Surgical incisional field containing releaseable agents.
Patent Information
- Application Number
- BR112021025807
- Authority / Receiving Office
- BR · BR
- Patent Type
- Patents
- Current Assignee / Owner
- Publication Date
- 2026-09-08
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Abstract
Description
1 / 28 “INCISIONAL SURGICAL FIELD CONTAINING RELEASEABLE AGENTS” FIELD OF THE INVENTION
[001] The present invention relates to antimicrobial wound bandages, more specifically, the invention relates to antimicrobial incisional surgical drapes that release a flowable antimicrobial agent onto the surgical instrument and the edges of the incision and wound by incision of the surgical drape. BACKGROUND OF THE INVENTION
[002] Bandages play an important role in wound management, since the moist, warm, and nutrient-rich environment of wound sites can provide beneficial conditions for microbial growth. Bacterial colonization and subsequent infection can interfere with the wound healing process by producing various substances (e.g., toxins, proteases, and pro-inflammatory molecules) that have the capacity to induce excessive and prolonged inflammatory responses. Antimicrobial bandages can be used against a range of bacteria such as methicillin-resistant Staphylococcus aureus (MRSA), Gram-negative rods, and Candida species.
[003] To prevent infection, maintaining sterility is of fundamental importance in surgical procedures, especially those involving incisions. Typically, the procedure to prevent surgical site infection includes bathing, washing, shaving or waxing, scrubbing, preparation, and placement of the surgical drape. Each of these tasks is performed to prevent the introduction of pathogenic flora into the surgical site. However, the entire process of maintaining surgical site sterility can be impeded, for example, by incision through a hair follicle. Hair follicles, regardless of how well the skin is washed, scrubbed, and prepared, Petition 870260058404, dated 06 / 16 / 2026, page 5 / 79 2 / 28 can be rich in bacteria. The act of making the surgical incision (i.e., cutting) can release bacteria from the hair follicles and other skin structures. Such small amounts of bacteria can be enough to cause a surgical site infection.
[004] In addition, it may be beneficial to release other agents into a surgical incision such as: hemostatic agents to prevent or reduce bleeding, lubricants to facilitate the insertion of surgical tools, anti-inflammatory agents to reduce postoperative swelling and pain, chemotactic agents to accelerate internal capillary growth after surgery, wound healing agents and the like, and combinations thereof.
[005] Publication of Patent Application No. US 20140373851, Filled Incise Drape discloses an article comprising: a liquid-impermeable wrapping comprising: a first film layer; a second film layer, wherein the first film layer and the second film layer are hermetically sealed together to form at least one interior region enclosing an antimicrobial liquid composition; and a pressure-sensitive adhesive layer disposed on an outer surface of the first film layer.
[006] PCT Patent Publication No. WO2017151226A1, Drape for Use with Medical Therapy Systems, discloses a surgical drape for medical applications, wherein the surgical drape comprises: a film layer having a first side and a second side; an adhesive layer coupled to the first side of the film layer, wherein the adhesive layer has a first bonding force before application of the surgical drape, a second bonding force in response to a force applied to the surgical drape, and a third bonding force after exposure of the adhesive layer to electromagnetic radiation in a visible light spectrum; and a barrier layer releasable coupled to the second side of the film layer and configured to Petition 870260058404, dated 06 / 16 / 2026, page 6 / 79 3 / 28 block at least a portion of electromagnetic radiation in the visible light spectrum.
[007] Patent Document No. US 4643181, Antimicrobial Dressing or Drape Material, discloses a surgical bandage comprising a substrate coated on a surface with a solvent-based skin contact adhesive, wherein said adhesive has a thickness of 30 to 60 microns, and polyhexamethylene biguanide hydrochloride particles distributed throughout the adhesive, wherein said particles have a size of 20 to 300 microns.
[008] Patent document US No. 8697112, Method for Treating a Surface with a Coating Comprising a Microencapsulated Therapeutic Agent and Device with Treated Surface, discloses a device comprising: a surface; a hydrophilic polymeric base layer comprising a hydrophilic polymer grafted onto the surface; and a layer comprising microparticles of a therapeutic agent arranged in and complexed with the hydrophilic polymeric base layer.
[009] Patent Document No. US 8691268, Transdermal Delivery Using Encapsulated Agent Released by Ultrasound and / or Heat, discloses a portable transdermal drug delivery device consisting of: (A) a transdermal patch for infusing active substances into a user's body through the skin comprising: an inner disc, wherein the inner disc includes (i) agents encapsulated in microcapsules, wherein the microcapsules retain the encapsulated agents before activation by energy capable of breaking the microcapsules and (ii) an outer matrix or vehicle; and an outer disc for attaching the patch to the user's skin, thereby facilitating contact of the inner disc with a skin surface; (B) an activation probe attached to said transdermal patch and equipped with a unique multi-source element, wherein said Petition 870260058404, dated 06 / 16 / 2026, page 7 / 79 4 / 28 multi-source element comprises multiple energy sources to provide ultrasound radiation or thermal energy to different localized areas of said inner disc, wherein said activation probe is adapted to activate the transdermal patch by breaking the microcapsules, thereby releasing said encapsulated agents in the outer matrix or vehicle of the inner disc of said transdermal patch; and (C) a power supply to provide energy to said multi-source element.
[0010] Patent Document No. US 3598123, Bandage for Administering Drugs, discloses a medical bandage for use in the continuous administration for circulation of controlled amounts of systemically active drugs over a prolonged period of time by absorption through the mucosa or external body skin, wherein said bandage comprises (1) a support member that supports (2) a pressure-sensitive adhesive on a surface thereof, wherein said pressure-sensitive adhesive has distributed thereon (3) a plurality of distinct microcapsules, wherein each of these microcapsules comprises a systemically active drug formulation confined within a wall member, wherein said wall member is formed from the drug release rate-controlling material to continuously measure the drug flow from said microcapsules into the skin or mucosa at a controlled and predetermined rate over a prolonged period of time.
[0011] Patent Document No. US 9925087, Wound and Therapy Compress and Dressing discloses a bandage for treating a surface of a part of the body of a human or animal patient, wherein the bandage comprises: a compress comprising a plurality of light granules contained in an envelope within the compress, wherein the plurality of light granules is configured to Petition 870260058404, dated 06 / 16 / 2026, page 8 / 79 5 / 28 releasing moist heat; a heat-transmitting block impregnated with an antibacterial medication, fixed to a surface of the compress so that the heat-transmitting block is positioned between the compress and the surface of a body part, wherein the heat-transmitting block is activated by the moist heat released from the compress to release the antibacterial medication from the heat-transmitting block onto the surface of the body part; and wherein the filling granules retain substantially at least one antimicrobial metal material in them and allow repeated absorption and dissipation of moisture to and from the filling granules.
[0012] Publication of Patent Application No. US 20030044380A1, Adhesive Including Medicament, discloses an adhesive for sealing a wound, wherein the adhesive comprises a cyanoacrylate, a substance and a defect-forming agent, wherein the defect-forming agent has the capacity to be removed from a cyanoacrylate matrix cured by solvation in an aqueous solution in which a plurality of defects in the matrix that allow the release of the substance from the matrix at a controlled rate are formed.
[0013] Patent Document No. US 6139856, Composition Useful for Providing One-Step Surgical Preparation and Drape, discloses a film-forming composition for providing a protective coating on a skin surface comprising: (a) about 30 to 60% by weight of solids selected from the group consisting of polyvinylidene difluoride and copolymers thereof; (b) about 10 to 20% by weight of solids of a polymer of monomers selected from the group consisting of a lower alkylacrylate, a lower alkyl(meth)acrylate, a lower hydroxyalkylacrylate, an alpha-beta unsaturated carboxylic acid having an acid number of about 20 to 150, and copolymers thereof; (c) about 30 to 60% by weight of solids of a polymer of monomers selected from the group consisting of a Petition 870260058404, dated 06 / 16 / 2026, page 9 / 79 6 / 28 dialkylaminoalkyl(meth)acrylate and a lower alkyl(meth)acrylate; (d) about 0.5 to 2.0% by weight of the total water-based composition; (e) an effective amount of an antimicrobial lipid; and (f) an aqueous organic solvent to dissolve all the components.
[0014] Patent Document No. US 4654256, Article Containing Microencapsulated Materials, discloses an article comprising a thermoplastic polymeric substrate that has partially embedded breakable microcapsules.
[0015] Patent Document No. US 7015156, Perfumed Abrasive Pad and Manufacturing Procedure discloses an abrasive cleaning article that generates an aroma during use, wherein said article comprises: a three-dimensional non-woven mat of fibers; abrasive particles adhesively bonded to the fibers; and microcapsules containing an aromatic substance adhesively bonded to the fibers, wherein the aromatic substance is released from the microcapsules during normal use of the article to produce an aroma.
[0016] Patent Document No. US 3691271, Sanitary Napkin having homogeneously distributed microcapsules filled with delayed-release bactericidal and fungicidal deodorant, reveals a sanitary napkin consisting essentially of a body of absorbent material of cellulose or paper in layers or cotton cloth and a multiplicity of individual microcapsules enveloping effective amounts of a bactericidal and fungicidal deodorant agent, wherein said microcapsules are homogeneously distributed in said cellulose or in alternating layers in said paper or cotton cloth, wherein the size of each of said microcapsules is in the range of 30-500 microns, the walls of said microcapsules are permeable or soluble during contact with the fluid associated with menstrual discharge, wherein the release of said deodorant agent from said microcapsules is achieved through the deodorant agent. Petition 870260058404, dated 06 / 16 / 2026, page 10 / 79 7 / 28 microcapsules in said sanitary absorbent are delayed until contact with sufficient quantities of said fluid to permeate or solubilize the walls of said homogeneously distributed microcapsules, wherein said walls of said microcapsules are made of a material selected from the group consisting of gelatin, ethylcellulose, cellulose acetate phthalate, polyvinyl alcohol and polyvinyl acetate, and the density of said microcapsules is essentially equal to the density of said absorbent material body.
[0017] PCT Patent Publication No. WO2012091457A2, Antimicrobial Pad discloses an antimicrobial pad comprising: polyurethane foam having pore voids of a predetermined size; and a microcapsule containing antimicrobial products therein and provided to be encapsulated within the pore voids of the polyurethane foam to coat the surface of the polyurethane foam.
[0018] Patent Document No. US 3490454, Catamenial Products having a Coating of Rupturable Microcapsules containing Medicants, discloses an absorbent catamenial device comprising an absorbent portion having a fluid-permeable packaging, and having, adhered to said absorbent portion, at least one layer of a multiplicity of distinct ruptureable microcapsules containing chemical materials capable of assisting in the control of fluid associated with menstrual discharge, wherein said microcapsules comprise minimal encapsulated clusters of smaller individual microcapsules, wherein the clusters are contained in shells of polymeric encapsulation materials.
[0019] Patent Document No. US 4,597,960, Microencapsulated Astringent Hemostatic Agents and Methods of Use discloses a granular composition for producing capillary homeostasis comprising: a selected granular astringent hemostatic agent Petition 870260058404, dated 06 / 16 / 2026, page 11 / 79 8 / 28 of the group consisting of inorganic aluminum and ferric salts encapsulated with a biocompatible cellulose-based polymer soluble in body fluids.
[0020] Patent Document US 5,717,005, Adhesive Compositions and Products discloses an adhesive composition, suitable for medical applications, comprising an adhesive having dispersed therein 2 to 10% by weight, based on the weight of the composition, of solid chlorhexidine gluconate particles, wherein said particles have a particle size of less than 125 μm and at least about 30% by volume of the particles have a particle size of not less than 5 μm.
[0021] Publication of Patent Application No. US 20080176262, Wound Dressing discloses a method for determining the load of metalloproteinases in biological tissues comprising: applying a diagnostic aid that has a first material, which has a chemical composition that is degradable by a metalloproteinase, and a second material that is confined by the first material and that experiences changes in spectral properties; waiting an appropriate time for the metalloproteinases to degrade the first material; observing the spectral changes that occur with the second material; and assessing the load of metalloproteinases within the tissues.
[0022] Publication of Patent Application No. US 20120330210, Antimicrobial Silicone-Based Wound Dressings discloses a bandage comprising a silicone gel sheet, wherein the silicone gel sheet comprises from about 95% by weight to about 98% by weight of a silicone elastomer and has dispersed therein (i) particulates of a chlorhexidine compound and (ii) at least one other antimicrobial, wherein the total amount of chlorhexidine present in the gel sheet is up to 5% by weight, the silicone elastomer being cross-linked to a degree that provides sufficient cohesive strength for the bandage to permit application and removal of the dressing. Petition 870260058404, dated 06 / 16 / 2026, page 12 / 79 9 / 28 bandage of a surface although it leaves minimal residue on the surface.
[0023] Some of the descriptions above refer to encapsulated microcapsules, so that only a few of these are ruptured during incision and therefore only a small portion of the therapeutic agent is released, resulting in insufficient protection. Others refer to large fluid-filled containment bags that will undesirably saturate the wound with therapeutic agent solutions, thus releasing a vast amount of agent regardless of wound size / incision size. There is a need to create a surgical field that can assist in controlling and releasing antiseptic and other medicinal agents to the surgical site and surgical tools during the surgical procedure in controlled amounts and under controlled release. SUMMARY OF THE INVENTION
[0024] In one embodiment, the present invention relates to an incisional surgical field comprising:
[0025] a substantially flat flexible areal substrate having an upper side and an opposite side facing the tissue, a longitudinal geometric axis and a pressure-sensitive adhesive disposed on the side facing the tissue; and
[0026] at least one hollow microtubular compartment containing a flowable medicinal agent, wherein said hollow microtubular compartment is positioned to cross the longitudinal geometric axis and is embedded in or positioned in the substrate.
[0027] In another embodiment, the invention relates to a method for using the surgical field of the aforementioned embodiment comprising the steps of:
[0028] position the surgical drape over a tissue with the tissue-facing side facing the tissue and in contact with Petition 870260058404, dated 06 / 16 / 2026, page 13 / 79 10 / 28 the fabric;
[0029] orient the longitudinal geometric axis generally along the expected incision line;
[0030] adhere the surgical field to the tissue using the pressure-sensitive adhesive;
[0031] to perform a surgical incision of the tissue through the surgical field, in which, in the process, at least one of the microtubular compartments is cut or ruptured, and thus at least one of the microtubular compartments is opened; and
[0032] allow the agent to leach or run off from at least one microtubular compartment to the edges of a tissue wound formed by said incision.
[0033] In yet another embodiment, the invention relates to an incisional surgical field comprising:
[0034] a substantially flat flexible areal substrate having an upper side and an opposite side facing the tissue, a longitudinal geometric axis and a pressure-sensitive adhesive disposed on the side facing the tissue; and
[0035] a plurality of hollow microtubular compartments for receiving a medicinal agent, wherein said microtubular compartments are arranged side by side and positioned across the longitudinal geometric axis, such that each of said microtubular compartments crosses the longitudinal geometric axis and is embedded in or positioned in the substrate, wherein said microtubular compartments do not initially contain medicinal agent and are connected to a peripheral channel that is distal from the longitudinal geometric axis and generally parallel to the longitudinal geometric axis and terminates with a port positioned on a periphery of said surgical field, wherein said port is configured to be connectable to a pressurized source of a medicinal agent. Petition 870260058404, dated 06 / 16 / 2026, page 14 / 79 11 / 28 BRIEF DESCRIPTION OF THE DRAWINGS
[0036] Figure 1A shows a schematic top view of an incisional surgical field.
[0037] Figure 1B shows a schematic lateral cross-sectional view of an incisional surgical field.
[0038] Figure 1C shows a schematic lateral cross-sectional view of an incisional surgical field with microtubular compartments comprising individual sealed microfluidic channels formed directly on the substrate.
[0039] Figure 2 shows a schematic perspective view of an incisional surgical field before cutting through the surgical field with a scalpel blade.
[0040] Figure 3 shows a schematic lateral cross-sectional view of an incisional surgical field.
[0041] Figure 4 shows a schematic top view of an incisional surgical field.
[0042] Figure 5 shows a schematic top view of an incisional surgical field.
[0043] Figure 6 shows a schematic top view of an incisional surgical field.
[0044] Figure 7 shows a schematic top view of an incisional surgical field.
[0045] Figure 8 shows a schematic top view of an incisional surgical field.
[0046] Figure 9 shows a schematic top view of an incisional surgical field.
[0047] Figure 10 shows a schematic top view of an incisional surgical field.
[0048] Figure 11A shows a schematic and connected top view of an incisional surgical field. Petition 870260058404, dated 06 / 16 / 2026, page 15 / 79 12 / 28 via cannula to a source of pressurized agent.
[0049] Figure 11B shows a schematic top view of an incisional surgical field that has no medical agent before connection via cannula to a pressurized agent source.
[0050] Figure 12 shows a schematic top view of an incisional surgical field.
[0051] Figure 13 shows a schematic top view of an incisional surgical field.
[0052] Figure 14 shows a schematic top view of an incisional surgical field.
[0053] Figure 15 shows a schematic top view of an incisional surgical field.
[0054] Figure 16A shows a schematic top view of an incisional surgical field in use positioned in a tissue.
[0055] Figure 16B shows a schematic lateral cross-sectional view of an incisional surgical field in use positioned in a tissue. DETAILED DESCRIPTION
[0056] Loaded incisional surgical drapes are described herein that can release therapeutic agents at and to the surgical site. Exemplary embodiments of loaded incisional surgical drapes of the present disclosure generally comprise liquid-impermeable microtubular compartments encapsulating a flowable therapeutic agent or fluid; such compartments are enclosed in a plaster or adhesive sheet used as a surgical drape. Once applied to the surgical site and appropriately prepared, an incision can be made through the loaded incisional surgical drape. By means of incision or otherwise perforation Petition 870260058404, dated 06 / 16 / 2026, page 16 / 79 13 / 28 through the loaded incisional surgical field, the therapeutic agent will be expressed from the surgical field and released into the incision. Embodiments of this invention enable the release of highly effective compositions of therapeutic agents typically not used after the initial incision in traditional surgery, as this would require an additional step, and incision bacteria are not typically recognized as a contributor to surgical infections. The loaded incisional surgical fields of this invention provide a single step to release a therapeutic agent directly to the surgical incision and surgical instrument as the incision is made.
[0057] In summary, an incisional surgical drape comprises a plaster or bandage or insulating block made of a flexible sheet of textile, mesh or non-woven material, which is adhesively and removablely attached to the tissue in the area where the tissue is about to be incised during a surgical procedure. The surgical drape is then cut during surgery as the underlying tissue is cut. Cutting through the surgical drape opens microcompartments loaded with fluxable antimicrobial agent containing fluid that is released into the area of the cut on the surgical instrument (such as a surgical incision tool, saw, knife, scalpel, etc.) and at the edge of the incision.
[0058] In an incisional surgical field of the present invention, an isolating plaster / bandage / block is adhesively fixed to the tissue and then cut during surgery. The surgical field material contains elongated sealed compartments, such as tubes, which are loaded with a liquid, flowable antimicrobial agent. The tubes are generally oriented along the geometric axis of the surgical field cut so that they are cut and opened during the incision, thus releasing the fluid agent along the cut, onto the inner wall of the wound, and onto the Petition 870260058404, dated 06 / 16 / 2026, page 17 / 79 14 / 28 scalpel, which provides antibacterial action at the beginning and throughout the surgery.
[0059] Advantageously, the release of the anti-infective drug is proportional to the size of the incision, which prevents excessive amounts of antimicrobial agent from flooding the wound area. Advantageously, in some embodiments, the medicinal agent is released slowly and over time, thus providing the necessary coverage during the procedure. Advantageously, the entire agent is available for release compared to systems with embedded microcapsules, so that only a small portion of the agent is released upon incision.
[0060] With reference now to Figure 1A, one embodiment of a surgical field 10 is shown in top view, wherein the surgical field 10 comprises a flat areal substrate 20 visible from the top side 22 in Figure 1A, wherein straight or linear closed microtubular compartments 30 contain liquid agent 100 included in the substrate 20 and shown in dashed lines. Microtubular compartments 30 are generally positioned and oriented across the longitudinal geometric axis 21 of the substrate 20, in other words, across the expected surgical incision line, which generally aligns with the geometric axis 21, with the incision generally made within the perimeter of the substrate 20 and in the central area of the substrate 20. At least a portion of microtubular compartments 30 is proximal and lies at least partially on the longitudinal geometric axis 21.With reference now to Figure 1B, the surgical field 10 is shown in lateral cross-sectional view, where the upper side 22 is facing upwards and the tissue-facing side 24 is facing downwards, with microtubular compartments 30 included in the substrate 20. On the tissue-facing side 24 of the substrate 20, is... Petition 870260058404, dated 06 / 16 / 2026, page 18 / 79 15 / 28 The adhesive 40 is arranged as a pressure-sensitive adhesive, which is configured for fixation to tissue prior to surgical incision and removal after the surgical procedure. Adhesive 40 may be present as a continuous coating, as shown, or applied in stripes, patches, dots, or any other shapes with some areas of the tissue-facing side 24 free of adhesive 40.
[0061] With reference now to Figure 1C, the surgical field 10 is shown in lateral cross-sectional view, wherein the upper side 22 is facing upwards and the tissue-facing side 24 is facing downwards, wherein the microtubular compartments 30 comprise individual sealed microfluidic channels formed directly in the substrate 20.
[0062] With reference to Figure 2, which shows a schematic perspective view, a scalpel blade 26 is shown in the position before cutting through the surgical field 10 along the longitudinal geometric axis 21 of the substrate 20. In use, cutting through the surgical field 10 and the underlying tissue (not shown) will also cut the microtubular compartments 30 included in the substrate 20, resulting in the instantaneous or delayed release of liquid agent 100. The microtubular compartments 30 are configured to be frangible, separable, easily cuttable, or combinations thereof.
[0063] Advantageously, in this mode, only microtubular compartments 30 that cross the cut made by blade 26 will release agent 100. This results in the release of an amount of agent proportional to the length of the cut. If all the agent 100 from all the microtubular compartments 30 were released in a relatively small cut that crosses only one microtubular compartment 30, potentially resulting in excessive amounts of agent 100 released, this could be detrimental due to flooding. Petition 870260058404, dated 06 / 16 / 2026, page 19 / 79 16 / 28 of a relatively small wound area, thus resulting in an excessive dose of antimicrobial agent. Therefore, in the embodiment shown, the amount of agent released is proportional to the length of the cut.
[0064] Advantageously, in some embodiments, microtubular compartments 30 are configured to slowly release agent 100 from each cut microtubular compartment 30, with some fluid released instantaneously and some fluid released slowly over time, thus delivering agent 100 to the wound edge. This is advantageously compared to including microcapsules in the surgical field 10 that have the capacity to release only a very small amount of agent 100 from a small number of capsules cut at the incision line, but not from other capsules, without a delay effect as in the case of the microtubular compartment 30. This is also advantageously compared to a large compartment in the surgical field 10, which will release all of the agent 100 in response to even a short cut.
[0065] With reference now to Figure 3, a modality of the surgical field 10 is shown in lateral cross-sectional view similar to Figure 1B, with the modality shown differing from Figure 1B in that the microtubular compartments 30 are not located in most or in the middle of the surgical field 10, but rather on the upper side 22.
[0066] With reference now to Figure 4, a modality of the surgical field 10 is shown in top view, with microtubular compartments 30a generally oriented not perpendicular and through the longitudinal geometric axis 21 of the substrate 20, as in Figure 1A, but rather at an angle to the longitudinal geometric axis 21 and which also intersects the longitudinal geometric axis 21 or the expected incision line. The angle between the compartments Petition 870260058404, dated 06 / 16 / 2026, page 20 / 79 17 / 28 microtubular 30a and the longitudinal geometric axis 21 is from about 20° to 70°, more preferably from about 30° to about 60°, with maximum preference about 45°, as shown.
[0067] With reference now to Figure 5, one embodiment of the surgical field 10 is shown in top view, with non-linear microtubular compartments 30b, as shown in the embodiments of Figures 1A, 4, but in V or U shape and generally oriented through the longitudinal geometric axis 21 of the substrate 20, wherein a midpoint M of the V or U shape is positioned approximately on the longitudinal geometric axis 21. This arrangement provides more agent 100 available to discharge, leach or drain from each cut microtubular compartment 30b compared to the microtubular compartments 30, 30a of other embodiments.
[0068] With reference now to Figure 6, one embodiment of the surgical field 10 is shown in top view, wherein microtubular compartments 30c comprise a long microcompartment generally spiral-shaped disposed over and through the longitudinal geometric axis 21 of the substrate 20. This arrangement provides all the agent 100 available to discharge, leach or drain from the spiral-shaped microtubular compartment 30c when it is cut anywhere. Advantageously, the release is slow due to the distance the agent 100 needs to travel through the microtubular compartment 30c to the area where the spiral-shaped microtubular compartment 30c was cut or ruptured. The spiral-shaped microtubular compartment 30c crosses the longitudinal geometric axis 21 at least 4 times, and up to 100 times, for example, 9 times, as shown in Figure 6.
[0069] With reference now to Figure 7, a modality of the surgical field 10 is shown in top view, with generally linear microtubular compartments 30d positioned across the axis Petition 870260058404, dated 06 / 16 / 2026, page 21 / 79 18 / 28 longitudinal geometric axis 21 of the substrate 20 and perpendicular to it, similarly to the embodiment in Figure 1A. The microtubular compartments 30d have a central capillary portion 32 of smaller diameter that is proximal and lies at least partially on the longitudinal geometric axis 21. The microtubular compartments 30d have a peripheral portion of larger volume (with larger diameter) 31 that is distal to the longitudinal geometric axis 21. In the embodiment shown, there are two peripheral portions 31 arranged on either side of the central capillary portion 32. This arrangement provides more agent 100 available for discharge from each cut microtubular compartment 30d, however, with slow leaching or runoff of agent 100 due to the smaller diameter central capillary portion 32.The peripheral portion 31 may be linear and rectangular in shape, cylindrical in shape, balloon-like in shape, or generally of any geometry suitable for providing a reservoir for additional agent 100 for leaching through a central capillary cutting portion 32.
[0070] In an alternative embodiment (not shown), there is only a peripheral portion 31 arranged on one side of the central capillary portion 32.
[0071] With reference now to Figure 8, a manifestation of the surgical field 10 is shown in top view, with microtubular compartments 30e in linear shape and positioned across the longitudinal geometric axis 21 of the substrate 20 and perpendicular to it, similar to the manifestation of Figure 1A. The microtubular compartments 30e are all connected to a peripheral channel of larger diameter 33 that is positioned distal to the longitudinal geometric axis 21 and generally parallel to it.
[0072] In the embodiment shown, there is a peripheral channel 33 arranged on one side of the substrate 20. This arrangement provides more agent 100 available to discharge from each cut microtubular compartment. Petition 870260058404, dated 06 / 16 / 2026, page 22 / 79 19 / 28 30e, however, with slow leaching or runoff of agent 100 due to the smaller diameter central capillary portion 32. The peripheral channel 33 may have a linear and rectangular shape, a cylindrical shape, a shape similar to a spherical balloon, or generally any geometry suitable to provide a repository for additional agent 100 for leaching through ruptured or cut microtubular compartments 30e. In an alternative embodiment (not shown), there are two peripheral channels 33 on each side of the substrate 20 that are located on the periphery of the substrate 20, in a distal position and generally parallel to the longitudinal geometric axis 21.
[0073] With reference now to Figure 9, an embodiment of the surgical field 10 is shown in top view, with microtubular compartments 30f randomly distributed across the substrate 20, with at least some longitudinal geometric axis of intersection 21. Advantageously, in this embodiment, cutting through the surgical field 10 in any direction will result in the release of agent 100.
[0074] With reference now to Figure 10, an embodiment of the surgical field 10 is shown in top view, with microtubular compartments 30g arranged perpendicular to microtubular compartments 30h, which are parallel to the longitudinal geometric axis 21, thus forming a substantially square grid. In one embodiment, microtubular compartments 30g, 30f are connected to each other at each intersection point 34.In another embodiment, the microtubular compartments 30g, 30f are not connected to each other at each intersection point, for example, by being positioned in different planes within the substrate 20. Advantageously, cutting the surgical field 10 in any direction will cross certain microtubular compartments 30g, 30f, resulting in the release of agent 100 along the cut and in the cut.
[0075] With reference now to Figure 11A, a modality of Petition 870260058404, dated 06 / 16 / 2026, page 23 / 79 The surgical field 10 is shown in top view, with linear microtubular compartments 30i positioned through or perpendicular to the longitudinal geometric axis 21 of the substrate 20, similar to the embodiment in Figure 1A. The microtubular compartments 30i are connected to a peripheral channel 35 that is distally positioned and generally parallel to the longitudinal geometric axis 21 and located on the periphery of the substrate 20, and terminates in a port 36 positioned on the periphery of the surgical field 10. The peripheral channel 35 may be linear or rectangular in shape, cylindrical in shape, or generally any geometry suitable for providing agent 100 delivery to the microtubular compartments 30i.
[0076] Port 36 is shown connected via cannula 37 to the pressurized agent source 100, such as a pump, which in one embodiment may be, as shown, a syringe 38. Alternatively, any pump 38 may be used, including a pump comprising a hydrostatic pressure source, i.e., an elevated source (not shown) of agent 100, which is positioned higher than the surgical field 10 to allow gravity-driven flow. Other pumps may include low-volume peristaltic pumps, piston pumps, elastic bulbs, and the like. In one embodiment (not shown), the pump 38 comprises a pressurized container.
[0077] The pressurizing agent 100 in the pump 38, as indicated by the arrow in Figure 11A, releases the agent 100, as needed, onto the edges of the wound after the surgical field 10 and the corresponding microtubular compartments 30i have been cut.
[0078] In some embodiments, as shown in Figure 11B, the surgical field 10 is supplied without agent 10 inside. After applying the surgical field 10 to the tissue, the pressurized agent 100 is supplied to the surgical field 10 through the cannula 37 connecting to the port 36 of Petition 870260058404, dated 06 / 16 / 2026, page 24 / 79 21 / 28 preference before cutting the surgical field 10. In this modality, an agent selection 100 can be made based on a specific need and the tissue area, patient needs, risks, etc. Advantageously, there can be a change in the agent supplied 100 from one agent to another agent (such as different types of agents or different concentrations of agents), intraoperatively, as needed.
[0079] With reference now to Figure 12, one embodiment of the surgical field 10 is shown in top view, with linear microtubular compartments 30j positioned across and perpendicular to the longitudinal geometric axis 21 of the substrate 20, similar to the embodiment in Figure 1A. The microtubular compartments 30i are connected to the peripheral channel 35 which is distally positioned and generally parallel to the longitudinal geometric axis 21 and located on the periphery of the substrate 20 and terminates in a hollow bulb 39 positioned on the periphery of the surgical field 10 and containing the agent 100. In one embodiment, the bulb 39 is elastic and contains agent 100 under pressure. The pressurized agent 100 in the bulb 39 is released at the wound edges after the surgical field 10 and the corresponding microtubular compartments 30j are cut or ruptured.In another embodiment, manual compression of bulb 39 facilitates additional flow of agent 100 through the microtubular compartments 30j that are cut or ruptured.
[0080] In some embodiments and with reference to Figure 13, which shows a schematic top view of a surgical field embodiment 10, the microtubular compartments present are of two or more types, wherein microtubular compartments 301 with smaller diameter have slower or delayed release of agent 100 and microtubular compartments 302 with larger diameter have faster release of agent 100 by rupture or cutting of Petition 870260058404, dated 06 / 16 / 2026, page 25 / 79 22 / 28 microtubular compartments 301, 302. As shown, most microtubular compartments of different types are preferably interspersed or arranged interdigitally, so that microtubular compartments 301 of the first type are surrounded by microtubular compartments 302 of the second type and mutatis mutandis microtubular compartments 302 of the second type are surrounded by microtubular compartments 301 of the first type. Such an arrangement results in the immediate release of agent 100 from microtubular compartments 302, and in the prolonged release of agent 100 during surgical procedures thereafter from microtubular compartments 301.
[0081] In some embodiments and with reference to Figure 14, the microtubular compartments present are of two or more types, wherein microtubular compartments 303 have a higher viscosity agent formulation 100 (indicated by the letters HV in Figure 14) and thus have a slower or delayed release of agent 100, and microtubular compartments 304 (shown slightly shorter in Figure 14 for easier identification) have a lower viscosity agent formulation 100 (indicated by the letters LV in Figure 14) and thus have a faster or instantaneous release of agent 100 upon rupture or cutting of microtubular compartments.As shown, microtubular compartments of different types are preferably interspersed or arranged interdigitally so that most microtubular compartments 303 are surrounded by microtubular compartments 304 of the second type and mutatis mutandis most microtubular compartments 304 of the second type are surrounded by microtubular compartments 303 of the first type. Such an arrangement results in the immediate release of agent 100 from the microtubular compartments 304, and prolonged release of agent 100 during subsequent surgical procedures, from the microtubular compartments 303. Petition 870260058404, dated 06 / 16 / 2026, page 26 / 79 23 / 28
[0082] In some embodiments and with reference to Figure 15, the microtubular compartments present are of two or more types, and have equal diameters (as shown) or different diameters (not shown, however, similar to the embodiments in Figure 13), wherein microtubular compartments 305 (shown slightly longer in Figure 15 for easier identification) contain a first agent 100a and microtubular compartments 306 contain a second agent 100b. Having two or more agents 100a, 100b in separate compartments simplifies storage for incompatible agents that may be active against different microorganisms, such as gram-negative and gram-positive bacteria.
[0083] Although the release of agent 100a, 100b may be simultaneous, in some embodiments, the release is carried out with a different profile, such as when agent 100a is released instantaneously or within the first 3-30 seconds, and agent 100b is released more slowly through delayed release. Delayed release can be achieved by microtubular compartment diameters as illustrated above and / or by formulating the viscosity of agent 100a, 100b with excipients and diluents, where higher viscosity results in delayed or slower release as illustrated above.
[0084] As shown, microtubular compartments of different types are preferably intercalated or arranged in an interdigitated manner so that most microtubular compartments 305 of the first type are surrounded by microtubular compartments 306 of the second type and mutatis mutandis most microtubular compartments 306 of the second type are surrounded by microtubular compartments 305 of the first type. Such an arrangement results in the release of both agents 100a, 100b upon rupture or cutting of microtubular compartments.
[0085] In use and with reference to Figures 16A, 16B, the field Petition 870260058404, dated 06 / 16 / 2026, page 27 / 79 Surgical substrate 24 / 28 10 is positioned in tissue 50 and adhered to tissue 50, with the upper side 22 facing upwards and the tissue-facing side 24 facing downwards towards tissue 50 and in contact with tissue 50. The longitudinal geometric axis 21 of the substrate 20 is generally oriented along the expected incision line. The tissue-facing side 24 of the substrate 20 is adhered to tissue 50 using adhesive 40.
[0086] The surgical incision 55 of the tissue 50 is then made through the surgical field 10, in the process cutting or breaking at least one of the microtubular compartments 30. The opening of the microtubular compartments 30 along the cut line or edge 55 of the wound 56 allows the agent 100 to leach or drain from the microtubular compartments 30 to the sides of the surgical instrument (not shown) and onto the edges 55 of the wound 56 and partially into the wound 56, as schematically shown by the arrows in Figure 16B.
[0087] In some embodiments, the microtubular compartments are collapsible. In some embodiments, the microtubular compartments 30 are elastic and pressurized. In some embodiments, the microtubular compartments 30 are configured to collapse when manually pressed through the substrate 20.
[0088] In some embodiments, the release or leaching / flow of all or up to about 80% of agent 100 from the microtubular compartments 30 is configured to release within about 3 to 10 seconds after cutting or rupturing microtubular compartments 30, such as within 5 to 10 seconds. In alternative embodiments, the release of all or up to 80% of agent 100 occurs over an extended period such as 10 to 600 seconds and up to 10 hours.
[0089] In some forms, the release of about 40 to 60% of Agent 100 occurs very rapidly, that is, within 10 seconds, and the remainder is slowly released over about 30 to 600 seconds (10 Petition 870260058404, dated 06 / 16 / 2026, page 28 / 79 25 / 28 min), or up to approximately 6000 seconds (100 min) or up to 10 hours. Dimensions
[0090] Microtubular compartments can have internal diameters ranging from about 0.15 mm to about 2 mm, more preferably 0.2 mm to 1 mm, such as 0.3, 0.5, 1 mm. Microtubular compartments can also have rectangular, oval, etc. cross-sections, with a similar cross-sectional area. The length of microtubular compartments is from about 10 mm to about 500 mm, such as 15, 20, 30, 50, 75, 100 mm. The wall thickness of microtubular compartments is from about 0.05 mm to about 1 mm, such as 0.1, 0.3, 0.5 mm.
[0091] The number of microtubular compartments can vary from 1 for the spiral modality to about 10 to 500, such as 8, 12, 20, 30, 40, 50, 80, 100.
[0092] Substrate 20 can have any geometric shape, including rectangular, oval, square or similar.
[0093] The length of substrate 20 is from about 5 cm to about 300 cm, such as 10, 15, 20, 25 cm. The width of substrate 20 is from about 2 cm to about 300 cm, such as 3, 5, 10, 15, 20, 25 cm. The thickness of substrate 20 is from about 0.5 mm to about 5 mm, such as 1, 2, 3 mm. Materials
[0094] The substrate materials 20 may be any polymeric materials that are inert and / or biocompatible, such as polyethylene, polypropylene, polyesters, oxidized regenerated cellulose (CRO), chitosan, collagen, gelatin and the like, and combinations thereof. The substrate 20 may be a molded or extruded sheet, woven fabric, nonwoven felt or combinations thereof. In one embodiment, the substrate 20 comprises an absorbent material that has the capacity to Petition 870260058404, dated 06 / 16 / 2026, page 29 / 79 26 / 28 distribute agent 100 from distinct microtubular compartments for release over the entire area of the surgical field that is cut.
[0095] Microtubular compartment materials 30 are any polymeric materials that are biocompatible and stable in contact with agent 100, such as polyethylene, polypropylene, polyesters and the like.
[0096] The fluxable medicinal or drug agent 100 comprises liquid or semi-liquid formulations containing a diluent and at least one antimicrobial and / or anti-infective and / or antiseptic agent. The diluent may be any fluid, such as water, saline solution, ethanol, etc., and combinations thereof. The agent may be a natural or synthetic agent suitable for topical application to wounds, skin, mucous membranes or cavities, a topical anti-infective agent that has therapeutic or prophylactic antibiotic properties against infectious viral, bacterial or protozoan agents by inhibiting the growth and survival of such organisms.
[0097] The agent may be ethanol, triclosan, chlorhexidine gluconate (CHG), polyhexamethylene biguanide, antibiotics such as gentamicin, and / or fluoroquinolone antibiotics, including ciprofloxacin, ofloxacin, and norfloxacin, etc. Several agents suitable for use with the present invention are known to a person skilled in the art, including 3,6-diamino-10-methylacridinium chloride; 8-hydroxyquinoline product; 8-hydroxyquinoline sulfate ointment; acriflavine product; acrisorcin; actinoquinol; alexidine; aluminum acetate; ambazone; aminacrine hydrochloride; aminacrine product; aminacrine pyruvate; aminacrine undecylate; amfomycin calcium; amylmetacresol; auriclosene; azelaic acid; bensalan; benzalkonium product; benzethonium chloride; benzethonium product; Petition 870260058404, dated 06 / 16 / 2026, page 30 / 79 27 / 28 benzododecinium; benzododecinium bromide; benzoin; benzoxyquine; benzoxonium chloride; benzoyl peroxide; benzyl alcohol; benzylsulfamide; bibrocatol; biclothymol; bismuth subgallate; bismuth tribromophenate; boric acid; calcium hydroxide; camphor product; carbamide peroxide; cetalkonium; cetalkonium chloride; cetrimonium; cetrimonium chloride; cetylpyridinium acetate; cetylpyridinium bromide; cetylpyridinium chloride; anhydrous cetylpyridinium chloride; cetylpyridinium product; chaulmosulfone; chloramine-T; chlorhexidine gluconate; chlorhexidine hydrochloride; chlorhexidine product; chlorindanol; chlorazodine; chlorocresol; chlorthymol; chloroxylenol; chlorphenesin product; chlorphenoctyl ansonate; cyclomenol; cinoquidox; cloflucarban; cloguanamil; cloponone; cocamidopropyl betaine (in water); crotamitone; crotoniazid; cuprimixine; cyclomenol; Dakins' solution; debropol; decominol; deditonium; deditonium bromide; dibromopropamidine product;dichlorobenzyl alcohol; dichloroxylenol; dicresulene; dipyrithione; disiquonium; disiquonium chloride; dodeclonium bromide; dofamium; dofamium chloride; famiraprinium chloride; fenticlor product; fepradinol; fludazonium; fludazonium chloride; fluorosalan; furmethoxadone; gloxazone; guaiacol product; halazone; halopenium chloride; haloprogin; hexachlorophene product; hexedine; hexetidine product; hexylresorcinol product; hydrogen peroxide; iodoform; laurcetium; laurcetium bromide; laurixamine; lauroguadine; laurolinium acetate; lopobutane; mafenide acetate; mecetronium; mecetronium ethyl sulfate; mequidox; meralein; merbromine product; mercury iodide; mercury ammonium chloride product; metabronsalan; metaniazid; methylisothiazolinone; monalazone; disodium monalazone; morniflumate; myristalkonium chloride; nibroxane; nifuradene; nifuralzone; nifuralide; nifuretazone; nifurfolin; nifurimide; nifurizone; nifuroquine; nifuroxazide; nifuroxime;nifurpirinol; nifurprazine; nifurvidin; nifurzide; nitromersol; noxythiolin product; octaphonium chloride; octenidine saccharin; olanhexidine; opratonium iodide; sulfate; Petition 870260058404, dated 06 / 16 / 2026, page 31 / 79 28 / 28 oxyquinoline; parachlorophenol; penoctonium; penoctonium bromide; fanquone; sodium phenolate; phenoxyethanol product; phenylethyl alcohol; phthalylsulfacetamide; picloxidine; picric acid; pyrralkonium; pyrralkonium bromide; pirtenidine; pirtenidine hydrochloride; prednicarbate; proflavine dihydrochloride; proflavine hemisulfate; proflavine product; proflavine sulfate; resorcinol; resorcinol monoacetate; romifenone; salicylanilide; sanguinarine chloride; selenium sulfide; sepazonium; sepazonium chloride; silver nitrate; silver oxide; silver picrate; silver sulfadiazine; sodium meralein; sulfacecol; sulfarsphenamine; sinclosene; talmetoprim; tavaborole; temodox; tetradonium; tetradonium bromide; thimerosal product; thymol iodide; thymol product; tibezonium; tibezonium iodide; toliodium; toliodium chloride; tribronsalan; trichlorocarbanilide product; undecoyl chloride; zinc carbonate; zinc phenolsulfonate;
[0098] Pressure-sensitive adhesive (PSA) materials are known to those skilled in the art and may include, for example, one of the following: hydrocolloids; homopolymer emulsion (PVA); water-based acrylic adhesives; polyurethane dispersions (PUDs); poly(ethylene glycol); dextrin / starch-based adhesives; N-vinyl caprolactam homopolymers; N-vinyl pyrrolidone copolymers; poly(vinyl alcohol); cellulose ethers; methylcellulose; carboxymethylcellulose; polyvinylpyrrolidone; polyvinyl acetates, non-water-based acrylic adhesives; cyanoacrylate adhesives; epoxy; silicone-based adhesives; urethane and similar products, and combinations thereof.
[0099] It should be understood that the aforementioned disclosure and description of embodiments of the present invention are illustrative and explanatory of the same, and various alterations in size, shape and materials, as well as in the description of the preferred embodiment, may be made without departing from the spirit of the invention. Petition 870260058404, dated 06 / 16 / 2026, p. 32 / 79
Claims
1 / 5 CLAIMS 1. Incisional surgical field (10), characterized in that it comprises: a flat flexible areal substrate (20) having an upper side (22) and a tissue-facing opposite side (24), a longitudinal geometric axis (21) and a pressure-sensitive adhesive (40) disposed on the tissue-facing side (24); and at least one hollow microtubular compartment (30) containing a flowable medicinal agent (100), wherein said hollow microtubular compartment (30) is positioned to cross the longitudinal geometric axis (21) and is embedded in or positioned in the substrate (20).
2. Incisional surgical field (10), according to claim 1, characterized in that said microtubular compartment (30) is frangible, separable, easily cuttable or combinations thereof.
3. Incisional surgical field (10), according to claim 2, characterized in that said microtubular compartment (30c) is arranged in a spiral configuration and crosses said longitudinal geometric axis (21) at least 4 times.
4. Incisional surgical field (10), according to claim 2, characterized in that it comprises a plurality of said hollow microtubular compartments (30) arranged side by side and positioned across the longitudinal geometric axis (21) such that each of said compartments (30) crosses the longitudinal geometric axis (21).
5. Incisional surgical field (10), according to claim 4, characterized in that it comprises at least eight of the hollow microtubular compartments (30).
6. Incisional surgical field (10), according to claim 4, characterized in that said microtubular compartment (30) is linear (30), angular (30a), U-shaped (30b), or V-shaped (30b).
7. Incisional surgical field (10), according to claim 4, characterized in that said microtubular compartments (30d) comprise a central capillary portion (32) having a smaller diameter, wherein said central capillary portion (32) is proximal and is at least partially on the longitudinal geometric axis (21), and a peripheral portion of larger diameter (31) that is positioned distal to the longitudinal geometric axis (21).
8. Incisional surgical field (10), according to claim 4, characterized in that said microtubular compartments (30) are all connected together to a peripheral channel (33) that is positioned distal to the longitudinal geometric axis (21) and parallel to the longitudinal geometric axis (21), optionally wherein said peripheral channel (35) terminates in a bulb (39) positioned on a periphery of said surgical field (10) and containing said agent (100), wherein said bulb (39) is elastic and contains said agent (100) under pressure.
9. Incisional surgical field (10), according to claim 4, characterized in that it further comprises a plurality of second microtubular compartments (30h) that do not cross the longitudinal geometric axis (21) and are interconnected with said microtubular compartments (30g) that form a grid.
10. Incisional surgical field (10), according to claim 4, characterized in that said microtubular compartments comprise Petition 870260058404, dated 06 / 16 / 2026, page 34 / 79 3 / 5 smaller diameter microtubular compartments (301) configured for slow release of the agent (100); and larger diameter microtubular compartments (302) configured for faster release of the agent (100), wherein said smaller diameter microtubular compartments (301) are interspersed or arranged interdigitally with said larger diameter microtubular compartments (302).
11. Incisional surgical field (10), according to claim 4, characterized in that said microtubular compartments comprise: first-type microtubular compartments (303) containing a high viscosity formulation of said agent (100) (HV) and configured for slow release of the agent (100); and second-type microtubular compartments (304) containing a low viscosity formulation of said agent (100) (LV) and configured for rapid release of the agent (100); wherein said first-type (303) and second-type (304) microtubular compartments are interleaved or arranged interdigitally with each other.
12. Incisional surgical field (10), according to claim 4, characterized in that said microtubular compartments comprise first-type microtubular compartments (305) containing a first agent (100a); and second-type microtubular compartments (306) containing a second agent (100b); wherein said first-type (305) and second-type (306) microtubular compartments are interleaved or arranged interdigitally with each other, optionally wherein said first-type microtubular compartments Petition 870260058404, dated 06 / 16 / 2026, p.35 / 79 4 / 5 type (305) containing the first agent (100a) are configured for rapid release of the first agent (100a); and the microtubular compartments of the second type (306) containing the second agent (100b) are configured for slow release of the second agent (100b); wherein said microtubular compartments of the first (305) and second (306) types are interleaved or arranged interdigitally with each other.
13. Incisional surgical field (10), according to claim 1, characterized in that said medicinal agent (100) comprises an antimicrobial agent, antibacterial agent, antibiotic, antiviral, triclosan, chlorhexidine gluconate, polyhexamethylene biguanide or combinations thereof.
14. Incisional surgical field (10), according to claim 4, characterized in that said hollow microtubular compartments (30) comprise individual sealed microfluidic channels formed directly in said substrate (20).
15. Incisional surgical field (10), characterized in that it comprises: a flat, flexible areal substrate (20) having an upper side (22) and an opposite side facing the tissue (24), a longitudinal geometric axis (21) and a pressure-sensitive adhesive (40) disposed on the side facing the tissue (24); and a plurality of hollow microtubular compartments (30i) for receiving a medicinal agent (100), wherein said microtubular compartments (30i) are arranged side by side and positioned across the longitudinal geometric axis (21), such that each of said microtubular compartments (30i) crosses the longitudinal geometric axis (21) and is embedded in or positioned in the substrate (20), wherein said microtubular compartments (30i) do not initially contain Petition 870260058404, dated 06 / 16 / 2026, page.36 / 79 5 / 5 medicinal agent (100) and are connected to a peripheral channel (35) that is distal from the longitudinal geometric axis (21) and parallel to the longitudinal geometric axis (21) and terminates with a port (36) positioned on a periphery of said surgical field (10), wherein said port (36) is configured to be connectable to a pressurized source of a medicinal agent (100). Petition 870260058404, dated 06 / 16 / 2026, p. 37 / 79.