JP7628532B2 - Hemostatic devices - Google Patents

Description

The present invention relates to a hemostatic device.

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 the affected area. When performing such a procedure, the surgeon stops bleeding at the puncture site before removing the medical elongated object from the puncture site.

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 the limb, and an expansion member such as a balloon that is connected to the band and expands when a fluid is injected into it to apply pressure to the puncture site (see Patent Document 1).

JP 2010-131296 A

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

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 a drug that exerts various medicinal effects while performing compression hemostasis using the hemostatic device described in Patent Document 1. In addition, as a method 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.

However, when a drug is placed on the surface of the expansion member of a hemostatic device, 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 some 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 the drug may not be able to fully exert its efficacy.

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 the metal ions and drugs contained in the hydrophilic polymer layer, and can prevent the hydrophilic polymer layer containing the metal ions and drugs from peeling off from the expansion member.

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 metal ions and a drug, the recess having a first recess located in the center of the expansion member and a plurality of second recesses having an outer shape smaller than the first recesses, the outer shape of the second recesses becoming smaller as the distance from the first recesses approaches the peripheral edge of the first surface . 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.

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 if 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 if 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.

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. 2 is a cross-sectional view taken along the line 2A-2A shown in FIG. 1. FIG. 3 is an enlarged view of part 3A shown in FIG. 2 . 4A is a plan view of a first surface of the expansion member as viewed from the direction of arrow 4A shown in FIG. 2. 5A is a cross-sectional view taken along the line 5A-5A shown in FIG. 4. 1 is a diagram showing a state in which a hemostatic device according to an embodiment is attached to a patient's limb. FIG. FIG. 11 is a plan view showing an expansion member according to a first modified example. 8 is a cross-sectional view taken along the line 8A-8A shown in FIG. 7. FIG. 11 is a plan view showing an expansion member according to Modification 2. 10A is a cross-sectional view taken along the line 10A-10A shown in FIG. 9. FIG. 13 is a plan view showing an expansion member according to Modification 3. FIG. 13 is a plan view showing an expansion member according to Modification 4. 13A is a cross-sectional view taken along the line 13A-13A shown in FIG. 12.

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 the terms described in the claims. Also, the dimensional ratios in the drawings have been exaggerated for the convenience of explanation and may differ from the actual ratios.

Figures 1 to 5 are diagrams for explaining the hemostatic device 100 relating to the embodiment, and Figure 6 is a diagram showing the hemostatic device 100 attached to a patient's forearm (corresponding to a "limb") A.

<Hemostatic instruments>
As shown in FIG. 6 , the hemostatic device 100 is configured as a medical device that stops 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.

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.

<Fixing member>
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 172 a and 172 b arranged on the belt portion 171 .

1 shows a plan view of the hemostatic device 100 as viewed from the inner surface 171a of the belt portion 171. The inner surface 171a of the belt portion 171 is the surface that is positioned 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.

The belt portion 171 can be made of, for example, a flexible material. 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 combination of these (blend resins, polymer alloys, laminates, etc.).

As shown in Figure 1, the first connecting portion 172a is disposed near one end portion 173a in the longitudinal direction of the belt portion 171. The first connecting portion 172a is also disposed on the inner surface 171a of the belt portion 171. In Figures 1, 2, and 4, the longitudinal direction of the belt portion 171 is indicated by the arrows X1-X2.

The second connecting portion 172b is disposed near the other longitudinal end portion 173b of the belt portion 171. The second connecting portion 172b is also disposed on the outer surface 171b of the belt portion 171.

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

When attaching the hemostatic device 100 to the patient's forearm A, the surgeon wraps the belt portion 171 around the patient's forearm A 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 patient's forearm A, the surgeon brings the connecting portions 172a, 172b arranged on the belt portion 171 into contact with each other and connects them. By connecting the connecting portions 172a, 172b to each other, the surgeon can fix the hemostatic device 100 to the patient's forearm A with the expansion member 110 arranged at the puncture site p.

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 patient's forearm A. 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 arranged on the belt part 171 and the number of connecting parts, etc. are also not particularly limited.

As shown in Fig. 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.

The holding member 175a is connected to the outer surface 171b of the belt portion 171. The holding member 175a forms a gap between the outer surface 171b of the belt portion 171 and the holding member 175a, which allows the holding plate 175b to be held. The holding plate 175b has a flat-shaped portion formed in at least a part of the longitudinal direction of the holding plate 175b (the vertical direction in FIG. 2) 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.

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.

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 that are made of a transparent, semi-transparent, colored transparent, etc. material so that the surgeon or the like can visually recognize the marker portion 125 (see Figures 3 and 5) when visually inspecting the expansion member 110 from the outer surface 171b side of the belt portion 171.

<Expansion member>
The expansion member 110 is configured as 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.

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

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 composed of a balloon that is expanded by injecting a fluid. The second surface 111b of the expansion member 110 is the outer surface of the portion located opposite the first surface 111a.

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

2, the auxiliary member 180 can be disposed at any position near 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).

As shown in FIG. 3, the internal space 113 of the expansion member 110 and the internal space 183 of the auxiliary member 180 are connected via a communication portion 190. The communication portion 190 is composed of a hole portion formed in the expansion member 110 and a hole portion formed in the auxiliary member 180.

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 adhesive.

The expansion 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 them. In this embodiment, the first surface 111a of the expansion member 110 is rectangular as shown in FIG. 4.

The constituent materials of the extension member 110 and the auxiliary member 180 may be, for example, the same materials as those exemplified as the materials of the belt portion 171.

The extension member 110 and the auxiliary member 180 may be formed, for example, so that their outer shapes in a planar view are substantially rectangular. However, the specific outer shapes of the extension member 110 and the auxiliary member 180 are not particularly limited.

The internal space 113 of the expansion member 110 is connected to the inner cavity of a tube 203 provided in the injection section 200 (see FIG. 1) described later. The tube 203 may be connected to the internal space 183 of the auxiliary member 180.

The surgeon can inject a fluid (e.g., 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.

With the hemostatic device 100 attached to the patient's forearm A (see FIG. 6), the surgeon can apply a compressive force to the puncture site p by expanding the expansion member 110. Furthermore, when the surgeon 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 toward the puncture site p. This allows the surgeon to effectively apply a compressive force from the expansion member 110 to the puncture site p.

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 composed of, for example, a member other than an expandable and deformable balloon.

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

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

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 the surgeon expands 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.

The surgeon can inflate the expansion member 110 by injecting air into the internal space 113 of the expansion member 110. When the surgeon 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 to expand the auxiliary member 180. When the surgeon expands the expansion member 110 and the auxiliary member 180, the bag portion 202, which is connected to the expansion member 110 via the tube 203, expands. The surgeon can visually confirm that the bag portion 202 expands, thereby confirming that the expansion member 110 and the auxiliary member 180 have expanded.

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

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

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

Figure 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 arrow 4A in Figure 2. Figure 5 is a cross-sectional view of the extension member 110 along the line of arrow 5A-5A in Figure 4.

The "outer surface side of the fixing member" which refers to the concave direction of the recess 120 is the second surface 111b side located opposite the first surface 111a of the expansion member 110 (see Figure 3).

The recess 120 is positioned so as to be located at the center C of the first surface 111a of the expansion member 110, as shown in Figure 4. The center C of the expansion member 110 is the center in the planar view shown in Figure 4. When the first surface 111a has a rectangular planar shape, as in the expansion member 110 of this embodiment, the center C of the expansion member 110 is the intersection of diagonals L1, L2 connecting the opposing vertices.

The recess 120 can be formed to have, for example, a circular planar shape as shown in Figure 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 other shape.

As shown in Fig. 5, the recess 120 can be formed, for example, in a rectangular cross-sectional shape with a substantially constant width (dimension in the vertical direction in the figure) along the depth direction of the recess 120 (left-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 are also no particular limitations on the depth or width of the recess 120.

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

The hydrophilic polymer layer 131 may be disposed on at least a portion 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 as colorless and transparent, colored and transparent, translucent, or the like, so as not to reduce the visibility of the marker portion 125.

The hydrophilic polymer layer 131 can be formed using known materials and methods. The hydrophilic polymer layer is, for example, a hydrogel layer having water swelling properties, and the hydrogel layer is configured to fix or retain metal ions or drugs. 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, etc. It is sufficient that the hydrophilic polymer layer 131 is provided on at least a portion of the recess 120.

As the drug to be contained in the hydrophilic polymer layer 131, known metal ions or known hemostatic agents can be used. As the metal ions, for example, known metal ions that are effective in early wound healing or hemostasis can be used. As the drug, known hemostatic agents that are effective in hemostasis, such as ascorbic acid or sodium alginate, can be used.

As shown in Fig. 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 to align the hydrophilic polymer layer 131 at the puncture site p or around the puncture site p.

In this embodiment, the marker portion 125 is disposed on the portion of the first surface 111a of the expansion 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 may not 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 on the central portion of the hydrophilic polymer layer 131 (only on the central portion of the recess 120) so as to increase the visibility of the puncture site p while making it easy to reliably place the hydrophilic polymer layer 131 at the puncture site p.

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

As shown in Figures 4 and 5, a water-repellent coating layer 140 is arranged in the area of the first surface 111a of the extension member 110 where no recess 120 is provided.

In this embodiment, the water-repellent coating layer 140 is provided on all areas 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 first surface 111a other than the recess 120. However, it is preferable that the water-repellent coating layer 140 is at least disposed at a position surrounding the recess 120 on the first surface 111a. By disposing 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.

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

Figure 6 shows the hemostatic device 100 attached to the patient's forearm A after a puncture site p has been formed.

Although the introducer is not shown in Figure 6, the surgeon can place the expansion member 110 at the puncture site p with the sheath tube of the introducer inserted into the puncture site p. The surgeon can also remove the sheath tube from the puncture site p with the hemostatic device 100 attached to the patient's forearm A.

When placing the expansion member 110 at the puncture site p, the surgeon 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 to easily place the recess 120 with the hydrophilic polymer layer 131 placed therein at the puncture site p.

In addition, in the hemostatic device 100, when viewed in a plan view 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 as colorless and transparent, colored transparent, colorless and transparent, etc., thereby preventing a decrease in the visibility of the marker portion 125.

The surgeon removes the sheath tube from the puncture site p with the recess 120 of the expansion member 110 positioned 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.

In addition, 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 in the expansion member 110.

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 arranged to surround 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 arranged in the recess 120 by guiding blood from the water-repellent coating layer 140 to the recess 120. Therefore, it is possible to effectively release metal ions and drugs contained in the hydrophilic polymer layer 131 arranged in the recess 120.

As described above, the hemostatic device 100 according to this embodiment includes an expansion member 110 configured to be placed on the patient's forearm A, and a 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 that is 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 that contains at least one of a metal ion and a drug.

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, 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 repair 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.

In addition, a water-repellent coating layer 140 is disposed on at least a portion of the area of the first surface 111a where the recesses 120 are not provided. Therefore, the hemostatic device 100 can repel blood that comes into contact with the water-repellent coating layer 140, thereby guiding the blood that comes 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.

The first surface 111a also has a marker portion 125. The marker portion 125 has a predetermined color and is disposed in the recess 120. Therefore, when attaching the hemostatic device 100 to the patient's forearm A, the surgeon can easily align the hydrophilic polymer layer 131 disposed in the recess 120 with the puncture site p.

Next, we will explain each of the modified examples of the above-mentioned embodiment. In the explanation of the modified examples, we will omit the explanation of the contents that overlap with the contents already explained in the above-mentioned embodiment. In addition, the contents that are not specifically explained in the explanation of the modified examples can be the same as the above-mentioned embodiment.

(Variation 1)
FIG. 7 is a plan view of an expansion member 110A according to the first modified example, and FIG. 8 is a cross-sectional view taken along the line 8A-8A shown in FIG.

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.

In this embodiment, the first recess 121 and each of the second recesses 122a and 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 and 122b. The diameter of the second recess 122a is also larger than the diameter of the second recess 122b.

As shown in Figure 7, a second recess is arranged on the first surface 111a of the extension member 110, the outer shape of which becomes smaller as it approaches the peripheral edge 115 of the first surface 111a from the first recess 121. That is, the outer shape of the second recess becomes smaller as it approaches the peripheral edge 115 of the first surface 111a from the first recess 121. Therefore, the second recess 122b arranged closer to the peripheral edge 115 of the first surface 111a has a smaller outer shape in a plan view than the second recess 122a arranged closer to the central portion C of the extension member 110A.

In this embodiment, as shown in Fig. 7, four second recesses 122a are arranged at positions in the up, down, left and right directions 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 each second recess 122b with a virtual line H is represented as an approximately square.

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

As described above, the first recess 121 located in the central portion C of the extension member 110A is formed larger than each of the second recesses 122a, 122b. In addition, the first surface 111a of the extension member 110A is provided with second recesses whose outer dimensions become smaller as they approach the peripheral portion 115 of the first surface 111a from the first recess 121.

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 placing the expansion member 110A at the puncture site p, the surgeon can easily check the condition 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, since the hydrophilic polymer layer 131 arranged in the plurality of recesses 121, 122a, 122b of the expansion member 110A according to the first modification contains metal ions or drugs, the hydrophilic polymer layer 131 arranged in the plurality of recesses 121, 122a, 122b of the expansion member 110A according to the first modification can release a sufficient amount of metal ions or drugs to the puncture site p while improving the visibility of the puncture site p.

In addition, each recess 121, 122a, 122b is 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 each recess 121, 122a, 122b as a marker for aligning the puncture site p. Therefore, the center C of the expansion member 110 can be aligned more easily with the puncture site p. In addition, when the operator visually checks the expansion member 110A, the first recess 121 is easier to see than the second recesses 122a, 122b, so the operator can easily recognize that the first recess 121 is the center of the first surface 111a, and it becomes easier to align the first recess 121 with the puncture site p.

The shape of each recess 121, 122a, 122b is not limited to a circle, and may be, for example, a rectangle, an ellipse, or other shape. The number of second recesses 122a, 122b is also not limited. The first recess 121 and each second recess 122a, 122b may be formed so that the first recess 121 is larger than each second recess 122a, 122b in terms of area ratio on the first surface 111a. Therefore, the first recess 121 and each second recess 122a, 122b do not have to be formed in a similar shape. The pattern represented by connecting the second recess (second recess 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.

(Variation 2)
FIG. 9 is a plan view of an expansion member 110B according to the second modification, and FIG. 10 is a cross-sectional view taken along the line 10A-10A shown in FIG.

As shown in FIG. 9, the extension member 110B has a guide groove 150 extending from the recess 120 toward the peripheral portion 115 of the first surface 111a of the extension member 110B.

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

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

As shown in FIG. 9, the enclosed portion 151 and the extended 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.

A water-repellent coating layer 140 is disposed in the area of the first surface 111a of the extension member 110B where the recess 120 and the guide groove 150 are not provided.

The hemostatic device having the expansion member 110B according to the second modification can guide blood from the recess 120 to the peripheral portion 115 through 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 performing hemostasis using the hemostatic device, excessive blood retention 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 has a hydrophilic polymer layer 133, the blood that has flowed into the guide groove 150 can be smoothly moved toward the peripheral portion 115 of the first surface 111a.

In addition, 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. In addition, the cross-sectional shape of the guide groove 150 is not particularly limited, and may be formed, for example, in a semicircular shape or a U-shape.

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

As shown in FIG. 11, the extension portion 152 of the guide groove 150 can be formed, for example, so as to become wider as it approaches the peripheral portion 115 of the extension member 110C.

The extension portion 152 of the extension member 110B according to the above-mentioned 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 of this shape is easily bent in a direction perpendicular to the longitudinal direction of the belt portion 171, with the extension portion 152 as the 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 the base point.

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

(Variation 4)
FIG. 12 is a plan view of an expansion member 110D according to the fourth modified example, and FIG. 13 is a cross-sectional view taken along the line 13A-13A shown in FIG.

As shown in FIG. 12, the first surface 111a of the extension member 110D of variant example 4 has a plurality of guide grooves 152a, 152b.

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 surgeon, etc., to use the marker portion 125 as a guide when arranging the expansion member 110D at the puncture site p, while grasping the position of the hydrophilic polymer layer 131, and to arrange the hydrophilic polymer layer 131 so as to surround the puncture site p.

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 the surgeon or the like places the expansion member 110D at the puncture site p and blood leaks from the puncture site p, the blood leaking from the puncture site p flows toward the guide grooves 152a and 152b and tends 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, so that the metal ions and drugs contained in the hydrophilic polymer layer 131 can be efficiently released 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).

12 and 13, protrusions 160 are arranged in areas around the 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 the puncture site p from leaking into areas where guide grooves 152a, 152b are not arranged.

In addition, in the expansion member 110D according to the fourth modified example, the hydrophilic polymer layer 131 is disposed between the adjacent guide grooves 152a and 152b, and therefore the hydrophilic polymer layer 131 containing metal ions or drugs 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 area 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.

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

The hemostatic device of the present invention has been described above 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.

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 process at a puncture site formed on the right forearm of a patient is exemplified, but the hemostatic device can also be configured to stop the hemostatic process at a puncture site formed on the left forearm. In addition, the hemostatic device may be configured to stop the hemostatic process 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).

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 when the hemostatic device is attached to at least a part of the limb, including the forearm or hand.

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.

100 Hemostatic device 110, 110A, 110B, 110C, 110D Expansion member 111a First surface 115 Peripheral edge portion of first surface 120 Recess 121 First recess 122a, 122b Second recess 125 Marker portion 130 Hydrophilic material region 131 Hydrophilic polymer layer 133 Hydrophilic polymer layer 140 Water-repellent coating layer 150 Guide groove 151 Surrounding portion 152 Extension portion 152a First guide groove 152b Second guide groove 153 Central groove (recess)
160: Convex portion 170: Fixing member 171: Belt portion 180: Auxiliary member 200: Injection portion A: Forearm portion (limb)
C: central portion of expansion member p: puncture site (site where bleeding should be stopped)

Claims (6)

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 . 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;
a guide groove extending from the recess toward a peripheral portion of the first surface;
The guide groove comprises a hydrophilic polymer layer . 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. 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. 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 the first surface where the recesses are not provided. 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.