WO2020232278A1 - Post-partum hemorrhage treatment device - Google Patents
Post-partum hemorrhage treatment device Download PDFInfo
- Publication number
- WO2020232278A1 WO2020232278A1 PCT/US2020/032945 US2020032945W WO2020232278A1 WO 2020232278 A1 WO2020232278 A1 WO 2020232278A1 US 2020032945 W US2020032945 W US 2020032945W WO 2020232278 A1 WO2020232278 A1 WO 2020232278A1
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- WIPO (PCT)
- Prior art keywords
- sponges
- pouch
- pph
- tubular
- patient
- Prior art date
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F13/15—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
- A61F13/36—Surgical swabs, e.g. for absorbency or packing body cavities during surgery
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F13/15—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
- A61F13/20—Tampons, e.g. catamenial tampons; Accessories therefor
- A61F13/2002—Tampons, e.g. catamenial tampons; Accessories therefor characterised by the use
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F13/15—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
- A61F13/20—Tampons, e.g. catamenial tampons; Accessories therefor
- A61F13/2022—Tampons, e.g. catamenial tampons; Accessories therefor characterised by the shape
- A61F13/2028—Tampons, e.g. catamenial tampons; Accessories therefor characterised by the shape adapted to change of shape after absorption of liquid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F13/15—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
- A61F13/20—Tampons, e.g. catamenial tampons; Accessories therefor
- A61F13/2022—Tampons, e.g. catamenial tampons; Accessories therefor characterised by the shape
- A61F13/2045—Cup-shaped type tampons
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F13/15—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
- A61F13/20—Tampons, e.g. catamenial tampons; Accessories therefor
- A61F13/2051—Tampons, e.g. catamenial tampons; Accessories therefor characterised by the material or the structure of the inner absorbing core
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F13/15—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
- A61F13/20—Tampons, e.g. catamenial tampons; Accessories therefor
- A61F13/2071—Tampons, e.g. catamenial tampons; Accessories therefor characterised by the material or the structure of the outer layer
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F13/15—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
- A61F13/20—Tampons, e.g. catamenial tampons; Accessories therefor
- A61F13/26—Means for inserting tampons, i.e. applicators
- A61F13/266—Insertion devices, e.g. rods or plungers, separate from the tampon
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F13/15—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
- A61F13/20—Tampons, e.g. catamenial tampons; Accessories therefor
- A61F13/34—Means for withdrawing tampons, e.g. withdrawal strings
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F13/15—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
- A61F2013/15008—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators characterized by the use
- A61F2013/1517—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators characterized by the use for puerperae, i.e. after childbirth
Definitions
- the present disclosure relates to hemostatic dressings useable in medical settings, and in particular, devices useable for managing post-partum and similar obstetrical bleeding or hemorrhaging.
- PPH postpartum hemorrhage
- Uterine atony, or the ineffective contraction of the uterus following delivery is responsible for the bulk of PPH cases. The majority of all deaths related to PPH will occur within 24 hours following delivery. Nearly all of these deaths could be prevented by timely and appropriate management.
- FIG. 1 is a top view of an example device for treatment of PPH, according to various embodiments.
- Fig. 2 is a side view of an example sponge that may be contained within the PPH device depicted in Fig. 1, according to various embodiments.
- FIG. 3 is a top view of the PPH device of Fig. 1 contained within an example applicator and alongside an example plunger for deploying the PPH device, according to various embodiments.
- FIG. 4 is a flowchart of possible actions to deploy the PPH device of Fig. 1 using the applicator and plunger of Fig. 3, according to various embodiments.
- FIG. 5 is a diagram of the positioning of the PPH device of Fig. 1 and applicator for deployment, according to various embodiments.
- Fig. 6 is a diagram of the PPH device of Fig. 1 in a deployed configuration, according to various embodiments.
- Fig. 7 is a diagram of the PPH device of Fig. 1 being removed from deployment, according to various embodiments.
- Fig. 8 is a diagram of a second example PPH device lacking a tip and a removal strand, according to various embodiments.
- the description may use perspective-based descriptions such as up/down, back/front, and top/bottom. Such descriptions are merely used to facilitate the discussion and are not intended to restrict the application of disclosed embodiments.
- Coupled may mean that two or more elements are in direct physical contact. However, “coupled” may also mean that two or more elements are not in direct contact with each other, but yet still cooperate or interact with each other.
- a phrase in the form "A/B” or in the form “A and/or B” means (A), (B), or (A and B).
- a phrase in the form "at least one of A, B, and C” means (A), (B), (C), (A and B), (A and C), (B and C), or (A, B and C).
- a phrase in the form "(A)B” means (B) or (AB) that is, A is an optional element.
- PPH may be treated using a number of different techniques.
- uterine tamponade is both an effective stabilizing treatment and an intermediate measure that can be implemented for reducing blood loss associated with childbirth.
- Various strategies have been utilized for uterine tamponade. These include uterine packing with sterile gauze, inflated foley catheters, condom catheters, and silicone obstetrical balloons. Case series data demonstrate the efficacy of these methods for reducing blood loss while preparing for definitive surgery. Despite the range of devices available, none is ideal. Effective packing with adequate amounts of sterile gauze is not readily accomplished by an inexperienced provider in a patient without an anesthetic.
- Disclosed embodiments include a device and associated applicator to be used in addressing PPH.
- the disclosed PPH device embodiments can employ sponge technology effective to absorb blood and other bodily fluids from wounds while also expanding to apply pressure on a wound to stanch flow.
- the disclosed PPH device embodiments enclose a plurality of small sponges (i.e., "minisponges”) in a porous pouch, designed to hold the plurality of sponges during insertion and removal, while allowing fluids to flow to and be absorbed by the plurality of sponges.
- the use of a pouch that encloses the plurality of sponges aids in rapid deployment and removal by allowing all sponges to be inserted in a single operation, rather that requiring a lengthy process of inserting and removing each sponge individually.
- the use of a plurality of sponges within a porous pouch, rather than a single or a few larger sponges, allows the sponges to assume the shape of and fill the uterine cavity when deployed, while deforming to the diameter of the cervix and vaginal canal to facilitate removal.
- a sponge may be implemented using any suitable liquid-expandable article or material, compatible with embodiments of the disclosed PPH device.
- “Liquid-expandable” refers to any material or substance that expands in occupied volume upon contact with a liquid. Once expanded, a liquid-expandable article, such as a sponge, may be soft and pliable. Without being limited to any particular theory, this quality may permit the liquid expandable articles to conform to irregular wound crevices, gaps, and fissures.
- the overall shape can change and conform as the plurality of sponges move relative to each other in the disclosed PPH device embodiments.
- Example PPH device 100 includes a roughly tubular pouch 102, a tip 104 disposed on a first end of pouch 102, and a removal strand 106 disposed on a second end of pouch 102 that is distal from the first end.
- Pouch 102 in the depicted embodiment, is filled with a plurality of sponges 108.
- the roughly tubular, or elongated, nature of pouch 102 helps facilitate removal of pouch 102 through a potentially contracted cervix following expansion of sponges 108.
- the sponge pouch 102 is composed of a porous, expandable pouch (4.5 cm flat width x 80 cm length) that contains approximately 300 compressed cel lulose sponges.
- the pouch 102 in some embodiments, is a tubular knit woven textile constructed with a medical- grade ultra-high molecular weight polyethylene (UHMWPE) fiber.
- UHMWPE ultra-high molecular weight polyethylene
- Pouch 102 is typically sized, in embodiments, with respect to the amount and type of sponges 108 enclosed within pouch 102.
- Pouch 102 in the depicted embodiments, is an elongated tube, with a length that is greater than its cross section. Pouch 102 may be roughly circular or ovoid in cross section.
- the cross section in embodiments, is sized to be easily received through the cervix of an uncontracted uterus, and to fit within the body of an applicator, discussed below.
- the elongated length of pouch 102 in embodiments, is selected to provide an optimal sponge density, which will maximize absorption and pressure to stanch blood flow while still allowing the PPH device 100 to be comfortably extracted from the patient’s uterus.
- the pouch may range in flat width from 1cm to 15cm, and in length from 25cm to 150cm. These dimensions should be taken as example ranges and not necessary limits; other dimensions outside of these ranges may be possible for a given implementation, provided the length exceeds the flat width.
- the selection of the specific width and length for a given pouch 102 will depend upon a given patient, the selection and properties of sponges 108 to fill pouch 102, and the way in which the dimensions of pouch 102 will change as the sponges 108 expand (discussed in greater detail below).
- pouch 102 is approximately 4.5cm flat width by 80cm in length (that is, empty and prior to being filled with sponges).
- pouch 102 will hold approximately 300 compressed sponges 108, the sponges 108 of a nominal diameter of 9.8mm and a compressed height of 4-5mm. Where such sponges are fabricated from compressed cellulose, this results in a sponge density of approximately 10 +/- 3 sponges per 2.5cm of pouch length, or expressed in weight, 1.6g of sponge for each 2.5cm of pouch length, or a density of 0.64 g/cm. In various embodiments, a range of densities between 0.45-0.83 g/cm may be employed. In other embodiments, a density as low as 0.2 g/cm may be employed, with an upper range of 1 g/cm.
- the number of sponges mentioned above is an approximate number, as the actual number of sponges inserted into pouch 102 may vary due to variations in the sponge material and dimensions.
- PPH device 100 may vary in size in embodiments to accommodate patients of different sizes, resulting in further variations in the number of sponges. In some embodiments, the number of sponges may range from 250 to 350.
- Other embodiments may have from 295 to 305 sponges, from 290 to 310 sponges, from 275 to 325 sponges, from 200 to 400 sponges, from 100 to 500 sponges, from 1 to 500 sponges, a range between any of the foregoing, another range of numbers outside the foregoing ranges, or at least one sponge, particularly in embodiments where the length and/or cross section of pouch 102 may vary.
- pouch 102 may be separated into two or more compartments or sections.
- One, more than one, or all compartments may be filled with sponges 108.
- a first compartment may be filled with a first type of sponge 108
- a second compartment may be filled with a second type of sponge 108.
- some of the compartments may be filled with a first type of sponge 108
- other compartments may be filled with a second or additional types of sponge 108.
- all compartments may be filled with the same sponge 108.
- the compartments may be of the same or different sizes, and/or may be filled with sponges 108 to different sponge densities, or the same sponge density.
- the textile of pouch 102 is essentially a mesh material that al lows fluids (such as blood from a PPH) to be readily passed to each of the sponges 108.
- the textile may be distensible in nature, in embodiments, to accommodate the expansion of the various sponges 108 as they absorb fluids while presenting minimal to no resistance against the sponges 108 as they expand.
- the sponges 108 are not prevented from achieving substantially maximum expansion by the pouch 102.
- pouch 102 may exhibit a positive Poisson’s ratio, radially narrowing (viz.
- the expansibility of pouch 102 may be achieved by selection of construction of the pouch textile.
- some embodiments may utilize a tubular weft knit. Other embodiments may additionally or alternatively introduce folds in the porous textile material.
- the fibers themselves may be manufactured from a low elasticity material, or a non-elastic material, such as ultra high molecular weight polyethlyene (UHMWPE), which also provides relatively high strength and high lubricity (e.g. low friction) properties.
- UHMWPE ultra high molecular weight polyethlyene
- the pouch 102 may utilize an elastic material.
- the degree of elasticity of the textile may be selected to control the degree of expansion of the sponges 108 and/or the overall expansion of the PPH device 100 to a predetermined and/or desired amount.
- the textile mayor may not be inherently elastic in nature, depending upon the desired distensible or elastic properties.
- Other embodiments may employ different types of textiles and/or different textile materials, with varying characteristics such as permeability and elasticity/expansion, as suitable for medical use and/or appropriate to a particular embodiment.
- textile materials may comprise one or more low friction materials to facilitate deployment of pouch 102 from applicator 300 and high tensile strength to facilitate removal of pouch 102 through a contracted cervix following expansion of sponges 108 without tearing.
- Optional removal strand 106 in embodiments including a removal strand, is a 1- cm x 20-cm woven cotton strand, attached to the pouch to facilitate post-treatment removal.
- Other materials capable of withstanding the stresses imposed by removal may instead be used for removal strand 106, such as a suitable medically safe synthetic material like nylon, polyester, polypropylene, etc.
- the length of removal strand 106 may also vary in some embodiments, or be modified to as necessary for a given patient/implementation.
- Removal strand 106 may be attached to pouch 102 (specifically, the second end of pouch 102) in any sort of secure fashion that will withstand the tension forces imposed upon removal strand 106 during the removal of PPH device 100, without separating from pouch 102 or tearing, either removal strand 106 or pouch 102. Removal strand 106 may be secured using sewing, adhesives, sonic welding, or another suitable attachment method. The size and/or material of removal strand 106 as well as the mechanism by which removal strand 106 is joined to pouch 102 may be selected with respect to the size of a given PPH device 100.
- the first end of the pouch may optionally contain a tip 104, in embodiments, that serves as the applicator tip and helps prevent fluid ingress into the sponges 108.
- tip 104 is enclosed inside pouch 102.
- pouch 102 may be separated into two or more compartments (such as described above), wherein tip 104 may be enclosed in one compartment and the sponges enclosed separately in the other compartment or compartments.
- tip 104 is secured or attached to the outside of pouch 102, such as a first end of a tubular pouch 102 that is opposite from a second end to which a removal strand 106 may be attached.
- tip 104 comprises a rubber or cork-like material.
- tip 104 comprises uncompressed sponge, which may be highly conformable and/or compliant when wetted, which can ease removal through a contracted cervix.
- tip 104 comprises compressed sponge.
- tip 104 may alternatively or additionally employ lamination, or another surface coating, in part to prevent the sponge tip from expanding during insertion.
- the core of tip 104 may be made from any suitably absorbent, medically safe material or materials that can help facilitate easy deployment within a patient, while preventing excessive fluid from reaching the sponges 108 during deployment that may cause premature expansion and prevent proper deployment. As depicted in the embodiment of Fig. 1, the tip 104 has a roughly dome shape.
- Embodiments that employ an uncompressed, unlaminated sponge may provide sufficient comformation or compliance, particularly when wetted, to facilitate a relatively easy removal through a contracted cervix.
- the dome portion of tip 104 comprises compressed sponge, and the non-dome portion comprises un compressed sponge.
- each sponge 108 is made from a liquid-expandable material or materials.
- liquid-expandable means a material that expands upon contact with a liquid. The material is considered “pre-expanded” when still in a dry, possibly compressed, form prior to contact with a liquid.
- each sponge 108 is made from a cellulose material. In other embodiments, other suitable materials may be used, such as starch, chitin, or chitosan material.
- each sponge 108 may be constructed from another medically safe liquid-expandable material or combination of materials that allows the sponge 108 to achieve a desired dimensional expansion, such as a natural or synthetic material.
- sponges 108 may be implemented using another form factor of absorbent material, such as beads, prills, a power, or another medium that can be retained within pouch 102 in both dry and wet form. The selection of the form factor may be influenced by the construction and configuration of pouch 102. [0030] One or more sponges 108 are placed into pouch 102 in a compressed form 202, and remain in the compressed form 202 until insertion.
- each sponge 108 within pouch 102 may be manufactured from the same material. In other embodiments, sponges 108 may be made from a variety of different materials, to achieve a desired effectiveness of PPH device 100. Following insertion, each sponge 108 may begin absorbing fluid, e.g. blood and sera, which causes each sponge 108 to expand to an expanded form 204. In some embodiments, expanded form 204 is approximately ten times the length of the compressed form 202, while not appreciably expanding in width. In the particular embodiment depicted in Fig. 2, each sponge 108 has a circular surface diameter of 9.8 mm and is compressed to an initial height of 4-5 mm.
- Each sponge 108 may be cut into a hexagonal shape. Upon contact with blood, each sponge 108 absorbs blood and, if unencumbered, expands to a pre-compressed height (e.g. expanded form 204) of 40-50 mm within approximately 20 seconds. Other embodiments of sponges 108 may expand to a different size and/or at a different rate, e.g. 5, 10, 15, 25, 30 or more seconds, depending upon the geometry and/or material(s) used to fabricate the sponge 108. The sponge 108 in the depicted embodiment expands only in length, not width. Other embodiments may employ sponges of different compressed form 202 and expanded form 204 dimensions, which may further expand in multiple dimensions, e.g. increasing in width as well as length.
- the time over which sponge 108 expands from its pre-expansion, unwetted form factor to a post-expansion, fully absorbed form factor may be selected with respect to a desired therapeutic outcome, e.g., how quickly the PPH device 100 is to expand within a uterus and stanch any blood flow.
- the speed of expansion may impact the amount of stanching force ultimately applied by PPH device 100.
- a relatively rapid speed e.g. less than one minute following exposure to fluid, is desirable to achieve a rapid stanching of flow.
- a slower or more gradual expansion may be desirable.
- a mixture of sponges 108 with varying expansion rates may be employed, with faster expanding sponges 108 providing a rapid initial stanching, and slower expanding sponges 108 providing continued, slower absorption of fluids that may continue to seep if the initial stanching is insufficient, thereby increasing the stanching pressure.
- the plurality of sponges 108 located within pouch 102 may all be uniform in size, or may comprise a mixture of sizes.
- each sponge 108 may have the same diameter, but may have different lengths. Alternatively, the diameters may vary among the sponges 108. Combinations of the above are also provided.
- an expanded sponge 108 occupies a volume greater than a compressed sponge 108.
- the average volume ratio of each compressed sponge 108 to an expanded sponge 108 is at least 4X.
- the average volume ratio of each compressed sponge 108 to expanded sponge 108 is at least 8X.
- the average volume ratio of a compressed sponge 108 to expanded sponge 108 is at least 10X.
- the average volume ratio of a compressed sponge 108 to expanded sponge 108 is at is at least 12X.
- Sponges 108 may vary in absorption capacity depending upon size, shape, and material. Sponges 108 may range in pre-expansion volume from 0.7 mm 3 to 7000 mm 3 , or may have a pre-expansion volume of a lesser or greater amount, depending upon the needs of a given embodiment. The pre-expansion volume may impact the speed at which each sponge 108 reaches full expansion and/or the ultimate pressure that PPH device 100 may impart to the uterus for stanching flow. In various embodiments, each sponge 108 may be capable of expanding to 80% or greater of its maximum expansion capacity in 60 seconds or less following immersion in liquid.
- each sponge 108 may be capable of expanding to 80% or greater of its maximum expansion capacity in 30 seconds or less following immersion in liquid. In other embodiments, each sponge 108 may be capable of expanding to 80% or greater of its maximum expansion capacity in 10 seconds or less following immersion in liquid. In other embodiments, each sponge 108 may be capable of expanding to 80% or greater of its maximum expansion capacity in 5 seconds or less following immersion in liquid.
- the plurality of sponges 108 may comprise one or more predetermined shapes, based on adjustments to the length, width, diameter, or cross-sectional shape. Without being limited by theory, the shape, size and/or pattern of each sponge 108 may influence the ability of the PPH device 100 to fit into, expand, fill, partially fill and conform to a uterine cavity. In addition, the shape may assist the PPH device 100 in retaining a desired position in the uterus.
- each sponge 108 is depicted as a cylindrical shape with a hexagonal cross-section.
- the predetermined shape of each sponge 108 may include round, triangular, rectangular, hexagonal, conical, or octagonal cross-sections.
- sponges 108 multiple projections e.g., a star
- PPH pouch 100 may include a plurality of sponges 108 with haphazard, random, irregular, or jagged shapes.
- PPH pouch 100 may include a plurality of sponges 108 with two or more predetermined shapes.
- PPH pouch 100 may have sponges 108 comprising a mixture of predetermined shapes and/or irregular shapes.
- the sponges 108 may comprise an absorbent material including, but not limited to, a sponge or fibrous material.
- the absorbent material may comprise a polysaccharide such as, but not limited to, cellulose, starch, chitin, or chitosan.
- sponges 108 may be biodegradable and/or bio- absorbable.
- the sponges 108 may comprise non-oxidized cellulose.
- the absorbent material may comprise synthetic sponges such as, but not limited to, various polyvinyl alcohol (PVA) polymers and derivatives thereof having desirable physical and mechanical properties.
- PVA polyvinyl alcohol
- an applicator system including an applicator 300 along with a plunger 310, to use in conjunction with applicator 300 for deployment of PPH device 100.
- Applicator 300 in the depicted embodiment, includes an applicator body 302, an end cap 304 to interface with plunger 310, and a grip 306 that joins between applicator body 302 and cap 304.
- Other embodiments may include more or fewer components.
- applicator 300 may include a valve coupled to the applicator body 302 at the end of the applicator body 302 that is distal from end cap 304.
- the valve may be employed as an alternative, or in addition to, tip 104 to prevent the premature exit of pouch 100 from applicator body 302, as well as impede the flow of liquid into applicator body 302 prior to the ejection of pouch 100, such as during application to a patient.
- the applicator body 302 Near the end of the applicator body 302 that is distal from end cap 304 is a curve 308 of a suitable angle to help assist in the insertion of applicator 300 into a patient for deployment of PPH device 100.
- the applicator body 302 is a 29 mm outer diameter x 38 cm length tubing with a curvature at the distal end to facilitate access into the lower uterine segment;
- the grip 306 is 8 cm long and may partially or fully overlay a portion of applicator body 302; and low-density polyethylene (LDPE) cap 304 is configured to engage (e.g. "clicks” into) plunger 310.
- applicator body 302 has a substantially round cross section.
- applicator body 302 may have an oblong or ovoid cross section, a polygonal cross section, or a complex or variable cross section depending upon the needs of a given implementation.
- Applicator body 302 has a cross section area sized to enclose PPH device 100 in its dry, e.g. unexpanded state, with an outer diameter small enough to insert into the patient’s cervix. The outer diameter may, in embodiments, vary to accommodate patients of different sizes.
- the PPH device 100 is inserted into applicator 300, with the sponge pouch 102 portion housed inside the applicator body 302, and tip 104 exposed at one end of applicator body 302.
- the curve 308 may be located more proximate the end of applicator body 302 that is inserted into the patient, and may have a relatively wide radius.
- Other embodiments may vary where the curve 308 begins on applicator body 302 and/or may vary the radius, such as to accommodate differing patient anatomies and/or sizes, or to adjust comfort for a particular patient.
- Still other embodiments may construct applicator body 302 from a semi-flexible material that allows the location and/or radius of curve 308 to be adjusted on the fly by a user of the applicator 300, or possibly to support more complex curves (e.g. multiple bends in three dimensions).
- Applicator body 302 is open at its end distal from cap 304, in embodiments, to expose tip 104 for application, and further to provide an aperture through which PPH device 100 will pass into a patient’s uterus when deployed.
- Cap 304 may be provided to retain removal strand 106 within applicator 300. In some embodiments, cap 304 may be removed prior to application of PPH device 100 into a patient, to expose removal strand 106. In other embodiments, cap 304 may be retained in place, and provide an interior aperture through which plunger 310 may be inserted for deployment of PPH device 100. Such an aperture may facilitate proper location of plunger 310 with respect to PPH device 100, to ensure that the plunger pushes PPH device 100 centrally and minimize the possibility of PPH device 100 being improperly deployed. Other embodiments may have cap 304 engage with and lock to plunger 310, such as tip 320, where a portion or all of cap 304 may act as a plunger to deploy PPH device 310. As mentioned above, cap 304 may be constructed from low-density polyethylene (LDPE), in embodiments. Other embodiments may construct cap 304 from other suitable materials, such as nylon or another (medically safe) suitable material.
- LDPE low-density polyethylene
- cap 304 regardless of whether acting as a plunger, may be temporarily secured to removal strand 106 to retain it within applicator body 302 as PPH device 100 is inserted into a patient. Removal of cap 304 from applicator body 302 in such embodiments will allow the removal strand 106 to be detached, with an end of removal strand 106 exposed either outside the patient or within the vaginal canal for subsequent removal of a deployed PPH device 100. This wil l be discussed in greater detail below with respect to Fig.4.
- Sleeve or grip 306 is provided, in embodiments, to provide a useful location for a user of applicator 300 to grip the applicator 300 and manipulate it during deployment of PPH device 100 into a patient.
- grip 306 may be configured with a textured surface to facilitate handling.
- grip 306 comprises a sleeve coupled to applicator body 302.
- grip 306 may be manufactured from vinyl.
- grip 306 may be manufactured from a material other than vinyl; any suitable material that allows a user to reliably grip applicator 300 during deployment of PPH device 100 may be employed.
- grip 306 may be created by texturizing the surface of applicator body 302. The size of grip 306 may vary depending upon the specific needs of a given implementation of applicator 300.
- Applicator body 302 may be manufactured from any suitable medical ly safe material that can withstand the forces imposed upon applicator 300 during the insertion of a PPH device 100 within a patient.
- applicator 300 is a single use device along with PPH device 100, and so may be constructed from a suitable plastic or other (relatively) cheap and/or disposable or recyclable material.
- cap 304 may be constructed from a plastic or another suitable material that can withstand any forces that may be imposed upon the cap during application of the PPH device 100.
- Plunger 310 in the depicted embodiment, includes a hand grip 312, a hilt 314, a plunger tubing 316, a finger grip 318, and a tip 320.
- Other embodiments may include additional components, or omit one or more of the foregoing components, such as the finger grip 318.
- Hand grip 312 is to be gripped by a user of applicator 300 to provide pressure into applicator 300 for deploying PPH device 100 into a patient.
- Hand grip 312 may be of a somewhat larger diameter from plunger tubing 316, and/or may be contoured to provide a more sure grip for a user of plunger 310.
- hand grip 312 may further include a textured surface.
- Hand grip 312 may be manufactured from any suitable material that can be sterilized or sanitized.
- Hilt 31 in embodiments, can act as a stop to prevent a user of applicator 300 from over-inserting plunger 310 and/or PPH device 100, which may otherwise cause internal injury to a patient.
- Hilt 314 thus may be sized at least as large as, or larger than, the diameter of applicator body 302 and/or cap 304 or grip 306, to prevent over-insertion.
- hilt 314 may be of sufficient size so as to prevent insertion past the vaginal opening.
- Hilt 314 may be manufactured from any suitable material that can be sterilized or sanitized.
- Plunger tubing 316 comprises the body of plunger 310, and is designed to transmit the force from a user to PPH device 100 as it is deployed from applicator 300.
- plunger tubing 316 is substantially round, and is manufactured from a material and to such dimensions so as to render plunger 310 sufficiently rigid to transmit the force necessary to deploy PPH device 100 from applicator 300.
- Such materials may include, but are not limited to, plastic or metal, or any other suitable material that can be sterilized or sanitized. It will also be observed that, in the depiction in Fig. 3, the length of plunger 310 measure from hilt 314 to tip 320 is just short of the overall length of applicator 300.
- This length may be selected relative to the length of applicator 300 to ensure that PPH device 100 is reliably deployed, but to prevent plunger 310 from extending past the end of applicator 300 (via interaction with hilt 314), where it could otherwise cause internal injury to the patient.
- plunger tubing 316 may be substantially straight and rigid, the diameter of plunger tubing 316 may be sized to accommodate the curve 308 of applicator body 302 without binding or otherwise interfering with the positioning of applicator body 302. Further still, curve 308 may be configured with consideration of the size of plunger tubing 316.
- Finger grip 318 in embodiments equipped with a finger grip, provides an additional point with which a user of plunger 310 may grip plunger 310 for better control when positioning plunger 310 into applicator 300.
- Finger grip 318 may be located approximately at the midpoint of plunger tubing 316 between hilt 314 and tip 320, in some embodiments, or may be located more proximate to either hilt 312 or tip 320 depending upon the needs of a given implementation. In still other embodiments, finger grip 318 may be moveable longitudinally along plunger tubing 316 to any position desired by a user of plunger 310.
- Finger grip 318 may be manufactured from any suitable material that can be sterilized or sanitized.
- tip 320 engages with cap 304 to act as the plunger to push PPH device 100 from applicator 300 into a patient.
- tip 320 may be configured with protrusions, notches, slots, or some other mechanical contrivance to allow it to engage with a corresponding contrivance on cap 304.
- tip 320 may itself act as the plunger, and either pass through cap 304, or through the end of applicator body 302 in embodiments where cap 304 is removed prior to use.
- Tip 320 may be manufactured from any medically compatible and suitable material that can be sterilized or sanitized.
- Method 400 may be performed in whole or in part with PPH device 100, applicator body 300, and plunger 310.
- the PPH device 100 is applied as follows: First, in operation 402, the applicator 300 and plunger 310 are removed from a sealed package that was previously sanitized, such as via gamma irradiation or another suitable sterilization method. In other embodiments, applicator 300 and plunger 310 may be located in separate sterilized or sanitized packages.
- PPH device 100 may be first assembled by filling the pouch 102 with sponges 202 to an amount appropriate to achieve the desired sponge density. Following filling, the PPH device 100 may need to be sterilized, if filling was not able to be accomplished in a sterile environment.
- the applicator body 302 of applicator 300 is inserted through the patient’s vagina and into the patient’s uterus, making certain that the applicator tip with tip 104 is inserted past the cervical canal and internal ostium.
- the user of applicator 300 may use the grip 306 to assist in positioning applicator 300.
- the curve 308 may be positioned to follow the natural shape of the patient’s cervix and uterus.
- the plunger 310 is inserted into the applicator body 302.
- tip 320 of plunger 310 is engaged with cap 304, which acts as the plunger.
- tip 302 of plunger 310 itself acts as the plunger, with cap 304 either being removed (such as where cap 304 closes the end of applicator body 302) or acting to center plunger 310 that passes through cap 304.
- the plunger is depressed to inject the sponge pouch 102 of PPH device 100 into the uterus.
- the plunger is depressed until physically stopped by hilt 314, which may be positioned to ensure that, provided applicator 300 is correctly positioned within the patient, full insertion to hilt 314 will result in a properly deployed PPH device 100.
- removal strand 106 is left in the vaginal canal.
- removal strand 106 extends past the vaginal canal to outside of the patient, as depicted.
- removal strand 106 stays within the patient in the vaginal canal.
- the removal strand 106 may either be shortened to a desired length (inside or outside the vaginal canal), such as by cutting, or may be preconfigured to a desired length.
- the free end of removal strand 106 may be removably attached to cap 304.
- Removal of cap 304 from applicator 300 thus frees the end of removal strand 106 to either within the vaginal canal or outside the patient, where it remains to facilitate later removal of PPH device 100.
- the sponges 108 absorb blood and expand the pouch, thereby packing the uterus and stanching blood flow.
- PPH device 100 may be removed by gentle pulling on the removal strand 106, discussed below with reference to Fig.7.
- the selection of sponges and dimensions of pouch 102 to achieve an optimal sponge density allows the PPH device 100, which may have coiled and/or folded to fill the uterus, to uncoil/unfold and be readily removed through a contracted cervix with minimal to no discomfort to the patient.
- Fig. 5 depicts the positioning of an applicator body 300, including an enclosed PPH device 100, within a patient to be treated for PPH. As seen, the tip 104 is inside the patient’s uterus, with the curve 308 of applicator body 302 positioned approximately about the cervix. The position depicted in Fig. 5 is pre-insertion of PPH device 100, and corresponds to the completion of operation 404 of method 400.
- Fig. 6 depicts the PPH device 100 as deployed within a patient, following completion of the entirety of method 400 through operation 410.
- the tube-like PPH device 100 may fold or coil to fit within the uterus, and fill the entire uterus following expansion.
- Fig. 6 also depicts the result of PPH device 100 having absorbed sufficient fluids, e.g. blood, to cause at least the majority of the sponges 108 to expand and thus cause PPH device 100 to expand and fill the patient’s uterus. This expansion thus imposes pressure on the interior of the patient’s uterus, acting to stanch blood flow from PPH.
- the position of removal strand 106 (depicted as a loop of material, but could also be implemented as a single end strand) is outside of the patient, to allow for ease of subsequent removal of the PPH device 100.
- Fig. 7 depicts how a deployed PPH device 100 may be removed from a patient, for example, once PPH has been successfully treated, or if the PPH device 100 needs to otherwise be changed or removed.
- the removal strand 106 is grasped, preferably outside of the patient, and gently pulled away.
- the removal strand 108 may be grasped for removal within the vaginal canal, possibly by use of a tool such as a forceps.
- the removal strand 106 thus carries the used PPH device 100 out of the uterus, and out of the patient via the vaginal canal.
- PPH device 100 in embodiments, is a single use device and is subsequently discarded in an appropriate fashion. As can be seen in Fig. 7, PPH device 100 narrows around a central region 700 while passing out of the uterus and through the vaginal canal due to the positive Poisson’s ratio, which results in PPH device 100 narrowing in cross section in response to being pulled along its length. This behavior was described above with respect to Fig. 1.
- Fig. 8 depicts another possible embodiment of a PPH device 800. Similar to PPH device 100, PPH device 800 includes a mesh pouch 802 that is filled with one or more sponges, similar to pouch 102 and sponges 108. However, unlike PPH device 100, PPH device 800 lacks a tip or a removal strand. PPH device 800 may used with the applicator described above in substantially the same fashion, and may be installed pursuant to example method 400, except for leaving a removal strand outside of the uterus. PPH device 800 may be removed by alternative methods, such as grasping by a practitioner using a tool, as may be understood by a person skilled in the relevant art.
- Example 1 is a method fortreating post-partum hemorrhaging (PPH), comprising placing a plurality of sponges disposed within a tubular pouch, into a patient’s uterus, wherein each of the plurality of sponges is configured to expand in volume upon absorption of a fluid; the tubular pouch is comprised of a mesh material; the tubular pouch has a length and a cross section, and is elongated in its length relative to its cross section; and the plurality of sponges is configured to expand within the patient’s uterus by absorbing blood.
- PPH post-partum hemorrhaging
- Example 2 includes the subject matter of example 1, or another example herein, wherein placing a plurality of sponges disposed within a tubular pouch into a patient’s uterus further comprises inserting a tubular applicator into a patient’s vaginal canal so that a portion of the tubular applicator including the open end is disposed within the patient’s uterus; injecting, using a plunger, the tubular pouch from the tubular applicator into the patient’s uterus; and removing the tubular applicator, leaving the tubular pouch in the patient’s uterus.
- Example 3 includes the subject matter of example 1 or example 2, or another example herein, wherein the sponges are distributed within the tubular pouch at a density of at most 1.6g of sponge per 2.5cm of tubular pouch length.
- Example 4 includes the subject matter of any of examples 1-3, or another example herein, further comprising, removing the tubular pouch from the patient’s uterus.
- Example 5 includes the subject matter of any of examples 1-4, or another example herein, wherein the tubular pouch further comprises a removal strand disposed upon an end of the tubular pouch; and removing the tubular applicator comprises leaving at least a portion of the removal strand outside of the patient’s uterus.
- Example 6 includes the subject matter of example 5, or another example herein, further comprising removing the tubular pouch from the patient’s uterus by pulling upon the removal strand.
- Example 7 is a device for treating post-partum hemorrhaging (PPH), comprising a tubular pouch having a first end and a second end distal from the first end, the tubular pouch comprised of a mesh material, the tubular pouch having a length and a cross section, wherein its length is elongated relative to its cross section; and a plurality of sponges disposed within the tubular pouch, each of the plurality of sponges configured to expand in volume upon absorption of a fluid; wherein the tubular pouch is configured to expand as at least a subset of the plurality of sponges expands upon absorption of the fluid.
- PPH post-partum hemorrhaging
- Example 8 includes the subject matter of example 7, or another example herein, wherein the tubular pouch is filled with between 250 to 350 sponges.
- Example 9 includes the subject matter of example 7 or 8, or another example herein, wherein the tubular pouch is sized so that the plurality of sponges disposed within the tubular pouch result in a sponge density no greater than 1.6g of sponge for each 2.5cm of the tubular pouch’s length.
- Example 10 includes the subject matter of any of examples 7-9, or another example herein, further comprising a sponge tip disposed upon the first end of the tubular pouch.
- Example 11 includes the subject matter of example 10, or another example herein, wherein the sponge tip is comprised of uncompressed sponge.
- Example 12 includes the subject matter of example 10 or 11, or another example herein, wherein the sponge tip comprises the same sponge material as the plurality of sponges.
- Example 13 includes the subject matter of any of examples 7-12, or another example herein, further comprising a removal strand disposed upon the second end.
- Example 14 includes the subject matter of any of claims 7-13, or another example herein, wherein the tubular pouch is configured to decrease in its cross section when its length increases.
- Example 15 includes the subject matter of any of examples 7-14, or another example herein, wherein each of the plurality of sponges occupies a volume within the range of 0.7-7000 mm3 prior to absorption of liquid.
- Example 16 is a system for treating post-partum hemorrhaging (PPH), comprising a PPH device comprised of an porous tubular pouch that has a length and a cross section, and is elongated in its length relative to its cross section; and a plurality of sponges disposed within the tubular pouch, each sponge comprised of a material that expands in volume upon absorption of a fluid; an applicator comprised of a hollow tube, sized to receive and enclose the PPH device; and a plunger configured to insert into the hollow tube.
- PPH post-partum hemorrhaging
- Example 17 includes the subject matter of example 16, or another example herein, wherein the plunger is comprised of a handle, a hilt sized larger than a diameter of the applicator, and a plunger shaft configured to insert into the hollow tube, and wherein the hilt separates the handle from the plunger shaft.
- Example 18 includes the subject matter of example 16 or 17, or another example herein, wherein the porous tubular pouch is comprised of a mesh material.
- Example 19 includes the subject matter of example 18, or another example herein, wherein the mesh material is expandable.
- Example 20 includes the subject matter of any of examples 16-19, or another example herein, wherein the plurality of sponges comprises between 250 to 350 sponges.
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- Health & Medical Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Surgery (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Surgical Instruments (AREA)
Abstract
Description
Claims
Priority Applications (4)
Application Number | Priority Date | Filing Date | Title |
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CA3139997A CA3139997A1 (en) | 2019-05-14 | 2020-05-14 | Post-partum hemorrhage treatment device |
EP20805574.9A EP3968926A4 (en) | 2019-05-14 | 2020-05-14 | Post-partum hemorrhage treatment device |
JP2021568409A JP2022532660A (en) | 2019-05-14 | 2020-05-14 | Postpartum bleeding treatment device |
AU2020275000A AU2020275000A1 (en) | 2019-05-14 | 2020-05-14 | Post-partum hemorrhage treatment device |
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US201962847462P | 2019-05-14 | 2019-05-14 | |
US62/847,462 | 2019-05-14 |
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PCT/US2020/032945 WO2020232278A1 (en) | 2019-05-14 | 2020-05-14 | Post-partum hemorrhage treatment device |
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EP (1) | EP3968926A4 (en) |
JP (1) | JP2022532660A (en) |
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CA (1) | CA3139997A1 (en) |
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Citations (5)
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US20110077682A1 (en) * | 2009-05-04 | 2011-03-31 | Gregory Kenton W | Hemorrhage Control Devices and Methods |
US20140142523A1 (en) * | 2011-02-16 | 2014-05-22 | Revmedx, Inc. | Self-expanding wound dressings |
US20140316012A1 (en) * | 2013-03-15 | 2014-10-23 | Toby Freyman | In-Situ Forming Foams for Embolizing or Occluding a Cavity |
US20140316367A1 (en) * | 2011-11-01 | 2014-10-23 | Gregory T. Zugates | Foam-Based Medical Treatments |
US20170340488A1 (en) * | 2012-10-19 | 2017-11-30 | Denise Harris Miller | Methods and Devices for Collecting Body Fluids |
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US3821350A (en) * | 1971-07-22 | 1974-06-28 | Kimberly Clark Co | Method of coating a tampon with an insertion aid |
US5383891A (en) * | 1991-04-08 | 1995-01-24 | Walker; Marshall D. | Nose bleed kid |
US6315763B1 (en) * | 1997-04-14 | 2001-11-13 | Tambrands, Inc. | Tampon |
US7935098B2 (en) * | 2008-03-31 | 2011-05-03 | Mcneil-Ppc, Inc. | Applicator for intravaginal devices |
GB0922258D0 (en) | 2009-12-21 | 2010-02-03 | Smith & Nephew | Device for administration to a wound cavity |
EP2675413B1 (en) * | 2011-02-16 | 2017-02-15 | Barofsky, Andrew | Wound stasis dressing for large surface wounds |
US9532907B1 (en) * | 2015-07-22 | 2017-01-03 | Thinx Inc. | Reusable tampon applicators, methods of manufacture, and methods of use |
EP3248578A1 (en) * | 2016-05-24 | 2017-11-29 | Biocer-Entwicklungs-GmbH | Unit for hemostasis and arrangement containing the same |
-
2020
- 2020-05-14 AU AU2020275000A patent/AU2020275000A1/en active Pending
- 2020-05-14 EP EP20805574.9A patent/EP3968926A4/en active Pending
- 2020-05-14 CA CA3139997A patent/CA3139997A1/en active Pending
- 2020-05-14 US US16/874,440 patent/US11872115B2/en active Active
- 2020-05-14 JP JP2021568409A patent/JP2022532660A/en active Pending
- 2020-05-14 WO PCT/US2020/032945 patent/WO2020232278A1/en unknown
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2023
- 2023-12-04 US US18/528,557 patent/US20240099902A1/en active Pending
Patent Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
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US20110077682A1 (en) * | 2009-05-04 | 2011-03-31 | Gregory Kenton W | Hemorrhage Control Devices and Methods |
US20140142523A1 (en) * | 2011-02-16 | 2014-05-22 | Revmedx, Inc. | Self-expanding wound dressings |
US20140316367A1 (en) * | 2011-11-01 | 2014-10-23 | Gregory T. Zugates | Foam-Based Medical Treatments |
US20170340488A1 (en) * | 2012-10-19 | 2017-11-30 | Denise Harris Miller | Methods and Devices for Collecting Body Fluids |
US20140316012A1 (en) * | 2013-03-15 | 2014-10-23 | Toby Freyman | In-Situ Forming Foams for Embolizing or Occluding a Cavity |
Non-Patent Citations (1)
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JP2022532660A (en) | 2022-07-15 |
US20240099902A1 (en) | 2024-03-28 |
US20200360192A1 (en) | 2020-11-19 |
EP3968926A1 (en) | 2022-03-23 |
AU2020275000A1 (en) | 2021-12-09 |
EP3968926A4 (en) | 2023-02-15 |
CA3139997A1 (en) | 2020-11-19 |
US11872115B2 (en) | 2024-01-16 |
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