Hemostatic devices

Abstract

[Problem] Provided is a hemostatic instrument capable of improving the wound repairing effect and hemostatic effect using metal ions or a drug in a hydrophilic polymer layer and capable of preventing separation of the hydrophilic polymer layer containing metal ions or a drug from an expansion member. [Solution] A hemostatic instrument 100 is provided with: an expansion member 110 configured to be placed on a forearm A of a patient; and a fixing member 170 configured to fix the expansion member to the forearm of the patient. The expansion member has a first surface 111a configured to be placed on a puncture site. The first surface has a recess 120 recessed toward the outer surface of the fixing member; and a hydrophilic material region 130 located in the recess. The hydrophilic material region is a hydrophilic polymer layer 131 containing metal ions and / or a drug.

Description

[Technical field]

[0001] The present invention relates to a hemostatic device. [Background technology]

[0002] Conventionally, there has been known a procedure in which various medical elongated objects (e.g., catheters) are introduced into blood vessels through a puncture site formed in a blood vessel of a patient's limb, such as a hand or arm, to treat or cure a lesion site. When performing such a procedure, the surgeon stops bleeding at the puncture site when removing the medical elongated object from the puncture site.

[0003] A hemostatic device used to stop bleeding at a puncture site has been proposed that has a fixing member with a band configured to be wrapped around a limb, and an expansion member such as a balloon that is connected to the band and expands when fluid is injected into it to apply pressure to the puncture site (see Patent Document 1). [Prior art documents] [Patent documents]

[0004] [Patent Document 1] JP 2010-131296 A Summary of the Invention [Problem to be solved by the invention]

[0005] In the method of hemostasis using the hemostatic device of Patent Document 1, the surgeon applies a compressive force to the puncture site by injecting a fluid into the expansion member to expand the hemostatic device while the device is fixed to the patient's limb. The surgeon can apply a compressive force to the puncture site for a predetermined period of time using a balloon to achieve compressive hemostasis at the puncture site.

[0006] For example, in a procedure for stopping bleeding at a puncture site formed in a limb, it is believed that it is possible to effectively stop bleeding at the puncture site by using various drugs that exert various medicinal effects while performing compression hemostasis using the hemostatic device described in Patent Document 1. In addition, as a measure for realizing such a hemostatic method, it is considered to place a drug on the surface of the expansion member that is placed facing the limb.

[0007] However, when a drug is placed on the surface of the expansion member of the hemostatic device, there is a possibility that the surface of the expansion member may come into contact with other members or objects when the hemostatic device is placed at the puncture site, and part of the drug may peel off from the surface of the expansion member due to abrasion, etc. Furthermore, if the amount of bleeding from the puncture site is small, the drug placed on the surface of the expansion member may not be appropriately released slowly to the puncture site, and may not be able to fully exert its medicinal effect.

[0008] The present invention has been made in consideration of the above problems, and aims to provide a hemostatic device that can improve the wound repair effect and hemostatic effect by using metal ions and drugs contained in a hydrophilic polymer layer, and can prevent the hydrophilic polymer layer containing metal ions and drugs from peeling off from an expansion member. [Means for solving the problem]

[0009] A hemostatic device that achieves the above object comprises an expansion member configured to be placed at a site of a limb where bleeding should be stopped, and a fixing member configured to fix the expansion member to the limb, the expansion member having a first surface configured to be placed at the site where bleeding should be stopped, the first surface having a recess recessed into the outer surface side of the fixing member, and a hydrophilic material region located in the recess, the hydrophilic material region being a hydrophilic polymer layer containing at least one of a metal ion and a drug. The recess includes a first recess located at a center of the expansion member and a plurality of second recesses each having an outer shape smaller than that of the first recesses, and the outer shape of the second recesses becomes smaller from the first recess toward the periphery of the first surface. do. In addition, a hemostatic device that achieves the above-mentioned objective comprises an expansion member configured to be placed at a site on a limb where bleeding is to be stopped, and a fixing member configured to fix the expansion member to the limb, wherein the expansion member has a first surface configured to be placed at the site where bleeding is to be stopped, the first surface having a recess recessed into the outer surface side of the fixing member and a hydrophilic material region located in the recess, the hydrophilic material region being a hydrophilic polymer layer containing at least one of a metal ion and a drug, and having an induction groove extending from the recess toward the peripheral portion of the first surface, the induction groove comprising a hydrophilic polymer layer. Effect of the Invention

[0010] In the hemostatic device configured as described above, since the hydrophilic polymer layer is provided in the recess of the first surface of the expansion member, even when the first surface of the expansion member comes into contact with and is rubbed against another member, the hydrophilic polymer layer can be prevented from peeling off from the expansion member. In addition, since the hydrophilic polymer layer, which is compatible with water, contains metal ions and drugs, the entire hydrophilic polymer layer is easily wetted even when the amount of blood leaking from the puncture site is small, and the metal ions and drugs can be efficiently released to the puncture site. In addition, by expanding the expansion member with the recess of the expansion member placed at the puncture site, the hemostatic device can compress the puncture site to stop bleeding while releasing the metal ions and drugs contained in the hydrophilic polymer layer placed in the recess to the periphery of the puncture site. Therefore, the hemostatic device can hasten the repair of the wound at the puncture site and improve the hemostatic effect at the puncture site due to the medicinal effects of the metal ions and drugs. [Brief description of the drawings]

[0011] [Figure 1] FIG. 2 is a diagram showing a hemostatic device according to an embodiment, and is a plan view seen from the inner surface side of a belt portion of a fixing member. [Diagram 2] 2 is a cross-sectional view taken along the line 2A-2A shown in FIG. [Diagram 3] FIG. 3 is an enlarged view of part 3A shown in FIG. 2. [Figure 4] 4 is a plan view of a first surface of the expansion member as viewed from the direction of arrow 4A shown in FIG. 2. [Diagram 5] 5 is a cross-sectional view taken along the line 5A-5A shown in FIG. 4. [Figure 6] 1 is a diagram showing a state in which a hemostatic device according to an embodiment is attached to a patient's limb. FIG. [Figure 7] FIG. 11 is a plan view showing an expansion member according to Modification 1. [Figure 8] 8 is a cross-sectional view taken along the line 8A-8A shown in FIG. 7. [Figure 9] FIG. 11 is a plan view showing an expansion member according to Modification 2. [Figure 10] 10A is a cross-sectional view taken along the line 10A-10A shown in FIG. 9. [Figure 11] FIG. 11 is a plan view showing an expansion member according to Modification 3. [Figure 12] FIG. 13 is a plan view showing an expansion member according to Modification 4. [Figure 13] 13A is a cross-sectional view taken along the line 13A-13A shown in FIG. 12. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0012] Hereinafter, embodiments and modifications of the present invention will be described with reference to the attached drawings. Note that the following description does not limit the technical scope or meaning of terms described in the claims. Also, the dimensional ratios in the drawings are exaggerated for the convenience of explanation and may differ from the actual ratios.

[0013] 1 to 5 are diagrams illustrating a hemostatic device 100 according to an embodiment, and FIG. 6 is a diagram showing the hemostatic device 100 attached to a patient's forearm (corresponding to a "limb") A.

[0014] <Hemostatic device> As shown in FIG. 6, the hemostatic device 100 is configured as a medical device for stopping bleeding at a puncture site p (corresponding to a "site to be stopped bleeding") formed in the forearm A for the purpose of inserting a catheter or the like for treatment, examination, etc., into a blood vessel (e.g., the radial artery) when removing a sheath tube (not shown) of an introducer that has been placed at the puncture site p from the puncture site p.

[0015] The hemostatic device 100, generally described with reference to Figures 1, 2, 3, and 6, comprises an expansion member 110 configured to be placed at a puncture site p of the forearm A, and a fixing member 170 configured to fix the expansion member 110 to the forearm A.

[0016] <Fixing material> As shown in FIGS. 1, 2 and 6, the fixing member 170 includes a belt portion 171 configured to be wrapped around the patient's forearm A, and connecting portions 172a and 172b disposed on the belt portion 171.

[0017] 1 shows a plan view of the hemostatic device 100 as viewed from the inner surface 171a side of the belt portion 171. The inner surface 171a of the belt portion 171 is the surface that is placed so as to face the surface of the skin of the patient's forearm A when the hemostatic device 100 is attached to the patient's forearm A. The outer surface 171b of the belt portion 171 (see FIG. 2) is the surface opposite the inner surface 171a.

[0018] The belt portion 171 can be made of, for example, a flexible member. Examples of materials that can be used to make the belt portion 171 include polyolefins such as polyvinyl chloride, polyethylene, polypropylene, polybutadiene, and ethylene-vinyl acetate copolymer (EVA), polyesters such as polyethylene terephthalate (PET) and polybutylene terephthalate (PBT), various thermoplastic elastomers such as polyvinylidene chloride, silicone, polyurethane, polyamide elastomers, polyurethane elastomers, and polyester elastomers, or any combinations of these (blend resins, polymer alloys, laminates, etc.).

[0019] 1, the first connecting portion 172a is disposed near one end portion 173a in the longitudinal direction of the belt portion 171. Moreover, the first connecting portion 172a is disposed on the inner surface 171a of the belt portion 171. In Fig. 1, Fig. 2, and Fig. 4, the longitudinal direction of the belt portion 171 is indicated by the arrow X1-X2.

[0020] The second connecting portion 172b is disposed near the other end portion 173b in the longitudinal direction of the belt portion 171. The second connecting portion 172b is disposed on the outer surface 171b of the belt portion 171.

[0021] The first connecting portion 172a and the second connecting portion 172b are configured to be connectable and detachable to each other. Each connecting portion 172a, 172b can be configured, for example, by a hook-and-loop fastener. In this embodiment, the first connecting portion 172a is configured by the female side of the hook-and-loop fastener, and the second connecting portion 172b is configured by the male side of the hook-and-loop fastener.

[0022] When attaching the hemostatic device 100 to the forearm A of a patient, the surgeon wraps the belt portion 171 around the forearm A of the patient with the inner surface 171a of the belt portion 171 to which the expansion member 110 is connected facing the skin surface of the patient's forearm A. With the belt portion 171 wrapped around the forearm A of the patient, the surgeon brings the connecting portions 172a, 172b arranged on the belt portion 171 into contact with each other and connects them together. By connecting the connecting portions 172a, 172b together, the surgeon can fix the hemostatic device 100 to the forearm A of the patient with the expansion member 110 arranged at the puncture site p.

[0023] The structure of each of the connecting parts 172a, 172b is not particularly limited as long as it is possible to maintain the hemostatic device 100 attached to the forearm A of the patient. Each of the connecting parts 172a, 172b may be configured, for example, with something other than a hook-and-loop fastener. Even when each of the connecting parts 172a, 172b is configured with a hook-and-loop fastener as in this embodiment, the female side and the male side can be arbitrarily switched. Furthermore, the positions at which each of the connecting parts 172a, 172b is disposed on the belt part 171, the number of connecting parts, etc. are also not particularly limited.

[0024] 2, the belt portion 171 is provided with a support portion 175. The support portion 175 has a holding member 175a disposed near the center of the belt portion 171 in the longitudinal direction, and a support plate 175b held between the holding member 175a and the belt portion 171.

[0025] The holding member 175a is connected to the outer surface 171b of the belt portion 171. A gap is formed between the holding member 175a and the outer surface 171b of the belt portion 171, allowing the holding plate 175b to be held. The holding plate 175b has a flat portion formed in at least a part of the longitudinal direction (the vertical direction in FIG. 2) of the holding plate 175b, and a curved portion that is curved in a concave shape toward the inner surface 171a of the belt portion 171. The holding plate 175b can be made of, for example, a material harder than the belt portion 171. Note that the specific cross-sectional shape, material, etc. of the holding plate 175b are not particularly limited.

[0026] When the expansion member 110 is expanded, the support plate 175b prevents the expansion member 110 from expanding in a direction away from the patient's forearm A. Therefore, when the expansion member 110 expands, the hemostatic device 100 can concentrate a compression force on the patient's forearm A to which the expansion member 110 is fixed.

[0027] It is preferable that the belt portion 171, the holding member 175a, and the support plate 175b have portions that are arranged to overlap the marker portion 125 (see Figures 3 and 5) described below, which are made of a transparent, semi-transparent, colored transparent, etc. material so that the surgeon, etc. can visually recognize the marker portion 125 when visually observing the extension member 110 from the outer surface 171b side of the belt portion 171.

[0028] <Extension member> The expansion member 110 is configured with a balloon that is expanded by injecting a fluid. As shown in FIG. 3, the expansion member 110 has an internal space 113 into which a fluid can be injected.

[0029] A recess 120, which will be described later, is provided on the first surface 111a of the expansion member 110 (see FIG. 5). The first surface 111a of the expansion member 110 is the outer surface of the portion that is placed at a puncture site p formed in the forearm A when the expansion member 110 is placed on the forearm A of a patient.

[0030] 2 and 3, a deformable auxiliary member 180, which has a smaller outer shape than the expansion member 110, is connected to the second surface 111b of the expansion member 110. The auxiliary member 180 is configured as a balloon that is expanded by injecting a fluid. The second surface 111b of the expansion member 110 is the outer surface of a portion located opposite to the first surface 111a.

[0031] The auxiliary member 180 has an internal space 183 into which a fluid can be injected. A first surface 181a of the auxiliary member 180 located on the side of the expansion member 110 is connected to a second surface 111b of the expansion member 110. A second surface 181b of the auxiliary member 180 located on the opposite side to the first surface 181a is connected to an inner surface 171a of the belt portion 171.

[0032] 2, the auxiliary member 180 can be disposed at any position close to the other end 173b in the longitudinal direction of the belt portion 171. The auxiliary member 180 is connected to the belt portion 171 near the end of the auxiliary member 180 (the end on the right side in FIG. 3).

[0033] 3, the internal space 113 of the expansion member 110 and the internal space 183 of the auxiliary member 180 communicate with each other via a communication part 190. The communication part 190 is composed of a hole formed in the expansion member 110 and a hole formed in the auxiliary member 180.

[0034] The expansion member 110 is connected to the auxiliary member 180 around the communication portion 190. Furthermore, the auxiliary member 180 is connected to the belt portion 171 as described above. Therefore, the expansion member 110 is connected to the belt portion 171 via the auxiliary member 180. The auxiliary member 180 and the belt portion 171, and the expansion member 110 and the auxiliary member 180 can each be connected by, for example, fusion or an adhesive.

[0035] The extension member 110 and the auxiliary member 180 can be formed, for example, by joining the peripheral portions of two sheet-like members formed in a substantially rectangular shape with the internal spaces 113, 183 formed between the two sheet-like members. In this embodiment, the sheet-like member used has a rectangular first surface 111a of the extension member 110 as shown in FIG.

[0036] The expansion member 110 and the auxiliary member 180 may be made of the same material as that exemplified for the belt portion 171, for example.

[0037] The expansion member 110 and the auxiliary member 180 can be formed, for example, so that their outer shapes in a plan view are substantially rectangular. However, the specific outer shapes of the expansion member 110 and the auxiliary member 180 are not particularly limited.

[0038] The internal space 113 of the expansion member 110 communicates with the inner cavity of a tube 203 provided in an injection section 200 (see FIG. 1) described below. The tube 203 may be connected to the internal space 183 of the auxiliary member 180.

[0039] The surgeon or the like can inject a fluid (eg, air) into the internal space 113 of the expansion member 110 via the tube 203, thereby expanding the expansion member 110 and the auxiliary member 180.

[0040] With the hemostatic device 100 attached to the patient's forearm A (see FIG. 6 ), the surgeon or the like can apply a compressive force to the puncture site p by expanding the expansion member 110. Furthermore, when the surgeon or the like expands the auxiliary member 180 together with the expansion member 110, the auxiliary member 180 can adjust the direction of the compressive force applied by the expansion member 110 to the direction toward the puncture site p. Therefore, the surgeon or the like can effectively apply a compressive force from the expansion member 110 to the puncture site p.

[0041] It should be noted that the hemostatic device 100 does not necessarily have to include the auxiliary member 180. Even if the hemostatic device 100 includes the auxiliary member 180, the auxiliary member 180 can be formed of, for example, a member other than an expandable and deformable balloon.

[0042] <Injection part> As shown in FIG. 1, the hemostatic device 100 has an injecting portion 200 for injecting a fluid into the expansion member 110 .

[0043] The injection section 200 has a connector 201 incorporating a check valve (not shown), a flexible bag section 202 with a space formed therein, and a tube 203 connecting the bag section 202 to the internal space 113 of the expansion member 110.

[0044] While the check valve of the connector 201 is closed, communication between the inside of the connector 201 and the inside of the bag portion 202 is blocked. When expanding the expansion member 110, the surgeon inserts the tip of a syringe (not shown) into the connector 201 to open the check valve. With the check valve of the connector 201 open, the surgeon can inject the air in the syringe into the internal space 113 of the expansion member 110 by pressing the plunger of the syringe.

[0045] The surgeon or the like can inflate the expansion member 110 by injecting air into the internal space 113 of the expansion member 110. Furthermore, when the surgeon or the like injects air into the internal space 113 of the expansion member 110, the air flows into the internal space 183 of the auxiliary member 180 via the communication portion 190. This allows the surgeon or the like to expand the auxiliary member 180. When the surgeon or the like expands the expansion member 110 and the auxiliary member 180, the bag portion 202, which is in communication with the expansion member 110 via the tube 203, expands. The surgeon or the like can visually confirm that the bag portion 202 expands, thereby confirming that the expansion member 110 and the auxiliary member 180 have expanded.

[0046] When contracting the expansion member 110 and the auxiliary member 180, the surgeon inserts the tip of the syringe into the connector 201 and pulls the plunger of the syringe. By performing the above operation, the surgeon can move air from the expansion member 110 and the auxiliary member 180 to the syringe. When the surgeon moves air from the expansion member 110 and the auxiliary member 180 to the syringe, the bag portion 202 contracts.

[0047] The bag portion 202 may be provided with, for example, an arrow-shaped marker that indicates the direction in which the syringe is inserted into the connector 201 .

[0048] <Concave part of expansion member> As shown in Figures 3, 4, and 5, the first surface 111a of the expansion member 110 has a recess 120 that is recessed toward the outer surface of the fixing member 170 (belt portion 171), and a hydrophilic material region 130 located in the recess 120.

[0049] Fig. 4 is a plan view of the first surface 111a of the extension member 110 and the inner surface 171a of the belt portion 171 as viewed from the direction of the arrow 4A in Fig. 2. Fig. 5 is a cross-sectional view of the extension member 110 along the line of the arrow 5A-5A in Fig. 4.

[0050] The "outer surface side of the fixing member" indicating the recessed direction of the recess 120 is the second surface 111b side located opposite to the first surface 111a of the expansion member 110 (see FIG. 3).

[0051] As shown in Fig. 4, the recess 120 is disposed so as to be located at the center C of the first surface 111a of the expansion member 110. The center C of the expansion member 110 is the center in the plan view shown in Fig. 4. When the first surface 111a has a rectangular planar shape like the expansion member 110 according to this embodiment, the center C of the expansion member 110 is the intersection point of diagonals L1, L2 connecting opposing vertices.

[0052] The recess 120 can be formed to have, for example, a circular planar shape as shown in Fig. 4. However, the planar shape of the recess 120 is not limited to a circle, and may be, for example, a square, a rectangle, an ellipse, a diamond, or another shape.

[0053] As shown in Fig. 5, the recess 120 can be formed, for example, in a rectangular cross-sectional shape having a substantially constant width (dimension in the vertical direction in the figure) along the depth direction of the recess 120 (left and right direction in Fig. 5). However, the cross-sectional shape of the recess 120 is not limited to a rectangle, and may be formed, for example, in a semicircular shape or a U-shape. There is also no particular limit to the depth or width of the recess 120.

[0054] The hydrophilic material region 130 is composed of a hydrophilic polymer layer 131 containing at least one of metal ions and a drug.

[0055] The hydrophilic polymer layer 131 may be disposed on at least a part of the recess 120. In this embodiment, the hydrophilic polymer layer 131 and the marker portion 125 described later are disposed in the recess 120. The hydrophilic polymer layer 131 is disposed in the recess 120 so as to cover the marker portion 125. When the hydrophilic polymer layer 131 and the marker portion 125 overlap in the plan view shown in FIG. 4 and are larger than the marker portion 125, or when the marker portion 125 has a portion that allows the puncture site p to be visually recognized, such as colorless and transparent, colored and transparent, or translucent, the hydrophilic polymer layer 131 is preferably formed to be colorless and transparent, colored and transparent, translucent, or the like so as not to reduce the visibility of the marker portion 125.

[0056] The hydrophilic polymer layer 131 can be formed by a known material and a known method. The hydrophilic polymer layer is, for example, a hydrogel layer having water swelling properties, and the hydrogel layer is configured to fix or hold metal ions or a drug. As an example, the hydrophilic polymer layer 131 can be formed from an acrylamide-based polymeric substance (for example, polyacrylamide, a block copolymer of polyglycidyl methacrylate-dimethylacrylamide (PGMA-DMAA)), polyvinylpyrrolidone, hyaluronic acid, or the like. Note that the hydrophilic polymer layer 131 may be provided on at least a part of the recess 120.

[0057] Known metal ions and known hemostatic agents can be used as the drug contained in the hydrophilic polymer layer 131. For example, known metal ions that are effective in early wound healing and hemostasis can be used as the metal ions. Also, known hemostatic agents that are effective in hemostasis, such as ascorbic acid and sodium alginate, can be used as the drug.

[0058] 5, a marker portion 125 is disposed on the first surface 111a. The marker portion 125 is given a predetermined color and is disposed in the recess 120. The marker portion 125 is configured to enable an operator or the like to grasp the position of the hydrophilic polymer layer 131 and align the hydrophilic polymer layer 131 with the puncture site p or the periphery of the puncture site p.

[0059] In this embodiment, the marker portion 125 is disposed on the portion of the first surface 111a of the extension member 110 that forms the bottom of the recess 120. The marker portion 125 can be configured, for example, by coloring the first surface 111a. The color of the marker portion 125 is, for example, green or blue. The specific shape, color, forming method, etc. of the marker portion 125 are not particularly limited. For example, the marker portion 125 does not have to be formed on the entire bottom of the recess 120. As an example, the marker portion 125 may be configured of a transparent central portion and a colored linear frame portion surrounding the central portion. In addition, the marker portion 125 may be provided with a colored square mark only in the central portion of the hydrophilic polymer layer 131 (only in the central portion of the recess 120) so as to increase the visibility of the puncture site p and to make it easy to reliably place the hydrophilic polymer layer 131 at the puncture site p.

[0060] The marker portion 125 may be configured, for example, by coloring the hydrophilic polymer layer 131 disposed in the recess 120. When forming the marker portion 125 in this manner, the hydrophilic polymer layer 131 can be configured as the marker portion 125 by adding a pigment of a predetermined color to the material forming the hydrophilic polymer layer 131.

[0061] As shown in FIGS. 4 and 5, a water-repellent coating layer 140 is disposed on the first surface 111a of the extension member 110 in an area where the recesses 120 are not provided.

[0062] In this embodiment, the water-repellent coating layer 140 is provided on the entire area of ​​the first surface 111a of the expansion member 110 except for the position where the recess 120 is provided. The water-repellent coating layer 140 may be provided on at least a part of the portion of the first surface 111a other than the recess 120. However, it is preferable that the water-repellent coating layer 140 is provided at least in a position surrounding the recess 120 on the first surface 111a. By providing the water-repellent coating layer 140 in this manner, when bleeding occurs from the puncture site p and blood comes into contact with the water-repellent coating layer 140 when hemostasis is performed using the hemostatic device 100, the hemostatic device 100 can easily move the blood that has come into contact with the water-repellent coating layer 140 to the recess 120.

[0063] The water-repellent coating layer 140 can be formed of a known material and a known method. As an example, the water-repellent coating layer 140 can be formed of silicone, polytetrafluoroethylene (PTFE), etc. There is no particular limit to the thickness of the water-repellent coating layer 140.

[0064] FIG. 6 shows a state in which the hemostatic device 100 is attached to a patient's forearm A where a puncture site p has been formed.

[0065] 6, the introducer is omitted from the illustration, but the surgeon can place the expansion member 110 at the puncture site p in a state where the sheath tube of the introducer is inserted into the puncture site p. In addition, the surgeon can remove the sheath tube from the puncture site p in a state where the hemostatic device 100 is attached to the forearm A of the patient.

[0066] When placing the expansion member 110 at the puncture site p, the surgeon or the like aligns the recess 120 of the expansion member 110 with the puncture site p using the marker portion 125 placed in the recess 120 as a guide. This allows the surgeon or the like to easily place the recess 120 with the hydrophilic polymer layer 131 placed therein at the puncture site p.

[0067] Furthermore, in the hemostatic device 100, when viewed in the plane as shown in Figure 4, the hydrophilic polymer layer 131 and the marker portion 125 overlap and the hydrophilic polymer layer 131 is larger than the marker portion 125, or when the marker portion 125 has a portion through which the puncture site p can be visually confirmed, such as colorless and transparent, colored transparent, translucent, etc., the hydrophilic polymer layer 131 arranged on top of the marker portion 125 in the recess 120 can be formed from colorless and transparent, colored transparent, colorless transparent, etc., thereby preventing a decrease in the visibility of the marker portion 125.

[0068] The surgeon or the like removes the sheath tube from the puncture site p with the recess 120 of the expansion member 110 placed at the puncture site p. At this time, as the sheath tube is removed, blood leaks from the puncture site p of the patient, and the blood leaking from the puncture site p comes into contact with the hydrophilic polymer layer 131 placed in the recess 120 of the expansion member 110. The hydrophilic polymer layer 131 is configured to contain metal ions and drugs. Therefore, when the hydrophilic polymer layer 131 comes into contact with blood and swells, the hydrophilic polymer layer 131 releases metal ions and drugs. The hydrophilic polymer layer 131 can gradually release metal ions to the puncture site p to suppress the formation of scar tissue at the puncture site p and repair the wound early, or gradually release a hemostatic agent to the puncture site p to promote blood coagulation at the puncture site p and shorten the hemostasis time.

[0069] When the Patent Hemostasis Technique is used as a hemostasis method, the hydrophilic polymer layer 131 disposed in the recess 120 of the expansion member 110 comes into contact with blood leaking from the puncture site p even in the event of rebleeding due to reduced pressure of the expansion member 110.

[0070] The water-repellent coating layer 140 provided on the first surface 111a of the expansion member 110 is configured to repel blood when blood comes into contact with the water-repellent coating layer 140. In this embodiment, the water-repellent coating layer 140 is disposed so as to surround the periphery of the recess 120, so that blood that comes into contact with the water-repellent coating layer 140 can be guided toward the recess 120. The hemostatic device 100 can more reliably bring blood into contact with the hydrophilic polymer layer 131 disposed in the recess 120 by guiding the blood from the water-repellent coating layer 140 to the recess 120. Therefore, it becomes possible to effectively release metal ions and drugs contained in the hydrophilic polymer layer 131 disposed in the recess 120.

[0071] As described above, the hemostatic device 100 according to this embodiment includes the expansion member 110 configured to be placed on the patient's forearm A, and the fixing member 170 configured to fix the expansion member 110 to the patient's forearm A. The expansion member 110 has a first surface 111a to be placed at the puncture site p. The first surface 111a has a recess 120 recessed into the outer surface side of the fixing member 170, and a hydrophilic material region 130 located in the recess 120, and the hydrophilic material region 130 is a hydrophilic polymer layer 131 containing at least one of a metal ion and a drug.

[0072] In the hemostatic device 100 configured as described above, the hydrophilic polymer layer 131 is provided in the recess 120 of the first surface 111a of the expansion member 110, so that even if the first surface 111a of the expansion member 110 comes into contact with and is rubbed against another member or the like, the hydrophilic polymer layer 131 can be prevented from peeling off from the expansion member 110. In addition, since the hydrophilic polymer layer 131, which is compatible with water, contains metal ions and drugs, the entire hydrophilic polymer layer 131 is easily wetted even if the amount of blood leaking from the puncture site p is small, and the metal ions and drugs can be efficiently released to the puncture site p. In addition, the hemostatic device 100 can release the metal ions and drugs contained in the hydrophilic polymer layer 131 placed in the recess 120 to the periphery of the puncture site p while compressing and stopping the hemostatic process at the puncture site p by expanding the expansion member 110 with the recess 120 of the expansion member 110 placed at the puncture site p. Therefore, the hemostatic device 100 can hasten the healing of the wound at the puncture site p and improve the hemostatic effect at the puncture site p by utilizing the medicinal properties of the metal ions and the drug.

[0073] Moreover, the water-repellent coating layer 140 is disposed on at least a part of the region of the first surface 111a where the recesses 120 are not provided. Therefore, the hemostatic device 100 can repel blood that has come into contact with the water-repellent coating layer 140, thereby guiding the blood that has come into contact with the water-repellent coating layer 140 to the recesses 120. By guiding the blood from the water-repellent coating layer 140 to the recesses 120, the hemostatic device 100 can more reliably bring the blood into contact with the hydrophilic polymer layer 131 disposed in the recesses 120.

[0074] In addition, the first surface 111a has a marker portion 125. The marker portion 125 has a predetermined color and is disposed in the recess 120. Therefore, when the surgeon or the like attaches the hemostatic device 100 to the forearm A of the patient, the surgeon or the like can easily align the hydrophilic polymer layer 131 disposed in the recess 120 with the puncture site p.

[0075] Next, each modified example of the above-mentioned embodiment will be described. In the description of the modified examples, the description of the contents that overlap with the contents already described in the above-mentioned embodiment will be omitted. In addition, the contents that are not specifically described in the description of the modified examples can be the same as those in the above-mentioned embodiment.

[0076] (Variation 1) FIG. 7 is a plan view of an extension member 110A according to the first modification, and FIG. 8 is a cross-sectional view taken along the line 8A-8A shown in FIG.

[0077] As shown in FIG. 7, the recess 120 on the first surface 111a of the extension member 110A has a first recess 121 located in the central portion C of the extension member 110 and a plurality of second recesses 122a, 122b having a smaller outer shape than the first recess 121.

[0078] In this embodiment, the first recess 121 and each of the second recesses 122a, 122b have a circular planar shape. As shown in Fig. 7, the diameter of the first recess 121 is larger than the diameter of each of the second recesses 122a, 122b. The diameter of the second recess 122a is also larger than the diameter of the second recess 122b.

[0079] 7, second recesses are arranged on the first surface 111a of the extension member 110, the outer shape of which becomes smaller as it approaches the peripheral portion 115 of the first surface 111a from the first recess 121. That is, the outer shape of the second recesses becomes smaller as it approaches the peripheral portion 115 of the first surface 111a from the first recess 121. Therefore, the second recess 122b arranged closer to the peripheral portion 115 of the first surface 111a has a smaller outer shape in a plan view than the second recess 122a arranged closer to the center C of the extension member 110A.

[0080] 7, four second recesses 122a are arranged at vertical and horizontal positions of the first recess 121. Eight second recesses 122b are arranged to surround the periphery of the second recess 122a. The planar shape pattern formed by connecting the second recesses 122b with virtual lines H is expressed as a substantially square.

[0081] As shown in FIG. 8, a hydrophilic polymer layer 131 and a marker portion 125 are disposed in the first recess 121 and each of the second recesses 122a and 122b.

[0082] As described above, the first recess 121 disposed in the central portion C of the extension member 110A is formed larger than each of the second recesses 122a, 122b. Also, the first surface 111a of the extension member 110A is provided with second recesses whose outer shape becomes smaller from the first recess 121 toward the peripheral portion 115 of the first surface 111a.

[0083] The expansion member 110A according to the first modification has a plurality of recesses 121, 122a, 122b in which a hydrophilic polymer layer 131 is arranged on the first surface 111a of the expansion member 110A, and each recess can be arranged so that its diameter is small. Therefore, when aligning the expansion member 110A with the puncture site p or after arranging the expansion member 110A at the puncture site p, the surgeon can easily check the state of the puncture site p by visually checking the puncture site p through the gaps between the recesses 121, 122a, 122b of the first surface 111a. In addition, the expansion member 110A according to the first modification can release a sufficient amount of metal ions or medicine to the puncture site p while improving the visibility of the puncture site p because the hydrophilic polymer layer 131 arranged in the plurality of recesses 121, 122a, 122b contains metal ions or medicine.

[0084] Moreover, the recesses 121, 122a, and 122b are arranged to form a pattern of a predetermined shape on the first surface 111a of the expansion member 110. Therefore, the operator can use the pattern formed by the recesses 121, 122a, and 122b as a marker for aligning the puncture site p. Therefore, the center C of the expansion member 110 can be aligned to the puncture site p more easily. Furthermore, when the operator visually checks the expansion member 110A, the first recess 121 is easier to see than the second recesses 122a and 122b, so the operator can easily recognize that the first recess 121 is the center of the first surface 111a, and can easily align the first recess 121 to the puncture site p.

[0085] The shape of each of the recesses 121, 122a, 122b is not limited to a circle, and may be, for example, a rectangle, an ellipse, or other shape. The number of the second recesses 122a, 122b is also not limited. The first recess 121 and each of the second recesses 122a, 122b may be formed so that the first recess 121 is larger than each of the second recesses 122a, 122b in terms of area ratio on the first surface 111a. Therefore, the first recess 121 and each of the second recesses 122a, 122b may not be formed in a similar shape. The pattern represented by connecting the second recesses (second recesses 122a) arranged at the position closest to the peripheral portion 115 of the first surface 111a with a virtual line H is not limited to a square, and may be, for example, a circle.

[0086] (Variation 2) FIG. 9 is a plan view of an extension member 110B according to the second modification, and FIG. 10 is a cross-sectional view taken along the line indicated by the arrows 10A-10A in FIG.

[0087] As shown in FIG. 9, the extension member 110B has a guide groove 150 that extends from the recess 120 toward the peripheral edge 115 of the first surface 111a of the extension member 110B.

[0088] The guide groove 150 has a surrounding portion 151 that surrounds the periphery of the recess 120 and an extending portion 152 that extends from the surrounding portion 151 in a direction perpendicular to the longitudinal direction of the belt portion 171 .

[0089] The width of the extension portion 152 (the width along the longitudinal direction of the belt portion 171) can be formed to be smaller than the width of the recessed portion 120, for example.

[0090] 9, the surrounding portion 151 and the extending portion 152 of the guide groove 150 have a hydrophilic polymer layer 133. The hydrophilic polymer layer 133 does not contain metal ions or drugs. However, the hydrophilic polymer layer 133 may contain metal ions or drugs.

[0091] A water-repellent coating layer 140 is disposed on the first surface 111a of the extension member 110B in an area where the recesses 120 and the guide grooves 150 are not provided.

[0092] The hemostatic device including the expansion member 110B according to the second modification can guide blood from the recess 120 to the peripheral portion 115 via the guide groove 150 (extension portion 152) extending to the peripheral portion 115 of the expansion member 110. Therefore, when bleeding occurs from the puncture site p while the hemostatic device is being used to stop bleeding, excessive blood accumulation near the recess 120 can be suppressed. Therefore, even when a relatively large amount of blood bleeds from the puncture site p, the hemostatic device can suppress a decrease in visibility around the puncture site p. In addition, since the guide groove 150 includes the hydrophilic polymer layer 133, blood that has flowed into the guide groove 150 can be smoothly moved toward the peripheral portion 115 of the first surface 111a.

[0093] Note that the guide groove 150 is not limited to a specific planar shape or cross-sectional shape as long as it extends at least from the recess 120 to the peripheral portion 115 of the first surface 111a. The cross-sectional shape of the guide groove 150 is also not particularly limited, and may be formed, for example, in a semicircular shape or a U-shape.

[0094] (Variation 3) FIG. 11 is a plan view of an extension member 110C according to the third modification.

[0095] As shown in FIG. 11, the extension portion 152 of the guide groove 150 can be formed so that its width increases toward the peripheral edge portion 115 of the expansion member 110C, for example.

[0096] The extension portion 152 of the extension member 110B according to the above-described modified example 2 has a linear pattern extending in a direction perpendicular to the longitudinal direction of the belt portion 171 (see FIG. 9). The extension member 110B provided with the extension portion 152 having such a shape is easily bent in a direction perpendicular to the longitudinal direction of the belt portion 171, with the extension portion 152 as a base point. Therefore, even if the surgeon or the like does not intend to do so when handling the extension member 110B, the extension member 110B may be deformed so as to be bent with the extension portion 152 as a base point.

[0097] The expansion member 110C according to the third modification does not have an extension in a region (a region located at the center of the first surface 111a and extending in a direction perpendicular to the longitudinal direction of the belt portion 171) at the position where the recess 120 of the first surface 111a is formed, and therefore the strength of the expansion member 110C can be secured against tension in the longitudinal direction of the belt portion 171. In addition, the width of the expansion member 110C increases as it approaches the peripheral portion 115 of the first surface 111a, so that the expansion member 110B can be prevented from being deformed so as to be folded around the extension portion 152 as described above. In addition, the width of the extension portion 152 of the expansion member 110C increases as it approaches the peripheral portion 115 of the expansion member 110C, so that blood can be moved more smoothly from the recess 120 to the peripheral portion 115.

[0098] (Variation 4) FIG. 12 is a plan view of an extension member 110D according to the fourth modification, and FIG. 13 is a cross-sectional view taken along the line indicated by the arrows 13A-13A in FIG.

[0099] As shown in FIG. 12, a first surface 111a of an extension member 110D according to the fourth modification has a plurality of guide grooves 152a and 152b.

[0100] The first guide groove 152a extends along the longitudinal direction of the belt portion 171. The second guide groove 152b extends in a direction perpendicular to the longitudinal direction of the belt portion 171. A central groove 153 (corresponding to the recess 120) is disposed at the intersection of the first guide groove 152a and the second guide groove 152b. The marker portion 125 may be formed by coloring the hydrophilic polymer layer 131 itself, or may be disposed on the surface of the central groove 153 (recess 120) located at the bottom of the hydrophilic polymer layer 131. This allows the operator, etc., to use the marker portion 125 as a guide when arranging the expansion member 110D at the puncture site p, to grasp the position of the hydrophilic polymer layer 131 and to arrange the hydrophilic polymer layer 131 so as to surround the puncture site p.

[0101] As shown in FIG. 12, the hydrophilic polymer layer 131 containing at least one of metal ions and a drug is disposed between the adjacent guide grooves 152a and 152b. As a result, when blood leaks from the puncture site p after the surgeon or the like places the expansion member 110D at the puncture site p, the blood leaking from the puncture site p flows toward the guide grooves 152a and 152b so as to converge, and is likely to gather in the hydrophilic polymer layer 131 located between the adjacent guide grooves 152a and 152b. Therefore, when blood leaks from the puncture site p, the expansion member 110D according to the fourth modification efficiently contacts the hydrophilic polymer layer 131 with the blood, and therefore can efficiently gradually release the metal ions and drugs contained in the hydrophilic polymer layer 131 to the puncture site p. In this modification, one hydrophilic polymer layer 131 is disposed between the adjacent first guide groove 152a and second guide groove 152b. Specifically, four hydrophilic polymer layers 131 are disposed in the central groove 153 (recess 120).

[0102] 12 and 13, protrusions 160 are arranged in areas around central groove 153 (recess 120) where guide grooves 152a, 152b are not arranged. Protrusions 160 can be made of, for example, a material containing a water-absorbent polymer or a known resin material. In this way, protrusions 160 prevent blood leaking from puncture site p from leaking into areas where guide grooves 152a, 152b are not arranged.

[0103] In addition, in the expansion member 110D according to the fourth modification, the hydrophilic polymer layer 131 is disposed between the adjacent guide grooves 152a, 152b, and therefore the hydrophilic polymer layer 131 containing metal ions or a drug is not disposed in the center of the central groove 153 (recess 120). Therefore, when aligning the expansion member 110D with the puncture site p or after disposing the expansion member 110D at the puncture site p, the surgeon can visually confirm the condition of the puncture site p through the region of the central groove 153 (recess 120) where the hydrophilic polymer layer 131 is not disposed. This allows the surgeon to easily confirm the condition of the puncture site p.

[0104] Furthermore, in expansion member 110D according to this modification, central groove 153 (recess 120) is disposed so as to connect first guide groove 152a and second guide groove 152b, so that even when a large amount of blood flows into the vicinity of central groove 153 (recess 120), the blood can be smoothly guided to peripheral portion 115 of first surface 111a via guide grooves 152a, 152b. Therefore, the hemostatic device can prevent a decrease in visibility around puncture site p even when a relatively large amount of blood bleeds from puncture site p.

[0105] The above describes the hemostatic device of the present invention through embodiments and modified examples, but the present invention is not limited to the contents described in the specification and can be modified as appropriate based on the description of the claims.

[0106] As long as the hemostatic device has a configuration including an expansion member (e.g., a balloon) having a recess in which a hydrophilic polymer layer is arranged, the limb to be stopped and the specific hemostatic method are not particularly limited. In the description of the embodiment, a hemostatic device for stopping the hemostatic at a puncture site formed in the right forearm of a patient is exemplified, but the hemostatic device can also be configured to be capable of stopping the hemostatic at a puncture site formed in the left forearm. In addition, the hemostatic device may be configured to be capable of stopping the hemostatic at a puncture site formed on the radial artery side of the palmar artery (deep palmar artery) running on the back of the hand located on the finger side of the patient's forearm or on the palm side of the hand (e.g., an artery around the anatomical snuff box, or a distal radial artery running on the fingertip side of the snuff box).

[0107] Furthermore, the shape, dimensions, structure, etc. of each part of the hemostatic device are not particularly limited, so long as the expansion member can apply a compressive force to the puncture site while the hemostatic device is attached to at least a part of the limb, including the forearm or hand.

[0108] This application is based on Japanese Patent Application No. 2020-058884 filed on March 27, 2020, the disclosure of which is incorporated by reference in its entirety. [Explanation of symbols]

[0109] 100 Hemostatic devices 110, 110A, 110B, 110C, 110D Extension members 111a 1st surface 115 Edge of first surface 120 Recess 121 First recess 122a, 122b Second recess 125 Marker section 130 Hydrophilic materials area 131 Hydrophilic polymer layer 133 Hydrophilic polymer layer 140 Water-repellent coating layer 150 Guide groove 151 Enclosed section 152 Extension 152a 1st guide groove 152b 2nd guide groove 153 Central groove (recess) 160 Convex 170 Fixing member 171 Belt section 180 Auxiliary Materials 200 Injection part A Forearm (limb) C Center of extension member p Puncture site (site where bleeding should be stopped)

Claims

1. an expansion member configured for placement on the limb at a site where hemostasis is desired; a fixation member configured to fix the expansion member to the limb, the expansion member has a first surface configured for placement at the site where hemostasis is desired; the first surface has a recess recessed into an outer surface side of the fixing member and a hydrophilic material region located in the recess, the hydrophilic material region is a hydrophilic polymer layer containing at least one of a metal ion and a drug; The recess includes a first recess located in a center portion of the expansion member and a plurality of second recesses each having an outer shape smaller than that of the first recesses, A hemostatic device, wherein an outer shape of the second recess decreases from the first recess toward a peripheral edge of the first surface.

2. An expansion member configured to be placed at a site of a limb where bleeding should be stopped; a fixation member configured to fix the expansion member to the limb, the expansion member has a first surface configured for placement at the site where hemostasis is desired; the first surface has a recess recessed into an outer surface side of the fixing member and a hydrophilic material region located in the recess, the hydrophilic material region is a hydrophilic polymer layer containing at least one of a metal ion and a drug; a guide groove extending from the recess toward a peripheral portion of the first surface; The guide groove comprises a hydrophilic polymer layer.

3. a guide groove extending from the recess toward a peripheral portion of the first surface; The hemostatic device of claim 1 , wherein the guide channel comprises a hydrophilic polymer layer.

4. The first surface has a plurality of the guide grooves, The hemostatic device according to claim 2 or 3, wherein the hydrophilic polymer layer containing at least one of a metal ion and a drug is disposed between adjacent guide grooves.

5. The hemostatic device according to any one of claims 1 to 4, wherein a water-repellent coating layer is disposed on at least a portion of the area of ​​said first surface where said recesses are not provided.

6. the first surface has a marker portion; The hemostatic device according to any one of claims 1 to 5, wherein the marker portion has a predetermined color and is disposed in the recess.

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