Wound closure system for reducing surgical site infection comprising an incise drape filled with a releasable antimicrobial agent

Abstract

A surgical incision cover cloth (10) includes a flexible substantially flat area substrate (20) having an upper side (22) and an opposing tissue-facing side having a longitudinal axis (21) and a pressure-sensitive adhesive (40) disposed on the tissue-facing side; at least one hollow microtubular compartment (30) containing a flowable agent (100), the hollow microtubular compartment (30) being positioned to intersect the longitudinal axis (21) and embedded in or positioned on the substrate (20).

Description

Technical Field

[0001] The present invention relates to antimicrobial wound dressings and, more particularly, to antimicrobial incise drapes that release a flowable antimicrobial agent to surgical instruments and the edges of an incision and into the wound when the drape is cut. Background Art

[0002] Dressings play a major role in wound management, as the moist, warm, and nutrient-rich environment of the wound site can provide conditions conducive to 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 can induce an excessive and prolonged inflammatory response. Antimicrobial dressings can be used against a range of bacteria, such as methicillin-resistant Staphylococcus aureus (MRSA), Gram-negative bacilli, and Candida species.

[0003] For infection prevention, maintaining sterility is crucial in surgical procedures, especially those involving incisions. Typically, the procedures for preventing surgical site infections include showering, washing, shaving, scrubbing, preparing and covering the surgical site. Each of these tasks is performed to prevent pathogenic flora from being introduced into the surgical site. However, the entire process for maintaining sterility of the surgical site can be offset by, for example, the occurrence of cutting through the hair follicles. No matter how the skin is washed, scrubbed and prepared, the hair follicles may be rich in bacteria. The action of making a surgical incision (i.e., cutting) can release bacteria from the hair follicles and other skin structures. Such a small amount of bacteria may be enough to cause a surgical site infection.

[0004] In addition, it may be beneficial to deliver other agents to the surgical incision, such as: hemostatic agents to prevent or reduce bleeding, lubricants to facilitate insertion of surgical tools, anti-inflammatory agents to reduce swelling and postoperative pain, chemotactic agents to accelerate postoperative capillary ingrowth, wound healing agents, etc. and their combinations.

[0005] U.S. Patent Application Publication No. 20140373851, “Filled Incise Drape,” discloses an article comprising: a liquid-impermeable shell 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 surrounding an antimicrobial liquid composition; and a pressure-sensitive adhesive layer disposed on an outer surface of the first film layer.

[0006] PCT Patent Publication No. WO2017151226A1, "Drape for Use with Medical Therapy Systems", discloses a drape for medical applications, the drape comprising: a film layer having a first side and a second side; an adhesive layer connected to the first side of the film layer, the adhesive layer having a first bonding strength before application of the drape, a second bonding strength in response to a force applied to the drape, and a third bonding strength after the adhesive layer is exposed to electromagnetic radiation in the visible light spectrum; and a barrier layer releasably connected to the second side of the film layer and configured to block at least a portion of the electromagnetic radiation in the visible light spectrum.

[0007] U.S. Patent No. 4,643,181, “Antimicrobial Dressing or Drape Material” discloses a surgical dressing comprising a substrate coated with a solvent-based skin contact adhesive on one surface, the adhesive having a thickness of 30 to 60 microns, and particles of polyhexamethylene biguanide hydrochloride distributed through the adhesive, the particle size of the particles being 20 to 300 microns.

[0008] U.S. Patent No. 8,697,112, "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 polymer substrate comprising a hydrophilic polymer grafted to the surface; and a layer comprising microparticles of a therapeutic agent disposed on and complexed with the hydrophilic polymer substrate.

[0009] U.S. Patent No. 8,691,268, “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 an active substance into a user through the skin, the transdermal patch comprising: an inner disk comprising (i) an encapsulating agent in microcapsules, wherein the microcapsules retain the encapsulating agent and (ii) an outer matrix or vehicle prior to activation by energy capable of rupturing the microcapsules; and an outer disk for attaching the patch to the user's skin, thereby facilitating contact of the inner disk with the skin surface; (B) an activation probe attached to the transdermal patch and equipped with a single multi-source element, wherein the multi-source element is composed of multiple energy sources for providing ultrasonic radiation or heat energy at different localized areas of the inner disk, wherein the activation probe is suitable for activating the transdermal patch by rupturing the microcapsules, thereby releasing the encapsulating agent into the outer matrix or vehicle of the inner disk of the transdermal patch; and (C) a power source for supplying energy to the multi-source element.

[0010] U.S. Patent No. 3,598,123, “Bandage for Administering Drugs,” discloses a medical bandage for circulating controlled amounts of a systemically active drug over a long period of time during continuous application by absorption through the skin or mucosa in vitro, the bandage comprising (1) a backing member carrying on one surface thereof (2) a pressure-sensitive adhesive having distributed therethrough (3) a plurality of discrete microcapsules, each of the plurality of discrete microcapsules comprising a systemically active drug formulation confined within a wall member, the wall member being formed of a drug release rate controlling material to continuously measure the flow of the drug from the microcapsules to the skin or mucosa at a controlled and predetermined rate over a long period of time.

[0011] U.S. Patent No. 9,925,087, “Wound and Therapy Compress and Dressing,” discloses a dressing for treating a surface of a body part of a human or animal patient, the dressing comprising: a compress including a plurality of loose fill particles contained in an enclosure within the compress, the plurality of loose fill particles being configured to deliver moist heat; a heat-transmitting pad impregnated with an antimicrobial agent, the heat-transmitting pad being attached to a surface of the compress such that the heat-transmitting pad is positioned between the compress and the surface of the body part, wherein the heat-transmitting pad is activated by moist heat delivered from the compress to release the antimicrobial agent from the heat-transmitting pad onto the surface of the body part; and wherein the fill particles substantially retain at least one antimicrobial metal material therein and allow repeated absorption and dissipation of moisture from the fill particles.

[0012] U.S. Patent Application Publication No. 20030044380A1, “Adhesive Including Medicament,” discloses an adhesive for sealing wounds, the adhesive comprising a cyanoacrylate, a substance, and a defect former, wherein the defect former is removable from a cured cyanoacrylate matrix by solvation in an aqueous solution, thereby forming a plurality of defects in the matrix, thereby allowing the substance to be released from the matrix at a controlled rate.

[0013] U.S. Patent No. 6,139,856, "Composition Useful for Providing One-step Surgical Preparation and Drape", discloses a film-forming composition for providing a protective coating on the skin surface, comprising: (a) about 30% to 60% by weight of solids selected from the group consisting of: polyvinylidene fluoride and its copolymers; (b) about 10% to 20% by weight of solids of polymers of monomers selected from the group consisting of: lower alkyl acrylates, lower (meth) alkyl acrylates, hydroxy lower alkyl acrylates, αβ unsaturated carboxylic acids with an acid value of about 20 to 150, and their copolymers; (c) about 30% to 60% by weight of solids of polymers of monomers selected from the group consisting of: dialkylaminoalkyl (meth) acrylates and lower (meth) alkyl acrylates; (d) about 0.5% to 2.0% of water by weight of the total composition; (e) an effective amount of antimicrobial lipids; and (f) an aqueous organic solvent for dissolving all ingredients.

[0014] US Patent No. 4,654,256, "Article Containing Microencapsulated Materials," discloses an article comprising a thermoplastic polymer substrate having rupturable microcapsules partially embedded therein.

[0015] U.S. Patent No. 7,015,156, “Perfumed Abrasive Pad and Manufacturing Procedure,” discloses an abrasive cleaning product that produces a fragrance during use, the product comprising: a three-dimensional nonwoven fiber web; abrasive particles bonded to the fibers in an adhesive manner; and microcapsules comprising a fragrant substance bonded to the fibers in an adhesive manner, wherein the fragrant substance is released from the microcapsules during normal use of the product to produce a fragrance.

[0016] U.S. Patent No. 3,691,271, "Sanitary Napkin having Homogeneously Distributed Microcapsules Filled with Delay Releasable Bactericidal and Fungicidal Deodorant," discloses a sanitary napkin consisting essentially of a body of absorbent material of cellulose wadding or layered paper or cotton fabric and a plurality of individual microcapsules encapsulating an effective amount of a bactericidal and fungicidal deodorant, the microcapsules being uniformly distributed in the cellulose wadding or in alternating layers on the paper or cotton fabric, the size of each microcapsule of the microcapsules being in the range of 30 microns to 500 microns, the walls of the microcapsules being permeable or soluble when in contact with fluid associated with menstrual discharge, thereby delaying the release of the deodorant from the microcapsules in the sanitary napkin until contact with a sufficient amount of fluid to penetrate or dissolve the walls of the uniformly distributed microcapsules, the walls of the microcapsules being made of a material selected from the group consisting of gelatin, ethylcellulose, cellulose acetate phthalate, polyvinyl alcohol and polyvinyl acetate, and the density of the microcapsules being substantially equal to the density of the body of absorbent material.

[0017] PCT Patent Publication No. WO2012091457A2, “Antimicrobial Pad” discloses an antimicrobial pad comprising: a polyurethane foam having pores of a predetermined size; and microcapsules containing an antimicrobial agent therein and provided to be encapsulated within the pores of the polyurethane foam to coat the surface of the polyurethane foam.

[0018] U.S. Patent No. 3,490,454, “Catamenial Products having a Coating of Rupturable Microcapsules containing Medicants,” discloses an absorbent catamenial device comprising an absorbent portion having a fluid permeable wrapper and at least one layer having a plurality of discrete rupturable microcapsules adhered to the absorbent portion, the plurality of discrete rupturable microcapsules containing chemical materials that can help control fluids associated with menstrual discharge, the microcapsules comprising minutely encapsulated clusters of smaller individual microcapsules contained in a shell of a polymeric encapsulating material.

[0019] US Patent No. 4,597,960, "Microencapsulated Astringent Hemostatic Agents and Methods of Use," discloses a particulate composition for producing capillary hemostasis, comprising: a particulate astringent hemostatic agent selected from the group consisting of: trivalent iron and aluminum inorganic salts encapsulated with a cellulose-based biocompatible polymer soluble in body fluids.

[0020] U.S. Patent No. 5,717,005, “Adhesive Compositions and Products,” discloses an adhesive composition suitable for medical applications, comprising an adhesive having dispersed therein 2 wt % to 10 wt % of solid particles of chlorhexidine gluconate, based on the weight of the composition, wherein the particles have a particle size of less than 125 μ and at least about 30 volume % of the particles have a particle size of not less than 5 μ.

[0021] U.S. Patent Application Publication No. 20080176262, “Wound Dressing,” discloses a method for determining the burden of metalloproteinases in biological tissue, comprising: applying a diagnostic aid having a first material, the first material having a chemical composition that is degradable by metalloproteinases, and a second material that is confined by the first material and undergoes a change in spectral properties; waiting an appropriate amount of time to allow the metalloproteinases to degrade the first material; observing the spectral changes that occur in the second material; and assessing the burden of metalloproteinases in the tissue.

[0022] U.S. Patent Application Publication No. 20120330210, “Antimicrobial Silicone-Based Wound Dressings,” discloses a dressing comprising a silicone gel sheet comprising from about 95% to about 98% by weight of a silicone elastomer and having dispersed therein the following components: (i) microparticles of a chlorhexidine compound and (ii) at least one other antimicrobial agent, the total amount of chlorhexidine present in the gel sheet being up to 5% by weight, the silicone elastomer being cross-linked to a degree that provides sufficient cohesive strength to the dressing to allow the dressing to be applied and removed from a surface while leaving minimal residue on the surface.

[0023] Some of the above disclosures involve encapsulated microcapsules, only a few of which will rupture during incision, and therefore only a small portion of the therapeutic agent will be released, resulting in insufficient protection. Others involve large fluid-filled bags that will undesirably irrigate the wound with the therapeutic agent solution, thereby releasing a large amount of the therapeutic agent regardless of the wound size / incision size. There is a need to create a drape that can assist in the control and delivery of antiseptic and other agents at and to the surgical site and surgical tools in controlled amounts and controlled release during surgical procedures. Summary of the invention

[0024] In one embodiment, the present invention relates to a surgical incision drape comprising:

[0025] a substantially planar flexible area substrate having an upper side and an opposing tissue-facing side, a longitudinal axis, and a pressure sensitive adhesive disposed on the tissue-facing side; and

[0026] At least one hollow microtubular compartment containing a flowable agent, wherein the hollow microtubular compartment is positioned to intersect the longitudinal axis and is embedded in or positioned on the substrate.

[0027] In another embodiment, the present invention relates to a method of using the cover cloth of the previous embodiment, the method comprising the steps of:

[0028] positioning the drape over the tissue with the tissue-facing side toward and in contact with the tissue;

[0029] orienting the longitudinal axis generally along the intended incision line;

[0030] adhering the drape to the tissue via a pressure sensitive adhesive;

[0031] performing a surgical incision of the tissue through the drape, cutting or severing at least one of the microtubular compartments in the process, thereby opening at least one of the microtubular compartments; and

[0032] The agent is allowed to leach or seep out of the at least one microtubular compartment onto the edges of the tissue wound formed by the incision.

[0033] In yet another embodiment, the present invention is directed to a surgical incision drape comprising:

[0034] a substantially planar flexible area substrate having an upper side and an opposing tissue-facing side, a longitudinal axis, and a pressure sensitive adhesive disposed on the tissue-facing side; and

[0035] A plurality of hollow microtubular compartments for receiving a drug, the microtubular compartments being arranged side by side and positioned across the longitudinal axis so that each of the microtubular compartments passes through the longitudinal axis and are embedded in or positioned on a substrate, wherein the microtubular compartments initially contain no drug and are connected to a peripheral channel away from the longitudinal axis and substantially parallel to the longitudinal axis, and terminate at a port positioned on the periphery of the cover cloth, the port being configured to be connectable to a pressurized source of the drug. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] Figure 1A An embodiment of an incision drape is shown in a schematic top view.

[0037] Figure 1B An embodiment of an incise drape is shown in a schematic side cross-sectional view.

[0038] Figure 1C An embodiment of a slit drape is shown in a schematic side cross-sectional view in which the microtubular compartments include individually sealed microfluidic channels formed directly in the substrate.

[0039] Figure 2 An embodiment of an incision drape is shown in a schematic perspective view prior to cutting through the drape with a surgical blade.

[0040] Figure 3 An embodiment of an incise drape is shown in a schematic side cross-sectional view.

[0041] Figure 4 An embodiment of an incision drape is shown in a schematic top view.

[0042] Figure 5 An embodiment of an incision drape is shown in a schematic top view.

[0043] Figure 6 An embodiment of an incision drape is shown in a schematic top view.

[0044] Figure 7 An embodiment of an incision drape is shown in a schematic top view.

[0045] Figure 8 An embodiment of an incision drape is shown in a schematic top view.

[0046] Fig. 9 An embodiment of an incision drape is shown in a schematic top view.

[0047] Fig.10 An embodiment of an incision drape is shown in a schematic top view.

[0048] Fig.11AAn embodiment of an incision drape is shown in a schematic top view and connected to a source of pressurized medication via a cannula.

[0049] Fig. 11B An embodiment of an incision drape is shown without medication in a schematic top view and prior to connection to a pressurized source of medication via a cannula.

[0050] Fig.12 An embodiment of an incision drape is shown in a schematic top view.

[0051] Fig.13 An embodiment of an incision drape is shown in a schematic top view.

[0052] Fig.14 An embodiment of an incision drape is shown in a schematic top view.

[0053] Fig.15 An embodiment of an incision drape is shown in a schematic top view.

[0054] Fig.16A An embodiment of an incise drape is shown in a schematic top view positioned on tissue in use.

[0055] Fig. 16B An embodiment of an incise drape is shown in a schematic side cross-sectional view positioned on tissue in use. DETAILED DESCRIPTION

[0056] Described herein are filled incise drapes that can deliver therapeutic agents at and to a surgical site. Exemplary embodiments of the filled incise drapes of the present disclosure are generally comprised of liquid-impermeable microtubular compartments encapsulating a flowable or fluid therapeutic agent, such compartments being embedded in an adhesive patch or sheet that serves as a drape. Once applied to a surgical site and properly prepared, an incision can be made with the filled incise drape. Upon cutting or otherwise puncturing the filled incise drape, the therapeutic agent will be squeezed out of the drape and delivered into the incision. Embodiments of the present invention enable the delivery of highly effective combinations of therapeutic agents that are not typically used after the initial incision in traditional surgery because this would require an additional step and bacteria from the incision are not typically considered a factor in surgical infections. The filled incise drapes of the present disclosure provide a single step for delivering therapeutic agents directly to the surgical incision and surgical instruments as the incision is made.

[0057] In short, a surgical wound incision drape comprises a barrier patch or dressing or pad made of a flexible sheet of fabric, mesh or nonwoven material that is adhesively and removably attached to the tissue in the area where the tissue is to be cut during the surgical procedure. The drape is then cut during surgery while the underlying tissue is cut. Cutting through the drape opens microcompartments filled with a flowable antimicrobial agent that is released in the cutting area onto surgical instruments (such as surgical incision tools, saws, knives, scalpels, etc.) and onto the edges of the incision.

[0058] In the surgical wound incision drape of the present invention, the barrier patch / dressing / pad is adhesively attached to the tissue and then cut open during surgery, and the drape material contains embedded elongated sealed compartments, such as tubes filled with liquid flowable antimicrobial agents. The tubes are oriented generally across the cutting axis of the drape so that they are cut and opened during the incision, thereby releasing the fluid agent along the incision, on the inner wall of the wound and above the scalpel, thereby providing antimicrobial action at the beginning and throughout the operation.

[0059] Advantageously, the release of the anti-infective agent is proportional to the size of the incision, thereby preventing excessive amounts of antimicrobial agent from flooding the wound area. Advantageously, in some embodiments, the agent is released slowly and over time, thereby providing the necessary coverage during surgery. Advantageously, all of the agent is available for release, compared to systems with embedded microcapsules in which only a small portion of the agent is released after incision.

[0060] Reference now Figure 1A , the embodiment of the cover cloth 10 is shown in a top view, wherein the cover cloth 10 includes Figure 1A 22 of the substrate 20, wherein the straight or linear closed microtubular compartments 30 contain a liquid agent 100 embedded in the substrate 20 and shown in dashed lines. The microtubular compartments 30 are positioned and oriented generally across the longitudinal axis 21 of the substrate 20, in other words across the intended surgical incision line, which can be generally aligned with the axis 21, wherein the incision is performed generally within the periphery of the substrate 20 and within the central region of the substrate 20. At least a portion of the microtubular compartments 30 is located proximal to the longitudinal axis 21 and at least partially above the longitudinal axis. Now referring to Figure 1B , the drape 10 is shown in a side cross-sectional view, wherein the upper side 22 faces upward and the tissue-facing side 24 faces downward, wherein the microtubular compartments 30 are embedded in the base 20. An adhesive 40, such as a pressure-sensitive adhesive, is provided on the tissue-facing side 24 of the base 20, which is configured to be attached to the tissue before the surgical incision and removed after the surgical procedure. The adhesive 40 can be present as a continuous coating as shown, or applied in stripes, spots, dots, or any other shape, wherein some areas of the tissue-facing side 24 are free of adhesive 40.

[0061] Reference now Figure 1C , the cover cloth 10 is shown in a side cross-sectional view with the upper side 22 facing upward and the tissue-facing side 24 facing downward, wherein the microtubular compartments 30 include individually sealed microfluidic channels formed directly in the substrate 20.

[0062] refer to Figure 2 , shows a schematic perspective view showing a surgical blade 26 in position prior to cutting through the drape 10 along the longitudinal axis 21 of the substrate 20. In use, cutting through the drape 10 and the underlying tissue (not shown) will also cut through the microtubular compartments 30 embedded within the substrate 20, resulting in immediate or delayed release of the liquid agent 100. The microtubular compartments 30 are configured to be breakable, severable, easily cuttable, or a combination thereof.

[0063] Advantageously, in this embodiment, only the microtubular compartments 30 intersecting the cut performed by the blade 26 will release the medicament 100. This results in the release of an amount of medicament proportional to the length of the cut. If all medicaments 100 from all microtubular compartments 30 are released into a relatively small incision intersecting only one microtubular compartment 30, thereby potentially resulting in excessive release of medicament 100, which may be harmful due to the irrigation of a relatively small wound area and result in an excessive dose of antimicrobial agent. Therefore, in the illustrated embodiment, the amount of medicament released is proportional to the length of the incision.

[0064] Advantageously, in some embodiments, the microtubular compartment 30 is configured to slowly release the agent 100 from each cut microtubular compartment 30, with some fluid released immediately and some fluid released slowly over time, thereby supplying the agent 100 to the wound edge. This is advantageous compared to embedding microcapsules in the drape 10, which would only be able to release very small amounts of agent 100 from a small number of cut capsules in the incision line, but not from other capsules, and without the time delay effect as in the case of the microtubular compartment 30. This is also advantageous compared to one large compartment in the drape 10, which would release all of the agent 100 in response to even a short incision.

[0065] Reference now Figure 3 , the embodiment of the cover cloth 10 is similar to Figure 1B The embodiment shown in FIG. 1 is a side cross-sectional view of FIG. Figure 1B The difference is that the micro-tubular compartments 30 are not located in the body or middle of the cover cloth 10, but are located on the upper side 22.

[0066] Reference now Figure 4 , an embodiment of the cover cloth 10 is shown in a top view, wherein the microtubular compartment 30a is substantially non-perpendicular to and crosses the longitudinal axis 21 of the substrate 20, as shown Figure 1AAs shown, but at an angle relative to the longitudinal axis 21, and still intersects the longitudinal axis 21 or the intended incision line. The angle between the microtubular compartment 30a and the longitudinal axis 21 is about 20° to 70°, more preferably about 30° to about 60°, and most preferably about 45°, as shown.

[0067] Reference now Figure 5 , the embodiment of the cover cloth 10 is shown in a top view, as shown Figure 1A , Figure 4 As shown in the embodiment of the present invention, the microtubular compartment 30b is not linear, but rather is "V"-shaped or "U"-shaped and oriented generally across the longitudinal axis 21 of the substrate 20, wherein the midpoint "M" of the "V" or "U" shape is generally positioned on the longitudinal axis 21. Compared to the microtubular compartments 30, 30a of other embodiments, this arrangement provides more pharmaceutical agent 100 available for discharge, leaching or seepage from each cut microtubular compartment 30b.

[0068] Reference now Figure 6 , an embodiment of the cover cloth 10 is shown in a top view, wherein the microtubular compartment 30c includes a long generally spiral microcompartment arranged on the longitudinal axis 21 of the base 20 and spanning the longitudinal axis. This arrangement provides for all agents 100 that can be discharged, leached or seeped from the spiral microtubular compartment 30c when cut anywhere. Advantageously, due to the distance the agent 100 needs to travel through the microtubular compartment 30c to the area where the spiral microtubular compartment 30c is cut or severed, the release is slow. The spiral microtubular compartment 30c intersects the longitudinal axis 21 at least 4 times, and at most 100 times, such as 9 times, as shown in FIG. Figure 6 shown.

[0069] Reference now Figure 7 , an embodiment of the cover cloth 10 is shown in a top view, wherein the generally linear microtubular compartments 30d are positioned transversely / perpendicularly to the longitudinal axis 21 of the substrate 20, similar to Figure 1AEmbodiment. The microtubular compartment 30d has a capillary core portion 32 of smaller diameter, which is located proximal to the longitudinal axis 21 and at least partially above the longitudinal axis. The microtubular compartment 30d has a larger volume (such as a larger diameter) peripheral portion 31, which is away from the longitudinal axis 21. In the embodiment shown, there are two peripheral portions 31 arranged on either side of the capillary core portion 32. This arrangement provides more medicaments 100 that can be discharged from each cut microtubular compartment 30d, but due to the smaller diameter capillary core portion 32, the medicament 100 leaches or seeps out slowly. The peripheral portion 31 can be linear and rectangular shapes, cylindrical, spherical capsule shapes or generally have any suitable geometry to provide a storage reservoir for additional medicaments 100 leached through the cut capillary core portion 32.

[0070] In an alternative embodiment (not shown), only one peripheral portion 31 is arranged on one side of the capillary core portion 32 .

[0071] Reference now Figure 8 , an embodiment of the cover cloth 10 is shown in a top view, wherein the microtubular compartments 30e are linear and positioned transversely / perpendicularly to the longitudinal axis 21 of the substrate 20, similar to Figure 1A The microtubular compartments 30e are all connected to a larger diameter peripheral channel 33 which is distal and generally parallel to the longitudinal axis 21 .

[0072] In the embodiment shown, there is one peripheral channel 33 arranged on one side of the substrate 20. This arrangement provides more medicament 100 available for discharge from each cut microtubular compartment 30e, but the medicament 100 leaches or seeps out slowly due to the smaller diameter capillary center portion 32. The peripheral channel 33 can be linear and rectangular in shape, cylindrical, spherical capsule-like, or generally have any suitable geometry to provide a reservoir for additional medicament 100 leached through the cut or cut microtubular compartment 30e. In an alternative embodiment (not shown), there are two peripheral channels 33 on each side of the substrate 20, which are located at the periphery of the substrate 20, away from and generally parallel to the longitudinal axis 21.

[0073] Reference now Fig. 9 , an embodiment of the drape 10 is shown in a top view, wherein the microtubular compartments 30f are randomly distributed throughout the base 20, at least some of which intersect the longitudinal axis 21. Advantageously, in this embodiment, cutting through the drape 10 in any direction will result in the release of the agent 100.

[0074] Reference now Fig.10, an embodiment of the cover cloth 10 is shown in a top view, wherein the microtubular compartments 30g are arranged perpendicular to the microtubular compartments 30h, which are parallel to the longitudinal axis 21, thereby forming a generally square grid. In one embodiment, the microtubular compartments 30g, the microtubular compartments 30f are connected to each other at each intersection 34. In another embodiment, the microtubular compartments 30g, the microtubular compartments 30f are not connected to each other at each intersection, such as by being positioned in different planes within the substrate 20. Advantageously, cutting the cover cloth 10 in any direction will cause certain microtubular compartments 30g, microtubular compartments 30f to intersect, thereby causing the agent 100 to be released along and at the incision.

[0075] Reference now Fig.11A , an embodiment of the cover cloth 10 is shown in a top view, wherein the microtubular compartments 30i are linearly shaped and positioned transversely or perpendicularly to the longitudinal axis 21 of the substrate 20, similar to Figure 1A The microtubular compartment 30i is connected to a peripheral channel 35 that is distal and generally parallel to the longitudinal axis 21 and located on the periphery of the base 20, and terminates in a port 36 positioned on the periphery of the cover cloth 10. The peripheral channel 35 can have a linear or rectangular shape, a cylindrical shape, or generally any suitable geometry to provide delivery of the agent 100 to the microtubular compartment 30i.

[0076] Port 36 is shown connected to a source of pressurized agent 100 via cannula 37, such as a pump, which in one embodiment can be a syringe 38 as shown. Alternatively, any pump 38 can be used, including a fluid static pressure source containing pressurized agent 100, i.e., a pump of an elevated source (not shown), which is positioned slightly above the cover cloth 10 to achieve gravity-driven flow. Other pumps may include low volume flow peristaltic pumps, piston pumps, elastic balls, and the like. In one embodiment (not shown), the pump 38 includes a pressurized container.

[0077] like Fig.11A As shown by the arrows in , the pressurized agent 100 in the pump 38 is delivered to the edge of the wound as needed after the cover cloth 10 and the corresponding microtubular compartment 30i are cut.

[0078] In some embodiments, such as Fig. 11B As shown, the drape 10 has no supply of agent 10 internally. After the drape 10 is applied to the tissue, a pressurized agent 100 is supplied to the drape 10 via the cannula 37 by connection to the port 36, preferably before cutting the drape 10. In this embodiment, the selection of agent 100 can be made based on specific needs and tissue area, patient needs, risks, etc. Advantageously, the supplied agent 100 can be changed from one agent to another (such as a different type of agent or a different concentration of agent) as needed during surgery.

[0079] Reference now Fig.12 , an embodiment of the cover cloth 10 is shown in a top view, wherein the microtubular compartments 30j are linearly shaped and positioned transversely or perpendicularly to the longitudinal axis 21 of the substrate 20, similar to Figure 1A The microtubular compartments 30i are connected to a peripheral channel 35 that is distal and substantially parallel to the longitudinal axis 21 and located on the periphery of the base 20 and terminates in a hollow ball 39 positioned at the periphery of the cover cloth 10 and containing the agent 100. In one embodiment, the ball 39 is elastic and contains the agent 100 under pressure. After the cover cloth 10 and the corresponding microtubular compartments 30j are cut or severed, the pressurized agent 100 in the ball 39 is delivered to the edge of the wound. In another embodiment, manual compression of the ball 39 promotes additional flow of the agent 100 through the cut or severed microtubular compartments 30j.

[0080] In some embodiments, and with reference to Fig.13 , shows a schematic top view of an embodiment of a drape 10, wherein there are two or more types of microtubular compartments, wherein when the microtubular compartments 301, 302 are severed or cut, the microtubular compartments 301 having a smaller diameter have a slower or delayed release of the agent 100, and the microtubular compartments 302 having a larger diameter have a faster release of the agent 100. As shown in the figure, most of the microtubular compartments of different types are preferably interspersed or cross-arranged, such that the microtubular compartments 301 of the first type are surrounded by the microtubular compartments 302 of the second type, and mutatis mutandis, the microtubular compartments 302 of the second type are surrounded by the microtubular compartments 301 of the first type. Such an arrangement results in the immediate release of the agent 100 from the microtubular compartments 302, and then the sustained release of the agent 100 from the microtubular compartments 301 during the surgical procedure.

[0081] In some embodiments, and with reference to Fig.14 , the microtubular compartments present are of two or more types, wherein the microtubular compartment 303 has a higher viscosity pharmaceutical agent 100 formulation ( Fig.14 ) and thus have a slower or delayed release of the agent 100 when the microtubular compartment is severed or cut, the microtubular compartment 304 (indicated by the letters "HV" in Fig.14 100 formulation (shown as slightly shorter in FIG. 100 for easier identification) having a lower viscosity pharmaceutical agent 100 formulation (shown as slightly shorter in FIG. Fig.14The invention relates to a method for treating a patient with a first type of microtubular compartment 300 (indicated by the letters "LV" in the figure) and thus having a faster or immediate release of the agent 100 when the microtubular compartment is severed or cut. As shown, the different types of microtubular compartments are preferably interspersed or arranged in a cross-section so that most of the microtubular compartments 303 are surrounded by the second type of microtubular compartments 304, and mutatis mutandis, most of the second type of microtubular compartments 304 are surrounded by the first type of microtubular compartments 303. Such an arrangement results in an immediate release of the agent 100 from the microtubular compartments 304, and then a sustained release of the agent 100 from the microtubular compartments 303 during the surgical procedure.

[0082] In some embodiments, and with reference to Fig.15 , the microtubular compartments present are of two or more types and have the same diameter (as shown) or different diameters (not shown, but similar to Fig.13 ), wherein the microtubular compartment 305 (in Fig.15 100a, and the microtubular compartment 306 contains the second agent 100b. Having two or more agents 100a, 100b in separate compartments simplifies the storage of incompatible agents that may be active against different microorganisms such as Gram-negative and Gram-positive bacteria.

[0083] Although the release of the agents 100a and 100b can be performed simultaneously, in some embodiments, the release is performed with different profiles, such as when the agent 100a is released immediately or within the first 3 seconds to 30 seconds, and the agent 100b is slowly released via delayed release. The delayed release can be achieved by the diameter of the microtubular compartment as shown above, and / or by formulating the viscosity of the agents 100a and 100b with excipients and diluents, wherein as shown above, higher viscosity leads to delayed or slower release.

[0084] As shown, the different types of microtubular compartments are preferably interspersed or interleaved so that most of the first type of microtubular compartments 305 are surrounded by the second type of microtubular compartments 306, and mutatis mutandis, most of the second type of microtubular compartments 306 are surrounded by the first type of microtubular compartments 305. Such an arrangement results in both agents 100a, 100b being released when the microtubular compartments are severed or cut.

[0085] In use and reference Fig.16A , Fig. 16B, the drape 10 is positioned on and adhered to the tissue 50, wherein the upper side 22 faces upward and the tissue-facing side 24 faces downward toward and in contact with the tissue 50. The longitudinal axis 21 of the base 20 is oriented generally along the intended incision line. The tissue-facing side 24 of the base 20 is adhered to the tissue 50 via the adhesive 40.

[0086] A surgical incision 55 of the tissue 50 is then performed through the drape 10, in which process at least one of the microtubular compartments 30 is cut or severed. 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 seep out of the microtubular compartments 30 onto the sides of the surgical instrument (not shown) and the edge 55 of the wound 56 and partially into the wound 56, as shown in FIG. Fig. 16B The arrows in FIG.

[0087] In some embodiments, the microtubular compartments 30 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 / exudation of all or up to about 80% of the agent 100 from the microtubular compartment 30 is configured to be released within about 3 seconds to 10 seconds, such as within 5 seconds to 10 seconds, after cutting or severing the microtubular compartment 30. In alternative embodiments, the release of all or up to 80% of the agent 100 occurs over an extended period of time, such as 10 seconds to 600 seconds and up to 10 hours.

[0089] In some embodiments, release of about 40% to 60% of the agent 100 occurs very quickly, i.e., within 10 seconds, with the remainder released slowly over about 30 seconds to 600 seconds (10 minutes) or up to about 6000 seconds (100 minutes) or up to 10 hours.

[0090] size

[0091] The inner diameter of the microtubular compartment can be about 0.15mm to about 2mm, more preferably 0.2mm to 1mm, such as 0.3mm, 0.5mm, 1mm. The microtubular compartment can also have a cross section such as a rectangle, an ellipse, with a similar cross-sectional area. The length of the microtubular compartment is about 10mm to about 500mm, such as 15mm, 20mm, 30mm, 50mm, 75mm, 100mm. The wall thickness of the microtubular compartment is about 0.05mm to about 1mm, such as 0.1mm, 0.3mm, 0.5mm.

[0092] The number of microtubular compartments may vary from 1 in the spiral embodiment to about 10-500, such as 8, 12, 20, 30, 40, 50, 80, 100.

[0093] Substrate 20 may have any geometric shape, including rectangular, oval, square, or the like.

[0094] The length of the substrate 20 is about 5 cm to about 300 cm, such as 10 cm, 15 cm, 20 cm, 25 cm. The width of the substrate 20 is about 2 cm to about 300 cm, such as 3 cm, 5 cm, 10 cm, 15 cm, 20 cm, 25 cm. The thickness of the substrate 20 is about 0.5 mm to about 5 mm, such as 1 mm, 2 mm, 3 mm.

[0095] Material

[0096] The substrate 20 material can be any polymer material that is inert and / or biocompatible, such as polyethylene, polypropylene, polyester, oxidized regenerated cellulose (ORC), chitosan, collagen, gelatin, and the like, and combinations thereof. The substrate 20 can be a molded or extruded sheet, woven fabric, nonwoven felt, or a combination thereof. In one embodiment, the substrate 20 includes a wicking material that is capable of dispensing the agent 100 from discrete microtubular compartments to release over the entire area of ​​the cut cover cloth.

[0097] The microtubular compartment 30 material is any polymer material that is biocompatible and stable in contact with the agent 100, such as polyethylene, polypropylene, polyester, and the like.

[0098] The flowable drug or medicament 100 comprises a liquid or semi-liquid formulation containing a diluent and at least one antimicrobial and / or anti-infective and / or preservative agent. The diluent may be any fluid, such as water, saline, ethanol, etc. and combinations thereof. The medicament may be a natural or synthetic agent suitable for topical application to wounds, skin, mucous membranes or cavities, a topical anti-infective agent having therapeutic or prophylactic antibiotic properties against infectious viruses, bacteria or protozoa by inhibiting the growth and survival of such organisms.

[0099] The agent may be ethanol, triclosan, chlorhexidine gluconate (CHG), polyhexamethylene biguanide, antibiotics (such as gentamicin) and / or fluoroquinolone antibiotics (including ciprofloxacin, ofloxacin and norfloxacin), and the like. Several agents suitable for use in the present invention are known to the skilled artisan, including 3,6-diamino-10-methylacridinium chloride; 8-hydroxyquinoline products; 8-hydroxyquinoline sulfate ointment; acriflavine products; acridinium sulfonate; actinquin; Alexidine; aluminum acetate; ambazone; acridine hydrochloride; acridine products; acridine pyruvate; acridine undecanoate; amphomycin calcium; amylmetacresol; aurantium; azelaic acid; benzalkonium; benzalkonium products; benzethonium chloride; benzethonium products; benzalkonium dodecanoate; benzalkonium bromide; benzoin; benzoylquinone; benzozonium chloride; benzoyl peroxide; benzyl alcohol; benzylsulfonamide; bismuth bromphenol; dichlorothymol; bismuth subgallate; bismuth tribromophenate; boric acid; calcium hydroxide; camphor products; products; urea peroxide; Cetalkonium; Cetalkonium chloride; Cetyltrimethylammonium; Cetyltrimethylammonium chloride; Cetylpyridinium acetate; Cetylpyridinium bromide; Cetylpyridinium chloride; Cetylpyridinium chloride anhydrous; Cetylpyridinium products; Jomosulfone; Chloramine-T; Chlorhexidine gluconate; Chlorhexidine hydrochloride; Chlorhexidine products; Chlorindol; Chloramidine; Chlorcresol; Chlorthymol; Chloroxylenol; Chlorphenesin products; Ansorclofenium; Cyclomethol; Chloroquindox; Halocaban; Cyclomethol; Chlorobutyric acid; Cocamidopropyl betaine (in water); Crotamiton; Buteniazide; Copper mycin; Cyclomethol; Dakin's solution; Bromopropyl bromopropanol; Decomidol; Decamyl ammonium ; Detropium; Dibromide products; Dichlorobenzyl alcohol; Dichlorodimethol; Diclisor; Dithiopyridine; Disiquonium; Diazepam; Doclidinium; Dofamium; Dofamium; Famimium; Fenticlor products; Fepridol; Fludazonium; Fluclodazole; Flusalan; Furoxanone; Gloxazone; Guaiacol products; Halazonium; Haloperidol; Chloropyrin iodine; Hexachlorophene products; Hexidine; Hexetidine products; Hexylresorcinol products; Hydrogen peroxide; Iodoform; Laurcetium; Laurisamine; Lauroguanidine; Laurinium acetate; Lopobutan; Mafenide acetate; Mecetronium; Methionium ethylsulfate; Mequindox; Melarline; Mercurochrome products; Mercurous iodide; Aminomercuric chloride products; Bromsalan; Iodoniazid; Methylisothiazolinone; Monalazone; Sodium moxanate; Moniflate; Myristylbenzyldimethylammonium chloride; Nibromide; Nifurazone; Nifurox; Nifurtrol; Nifuroxine; Nifuroquine; Nifurazol; Nifuraloxime; Nifuranolol; Nifurazine; Nifuviridine; Nifuroxine; Nifuroquine; Nifuroxide; Nifuraloxime; Nifuranolol; Nifurazine; Nifuviridine; Nifuroxine; Nitrocresol mercuric; Northiocarbamide products; Octammonium chloride; Octenidine saccharide; Olancinium; Oxapranium iodide; Hydroxyquinoline sulfate; Parachlorophenol; Penofinonium; Penoctinium bromide; Ubiquinone; Sodium phenolate;Phenoxyethanol products; Phenylethanol; Phthaloylsulfonacetamide; Piperidine; Picric acid; Pirralkonium; Pyralkonium bromide; Pyritinidine; Pyritinidine hydrochloride; Prednicarbate; Diaminoacridine dihydrochloride; Proflavine hemisulfate; Proflavine products; Proflavine sulfate; Resorcinol; Resorcinol monoacetate; Romipolone; Salicylaniline; Sanguinonium chloride; Selenium sulfide; Sepazonium; Triphenylazoline chloride ; Silver nitrate; Silver oxide; Silver picrate; Silver sulfadiazine; Melarline sodium; Sulfasicol; Arsphenamine; Chlorooxytriazine; Thalomethoprine; Tavaborole; Temodos; Tetradonium; Tetramersal bromide; Thimerosal products; Thymol iodine; Thymol products; Thibenzamide; Tebemidonium iodide; Tolidium; Toliodimol; Tribromosalan; Trichlorocarbanilide products; Encyclopedia chloride; Zinc carbonate; Zinc phenolsulfonate;

[0100] Pressure sensitive adhesive (PSA) materials are known to those skilled in the art and may include, for example, one of the following: hydrophilic colloids; homopolymer emulsions (PVA); water-based acrylic adhesives; polyurethane dispersions (PUD); polyethylene glycol; dextrin / starch-based adhesives; N-vinyl caprolactam homopolymers; N-vinyl pyrrolidone copolymers; polyvinyl alcohol; cellulose ethers; methyl cellulose; carboxymethyl cellulose; polyvinyl pyrrolidone; polyvinyl acetate, non-water-based acrylic adhesives; cyanoacrylate adhesives; epoxy resins; silicone-based adhesives; polyurethanes and the like, and combinations thereof.

[0101] It should be understood that the foregoing disclosure and description of embodiments of the present invention are exemplary and illustrative and that various changes in size, shape and materials, as well as in the description of the preferred embodiments, may be made without departing from the spirit of the present invention.

Claims

1. A surgical incision cover cloth, comprising: a substantially planar flexible area substrate having an upper side and an opposing tissue-facing side, a longitudinal axis, and a pressure sensitive adhesive disposed on the tissue-facing side; as well as At least one hollow microtubular compartment, the at least one hollow microtubular compartment containing a flowable agent, wherein the hollow microtubular compartment is positioned to intersect the longitudinal axis and is embedded in the substrate or positioned on the substrate, the microtubular compartment is fragile, cuttable, easy to cut or a combination thereof, the cover cloth includes a plurality of the hollow microtubular compartments, the plurality of hollow microtubular compartments are arranged side by side and positioned across the longitudinal axis so that each of the compartments passes through the longitudinal axis, the microtubular compartments are all connected together to a peripheral channel, the peripheral channel is away from the longitudinal axis and is roughly parallel to the longitudinal axis, the peripheral channel terminates in a ball positioned on the periphery of the cover cloth and containing the agent, and the ball is elastic and contains the agent under pressure.

2. The surgical incision cover according to claim 1, wherein the microtubular compartments are arranged in a spiral configuration and pass through the longitudinal axis at least 4 times.

3. A surgical incision cover according to claim 1, wherein the cover comprises at least eight hollow microtubular compartments.

4. The surgical incision cover according to claim 1, wherein the microtubular compartment is linear, angular or U-shaped.

5. The surgical incise cover according to claim 1, wherein the microtubular compartment is V-shaped.

6. The surgical incision drape according to claim 1, wherein the microtubular compartment comprises: a capillary core portion having a smaller diameter, and A larger diameter peripheral portion, wherein the capillary center portion is closer to the longitudinal axis than the peripheral portion and intersects the longitudinal axis.

7. The surgical incision cover cloth according to claim 1, wherein the cover cloth further comprises a plurality of second microtubular compartments, the plurality of second microtubular compartments do not intersect the longitudinal axis and are interconnected with the microtubular compartments to form a grid.

8. The surgical incision drape according to claim 1, wherein the microtubular compartment comprises: a smaller diameter microtubular compartment configured to slowly release the agent; and microtubular compartments of larger diameter configured to release the agent faster, wherein the microtubular compartments of smaller diameter are interspersed or intersected with the microtubular compartments of larger diameter.

9. The surgical incision drape according to claim 1, wherein the microtubular compartment comprises: a first type of microtubular compartment containing a high viscosity formulation of the agent and configured to slowly release the agent; and a second type of microtubular compartment containing a low viscosity formulation of the agent and configured for rapid release of the agent; The first type of microtubular compartments and the second type of microtubular compartments are interspersed or intersecting with each other.

10. The surgical incision drape according to claim 1, wherein the microtubular compartment comprises: a first type of microtubular compartment containing a first agent; and a second type of microtubular compartment containing a second agent; The first type of microtubular compartments and the second type of microtubular compartments are interspersed or intersecting with each other.

11. The surgical incision drape of claim 10, wherein the first type of microtubular compartment containing the first agent is configured to quickly release the first agent; and said second type of microtubular compartments containing said second agent are configured to slowly release said second agent; The first type of microtubular compartments and the second type of microtubular compartments are interspersed or intersecting with each other.

12. The surgical incise drape of claim 1, wherein the agent comprises an antimicrobial agent.

13. The surgical incise drape of claim 1, wherein the agent comprises an antimicrobial agent.

14. The surgical incise drape of claim 1, wherein the medicament comprises an antibiotic.

15. The surgical incise drape of claim 1, wherein the agent comprises an antiviral agent.

16. The surgical incise drape of claim 1, wherein the agent comprises triclosan, chlorhexidine gluconate, polyhexamethylene biguanide, or a combination thereof.

17. The surgical incise drape of claim 1, wherein the hollow microtubular compartments comprise individually sealed microfluidic channels formed directly in the substrate.

18. A surgical incision cover, comprising: a substantially planar flexible area substrate having an upper side and an opposing tissue-facing side, a longitudinal axis, and a pressure sensitive adhesive disposed on the tissue-facing side; as well as A plurality of hollow microtubular compartments for receiving a drug, the microtubular compartments being arranged side by side and positioned across the longitudinal axis such that each of the microtubular compartments passes through the longitudinal axis and is embedded in or positioned on the substrate, wherein the microtubular compartments are initially free of drug and are connected to a peripheral channel away from and substantially parallel to the longitudinal axis, and the peripheral channel terminates in a ball positioned on the periphery of the cover cloth and containing the drug, and the ball is elastic and contains the drug under pressure.

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