Kit for loading and applying hemostatic material

Abstract

The present disclosure relates to a kit for loading and applying a hemostatic material, comprising: an applicator, comprising a tube and a push rod, wherein the tube comprises a proximal end, a distal end, and a lumen extending between the proximal end and the distal end, and the push rod comprises a proximal end and a distal end and can be inserted from an opening at the proximal end of the tube, pushed to pass through the lumen to arrive at the position near an opening at the distal end of the tube, and withdrawn from the opening at the proximal end of the tube through the lumen; a loading device, comprising an outlet port and a transfer channel, wherein the transfer channel is configured to receive a hemostatic material, and when the outlet port of the loading device is connected to the opening at the proximal end or distal end of the tube, the transfer channel is in communication with the lumen; and a rod, comprising a contact head configured to act on the hemostatic material received in the loading device so as to move the hemostatic material towards the interior of lumen.

Description

Kit for filling and applying hemostatic material

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] The present disclosure is based on and claims priority to a Chinese application with application number 202311006495.4 and application date August 10, 2023. The disclosed content of the Chinese application is hereby introduced into the present disclosure as a whole. Technical Field

[0003] The present disclosure relates to kits for filling and administering hemostatic materials. Background Art

[0004] After a tissue is injured or cut, the opening can be surgically closed to stop bleeding and allow the tissue to heal. In addition, to prevent blood loss, a hemostatic material can be applied to the site in need of hemostasis to form a dressing. For example, a hemostatic material can achieve a hemostatic effect by contacting blood.

[0005] During laparoscopic surgery requiring the use of hemostatic materials, the patient's abdominal cavity may be pressurized with gas to lift the muscles of the abdominal wall away from the internal organs. A cannula or perforator extending through the patient's abdominal wall provides access to the abdominal cavity for the hemostatic material application instrument.

[0006] There is a need for improved systems and methods for the preparation and administration of hemostatic materials.

[0007] Summary of the Invention

[0008] The present disclosure provides a kit for loading and applying hemostatic materials, rather than using an applicator with limited pre-loaded specifications. This is because the demand for hemostatic materials can vary due to the complexity of field conditions, and mismatched specifications can lead to cost issues. Furthermore, the kit for loading and applying hemostatic materials helps overcome the material properties of some hemostatic materials, which hinder their ease of rapid preparation and application in the field.

[0009] According to the present disclosure, a kit for loading and applying a hemostatic material is provided, comprising: an applicator, the applicator comprising a tube and a push rod, the tube comprising a proximal end, a distal end, and a lumen extending therebetween, the push rod comprising a proximal end, a distal end, and being insertable from an opening at the proximal end of the tube and advanced through the lumen to the vicinity of an opening at the distal end of the tube and retractable from the opening at the proximal end of the tube through the lumen; a loading device comprising an outlet port and a transfer channel, the transfer channel being configured to receive a hemostatic material, the transfer channel being in communication with the lumen when the outlet port of the loading device is connected to an opening at the proximal end or the distal end of the tube; and a rod comprising a contact head configured to act on the hemostatic material received in the loading device to move the hemostatic material toward the lumen, wherein the transfer channel defines a channel extension direction, the transfer channel being laterally open to the exterior of the loading device along the channel extension direction to form a groove and defining an open side. By providing a rod and a filling device that opens laterally along the extension direction of the channel as two auxiliary tools, it can help to more freely input the amount of hemostatic material required according to on-site needs, and complete the filling preparation of the hemostatic material in a timely, accurate and fast manner, thereby improving efficiency.

[0010] According to the present disclosure, the loading device includes an expanded receiving surface for the hemostatic material, the expanded receiving surface extending away from the groove on one or both sides of the groove. Providing an expanded surface for receiving the hemostatic material that is open toward the open side facilitates easier insertion of the desired amount of hemostatic material, thereby further improving efficiency.

[0011] According to the present disclosure, the expanded receiving surface forms a guide slope that extends away from the groove on one or both sides of the groove toward the open side of the transfer channel. By providing an inclined, expanded surface that at least partially guides the hemostatic material, the burden of collecting the hemostatic material using the rod can be reduced, thereby further improving efficiency.

[0012] According to the present disclosure, the guide slope includes at least a first slope portion proximal to the groove and a second slope portion distal to the groove, wherein the slope of the second slope portion is less than the slope of the first slope portion. By providing a slope that gradually becomes steeper toward the groove, the formation of a pooling recess can be avoided, thereby improving the guidance of initially fallen hemostatic material or residual hemostatic material displaced by the contact head of the rod.

[0013] According to the present disclosure, when the outlet port of the filling device is connected to the opening at the proximal end or distal end of the tube, the channel extension direction is substantially aligned with the tube. Providing a substantially aligned channel extension direction can help establish a transfer channel for the filling device that is as smooth as possible within a given dimension along the proximal and distal directions, promote the most relaxed operational orientation of the rod, and form a substantially symmetrical configuration of the filling device.

[0014] According to the present disclosure, the transfer channel includes a proximal open end located opposite to the outlet port. Providing an opening along the extension direction of the channel can help the inserted rod extend as deep as possible into the lumen to push the hemostatic material toward the lumen far enough away from the connection portion of the filling device.

[0015] According to the present disclosure, the loading device includes a rest seat on the side opposite to the open side of the transfer channel. By providing the rest seat, the loading device can be stably placed on a surface during standalone operation and during operation connected to a pipe, even one having a tubular shape, reducing the burden of gripping.

[0016] According to the present disclosure, the filling device comprises a peripheral rib extending towards the open side of the transfer channel. By providing the peripheral rib, the placement of the hemostatic material on the groove or even the extended receiving surface can be more facilitated.

[0017] According to the present disclosure, the peripheral rib includes a proximal rib, the terminal edge of which extends in a progressive manner toward the open side of the transfer channel as it moves away from the slot. By making the proximal rib have a shorter extension near the slot, an operating orientation of the rod that is as loose as possible can be promoted.

[0018] According to the present disclosure, the applicator includes a flange member at the proximal end of the tube, and the opening at the proximal end of the tube includes a flange opening of the flange member that is substantially aligned with the tube, for inserting a push rod through the flange opening into the lumen of the tube, wherein the outlet port of the charging device is configured to connect with the flange opening. By removably fitting the charging device into the flange opening of the flange member, which is typically provided at the proximal end of the applicator, it is possible to facilitate user operation in a familiar orientation, including actions such as removing the push rod, inserting the charging device, and / or charging the hemostatic material.

[0019] According to the present disclosure, the flange opening receives the outlet port of the charging device with an interference fit at least in its distal portion. Capturing the charging device through the interference fit facilitates temporary, secure engagement of the charging device without compromising disassembly. By implementing the interference fit primarily in the distal portion of the flange opening, the rotational orientation of the charging device and the flange member relative to each other can be easily adjusted during the initial stages of engagement of the outlet port into the flange opening.

[0020] According to the present disclosure, the flange opening is provided with a tapered surface on its inner wall at least at its distal portion, and the outlet port of the loading device is provided with a corresponding tapered surface on its outer circumferential surface at least at its distal portion, with the interference fit formed by the tapered surface and the corresponding tapered surface. Forming an interference fit with the corresponding tapered surfaces facilitates the manufacture of the loading device and the flange member, enabling direct use of the draft angle.

[0021] According to the present disclosure, the outlet port of the filling device is connected to the opening at the proximal end of the tube. The filling device includes an integral flange at the proximal end of the filling device. The flange includes a flange opening that is generally aligned with the tube and is used for inserting a push rod through the flange opening and through the transfer channel into the lumen of the tube. By integrating a finger-friendly flange on the filling device, steps and the associated time and labor can be saved during the filling process.

[0022] According to the present disclosure, the filling device includes an outer sidewall extending distally from the flange at least partially along the transfer channel, wherein a portion of the outer sidewall near the flange is recessed toward the transfer channel compared to a portion of the outer sidewall distal to the flange. Providing the outer sidewall at different distances proximally and distally relative to the flange can both increase the receiving area for the filling operation and improve the comfort of the application operation.

[0023] According to the present disclosure, the charging device is convertible between an open configuration, in which the transfer channel is laterally open to the exterior of the charging device along the channel extension direction to form a groove and define an open side, and a closed configuration, in which the transfer channel is substantially laterally closed along the channel extension direction. By providing closure of the transfer channel, the received hemostatic material can be protected, thereby facilitating, for example, temporary storage and long-distance transfer of the charging device.

[0024] According to the present disclosure, the loading device includes a first half and a second half that are opposed to each other relative to the direction in which the channel extends. Each of the first half and the second half includes a channel segment for forming a transfer channel and a coupling segment extending from the channel segment toward the open side of the transfer channel. The first half and the second half are hingedly connected by their respective channel segments on a side opposite the open side of the transfer channel. The coupling segments of the first half and the second half each include corresponding coupling features configured to engage with each other in the closed configuration. By providing a transfer channel that can be transitioned between an open configuration and a closed configuration by hinged motion and locked in the closed configuration by coupling, a structurally simple and material-saving loading device can be achieved.

[0025] According to the present disclosure, each of the first and second halves includes a port segment extending distally from and / or distally integrally formed with the channel segment, forming an outlet port. The first and second halves are hingedly connected by their respective port segments on a side opposite the open side of the transfer channel. The port segment is configured to form a distal portion of the trough in the open configuration and to connect to an opening at the proximal or distal end of the tube in the closed configuration. Providing an outlet port that can be transitioned between the open and closed configurations by hinged motion and locked in the closed configuration by mating further contributes to increasing the receiving area for the filling operation.

[0026] According to the present disclosure, the rod defines a central axis, the contact head includes first to fourth beveled features and defines an end face at its distal end, wherein the first beveled feature has the smallest inclination angle relative to the central axis, the second beveled features may be opposite to each other across the first beveled feature and have a second smallest inclination angle relative to the central axis, the third beveled feature further cuts off a portion of the first and second beveled features on the same side of the first beveled feature, and the fourth beveled feature further cuts off a portion of the second beveled feature on the opposite side of the beveled feature across the end face, such that the end face is offset from the central axis. Providing a contact head with a specific bevel distribution can adapt to various contact conditions, thereby facilitating loading.

[0027] According to the present disclosure, the hemostatic material is a flocculent hemostatic material. By specifically applying the kit to flocculent hemostatic materials, which are challenging to prepare on-site but are increasingly used, it can meet actual clinical needs and be cost-effective.

[0028] According to the present disclosure, the applicator is configured such that the distal end of the tube is passed through a body puncture and into a target site within the body. By positioning the distal end of the tube, to which the push rod can be advanced, sufficiently close to the target site, a hemostatic material, particularly a flocculent hemostatic material, can be delivered more accurately without relying on the fluidity of the hemostatic material. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Further features of the present disclosure will become apparent from the following description of exemplary embodiments with reference to the attached drawings.

[0030] FIG. 1 is a schematic diagram of an exemplary hemostatic material.

[0031] 2A is a schematic diagram of components of a kit according to a first embodiment of the present disclosure.

[0032] 2B is a schematic diagram of a loaded configuration of a kit according to the first embodiment of the present disclosure.

[0033] 2C is a partial cutaway view of the loaded configuration of the kit according to the first embodiment of the present disclosure.

[0034] 2D-2E are schematic diagrams of a filling device of a kit according to a first embodiment of the present disclosure.

[0035] 3A is a schematic diagram of components of a kit according to a second embodiment of the present disclosure.

[0036] 3B is a schematic diagram of a loaded configuration of a kit according to a second embodiment of the present disclosure.

[0037] 3C is a partial cutaway view of a loaded configuration of a kit according to a second embodiment of the present disclosure.

[0038] 3D-3E are schematic diagrams of a filling device of a kit according to a second embodiment of the present disclosure.

[0039] 4A-4B are schematic diagrams of a filling device of a kit according to a third embodiment of the present disclosure.

[0040] 5A-5B are schematic illustrations of wands that may be used in a kit according to the present disclosure. DETAILED DESCRIPTION

[0041] The present disclosure is described with reference to the accompanying drawings, in which certain embodiments of the present disclosure are shown. However, the present disclosure can be implemented in many different forms and should not be construed as limited to the embodiments depicted and described herein; rather, these embodiments are provided so that the present disclosure will be thorough and complete and will fully convey the scope of the present disclosure to those skilled in the art. It will also be understood that the embodiments disclosed herein can be combined in any manner and / or combination to provide many additional embodiments.

[0042] Unless otherwise defined, all technical and scientific terms used in this disclosure have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. The terms used in the above description are only for the purpose of describing specific embodiments and are not intended to limit the present disclosure.

[0043] As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. It should also be noted that the term "or" is generally employed in its sense including "and / or" unless the content clearly dictates otherwise.

[0044] As used in this disclosure, the terms "proximal" and "distal" may refer to directions closer to and farther from, respectively, a clinician who places the applicator in contact with a patient. Thus, for example, the end of the applicator closer to the patient's body would be the distal end, while the opposite end of the applicator (e.g., the end of the device that is manipulated by the clinician) would be the proximal end of the applicator.

[0045] For ease of description, the same reference numerals throughout the drawings designate the same modules, units and / or components.

[0046] The embodiments described below are only specific examples. However, the present disclosure is not limited to the embodiments described in the specification.

[0047] Referring to FIG1 , an exemplary hemostatic material is shown. The exemplary hemostatic material may be a flocculent hemostatic material 1 that is generally held together in a mass (e.g., a fluffy mass) like cotton wool, rather than as a particle or fluid or sheet or sponge. The exemplary hemostatic material may include Avitene available from Becton Dickinson. TM Microfibrillar collagen hemostatic products. Exemplary hemostatic materials can be applied to areas where hemostasis is needed, including areas within the body, such as occurs during endoscopic (e.g., laparoscopic) surgery. Exemplary hemostatic materials can be delivered into the interior of the body through a body puncture, which, as a non-limiting example, can be created and maintained by a perforator.

[0048] The present disclosure provides a kit for loading and applying hemostatic material, particularly the aforementioned flocculent hemostatic material 1, which allows users to load hemostatic material on-site, facilitates controlling the amount of hemostatic material, and simplifies the structure and manufacturing process of the application instrument and auxiliary tools, thereby reducing the difficulty of handling the flocculent hemostatic material 1. Therefore, the present disclosure provides an economical and effective solution to cost-sensitive requirements.

[0049] 2A-2E , a kit 200 according to a first embodiment of the present disclosure, its components, and use are illustrated. FIG2A illustrates the components of the kit 200 according to a first embodiment of the present disclosure. FIG2B illustrates a loaded configuration of the kit 200 according to a first embodiment of the present disclosure. FIG2C illustrates details of the connection between the applicator 210 and the loading device 220 of the kit 200 according to a first embodiment of the present disclosure. FIG2D-2E illustrate the loading device 220 of the kit 200 according to a first embodiment of the present disclosure.

[0050] The kit 200 can be used to load and apply hemostatic materials. The kit 200 can include an applicator 210, a loading device 220, and a stick 230.

[0051] Applicator 210 may include a tube 211 and a push rod 212 .

[0052] The tube 211 may include a proximal end 2112, a distal end 2111, and a lumen 2110 extending between the proximal end 2112 and the distal end 2111. The tube 211 may be generally cylindrical and / or have a slight taper.

[0053] The push rod 212 may include a proximal end 2122 and a distal end 2121. The push rod 212 can be inserted from the opening at the proximal end 2112 of the tube 211 and advanced through the lumen 2110 to the vicinity of the opening at the distal end 2111 of the tube 211. The push rod 212 can also be withdrawn from the opening at the proximal end 2112 of the tube 211 through the lumen 2110, for example, so that the push rod 212 can be completely separated from the tube 211. The push rod 212 may include a piston 2123 at the distal end 2121 of the push rod 212. When the lumen 2110 is filled with hemostatic material to be administered, for example, by means of the filling device 220 and the rod 230 of the first embodiment kit 200, the user can manipulate the push rod 212 to advance distally to displace the hemostatic material distally and allow the material to exit the applicator 210 from the opening at the distal end 2111 of the tube 211, for example, to reach a site where hemostasis is desired.

[0054] The applicator 210 may further include a flange member 213 at the proximal end 2112 of the tube 211. The flange member 213 may include a flange opening 2130 substantially aligned with the tube 211 for inserting the push rod 212 into the lumen 2110 through the flange opening 2130. The flange member 213 may include a sleeve portion 2131 and / or finger wings 2132. The sleeve portion 2131 may be at least partially fixedly connected (e.g., sleeved) to the tube section of the proximal end 2112 of the tube 211, and a stop shoulder 2133 may be provided on the inner wall to axially limit the proximal end 2112 of the tube 211. The finger wings 2132 may be formed in a rectangular, square, or other shape with or without rounded corners. Here, the flange opening 2130 of the flange member 213 may serve as the opening at the proximal end 2112 of the tube 211 , as the flange opening 2130 may extend proximally beyond the proximal end 2112 of the tube 211 .

[0055] The filling device 220 can include an outlet port 221 and a transfer channel 222. The transfer channel 222 can be configured to receive a hemostatic material. When the outlet port 221 of the filling device 220 is connected (e.g., removably engaged) to an opening at the proximal end 2112 or distal end 2111 of the tube 211 (e.g., an opening in the tube 211 itself or the flange opening 2130 described above), the transfer channel 222 can communicate with the lumen 2110. The outlet port 221 can be generally cylindrical and / or slightly tapered. The transfer channel 222 can receive the hemostatic material when the outlet port 221 of the filling device 220 is not yet connected to the opening at the proximal end 2112 or distal end 2111 of the tube 211 or when it is already connected.

[0056] The rod 230 may include a contact head 231. The contact head 231 may be configured to act on the hemostatic material received in the loading device 220 to move the hemostatic material toward the lumen 2110. The rod 230 may be manipulated by a user, and acting on the hemostatic material may include contacting and pushing and / or moving the hemostatic material. The rod 230 may be generally cylindrical and / or slightly tapered. When the loading device 220 (e.g., at least the transfer channel 222) receives the hemostatic material to be loaded and the outlet port 221 of the loading device 220 is connected to the opening at the proximal end 2112 or the distal end 2111 of the tube 211, the user may manipulate the rod 230 to use the contact head 231 to move the hemostatic material distally through the transfer channel 222 and from the outlet port 221 into the lumen 2110.

[0057] The outlet port 221 of the charging device 220 can be configured to connect to an opening at the proximal end 2112 of the tube 211, such as the flange opening 2130 of the flange member 213. The outlet port 221 of the charging device 220 can be inserted into the flange opening 2130 of the flange member 213. Here, the push rod 212 can be completely removed from the tube 211 to facilitate connection of the charging device 220 and charging using the charging device 220. Distal displacement of the outlet port 221 of the charging device 220 within the flange opening 2130 of the flange member 213 can be limited by the aforementioned stop shoulder 2133 and / or the proximal end surface 2135 of the flange member 213. The flange opening 2130 of the flange member 213 and the outlet port 221 of the charging device 220 can form an interference fit. This interference fit can occur at least at the distal portion of the flange opening 213. The flange opening 2130 of the flange member 213 may have a slightly tapered surface (e.g., 2-10 degrees, particularly 3-5 degrees) on its inner wall, while the outlet port 221 of the loading device 220 may have a tapered surface on its outer circumference corresponding to the tapered surface on the inner wall of the flange opening 2130. Due to the interference fit between the tapered surface on the inner wall of the flange opening 2130 and the corresponding tapered surface on the outer circumference of the outlet port 221, the outlet port 221 can be inserted into the flange opening 2130 with an interference fit, for example, until it abuts against the aforementioned stop shoulder 2133 and / or the proximal end surface 2135 of the flange member 213. In embodiments not shown, other interference fit arrangements between the flange opening 2130 and the outlet port 221 are contemplated. For example, one of the inner wall of the flange opening 2130 or the outer circumference of the outlet port 221 may be provided with a protrusion to form an interference fit. The protrusions can be fully annular or partially annular, or can be discrete, such as laterally distributed. Alternatively, the diameter of the cylindrical inner circumference of the flange opening 2130 can be smaller than the diameter of the cylindrical outer circumference of the outlet port 221, thereby forming an interference fit. In embodiments not shown, other mating arrangements between the flange opening 2130 and the outlet port 221 are contemplated, such as a positive-locking engagement of a projection and a recess. In embodiments not shown, the outlet port 221 of the filling device 220 can also be connected to the proximal or distal opening of the tube 211 itself.

[0058] The transfer channel 222 can define a channel extension direction. The channel extension direction can be the direction in which the transfer channel 222 runs between the position closest to the outlet port 221 and the position farthest from the outlet port 221. The transfer channel 222 can open laterally to the exterior of the loading device 220 along the channel extension direction to form a slot and define an open side. The slot can be continuously open along the channel extension direction. Here, the slot side of the slot can serve as the open side of the transfer channel 222. When the loading device 220 is positioned in the orientation shown in Figures 2D-2E, the transfer channel 222 can form an upwardly open slot. On the side opposite the open side of the transfer channel 222 (e.g., the upper side shown), the slot can include a slot wall 2220 (also referred to as a channel wall), which can be, for example, an arc or other shape. At least the contact head 231 of the rod 230 can access the interior of the transfer channel 222 through the open side of the transfer channel 222, and can even extend into the lumen 2110. Since the transfer channel 222 forms a groove, the running direction of the bottom of the groove wall 2220 can be used as the channel extension direction.

[0059] The loading device 220 may also include an extended receiving surface 223 for the hemostatic material. The extended receiving surface 223 may extend away from the groove on one or both sides. The extended receiving surface 223 may extend continuously along the channel extension direction and may be continuous with the groove edge. The extended receiving surface 223 may include two extended receiving surfaces 223 extending away from each other on either side of the groove. The two extended receiving surfaces 223 may be positioned approximately symmetrically on either side of the groove. The extended receiving surfaces 223 may form guide ramps. The guide ramps may extend away from the groove on one or both sides toward the open side of the transfer channel 222. The one or more guide ramps may include at least a first ramp portion 2231 and a second ramp portion 2232. The first ramp portion 2231 may be closer to the groove, while the second ramp portion 2232 may be farther away from the groove. The slope of the second ramp portion 2232 may be less than that of the first ramp portion 2231. One or more guide ramps, or their first and second ramp portions 2231, 2232 (if present), may include planar and / or arcuate surfaces. The guide ramps may be configured to receive hemostatic material, making it easier for a user to add the hemostatic material due to the increased receiving area. The guide ramps may receive the hemostatic material while the outlet port 221 of the filling device 220 is not yet connected to the opening at the proximal end 2112 or distal end 2111 of the tube 211, or while already connected. The guide ramps may be configured to direct at least a portion of the received hemostatic material toward the transfer channel 222, causing it to fall into the groove. At least the contact head 231 of the rod 230 may be brought into proximity with the guide ramp through the open side of the transfer channel 222. If another portion of the hemostatic material received by the guide ramp becomes lodged, the user may manipulate the rod 230 to utilize the contact head 231 to move the hemostatic material from the guide ramp toward the transfer channel 222, ultimately passing through the transfer channel 222 and into the lumen 2110. In an embodiment not shown, the extended receiving surfaces 223 may extend approximately flush with the notch of the slot and / or approximately perpendicular to the direction of the open side and / or parallel to each other.

[0060] When the outlet port 221 of the loading device 220 is connected to the opening at the proximal or distal end of the tube 211, the channel extension direction can be substantially aligned with the tube 211. The transfer channel 222 may include a proximal open end 2221 located opposite the outlet port 221. In other words, the transfer channel 222 may open at a position farthest from the outlet port 221 along the channel extension direction. At least the contact head 231 of the rod 230 can access the interior of the transfer channel 222 through the proximal open end 2221 of the transfer channel 222, and even extend into the lumen 2110.

[0061] The device 220 may also include a peripheral rib 224 extending toward the open side of the transfer channel 222. The peripheral rib 224 may include a proximal rib 2242, a distal rib 2241, and an intermediate rib 2243 extending between the proximal rib 2242 and the distal rib 2241. The proximal rib 2242 and the distal rib 2241 may be substantially parallel, and the intermediate rib 2243 may include two intermediate ribs 2243 that are substantially parallel and / or symmetrical along a direction between the proximal and distal sides. Each of the ribs 2241, 2242, and 2243 in the peripheral rib 224 may extend substantially parallel to one another toward the open side of the transfer channel 222. The terminal edges and / or terminal faces of at least the distal rib 2241 and the intermediate rib 2243 in the peripheral rib 224, facing the open side of the transfer channel 222, may be substantially flush and / or substantially coplanar. Peripheral rib 224 can surround transfer passage 222, and surround expansion receiving surface 223 or its first ramp portion 2231 and second ramp portion 2232 (if any).Intermediate rib 2243 (and distal rib 2241) can extend beyond the edge of expansion receiving surface 223 or its second ramp portion 2232 (if any) farthest from groove.The terminal edge and / or terminal face of proximal rib 2242 can extend toward the open side of transfer passage 222 in a progressive manner away from groove.The proximal open end 2221 can be formed by the notch of proximal rib 2242.Outlet port 221 can be located at the far side of distal rib 2241. When the outlet port 221 of the loading device 220 is connected to the flange opening of the flange member 213, for example, when the outlet port 221 of the loading device 220 is inserted into the flange opening of the flange member 213, the distal rib 2241 can be adjacent to the proximal end face 2135 of the flange member 213 or be spaced apart from it by a certain distance, and can at least partially and as much as possible shield the area of ​​the proximal end face 2135 of the flange member 213 from the proximal side toward the open side of the transfer channel 222, in which the recess 2136 may be present.

[0062] The loading device 220 may also include a rest 225 on a side opposite the open side of the transfer channel 222. The rest 225 may allow the loading device 220 to rest on a surface (e.g., along an axis extending in a direction between the proximal and distal sides) in a manner that prevents rolling. The rest 225 may include a proximal member and a distal member spaced apart from each other. The terminal edges and / or terminal faces of the proximal and distal members away from the open side of the transfer channel 222 may be substantially flush and / or substantially coplanar. In an embodiment not shown, the rest 225 may include a continuous terminal edge and / or terminal face for resting, which may be substantially flush and / or substantially coplanar. The rest 225 (or the proximal and distal members) may extend away from the open side of the transfer channel 222 in a substantially opposite, parallel direction to the direction in which the respective ribs 2241, 2242, 2243 of the peripheral ribs 224 extend toward the open side of the transfer channel 222.

[0063] 3A-3E , a second embodiment of a kit 300 according to the present disclosure, and its components and use are illustrated. FIG3A illustrates the components of the second embodiment of the kit 300 according to the present disclosure. FIG3B illustrates the loaded configuration of the second embodiment of the kit 300 according to the present disclosure. FIG3C illustrates the connection details of the applicator 310 and the loading device 320 of the second embodiment of the kit 300 according to the present disclosure. FIG3D-3E illustrate the loading device 320 of the second embodiment of the kit 300 according to the present disclosure.

[0064] The kit 300 can be used to load and apply hemostatic materials. The kit 300 can include an applicator 310, a loading device 320, and a stick 330.

[0065] Applicator 310 may include a tube 311 and a push rod 312 .

[0066] The tube 311 may include a proximal end 3112, a distal end 3111, and a lumen 3110 extending between the proximal end 3112 and the distal end 3111. The tube 311 may be generally cylindrical and / or have a slight taper.

[0067] The push rod 312 may include a proximal end 3122 and a distal end 3121. The push rod 312 can be inserted from the opening at the proximal end 3112 of the tube 311 and advanced through the lumen 3110 to the vicinity of the opening at the distal end 3111 of the tube 311. The push rod 312 can also be withdrawn from the opening at the proximal end 2112 of the tube 311 through the lumen 3110, for example, to completely separate the push rod 312 from the tube 311. The push rod 312 may include a piston 3123 at the distal end 3121 of the push rod 312. When the lumen 3110 is filled with hemostatic material to be administered, for example, using the filling device 320 and the wand 330 of the second embodiment kit 300, the user can manipulate the push rod 312 to distally advance the hemostatic material so that the material is displaced distally and exits the applicator 310 from the opening at the distal end 3111 of the tube 311, for example, to a site where hemostasis is desired.

[0068] Unlike the applicator 210 of the first embodiment kit 200, which may include a flange member 213 at the proximal end 2112 of the tube 211, the loading device 320 of the second embodiment kit 300 may include an integral flange 326 at the proximal end 3202 of the loading device 320. That is, the loading device 320 functions both during loading and application of the hemostatic material and may be connected to the opening at the proximal end 3112 of the tube 311 via the outlet port 321. The flange 326 may include a flange opening 3260 generally aligned with the tube 311 for inserting the push rod 312 through the flange opening 3260 and into the lumen 3110 via the transfer channel 322 of the loading device 320. The flange 326 may include finger wings. The finger wings may be formed in a rectangular, square, or other shape with or without rounded corners.

[0069] The filling device 320 may include an outlet port 321 and a transfer channel 322. The transfer channel 322 may be configured to receive a hemostatic material. When the outlet port 321 of the filling device 320 is connected (e.g., fixedly connected) to the proximal opening of the tube 311 itself, the transfer channel 322 may be in communication with the lumen 3110. The outlet port 321 may be generally cylindrical and / or slightly tapered. The outlet port 321 may form a sleeve portion. The sleeve portion may be at least partially fixedly connected (e.g., sleeved) to the tube section of the proximal end 3112 of the tube 311, and a stop shoulder 3211 may be provided on the inner wall to axially limit the proximal end 3112 of the tube 311.

[0070] The rod 330 may include a contact head 331. The contact head 331 may be configured to act on the hemostatic material received in the filling device 320 to move the hemostatic material toward the lumen 3110. The rod 330 may be manipulated by a user, and acting on the hemostatic material may include contacting and pushing and / or moving the hemostatic material. The rod 330 may be generally cylindrical and / or slightly tapered. When the hemostatic material to be loaded is received in the filling device 320 (e.g., at least the transfer channel 322), the user may manipulate the rod 330 to utilize the contact head 331 to move the hemostatic material distally through the transfer channel 322 and out of the outlet port 321 into the lumen 3110.

[0071] The outlet port 321 of the filling device 320 can be connected to, for example, sleeved with, the proximal opening of the tube 311. Here, the push rod 312 can be completely removed from the tube 311 to facilitate filling using the filling device 320. Distal displacement of the outlet port 321 of the filling device 320 relative to the tube 311 can be limited by the aforementioned stop shoulder 3211 and / or the aforementioned fixed connection.

[0072] The transfer channel 322 can define a channel extension direction. The channel extension direction can be the direction in which the transfer channel 322 runs between the position closest to the outlet port 321 and the position farthest from the outlet port 321. The transfer channel 322 can open laterally to the exterior of the loading device 320 along the channel extension direction to form a slot and define an open side. The slot can be continuously open along the channel extension direction. Here, the slot side of the slot can serve as the open side of the transfer channel 322. When the loading device 320 is positioned in the orientation shown in Figures 3D-3E, the transfer channel 322 can form an upwardly open slot. On the side opposite the open side of the transfer channel 322 (e.g., the upper side shown), the slot can include a slot wall 3220 (also referred to as a channel wall), which can be, for example, an arc or other shape. At least the contact head 331 of the rod 330 can access the interior of the transfer channel 322 through the open side of the transfer channel 322, even as far as at least the proximal end 3112 of the tube 311 or even further distally into the lumen 3110. Since the transfer channel 322 forms a groove, the running direction of the bottom of the groove wall 3220 can be used as the channel extension direction.

[0073] The loading device 320 may also include an extended receiving surface 323 for the hemostatic material. The extended receiving surface 323 may extend away from the groove on one or both sides. The extended receiving surface 323 may extend continuously along the channel extension direction and may be continuous with the groove edge. The extended receiving surface 323 may include two extended receiving surfaces 323 extending away from each other on either side of the groove. The two extended receiving surfaces 323 may be positioned approximately symmetrically on either side of the groove. The extended receiving surfaces 323 may form a guide ramp. The guide ramp may extend away from the groove on one or both sides toward the open side of the transfer channel 322. In an embodiment not shown, one or more guide ramps may include at least a first ramp portion and a second ramp portion. The first ramp portion may be proximal to the groove, while the second ramp portion may be distal to the groove. The slope of the second ramp portion may be less than the slope of the first ramp portion. One or more guide ramps, or their first and second ramp portions (if present), may include a planar surface and / or an arcuate surface. The guide ramp can be configured to receive hemostatic material, making it easier for the user to add the hemostatic material due to the increased receiving area. The guide ramp can be configured to guide at least a portion of the received hemostatic material toward the transfer channel 322, causing it to fall into the groove. At least the contact head 331 of the rod 330 can access the guide ramp through the open side of the transfer channel 322. In the event that another portion of the hemostatic material received by the guide ramp becomes lodged, the user can manipulate the rod 330 to use the contact head 331 to move the hemostatic material from the guide ramp toward the transfer channel 322, ultimately moving it through the transfer channel 322 into the lumen 3110. In an embodiment not shown, the extended receiving surface 323 can extend substantially flush with the notch of the groove and / or substantially perpendicular to the direction of the open side and / or parallel to each other.

[0074] The channel extension direction can be substantially aligned with the tube 311. The transfer channel 322 can include a proximal open end located opposite the outlet port 321. The proximal open end can be formed by a flange opening 3260. In other words, the transfer channel 322 can be open along the channel extension direction at a position farthest from the outlet port 321. At least the contact head 331 of the rod 330 can access the interior of the transfer channel 322 through the flange opening 3260, even as far as the lumen 3110 at least at the proximal end 3112 of the tube 311 or even further distally.

[0075] The device 320 may also include a peripheral rib 324 extending toward the open side of the transfer channel 322. The peripheral rib 324 may include a proximal rib 3242, a distal rib 3241, and an intermediate rib 3243 extending between the proximal rib 3242 and the distal rib 3241. The proximal rib 3242 and the distal rib 3241 may be substantially parallel, and the intermediate rib 3243 may include two intermediate ribs 3243 that are substantially parallel and / or symmetrical along a direction between the proximal and distal sides. Each of the peripheral ribs 3241, 3242, 3243 may extend substantially parallel to one another toward the open side of the transfer channel 322. The terminal edges and / or terminal faces of each of the peripheral ribs 3241, 3242, 3243, facing the open side of the transfer channel 222, may be substantially flush and / or substantially coplanar. The peripheral rib 324 can surround the transfer passage 322, and surround the expansion receiving surface 323 or its first and second slope portions (if any). The intermediate rib 3243 (as well as the proximal rib 3242 and the distal rib 3241) can extend beyond the edge of the expansion receiving surface 323 or its second slope portion (if any) farthest from the groove. The proximal rib 3242 can be formed by a part of the flange 326 (for example, toward a part of the open side of the transfer passage 222). The outlet port 321 can be located at the far side of the distal rib 3241.

[0076] The loading device 320 may also include a shelf 325 on a side opposite the open side of the transfer channel 322. The shelf 325 can allow the loading device 320 to rest on a surface (e.g., along an axis extending in a direction between the proximal and distal sides) in a manner that prevents rolling. The shelf 325 can include a continuous terminal edge and / or terminal surface for resting, which can be substantially flush and / or substantially coplanar. The proximal portion of the shelf 325 can be formed by a portion of the flange 326 (e.g., a portion of the open side away from the transfer channel 222). In an embodiment not shown, the shelf 325 can include a proximal member and a distal member spaced apart from each other. The terminal edges and / or terminal surfaces of the proximal and distal members on the open side away from the transfer channel 325 can be substantially flush and / or substantially coplanar. The shelf 325 (or proximal and distal members) may extend away from the open side of the transfer passage 322 in a generally opposite and parallel direction to the extension of the individual ribs 3241 , 3242 , 3243 of the peripheral ribs 324 toward the open side of the transfer passage 322 .

[0077] The loading device 320 may include an outer sidewall 327 extending distally from the flange 326 at least partially along the transfer channel 322. A portion of the outer sidewall 327 near the flange 326 may be recessed toward the transfer channel 322 compared to a portion of the outer sidewall 327 distal to the flange 326. The outer sidewall 327 may include two outer sidewalls 327 extending distally together on either side of the transfer channel 322 (e.g., a groove). The two outer sidewalls 327 may be positioned generally symmetrically on either side of the transfer channel 322 (e.g., a groove). The flange 326 may include finger wings extending away from each other on either side of the transfer channel 322 (e.g., a groove), for example, such that the recessing of the outer sidewall 327 may provide a finger receiving space distal to the finger wings, thereby facilitating both loading and application of hemostatic material. The outer sidewall 327 may form a portion of the rib 324 (eg, the middle rib 3243 ) and a portion of the shelf 325 , and may extend generally parallel in directions toward and away from the open side of the transfer channel 322 .

[0078] 4A-4B , a filling device 420 of a kit according to a third embodiment of the present disclosure is shown.

[0079] The third embodiment kit can be used to load and apply a hemostatic material. The third embodiment kit can include an applicator, a loading device 420, and a wand. The applicator and wand of the third embodiment kit can include the features described for the applicator 210 and wand 230 of the first embodiment kit 200, and can have the same operations and functions as the applicator 210 and wand 230 of the first embodiment kit 200. The applicator and wand of the third embodiment kit can be provided as the applicator 210 and wand 230 of the first embodiment kit 200.

[0080] The filling device 420 can include an outlet port 421 and a transfer channel 422. The transfer channel 422 can be configured to receive a hemostatic material. When the outlet port 421 of the filling device 420 is connected (e.g., removably engaged) to an opening at the proximal or distal end of the tube (e.g., an opening in the tube itself or a flange opening), the transfer channel 422 can communicate with the lumen of the tube. The outlet port 421 can be generally cylindrical and / or slightly tapered.

[0081] The outlet port 421 of the filling device 420 can be configured to connect to an opening at the proximal end of the tube, such as a flange opening of a flange member. The outlet port 421 of the filling device 420 can be inserted into the flange opening of the flange member. Here, the push rod can be completely removed from the tube to facilitate connection of the filling device 420 and loading using the filling device 420. Distal displacement of the outlet port 421 of the filling device 420 within the flange opening of the flange member can be limited by a stop shoulder and / or a proximal end face of the flange member. The flange opening of the flange member and the outlet port 421 of the filling device 420 can have an interference fit. This interference fit can occur at least at the distal portion of the flange opening. The flange opening of the flange member can be provided with a tapered surface with a small taper (for example, 2 degrees to 10 degrees, in particular 3 degrees to 5 degrees) on the inner wall, and the outlet port 421 of the filling device 420 can be provided with a tapered surface on its outer circumference corresponding to the tapered surface on the inner wall of the flange opening. Based on the interference fit between the tapered surface on the inner wall of the flange opening and the corresponding tapered surface on the outer circumference of the outlet port, the outlet port 421 can be inserted into the flange opening with an interference fit, for example, until it abuts against the above-mentioned stop shoulder and / or the proximal end face of the flange member. Alternatively, other interference fit methods between the flange opening and the outlet port 421 can be considered. For example, one of the inner wall of the flange opening and the outer circumference of the outlet port 421 can be provided with a ridge for forming an interference fit. The ridge can be a complete annular or partial annular, or can be discrete, for example, distributed laterally. Alternatively, the diameter of the cylindrical inner circumference of the flange opening can be smaller than the diameter of the cylindrical outer circumference of the outlet port 421, thereby forming an interference fit. Alternatively, other mating arrangements between the flange opening and the outlet port 421 are contemplated, such as a positive-locking engagement of a projection and a recess. Alternatively, the outlet port 421 of the filling device 420 can be connected to the proximal or distal opening of the tube itself.

[0082] The transfer channel 422 can define a channel extension direction. The channel extension direction can be the direction in which the transfer channel 422 runs between a position closest to the outlet port 421 and a position farthest from the outlet port 421. The loading device 420 can be switched between an open configuration and a closed configuration. In the open configuration, the transfer channel 422 can open laterally to the exterior of the loading device 420 along the channel extension direction to form a slot and define an open side. In the open configuration, the slot can be continuously open along the channel extension direction. Here, the slot side of the slot can serve as the open side of the transfer channel 422. When the loading device 420 is positioned in the orientation shown in Figures 4A-4B, the transfer channel 422 can form an upwardly open slot. In the closed configuration, the transfer channel 422 can be substantially closed laterally along the channel extension direction. The transfer channel 422 itself can be switched between an open configuration and a closed configuration. In embodiments not shown, the loading device 420 can include a closing member (e.g., a lid, etc.) for closing the transfer channel 422.

[0083] The loading device 420 may include a first half 4201 and a second half 4202, which are opposed to each other relative to the direction in which the channel extends. Each half 4201, 4202 may include a channel segment 4220 for forming a transfer channel 422 and a joint segment 4230 extending from the channel segment 4220 toward the open side of the transfer channel 422. The two halves 4201, 4202 may be connected by a hinge 4203 on the side of their respective channel segments 4220 opposite the open side of the transfer channel 422. The joint segments 4230 of the two halves 4201, 4202 may each include corresponding joint features. The joint features may be configured to mate with each other in the closed configuration. For example, the coupling section 4230 of the first half 4201 may include snap recesses 4231 (including through recesses) (e.g., one each on the proximal and distal sides), and the coupling section 4230 of the second half 4202 may include corresponding snap protrusions 4232 (e.g., one each on the proximal and distal sides).

[0084] Each channel segment 4220 can roughly form one half of the transfer channel 422 (e.g., a substantially semicircular arc shape). In the open configuration, the two halves of the transfer channel 422 are opened relative to each other due to the hinge 4203, thereby forming a groove. On the side opposite the open side of the transfer channel 422 (e.g., the upper side shown), the groove can include a groove wall (also referred to as a channel wall) formed by the inner surfaces of the two channel segments 4220, and can have a shape imparted by the inner surfaces of the two channel segments 4220 (e.g., a double arc). In the closed configuration, the two halves of the transfer channel 422 are brought closer together relative to each other due to the hinge 4203, so as to be substantially closed in the lateral direction (e.g., except for the seam, which can remain relatively narrow due to the engagement of the joint segment 4230). Because the transfer channel 422 hinge 4203 opens to form the groove, the bottom of the groove wall and / or the direction of travel of the hinge 4203 can serve as the channel extension direction.

[0085] The outlet port 421 itself can be converted between an open configuration and a closed configuration, and can be configured to be connected to an opening at the proximal end or distal end of the tube in the closed configuration. Each half 4201, 4202 may include a port segment 4210 extending distally from the channel segment 4220 and / or being integrated therewith distally to form the outlet port 421. Each port segment 4210 can roughly form one half (e.g., a basic semicircular arc shape) of the outlet port 421. The two half bodies 4201, 4202 can be connected by a hinge (e.g., coaxial or identical with hinge 4203) on a side opposite to the open side of the transfer channel 422 by their respective port segments 4210. In the open configuration, the two halves of the outlet port 421 are opened relative to each other due to the hinge, thereby forming the distal portion of the groove. That is, when the outlet port 421 of the filling device 420 is not yet connected to the opening at the proximal end or distal end of the tube and / or when the filling device 420 is in an open configuration, both the transfer channel 422 and the outlet port 421 can receive hemostatic material from the open side. In the closed configuration, the two halves of the outlet port 421 are close relative to each other due to the hinge so as to be generally closed in the lateral direction (e.g., except for the seam, which can remain relatively narrow due to the cooperation of the joint section 4230).

[0086] The loading device 420 may also include an expanded receiving surface for the hemostatic material. The expanded receiving surface may form a guide ramp. The guide ramp may be formed by the engagement section 4230 in the open configuration. In other words, the guide ramp may be present in the open configuration. The guide ramp may extend away from the groove on one or both sides of the groove toward the open side of the transfer channel 422. The guide ramp may extend continuously along the direction in which the channel extends. The guide ramp may include two guide ramps extending away from each other on either side of the groove. The two guide ramps may be positioned approximately symmetrically on either side of the groove (e.g., excluding the engagement features on the engagement section 4230). The one or more guide ramps may include at least a first ramp portion and a second ramp portion (e.g., the engagement region of the engagement section 4230 and the edge region facing the open side of the transfer channel 422). The first ramp portion may be proximal to the groove, while the second ramp portion may be distal to the groove. The slope of the second ramp portion may be less than the slope of the first ramp portion. One or more guide ramps or their first and second ramp portions (if any) may include a planar surface and / or an arcuate surface. The guide ramps may be configured to receive hemostatic material, making it easier for a user to add the hemostatic material because the receiving area is increased. The guide ramps may receive the hemostatic material when the outlet port 421 of the loading device 420 is not yet connected to the opening at the proximal end or distal end of the tube. The guide ramps may be configured to guide at least a portion of the received hemostatic material toward the transfer channel 422 so that it falls into the groove. At least the contact head of the rod may approach the guide ramp through the open side of the transfer channel 422. In the event that another portion of the hemostatic material received by the guide ramp may become attached, the user may manipulate the rod to use the contact head to move the hemostatic material from the guide ramp toward the transfer channel 422 so that it is ultimately moved toward the lumen through the transfer channel 422.

[0087] When the outlet port 421 of the filling device 420 is connected to an opening at the proximal or distal end of the tube, the channel extension direction can be substantially aligned with the tube. The transfer channel 422 can include a proximal open end 4221 located opposite the outlet port 421. In other words, the transfer channel 422 can be open along the channel extension direction at a position farthest from the outlet port 421, regardless of whether the filling device 420 is in a closed or open configuration. At least the contact tip of the rod can access the interior of the transfer channel 422 through the proximal open end 4221 of the transfer channel 422, and even extend into the lumen of the tube.

[0088] The loading device 420 may also include a shelf on a side opposite the open side of the transfer channel 422. The shelf may be formed by the channel segment 4230 and / or the port segment 4210 in the open configuration. In other words, the shelf may exist in the open configuration. The channel segment 4230 may also be provided with additional support features on its outer surface so that the shelf can exist in the closed configuration. The shelf may allow the loading device 420 to rest on a surface in a manner that prevents rolling (e.g., along an axis extending in a direction between the proximal and distal sides). The shelf may include the top end of the channel segment 4230 and / or the port segment 4210 in the open configuration, facing away from the open side of the transfer channel 222 (e.g., a portion where the two arc-shaped outer walls have a common tangent line and / or common tangent plane, which may extend continuously along the channel extension direction).

[0089] 5A-5B , a wand 500 is shown that can be used in a kit (e.g., any one of the first embodiment kit 200 , the second embodiment kit 300 , the third embodiment kit, or another kit) according to the present disclosure. In other words, wand 230 of the first embodiment kit 200 , wand 330 of the second embodiment kit 300 , and wands in the third embodiment kit can include the features described with respect to wand 500 and can have the same operations and functions as wand 500. Wand 230 of the first embodiment kit 200 , wand 330 of the second embodiment kit 300 , and wands in the third embodiment kit can be provided as wand 500.

[0090] Rod 500 may include a contact head 501. Contact head 501 may be configured to act on hemostatic material received in a filling device to move the hemostatic material toward the lumen. Rod 500 may define a central axis and may be generally cylindrical and / or slightly tapered. Contact head 501 may include first to fourth beveled features 5011-5014 and may define an end face 5010 at a distal end. The first beveled feature 5011 may have a minimum inclination angle relative to the central axis, the second beveled features 5012 may be opposite to each other (e.g., substantially symmetrically) across the first beveled feature 5011 and may have a second minimum inclination angle relative to the central axis, the third beveled feature 5013 may further cut away portions of the first beveled feature 5011 and the second beveled feature 5012 on the same side of the first beveled feature 5011, and the fourth beveled feature 5014 may further cut away portions of the second beveled features 5012 on opposite sides of the beveled feature 5011 across the end surface 5010, such that the end surface 5010 may be offset from the central axis. The end surface 5010 may be substantially perpendicular to the central axis. The inclination angle of each of the third beveled feature 5013 and the fourth beveled feature 5014 relative to the central axis may be greater than the minimum inclination angle and the second minimum inclination angle, and may be different from each other.

[0091] The rod 500 may include gripping features, such as grooves 502 and / or ridges (not shown).

[0092] For each kit, the hemostatic material can be a flocculent hemostatic material 1. When disposed in a flocculent manner in the transfer channel 220, 320, 420 (and / or other locations that can receive hemostatic material, such as an extended receiving surface, an outlet port) and / or a tube, the flocculent hemostatic material 1 can at least partially remain in place autonomously against gravity (e.g., without contact being applied by hand, a push rod, and / or a wand, etc.).

[0093] For each kit, the applicator may be formed as a thin wall member or shell member.

[0094] For each kit, the applicator can be configured such that the distal end of the tube is passed through the body puncture and into the target site within the body.

[0095] An example operation of the first embodiment kit 200 is described below, and the second embodiment kit 300 , the third embodiment kit 400 , or another kit may operate similarly.

[0096] The desired amount of hemostatic material can be obtained from a package containing flocculent hemostatic material 1 included in the kit 200 or separately.

[0097] The push rod 212 of the applicator 210 of the kit 200 can be separated from the tube 211 .

[0098] The outlet port 221 of the filling device 220 of the kit 200 may be inserted into the flange opening 2130 of the flange member 213 at the proximal end 2112 of the tube 211 .

[0099] A desired amount of hemostatic material may be poured into the groove and / or extended receiving surface 223 .

[0100] The contact head 231 of the rod 230 of the kit 200 can be brought close to the location where the hemostatic material remains in the filling device 220 through the open side and / or proximal open end 2221, acting on the retained hemostatic material to move it toward the transfer channel 222, and then toward the lumen 2110 of the tube 211 of the application device 210.

[0101] The outlet port 221 of the filling device 220 of the kit 200 can be removed from the flange opening 2130 of the flange member 213 at the proximal end 2112 of the tube 211 .

[0102] The push rod 212 of the applicator 210 of the kit 200 can be inserted into the flange opening 2130 of the flange member 213 at the proximal end 2112 of the tube 211 and advanced through the lumen 2110 to move the hemostatic material toward the vicinity of the distal end 2111 of the tube 211 of the applicator 210.

[0103] The distal end 2111 of the tube 211 of the applicator 210 of the kit 200 can be inserted through a body puncture into a site inside the body where hemostasis is desired.

[0104] The push rod 212 of the applicator 210 of the kit 200 can be further advanced through the lumen 2110 to expel the hemostatic material from the distal end 2111 of the tube 211 of the applicator 210 to the site where hemostasis is desired.

[0105] In combination with the above description, different operating steps and / or orders may be conceived without departing from the spirit, concept and scope of the present disclosure.

[0106] It is noted that while the present disclosure describes advantageous forms of kits for loading and administering hemostatic materials, the present disclosure is not limited to the exact forms shown and described. Rather, the specific descriptions should be understood as merely exemplary. Thus, comparable features of one example may be applied to or substituted for another example without materially departing from the novel teachings and advantages of the present disclosure.

[0107] The above is an explanation of the present disclosure and should not be construed as limiting the present disclosure. Although exemplary embodiments of the present disclosure have been described, those skilled in the art will readily appreciate that many modifications may be made to the exemplary embodiments without materially departing from the novel teachings and advantages of the present disclosure. For example, features of the apparatus and features of the method may be combined in any manner to form additional embodiments. Therefore, all such modifications are intended to be included within the scope of the present disclosure as defined in the claims. The present disclosure is defined by the appended claims, which include equivalents to the claims.

Claims

1. A kit for filling and applying a hemostatic material, comprising: an applicator, the applicator comprising a tube including a proximal end, a distal end and a lumen extending therebetween, and a push rod including a proximal end, a distal end and capable of being inserted from an opening at the proximal end of the tube and advanced through the lumen to the vicinity of an opening at the distal end of the tube and withdrawn through the lumen from the opening at the proximal end of the tube; a charging device including an outlet port and a transfer channel configured to receive a hemostatic material, the transfer channel communicating with the lumen when the outlet port of the charging device is connected to an opening at the proximal end or the distal end of the tube; a rod including a contact head configured to act on the hemostatic material received in the filling device to move the hemostatic material toward the lumen, The transfer channel defines a channel extension direction, and the transfer channel is laterally open to the outside of the charging device along the channel extension direction to form a groove and define an open side.

2. A kit according to claim 1, wherein the filling device includes an extended receiving surface for hemostatic material, the extended receiving surface extending away from the groove on one or both sides of the groove.

3. The kit of claim 2, wherein the extended receiving surface forms a guide ramp extending away from the groove on one or both sides of the groove toward the open side of the transfer channel. 4 . The kit according to claim 3 , wherein the guide slope comprises at least a first slope portion close to the groove and a second slope portion away from the groove, the slope of the second slope portion being smaller than the slope of the first slope portion.

5. A kit according to any one of claims 2 to 4, wherein the channel extends in substantially straight alignment with the tube when the outlet port of the filling device is connected to an opening at the proximal end or the distal end of the tube.

6. The kit of claim 5, wherein the transfer channel includes a proximal open end located opposite the exit port.

7. A kit according to any one of claims 1 to 6, wherein the filling device comprises a rest on a side opposite to the open side of the transfer channel.

8. A kit according to any one of claims 1 to 7, wherein the filling device comprises a peripheral rib extending towards an open side of the transfer channel.

9. The kit of claim 8, wherein the peripheral rib includes a proximal rib having a terminal edge that extends in a progressive manner toward an open side of the transfer passage as it moves away from the slot.

10. A kit according to any one of claims 1 to 9, wherein the application device includes a flange member at the proximal end of the tube, the opening at the proximal end of the tube includes a flange opening of the flange member that is roughly aligned with the tube, for inserting a push rod through the flange opening into the tube cavity, and wherein the outlet port of the filling device is configured to be connected to the flange opening.

11. The kit of claim 10, wherein the flange opening receives the outlet port of the filling device with an interference fit at least at a distal portion thereof.

12. A kit according to claim 11, wherein the flange opening is provided with a conical surface on the inner wall at least at the distal portion thereof, and the outlet port of the loading device is provided with a corresponding conical surface on the outer peripheral surface at least at the distal portion thereof, and the interference fit is formed by means of the conical surface and the corresponding conical surface.

13. A kit according to any one of claims 1 to 12, wherein the outlet port of the filling device is connected to the opening at the proximal end of the tube, and the filling device includes an integral flange at the proximal end of the filling device, and the flange includes a flange opening roughly aligned with the tube for inserting a push rod through the flange opening through the transfer channel into the tubular cavity.

14. The kit of claim 13, wherein the filling device includes an outer sidewall extending distally from the flange at least partially along the transfer channel, a portion of the outer sidewall near the flange being recessed toward the transfer channel than a portion of the outer sidewall distal to the flange.

15. A kit according to any one of claims 1 to 14, wherein the filling device is capable of being converted between an open configuration and a closed configuration, wherein in the open configuration, the transfer channel is laterally open to the outside of the filling device along the direction in which the channel extends to form a groove and define an open side, and in the closed configuration, the transfer channel is substantially closed laterally along the direction in which the channel extends.

16. A kit according to claim 15, wherein the loading device includes a first half body and a second half body opposite to each other relative to the extension direction of the channel, each of the first half body and the second half body includes a channel section for forming a transfer channel and a joining section extending from the channel section toward the open side of the transfer channel, the first half body and the second half body are hingedly connected at a side opposite to the open side of the transfer channel by their respective channel sections, and the respective joining sections of the first half body and the second half body include corresponding joining features, and the joining features are configured to cooperate with each other in the closed configuration.

17. A kit according to claim 16, wherein each of the first half and the second half includes a port segment extending distally from the channel segment and / or being integrated with it distally for forming an outlet port, the first half and the second half are hingedly connected on the side opposite to the open side of the transfer channel by their respective port segments, and the port segment is configured to form a distal portion of the groove in the open configuration and to be connected to an opening at the proximal end or the distal end of the tube in the closed configuration.

18. A kit according to any one of claims 1 to 17, wherein the rod defines a central axis, the contact head includes first to fourth bevel features and defines an end face at the end, wherein the first bevel feature has a minimum inclination angle relative to the central axis, the second bevel features can be opposite to each other across the first bevel feature and have a secondary small inclination angle relative to the central axis, the third bevel feature further cuts off a portion of the first bevel feature and the second bevel feature on the same side of the first bevel feature, and the fourth bevel feature further cuts off a portion of the second bevel feature on the opposite side of the bevel feature across the end face, so that the end face is offset from the central axis.

19. The kit of any one of claims 1 to 18, wherein the hemostatic material is a flocculent hemostatic material.

20. The kit of any one of claims 1 to 19, wherein the applicator is configured such that the distal end of the tube passes through a body piercing into a target site within the body.

Images