Patent Application
20230165727
Disclosed embodiments are related to hemostatic devices and related methods of use. More specifically, methods and apparatuses related to uterine hemostasis devices for management of postpartum hemorrhaging are disclosed.
Postpartum hemorrhage is one of the top five causes of maternal mortality worldwide, and can be caused by a variety of conditions such as uterine atony (ineffective contraction of the uterus after delivery), uterine tearing, and improper placenta delivery. Symptoms of postpartum hemorrhage include uncontrolled uterine bleeding, decreased blood pressure, increased heart rates, decrease in red blood cell count, hypotension, and in severe instances, death.
In some aspects, uterine hemostasis devices are provided. In some embodiments, a uterine hemostasis device includes at least one pouch enclosing at least one fluid absorbing body, wherein the at least one fluid absorbing body is configured to expand in volume upon absorption of a fluid, and at least one tether operatively coupled to an internal surface of the at least one pouch, wherein the at least one tether is configured to be manipulated, and wherein manipulation of the at least one tether at least partially compresses the at least one fluid absorbing body.
In some aspects, uterine hemostasis devices are provided. In some embodiments, a uterine hemostasis device includes a first pouch containing a first at least one fluid absorbing body, a second pouch containing a second at least one fluid absorbing body, the second pouch disposed at least partially in the first pouch, a first tether operatively coupled to the first pouch, and a second tether operatively coupled to the second pouch.
In some aspects, methods of operating a uterine hemostasis device are provided. In some embodiments, a method of operating a uterine hemostasis device includes positioning a first pouch in a uterus of a patient, the first pouch containing a first at least one fluid absorbing body, absorbing fluids from the uterus of the patient with the first at least one fluid absorbing body, and manipulating a first tether to at least partially compress the first at least one fluid absorbing body, wherein the first tether is coupled to an internal surface of the first pouch.
In some aspects, methods of operating a uterine hemostasis device are provided. In some embodiments, a method of operating a uterine hemostasis device includes positioning a first pouch and a second pouch in a uterus of a patient, the first pouch containing a first at least one fluid absorbing body and the second pouch containing a second at least one fluid absorbing body, wherein the second pouch is disposed at least partially within the first pouch, absorbing fluids from the uterus of the patient with the first at least one fluid absorbing body and the second at least one fluid absorbing body, extracting the second pouch from the first pouch and from the uterus of the patient, and extracting the first pouch from the uterus of the patient.
It should be appreciated that the foregoing concepts, and additional concepts discussed below, may be arranged in any suitable combination, as the present disclosure is not limited in this respect. Further, other advantages and novel features of the present disclosure will become apparent from the following detailed description of various non-limiting embodiments when considered in conjunction with the accompanying figures.
The accompanying drawings are not intended to be drawn to scale. In the drawings, each identical or nearly identical component that is illustrated in various figures may be represented by a like numeral. For purposes of clarity, not every component may be labeled in every drawing. In the drawings:
Conventional treatment for postpartum hemorrhaging can include medicine or physical massages to induce uterine contraction. In some instances, a flexible vessel, such as a balloon and/or a liquid-expandable packing material (e.g., gauze), may be inserted into the uterus to apply pressure to the uterine walls. These exemplary structures may serve as intrauterine tamponades, such that the pressure applied to the uterine walls may stop or limit bleeding to achieve hemostasis. Conventionally, the packing material (which may comprise a plurality of components, such as rolls of gauze) is manually inserted in the uterus to induce hemostasis, and may therefore need to be removed from the uterus after use to reduce the risk of infection or adhesion formation.
Thus, the inventors have recognized that the manual nature of the conventional techniques for uterine hemostasis may be time and skill intensive. For example, significant training may be required to pack the uterus with the sufficient amount of packing materials to apply an appropriate amount of pressure to the uterus. In addition, manual packing and unpacking of the uterus with individual packing material pieces may pose a risk of infection, adhesion formation, and/or a variety of other adverse reactions if even a single piece is left inside the uterus. The unpacking process typically involves forceps inserted into the vagina/cervix/uterus to grasp and remove the packing materials, which may be invasive for the patient and time-consuming for the clinician.
Based on the foregoing, the inventors have recognized the benefits associated with a uterine hemostasis device for reducing the risk of postpartum hemorrhage. The uterine hemostasis device may be easy to use, such that it may be employed by clinicians without significant training and experience. The uterine hemostasis device may allow packing material to be deployed into the uterus with minimal delivery steps, such that the device may be positioned within the uterus more quickly and/or more easily than with conventional uterine gauze packing with forceps. The system may also permit the packing material to be more quickly, more easily removed, and/or more completely removed (e.g., no materials remaining in the uterus) after the hemostasis procedure, potentially reducing the risk of infection, adhesion formation, and/or other adverse reactions.
In some embodiments, a uterine hemostasis device described herein may include at least one pouch configured to be positioned at least partially in a patient's uterus, the pouch filled with one or more fluid absorbing bodies. The fluid absorbing bodies may absorb uterine fluids (e.g., blood) and expand, thereby applying pressure to the uterine walls to provide a hemostatic effect. The pouch may enclose the fluid absorbing bodies, such that the fluid absorbing bodies may be delivered to and extracted from the uterus simultaneously with the pouch, which may simplify the procedure for the clinician, in terms of both time and skill. In some embodiments, the pouch enclosure may help ensure that every piece of fluid absorbing body has been appropriately extracted from the uterus. In this way, the risk of infection from a misplaced fluid absorbing body (e.g., remaining in the uterus) may be significantly reduced.
In some embodiments, the pouch size may expand upon exposure of the fluid absorbing bodies to the uterine fluids. In other words, the pouch may stretch or otherwise expand to accommodate the expanding fluid absorbing bodies. As such, the pouch may at least partially fill the uterine cavity during the hemostasis procedure. The inventors have recognized that this expanded size of the pouch may be larger than a cross-section of the patient's cervical canal, such that removal of the expanded pouch from the uterus may be challenging. Accordingly, the pouches of the present disclosure include one or more compression tethers, accessible to the clinician from the vagina and/or outside the vaginal opening, configured to partially compress the pouch and reduce its volume (e.g., by partially expelling some of the absorbed blood). In this way, the pouch may be more readily extracted from the patient's cervical canal. Specific implementation and use of the compression tethers are described in greater detail below with reference to the figures.
In some embodiments, the uterine hemostasis devices described herein may include more than one pouch (e.g., a secondary pouch) containing one or more fluid absorbing bodies. The secondary pouch(es) may be positioned inside a main pouch, and may be configured to be extracted independently from the main pouch. The secondary pouch may reduce the overall volume of the main pouch, facilitating removal through the cervical canal. In such embodiments, the secondary pouch may not be as flexible as the main pouch, such that it may not expand as much as the main pouch (e.g., throughout the uterus), and may accordingly be extracted through the cervical canal more easily.
The pouches of the uterine hemostasis devices described herein may be formed of any suitable material which may be fluid permeable. In other words, the pouch may be formed of a material which may not inhibit fluid flow into the pouch. For example, the pouch may be porous. In this way, the fluid absorbing bodies may be able to absorb the uterine fluids (e.g., blood) without exiting the pouch(es). The pouch may be formed of a mesh material (e.g., open worked mesh), with sufficiently large pores to allow fluid to pass through uninhibited. In some embodiments, the pouch may be formed of a fluid-permeable material. In some embodiments, the mesh material may be flexible and/or stretchable. The pouches may be formed of any suitable fluid permeable form factor, including, but not limited to fabrics, meshes, gauzes, sponges, nonwoven fabrics, melt-blown webs, foams, spun-bonded webs, thermal-bonded webs, spun-laced webs, paper, thermally-embossed nonwoven fabrics, woven fabrics, knitted fabrics, non-woven fabrics, perforated films, combinations thereof, and/or any other suitable form factor. It should be appreciated that the pore size of the pouches may permit fluid flow but may inhibit passage of the fluid absorbing bodies out of the pouches—either in the initial un-expanded state (e.g., before absorption of blood), or in the expanded state (e.g., after absorption of blood).
As will be described in greater detail below, the pouch(es) may include one or more retrieval tethers positioned in the vagina and/or outside the vaginal opening, such that a clinician may readily access and pull (or otherwise manipulate) the tethers to extract the pouch(es) from the uterus. The retrieval tethers may be significantly less invasive than conventional means of packing material removal, which involves forceps and repeated re-entry of said forceps inside the patient's uterus. Of course, other functions and/or benefits of the tethers are also contemplated, as the present disclosure is not so limited.
In some embodiments, the uterine hemostasis device described herein may be delivered with an applicator, which may be in the form of a syringe. The applicator may include a barrel, which may hold the fluid absorbing bodies enclosed in one or more pouches, as well as a plunger. The plunger may include at least one flange accessible to the clinician, serving as a push surface, and at least one flange positioned inside the barrel, to urge the pouch(es) out of the barrel. In some embodiments, the flange accessible to the clinician may be located external to the patient (e.g., from outside the vagina), whereas in other embodiments, the flange may be accessible to the clinician internal to the patient (e.g., from inside the vagina). In some embodiments, the plunger may be hollow to allow the one or more tethers to extend from the plunger into the vagina during operation. Of course, non-hollow (e.g., solid) embodiments of the plunger are also contemplated.
In operation, a clinician may insert an applicator into a patient's vagina and press the applicator upwards into the cervical canal. The applicator may be sized to fit within the cervical canal, such that the clinician may be able to determine when to stop (e.g., not pass into the uterus) with a tactile feel. The clinician may then deploy the pouch (which may include the fluid absorbing bodies) by advancing the plunger through the barrel. After the pouch is deployed out of the barrel, the clinician may remove the applicator from the patient. In some embodiments, the position of at least one flange on the plunger may be designed to reduce the risk of the clinician inserting the applicator too far and/or advancing the plunger too far. In some embodiments, the flange may be sized to reduce the risk of the pouch contacting the uterine walls during deployment.
The pouch (which may, in some embodiments, enclose one or more pouches) may be deployed into the uterus, such that the fluid absorbing bodies may begin absorbing fluids from the uterus (e.g., blood) and expanding to apply pressure to the uterine walls. This pressure may serve a tamponading effect and reduce the risk of postpartum hemorrhage. The pouch and fluid absorbing bodies may be left in the uterus for any clinically relevant duration. The clinician may determine that hemostasis has been achieved by measuring the patient's blood pressure and/or any other indicator of hemostasis. Once an appropriate level of hemostasis has been achieved (and/or if the clinician determines that more fluid absorbing bodies are needed), the system may be extracted from the patient. In some embodiments, the pouch(es) may first be partially compressed, expelling some of the absorbed blood, and subsequently extracted through the vagina. The compression may serve to reduce the size of the pouch(es), such that they may pass through the cervical canal more easily. In some embodiments, the system may be extracted in sequence, such that multiple pouches may be extracted sequentially, to reduce the total volume of fluid absorbing bodies that need to pass through the cervical canal. The one or more pouches may be extracted by tethers accessible to the clinician.
In some embodiments, the uterine hemostasis devices may be delivered to the patient without an applicator, for example, with a catheter, although other embodiments of delivery are also contemplated. In some embodiments, the uterine hemostasis device may be directly delivered manually by a clinician, who may insert the pouch (which may be initially small, not having absorbed any uterine fluids) through the vagina and into the cervical canal.
In some embodiments, the fluid absorbing bodies may be formed of any suitable material which may absorb fluids and expand to apply pressure to the uterus. Of course, non-expanding embodiments of the fluid absorbing bodies are also contemplated. The fluid absorbing bodies may be any suitable porous form factor, including, not limited to, fabrics, meshes, gauzes, sponges, nonwoven fabrics, melt-blown webs, foams, spun-bonded webs, thermal-bonded webs, spun-laced webs, paper, thermally-embossed nonwoven fabrics, woven fabrics, knitted fabrics, non-woven fabrics, perforated films, combinations thereof, and/or any other suitable fluid absorbing material.
In some embodiments, the fluid absorbing bodies (and/or any other component of the uterine hemostasis devices described herein) may include a hemostatic agent. The agent may be formed integrally with the fluid absorbing bodies and/or may be a coating on the fluid absorbing bodies. The hemostatic agent may be any composition or combination of compositions which may induce hemostasis (and/or coagulation) known in the art, including, but not limited to, tranexamic acid, calcium chloride, thrombin, glucosamine, chitosan, kaolin, fibrinogen/fibrin, chitin, cellulose, gelatin, alginate, protamine sulfate, and/or combinations thereof. It should be appreciated that in some embodiments, the hemostatic agent may be delivered to the uterus along with a secondary active material, including, but not limited to, antibacterial, antifungal, anti-inflammatory, analgesics, antihistamines, antibiotics, and/or any other active material or combination of materials.
In some embodiments, the fluid absorbing bodies and/or pouches which enclose the fluid absorbing bodies may be formed of a porous, non-bioabsorbable material. Examples of non-bioabsorbable materials include, but are not limited by, polyethylene terephthalate (PET), polyamides, aramids, expanded polytetrafluoroethylene, polyurethane, polyvinylidene difluoride (PVDF), polybutyl esters, polyetheretherketone (PEEK), polyolefins (such as polyethylene or polypropylene), cotton, cellulose, paper, and/or combinations thereof.
In some embodiments, the fluid absorbing bodies and/or pouches which enclose the fluid absorbing bodies may be formed of a porous, bioabsorbable material. In this way, the pouch and fluid absorbing bodies may be left inside the patient's uterus, and may degrade naturally after the hemostasis state has been achieved. Examples of bioabsorbable materials include, but are not limited by, polylactic acid (PLA), polyglycolic acid (PGA), oxidized cellulose, polycaprolactone (PCL), polydioxanone (PDO), trimethylene carbonate (TMC), polyvinyl alcohol (PVA), polyhydroxyalkanoates (PHAs), polyamides, polyethers, copolymers thereof, and/or and combinations thereof.
As used herein, the terms “bioabsorbable” or “biodegradable” refer to materials that are degraded by the body's enzymatic and/or hydrolytic pathways through a reaction against “foreign” material. Depending on the chemical nature of the material, the bioabsorbable material may degrade or absorb into the in vivo environment after a defined period, which can vary, for example, from a few hours to several months.
It should be appreciated that any and/or all components of the uterine hemostasis devices described here (at least the components which are inserted internally to the patient) may be formed of a biocompatible material. The term “biocompatible materials” used herein refers to materials that have the ability to perform with an appropriate host response in a specific application. Biocompatible materials have the quality of not having toxic or injurious effects on biological systems.
It should be appreciated that as with most other uterine hemostasis devices which are configured to absorb bodily fluids, the uterine hemostasis devices of the present disclosure may not be re-usable. To reduce the risk of infection, abscess formation, hematoma, wound dehiscence, mediastinitis, allergic reactions, adhesion formations, foreign body reactions, seromas, and/or any other unintended side effects, the fluid absorbing bodies of the present disclosure are configured to be appropriate discarded after use. Of course, in some embodiments, the applicator may be formed of a sterilizable material for re-use.
Turning to the figures, specific non-limiting embodiments are described in further detail. It should be understood that the various systems, components, features, and methods described relative to these embodiments may be used either individually and/or in any desired combination as the disclosure is not limited to only the specific embodiments described herein.
In some embodiments, as shown in
In operation, a clinician may insert the device 10 inside a patient's cervical canal and subsequently apply force to the flange 32 to deploy the pouch 40 in the patient's uterus. Application of force to the flange 32 may move the plunger 30 and the second flange 34 through the barrel 20, thus displacing the pouch 40 out of the barrel 20. In some embodiments, a distal end 13 of the barrel 20 may have a valve 22, which may allow the pouch 40 to exit the barrel 20. The valve 22 may keep the pouch 40 and fluid absorbing bodies 50 in a sterile environment prior to deployment. In some embodiments, the valve 22 may be pressure-sensitive, such that it may be opened to permit the pouch 40 to exit the barrel 20 if sufficient pressure is applied. In some embodiments, the valve 22 may be a one-time valve (e.g., a frangible valve, such as a seal), although other embodiments of the valve 22 are also contemplated. In some embodiments, instead of having a valve, the distal end 13 of the barrel is an opening, such that the pouch 40 may freely exit the barrel 20 without having to pass any valve.
In some embodiments, the pouch 40, which may be formed of a flexible and/or expandible material, may contain the fluid absorbing bodies 50. For example, the pouch may be formed of a non-stretchable material (e.g., a non-stretchable open-worked mesh which may be scrunched or otherwise compressed in the applicator prior to deployment. It may therefore be permitted to relax once released in the uterus (and upon expansion of the fluid absorbing bodies), without physically stretching. In other embodiments, the pouch may be formed of a flexible material, such that it may stretch or otherwise expand in the uterus to accommodate the fluid absorbing materials. It should be appreciated that any suitable biocompatible material may be employed for the pouches of the present disclosure, and that the pouches may not significantly inhibit the expansion of the enclosed fluid expansion bodies.
The bodies 50 may be formed of a fluid absorbing material, and may, in some embodiments, expand upon absorption of one or more fluids (e.g., blood). Accordingly, prior to deployment, the bodies 50 may be sufficiently small to fit within the barrel 20. In some embodiments, the bodies may be pre-loaded with a therapeutic agent, such as a hemostatic agent. It should be appreciated that although multiple bodies 50 are shown in
As shown in
As shown in
As shown in
It should be appreciated that although the expanded size of the pouch 40 (and accordingly, the expanded fluid absorbing bodies 52) may be useful in applying pressure to the uterine walls, the pouch and expanded fluid absorbing bodies may be too large to easily extract from the uterus after hemostasis. Thus, the compression tethers 42 may be used to initially compress the pouch 40 (and bodies 52), facilitating extraction from the patient.
In some embodiments, the compression tethers 42 may be formed of a flexible material, such that they may stretch to accommodate the compression of the pouch 40. In other embodiments, the compression tethers 42 may be substantially non-stretchable. Of course, any suitable biocompatible material which may be able to compress the pouch 40 at one or more locations 45 may be employed for the compression tethers.
It should be appreciated that handle 44 may be inhibited from extracting the pouch 40 from the uterus due to the presence of a ring 60, positioned against the cervical canal. As noted previously, the ring may be slightly larger than the cervical canal, such that it may inhibit the passage of the pouch out of the uterus. Accordingly, pulling on the tether handle 44 may only serve to compress the pouch 40, such that the pouch may be easier to extract. It should be appreciated that in some embodiments, the compression process may squeeze or compress the bodies 52, such that a small volume of the absorbed fluid (e.g., blood) may be expelled back into the uterus.
The clinician may then apply tension or pull a retrieval tether 64, connected to the pouch 40 and ring 60, to urge the ring 60 out of the uterus and through the cervical canal. In this way, the extraction process may be facilitated, as the size of the pouch may be reduced to limit the amount of pressure the pouch may apply to the cervical canal as the pouch is extracted. The retrieval tether 64 may be configured to collapse or otherwise deform the ring 60 to allow the ring to pass through the cervical canal. In some embodiments, the ring may be hinged, such that pulling the retrieval tether may open the hinges of the ring, such that it may more comfortably fit through the cervical canal.
In some embodiments, the retrieval tethers 64 and compression tether handles 44 may have unique characteristics to allow a clinician to differentiate between the two (or more, if multiple tethers are employed). For example, the retrieval tether 64 may be colored differently than the compression tether handle 44. In another example, the retrieval tether 64 may have a different texture or feel than the compression tether handle 44, such that the clinician may differentiate between the two without having visibility (e.g., during cases with massive blood loss). In yet another example, the tethers may have identifying labels at the ends that a clinician interacts with. Of course, other means of differentiating the tethers are also contemplated, as the present disclosure is not so limited.
In some embodiments, the uterine hemostasis devices described herein may not include any compression tethers. Accordingly, the size of the pouch may be reduced solely by the retrieval tether and pressure from the cervical canal.
It should be appreciated that all of the expanded bodies 52 may be simultaneously extracted from the uterus at once with the pouch 40. In this way, the risk of leaving behind a fluid absorbing body (which may pose a risk of infection) may be greatly reduced. In addition, the extraction process may be rendered easier for the clinician—such that they may not need to reach inside the patient to retrieve each individual fluid absorbing body, and more comfortable for the patient.
In operation, an applicator 15 may be used to deliver the main pouch 41 into the patient's uterus. A clinician may position a barrel 20 of the applicator 15 in the patient's cervical canal, and subsequently apply pressure to a flange 32 (e.g., in an axial direction A1, as shown in
As shown in
In contrast, and as discussed previously, the main pouch 41 may expand to accommodate the expanding fluid absorbing bodies 50. The lack of flexibility of the secondary pouch 70 may inhibit the secondary pouch 70 from being too large, and subsequently, may reduce the need for the secondary pouch 70 to be compressed. In other words, the secondary pouch 70 may not need to be compressed to be comfortably extracted. As such, the secondary pouch diameter D4 may be smaller than the inner diameter D5 of the ring 60 (e.g., the size of the opening 62). Accordingly, the secondary pouch 70 may be able to be extracted from the uterus through the ring 60 without any compression. As discussed in relation to the retrieval tethers 64 connected to main pouch 41, in some embodiments, the secondary pouch 70 may be extracted from the uterus by a clinician pulling on one or more retrieval tethers 74 (e.g., along an axial direction A2).
Following deployment, the pouches 41, 70 may be left in the uterus for a sufficient period of time to allow for hemostasis to occur, during which the fluid absorbing bodies 50, 80 may absorb blood from the uterus and expand, applying pressure to the uterine walls. The clinician may then elect to first extract the secondary pouch 70 with retrieval tethers 74, reducing the overall volume of the main pouch 41. Subsequently, the clinician may follow a similar protocol as described with reference to
In some embodiments, the bodies 50 may be similar to bodies 80, in terms of material composition and structure (e.g., porosity, shape, etc.), whereas in other embodiments, the bodies 50 may be different from bodies 80. It should be appreciated that the present disclosure is not limited by the type, arrangement, variation, size, structure, and/or any other parameter of the fluid absorbing bodies (contained in either main pouch 41, 70).
It should be appreciated that although only one secondary pouch is shown in the figures, in some embodiments, multiple secondary pouches, each with a respective retrieval tether, may be employed to reduce the size of the main pouch 41 in a step-wise fashion.
While several embodiments of the present invention have been described and illustrated herein, those of ordinary skill in the art will readily envision a variety of other means and/or structures for performing the functions and/or obtaining the results and/or one or more of the advantages described herein, and each of such variations and/or modifications is deemed to be within the scope of the present invention. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the teachings of the present invention is/are used. Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific embodiments of the invention described herein. It is, therefore, to be understood that the foregoing embodiments are presented by way of example only and that, within the scope of the appended claims and equivalents thereto, the invention may be practiced otherwise than as specifically described and claimed. The present invention is directed to each individual feature, system, article, material, kit, and/or method described herein. In addition, any combination of two or more such features, systems, articles, materials, kits, and/or methods, if such features, systems, articles, materials, kits, and/or methods are not mutually inconsistent, is included within the scope of the present invention.
Any terms as used herein related to shape, orientation, alignment, and/or geometric relationship of or between, for example, one or more articles, structures, forces, fields, flows, directions/trajectories, and/or subcomponents thereof and/or combinations thereof and/or any other tangible or intangible elements not listed above amenable to characterization by such terms, unless otherwise defined or indicated, shall be understood to not require absolute conformance to a mathematical definition of such term, but, rather, shall be understood to indicate conformance to the mathematical definition of such term to the extent possible for the subject matter so characterized as would be understood by one skilled in the art most closely related to such subject matter.
