JP7360980B2 - hemostasis device - Google Patents

Description

BACKGROUND OF THE INVENTION The present invention relates to a hemostasis device.

Traditionally, various medical elongated bodies (e.g., catheters) are introduced into blood vessels through puncture sites formed in blood vessels of limbs such as hands and arms of patients, and procedures and treatments for diseased areas have been used. Are known. When performing such a procedure, the operator or the like stops the bleeding at the puncture site when removing the medical elongated body from the puncture site.

As a hemostasis device used to stop bleeding at a puncture site, there is a fixing member that includes a band that wraps around the limb, and an expansion device such as a balloon that is connected to the band and expands by injecting fluid to compress the puncture site. A device having a member has been proposed (see Patent Document 1).

Japanese Patent Application Publication No. 2010-131296

In the hemostasis method using the hemostatic device disclosed in Patent Document 1, the operator applies pressure to the puncture site by injecting fluid into the expandable member to expand it while the hemostatic device is fixed to the patient's limb. Grant. The operator or the like can apply pressure to the puncture site for a predetermined period of time using the expansion member to stop bleeding by applying pressure to the puncture site.

For example, in a treatment to stop bleeding at a puncture site formed on a limb, the puncture site can be effectively stopped by applying pressure to stop bleeding using the hemostatic device described in Patent Document 1 and using drugs that exhibit various medicinal effects. It is thought that it is possible to stop bleeding. As such a hemostasis method, a method can be considered in which a wound healing dressing loaded with a drug is used in combination with a hemostatic device including an expansion member.

However, in the method of fixing the dressing to the expansion member of a hemostasis device and pressing the dressing against the puncture site, when the expansion member is expanded, the dressing does not adhere tightly to the puncture site due to the unevenness of the patient's skin surface. It may not be possible to obtain the full medicinal effect of the drug loaded on the device. Furthermore, since the covering material is placed on the surface of the expansion member, there is a possibility that a part of the covering material may come off due to abrasion or the like due to an erroneous operation before the expansion member is placed at the puncture site.

The present invention has been made in view of the above-mentioned problems, and provides a hemostasis device that is equipped with an expansion member that enables pressure hemostasis at a puncture site, and that can improve wound repair effects and hemostasis effects using drugs. The purpose is to

A hemostasis device that achieves the above object includes an expansion member configured to be placed at a site of a limb where bleeding is to be stopped, and a fixing member configured to fix the expansion member to the limb, The member includes an expanded portion that can be expanded and deformed, a covering member that covers at least a part of the surface of the expanded portion, and a drug layer disposed in a space between the expanded portion and the covering member. , the covering member has a release part that fixes the expansion member to the limb and releases the drug contained in the drug layer to the skin surface side of the limb in a state where the expansion member is expanded. The covering member includes a sheet member fixed to the surface of the expansion part, and a through hole provided in the sheet member, and the discharge part The valve mechanism includes a first region, a second region surrounding the first region, and a second region surrounding the first region. , the first region has at least one slit or hole, and the second region is made of a harder material than the first region.

When the hemostatic device configured as described above is expanded while the expansion member is fixed to the patient's limb, the drug contained in the drug layer is released to the skin surface side of the patient's limb via the release portion. Specifically, when an operator or the like expands the expansion member, the expansion part deforms and applies compressive force to the space located between the expansion part and the covering member. The drug in the drug layer disposed in the space is released through the space. As a result, the operator, etc. can release the drug in the drug layer placed in the space to the puncture site while expanding the expansion member and pressing the covering member against the skin surface side of the patient's limb. can. Therefore, the operator can administer the drug around the puncture site while pressing the covering member against the skin surface side of the patient's extremities. The hemostatic effect of can be effectively enhanced. In addition, in the hemostatic device configured as described above, the drug is released to the puncture site when the expansion member is expanded, so it is possible to hygienically deliver the drug to the puncture site while preventing the drug from peeling off due to friction etc. before use. Can be released. In addition, the hemostasis device configured as described above contains protein as an active ingredient, which is difficult to use by soaking into the dressing material, because the drug is retained in the space between the expansion part and the covering member. Biopharmaceuticals, etc. that can be used as drugs can also be used.

FIG. 3 is a diagram showing the hemostasis device according to the first embodiment, and is a plan view seen from the inner surface of the band of the fixing member. 2 is a sectional view taken along the arrow 2A-2A line shown in FIG. 1. FIG. 3 is an enlarged view of a broken line portion 3A shown in FIG. 2. FIG. FIG. 3 is a diagram showing how the hemostatic device according to the first embodiment is attached to a patient's limb. 5 is a cross-sectional view schematically showing an example of use of the hemostasis device according to the first embodiment, and is a cross-sectional view corresponding to arrow 5A-5A shown in FIG. 4. FIG. FIG. 2 is a cross-sectional view schematically showing an example of use of the hemostatic device according to the first embodiment. FIG. 2 is a cross-sectional view schematically showing an example of use of the hemostatic device according to the first embodiment. FIG. 2 is a cross-sectional view schematically showing an example of use of the hemostatic device according to the first embodiment. It is a sectional view showing modification example 1 of a discharge part. It is a sectional view showing modification example 1 of a discharge part. It is a sectional view showing modification example 1 of a discharge part. It is a top view which shows the modification 2 of a discharge part. It is a sectional view showing modification example 2 of a discharge part. It is a sectional view showing modification example 2 of a discharge part. It is a sectional view showing modification example 3 of a discharge part. It is a sectional view showing modification example 3 of a discharge part. It is a sectional view showing modification 4 of a discharge part. It is a sectional view showing modification 4 of a discharge part. It is a sectional view for explaining the function of modification 4 of a discharge part. It is a sectional view for explaining the function of modification 4 of a discharge part. It is a sectional view for explaining the function of modification 4 of a discharge part. It is a sectional view for explaining the function of modification 4 of a discharge part. It is a sectional view for explaining the function of modification 4 of a discharge part. FIG. 7 is a cross-sectional view showing a modification of the expanded portion. FIG. 7 is a cross-sectional view showing a modification of the expanded portion. It is a figure which shows the hemostasis instrument based on 2nd Embodiment, and is a top view seen from the outer surface side of the main body part of a fixing member. It is a figure which shows the situation when the hemostasis device based on 2nd Embodiment is attached to a patient's limb.

Embodiments and modifications of the present invention will be described below with reference to the accompanying drawings. Note that the following description does not limit the technical scope or meaning of terms described in the claims. Further, the dimensional ratios in the drawings are exaggerated for convenience of explanation and may differ from the actual ratios.

(First embodiment)
1 to 3 are diagrams for explaining the configuration of each part of the hemostasis device 100 according to the first embodiment, and FIGS. 4 to 8 are diagrams for explaining usage examples of the hemostasis device 100.

<Bleeding device>
As shown in FIGS. 4 and 5 to 8, the hemostasis device 100 according to the first embodiment is used in a forearm portion A for the purpose of inserting a catheter or the like for treatment or examination into a blood vessel (for example, a radial artery). As a medical device to stop the bleeding at the puncture site p (corresponding to the "limb") when removing the sheath tube of the introducer placed in the puncture site (corresponding to the "site to stop bleeding") p. It consists of

In this embodiment, the forearm A is illustrated as the limb to which the hemostasis device 100 is attached. However, the limb to which the hemostatic device is attached may be, for example, the hand (for example, the left hand) H located on the finger side of the patient's forearm A, as explained in the embodiment described later (see FIG. 27). reference).

To outline the hemostatic device 100 with reference to FIG. 1, FIG. 2, FIG. 3, and FIG. A fixing member 110 configured to be fixed to.

<Fixed member>
As shown in FIGS. 1, 4, and 8, the fixing member 110 includes a band 111 configured to be wrapped around the patient's forearm A, and connecting parts 112a and 112b arranged on the band 111. Be prepared.

FIG. 1 shows a plan view of the hemostatic device 100 viewed from the inner surface 111a side of the band member 111. The inner surface 111a of the band 111 is the side surface that is arranged to face the skin surface layer Af of the patient's forearm A (see FIGS. 5 to 8) when the hemostatic device 100 is attached to the patient's hand H. be. The outer surface 111b of the band 111 is the surface opposite to the inner surface 111a.

The band 111 can be made of a flexible member, for example. Examples of the material constituting the band 111 include polyvinyl chloride, polyethylene, polypropylene, polybutadiene, polyolefin such as ethylene-vinyl acetate copolymer (EVA), polyethylene terephthalate (PET), and polybutylene terephthalate (PBT). Various thermoplastic elastomers such as polyester, polyvinylidene chloride, silicone, polyurethane, polyamide elastomer, polyurethane elastomer, and polyester elastomer, or any combination of these (blended resin, polymer alloy, laminate, etc.) can be used. can.

As shown in FIG. 1, the first connecting portion 112a is arranged near one end of the band 111 in the longitudinal direction (the end located on the lower side of FIG. 1). Further, the first connecting portion 112a is arranged on the inner surface 111a of the band 111.

The second connecting portion 112b is disposed near the other end of the band 111 in the longitudinal direction (the end located on the upper side in FIG. 1). Further, the second connecting portion 112b is arranged on the outer surface 111b of the band 111.

The first connecting part 112a and the second connecting part 112b have a configuration that can be connected and separated from each other. Each of the connecting portions 112a and 112b can be made of, for example, a hook-and-loop fastener. In this embodiment, the first connecting portion 112a is configured on the female side of the hook-and-loop fastener, and the second connecting portion 112b is configured on the female side of the hook-and-loop fastener.

When attaching the hemostatic device 100 to the patient's forearm A, the operator etc. places the inner surface 111a side of the band 111 connected to the expansion member 120 facing the skin surface layer Af of the patient's forearm A. Then, the band 111 is wrapped around the patient's forearm A. The operator or the like connects the connecting parts 112a and 112b arranged on the band 111 by bringing them into contact with each other while the band 111 is wrapped around the skin surface layer Af of the patient's forearm A. The operator or the like can fix the band 111 to which the expansion member 120 is connected to the patient's forearm A by connecting the connecting parts 112a and 112b.

The structure of each connecting part 112a, 112b is not particularly limited as long as it is possible to maintain the state in which the hemostatic device 100 is attached to the patient's forearm A. For example, each connecting portion 112a, 112b may be made of a material other than a hook-and-loop fastener. Further, even when each of the connecting portions 112a and 112b is formed of a hook-and-loop fastener as in this embodiment, the female side and the male side can be replaced as desired. Furthermore, the positions of the connecting portions 112a and 112b in the band 111, the number of connecting portions, etc. are not particularly limited.

As shown in FIG. 2, the band 111 is provided with a support portion 115. The support portion 115 includes a holding member 115a arranged near the center of the band 111 in the longitudinal direction, and a support plate 115b held between the holding member 115a and the band 111.

The holding member 115a is connected to the outer surface 111b of the band 111. The holding member 115a forms a gap portion between the holding member 115a and the outer surface 111b of the band member 111 so that the support plate 115b can be held. The support plate 115b includes a flat portion formed in at least a portion of the longitudinal direction (vertical direction in FIG. 2) of the support plate 115b, and a curved portion concavely curved toward the inner surface 111a of the band 111. have The support plate 115b can be made of a material harder than the band 111, for example. Note that the specific cross-sectional shape, material, etc. of the support plate 115b are not particularly limited.

The support plate 115b suppresses the expansion of the expansion part 130 in the direction away from the skin surface layer Af of the patient's forearm A when the expansion part 130 is expanded. Therefore, when the expansion part 130 is expanded, the hemostasis device 100 can concentrate the compressive force on the patient's forearm A to which the expansion part 130 is fixed.

The band member 111, the holding member 115a, and the support plate 115b are arranged so that when an operator or the like visually observes the expansion member 120 from the outer surface 111b side of the band member 111, a marker portion 135 (see FIG. 4), which will be described later, can be visually recognized. In order to achieve this, it is preferable to use transparent, semi-transparent, colored transparent materials, etc.

<Expansion member>
As shown in FIG. 1, FIG. 2, FIG. 3, FIG. 7, and FIG. and a drug layer 190A disposed in the space 190 between the expanded portion 130 and the covering member 160.

<Extension section>
The expansion section 130 is composed of a balloon that is expanded by injecting fluid. The expansion part 130 has an internal space 133 into which fluid can be injected, as shown in FIG. 3 .

The first surface 131a of the expansion part 130 to which the covering member 160 is connected is the outer surface of the surface that will be placed on the skin surface layer Af side of the patient's forearm A when the expansion part 130 is placed on the patient's forearm A. be. The second surface 131b of the extended portion 130 is an outer surface located on the opposite side of the first surface 131a, and is a surface arranged to face the inner surface 111a of the band 111.

A deformable auxiliary member 150 is connected to the second surface 131b of the expanded portion 130, which has a smaller external shape than the expanded portion 130. The auxiliary member 150 is composed of a balloon that is expanded by injecting fluid.

The auxiliary member 150 has an internal space 153 into which fluid can be injected. The first surface 151a of the auxiliary member 150 is connected to the second surface 131b of the extension 130. The second surface 151b of the auxiliary member 150 is connected to the inner surface 111a of the band 111.

For example, as shown in FIG. 2, the auxiliary member 150 can be placed at any position on one end of the band 111 in the longitudinal direction (the end located on the upper side of FIG. 2). The auxiliary member 150 is connected to the band 111 near one end of the auxiliary member 150 (the right end in FIG. 3).

As shown in FIG. 3, the internal space 131 of the expansion part 130 and the internal space 151 of the auxiliary member 150 communicate with each other via the communication part 140. The communication portion 140 is configured by a hole formed in the expanded portion 130 and a hole formed in the auxiliary member 150.

The expansion part 130 is connected to the auxiliary member 150 around the communication part 140. Further, the auxiliary member 150 is connected to the band body 111. Therefore, the expansion part 130 is connected to the band body 111 via the auxiliary member 150. The auxiliary member 150 and the band member 111 and the extended portion 130 and the auxiliary member 150 can be connected, for example, by fusion bonding or adhesive.

The expansion part 130 and the auxiliary member 150 are configured, for example, to form inner spaces 131 and 151 between two sheet-like members formed in a substantially rectangular shape, and to extend the outer peripheral edges of the two sheet-like members. It can be formed by joining. Note that the specific structures of the expanding portion 130 and the auxiliary member 150 are not particularly limited as long as they are configured to be expandable and contractible as fluid is injected and discharged.

As the constituent material of the expansion part 130 and the auxiliary member 150, for example, the same material as that exemplified as the material of the band body 111 can be used.

The expanded portion 130 and the auxiliary member 150 can have, for example, a substantially rectangular outer shape in a plan view. However, the specific external shapes of the expansion part 130 and the auxiliary member 150 are not particularly limited.

The internal space 131 of the expansion section 130 communicates with the lumen of a tube 203 provided in the injection section 200 (see FIGS. 1 and 4), which will be described later. Note that the tube 203 may be connected to the internal space 151 of the auxiliary member 150.

The expansion section 130 and the auxiliary member 150 can be expanded by an operator or the like injecting fluid (for example, air) into the internal space 131 of the expansion section 130 through the tube 203 .

The operator or the like can apply pressure to the puncture site p by expanding the expansion section 130 while the hemostasis device 100 is attached to the patient's forearm A (see FIG. 4). Further, when the operator or the like expands the auxiliary member 150 together with the expansion section 130, the direction of the compressive force applied by the expansion section 130 can be adjusted by the auxiliary member 150 in the direction toward the puncture site p. Therefore, the operator or the like can effectively apply compressive force to the puncture site p using the expansion section 130.

Note that the hemostasis device 100 does not need to include the auxiliary member 150. Further, even when the hemostasis device 100 includes the auxiliary member 150, the auxiliary member 150 can be made of a member other than an expandable and deformable balloon, for example.

As shown in FIGS. 2 and 3, a marker section 135 is arranged in the expansion section 130 to align the expansion member 120 with respect to the puncture site p.

The marker portion 135 can be provided, for example, so as to be located at the center of the expansion portion 130 in the planar direction when the expansion member 120 is in a contracted state (the state shown in FIGS. 2 and 3).

The marker portion 135 can be provided on the second surface 131b of the extension portion 130, for example.

In addition, the marker part 135 can also be arrange|positioned, for example on the inner surface of each surface 131a, 131b located on the internal space 131 side of the expansion part 130, or the inner surface 111a of the band body 111.

The marker portion 135 is formed of a rectangular marker in which the entire marker portion 135 is colored. However, the marker section 135 may include, for example, a transparent center and a colored linear frame surrounding the center. Note that the specific shape, color, and method of forming the marker portion 135 on each part of the hemostasis device 100 are not particularly limited.

<Coated member>
As shown in FIGS. 2 and 3, the covering member 160 includes a sheet member 161 fixed to the first surface 131a of the extended portion 130, and a through hole 163 provided in the sheet member 161.

The outer peripheral edge of the sheet member 161 is connected to the outer peripheral edge of the first surface 131a of the extended portion 130. As a method for connecting the sheet member 161 and the extended portion 130, for example, fusion bonding or adhesion can be employed.

The outer shape of the sheet member 161 in a plan view can be formed to be substantially the same as the outer shape of the extended portion 130 in a plan view. In this embodiment, since the extended portion 130 has a substantially rectangular outer shape in plan view, the sheet member 161 also has a substantially rectangular outer shape in plan view. Further, the sheet member 161 can be formed to have substantially the same size as the expanded portion 130.

The through hole 163 of the sheet member 161 is arranged at approximately the center position of the sheet member 161 when viewed from above. In this embodiment, the through hole 163 is arranged at a position that overlaps the marker section 135 arranged at the center of the expanded section 130 in a plan view.

The through hole 163 is formed in a circular shape in plan view. However, the shape of the through hole 163 in plan view may be a rectangle, an ellipse, or another shape.

The sheet member 161 can be made of, for example, a flexible material. As the constituent material of the sheet member 161, for example, the same material as that exemplified as the material of the band 111 can be used.

As shown in FIGS. 4 and 5 to 8, the covering member 160 covers the skin of the forearm A from the drug layer 190A when the expansion member 120 is fixed to the forearm A and the expansion member 120 is expanded. It has a release part 170 that can release the drug d contained in the drug layer 190A toward the surface layer Af side.

In this embodiment, as shown in FIGS. 7 and 8, as the expansion member 120 expands, the release unit 170 connects the drug layer 190A to the outside of the expansion member 120 (the outside of the space 190) via the through hole 163. ) is comprised of a valve mechanism 180 that enables communication with the

The valve mechanism 180 has a first region 181 and a second region 182 surrounding the first region 181.

The first region 181 has at least one slit portion 181a.

The second region 182 can be made of a harder material than the first region 181. As the material constituting the second region 182, for example, vinyl chloride, silicone rubber, or natural rubber can be used.

The second region 182 is composed of an annular member disposed on the inner peripheral side of the through hole 163. A hole passing through the second region 182 is formed at the center of the second region 182 .

The first region 181 is composed of a sheet-shaped valve body 185 that forms a slit portion 181a.

The sheet-shaped valve body 185 has a first seat 185a and a second seat 185b. The first sheet 185a and the second sheet 185b are connected to the second region 182.

In this embodiment, as shown in FIG. 3, each sheet 185b, 185a is arranged within a space 190. However, each sheet 185a, 185b may be arranged outside the space 190 (on the outer surface of the sheet member 161 arranged on the skin surface layer Af side).

The first sheet 185a and the second sheet 185b are arranged so as to overlap each other at a position near the center of the second region 182, as shown in FIG. A gap-like slit portion 181a is formed in the overlapped portion of each sheet 185a, 185b to allow release of the drug d.

The outer shapes of the first sheet 185a and the second sheet 185b can be formed into, for example, a rectangle (for example, a rectangle or a square). The first sheet 185a and the second sheet 185b are arranged in the covering member 160 so that the through hole 163 is covered by each sheet 185a and 185b when the sheet-shaped valve body 185 is closed (see FIG. 4). .

The outer shape, size, thickness, arrangement, etc. of each of the sheets 185a and 185b constituting the sheet-like valve body 185 are such that the slit portion 181a of the sheet-like valve body 185 is pushed out as the expansion member 120 expands. There is no particular limitation as long as the drug d can be released from the drug layer 190A.

The first sheet 185a is connected to the second region 182 at the outer peripheral edge of the first sheet 185a. Similarly, the outer peripheral edge of the second sheet 185b is connected to the second region 182.

As for the constituent material of each sheet 185a, 185b, for example, silicone rubber, natural rubber, or vinyl chloride can be used, similarly to the second region 182. However, the specific materials forming each sheet 185a, 185b are not particularly limited.

In this embodiment, the covering member 160 is composed of a sheet member 161 in which a through hole 163 is formed. When the expansion part 130 is expanded, the expansion member 120 applies compressive force to the space 190 located between the expansion part 130 and the covering member 160 and the sheet member 161 due to the deformation of the expansion part 130. Therefore, the sheet member 161 is stretched in the radial direction from near the center of the sheet member 161 due to the compressive force of the expanded portion 130 (deformation of the expanded portion 130). When the sheet member 161 extends, the second region 182 connected to the sheet member 161 expands in the plane direction. When the second region 182 expands, the sheets 185a and 185b connected to the second region 182 are relatively separated from each other as shown in FIG. As shown in FIG. 7, when the distance between the sheets 185a and 185b increases beyond a certain level, the drug d contained in the drug layer 190A is released from the slit portion 181a formed between the sheets 185a and 185b.

When the expansion section 130 is contracted, the relative positional relationship between the sheets 185a and 185b returns to the state shown in FIG. 5 before the expansion section 130 was expanded. Therefore, by contracting the expansion part 130, release of the drug d from the slit part 181a can be restricted. Further, by returning the slit portion 181a to the state shown in FIG. 5, blood leaked from the puncture site p can be prevented from flowing into the space portion 190.

<Drug layer>
The drug layer 190A is formed between the first surface 131a of the extended portion 130 and the covering member 160. A predetermined drug d is held in the drug layer 190A.

The drug d is, for example, a solution containing metal ions that speed up wound repair, a hemostatic agent that promotes blood coagulation, and the like. Further, the drug d may be a solution containing alginic acid together with metal ions and a hemostatic agent. When the drug d is a solution containing alginic acid, the drug d can be gelled by reacting the alginic acid with metal ions contained in blood. Therefore, the drug solution containing alginic acid gels according to the unevenness of the patient's skin surface layer Af around the puncture site p, so that while the drug d is in close contact with the puncture site p, the medicine d is displaced from the puncture site p. This can be prevented. Further, the gelled drug d can sustainably release the metal ions and hemostatic agent contained in the drug d to the puncture site p while forming a moist environment around the puncture site p. Therefore, the drug d is preferably a solution containing alginic acid together with the metal ions and the hemostatic agent, since it can efficiently provide the metal ions and the hemostatic agent to the puncture site p. In addition, when the drug d contains a metal ion and alginic acid, a metal ion that does not react with alginic acid to form a gel is used.

Note that the form of the drug d held in the drug layer 190A is not limited to a solution, and may be, for example, a highly viscous liquid, powder, gel, solid, or the like. Moreover, the drug d does not need to contain alginic acid.

<Injection part>
As shown in FIGS. 1 and 3, the hemostatic device 100 includes an injection section 200 for injecting fluid into the expanded section 130.

The injection part 200 communicates with a connector 201 incorporating a check valve (not shown), a flexible bag part 202 with a space formed inside, and an internal space 131 of the expansion part 130 and the bag part 202. It has a tube 203.

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 cut off. When expanding the expanding portion 130, the operator or the like inserts the tip of a syringe (not shown) into the connector 201 and opens the check valve. The operator or the like can inject the air in the syringe into the internal space 131 of the expansion part 130 by pushing the pusher of the syringe with the check valve of the connector 201 open.

A surgeon or the like can expand the expansion section 130 by injecting air into the internal space 131 of the expansion section 130. Furthermore, when the operator or the like injects air into the internal space 131 of the expansion section 130, the air flows into the internal space 151 of the auxiliary member 150 via the communication section 140. This allows the operator or the like to expand the auxiliary member 150. When the operator or the like expands the expansion section 130 and the auxiliary member 150, the bag section 202 communicating with the expansion section 130 via the tube 203 expands. The operator or the like can confirm that the expansion section 130 and the auxiliary member 150 have expanded by visually confirming that the bag section 202 has expanded.

When contracting the expansion part 130 and the auxiliary member 150, the operator or the like inserts the leading end of the syringe into the connector 201 and pulls the pusher of the syringe. By performing the above operations, the operator or the like can move air from the expansion section 130 and the auxiliary member 150 to the syringe. When the operator or the like moves air from the expansion section 130 and the auxiliary member 150 to the syringe, the bag section 202 contracts.

For example, an arrow-shaped marker indicating the insertion direction of the syringe into the connector 201 can be provided on the bag portion 202.

<Example of use of hemostasis device>
Next, an example of how the hemostatic device 100 is used will be described with reference to FIGS. 4 to 8. Note that FIGS. 5 to 8 are diagrams schematically showing cross sections taken along the arrow 5A-5A line shown in FIG. 4.

When starting to stop the bleeding at the puncture site p formed on the patient's forearm A, the operator or the like fixes the expansion member 120 to the forearm A, as shown in FIG. 4 . At this time, the operator or the like wraps the band 111 around the patient's forearm A with the expansion member 120 placed at the puncture site p. The operator or the like can fix the hemostasis device 100 to the patient's forearm A by bringing the connecting parts 112a and 112b arranged on the band 111 into contact with each other.

Although the introducer is not shown in FIG. 4, the operator or the like can fix the expansion member 120 to the patient's forearm A with the sheath tube of the introducer inserted into the puncture site p. . In that case, the operator or the like removes the sheath tube from the puncture site p with the expansion member 120 fixed to the patient's forearm A.

After removing the sheath tube from the puncture site p, the operator or the like expands the expansion section 130 by injecting fluid into the internal space 133 of the expansion section 130. The space 190 defined between the first surface 131a of the expansion part 130 and the covering member 160 is compressed by the expansion of the expansion part 130. Therefore, as shown in FIG. 5, the space 190 projects in the direction of the puncture site p via the through hole 163 (see FIG. 3). Note that the operator or the like may expand the expansion section 130 while removing the sheath tube from the puncture site p.

When the expansion portion 130 expands, the second region 182 prevents the slit portion 181a of the first region 181 from being forced wide as the expansion portion 130 expands. That is, since the second region 182 is made of a harder material than the first region 181, it suppresses the first region 181 from expanding in the lateral direction due to the compression of the expansion portion 130. Therefore, it is possible to prevent the distance between the sheets 185a and 185b from unintentionally widening and the drug d being released from the drug layer 190A before the internal pressure of the expansion part 130 reaches a sufficient level.

The first region 181 is the first region 181 that is used when the operator or the like further injects fluid into the internal space 133 of the expansion section 130 and the internal pressure of the internal space 133 reaches a predetermined level, as shown in FIGS. 6 and 7. The slit portion 181a formed between the first sheet 185a and the second sheet 185b is pushed open. When the slit portion 181a is sufficiently widened, the drug d placed in the drug layer 190A passes through the slit portion 181a and is released to the skin surface layer Af side of the forearm portion A.

As shown in FIG. 8, when the drug d contains alginic acid, when the drug d placed on the skin surface layer Af of the forearm A comes into contact with the blood leaked from the puncture site p, metal ions contained in the blood It reacts with and turns into a gel. Therefore, the drug d forms a gel layer around the puncture site in accordance with the unevenness of the skin surface, and remains on the skin surface layer Af of the forearm A. Further, the gelled drug d forms a moist environment around the puncture site p, and slowly releases the metal ions and hemostatic agent contained together with alginic acid to the puncture site p over time. As a result, the gelled drug d can suppress the formation of scar tissue at the puncture site p and repair the wound early by slowly releasing metal ions at the puncture site p, or apply a hemostatic agent to the puncture site p. By slow release, blood coagulation at the puncture site p can be promoted and the time required for hemostasis to stop can be shortened. In addition, when the gelled drug d releases metal ions in a sustained manner to the puncture site p, the gelled drug d can enhance the antibacterial properties around the puncture site p due to the antibacterial action of the metal ions. Therefore, the gelled drug d can also prevent the occurrence of infection through the puncture site p due to the antibacterial effect of the metal ions. Note that, as shown in FIG. 8, in the first region 181, when a predetermined amount of the drug is released to the skin surface layer side, the internal pressure of the space 190 decreases, so the slit portion 181a closes.

After releasing the drug d from the drug layer 190A, the operator or the like can maintain the expanded state of the expanded portion 130 to apply compressive force to the puncture site p from the expanded portion 130. Therefore, the operator or the like can exert the medicinal effect of the drug d on the puncture site p while applying pressure to the puncture site p using the expanding portion 130 to stop bleeding. Thereby, the operator or the like can speed up the wound repair at the puncture site p and enhance the hemostasis effect using the hemostasis device 100.

The drug layer 190A is arranged in a space 190 defined by the covering member 160 connected to the first surface 131a of the expansion section 130. Therefore, the operator or the like can control the internal pressure of the space 190 and release the drug d in the space 190 by adjusting the amount of expansion of the expansion section 130. Therefore, the operator or the like can prevent the drug d from remaining in the space 190 by adjusting the amount of expansion of the expansion section 130. Thereby, the operator or the like can use up the drug d in the drug layer 190A without wasting it so that it does not remain in the space 190.

In addition, in the case of hemostasis devices that use wound healing dressings (dressings impregnated with drugs), in order to develop the medicinal effects of the drugs contained in the dressing, it is necessary to use a solvent (blood (e.g., body fluids) are required. Therefore, the efficacy of the drug contained in the dressing depends on the amount of blood that comes into contact with the dressing. However, since the hemostasis device 100 can control the release of the drug in the space 190 by adjusting the amount of expansion of the expansion section 130, the medicinal effects of the drug can be expressed without depending on the amount of blood that comes into contact with the covering member 160. be able to. Therefore, the hemostasis device 100 can sufficiently exert the medicinal effect of the drug on the puncture site p, compared to a hemostatic device using a dressing for wound healing.

As described above, the hemostatic device 100 according to the present embodiment includes the expansion member 120 configured to be placed at the puncture site p of the forearm A, and the expansion member 120 configured to be fixed to the forearm A. A fixing member 110 is provided. The expansion member 120 is arranged in an expansion portion 130 that can be expanded and deformed, a covering member 160 that covers at least a portion of the first surface 131a of the expansion portion 130, and a space 190 between the expansion portion 130 and the covering member 160. It has a drug layer 190A. The covering member 160 fixes the expansion member 120 to the forearm part A, and in a state where the expansion member 120 is expanded, the medicine d held in the medicine layer 190A is transferred from the medicine layer 190A to the skin surface layer Af side of the forearm part A. It has a discharge part 170 that can discharge.

According to the hemostasis device 100 configured as described above, when the expansion member 120 is expanded while being fixed to the puncture site p formed in the patient's forearm A, the drug contained in the drug layer 190A is released through the release portion 170. The drug d is released to the skin surface layer Af side of the patient's forearm A. Specifically, when the expansion member 120 is expanded by an operator or the like, the expansion part 130 deforms and applies compressive force to the space 190 located between the expansion part 130 and the covering member 160. By applying the drug, the drug d in the drug layer 190A arranged in the space 190 is released via the release part 170. Thereby, the operator or the like expands the expansion member 120 and presses the covering member 160 against the skin surface layer Af side of the patient's forearm A, and applies the drug layer disposed in the space 190 to the puncture site p. 190A of drug d can be released. Therefore, the operator or the like can administer the drug d around the puncture site p while pressing the covering member 160 against the skin surface layer Af side of the patient's forearm A. Therefore, the operator can appropriately administer the drug d to the puncture site p. The hemostatic effect of the hemostatic device 100 at the puncture site p can be effectively enhanced. In addition, in the hemostasis device 100 configured as described above, the drug d is released to the puncture site p when the expansion member 120 is expanded, so that it is possible to prevent the drug from peeling off due to friction etc. before use, and to apply the drug to the puncture site p. Drugs can be released hygienically. In addition, the hemostasis device 100 uses a biochemical agent containing protein as an active ingredient, which is difficult to use by soaking into a dressing material etc., since the drug d is held in the space 190 between the expansion part 130 and the covering member 160. Pharmaceutical products and the like can also be used as medicines.

Further, the covering member 160 includes a sheet member 161 fixed to the first surface 131a of the extended portion 130 and a through hole 163 provided in the sheet member 161. The discharge section 170 includes a valve mechanism 180 that enables communication between the drug layer 190A and the outside of the expansion section 130 via the through hole 163 as the expansion member 120 expands.

According to the hemostasis device 100 configured as described above, since the covering member 160 that defines the space between which the expanding portion 130 and the drug layer 190A is disposed is constituted by the sheet member 161, the thickness of the expanding member 120 is reduced. You can prevent it from getting bigger. In addition, by expanding the expansion part 130, the operator etc. communicates the drug layer 190A with the outside of the expansion member 120 via the valve mechanism 180 provided in the covering member 160, and infuses the drug d into the puncture site p. can be released. The operator or the like can prevent the drug d from being released to the outside of the expansion member 120 (space portion 190) before expanding the expansion portion 130. Therefore, the hemostasis device 100 can control the release of the drug with a simple structure such as a valve mechanism, and the sanitary condition of the drug d can be maintained until the hemostasis using the hemostasis device 100 is started.

Further, the valve mechanism 180 has a first region 181 and a second region 182 surrounding the first region 181. The first region 181 has at least one slit portion 181a. The second region 182 is made of a harder material than the first region 181.

According to the hemostasis device 100 configured as described above, when the expansion portion 130 expands, the second region 182 prevents the slit portion 181a of the first region 181 from being pushed wide as the expansion portion 130 expands. suppress. That is, since the second region 182 is made of a harder material than the first region 181, it suppresses expansion of the first region 181 in the direction in which the slit portion 181a widens due to the pressure of the expansion portion 130. Therefore, it is possible to prevent the valve mechanism 180 from opening unintentionally and releasing the drug d from the drug layer 190A before the internal pressure of the expansion part 130 reaches a predetermined level.

Further, the first region 181 is made up of a sheet-shaped valve body 185 that forms a slit portion 181a.

In the hemostasis device 100, since the first region 181 is composed of the sheet-like valve body 185, the valve body 185 can be formed with a simple structure, and an increase in the thickness and weight of the expansion member 120 can be prevented. Further, the sheet-shaped valve body 185 can easily control the amount of the drug d released from a predetermined position in the first region 181 by adjusting the size and position of the slit portion 181a.

Moreover, drug d is a solution containing alginic acid.

The operator etc. places the drug d on the skin surface layer Af of the forearm A, and gels the drug d by reacting the metal ions contained in the blood leaked from the puncture site p with the alginic acid of the drug d. be able to. Therefore, since the drug d gels according to the irregularities of the patient's skin surface layer Af around the puncture site p, the drug d is kept in close contact with the puncture site p while preventing the drug d from shifting from the puncture site p. can. In addition, the gelled drug d forms a moist environment around the puncture site p and promotes cell activation and proliferation, thereby promoting wound repair. In addition, when drug d contains metal ions and hemostatic agents together with alginic acid, gelled drug d can promote wound repair and hemostasis by gradually releasing metal ions and hemostatic agents from gelled drug d. It can have medicinal effects. Note that when the gelled drug d contains metal ions together with alginic acid, the gelled drug d can also prevent the occurrence of infection through the puncture site p due to the antibacterial action of the metal ions.

Next, each modification of the embodiment described above will be explained. In the description of the modification, description of contents that overlap with those already explained in the above-described embodiment will be omitted. Further, in the description of the modification, contents that are not particularly explained can be the same as those in the above-described embodiment.

<Modification example 1 of discharge part (valve mechanism)>
9 to 11 show a first modification of the discharge section 170 (valve mechanism 180). 9 to 11 are cross-sectional views schematically showing the state before and after the ejection unit 170 ejects the drug d according to the first modification.

The discharge section 170 according to the first modification is configured with a sheet-shaped valve body 185A including a first sheet 185a and a second sheet 185b.

As shown in FIG. 9, the first sheet 185a and the second sheet 185b form a slit portion 181a therebetween when the sheet-shaped valve body 185A is closed. Further, the first seat 185a and the second seat 185b are arranged so that they do not overlap each other when the sheet-shaped valve body 185A is closed. Note that the sheet-shaped valve body 185 according to the embodiment described above is arranged such that the first sheet 185a and the second sheet 185b partially overlap each other when the sheet-shaped valve body 185 is closed. (see Figure 5).

As shown in FIGS. 9 to 11, the sheet-shaped valve body 185A is formed between the first sheet 185a and the second sheet 185b as the expansion member 120 expands, similar to the valve body 185A described above. The slit portion 181a is pushed wider. Thereby, the drug d contained in the drug layer 190A can be released to the skin surface layer Af side of the patient's forearm A.

As shown in FIG. 10, the end of the first sheet 185a on the second sheet 185b side forming the slit portion 181a and the end of the second sheet 185b on the first sheet 185a side forming the slit portion 181a are as follows: It can be formed so that the space portion 190 side has a curved cross-sectional shape. Therefore, when the drug d is released from the slit portion 181a, the drug d is delivered to the patient's forearm A along the curved end of the first sheet 185a and the curved end of the second sheet 185b, as shown in FIG. becomes easier to move toward the skin surface layer Af. Thereby, the operator or the like can smoothly release the drug d from the space 190.

<Modification example 2 of discharge section (valve mechanism)>
12 to 14 show a second modification of the discharge section 170 (valve mechanism 180). FIG. 12 shows a plan view of the emitting section 170 before the expansion section 130 expands. FIGS. 13 and 14 are cross-sectional views showing the state before and after the emitting unit 170 releases the drug d.

The first region 181A according to the second modification is made of a flexible membrane-like member. The first region 181A can be made of, for example, silicone rubber or the like that can be expanded as the expansion portion 130 expands.

As shown in FIGS. 13 and 14, the first region 181A is a hole that can release the drug d when the expanding portion 130 expands and compressive force is applied to the drug layer 190A. 181b' is formed. The operator or the like can place the drug d on the skin surface layer Af of the patient's forearm A by releasing the drug d through the hole 181b'.

As shown in FIGS. 12 and 13, the first region 181A can be provided with a broken portion 181b that induces breakage at a position corresponding to the hole 181b' when the expanded portion 130 is expanded. The to-be-broken portion 181b can be configured, for example, by a thin portion or a cut formed in the first region 181A.

Note that the shape, position, size, number, etc. of the broken portions 181b formed in the first region 181A are not particularly limited. Further, the first region 181A may be provided in advance with a hole 181b' (for example, see FIG. 15) that penetrates the first region 181A before the expansion part 130 is expanded.

<Modification 3 of discharge part (valve mechanism)>
15 and 16 show a third modification of the discharge section 170 (valve mechanism 180). 15 and 16 are cross-sectional views showing the state before and after the emitting unit 170 ejects the drug d.

As shown in FIG. 15, the discharge section 170 according to the fifth modification has a convex section 186 arranged at a position corresponding to the first region 181 of the expansion section 130.

The convex portion 186 is fixed to the first surface 131a of the extended portion 130. Further, the convex portion 186 is arranged within a space 190 in which the drug layer 190A is arranged.

The convex portion 186 is disposed at a position facing the first region 181 of the first surface 131a of the extended portion 130. Therefore, as shown in FIG. 16, when the expansion portion 130 expands, the convex portion 186 and the first region 181 come relatively close to each other and come into contact with each other.

The first region 181 is composed of a membrane-like member in which a plurality of holes 181b' are formed. As shown in FIG. 15, the plurality of holes 181b' can be formed with a size (eg, inner diameter) that can prevent the drug d from being released when the expansion part 130 is not expanded.

As shown in FIG. 16, when the operator or the like expands the expanding portion 130 and brings the convex portion 186 into contact with the first region 181, the first region 181 expands and the hole 181b' is pushed wide. Thereby, the drug d contained in the drug layer 190A can be released to the skin surface layer Af side of the patient's forearm A.

The discharge section 170 (valve mechanism 180) according to this modification prevents the first region 181 and the convex section 186 from coming into contact with each other in a state before the expansion section 130 expands, and allows the drug to flow through the discharge section 170. d can be prevented from being released. Further, when the first region 181 and the convex portion 186 come into contact with each other and the first region 181 expands as the expansion portion 130 expands, the discharge portion 170 opens the hole 181b′ provided in the first region 181. The drug can be released through the drug.

Note that there are no particular limitations on the cross-sectional shape, material, size, specific arrangement, number, etc. of the convex portions 186.

<Modification 4 of discharge part (valve mechanism)>
17 to 23 show a fourth modification of the discharge section 170 (valve mechanism 180). FIGS. 17 and 18 are cross-sectional views showing the state before and after the emitting unit 170 releases the drug d. 19 to 23 are cross-sectional views illustrating an example of a procedure for releasing the drug d by the release unit 170 according to the fourth modification.

As shown in FIGS. 17 and 18, a discharge section 170 according to Modification 4 has a convex section 186A. The convex portion 186A is different in structure from the convex portion 186 of the third modification. Specifically, the convex portion 186A is constituted by a cylindrical member having a space 186a inside. A plurality of side holes 186b and 186c communicating with the space 186a are provided on the side surface of the cylindrical member.

The side hole 186b is located closer to the first surface 131a of the expanded portion 130 than the side hole 186c is. The side hole 186b and the side hole 186c communicate with each other via the space 186a.

For example, the lower end of the convex portion 186A can be configured to have a shape that allows it to penetrate the first region 181 when it comes into contact with the first region 181. As shown in FIGS. 17 and 18, since the lower end of the convex portion 186A protrudes toward the puncture site p, it is preferable that the leading edge is flat. Note that the specific cross-sectional shape of the convex portion 186A is not particularly limited.

As shown in FIG. 17, the convex portion 186A is kept out of contact with the first region 181 when the expansion portion 130 is not expanded. As shown in FIG. 18, when the expanded portion 130 expands, the lower end portion of the convex portion 186A connected to the expanded portion 130 comes into contact with the sheet member 161. As shown in FIG. When the convex portion 186A is pressed against the sheet member 161 with a predetermined pressing force as the expansion portion 130 expands, the convex portion 186A penetrates the sheet member 161. In a state in which the convex portion 186A penetrates the sheet member 161, the side hole 186b of the convex portion 186A is disposed in the space 190, and the side hole 186c of the convex portion 186A is disposed outside the space 190. By arranging the convex portion 186A in this way, the operator or the like can transfer the drug d placed in the drug layer 190A to the skin surface Af of the patient's forearm A through the side hole 186b, the space 186a, and the side hole 186c. Can be released to the side.

Next, with reference to FIGS. 19 to 23, a procedure for releasing the drug d by the convex portion 186A will be specifically described.

As shown in FIG. 19, the operator or the like moves the convex portion 186A close to the first region 181 to a distance that does not contact the first region 181 by expanding the expansion portion 130. At this time, the internal pressure of the expansion part 130 can be adjusted to a level comparable to the pressure when the expansion part 130 compresses the puncture site p to stop bleeding.

The surgeon or the like further expands the expansion section 130. When the expansion part 130 expands further, the convex part 186A penetrates the first region 181, as shown in FIG. A lower end portion of the convex portion 186A passing through the first region 181 is arranged outside the space portion 190.

As shown in FIG. 21, when the convex portion 186A penetrates the first region 181, the drug d placed in the drug layer 190A passes through the side hole 186b, the space 186a, and the side hole 186c to the skin of the patient's forearm A. It is released to the surface layer Af side.

As shown in FIG. 22, after the drug d included in the drug layer 190A is placed on the skin surface layer Af, the operator or the like contracts the expansion portion 130 to move the convex portion 186A into the space 190. By this operation, each side hole 186b, 186c of the convex portion 186A is arranged in the space 190, so even if the drug d remains in the drug layer 190A, the space 186a and each side hole 186b, 186c are arranged in the space 190. Through this, the drug d can be prevented from being released from the space 190.

As shown in FIG. 23, when the drug d contains alginic acid, the drug d placed on the skin surface Af of the patient's forearm A reacts with the metal ions contained in the blood leaked from the puncture site p, thereby forming a gel. become The operator or the like can speed up the wound repair at the puncture site p and enhance the hemostasis effect by slowly releasing metal ions and hemostatic agents using the gelled drug d. Further, when the gelled drug d releases metal ions in a sustained manner to the puncture site p, the gelled drug d can also prevent the occurrence of infection via the puncture site p due to the antibacterial action of the metal ions.

As described above, the convex portion 186A according to the present modification is composed of a cylindrical member having a space 186a inside, and a plurality of side holes 186b communicating with the space 186a on the side surface of the cylindrical member. 186c is provided. According to the hemostasis device including such a protrusion 186A, the space 190 in which the drug layer 190A is disposed communicates with the outside of the space 190 via the space 186a of the protrusion 186A and the side holes 186b, 186c. Accordingly, the drug d contained in the drug layer 190A can be released to the skin surface layer Af side of the patient's forearm A. Further, in a state before expanding the expansion portion 130, the convex portion 186A can be prevented from penetrating the first region 181. Therefore, the operator or the like can suitably prevent the drug d from being unintentionally released through each part 186a, 186b, 186c of the convex part 186A.

<Modified example of extension part>
24 and 25 show modified examples of the expansion member 120. FIG. 24 shows a cross-sectional view of the expanding portion 130A of the expanding member 120A before expanding, and FIG. 25 shows a cross-sectional view of the expanding portion 130A of the expanding member 120A in an expanded state.

As shown in FIG. 24, in the expanded portion 130A of the expanded member 120A according to the modification, a folded portion 139a is formed in a portion constituting the first surface 131a of the expanded portion 130A in a state before the expanded portion 130A is expanded. ing.

As shown in FIG. 25, the folding portion 139a of the expansion portion 130A is expanded and released from the folded state when the expansion portion 130A is expanded. As a result, the expanded portion 130A protrudes toward the sheet member 161 of the covering member 160, forming a protruding portion, as shown in FIG. 25. At this time, the protruding portion of the expanded portion 130A is formed to compress the drug in the drug layer 190A and compress the space 190 between the expanded portion 130A and the sheet member 161. Therefore, when the expansion part 130A is expanded, the expansion member 120A presses the space 190 with the protrusion of the expansion part 130A, and releases the drug d from the drug layer 190A via the valve mechanism 180. That is, the expansion member 120A expands the expansion portion 130A so that the protruding portion projects in the direction of the first region 181, thereby releasing the drug d from the drug layer 190A via the valve mechanism 180. Therefore, the operator or the like can control the amount of the drug d released from the drug layer 190A by controlling the amount of expansion of the expansion portion 130A and controlling the shape of the protruding portion. In addition, the expansion member 120A extends the expansion portion 130A into the first region 181 connected to the sheet member 161 of the covering member 160 until the expansion portion 130A expands and the folding portion 139a is unfolded. It is possible to suppress the transmission of pressure associated with this. Therefore, the operator or the like can prevent the valve mechanism 180 from opening unintentionally and releasing the drug d from the drug layer 190A until the expansion portion 130A expands to a predetermined expansion amount. In this way, the expansion member 120A according to FIGS. 24 and 25 controls the shape of the expansion part 130 without adjusting the elasticity of the sheet member 161 of the expansion member 120A or providing a convex part in the expansion part 130. This controls the amount of the drug d released from the drug layer 190A.

(Second embodiment)
FIG. 26 shows a hemostatic device 100A according to the second embodiment. FIG. 27 shows an example of how the hemostatic device 100A is used. In the description of the second embodiment, description of contents that overlap with those already described in the first embodiment will be omitted. Further, in the description of the second embodiment, contents that are not particularly explained can be the same as those of the first embodiment.

In the first embodiment, a hemostasis device 100 was described that is configured to be able to stop bleeding at a puncture site p formed in a patient's forearm A. As shown in FIG. 27, a hemostasis device 100A of the second embodiment described below has a palmar artery ( The puncture site P (the area to stop bleeding ) is configured to be able to stop bleeding. Note that the anatomical snuff box is a depression in the hand located on the radial side of the forearm A when the patient spreads the thumb f1 of the hand H.

FIG. 27 is a plan view of the band 111 of the hemostasis device 100A viewed from the outside.

The hemostatic device 100A includes a fixing member 110 for fixing the hemostatic device 100A to the patient's hand H, and an expansion member 120 connected to the inner surface of the main body portion 110A of the fixing member 110.

The fixing member 110 includes a main body 110A, a first arm 116 extending from the main body 110A in a predetermined first direction, a second arm 117 extending from the main body 110A in a second direction different from the first direction, and a main body. The third arm portion 118 extends from the portion 110A in a direction different from the first direction and the second direction.

Each arm portion 116, 117, 118 can be provided with a connecting member (for example, a hook-and-loop fastener) that allows the arm portions 116, 117, 118 to be connected to each other. A window 129 may be provided to allow the expansion member 120 to be viewed from the outside.

As shown in FIG. 28, in order to stop bleeding at the puncture site p formed on the patient's hand H, the operator or the like places the expansion member 120 connected to the main body portion 110A at the puncture site p. The operator or the like wraps the second arm portion 117 along the outer periphery of the patient's hand H. Further, the operator or the like connects the second arm section 117 to the third arm section 118. Further, the operator or the like places the first arm section 116 between the thumb f1 and the index finger f2 of the patient's hand H. The operator or the like connects the first arm section 116 to the second arm section 117 wrapped around the outer circumference of the hand H. Through the above procedure, the operator or the like can attach the hemostasis device 100A to the patient's hand H.

The operator or the like expands the expansion member 120 with the hemostasis device 100A attached to the patient's hand H, thereby allowing the expansion portion 130 to expand as in the case of using the hemostasis device 100 according to the first embodiment described above. While performing compression hemostasis, the hemostasis effect at the puncture site p can be enhanced by the medicinal effect of the drug d.

Although the introducer is not shown in FIG. 27, the operator or the like can fix the expansion member 120 to the patient's hand H with the sheath tube of the introducer inserted into the puncture site p. . In that case, the operator or the like removes the sheath tube from the puncture site p with the expansion member 120 fixed to the patient's hand H.

Although the hemostasis device according to the present invention has been described above through multiple embodiments and multiple modified examples, the present invention is not limited to only the content explained in the specification, and based on the description of the claims. It is possible to change it as appropriate.

The part of the patient's body to be stopped by the hemostasis device is not particularly limited as long as it is a limb. For example, in the description of the first embodiment, a hemostatic device for stopping bleeding at a puncture site formed on the patient's right forearm was illustrated, but the hemostatic device is configured to be able to stop bleeding at a puncture site formed on the left forearm. It is also possible. In addition, in the description of the second embodiment, a hemostasis device for stopping bleeding at a puncture site formed on the back of the left hand was illustrated, but the hemostatic device includes a puncture site formed on the back of the right hand, a puncture site formed on the palm of the right hand, It is also possible to configure it as an instrument for stopping bleeding at a puncture site formed in the palm of the left hand.

Further, the hemostasis devices described in each embodiment and each modification can be arbitrarily combined as long as the effects of the present invention can be exhibited.

In addition, the shape, dimensions, structure, etc. of each part of the hemostatic device are such that it is possible to apply pressure to the puncture site with the expansion member while the hemostatic device is attached to at least part of the limb, including the forearm or hand. There are no particular limitations as far as possible.

100, 100A Hemostasis device 110 Fixing member 111 Band 111a Inner surface 111b of the band Outer surface 120 of the band Expansion member 130, 130A Expanded portion 131a First surface (surface) of the expanded portion
131b Second surface of expansion part 150 Auxiliary member 160 Covering member 161 Sheet member 163 Through hole 170 Discharging part 180 Valve mechanism 181, 181A First region 181a Slit part 181b To be broken part 181b' Hole part 182 Second region 185, 185A Sheet Shaped valve body 185a First sheet 185b Second sheet 186, 186A Convex portion 186a Space 186b, 186c Side hole 190 Space 190A Drug layer 200 Injection part A Forearm (limb)
Af Skin surface layer H Hand (limb)
d Drug p Puncture site (site to stop bleeding)

Claims (5)

an expansion member configured to be placed at a site of a limb where bleeding is to be stopped;
a fixing member configured to fix the expansion member to the limb,
The expansion member includes an expansion section that can be expanded and deformed, a covering member that covers at least a part of the surface of the expansion section, and a drug layer disposed in a space between the expansion section and the covering member. have,
The covering member has a release part that fixes the expansion member to the limb and allows the medicine contained in the drug layer to be released to the skin surface side of the limb in a state where the expansion member is expanded. death,
The covering member includes a sheet member fixed to the surface of the expanded portion, and a through hole provided in the sheet member,
The discharge part is configured with a valve mechanism that enables communication between the drug layer and the outside of the expansion member via the through hole as the expansion member expands,
The valve mechanism has a first region and a second region surrounding the first region,
The first region has at least one slit or hole,
The second region is a hemostasis device, wherein the second region is made of a harder material than the first region . The hemostatic device according to claim 1 , wherein the first region is comprised of a sheet-shaped valve body that forms the slit portion or the hole portion. The valve mechanism has a convex portion arranged at a position corresponding to the first region of the expansion member and configured to contact the first region when the expansion portion is expanded. The hemostatic device according to claim 2 . The convex portion is composed of a cylindrical member having a space inside,
The hemostatic device according to claim 3 , wherein a plurality of side holes communicating with the space are provided on a side surface of the cylindrical member. The hemostatic device according to any one of claims 1 to 4 , wherein the drug is a solution containing alginic acid.