of the flexural body portion varies along the lateral width.
  • Example 10 The apparatus of Example 10, wherein a buckling strength of the flexural body portion increases from the midplane in orthogonal directions toward the lateral sides, wherein a buckling strength of the spreading tip decreases from the midplane in orthogonal directions toward the lateral sides.
  • Example 13 The apparatus of any of the preceding Examples, wherein distal body portion is at least partially transparent and includes an alignment indicator configured to be aligned with a longitudinal axis of a wound when spreading topical adhesive over the wound.
  • a system comprising: (a) a wound closure device having a mesh layer and a pressure sensitive adhesive layer on an underside of the mesh layer, wherein the wound closure device is configured to be applied over a wound in a patient’s skin; (b) an adhesive applicator containing a topical skin adhesive, wherein the adhesive applicator is operable to dispense the topical skin adhesive onto the mesh layer of the applied wound closure device; and (c) the apparatus of Example 1, wherein the apparatus is configured to spread topical skin adhesive applied to the mesh layer of the wound closure device by the adhesive applicator.
  • Example 14 The system of Example 14, wherein the topical skin adhesive comprises silicone.
  • An apparatus comprising: (a) a proximal body portion; (b) a distal body portion that extends coaxially with the proximal body portion and terminates distally at a spreading tip configured to spread a topical skin adhesive along an application surface; and (c) a flexural body portion that interconnects the proximal and distal body portions to define a monolithic body, wherein the flexural body portion includes a void feature configured to promote elastic deformation of the monolithic body at the flexural body portion so that the distal body portion angularly deflects relative to the proximal body portion in response to an input force applied by a user to the proximal body portion to thereby limit a resultant normal force exerted by the spreading tip on the topical skin adhesive along the application surface.
  • Example 16 The apparatus of Example 16, wherein the void feature comprises a pair of wedge- shaped channels arranged on opposing sides of the monolithic body.
  • Example 19 An apparatus, comprising: (a) a proximal body portion configured to be gripped by a user; (b) a distal body portion that terminates distally at a spreading tip configured to spread a topical skin adhesive along an application surface; and (c) a flexural body portion that interconnects the proximal and distal body portions to define a monolithic body, wherein the flexural body portion is configured to elastically deform so that the distal body portion angularly deflects relative to the proximal body portion in response to an input force applied by a user to the proximal body portion to thereby limit a resultant normal force exerted by the spreading tip on the topical skin adhesive along the application surface, wherein the monolithic body is symmetric about a midplane that bisects the monolithic body along its thickness between opposed lateral sides of the monolithic body, wherein a thickness of the flexural body increases or decreases from the midplane in orthogon
  • Example 19 The apparatus of Example 19, wherein the thickness of the flexural body portion increases from the midplane in directions toward the lateral sides, wherein the thickness of the spreading tip decreases from the midplane in orthogonal directions toward the lateral sides.
  • a system comprising: (a) a wound closure device having a mesh layer and a pressure sensitive adhesive layer on an underside of the mesh layer, wherein the wound closure device is configured to be applied over a wound in a patient’s skin; (b) an adhesive applicator containing a topical skin adhesive, wherein the adhesive applicator is operable to dispense the topical skin adhesive onto the mesh layer of the applied wound closure device; and (c) an adhesive spreader operable to spread the applied topical skin adhesive over and through the wound closure device, wherein the adhesive spreader comprises: (i) a proximal body portion configured to be gripped by a user, (ii) a distal body portion that terminates distally at a spreading tip configured to spread the topical skin adhesive along a top surface of the wound closure device, and (iii) a flexural body portion that interconnects the proximal and distal body portions to define a monolithic body, wherein in response to an input force applied by a user to the
  • Example 21 The apparatus of Example 21, wherein the topical skin adhesive is curable and is configured to remain elastomeric after curing.
  • a method of spreading a topical skin adhesive on a wound closure device positioned over a wound in the skin of a patient with an adhesive spreader that includes a proximal body portion, a distal body portion that terminates distally at a spreading tip, and a flexural body portion that interconnects the proximal and distal body portions comprising: (a) positioning the spreading tip in contact with the topical skin adhesive on a top surface of the wound closure device; (b) angling the adhesive spreader such that its longitudinal axis defines an angle of approximately 45° to approximately 60° relative to the top surface; (c) applying a force to the proximal body portion such that the flexural body portion elastically deforms and the distal body portion angularly deflects relative to the proximal body portion such that the spreading tip exerts a normal force on the topical skin adhesive and the top surface in the range of approximately E5 Ibf to approximately 5 Ibf; and (d) dragging the spreading tip along the top
  • any one or more of the teachings herein may be combined with any one or more of the teachings disclosed in U.S. Pat. App. No. 29/860,717, entitled “Device for Spreading Topical Skin Adhesive,” filed November 22, 2022, the disclosure of which is incorporated by reference herein, in its entirety; U.S. Pat. App. No. 17/991,992, entitled “Application of Topical Skin Adhesive to Surgical Mesh,” filed November 22, 2022, the disclosure of which is incorporated by reference herein, in its entirety; U.S. Pat. App. No.
  • Versions of the devices described above may have application in conventional medical treatments and procedures conducted by a medical professional, as well as application in robotic-assisted medical treatments and procedures.
  • various teachings herein may be readily incorporated into a robotic surgical system such as the DAVINCITM system by Intuitive Surgical, Inc., of Sunnyvale, California.
  • Versions of the devices described above may be designed to be disposed of after a single use, or they can be designed to be used multiple times. Versions may, in either or both cases, be reconditioned for reuse after at least one use. Reconditioning may include any combination of the steps of disassembly of the device, followed by cleaning or replacement of particular pieces, and subsequent reassembly. In particular, some versions of the device may be disassembled, and any number of the particular pieces or parts of the device may be selectively replaced or removed in any combination. Upon cleaning and/or replacement of particular parts, some versions of the device may be reassembled for subsequent use either at a reconditioning facility, or by a user immediately prior to a procedure.
  • reconditioning of a device may utilize a variety of techniques for disassembly, cleaning/replacement, and reassembly. Use of such techniques, and the resulting reconditioned device, are all within the scope of the present application.
  • versions described herein may be sterilized before and/or after a procedure.
  • the device is placed in a closed and sealed container, such as a plastic or TYVEK bag.
  • the container and device may then be placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons.
  • the radiation may kill bacteria on the device and in the container.
  • the sterilized device may then be stored in the sterile container for later use.
  • a device may also be sterilized using any other technique known in the art, including but not limited to beta or gamma radiation, ethylene oxide, or steam.

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  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
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Abstract

Un appareil comprend une partie de corps proximale configurée pour être saisie par un utilisateur, une partie de corps distale qui se termine au niveau d'une pointe d'étalement configurée pour étaler un adhésif cutané topique le long d'une surface d'application, et une partie de corps de flexion qui interconnecte les parties de corps proximale et distale pour définir un corps monolithique. En réponse à une force d'entrée appliquée par un utilisateur à la partie de corps proximale lorsque la pointe d'étalement est positionnée contre la surface d'application, la partie de corps de flexion est configurée pour se déformer de manière non uniforme le long d'une largeur latérale de l'appareil. En outre, ou en variante, la partie de corps de flexion est configurée pour se déformer élastiquement de telle sorte que la partie de corps distale dévie angulairement par rapport à la partie de corps proximale pour ainsi limiter à une plage prédéterminée une force normale résultante exercée par la pointe d'étalement sur l'adhésif cutané topique le long de la surface d'application.
PCT/IB2023/061727 2022-11-22 2023-11-21 Dispositif d'étalement d'adhésif cutané topique Ceased WO2024110860A1 (fr)

Priority Applications (6)

Application Number Priority Date Filing Date Title
KR1020257020679A KR20250112845A (ko) 2022-11-22 2023-11-21 국소 피부 접착제를 펼치기 위한 기구
JP2025529812A JP2025538547A (ja) 2022-11-22 2023-11-21 局所皮膚接着剤を塗布するためのデバイス
EP23813080.1A EP4622560A1 (fr) 2022-11-22 2023-11-21 Dispositif d'étalement d'adhésif cutané topique
CN202380080515.4A CN120239589A (zh) 2022-11-22 2023-11-21 用于铺展局部皮肤粘合剂的装置
AU2023386025A AU2023386025A1 (en) 2022-11-22 2023-11-21 Device for spreading topical skin adhesive
MX2025005950A MX2025005950A (es) 2022-11-22 2025-05-21 Dispositivo para esparcir adhesivo topico para la piel

Applications Claiming Priority (4)

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US202263427132P 2022-11-22 2022-11-22
US63/427,132 2022-11-22
US18/490,875 2023-10-20
US18/490,875 US12533132B2 (en) 2023-10-20 Device for spreading topical skin adhesive

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE29501724U1 (de) * 1995-02-03 1995-03-23 Kaul, Friedrich, 90411 Nürnberg Spachtel zur Nachbearbeitung von Silikonfugen o.dgl.
US5749117A (en) * 1996-09-20 1998-05-12 Forsline; Ladd B. Paint applicator having an improved working tip
US6325565B1 (en) * 1998-06-30 2001-12-04 The Procter & Gamble Company Anti-perspirant/deodorant applicator
US8097008B2 (en) * 2005-09-09 2012-01-17 University Of South Florida Laparoscopic hernia mesh spreader
ITBS20110140A1 (it) * 2011-10-05 2013-04-06 Francesco Gentile Spatola per stendere un materiale su una superficie
US20180085260A1 (en) * 2016-09-29 2018-03-29 Ethicon, Inc. METHODS and DEVICES for SKIN CLOSURE
US20190261762A1 (en) * 2018-02-28 2019-08-29 L'oreal Cosmetic applicator
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US11589867B2 (en) 2020-05-28 2023-02-28 Ethicon, Inc. Anisotropic wound closure systems
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EP4622560A1 (fr) 2025-10-01
MX2025005950A (es) 2025-06-02
KR20250112845A (ko) 2025-07-24
CN120239589A (zh) 2025-07-01
JP2025538547A (ja) 2025-11-28
AU2023386025A1 (en) 2025-07-03

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