EP4132630A1 - Dispositifs de réduction de saignement et leurs procédés de fabrication et d'utilisation - Google Patents

Dispositifs de réduction de saignement et leurs procédés de fabrication et d'utilisation

Info

Publication number
EP4132630A1
EP4132630A1 EP21785331.6A EP21785331A EP4132630A1 EP 4132630 A1 EP4132630 A1 EP 4132630A1 EP 21785331 A EP21785331 A EP 21785331A EP 4132630 A1 EP4132630 A1 EP 4132630A1
Authority
EP
European Patent Office
Prior art keywords
ampule
medication
wound
reservoir
topical applicator
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP21785331.6A
Other languages
German (de)
English (en)
Other versions
EP4132630A4 (fr
Inventor
Anton Travis MANASCO
Christopher J. DUNATOV
Nicholas Joseph JARDINE
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Bio 54 LLC
Original Assignee
Alacrity Medical Innovations LLC
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 Alacrity Medical Innovations LLC filed Critical Alacrity Medical Innovations LLC
Publication of EP4132630A1 publication Critical patent/EP4132630A1/fr
Publication of EP4132630A4 publication Critical patent/EP4132630A4/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M35/00—Devices for applying media, e.g. remedies, on the human body
    • A61M35/003—Portable hand-held applicators having means for dispensing or spreading integral media
    • A61M35/006—Portable hand-held applicators having means for dispensing or spreading integral media using sponges, foams, absorbent pads or swabs as spreading means

Definitions

  • the present invention relates generally to devices having topical applicators, and more specifically to devices having topical applicators for reducing bleeding of a wound and/or achieving hemostasis at a wound.
  • the invention provides a device and methods for treating wounds and reducing bleeding of a wound.
  • the invention provides devices for delivering a medication to a wound.
  • the devices comprise: (a) a reservoir comprising a closed end, an open end, wails between the closed end and open end that have an outer surface and an inner surface, and a longitudinal axis extending from the closed end to the open end; (b) an ampule contained within the reservoir, wherein the ampule comprises the medication and is comprised of a material that can be punctured or broken; (c) a release mechanism comprised in the reservoir, the release mechanism being configured to apply a mechanical force to the ampule upon activation of the release mechanism, wherein application of the mechanical force to the ampule directly or indirectly causes the ampule to break or puncture, and the medication to be released; and (d) a topical applicator atached to the open end of the reservoir, wherein the topical applicator comprises a material capable of retaining the medication released from the ampule.
  • the ampule comprises a body portion and a neck portion, in which the neck portion is thinner than the body portion.
  • the ampule is oriented in the reservoir such that the neck portion is positioned closer to the open end of the reservoir and the body portion is positioned closer to the closed end of the reservoir.
  • the ampule comprises a glass ampule.
  • the inner s urface of the wall of the reservoir comprises an abutment located adjacent to the ampule.
  • the abutment is located adjacent to the neck portion of the ampule.
  • the abutment comprises an incline plane.
  • the release mechanism is positioned at the closed end of the reservoir, and the application of the mechanical force to the ampule upon activation of the release mechanism causes the ampule, preferably the neck portion of the ampule, to contact the abutment and results in the ampule breaking, preferably breaking at the neck portion.
  • the release mechanism is positioned at the wall of the reservoir, and the application of the mechanical force to the ampule upon activation of the release mechanism causes the ampule to break, preferably break at the neck portion,
  • the devices comprise: (a) a reservoir comprising a closed end, an open end, walls between the closed end and open end that have an outer surface and an inner surface, and a longitudinal axis extending from the closed end to the open end; in which the reservoir is configured to contain an ampule comprising a medication; (b) a release mechanism comprised in the reservoir, the release mechanism being configured to apply a mechanical force to the ampule upon activation of the release mechanism, wherein application of the mechanical force to the ampule directly or indirectly causes the ampule to break or puncture, and the medication to be released; and (c) a topical applicator attached to the open end of the reservoir, wherein the topical applicator comprises a material capable of retaining the medication released from the ampule.
  • the reservoir is configured to contain an ampule that comprises a body portion and a neck portion, in which the neck portion is thinner than the body portion.
  • the reservoir is configured to contain an ampule that is oriented in the reservoir such that the neck portion is positioned closer to the open end of the reservoir and the body portion is positioned closer to the closed end of the reservoir.
  • the reservoir is configured to contain an ampule comprising a glass ampule.
  • the inner surface of the wall of the reservoir comprises an abutment that is configured to be located adjacent to the ampule when the ampule is contained in the reservoir.
  • the abutment is configured to be located adjacent to the neck portion of the ampule.
  • the abutment comprises an incline plane,
  • the release mechanism is positioned at the closed end of the reservoir and, when an ampule is installed and contained in the reservoir, the application of the mechanical force to the ampule upon activation of the release mechanism causes the ampule, preferably the neck portion of the ampule, to contact the abutment and results in the ampule breaking, preferably breaking at the neck portion.
  • the release mechanism is positioned at the wall of the reservoir and, when an ampule is installed and contained in the reservoir, the application of the mechanical force to the ampule upon activation of the release mechanism causes the ampule to break, preferably break at the neck portion.
  • the release mechanism is acti vated by applying a force to the release mechanism, such as the force that can he generated by a thumb or finger of one hand.
  • one or more portions of the outer surface of the reservoir of the devices comprise a surface feature that aids in gripping or holding the device.
  • the surface feature comprises one or more ridges, In certain embodiments, the surface feature comprises a textured surface.
  • the reservoir comprises one or more tabs on the inner surface of the walls of the reservoir that maintain, or are configured to maintain, the position of the ampule within the reservoir.
  • the medication comprises an antifibrinolytic.
  • the antifibrinoiytic is selected from tranexamic acid, aminocaproic acid, and the medication protamine sulfate, In preferred embodiments, the antifibrinoiytic is tranexamic acid.
  • the topical applicator is attached to the reservoir via a fixation plate.
  • the fixation plate is attached to the reservoir by an adhesive or welding.
  • the topical applicator comprises a foam or sponge. In preferred embodiments, the topical applicator comprises a foam.
  • the topical applicator is removably attached to the reservoir.
  • the topical applicator comprises a medication pad and a blood absorption pad, and a divider therebetween. In certain embodiments, the topical applicator is configured such that only the medication pad is positioned to receive the medication from the ampule.
  • a filter is positioned above the topical applicator.
  • the devices further comprise an applicator cap that is configured to fit over the topical applicator.
  • the invention provides methods involving the devices of the invention.
  • the method is of treating a wound in a subject in need thereof, reducing bleeding of a wound in a subject in need thereof, controlling bleeding of a wound in a subject in need thereof, treating a wound having excess bleeding of a wound in a subject in need thereof, delivering a medication to a wound in a subject in need thereof, treating post-surgical or post-procedural external bleeding in a subject in need thereof, or treating a post-surgical or post-procedural wound in a subject in need thereof.
  • the method comprises obtaining the de vice of the invention comprising a reservoir, ampule, release mechanism, and topical applicator; activating the release mechanism of the device to release the medication in the ampule of the device and expose the topical applicator to the medication: and applying the topical applicator of the device to the wound.
  • the method comprises obtaining the device of the invention comprising a reservoir, ampule, release mechanism, and topical applicator; applying the topical applicator of the device to the wound; and activating the release mechanism of the de vice to release the medication in the ampule of the device and expose the topical applicator to the medication.
  • the method comprises obtaining the device of the invention comprising a reservoir, release mechanism, and topical applicator, and obtaining an ampule; installing the ampule into the device; activating the release mechanism of the device to release the medication in the ampule of the device and expose the topical applicator to the medication; and applying the topical applicator of the device to the wound.
  • the method comprises obtaining the device of the invention comprising a reservoir, release mechanism, and topical applicator, and obtaining an ampule; installing the ampule into the device; applying the topical applicator of the device to the wound; and activating the release mechanism of the device to release the medication in the ampule of the device and expose the topical applicator to the medication.
  • the method further comprises removing the topical applicator from the device and fixating the topical applicator to the wound.
  • the topical applicator is fixated to the wound using a bandage, patch, film, or surgical dressing.
  • the method is performed by the subject in need of the treatment, the reduction in bleeding, the controlling of bleeding, or the delivery of the medication.
  • the invention provides a kit.
  • the kit comprises (a) a device of the invention comprising a reservoir, ampule, release mechanism, and topical applicator; and (b) instructions on how to use the device according to the methods of the invention.
  • the kit comprises (a) a device of the invention comprising a reservoir, release mechanism, and topical applicator; (b) an ampule of the invention; and (c) instructions on how to use the device and ampule according to the methods of the invention.
  • the kit further comprises a container for disposal of the device.
  • FIG. 1 is a perspective view of a device according to embodiments of the present invention, in which the release mechanism is at the closed end of the reservoir and is activated by applying a mechanical force to the release mechanism.
  • FIG. 2 is a cut-away view of a device according to embodiments of the present invention, in which the device comprises a reservoir, ampule, release mechanism, and topical applicator; and in which the release mechanism is at the closed end of the reservoir.
  • FIG. 3 is a cut-away view of a device according to embodiments of the present invention, in which the device comprises a reservoir, ampule, release mechanism, and topical applicator; and in which the release mechanism is at the closed end of the reservoir and comprises at outer portion and an inner portion.
  • FIG. 4 is a perspective view' of a device according to embodiments of the present invention, in which the release mechanism is at the wall of the reservoir.
  • FIG. 5 is a cut-away view of a device according to embodiments of the present invention, in which the device comprises a reservoir, ampule, release mechanism, and topical applicator; and in which the release mechanism is at the wall of the reservoir.
  • FIG. 6 is a perspective view of a device according to embodiments of the present invention, in which the release mechanism is at the closed end of the reservoir and is activated by rotating the release mechanism.
  • FIG. 7 is a cut-away view of a device according to embodiments of the present invention, in which the device comprises a reservoir, ampule, release mechanism, and topical applicator; and in which the release mechanism is at the closed end of the reservoir and is activated by rotating the release mechanism,
  • FIG. 8 is a cut-away view of a device according to embodiments of the present invention, in which the device comprises a reservoir, ampule, release mechanism, and topical applicator; and in which the release mechanism is at the closed end of the reservoir and is activated by rotating the release mechanism, which activates a spring.
  • FIG. 9 is a perspective view of a topical applicator according to embodiments of the present invention, in which the topical applicator comprises a medication pad and a blood absorption pad.
  • FIG, 10 is a cut-away view of a device according to embodiments of the present invention, in which the device comprises a reservoir, release mechanism, and topical applicator; and in which the release mechanism is at the closed end of the reservoir.
  • FIG, 11 is a cut-away view of a device according to embodiments of the present invention, in which the device comprises a reservoir, release mechanism, and topical applicator; and in which the release mechanism is at the wall of the reservoir.
  • FIG. 12 is a cut-away view of a device according to embodiments of the present invention, in which the device comprises a reservoir, release mechanism, and topical applicator; and in which the release mechanism is at the closed end of the reservoir and is activated by rotating the release mechanism.
  • FIG. 13 is a cut-away view of a device according to embodiments of the present invention, in which the device comprises a reservoir, release mechanism, and topical applicator; and in which the release mechanism is at the closed end of the reservoir and is activated by rotating the release mechanism, which activates a spring.
  • the present invention relates to devices and their use to treat and/or reduce bleeding of a wound
  • the devices are used to deliver medication to the wound in order to treat or reduce bleeding of the wound.
  • the devices are advantageously easy to use, and can be operated by persons with or without medical training, including at home or any other non- hospital/medica! facility setting.
  • “and/or” is to be taken as specific disclosure of each of the two specified features or components with or without the other.
  • the term “and/or” as used in a phrase such as “A and/or B” is intended to include A and B, A or B, A (alone), and B (alone).
  • the term “and/or” as used in a phrase such as “A, B, and/or C” is intended to include A, B, and C; A, B, or C; A or B; A or C; B or C; A and B; A and C; B and C; A (alone); B (alone); and C (alone).
  • Units, prefixes, and symbols are denoted in their Systeme international de Unites (SI) accepted form. Numeric ranges are inclusive of the numbers defining the range, and any individual value provided herein can serve as an endpoint for a range that includes other individual values provided herein. For example, a set of values such as 1, 2, 3, 8, 9, and 10 is also a disclosure of a range of numbers from 1-10, from 1-8, from 3-9, and so forth.
  • SI Systeme international de Unites
  • a disclosed range is a disclosure of each individual value encompassed by the range.
  • a stated range of 5-10 is also a disclosure of 5, 6, 7, 8, 9, and 10.
  • a “subject” or “individual” or “patient” is any subject, particularly a mammalian subject, for whom diagnosis, prognosis, or therapy is desired.
  • Mammalian subjects include humans, domestic animals, farm animals, sports animals, and laboratory animals including, e.g., humans, non-human primates, canines, felines, porcines, bovines, equines, rodents, including rats and mice, rabbits, etc.
  • bleeding refers to conditions where blood flows through a break in the skin or mucosa of a subject.
  • Non-limiting examples of bleeding include cuts and abrasions from trauma including from surgery'.
  • cuts and abrasions is intended to include any and all cuts and abrasions that do not require hospitalization. Cuts and abrasions that do not require hospitalization my include those that do not require stitches, liquid stitches, or butterfly stitches to close and heal.
  • treating refers to reduction in severity' and/or frequency of symptoms, elimination of symptoms and/or underlying cause, prevention of the occurrence of symptoms and/or their underlying cause, and improvement or remediation of damage.
  • the term “reduce” is used to refer to any decrease in occurrence or activity, including full blocking of the occurrence or activity.
  • An aspect of the invention relates to devices that can deliver to a wound a medication that treats wounds or reduces wound bleeding. Embodiments of the devices of the present invention are shown in FIGS. 1-13.
  • Devices 100 may comprise a reservoir 110, an ampule 130, a release mechanism 140, and a topical applicator 150.
  • the reservoir 110 comprises a closed end 112, an open end 114, walls 116 between the closed end 112 and open end 114 wherein the walls 116 have an outer surface 118 and an inner surface 120, and a longitudinal axis 122 extending from the closed end 112 to the open end 114.
  • One or more portions of the outer surface 118 of the wall 116 of the reservoir 110 may comprise surface features 124 that aid in holding or gripping the device 100.
  • Surface features 124 may include, but are not limited to, one or more ridges (as shown in, for example, FIGS, 1, 2, 4, and 5), concave and/or convex curvatures (not shown), and a textured or course surface (not shown).
  • the reservoir 110 may comprise a shape that is ergonomic and easy to hold within one hand. Examples of such shape include, but are not limited to, cylinder, including a circular cylinder, oval cylinder, or elliptical cylinder; and a prism, including a cube, rounded square prism, rectangular prism, rounded rectangular prism, triangular prism, pentagonal prism, hexagonal prism, etc.
  • the reservoir comprises one or more rounded or beveled edges, in certain embodiments, the reservoir comprises a rounded rectangular prism shape with one or more rounded edges, as shown in FIGS. 1 and 4. in certain embodiments, the reservoir comprises a cylindrical shape, as shown in FIG. 6.
  • the reservoir 110 may be comprised of a rigid polymer material.
  • rigid polymer materials include, but are not limited to, polyethylene, polypropylene, polyamide, polycarbonate, and the like.
  • the reservoir 110 is configured to contain the ampule 130 (see FIGS. 2, 3, 5, 7, 8, and 10-13),
  • the inner surface 120 of the reservoir 110 may comprise one or more tabs or other features that maintain the general position of the ampule 130 within the reservoir 110.
  • the ampule 130 contains the medication 132.
  • the ampule 130 is comprised of a material that can be broken or punctured in order to release the medication 132.
  • the ampule 130 is comprised of a plastic or glass.
  • the ampule is a glass ampule.
  • the ampule 130 may comprise a neck portion 134 and a body portion 136, and a longitudinal axis 138 extending between the neck portion 134 and the body portion 136.
  • the neck portion 134 may be narrower than the body portion 136.
  • the ampule 130 is oriented in the reservoir 110 such that the neck portion 134 is positioned closer to the open end 114 of the reservoir 110 and the body portion 136 is positioned closer to the closed end 112 of the reservoir 110. (see, e.g., FIGS. 2, 5, 7, and 8).
  • the ampule comprises a glass ampule.
  • the ampule 130 may comprise a metered dose of the medication 132 ranging from about 1 mL to about 20 mL, or about 1 ml, to about 1.5 mL, or about 2,5 ml, to about 5 mL, or about 5 mL to about 10 ml,, or about 10 mL to about 15 mL, or about 15 mL to about 20 mL.
  • the ampule 130 may comprise a metered dose of the medication 132 of about 1 mL, or about 2 mL, or about 3 mL, or about 4 mL, or about 5 mL, or about 6 mL, or about 7 mL, or about 8 ml,, or about 9 mL, or about 10 mL, or about 11 ml ⁇ ,, or about 12 mL, or about 13 mL, or about 14 mL, or about 15 mL, or about 16 mL, or about 17 mL, or about 18 mL, or about 19 mL, or about 20 mL.
  • the medication 132 may comprise an antifibrinolytic.
  • antifibrinolytics include, but are not limited to, tranexamic acid, aminocaproic, and a medication equal or similar to protamine sulfate.
  • the medication 132 comprises tranexamic acid.
  • the medication 132 also comprises a carrier, wherein the carrier comprises sterile water and/or a saline solution.
  • the medication 132 may comprise between about 50% and about 100% tranexamic acid, and between about 50% and about 0% of the carrier.
  • the medication 132 may comprise between about 10% and about 50% tranexamic add, and between about 90% and about 50% of the carrier.
  • the medication 132 may comprise an antifibrinolytic in an amount of about 50 mg/mL to about 300 mg/niL, including about 50 mg/mL, about 100 mg/ml,, about 150 mg/mL, about 200 mg/mL, about 250 mg/mL, or about 300 mg/mL,.
  • the medication 132 may be comprised of a liquid or gel.
  • the medication 132 may have a viscosity of between about 0.75 mPa-s and about 0.98 mPa-s at approximately 25° C.
  • the medication 132 may also include a colored dye to indicate that the medication 132 has been dispensed to the wound and is of a composition to be human viewable based on skin color and blood color (before and after clotting). In other embodiments, the medication 132 may not contain a colored dye.
  • the release mechanism 140 is comprised in the reservoir 110 and is configured to, upon activation, apply a mechanical force that directly or indirectly causes the ampule 130 to break and the medication 132 to be released.
  • the release mechanism 140 is at the dosed end 112 of the reservoir 110 and is mechanically coupled to the ampule 130.
  • the reservoir 110 may further comprise an abutment 126, such as an inclined plane, on the inner surface 120 of the reservoir 110, in which the abutment 126 is adjacent to ampule 130, preferably to the neck portion 134 of the ampule 130, in the reservoir 110.
  • Activation of the release mechanism 140 by application of a force on the release mechanism 140 in the direction along the longitudinal axis 122 towards the open end 114 of the reservoir 110 in turn applies a force on the ampule 130 in the direction along its longitudinal axis 138.
  • a force can move the ampule 130 towards the open end of the reservoir 110, causing the ampule 130, preferably the neck portion 134 of the ampule 130, to contact against the abutment 126, and the ampule 130 to therefore break, preferably to break at the neck portion 134, and release the medication 132.
  • the release mechanism 140 is at the closed end 112 of the reservoir 110 and comprises an outer portion 140a and an inner portion 140b
  • the release mechanism 140 may comprise a plunger, a lever, or a twisting, or the like, and is configured such that activation of outer portion 140a causes the inner portion 140b to apply a force that directly or indirectly breaks the ampule 130 and release the medication 132.
  • the release mechanism 140 may be completely internal within the reservoir 110, such that squeezing the reservoir 110 causes the ampule 130 to compress and break, thereby releasing the medication 132 (not shown).
  • the release mechanism 140 is on the wall 116 of the reservoir 110. Activation of the release mechanism 140 by application of a force on the release mechanism 140 in the direction perpendicular, or generally perpendicular, to the longitudinal axis 122 of the reservoir 110 in turn applies a force on the ampule 130, preferably on the neck portion 134 of the ampule 130, in the direction perpendicular, or generally perpendicular, of its longitudinal axis 138. Such a force can break the ampule 130, preferably the neck portion 134 of the ampule 130, causing the ampule 130 to break, preferably at the neck portion 134, and release the medication 132.
  • the release mechanism 140 is at the closed end 112 of the reservoir 110 and is activated by rotating or otherwise activating the release mechanism 140.
  • the release mechanism 140 is mechanically coupled to the ampule 130.
  • the reservoir 110 may further comprise an abutment 126, such as an inclined plane, on the inner surface 120 of the reservoir 110, in which the abutment 126 is adjacent to the ampule 130, preferably to the neck portion 134 of the ampule 130, in the reservoir 110.
  • turning the release mechanism 140 applies a force on the ampule 130 in the direction along its longitudinal axis 138, and such a force moves the ampule 130 towards the open end of the reservoir 110, causing the ampule 130, preferably the neck portion 134 of the ampule 130, to contact against the abutment 126, and the ampule 130 to therefore break, preferably break at the neck portion 134, and release the medication 132 (see FIG. 7).
  • rotating or otherwise activating the release mechanism 140 acti vates a spring 142, which applies a force on the abutment 126 in the direction along the longitudinal axis 138 of the ampule 130 and towards the body portion 136 of the ampule 130, and such a force contacts the abutment 126 against the ampule 130, preferably against the neck portion 134 of the ampule 130, causing the ampule 130 to break, preferably break at the neck portion 134, and release the medication 132. (see FIG. 8).
  • the device 100 may comprise a means of preventing the releasing mechanism 140 from being inadvertently activated.
  • Such means include, but are not limited to, one or more tabs within the device 100 that prevent the release mechanism 140 from being able to apply a force to the ampule 130 unless a particular level offeree is applied to the release mechanism 140; or a locking mechanism that requires the release mechanism 140 to be unlocked before it is activated (not shown).
  • the device 100 may comprise a means of preventing the neck portion 134 of the ampule 130 from inadvertently contacting the abutment 126.
  • Such means include, but are not limited to, one or more tabs 128 within the device 100, for example on the inner surface 120 of the reservoir 110 that prevents ampule 130 from moving to contact the abutment 126 unless a sufficient force is applied to the release mechanism 140.
  • the topical applicator ISO is attached to the open end 114 of the reservoir 110, and comprises a porous material.
  • the topical applicator ISO comprises a sponge or foam pad, preferably a foam pad, capable of retaining the medication 132, to which the topical applicator ISO is exposed when the ampule 130 inside the reservoir 110 is broken.
  • the foam pad is capable of releasing the retained medication 13:2 by physical contact.
  • the topical applicator ISO is attached to the reservoir via a fixation plate 160, as shown in FIGS. 1, 4, and 6.
  • the fixation plate 160 is attached to the closed end of the reservoir via an adhesive or welding, and creates a seal to ensure that the medication 132 is directed to the topical applicator ISO.
  • the fixation plate 160 comprises an opening (not shown) through which the medication 132 can contact the topical applicator 150.
  • the topical applicator 150 may comprise a surface area of between about 2 cnr ' and about 25 cm 2 . In certain embodiments, the surface area may be between about 3 cnr and about 10 cm 2 , or between about 10 cm 2 and about 20 cm 2 .
  • the surface area may be about 2 cm 2 , or about 3 cm 2 , or about 4 cm 2 , or about 5 cm 2 , or about 6 cm 2 , or about 7 cm 2 , or about 8 cm 2 , or about 9 cm 2 , or about 10 cm 2 , or about 11 cm 2 , or about 12 cm 2 , or about 13 cm 2 , or about 14 cm 2 , or about 15 cm 2 , or about 16 cm 2 , or about 17 cm 2 , or about 18 cm 2 , or about 19 cm 2 , or about 20 cm 2 , or about 21 cm 2 , or about 22 cm 2 , or about 23 cm 2 , or about 24 cm 2 , or about 25 cm 2 .
  • the topical applicator 150 may comprise a shape appropriate for contacting and covering a wOund.
  • shapes include, but are not limited to, a circle, oval, ellipse, square, rounded square, rectangle, rounded rectangle, triangle, pentagon, hexagon, etc.
  • the topical applicator 150 is removable from the reservoir 110 or the fixation plate 160.
  • the topical applicator ISO may be attached to the reservoir 110 or the fixation plate 160 via an adhesive, and may be removed by peeling or by otherwise applying a force.
  • the topical applicator 150 comprise a medication pad 150a and a blood absorption pad 150b.
  • the medication pad 150a and the blood absorption pad 150b may comprise the same material or may be different materials.
  • the medication pad 150a and the blood absorption pad 150b may be configured such that only the medication pad 150a can be accessed by the medication.
  • the medication pad 150a may be adjacent, or may be concentric, with the blood absorption pad, as shown in FIG. 9.
  • a divider 152 may be positioned between the medication pad 150a and the blood absorption pad 150b.
  • the topical applicator 150 may contain a colored dye to indicate that the medication 132 has been dispensed to the wound and is of a composition to be human viewable based on skin color and blood color (before and after cloting).
  • the device may further comprise a filter (not shown).
  • the filter can be positioned within the reservoir, between the ampul and the topical applicator.
  • the filter is positioned adjacent to the topical applicator.
  • the filter may be configured to capture particles or pieces (e.g., glass particles or pieces) generated from the breaking of the ampul, and prevent such particles or pieces from entering or contacting the topical applicator.
  • the device 100 may further comprise an applicator cap 170 (see, e.g., FIG. 3).
  • the applicator cap 170 comprises the same general shape as the topical applicator 150, and is configured to fit over the topical applicator 150.
  • the applicator cap 170 when positioned on the topical applicator 150, protect the topical applicator 150 from the external environment until the device 100 is used as intended.
  • the device 100 may further comprise an information label (not shown).
  • the information label may be adhered to the outside of the reservoir 110 and/or to the applicator cap 170.
  • the information label may contain user instructions similar to the following:
  • the information label may further comprise one or more statements indicating one or more of the following: (i) remove the applicator cap before pressing down with the device over the wound; and (ii) peel the topical applicator from the rest of the device and use an adhesive bandage to keep the topical applicator on the wound.
  • the device 100 may he labeled or stamped with an expiration date.
  • the device 100 may h ave a shelf life from a date of manufacture of three years. In other embodiments, the shelf life may be greater or less than three years.
  • the device may also be labeled or stamped with a lot number and/or a date of manufacture. Additionally, the device 100 may he labeled with a bar code and/or Quick Response (QR) code.
  • QR Quick Response
  • the device 100 may be implemented as a pipette.
  • the pipette may be configured in a manner most suitable for the accuracy and precision needed for the size and l ocation of the wound.
  • the pipette may be configured to be positioned within a patient’s nostril.
  • FIGS. 10-13 depict the same reservoir, release mechanism, and topical applicator as shown in FIGS. 2, 5, 7, and 8, respectively.
  • Aii aspect of the invention relates to use of the device of the invention to deliver to a wound a medication that treats wounds or reduces wound bleeding.
  • the present invention is directed to (i) a method of treating a wound; (ii) a method of reducing bleeding of a wound; (iii) a method of controlling bleeding of a wound; (iv) a method of treating a wound having excess bleeding of a wound; (v) a method of delivering medication to a wound; (vi) a method of treating post-surgical or post-procedural external bleeding; or (vii) a method of treating post-surgical or post-procedural wound.
  • the invention is also directed to the use of the device of the present invention to (i) treat a wound; (ii) reduce bleeding of a wound; (iii) control bleeding of a wound; (iv) treat a wound having excess bleeding of a wound; (v) deliver medication to a wound; (vi) treat post-surgical or post-procedural external bleeding; or (vii) treat post-surgical or post-procedural wound.
  • the present invention is directed to a device of the present invention for use in (i) treating a wound; (ii) reducing bleeding of a wound; (iii) controlling bleeding of a wound; (iv) treating a wound having excess bleeding of a wound; (v) delivering medication to a wound; (vi) treating post-surgical or post-procedural external bleeding; or (vii) treating post- surgical or post-procedural wound.
  • the methods and uses are performed with a device according to the present invention.
  • these methods and uses may comprise activating the release mechanism of the device, and applying the topical applicator of the device to the wound. In other embodiments of the invention, these methods and uses may comprise applying the topical applicator of the device to the wound, and activating the release mechanism of the device,
  • the methods and uses may also comprise obtaining the device of the invention.
  • the methods and uses of the invention may further comprise removing the applicator cap before activating the release mechanism of the device, or before applying the topical applicator to the wound.
  • the methods and uses of the invention may further comprise unlocking the locking mechanism before activating the release mechanism.
  • the methods and uses of the invention may further comprise removing the topical applicator from the device and fixating the topical applicator to the wound.
  • the topical applicator may be fixated to the wound using a bandage, patch, film, or surgical dressing.
  • the methods and uses of the invention may further comprise installing an ampule into the reservoir, for example, before activating the release mechanism of the device, and/or before applying the topical applicator of the device to the wound.
  • the wound is a superficial wound.
  • a superficial wound includes, but is not limited to, a minor cut, abrasion, laceration, or break in the skin no greater than about 3 inches (e.g., about 1 to about 3 inches, about 1 inch, about 2 inches, about three inches, less than 1 inch) in any direction.
  • the device may be used for post-vascular access or post-procedural bleeding (e.g., central venous catheter insertion, arterial cannulation, chest thoracostomy tube, paracentesis, tracheostomy site, or other types of vascular access), hemostasis, or wound care.
  • the wound is not one or more of: a penetrating wound, a puncture wound, a deep wound, and an arteriovenous fistula, in some embodiments, the wound is not on the mouth or on any mucosal surface.
  • the methods and uses are performed on a subject in need thereof, in some embodiments, the methods and uses are performed by the subject who is in need thereof.
  • the subject is a mammalian subject.
  • the subject is a domestic animal.
  • the subject is human.
  • the subject was taking or was prescribed, or is taking or is prescribed, an anticoagulant therapy.
  • an anticoagulant therapy include, but are not limited to, heparin, warfarin, factor Xa inhibitor, and thrombin inhibitors.
  • the subject may be administered or is to be administered one or more antiplatelet therapies.
  • antiplatelet therapies include, but are not limited to, glycoprotein platelet inhibitors such as abciximab, eptifibatide, and tirofiban; platelet aggregation inhibitors such as aspirin, cangrelor, cilostazol, clopidogrel, dipyridamole, prasugrel, ticlopidme, and tieagrelor: and protease-activated receptor- 1 antagonists such as vorapaxar.
  • glycoprotein platelet inhibitors such as abciximab, eptifibatide, and tirofiban
  • platelet aggregation inhibitors such as aspirin, cangrelor, cilostazol, clopidogrel, dipyridamole, prasugrel, ticlopidme, and tieagrelor
  • protease-activated receptor- 1 antagonists such as vorapaxar.
  • the methods and uses can be performed by the subject with the wound. In some embodiments, the methods and uses can be performed outside of a hospital or medical facility, for example, at home or outside. [0110] In some embodiments, the device is intended for a single user and one wound application. Therefore, the method and uses may further comprise discarding the device after a single use. The device may be discarded in a container such as a re-sealable hag, or the like.
  • Another aspect of the invention relates to methods of manufacturing the device of the invention.
  • the method of manufacturing the device comprises installing the release mechanism to the reservoir, introducing the ampule to the reservoir, and coupling the topical applicator to the reservoir.
  • the method may further comprise installing the applicator cap onto the topical applicator. These steps may be reordered as needed by the manufacturer.
  • Additional steps may include, but are not limited to, affixing user instruction labels to the reservoir and/or topical applicator cap; applying barcodes and/or QR codes to the reservoir and/or topical applicator cap; and labeling the reservoir and/or applicator cap with an expiration date.
  • kits that comprise the device of the invention, and instructions on how to use the device according to the invention.
  • the kit may comprise the device, one or more ampules, and instructions on how to use the device.
  • the kit may also comprise a container for disposal of the device after use.
  • the container may be a resealable bag or the like, in certain embodiments, the kit may further comprise a biohazard label and/or instructions for disposal.

Landscapes

  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Anesthesiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Containers And Packaging Bodies Having A Special Means To Remove Contents (AREA)
  • Medicinal Preparation (AREA)
  • Road Signs Or Road Markings (AREA)
  • Diaphragms For Electromechanical Transducers (AREA)
  • Materials For Medical Uses (AREA)

Abstract

Un dispositif qui comprend un réservoir, une ampoule à l'intérieur du réservoir contenant un médicament, un mécanisme de libération accouplé mécaniquement à l'ampoule, et un applicateur topique fixé au réservoir. Le mécanisme de libération est conçu pour, lors de l'activation, appliquer une force mécanique qui provoque la rupture de l'ampoule et la libération du médicament. Le médicament libéré peut être retenu par l'applicateur topique et administré sur une plaie. Le médicament peut comprendre de l'acide tranexamique. Le dispositif peut être utilisé pour traiter une plaie et réduire le saignement d'une plaie.
EP21785331.6A 2020-04-09 2021-04-09 Dispositifs de réduction de saignement et leurs procédés de fabrication et d'utilisation Withdrawn EP4132630A4 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202063007543P 2020-04-09 2020-04-09
PCT/US2021/026714 WO2021207698A1 (fr) 2020-04-09 2021-04-09 Dispositifs de réduction de saignement et leurs procédés de fabrication et d'utilisation

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EP4132630A1 true EP4132630A1 (fr) 2023-02-15
EP4132630A4 EP4132630A4 (fr) 2024-06-05

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EP (1) EP4132630A4 (fr)
JP (1) JP2023521142A (fr)
CN (1) CN115988997A (fr)
AU (1) AU2021254290A1 (fr)
CA (1) CA3179861A1 (fr)
WO (1) WO2021207698A1 (fr)

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11654057B2 (en) 2020-04-09 2023-05-23 Bio 54, Llc Devices for bleeding reduction and methods of making and using the same
WO2022076467A1 (fr) * 2020-10-05 2022-04-14 Bio 54, Llc Dispositifs de réduction de saignement et leurs procédés de fabrication et d'utilisation
US11642324B1 (en) 2022-03-01 2023-05-09 Bio 54, Llc Topical tranexamic acid compositions and methods of use thereof

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JP3029010U (ja) * 1996-03-13 1996-09-17 和枝 大橋 塗り薬の塗布装置
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EP2834185B1 (fr) * 2012-04-03 2017-01-18 Synthes GmbH Dispositif et procédé d'ouverture d'ampoule
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Publication number Publication date
JP2023521142A (ja) 2023-05-23
WO2021207698A1 (fr) 2021-10-14
EP4132630A4 (fr) 2024-06-05
CA3179861A1 (fr) 2021-10-14
CN115988997A (zh) 2023-04-18
AU2021254290A1 (en) 2022-11-03

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