WO2015089106A1 - Adhésifs médicaux, agents accélérateurs, systèmes d'administration et méthodes associées - Google Patents

Adhésifs médicaux, agents accélérateurs, systèmes d'administration et méthodes associées Download PDF

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Publication number
WO2015089106A1
WO2015089106A1 PCT/US2014/069395 US2014069395W WO2015089106A1 WO 2015089106 A1 WO2015089106 A1 WO 2015089106A1 US 2014069395 W US2014069395 W US 2014069395W WO 2015089106 A1 WO2015089106 A1 WO 2015089106A1
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WO
WIPO (PCT)
Prior art keywords
delivery system
adhesive
vessel
medical
delivery
Prior art date
Application number
PCT/US2014/069395
Other languages
English (en)
Inventor
Jeffery Brandon BUTTE
Original Assignee
Accelefx
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Accelefx filed Critical Accelefx
Publication of WO2015089106A1 publication Critical patent/WO2015089106A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00491—Surgical glue applicators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B50/30—Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
    • A61L24/001—Use of materials characterised by their function or physical properties
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
    • A61L24/04—Surgical adhesives or cements; Adhesives for colostomy devices containing macromolecular materials
    • A61L24/06—Surgical adhesives or cements; Adhesives for colostomy devices containing macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00491—Surgical glue applicators
    • A61B2017/00495—Surgical glue applicators for two-component glue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00491—Surgical glue applicators
    • A61B2017/00522—Sprayers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00681—Aspects not otherwise provided for
    • A61B2017/00738—Aspects not otherwise provided for part of the tool being offset with respect to a main axis, e.g. for better view for the surgeon
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/28—Surgical forceps
    • A61B17/29—Forceps for use in minimally invasive surgery
    • A61B17/2909—Handles
    • A61B2017/2912—Handles transmission of forces to actuating rod or piston
    • A61B2017/2918—Handles transmission of forces to actuating rod or piston flexible handles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B42/00—Surgical gloves; Finger-stalls specially adapted for surgery; Devices for handling or treatment thereof

Definitions

  • the present disclosure generally relates to chemical accelerants that reduce cure time in medical- or surgical-grade adhesive that is applied to wounds or incisions for closure.
  • the disclosure also relates to delivery systems for delivering both adhesive and accelerant.
  • the disclosure also relates to the approximation of tissue as adhesive and accelerant are delivered to a region comprising a wound.
  • Medical/surgical adhesives e.g., glues
  • These high-strength adhesives are often applied to an incision or laceration once the skin edges have been approximated. Once the adhesive has dried, the adhesive provides a barrier to water and bacteria, thus keeping the wound clean.
  • Medical- grade adhesives often comprise one or more cyanoacrylates. Under appropriate conditions, cyanoacrylates may rapidly polymerize. Such polymerization may be used to attach objects to one another. In some applications or conditions, however, polymerization may proceed relatively slowly (e.g., several minutes).
  • cyanoacrylates may be sped up through the use of one or more accelerants.
  • Common cyanoacrylate accelerants such as those used by hobbyists to attach miniature components to one another, may have one or more drawbacks for use in medical applications such as wound closure.
  • some accelerants may be unsafe or harmful due their reactivity or flammability.
  • some accelerants are problematic due to the exothermic nature of the reaction that takes place when used. The exothermic nature of the reaction may burn the skin and/or tissue of the patient as it is applied.
  • Some accelerants do not provide adequate acceleration of cyanoacrylate polymerization in certain scenarios. These drawbacks may render such accelerants unsuitable for human use and/or ineligible for FDA approval.
  • Common delivery systems for delivering adhesive and/or accelerant may also have one or more drawbacks. In some delivery systems, it is difficult to apply the adhesive consistently and evenly. Some delivery systems may be uncomfortable due to a deficiency of ergonomic design. Some delivery systems may make it difficult to approximate wounds for closure. Some delivery systems have other drawbacks as well.
  • FIG. 1 is a cross-sectional side view of a medical adhesive delivery system for the delivery of a medical adhesive and an accelerant.
  • FIG. 2 is a side view of the medical adhesive delivery system of FIG. 1 .
  • FIG. 3 is a side view of a medical adhesive delivery system according to another embodiment.
  • FIG. 4A is a cross-sectional side view of a medical adhesive delivery system according to another embodiment.
  • FIG. 4B is an end view of the medical adhesive delivery system of FIG. 4A.
  • FIG. 5A is a perspective view of a medical adhesive delivery system according to another embodiment.
  • FIG. 5B is an perspective view of the delivery ports of the medical adhesive delivery system of FIG. 5A.
  • FIG. 6A is a side view of a medical adhesive delivery system according to another embodiment.
  • FIG. 6B is a perspective view of the delivery ports of the medical adhesive delivery system of FIG. 6A.
  • FIG. 7A is a cross-sectional side view of at least a portion of a medical adhesive delivery system that includes a vessel for containing an adhesive and a housing.
  • FIG. 7B is a cross-sectional side view of the portion of the medical adhesive delivery system depicted in FIG. 7A when in a bent configuration.
  • FIG. 8 is a cross-sectional side view of at least a portion of a medical adhesive delivery system according to another embodiment.
  • FIG. 9 is a cross-sectional side view of at least a portion of a medical adhesive delivery system according to another embodiment.
  • FIG. 10A is an end view of a delivery port having a single circular opening.
  • FIG. 10B is an end view of a delivery port having an elongate shape with multiple openings.
  • FIG. 10C is an end view of a delivery port having an elongate shape with a single elongate opening.
  • FIG. 10D is an end view of a delivery port having a circular shape with an arrangement of multiple openings.
  • FIG. 1 1A is a side view of a delivery port configured as an atomizer for delivering accelerant as a narrow stream.
  • FIG. 1 1 B is a side view of a delivery port configured as an atomizer for delivering accelerant as a heavy spray.
  • FIG. 1 1 C is a side view of a delivery port configured as an atomizer for delivering accelerant as a fine spray.
  • FIG. 12A is a perspective view of a medical adhesive delivery system with a delivery port configured as a rotating atomizer with multiple settings.
  • FIG. 12B is a top down view of the medical adhesive delivery system of
  • FIG. 12A showing settings for the rotating atomizer.
  • FIG. 13A is a front view of a button for activating a delivery port.
  • FIG. 13B is a side view of the button of FIG. 13A for activating a delivery port.
  • FIG. 13C is a back view of the button of FIG. 13A for activating a delivery port.
  • FIG. 14A is a front view of a closed-ring button for activating a delivery port.
  • FIG. 14B is a side view of the closed-ring button of FIG. 14A for activating a delivery port.
  • FIG. 15A is a front view of a partial-ring button for activating a delivery port.
  • FIG. 15B is a side view of the partial-ring button of FIG. 15A for activating a delivery port.
  • FIG. 16A is a cross-sectional side view of a medical adhesive delivery system for pressure-assisted delivery of an adhesive and delivery of an accelerant via a pump atomizer.
  • FIG. 16B is a cross-sectional side view of the medical adhesive delivery system of FIG. 16A in a second state.
  • FIG. 17 is a cross-sectional side view of a medical adhesive delivery system in which the vessel containing the adhesive is configured to be punctured by a threaded tip.
  • FIG. 18 is a cross-sectional side view of a medical adhesive delivery system configured for pressure-assisted delivery of both an adhesive and an accelerant.
  • FIG. 19A is a perspective view of a portion of a delivery port with threads.
  • FIG. 19B is a perspective (upper) and end-on (lower) view of an applicator tip for threaded attachment to a portion of a delivery port.
  • FIG. 19C is a perspective (upper) and end-on (lower) view of an applicator tip, according to another embodiment.
  • FIG. 19D is a perspective (upper) and end-on (lower) view of an applicator tip, according to another embodiment.
  • FIG. 20 is a side view of a kit that includes a medical adhesive delivery systems with different applicator tips.
  • FIG. 21 is a side view of a kit that includes a medical adhesive delivery system with multiple tips for attachment to a portion of a delivery port.
  • Coupled to is used in its ordinary sense, and is broad enough to refer to any suitable coupling or other form of interaction between two or more entities, including mechanical, fluid and thermal interaction. Two components may be coupled to one another even though they are not in direct contact with each other.
  • biocompatible when used in reference to an accelerant, refers to a non-flammable accelerant that may be safely applied to a patient's skin without burning the patient.
  • a solution comprising a weak base is considered dilute with respect to the base if the solution comprises less than or equal to 15% base by weight.
  • the present disclosure generally relates to chemical accelerants that reduce cure time in medical- or surgical-grade adhesives that are applied to wounds for closure.
  • the disclosure also relates to delivery systems for delivering both adhesive and accelerant.
  • the disclosure also relates to the approximation of tissue as adhesive and accelerant is delivered to a region comprising a wound.
  • a wound may be closed by using a delivery system to (1 ) apply surgical- or medical-grade adhesive to a wound and (2) deliver an accelerant to speed up the cure time of the adhesive. This may be done while fingers or an approximation tool is used to hold the edges of the wound together.
  • An exemplary method for using a medical-grade adhesive such as a medical-grade cyanoacrylate adhesive, may include one or more of the following steps: (1 ) approximating skin and/or tissue edges of a wound, (2) deploying adhesive from an ampule or other vessel, (3) applying the adhesive to the approximated tissue/skin of the wound, and (4) applying accelerant to the section of approximated tissue to which the medical adhesive has been applied.
  • the use of an accelerant may decrease the cure time. In some embodiments, the cure time may be decreased more than about 6-fold and/or between about 6- to 8-fold.
  • FIG. 1 provides a cross-sectional side view of a medical adhesive delivery system 100 for the delivery of a medical adhesive 101 and an accelerant 102.
  • the medical adhesive delivery system may also be referred to herein as a "delivery system” or an "accelerant delivery system.”
  • the medical adhesive delivery system 100 comprises a first vessel 1 10 for containing an adhesive 101 , a second vessel 120 for containing a biocompatible material that accelerates the polymerization of the adhesive (i.e., an accelerant 102), a first delivery port 130, and a second delivery port 140.
  • the first delivery port 130 is configured for dispensing the adhesive 101 from the first vessel 1 10 to the skin or tissue of an approximated wound.
  • the second delivery port 140 is configured for dispensing the accelerant 102 from the second vessel 120 to the adhesive 101 that has been applied to the wound.
  • the first vessel 1 10 for containing an adhesive 101 is a glass ampule.
  • the first vessel comprises or consists of a vial, a tube, a sleeve, etc. made of glass, plastic, metal (e.g., aluminum or an aluminum alloy) or any other material suitable for containing a medical-grade biocompatible adhesive.
  • the first vessel 1 10 may be airtight and/or watertight. Additionally or alternatively, the first vessel 1 10 may keep the adhesive 101 in a sterile environment and/or prevent contamination of the adhesive 101 with a material that could alter the acidity of the adhesive 101 .
  • Adhesive 101 within the first vessel 1 10 may be accessed by breaking a glass ampule, opening a lid, puncturing a membrane (such as an aluminum membrane), or by any other suitable method for accessing medical-grade adhesive in a vessel 1 10.
  • the glass ampule may be broken by squeezing piercing elements 172 disposed on opposite sides of the glass ampule. Once the glass ampule has been broken, the adhesive 101 may flow from the first vessel 1 10 through the first delivery port 130 to a wound.
  • the adhesive may be dispensed through the first delivery port 130 by any suitable mechanism.
  • the practitioner may pinch the first vessel 1 10, actuate a trigger mechanism, twist a plunger, advance a plunger, etc. to dispense the adhesive 101 from the first vessel 1 10.
  • the adhesive 101 may be dispensed by orienting the first delivery port 130 below the first vessel 1 10 so that the adhesive 101 flows from the first vessel 1 10 through the first delivery port 130 due to the force of gravity.
  • the medical adhesive delivery system is configured to aerosolize the adhesive during delivery.
  • one or more of the delivery mechanisms described below in connection with the accelerant 102 e.g., pressure-assisted delivery via a compressed gas
  • the first delivery port 130 through which the adhesive passes when dispensed from the first vessel may be sized and shaped in any suitable manner.
  • the first delivery port 130 comprises a diffuser tip 132. Due to the shape of the diffuser tip 132, the adhesive 101 fans out at the bottom of the diffuser tip 132 to provide a relatively consistent swath of adhesive 101 that may be applied across approximated skin or tissue.
  • the diffuser tip 132 is sized and shaped to dispense adhesive 101 that is approximately 1 mm thick and 1 cm wide, although the adhesive can be dispensed in other dimensions as well.
  • the diffuser tip 132 is configured such that adhesive 101 flows through a hollow interior of the diffuser tip 132. In other or further embodiments, the adhesive 101 flows on an outer surface of the diffuser tip 132.
  • the adhesive 101 may comprise any adhesive suitable for use in closing wounds.
  • the adhesive 101 is a medical-grade adhesive.
  • the adhesive 101 polymerizes in the presence of a biocompatible accelerant 102.
  • the adhesive 101 is selected based on its ability to rapidly polymerize in the presence of a particular accelerant 102.
  • the adhesive comprises one or more cyanoacrylates, such as methyl 2-cyanoacrylate, ethyl-2-cyanoacrylate, n-butyl cyanoacrylate, and/or 2-octyl cyanoacrylate.
  • the adhesive comprises other adhesive materials.
  • the adhesive 101 is formulated to include antimicrobial additives or other medically advantageous additives.
  • the second vessel 120 is configured for containing an accelerant 102.
  • the accelerant 102 comprises a weak base, such as sodium bicarbonate, alcohol, or ammonia. More particularly, in some embodiments, a dilute solution of weak base may be used. Such solutions may involve a combination of weak base with water, saline, and/or one or more other biocompatible fluids.
  • the accelerant 102 comprises and/or consists essentially of a solution of sodium bicarbonate.
  • the sodium bicarbonate solution is a 5-12% solution (w/w) of sodium bicarbonate in water.
  • the accelerant 102 may be in some other state, such as a powder.
  • the accelerant 102 may include antimicrobial additives or other medically advantageous additives.
  • the base may be selected based on compatibility with a particular medical-grade adhesive 101 .
  • the second delivery port 140 is configured for dispensing accelerant 102 from the second vessel 120 to accelerate polymerization of an applied adhesive 101 .
  • the second delivery port 140 may comprise any suitable mechanism for delivery of the accelerant 102.
  • the second delivery port 140 comprises an atomizer, such as an aerosol atomizer, a pump atomizer, or a syringe atomizer.
  • the second delivery port comprises a syringe for dispensing the accelerant.
  • the second delivery port 140 comprises a simple opening through which accelerant may be poured or otherwise dispensed.
  • the accelerant 102 may be dispensed from the second vessel 120 through the second delivery port 140 as droplets, an aerosol, a powder, or in any other suitable form.
  • the medical adhesive delivery system 100 comprises a biocompatible propellant (e.g., compressed gas) that allows for pressure-assisted delivery of the accelerant 102.
  • the second delivery port 140 comprises a single-pump atomizer.
  • accelerant within the second vessel 120 is ejected from the a nozzle 142 of the pump.
  • the second delivery port 140 may be configured to dispense a fixed amount (e.g., volume) of accelerant 102 with each actuation of the medical adhesive device 100.
  • a single pump may dispense a fixed amount of accelerant 102. In some embodiments, this fixed amount is selected to provide an appropriate rate of polymerization for the adhesive 101 .
  • the first vessel 1 10 and the second vessel 120 are contained within a single housing 150.
  • the housing that contains both the first vessel and the second vessel is a separate component from both the first vessel and the second vessel.
  • the housing 150 comprises one or more of the first vessel 1 10 and the second vessel 120.
  • the housing 150 does not comprise the first vessel 1 10, but does comprise the second vessel 120.
  • the medical adhesive delivery system 100 further comprises an approximation device or an approximator (not shown).
  • An approximation device or approximator is an instrument, device, or component that holds the edges of skin and/or tissue together at a treatment site to facilitate sealing of the wound by an adhesive 101 .
  • Examples of approximation devices or approximators include one or more stitches, a stitching device, forceps with tacky small appendages for holding skin or tissue, a clamp, or any other device that approximates skin or tissue.
  • adhesive 101 may be dispensed adjacent the edges of the wound.
  • the adhesive 101 is dispensed approximately 1 cm wide and 1 mm deep. In other embodiments, the adhesive 101 is dispensed in other dimensions, as one of ordinary skill in the art will appreciate that the desired consistency, depth, width, length, etc. of delivered adhesive 10 varies depending on the particular conditions of the closure site. Accordingly, variations in the delivery of adhesive 101 are within the scope of this disclosure.
  • the accelerant 102 may be applied to the adhesive 101 .
  • application of the accelerant generally involves rotation of the medical adhesive delivery system such that the second delivery port 140 is oriented to direct accelerant to the applied adhesive 101 .
  • Application of the accelerant 102 to the adhesive 101 may catalyze or otherwise promote polymerization of the adhesive 101 , causing the adhesive 101 to cure. Such curing may hold approximated skin or tissue together to allow for healing.
  • closure techniques described herein may be useful in the following non-exhaustive list of illustrative scenarios: closure of a surgical incision, closure of a laceration, closure of an internal wound or incision, closure of an anastomosis, and other surgical situations in which an adhesive 101 , such as a cyanoacrylate adhesive, is used to close or seal a wound or incision.
  • an adhesive 101 such as a cyanoacrylate adhesive
  • a glove or other surface that is used by the practitioner to facilitate closure of a wound may be coated with a substance that prevents adhesion to the adhesive and/or the accelerant.
  • the substance may have the consistency and/or composition of petroleum jelly, Teflon liquid, gel, or a powder coating.
  • the non-stick substance is disposed adjacent the fingertip regions of a glove.
  • the gloves are pre-treated with anti-stick material. Gloves and other surfaces that have been treated with one or more non-stick substances may be used in connection with the systems and method described herein.
  • FIGS. 2-4 depict various medical adhesive delivery systems which differ in the arrangement of their component parts. These medical adhesive delivery systems may resemble the medical adhesive delivery system 100 described above in certain respects. Accordingly, like features are designated with like reference numerals, in which the leading digits are incremented.
  • the embodiment depicted in FIG. 2 includes a medical adhesive delivery system 200 that may, in some respects, resemble the medical adhesive delivery system 100 of FIG. 1 . Relevant disclosure set forth above regarding similarly identified features thus may not be repeated hereafter.
  • specific features of medical adhesive assemblies and related components shown in FIG. 1 may not be shown or identified by a reference numeral in the drawings or specifically discussed in the written description that follows.
  • FIG. 2 depicts a medical adhesive delivery system 200 comprising a housing 250 that contains a first vessel (not shown) and a second vessel (not shown).
  • a first delivery port 230 for dispensing adhesive is disposed adjacent a bottom end of a housing 250, while a second delivery port 240 is disposed adjacent an opposite (i.e., upper) end of the housing 250.
  • FIG. 3 is a side view of a medical adhesive delivery system 300 according to another embodiment.
  • the first delivery port 330 is disposed adjacent a bottom end of the housing 350.
  • the second delivery port 240 is disposed away from both the upper and bottom ends of the housing 350 on a lateral aspect of the housing 350.
  • accelerant may be delivered to a wound closure site without needing to rotate the medical adhesive delivery system after delivery of the adhesive.
  • FIGS. 4A and 4B depict a medical adhesive delivery system 400 according to another embodiment. More particularly, FIG. 4A provides a cross-sectional side view of the medical adhesive delivery system 400, while FIG. 4B provides an end view of the same medical adhesive delivery system 400.
  • the medical adhesive delivery system 400 comprises a housing 450 that contains both a first vessel 410 for containing a medical adhesive 401 and a second vessel 420 for containing an accelerant 402. As shown in these figures, the first vessel 410 and second vessel 420 are disposed next to one another in a side-by-side configuration.
  • the medical adhesive delivery system 400 also comprises a first delivery port 430 and a second delivery port 440 that are disposed adjacent one another at the bottom end of the housing 450.
  • the first delivery port 430 comprises a diffuser tip 432 while the second delivery port 440 comprises an atomizer.
  • both the first vessel 410 and the second vessel 420 are pressurized with a compressed gas.
  • the adhesive 401 may be dispensed from the first vessel 410 by actuation of an actuator (e.g., depression of button 482). Actuation of the actuator allows adhesive 410 to be propelled through the first delivery port 430 to the wound closure site.
  • Accelerant 402 may be dispensed in a similar manner (e.g., by depressing button 484 to allow accelerant to be propelled through the second delivery port 440).
  • the first delivery port 430 and second delivery port 440 may be sized and shaped differently to tailor delivery to the characteristics of the particular adhesive 401 and/or accelerant 402 used to seal the wound.
  • the nozzle of the second delivery port 440 for dispensing accelerant 402 may be generally smaller than the opening of the first delivery port 430 for dispensing adhesive 401 .
  • FIG. 5A is a perspective view of a medical adhesive delivery system 500 according to another embodiment.
  • the medical adhesive delivery system 500 is configured to simultaneously deliver both adhesive and accelerant.
  • the medical adhesive delivery system 500 is configured such that the adhesive is delivered to a first region, while the accelerant is delivered to a region disposed above the first region.
  • the medical adhesive delivery system 500 comprises a spray button 592, a first delivery port 510 for delivering adhesive, and a second delivery port 530 for delivering accelerant.
  • the spray button 592 is in communication with both adhesive and accelerant within a housing 550 that is disposed below the spray button 592. By depressing the spray button 592, both the adhesive and the accelerant are advanced through their respective delivery ports 510, 530.
  • the distal ends of the delivery ports 530, 510 are of different lengths so as to be offset from one another.
  • the distance of the offset may be any suitable distance (e.g., relatively large or relatively small) as determined by one of ordinary skill in the art.
  • This offset relationship between the distal ends of the delivery ports 530, 510 may prevent accelerant that is ejected from the second delivery port from contacting adhesive that is emerging from the first delivery port 510.
  • this configuration may prevent emerging adhesive from curing before the adhesive is applied to the wound closure site.
  • FIG. 5B is an perspective view of the delivery ports of the delivery system of FIG. 5A.
  • the openings 512, 532 at the distal ends of the elongate delivery ports 510, 530 may be sized and shaped differently to tailor delivery to the characteristics of the particular adhesive or accelerant used to seal the wound.
  • the distal opening 512 for delivery of the adhesive is generally elongate in shape for dispensing adhesive in a swath of appropriate width.
  • FIGS. 6A and 6B depict a medical adhesive delivery system 600 that resembles the medical adhesive delivery system 500.
  • FIG. 6A provides a side view of the medical adhesive delivery system 600
  • FIG. 6B provides a perspective view of the distal ends of the delivery ports 610, 630 of the medical adhesive delivery system 600.
  • the medical adhesive delivery system 600 comprises a spray button 692, a first delivery port 610 for delivering adhesive, and a second delivery port 630 for delivering accelerant.
  • the spray button 692 is in communication with both adhesive and accelerant disposed within a housing 650 that is disposed below the spray button 692. By depressing the spray button 692, both the adhesive and the accelerant are advanced through their respective delivery ports 610, 630.
  • the distal ends of the delivery ports 630, 610 are of different lengths so as to be offset from one another. In the depicted embodiment, the delivery ports 610, 630 are separated from one another by a separator 694.
  • FIG. 6B is an perspective view of the delivery ports 610, 630 of the delivery system 600 of FIG. 6A.
  • both the adhesive and the accelerant may be sprayed from the medical adhesive delivery system 600.
  • the accelerant and the adhesive may exit from the distal openings 612, 632 as a mist or spray.
  • FIGS. 7A-9 depict various approaches for storing an adhesive prior to use.
  • FIG. 7A and 7B provide cross-sectional side view of a first vessel 710 for containing adhesive 701 .
  • the first vessel 710 may comprise an ampule, such as a glass ampule that contains and protects the adhesive 710 disposed therein.
  • the first vessel 710 is disposed within a flexible housing 750.
  • Adhesive may flow from the broken ampule out of a first delivery port 730 to apply adhesive to a wound.
  • FIG. 8 provides a cross-sectional side view of at least a portion of a medical adhesive delivery system 800 that includes a first vessel 810 for containing adhesive.
  • the first vessel 810 may protect the adhesive from the external environment.
  • the practitioner may pull the pull ring 896 which is coupled to a seal 870 that is disposed between the adhesive and the external environment. Pulling the pull ring may disrupt the seal 870, allowing adhesive to exit from the first vessel 810 for application to a wound closure site.
  • FIG. 9 provides a cross-sectional side view of at least a portion of a medical adhesive delivery system 900 according to another embodiment.
  • the medical adhesive system 900 comprises a first vessel 910 for containing adhesive 901 and a first delivery port 930 for dispensing adhesive 901 to a wound closure site.
  • the first vessel 910 protects the adhesive 901 from the external environment.
  • the first vessel 910 is coupled to a first set of threads 974 which are complementary to a second set of threads 975 on the first delivery port 930.
  • the practitioner may rotate the first delivery port 930, causing the first delivery port 930 to advance toward the first vessel 910.
  • the first delivery port 930 may comprise or be coupled to a piercing element 972.
  • the piercing element 972 may pierce the first vessel 910, allowing the adhesive 901 to flow through the first delivery port 930 to the wound closure site.
  • FIGS. 10A-10D provide an end views of various delivery ports that may be used in connection with the medical adhesive delivery systems described herein.
  • FIG. 10A depicts a delivery port with a single circular opening or aperture.
  • FIG. 10B depicts a delivery port having an elongate shape and multiple openings or apertures.
  • FIG. 10C depicts a delivery port having an elongate shape with a single elongate opening aperture.
  • FIG. 10D depicts a delivery port with an arrangement of a plurality of openings or apertures.
  • the plurality of openings or apertures are arranged in a regular pattern and each opening or aperture is substantially identical in size or shape.
  • the plurality of openings/apertures are arranged in an irregular pattern.
  • the apertures have dissimilar shapes and sizes.
  • one or more delivery ports has a cross-sectional shape that is one or more of spatulated, rectangular, circular, elliptical, and curvilinear.
  • FIGS. 1 1A-1 1 C depict various spray patterns from a delivery port that may be employed in connection with the embodiments described herein. Although the following disclosure will describe these spray patterns in connection with accelerant, similar spray patterns may be employed with adhesive as well.
  • FIG. 1 1A depicts a second delivery port 1040 for delivery of an accelerant 1002 where the accelerant 1002 is delivered as a narrow stream or spray.
  • FIG. 1 1 B depicts a second delivery port 1040 for delivery of an accelerant 1002 where the accelerant is delivered as a heavy spray.
  • FIG. 1 1 C depicts a second delivery port 1040 where the accelerant 1002 is delivered as a fine spray from an atomizer.
  • FIGS. 12A and 12B depict a medical adhesive system according to another embodiment.
  • FIG. 12A provides a perspective view of the medical adhesive system 1 100
  • FIG. 12B provides a top-down view of the medical adhesive system 1 100.
  • the second delivery port 1 140 of the medical adhesive delivery system 1 100 is configured as a rotating atomizer with multiple settings. In a first setting, the second delivery port 1 140 is configured to deliver a heavy spray from a first opening 1 142a. In a second setting, the second delivery port 1 140 is configured to deliver a mist from a second opening 1 142b. In a third setting, the second delivery port 1 140 is in an "off configuration which prevents the delivery of accelerant.
  • FIGS. 13A-15B depict various mechanisms for activating a delivery port for delivery of an accelerant or an adhesive.
  • FIGS. 13A-13C provide various views of an exemplary pump button 1245 for activating a delivery port, such as an atomizer configured to deliver accelerant. These figures provide a front view (FIG. 13A), a side view (FIG. 13B), and a back view (FIG. 13C) of the pump button 1245.
  • the pump button 1245 may provide a recessed surface 1246 to prevent a practitioner's finger from slipping off the surface when attempting to depress the button 1245.
  • FIGS. 14A-14B provide various views of a pump button 1345 according to another embodiment.
  • FIG. 14A provides a front view
  • FIG. 14B provides a side view.
  • the pump button 1345 comprises ring 1347 into which a practitioner may insert a finger, such as an index finger.
  • the ring 1347 surrounds the inserted finger to provide a more secure handle.
  • FIGS. 15A-15B provide various views of a pump button 1445 according to another embodiment.
  • FIG. 15A provides a front view
  • FIG. 15B provides a side view.
  • the pump button comprises a partial ring 1447.
  • the internal edges of the partial ring may provide a more secure handle when depressing the pump button 1445.
  • FIGS. 16A and 16B provide cross-sectional side views of a medical adhesive delivery system 1500 according to another embodiment. More particularly, FIG. 16A depicts the medical adhesive system 1500 when in a first state, while FIG. 16B depicts the medical adhesive system 1500 in a second state. The upper portion of the depicted medical adhesive delivery system 1500 functions in a manner analogous to that described in connection with FIG. 1 .
  • the medical adhesive delivery system 1500 also comprises a lower portion that is configured to provide pressure-assisted delivery of an adhesive 1501 .
  • the lower portion of the medical adhesive delivery system 1500 comprises a first vessel 1510, a compartment of pressured gas 1560, and a side actuator 1565.
  • Actuation of the side actuator 1565 may one or more of (1 ) release gas (e.g., CO 2 ) from the compressed air compartment, (2) release adhesive from the first vessel 1510 (e.g., by puncturing the first vessel 1510), and (3) control a valve 1567 that opens and shuts in response to the side actuator 1565.
  • (1 ) release gas e.g., CO 2
  • release adhesive from the first vessel 1510 e.g., by puncturing the first vessel 1510
  • control a valve 1567 that opens and shuts in response to the side actuator 1565.
  • the actuator 1565 is coupled to a piercing element 1569 that pierces the first vessel 1510 when the actuator 1565 is depressed.
  • the adhesive 1510 may be placed under pressure, causing the adhesive 1510 to advance toward the bottom of the medical adhesive delivery system 1500.
  • Actuation of the actuator 1565 may also open a valve 1567 disposed adjacent the bottom end of the medical delivery system 1500. For instance, depression of the actuator 1565 may cause the valve 1567 to open in a manner analogous to a mechanical pencil with a side-advance feature.
  • the valve 1567 comprises an elongate shaft that is advanced toward the bottom of the medical adhesive delivery system 1500 in response to actuation of the actuator 1565.
  • the advancement of the elongate shaft toward the bottom of the medical adhesive system 1500 allows the distal end of the valve 1567 to open up. Pressurized adhesive 1501 may then be delivered through the open valve 1567.
  • FIG. 17 is a cross-sectional side view of a medical adhesive delivery system 1600 according to another embodiment.
  • the medical adhesive delivery system 1600 is analogous to the medical delivery system 1500.
  • the first vessel 1610 is punctured by a piercing element 1669 on the delivery port 1630 that is coupleable to the remaining components of the medical adhesive delivery system 1600 via threads.
  • FIG. 18 is a cross-sectional view of a medical adhesive delivery system 1700 configured for pressure-assisted delivery of both an adhesive 1701 and an accelerant 1702.
  • the medical adhesive delivery system 1700 comprises a first vessel 1710 for delivering adhesive 1701 , a second vessel for delivering accelerant 1702, a first compressed gas compartment 1760, and a second compressed gas compartment 1762.
  • the medical adhesive delivery system 1700 is configured such that adhesive 1701 may be dispensed from the medical adhesive delivery system 1700 in a manner analogous to that described in connection with FIGS. 16A and 16B.
  • actuation of side actuator 1765 may puncture the first vessel 1710 and cause compressed gas to proceed in a downward direction from the first vessel 1710.
  • the medical adhesive delivery system 1700 may comprise a valve 1767 that is operable via a button 1791 or other actuator. Depression of the button 1791 may release an aliquot of adhesive. The button 1791 may be depressed consecutively as the medical adhesive delivery system 1700 is maneuvered across the wound closure site to deliver adhesive 1701 in a consistent and even manner.
  • the accelerant 1702 may also be dispensed with the aid of compressed gas.
  • the medical adhesive delivery system 1700 may comprise a button or other actuator that allows the accelerant 1702 to be propelled from the second vessel 1720 to adhesive 1701 that has been applied to the wound closure site.
  • the medical adhesive delivery device 1700 may first be held by the practitioner adjacent the second port 1730 between the first and middle fingers to deliver adhesive 1701 to the wound closure site.
  • the medical adhesive delivery system 1700 may then be rotated by flexing the wrist approximately 30° to deploy accelerant 1702 to the previously applied adhesive 1701 .
  • the medical adhesive system 1700 may be gripped such that the arm of the system that includes the accelerant 1720 is disposed between the middle finger and ring finger.
  • FIGS. 19A-19D depict various applicator tips and connections that may be used to apply adhesive to a wound closure site.
  • FIG. 19A provides a perspective view of a threaded region of a first delivery port 1830 to which various applicator tips may be attached.
  • FIG. 19B provides a perspective (upper) and end-on (lower) view of a bevel tip 1832a.
  • FIG. 19C provides similar views for a flat circular or oval tip 1832b.
  • FIG. 19D provides the same views for a tip 1832c that includes a plurality of openings.
  • the tips 1832 are coupleable to the first delivery port 1830 by threads.
  • the applicator tips 1832 may be tailored to deliver adhesive in a desired manner. Stated differently, different applicator tips 1832 may provide adhesive in a different shape, thickness, location, etc.
  • kits may be assembled in relation to the medical adhesive delivery systems described herein.
  • a plurality of medical adhesive delivery systems are packaged together, with each medical adhesive delivery system having a different applicator tip.
  • the kit may include a single medical adhesive delivery system with various tips that may be attached based on user preference for the particular wound to be closed.
  • kits may include a plurality of medical adhesive systems, with each medical adhesive system providing a delivery port that provides a different spray pattern for the accelerant. Stated differently, some kits may include multiple medical adhesive systems, each of which is configured to deliver accelerant in a different spray pattern.
  • a kit may include various first delivery ports for delivering adhesive and various second delivery ports that provide different spray patterns for delivering accelerant.
  • the delivery ports may be selectively coupleable to each other such that a practitioner may match delivery ports according to user preference or the characteristics of the wound to be sealed.
  • the medical-grade adhesive applicator and accelerant may be packaged together or separately or may be part of one unitary applicator.
  • the kit components described above may be packaged together in sterile packaging.
  • Any methods disclosed herein include one or more steps or actions for performing the described method.
  • the method steps and/or actions may be interchanged with one another.
  • the order and/or use of specific steps and/or actions may be modified.
  • sub-routines or only a portion of a method described herein may be a separate method within the scope of this disclosure. Stated otherwise, some methods may include only a portion of the steps described in a more detailed method.

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  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention concerne des adhésifs médicaux, des agents accélérateurs, des systèmes d'administration et des méthodes associées pour refermer une plaie de manière hermétique. Le système d'administration d'adhésif médical peut comporter un premier récipient contenant l'adhésif, un premier port d'administration délivrant l'adhésif, un second récipient contenant un matériau biocompatible qui accélère la polymérisation de l'adhésif, et un second port d'administration qui délivre le matériau biocompatible depuis le second récipient.
PCT/US2014/069395 2013-12-09 2014-12-09 Adhésifs médicaux, agents accélérateurs, systèmes d'administration et méthodes associées WO2015089106A1 (fr)

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US61/913,549 2013-12-09

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7861893B2 (en) * 2006-11-10 2011-01-04 Ethicon Endo-Surgery, Inc. Adhesive dispenser for surgery
US20120070220A1 (en) * 2010-09-20 2012-03-22 Adhezion Biomedical, Llc Applicators for dispensing adhesive or sealant material
US20130108352A1 (en) * 2011-11-02 2013-05-02 Adhezion Biomedical, Llc Applicators for storing sterilizing, and dispensing an adhesive
US20130253580A1 (en) * 2010-11-10 2013-09-26 The Chemo-Sero-Therapeutic Research Institute Adhesive applicator for biological tissue

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7861893B2 (en) * 2006-11-10 2011-01-04 Ethicon Endo-Surgery, Inc. Adhesive dispenser for surgery
US20120070220A1 (en) * 2010-09-20 2012-03-22 Adhezion Biomedical, Llc Applicators for dispensing adhesive or sealant material
US20130253580A1 (en) * 2010-11-10 2013-09-26 The Chemo-Sero-Therapeutic Research Institute Adhesive applicator for biological tissue
US20130108352A1 (en) * 2011-11-02 2013-05-02 Adhezion Biomedical, Llc Applicators for storing sterilizing, and dispensing an adhesive

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