Patent Description:
As a catheter procedure, a procedure is known in which a blood vessel (for example, radial artery) in an arm of a patient is punctured, and various medical elongated bodies are introduced into the blood vessel via a puncture site formed in the blood vessel in the arm of the patient so as to perform treatment or therapy on a lesion area (see PTL <NUM> below). The catheter procedure utilizing the radial artery is referred to as transradial artery approach and is considered as a useful technique for, for example, coronary artery access and lower limb artery access.

A radial artery located in an arm of a human body is connected to a palmar artery which bypasses a hand side. Therefore, currently, as a new method of transradial artery approach, a catheter procedure using distal transradial approach (dTRA) has been attempted to access the palmar artery (including a distal radial artery) from an anatomical snuffbox located on a dorsal side of the hand or from a position around the snuffbox, and perform treatment through the vascular access site.

Blood vessels such as palmar arteries located in the hand are located in places where there are many movable parts such as fingers. For this reason, a shape around the puncture site in the hand changes with movement of the hand. Therefore, when hemostasis is performed on the puncture site, a pressing member placed on the hand is preferably an inflatable member that follows the movement of the hand and can easily adjust a compressive force on the puncture site.

However, when the pressing member is the inflatable member, the inflatable member exerts a force to inflate from the inside to the outside of the inflatable member in an inflated state. For this reason, in a hemostatic device having the inflatable member, a shape around a hemostatic site changes due to the movement of the hand, the inflatable member is shifted from the puncture site, and it may not be possible to properly maintain the compressive force of the inflatable member on the puncture site in some cases. Therefore, when hemostasis is performed on the puncture site of the hand, the hemostatic device having the inflatable member needs to suppress position shift of the inflatable member by force acting in a direction away from the puncture site, thereby appropriately securing the inflatable member to the puncture site. In this way, it is considered that the hemostatic device having the inflatable member can appropriately maintain the compressive force of the inflatable member on the puncture site even when the shape around the puncture site is changed by the movement of the hand.

In view of the above problems, an object of the invention is to provide a hemostatic device capable of suppressing position shift of an inflatable member with respect to a site where bleeding is to be stopped on a hand and appropriately maintaining a compressive force of the inflatable member on the site where bleeding is to be stopped on the hand even when a patient moves the hand while the inflatable member is inflated.

The invention is defined by appended claim <NUM>.

In the hemostatic device according to the aspect of the invention, the main body in which the inflatable member is disposed can be secured to the limb by disposing a part of the second arm portion between adjacent fingers of the patient and connecting the convex portion and the second arm portion while wrapping the first arm portion and the second arm portion around the limb of the patient. The first arm portion and the second arm portion are fastened to the limb by connecting the convex portion and the second arm portion, and the main body is secured to the limb. Further, by disposing the second arm portion between the adjacent fingers of the patient, it is possible to suppress position shift of the inflatable member disposed in the main body with respect to the site where bleeding is to be stopped. Further, the hemostatic device has a simple securing structure capable of tightening the inflatable member to the hand of the patient by connecting the two arm portions protruding from the main body. For this reason, the hemostatic device can reduce the number of arm portions installed for securing the inflatable member. In this way, the hemostatic device can suppress an increase in arm portions that may interfere with a medical device such as an introducer in a state where the hemostatic device is attached to the hand of the patient, and thus it is possible to easily remove the medical device from the site where bleeding is to be stopped even after the hemostatic device is attached. In addition, a movable range of the hand increases from a wrist side to a fingertip side of the hand. In the hemostatic device, the first arm portion and the second arm portion extend from the fingertip side to the wrist side of the hand while forming an obtuse angle, so that the first arm portion and the second arm portion can be connected on the wrist side of the hand of the patient. Therefore, in the hemostatic device, the first arm portion and the second arm portion can be secured on the wrist side where the movable range is small, and thus the main body can be secured to the limb while maintaining the movable range on the fingertip side of the hand. Note that an outer circumference of the hand becomes larger from the wrist side to the fingertip side of the hand in a state where the hand is spread. Therefore, since the first arm portion and the second arm portion extend in a direction opposite to a direction in which the outer circumference of the hand becomes larger, the first arm portion and the second arm portion can be reliably connected on the wrist side of the hand in the state where the hemostatic device is attached. Furthermore, in the hemostatic device, even in the case where the patient moves the hand with the inflatable member inflated, when the first arm portion and the second arm portion are secured in a state of being tightened to the limb of the patient, it is possible to prevent rising of the distal side (fingertip side) of the main body to which the inflatable member is connected, and to appropriately maintain the compressive force of the inflatable member on the site where bleeding is to be stopped formed on the dorsal side of the hand of the patient.

In the hemostatic device according to the other aspect of the invention, since the first arm portion and the second arm portion protrude from the main body so as to form an obtuse angle, when the hemostatic device is attached to the limb of the patient, the respective arm portions can be connected so that the entire finger of the patient is not covered by the covering member. For this reason, the patient is less likely to be restricted in movement of the hand even when the hemostatic device is attached, and thus a degree of freedom on the fingertip side can be increased. Further, since the hemostatic device has the deformable auxiliary member located on the distal side of the first inflatable portion, when the first inflatable portion is inflated, the auxiliary member presses the first inflatable portion against the limb of the patient to inhibit the first inflatable portion from rising in a direction away from the puncture site on the hand of the patient. As a result, the hemostatic device can maintain an appropriate compressive force on the site where bleeding is to be stopped while increasing the degree of freedom on the fingertip side. Furthermore, in the hemostatic device, since the first arm portion and the second arm portion extend from the fingertip side to the wrist side of the hand while forming an obtuse angle, the first arm portion and the second arm portion can be secured on the wrist side where the movable range is small. Therefore, the main body can be appropriately secured to the limb while maintaining the movable range on the fingertip side of the hand. Further, in the hemostatic device, since the first inflatable portion can be secured to the site where bleeding is to be stopped by the two arm portions including the first arm portion and the second arm portion and the auxiliary member, it is unnecessary to add different arm portions between the first arm portion and the second arm portion. Therefore, the operator, etc. can easily remove the medical device such as an introducer sheath after attaching the hemostatic device. Further, since the first arm portion and the second arm portion are connected in a state of being wrapped around the limb of the patient, the first arm portion and the second arm portion are pressed against the hand of the patient while pulling the main body located therebetween toward the both side portion sides of the main body. Since the auxiliary member is located between the first arm portion and the second arm portion, the inflatable member can be reliably pressed against the body surface of the hand of the patient by connection of the first arm portion and the second arm portion. Therefore, the hemostatic device can press the first inflatable portion against the limb of the patient by the auxiliary member, and reliably inhibit the first inflatable portion from rising in the direction away from the site where bleeding is to be stopped on the hand of the patient. In this way, the hemostatic device can reliably press the first inflatable portion against the hand of the patient and maintain an appropriate compressive force on the puncture site while increasing the degree of freedom on the fingertip side during attachment of the hemostatic device.

Note that the following description does not limit the technical scope or the meaning of terms described in the appended claims. In addition, the dimensions or scales on the drawings may be exaggerated for convenience of description, and different from actuality ones.

<FIG> are diagrams for description of a hemostatic device <NUM> according to a first embodiment, <FIG> are diagrams for description of usage examples of the hemostatic device <NUM>, and <FIG> are diagrams for description of other usage examples of the hemostatic device <NUM>.

For example, as illustrated in <FIG>, <FIG>, and <FIG>, when removing a sheath tube of an introducer <NUM> indwelling at a puncture site t1 (corresponding to a site where bleeding is to be stopped) formed on a radial artery side (for example, an artery around an anatomical snuffbox or a distal radial artery running on a fingertip side of the snuffbox) of a palmar artery (deep palmar artery) B1 running on a dorsal side Hb of a right hand H1 (or a left hand H2) located on the fingertip side of a forearm A of a patient, the hemostatic device <NUM> is used to perform hemostasis on the puncture site t1. Note that the anatomical snuffbox is a cavity in the hand located on the radial side of the forearm A when the patient spreads a thumb f1 of the right hand H1 or the left hand H2.

In brief, as illustrated in <FIG>, <FIG>, and <FIG>, the hemostatic device <NUM> includes a covering member <NUM> configured to be disposed to cover the puncture site t1 on the right hand H1 of the patient, a plurality of securing members <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, and <NUM> for securing the covering member <NUM> while the covering member <NUM> covers the puncture site t1, and an inflatable member <NUM> connected to the covering member <NUM> and configured to be inflated by injection of a fluid.

<FIG> illustrates a plan view of the hemostatic device <NUM> seen from an outer surface side of a main body <NUM> of the covering member <NUM>, and <FIG> illustrates a plan view of the hemostatic device <NUM> seen from an inner surface side of the main body <NUM> of the covering member <NUM>. The inner surface of the main body <NUM> is a surface on a side to which the inflatable member <NUM> disposed to face a body surface of the patient when the hemostatic device <NUM> is attached to the patient is connected, and the outer surface of the main body <NUM> is a surface opposite to the inner surface (surface on a side where a support member <NUM> is disposed in the present embodiment). In addition, a "distal side" used in the following description is a side on which the fingertip of the right hand H1 is disposed (left side of <FIG> and <FIG>) in a state in which hemostatic device <NUM> is attached to the right hand H1 of the patient.

As illustrated in <FIG> and <FIG>, the covering member <NUM> includes the main body <NUM> to which the inflatable member <NUM> is connected, a first arm portion <NUM> protruding from the main body <NUM>, and a second arm portion <NUM> protruding from the main body <NUM> while forming an obtuse angle with a longitudinal direction of the first arm portion <NUM>.

The first arm portion <NUM> has an inclined portion <NUM> located on an end portion side connected to a first region 121a of the main body <NUM>, and a convex portion 133a protruding in a width direction of the first arm portion <NUM> at an end portion <NUM> opposite to a side where the inclined portion <NUM> is disposed.

As illustrated in <FIG> and <FIG>, the longitudinal direction of the first arm portion <NUM> is a vertical direction of <FIG> and <FIG> in which the first arm portion <NUM> extends in a state in which the first arm portion <NUM> is extended without attaching the hemostatic device <NUM> to the right hand H1 of the patient. In addition, a width direction of the first arm portion <NUM> is a direction intersecting the longitudinal direction of the first arm portion <NUM> on the plan views illustrated in <FIG> and <FIG> and a left-right direction of <FIG> and <FIG>. Similarly, a longitudinal direction of the second arm portion <NUM> is the vertical direction of <FIG> and <FIG> in which the second arm portion <NUM> extends in a state in which the second arm portion <NUM> is extended without attaching the hemostatic device <NUM> to the right hand H1 of the patient, and a width direction of the second arm portion <NUM> is the left-right direction of <FIG> and <FIG> intersecting the longitudinal direction of the second arm portion <NUM> on the plan views illustrated in <FIG> and <FIG>.

The inclined portion <NUM> and the convex portion 133a of the first arm portion <NUM> are formed of a flexible band-shaped member that can wrap the first arm portion <NUM> around the right hand H1 of the patient.

As illustrated in <FIG>, the inclined portion <NUM> is inclined in a direction away from a distal side of the main body <NUM>. A convex portion 113a protrudes toward the distal side of the main body <NUM> in a direction intersecting the longitudinal direction of the first arm portion <NUM>. Further, the convex portion 113a is inclined in a direction toward the main body <NUM> side. For example, a width W3 of the convex portion 133a can be set to <NUM> to <NUM>.

As illustrated in <FIG> and <FIG>, the second arm portion <NUM> is formed longer than the first arm portion <NUM>. Further, as illustrated in <FIG>, <FIG>, and <FIG>, the second arm portion <NUM> is configured to be secured to the convex portion 133a of the first arm portion <NUM> and secured to the second arm portion <NUM> by passing between fingers f1 and f2 of the patient in a state in which the second arm portion <NUM> is wrapped around a limb of the patient.

The second arm portion <NUM> is formed of a flexible band-shaped member that can be wrapped around the limb of the patient. Note that the limb around which the second arm portion <NUM> is wrapped includes, for example, a part of the right hand H1 of the patient, a part of the forearm A, and a part of a wrist. Further, a space between the fingers (inter-finger portion) through which the second arm portion <NUM> passes is, for example, a space between the thumb f1 and the index finger f2 of the right hand H1 of the patient. However, a position of the limb around which the second arm portion <NUM> is wrapped or a position of the inter-finger portion through which the second arm portion <NUM> is passed is not particularly limited. Note that the hemostatic device <NUM> according to the present embodiment can be attached to the left hand H2 in the same manner as each part of the right hand H1 described above (see <FIG>).

As illustrated in <FIG>, a magnitude relationship between a length L1 of the first arm portion <NUM> and a length L2 of the second arm portion <NUM> can be defined by lineal distances L1 and L2 of the respective arm portions <NUM> and <NUM> in a state in which the respective arm portions <NUM> and <NUM> are extended without attaching the hemostatic device <NUM> to the right hand H1 of the patient. Note that, for example, the length L1 of the first arm portion <NUM> can be set to <NUM> to <NUM>. In addition, for example, the length L2 of the second arm portion <NUM> can be set to <NUM> to <NUM>.

In the present embodiment, as illustrated in <FIG>, an obtuse angle θ1 formed between the longitudinal direction of the first arm portion <NUM> and the longitudinal direction of the second arm portion <NUM> can be defined as an angle formed by intersection of a straight line d1 extending substantially parallel to a longitudinal direction of the inclined portion <NUM> of the first arm portion <NUM> and a straight line d2 extending substantially parallel to a longitudinal direction of a first inclined portion 141a of the second arm portion <NUM> on the main body <NUM>. For example, the obtuse angle θ1 can be set to <NUM>° to <NUM>°.

As described above, in the hemostatic device <NUM>, the first arm portion <NUM> and the second arm portion <NUM> form an obtuse angle on the plan views illustrated in <FIG> and <FIG>. Therefore, the first arm portion <NUM> is inclined and extends in a direction away from the distal side of the main body <NUM>. Similarly, the second arm portion <NUM> is inclined and extends in a direction away from the distal side of the main body <NUM>. Therefore, the first arm portion <NUM> and the second arm portion <NUM> extend from the distal side of the main body <NUM> toward the proximal side so as to spread in the shape of the kanji character for the number eight without intersecting each other.

Note that an angle formed by a straight line d3 passing through a center position of the main body <NUM> (corresponding to a center line of a first inflatable portion <NUM>) and a straight line d1 along the longitudinal direction of the first arm portion <NUM> may be the same as or different from an angle formed by the straight line d3 passing through the center portion of the main body <NUM> and a straight line d2 along the longitudinal direction of the second arm portion <NUM>.

As illustrated in <FIG> and <FIG>, the second arm portion <NUM> has an inclined portion <NUM> and a second arm end portion <NUM> that is continuously formed with the inclined portion <NUM> and forms an end portion of the second arm portion <NUM>.

The inclined portion <NUM> of the second arm portion <NUM> has the first inclined portion 141a connected to the first region 121a of the main body <NUM> and a second inclined portion 141b extending between the first inclined portion 141a and the second arm end portion <NUM>.

The first inclined portion 141a is inclined in a direction away from the distal side of the main body <NUM>. Similarly to the first inclined portion 141a, the second inclined portion 141b is inclined in a direction away from the distal side of the main body <NUM>.

A width of the first inclined portion 141a gradually decreases from the first region 121b side of the main body <NUM> toward the second inclined portion 141b side. A width of the second inclined portion 141b gradually decreases from the first inclined portion 141a side to the second arm end portion <NUM> side.

The second arm end portion <NUM> extends linearly along an extending direction of the second arm portion <NUM> with a substantially constant width. Note that the second arm end portion <NUM> is a portion including a predetermined range in the extending direction of the second arm portion <NUM> from an end portion (terminal) of the second arm portion <NUM>.

As illustrated in <FIG>, a width W1 of the inclined portion <NUM> is larger than a width W2 of the second arm end portion <NUM>. The width W1 is a width of the inclined portion (the first inclined portion 141a and the second inclined portion 141b) <NUM> at an arbitrary position.

For example, the width W1 of the inclined portion <NUM> can be set to <NUM> to <NUM>. Further, for example, the width W2 of the second arm end portion <NUM> can be set to <NUM> to <NUM>. A maximum value of the width W1 of the inclined portion <NUM> illustrated above is a maximum value of the first inclined portion 141a, and a minimum value of the width W1 of the inclined portion <NUM> is a minimum value of the second inclined portion 141b. Note that the inclined portion <NUM> can be formed by one inclined portion extending from the first region 121b side of the main body <NUM> to the second arm end portion <NUM>. Even in such a configuration, the width W1 of the inclined portion <NUM> illustrated above can be adopted.

In the first arm portion <NUM> and the second arm portion <NUM>, for example, it is possible to provide an entry portion that allows the operator, etc. to enter the amount of air injected into the inflatable member <NUM>, a hemostatic time, etc. in a procedure using the hemostatic device <NUM>. For example, the entry portion can be made of a material on which a character, etc. can be written using ink, etc. provided in a known pen.

As illustrated in <FIG>, the main body <NUM> of the covering member <NUM> has the first regions 121a and 121b, and a second region <NUM> in which the inflatable member <NUM> is disposed unlike the first regions 121a and 121b.

The first region 121a is disposed between the second region <NUM> and the first arm portion <NUM>. The first region 121b is disposed between the second region <NUM> and the second arm portion <NUM>.

As illustrated in <FIG>, the second region <NUM> of the main body <NUM> has the support member <NUM> having a larger rigidity than that of the first regions 121a and 121b of the main body <NUM>. In the support member <NUM>, both side portion sides located in the left-right direction are adjacent to the first regions 121a and 121b on the plan view illustrated in <FIG>.

As illustrated in <FIG>, the support member <NUM> is inserted into an insertion portion 128a disposed on an outer surface side of the second region <NUM> (surface opposite to a side where each of the inflatable portions <NUM> and <NUM> is disposed in the second region <NUM>, which is a surface on an upper side of <FIG>).

The insertion portion 128a is a space formed between the cover member <NUM> disposed to cover a part of the outer surface of the main body <NUM> and the main body <NUM>.

An insertion port 128b communicating with the insertion portion 128a is formed on the proximal side (lower side of <FIG> and left side of <FIG>) of the main body <NUM>. The support member <NUM> can be inserted into the insertion portion 128a via the insertion port 128b.

For example, the cover member <NUM> can be connected to the covering member <NUM> by adhesion or welding. In the present embodiment, the cover member <NUM> is connected to the covering member <NUM> at three sides other than a part where the insertion port 128b is formed.

As illustrated in <FIG>, the support member <NUM> has a curved portion 125a formed on the distal side of the main body <NUM>. The curved portion 125a has a cross-sectional shape protruding upward so as to be separated from the main body <NUM> on the cross-sectional view illustrated in <FIG>. Note that the distal side of the man body <NUM> means an upper side of the center position with reference to a center position (position where a marker portion <NUM> is disposed in the present embodiment) on the plan view of the inflatable member <NUM> illustrated in <FIG>.

When the inflatable member <NUM> is inflated, the curved portion 125a of the support member <NUM> wraps the vicinity of the end portion of the inflatable member <NUM> on the distal side (an end portion <NUM> of the first inflatable portion <NUM> and an end portion <NUM> of the second inflatable portion <NUM>), so that the compressive force of the inflatable member <NUM> is directed toward the central side of the support member <NUM> (center side in the left-right direction of <FIG>). Thus, the compressive force of the inflatable member <NUM> is inhibited from escaping to the outside of the support member <NUM>. As a result, the hemostatic device <NUM> can suppress a decrease in the compressive force of the inflatable member <NUM> on the puncture site t1, and thus it is possible to appropriately maintain the compressive force of the inflatable member <NUM> on the puncture site t1.

Note that, for example, an apex 125c of the curved portion 125a of the support member <NUM> (a part of the curved portion 125a most distant from the inflatable member <NUM>) can be disposed on the distal side of the main body <NUM> with respect to the center position of the inflatable member <NUM>. By disposing the apex 125c of the curved portion 125a at the position described above, the support member <NUM> can reliably wrap the vicinity of the end portion of the inflatable member <NUM> on the distal side when the inflatable member <NUM> inflates, and thus it is possible to effectively inhibit the compressive force of the inflatable member <NUM> from escaping to the outside of the support member <NUM>.

As illustrated in <FIG>, the support member <NUM> has an inclined portion 125b extending from the curved portion 125a toward the proximal side of the main body <NUM>. The inclined portion 125b extends substantially linearly toward the proximal side of the main body <NUM>.

A width direction dimension (vertical direction dimension of <FIG>) of the support member <NUM> is not particularly limited. However, for example, it is preferable to adopt a size that allows the proximal end of the support member <NUM> to be disposed near the proximal end of the main body <NUM> in a state in which a distal end of the support member <NUM> is disposed near a distal end of the auxiliary member <NUM> as illustrated in <FIG>. Further, a longitudinal direction dimension (left-right direction dimension of <FIG>) of the support member <NUM> is not particularly limited. However, for example, when the first regions 121a and 121b are formed on the main body <NUM>, it is preferable to adopt a dimension that allows formation of the first regions 121a and 121b having desired sizes on both side portion sides of the main body <NUM>.

Note that, for example, the support member <NUM> may be disposed on the inner surface side of the main body <NUM> of the covering member <NUM> (surface on a side where each of the inflatable portions <NUM> and <NUM> is disposed, which is a surface on a lower side of <FIG>). When the support member <NUM> is disposed in this way, connection of the cover member <NUM> to the main body <NUM> can be omitted, and each of the inflatable portions <NUM> and <NUM> can be fixed to the support member <NUM>.

In the present embodiment, the first regions 121a and 121b and the second region <NUM> of the main body <NUM> are integrally formed of one member. However, the first region 121a and 121b and the second region <NUM> may be configured by connecting different members.

In the second region <NUM> of the main body <NUM>, the cover member <NUM>, the support member <NUM>, the first inflatable portion <NUM>, and the second inflatable portion <NUM>, a portion overlapping the marker portion <NUM> in the plan view illustrated in <FIG> and <FIG> and surroundings thereof are preferably transparent (including colored transparent, colorless transparent, and translucent). By adopting such a configuration, the operator can visually recognize the puncture site t1 from the outer surface side of the main body <NUM> even when the marker portion <NUM> is superposed on the puncture site t1.

Note that it is preferable that the first regions 121a and 121b of the main body <NUM> are made of a material having higher elasticity than that of the first arm portion <NUM> and the second arm portion <NUM>. In this way, when the hemostatic device <NUM> is attached to the right hand H1 of the patient, by wrapping each of the arm portions <NUM> and <NUM> around the limb of the patient, the first region 121a is pulled toward the first arm portion <NUM> side and extended, and the first region 121b is pulled toward the second arm portion <NUM> side and extended. As a result, a physical property of the main body <NUM> changes at each boundary between the first arm portion <NUM> and the second arm portion <NUM> to allow the main body to be deformed easily, and thus the first arm portion <NUM> and the second arm portion <NUM> can be easily disposed on the right hand H1 of the patient in a state where the main body <NUM> is disposed on the puncture site t1 formed on the right hand H1 of the patient.

Further, a material of the support member <NUM> is preferably more rigid than a material of each of the first arm portion <NUM> and the second arm portion <NUM>. As a result, when the inflatable member <NUM> inflates, the support member <NUM> can suppress rising of the main body <NUM> by the inflatable member <NUM> due to the rigidity of the support member <NUM>. Further, since the first arm portion <NUM> and the second arm portion <NUM> are configured to be more flexible than the support member <NUM>, the hemostatic device <NUM> can be easily attached to the patient along the limb of the patient when being attached to the patient.

Note that in the present embodiment, in the covering member <NUM>, each of the main body <NUM>, the first arm portion <NUM>, and the second arm portion <NUM> is formed as a separate member. When each portion of the covering member <NUM> is configured as a separate member in this way, each of the main body <NUM>, the first arm portion <NUM>, and the second arm portion <NUM> can be connected by, for example, adhesion, welding, etc. However, in the covering member <NUM>, an arbitrary part of the main body <NUM>, the first arm portion <NUM>, and the second arm portion <NUM> may be integrally formed of one member.

The material used for the main body <NUM> of the covering member <NUM> is not particularly limited. Examples thereof include polyvinyl chloride, polyolefin such as polyethylene, polypropylene, polybutadiene, or ethylene-vinyl acetate copolymer (EVA), polyester such as polyethylene terephthalate (PET) or polybutylene terephthalate (PBT), polyvinylidene chloride, silicone, polyurethane, various thermoplastic elastomers such polyamide elastomer, polyurethane elastomer, and polyester elastomer, nylon, nylon elastomer, or any combination thereof (blended resin, polymer alloy, laminate, etc.).

The material used for the cover member <NUM> is not particularly limited, and examples thereof include the same materials as those exemplified as the material of the covering member <NUM>.

The material used for the support member <NUM> preferably has a higher rigidity than that of the material used for the first regions 121a and 121b of the main body <NUM> of the covering member <NUM>. Examples of such a material may include acrylic resin, polyvinyl chloride (especially hard polyvinyl chloride), polyolefin such as polyethylene, polypropylene, or polybutadiene, polystyrene, poly-(<NUM>-methylpentene-<NUM>), polycarbonate, ABS resin, polymethylmethacrylate (PMMA), polyacetal, polyacrylate, polyacrylonitrile, polyvinylidene fluoride, ionomer, acrylonitrile-butadiene-styrene copolymer, polyester such as polyethylene terephthalate (PET) or polybutylene terephthalate (PBT), butadiene-styrene copolymer, aromatic or aliphatic polyamide, fluorine-based resin such as polytetrafluoroethylene, etc..

The material used for the first arm portion <NUM> and the second arm portion <NUM> of the covering member <NUM> is not particularly limited. Examples thereof may include the same materials as the materials exemplified as the main body <NUM> of the covering member <NUM>, woven fabric, nonwoven fabric, felt, cloth, knitted fabric, and paper.

As illustrated in <FIG> and <FIG>, the hemostatic device <NUM> includes six securing members of a first securing member <NUM>, a second securing member <NUM>, a third securing member <NUM>, a fourth securing member <NUM>, a fifth securing member <NUM>, and a sixth securing member <NUM>.

As illustrated in <FIG>, the first securing member <NUM> is disposed on the outer surface of the first arm portion <NUM>. The first securing member <NUM> is disposed on a part of the inclined portion <NUM> on the distal side and the entire end portion <NUM>.

As illustrated in <FIG>, the second securing member <NUM> and the third securing member <NUM> are disposed on the outer surface of the second arm portion <NUM>. The second securing member <NUM> is disposed on a part of the first inclined portion 141a on the distal side and a part of the second inclined portion 141b on the distal side. The third securing member <NUM> is disposed on the entire second arm end portion <NUM>.

As illustrated in <FIG>, the fourth securing member <NUM> is disposed on the inner surface of the first arm portion <NUM>. The fourth securing member <NUM> is disposed on a part of the inclined portion <NUM> on the distal side and the entire end portion <NUM>.

As illustrated in <FIG>, the fifth securing member <NUM> and the sixth securing member <NUM> are disposed on the outer surface of the second arm portion <NUM>. The fifth securing member <NUM> is disposed on a part of the first inclined portion 141a on the distal side and a part of the second inclined portion 141b on the distal side. The sixth securing member <NUM> is disposed on the entire second arm end portion <NUM>.

The first securing member <NUM> and the second securing member <NUM> are formed on a male side of a surface fastener. The third securing member <NUM>, the fourth securing member <NUM>, the fifth securing member <NUM>, and the sixth securing member <NUM> are formed on a female side of the surface fastener. The surface fastener is a fastener that is removable in terms of surface, and is, for example, Magic Tape (registered trademark) or Velcro (registered trademark).

Note that a specific configuration of each of the securing members <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, and <NUM> is not limited as long as the second arm portion <NUM> wrapped around the limb of the patient can be secured to the convex portion 133a, and a part of the second arm portion <NUM> passed between the thumb f1 and the index finger f2 can be secured to the second arm portion <NUM>. For example, some of the securing members <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, and <NUM> can be omitted, and positions where the securing members are disposed on the respective arm portions <NUM> and <NUM> can be changed as appropriate. Further, when each of the securing members <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, and <NUM> includes a surface fastener, a male side and a female side of the surface fastener may be interchanged. Further, for example, each of the securing members <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, and <NUM> may be a snap, a button, a clip, a frame member in which a hole is formed, etc..

As illustrated in <FIG>, the inflatable member <NUM> has the first inflatable portion <NUM> and the deformable auxiliary member <NUM> having a smaller outer shape (outer shape on the plan view of <FIG>) than that of the first inflatable portion <NUM>.

The auxiliary member <NUM> is disposed to overlap the first inflatable portion <NUM> on the distal side of the main body <NUM>.

The first inflatable portion <NUM> has a lumen <NUM> into which a fluid can be injected, and a communication hole <NUM> formed at a position facing the auxiliary member <NUM>.

In the present embodiment, the auxiliary member <NUM> is a second inflatable portion configured to be inflated by injection of a fluid. Hereinafter, the auxiliary member <NUM> will be referred to as a second inflatable portion.

The second inflatable portion <NUM> has a lumen <NUM> into which a fluid can be injected, and a communication hole <NUM> disposed at a position facing the communication hole <NUM> of the first inflatable portion <NUM>.

The lumen <NUM> of the second inflatable portion <NUM> communicates with the lumen <NUM> of the first inflatable portion <NUM> through the communication hole <NUM> of the second inflatable portion <NUM> and the communication hole <NUM> of the first inflatable portion <NUM>.

As illustrated in <FIG>, the second inflatable portion <NUM> is disposed to have bilateral symmetry with respect to the center line d3 of the first inflatable portion <NUM> (inflatable member <NUM>). Further, the first securing member <NUM>, the second securing member <NUM>, and the third securing member <NUM> described above are disposed on the outer surface of the first arm portion <NUM> and the outer surface of the second arm portion <NUM> opposing to each other with the main body <NUM> interposed therebetween.

In the present embodiment, the second inflatable portion <NUM> has a substantially square shape. Therefore, in the second inflatable portion <NUM>, a center position of the square in the left-right direction is disposed at the center position of the main body <NUM>. Further, the marker portion <NUM>, which will be described later, is disposed at the center position of the second inflatable portion <NUM>.

The second inflatable portion <NUM> is fixed to the inner surface of the covering member <NUM> (the inner surface of the main body <NUM> of the covering member <NUM>). Specifically, the end portion <NUM> located on the distal side of the second inflatable portion <NUM> is fixed to the inner surface of the covering member <NUM>.

In the first inflatable portion <NUM>, the periphery of the communication hole <NUM> of the first inflatable portion <NUM> is fixed to the periphery of the communication hole <NUM> of the second inflatable portion <NUM>. Specifically, in the first inflatable portion <NUM>, only a certain range around each of the communication holes <NUM> and <NUM> located near the central portion of the second inflatable portion <NUM> is fixed to the second inflatable portion <NUM>. As described above, the first inflatable portion <NUM> is not directly connected to the covering member <NUM>, and is indirectly connected to the covering member <NUM> via the second inflatable portion <NUM>. As a result, in the second inflatable portion <NUM>, the peripheral edge of the second inflatable portion <NUM> is not fixed to the first inflatable portion <NUM>, and thus the outer shape of the second inflatable portion <NUM> is freely deformed. For this reason, even when the patient bends the finger (for example, the thumb f1) or the wrist upward (to the dorsal side Hb of the hand), the hemostatic device <NUM> can maintain a large area in which the second inflatable portion <NUM> compresses the first inflatable portion <NUM>. Therefore, the hemostatic device <NUM> can effectively apply a compressive force to the puncture site t1 from the inflatable member <NUM>. Note that in the first inflatable portion <NUM> and the second inflatable portion <NUM>, for example, the first inflatable portion <NUM> and the second inflatable portion <NUM> may be integrally connected to the covering member <NUM> by fixing the end portion <NUM> of the second inflatable portion <NUM> to the covering member <NUM> in a state where the first inflatable portion <NUM> and the second inflatable portion <NUM> are connected.

The inflatable member <NUM> may be fixed to the inner surface of the covering member <NUM> at a position different from that in <FIG> as long as the inflatable member <NUM> is fixed to the covering member <NUM> on the curved portion 125a side of the support member <NUM>. Specifically, a part or the whole of the outer surface side of the second inflatable portion <NUM> may be fixed to the inner surface of the covering member <NUM> on the curved portion 125a side of the support member <NUM>. Even in such a configuration, in the hemostatic device <NUM>, a compression direction of the inflatable member <NUM> is directed to the center side of the first inflatable portion <NUM> (the center side in the left-right direction of <FIG>) by the curved portion 125a of the support member <NUM>. Therefore, the hemostatic device <NUM> suppresses a decrease in the compressive force due to the inflatable member <NUM> even when a gap is generated between the main body <NUM> and the body surface of the hand H due to movement of the finger of the patient or bending of the wrist.

Further, it is preferable that the second inflatable portion <NUM> is located inside the curved portion 125a of the support member <NUM> and is disposed to overlap the first inflatable portion <NUM>. As a result, since the second inflatable portion <NUM> is located inside the curved portion 125a of the support member <NUM>, the compressive force of the second inflatable portion <NUM> is directed toward the center side of the support member <NUM> by the curved portion 125a, and inhibited from escaping to the outside of the support member <NUM>. Further, when the second inflatable portion <NUM> is disposed to overlap the first inflatable portion <NUM> on the curved portion 125a side of the support member <NUM>, the second inflatable portion <NUM> can prevent the first inflatable portion <NUM> from rising on the distal side of the right hand H1 or the left hand H2 while preventing position shift of the first inflatable portion <NUM>. Therefore, the hemostatic device <NUM> can more reliably prevent the inflatable member <NUM> from rising, and can suppress a decrease in the compressive force applied to the puncture site t1 by the inflatable member <NUM>.

The first inflatable portion <NUM> has a substantially square shape on the plan view illustrated in <FIG>. The second inflatable portion <NUM> has a substantially rectangular shape that includes a set of long sides having substantially the same length as that of one side of the first inflatable portion <NUM> and a set of short sides having a length which is approximately half a length of one side of the first inflatable portion <NUM>.

The lumen <NUM> of the first inflatable portion <NUM> communicates with a lumen of a tube <NUM> for supplying a fluid such as air to the first inflatable portion <NUM>. As illustrated in <FIG> and <FIG>, the tube <NUM> is connected to the first inflatable portion <NUM> on the proximal side of the first inflatable portion <NUM>. The tube <NUM> is pulled out to the outside of the main body <NUM> through the inner surface side of the main body <NUM> of the covering member <NUM>. A position where the tube <NUM> is pulled out from the first inflatable portion <NUM> is not particularly limited. However, as illustrated in <FIG>, when the tube <NUM> is pulled out to the proximal side of the main body <NUM>, so that the hemostatic device <NUM> is attached to the patient, the tube <NUM> is disposed laterally to the right hand H1 (in a direction intersecting a direction in which the finger of the right hand H1 extends) (see <FIG>). For this reason, when the hemostatic device <NUM> is attached to the patient, the tube <NUM> can be prevented from interfering with the introducer <NUM>.

Note that the tube <NUM> may be connected to the second inflatable portion <NUM>. Further, a position at which the tube <NUM> is pulled to the outside of the main body <NUM> can be appropriately changed.

As illustrated in <FIG>, the hemostatic device <NUM> has the marker portion <NUM> for aligning the inflatable member <NUM> with respect to the puncture site t1.

The marker portion <NUM> is disposed at a position corresponding to a substantially center position (center position on the plan view illustrated in <FIG>) of the first inflatable portion <NUM>.

As illustrated in <FIG>, for example, the marker portion <NUM> can be disposed on an inner surface of a side surface (inner surface) of the first inflatable portion <NUM> disposed to face the body surface. However, for example, the marker portion <NUM> may be disposed on an internal surface of a surface (outer surface) opposite to the side surface of the first inflatable portion <NUM> disposed to face the body surface or an external surface thereof, an internal surface or an external surface of the main body <NUM> of the covering member <NUM>, an internal surface or an external surface of the support member <NUM>, an internal surface or an external surface of the cover member <NUM>, etc. In addition, when a center portion of the first inflatable portion <NUM> and an end portion of the second inflatable portion <NUM> (an end portion on the proximal side, which is an end portion on the left side of <FIG>) are disposed to overlap each other on the cross-sectional view illustrated in <FIG>, the marker portion <NUM> may be disposed on an external surface of the end portion of the second inflatable portion <NUM>.

For example, the marker portion <NUM> preferably includes a transparent central portion and a colored linear frame portion surrounding the central portion. In this way, the operator can dispose the marker portion <NUM> at the puncture site t1 while confirming the puncture site t1 through the transparent central portion of the marker portion <NUM>. For this reason, the operator can easily dispose the center position of the first inflatable portion <NUM> at the puncture site t1 using the marker portion <NUM>. Note that, for example, the marker portion <NUM> may be formed only by the colored central portion without having the frame portion. Further, a specific shape and color of the marker portion <NUM>, a formation method on each portion of the hemostatic device <NUM>, etc. are not particularly limited.

In the present embodiment, the first inflatable portion <NUM> is formed of two sheet-shaped members. For example, the first inflatable portion <NUM> can be formed by forming the lumen <NUM> between two sheet-shaped members formed in a substantially rectangular shape and bonding outer peripheral edges of the two sheet-shaped members in this state. Similarly to the first inflatable portion <NUM>, the second inflatable portion <NUM> can be formed of two substantially rectangular sheet-shaped members bonded together.

A method of bonding the sheet-shaped members forming the first inflatable portion <NUM>, and a method of bonding the sheet-shaped members forming the second inflatable portion <NUM> are not particularly limited. For example, it is possible to adopt adhesion or welding. Further, a method of connecting the second inflatable portion <NUM> and the main body <NUM> of the covering member <NUM> is not particularly limited. For example, adhesion or welding can be adopted. Further, a method of fixing the first inflatable portion <NUM> and the second inflatable portion <NUM> is not particularly limited. For example, adhesion or welding can be adopted.

Note that the first inflatable portion <NUM> and the second inflatable portion <NUM> may not have a structure in which a plurality of sheet-shaped members is bonded. The first inflatable portion <NUM> and the second inflatable portion <NUM> may be formed of, for example, one bag-shaped member in which a space into which a fluid can flow is formed.

A material used for the first inflatable portion <NUM> and the second inflatable portion <NUM> is not particularly limited, and examples thereof may include the same materials as those exemplified as the material of the covering member <NUM>.

As illustrated in <FIG>, the hemostatic device <NUM> has an injection portion <NUM> for injecting a fluid into the inflatable member <NUM> (the first inflatable portion <NUM> and the second inflatable portion <NUM>).

The injection portion <NUM> includes a connector having an incorporated check valve (not illustrated). A syringe (not illustrated) can be connected to the injection portion <NUM>.

A cushioning member <NUM> having an inflatable space is disposed between the injection portion <NUM> and the inflatable member <NUM>. The cushioning member <NUM> includes a flexible bag-shaped member having a space formed inside. Note that the cushioning member <NUM> may be provided with an arrow-shaped marker indicating a direction in which the syringe is inserted into the injection portion <NUM>.

The injection portion <NUM> is connected to one end side of the cushioning member <NUM>. A lumen of the injection portion <NUM> communicates with a space in the cushioning member <NUM>. However, while the check valve incorporated in the injection portion <NUM> is closed, communication between the lumen of the injection portion <NUM> and the space in the cushioning member <NUM> is cut off.

A flexible tube <NUM> is connected to the other end side of the cushioning member <NUM>. A lumen of the tube <NUM> communicates with the space in the cushioning member <NUM>. Further, in the tube <NUM>, the other end portion opposite to one end portion connected to the cushioning member <NUM> is connected to the first inflatable portion <NUM>. The lumen of the tube <NUM> communicates with the lumen <NUM> of the first inflatable portion <NUM>.

For example, the other end portion of the tube <NUM> can be connected to the first inflatable portion <NUM> using an adhesive, etc. while being interposed between the two sheet-shaped members forming the first inflatable portion <NUM>. Note that, in the sheet-shaped members forming the first inflatable portion <NUM>, for example, convex portions partially protruding outward from the sheet-shaped members may be formed at parts interposing the tube <NUM> therebetween.

To inflate the first inflatable portion <NUM> and the second inflatable portion <NUM>, the operator inserts a distal tubular portion of a syringe (not illustrated) into the injection portion <NUM> to open the check valve. The operator injects air in the syringe into the lumen <NUM> of the first inflatable portion <NUM> by pushing a plunger of the syringe with the check valve of the injection portion <NUM> open.

When air is injected into the lumen <NUM> of the first inflatable portion <NUM>, the first inflatable portion <NUM> inflates. Further, the air injected into the lumen <NUM> of the first inflatable portion <NUM> flows into the lumen <NUM> of the second inflatable portion <NUM> via the communication hole <NUM> of the first inflatable portion <NUM> and the communication hole <NUM> of the second inflatable portion <NUM>. When air flows into the lumen <NUM> of the second inflatable portion <NUM>, the second inflatable portion <NUM> inflates. When the first inflatable portion <NUM> and the second inflatable portion <NUM> inflate, the cushioning member <NUM> communicating with the lumen <NUM> of the first inflatable portion <NUM> via the tube <NUM> inflates.

The space in cushioning member <NUM> and the lumen <NUM> of the first inflatable portion <NUM> are in communication with each other via the tube <NUM> at all times. The injection portion <NUM> maintains the check valve incorporated in the injection portion <NUM> in a closed state when the syringe is not inserted into the injection portion <NUM> to prevent air from leaking from the injection portion <NUM>. For this reason, when the internal pressure of the inflatable member <NUM> increases due to movement of the right hand H of the patient, etc., the air in the lumen <NUM> of the first inflatable portion <NUM> and the lumen <NUM> of the second inflatable portion <NUM> moves to the cushioning member <NUM> side which is not pressed against the puncture site t1 by the covering member <NUM>. In this way, the compressive force applied to the puncture site t1 by the inflatable member <NUM> is adjusted, and thus the compressive force to the puncture site t1 by the inflatable member <NUM> can be appropriately maintained.

When the operator contracts the first inflatable portion <NUM> and the second inflatable portion <NUM>, the operator inserts the distal tubular portion of the syringe into the injection portion <NUM> and pulls the plunger of the syringe. By performing the above operation, the operator can discharge the air in the first inflatable portion <NUM> and the air in the second inflatable portion <NUM> to the syringe.

Note that when the operator, etc. inflates the inflatable member <NUM>, the operator, etc. can visually confirm that the first inflatable portion <NUM> and the second inflatable portion <NUM> can be pressurized without leakage of air by confirming expansion of the cushioning member <NUM>.

Next, a usage example of the hemostatic device <NUM> will be described with reference to <FIG>. In the following, a description will be given of an example of a procedure for attaching the hemostatic device <NUM> to the right hand H1 of the patient on which the puncture site t1 is formed.

<FIG> illustrates a state in which various procedures are performed by inserting the sheath tube of the introducer <NUM> into the distal radial artery side of the palmar artery B1 via the puncture site t1 (see <FIG>) formed on the dorsal side Hb of the right hand H1 of the patient. Further, <FIG> illustrates a state in which a part of the sheath tube of the introducer <NUM> is pulled out from the puncture site t1 after the above procedure is completed.

At the start of hemostasis, as illustrated in <FIG>, the operator, etc. disposes the main body <NUM> of the covering member <NUM> so that the main body <NUM> overlaps a side of the dorsal side Hb of the right hand H1. In this instance, the marker portion <NUM> disposed at a substantially center position of the first inflatable portion <NUM> is disposed on the puncture site t1.

Subsequently, as illustrated in <FIG> and <FIG>, the operator, etc. wraps the inclined portion (the first inclined portion 141a and the second inclined portion 141b) <NUM> of the second arm portion <NUM> along the right hand H1 of the patient while wrapping the convex portion 133a of the first arm portion <NUM> around the right hand H1 of the patient. In this instance, the operator, etc. secures the convex portion 133a and the second arm portion <NUM> via the respective securing members <NUM> and <NUM> by bringing the fifth securing member <NUM> (female side of the surface fastener) disposed on the inner surface of the inclined portion <NUM> into contact with the first securing member <NUM> (male side of the surface fastener) disposed on the outer surface of the convex portion 133a of the first arm portion <NUM> on the palm Hp side of the right hand H1 of the patient.

When the second arm portion <NUM> is secured to the convex portion 133a, the operator, etc. can confirm the position of the convex portion 133a and the shape of the convex portion 133a by the feel of the fingers. Therefore, the operator, etc. can guide the second arm portion <NUM> to the convex portion 133a disposed on the palm Hp side of the right hand H1 of the patient and recognize a direction in which the second arm portion <NUM> is disposed on the convex portion 133a, and thus the second arm portion <NUM> can be easily secured to the convex portion 133a.

Subsequently, as illustrated in <FIG>, the operator, etc. passes the second arm portion <NUM> between the thumb f1 and the index finger f2 of the right hand H1 of the patient to dispose the second arm end portion <NUM> on the side of the dorsal side Hb of the hand H of the patient. Subsequently, operator, etc. secures the first inclined portion 141a and the second arm end portion <NUM> via the respective securing members <NUM> and <NUM> by bringing the sixth securing member <NUM> (female side of the surface fastener) disposed on the inner surface of the second arm end portion <NUM> into contact with the second securing member <NUM> (male side of the surface fastener) disposed on the outer surface of the first inclined portion 141a on the side of the dorsal side Hb of the right hand H1 of the patient.

Subsequently, the operator, etc. wraps a portion (surplus portion) of the second arm end portion <NUM> not secured to the first inclined portion 141a along a circumferential direction of the right hand H1 of the patient, thereby further securing the second arm end portion <NUM> to the convex portion 133a. In this way, the hemostatic device <NUM> can prevent the second arm end portion <NUM> from being caught in a surrounding article, etc. while the hemostatic device <NUM> is attached to the operator, etc..

The operator, etc. can secure the hemostatic device <NUM> to the right hand H1 of the patient by the above procedure. <FIG> illustrates a state in which the hemostatic device <NUM> is attached to the right hand H1 of the patient. Note that <FIG> illustrates a state in which the introducer <NUM> is removed from the puncture site t1.

Next, the operator, etc. connects the syringe to the injection portion <NUM> and injects air into the first inflatable portion <NUM> to inflate the first inflatable portion <NUM> and the second inflatable portion <NUM>. In the hemostatic device <NUM>, when the first inflatable portion <NUM> and the second inflatable portion <NUM> are inflated, the first inflatable portion <NUM> applies a compressive force to the puncture site t1. After inflating the respective inflatable portions <NUM> and <NUM>, as illustrated in <FIG>, the operator, etc. removes the sheath tube of the introducer <NUM> from the puncture site t1. In this instance, as illustrated in <FIG>, since the second arm portion <NUM> is disposed between the thumb f1 and the index finger f2 of the right hand H1 of the patient, the hemostatic device <NUM> does not have an arm portion protruding from the main body <NUM> in a region where the curved portion 125a of the support member <NUM> and the second inflatable portion <NUM> are located in the main body <NUM>. For this reason, after inflating the respective inflatable portions <NUM> and <NUM>, as illustrated in <FIG>, the operator, etc. can remove the sheath tube of the introducer <NUM> from the puncture site t1.

The operator, etc. confirms that there is no bleeding from the puncture site t1 during hemostasis using the hemostatic device <NUM>. When there is bleeding from the puncture site t1, the operator, etc. adjusts the amount of air injected into each of the inflatable portions <NUM> and <NUM>.

After a certain period of time from the start of hemostasis, the operator, etc. gradually depressurizes each of the inflatable portions <NUM> and <NUM> to confirm that hemostasis is properly performed on the puncture site t1. After the hemostasis on the puncture site t1 is completed, the operator, etc. sufficiently depressurizes each of the inflatable portions <NUM> and <NUM>. Then, the operator, etc. releases securing of the hemostatic device <NUM> by the first arm portion <NUM> and the second arm portion <NUM>, and removes the hemostatic device <NUM> from the hand H of the patient.

As illustrated in <FIG>, during hemostasis, the hemostatic device <NUM> is firmly secured to the right hand H1 of the patient by the second arm portion <NUM> passed between the thumb f1 and the index finger f2 of the right hand H1 of the patient while being wrapped around the limb of the patient. For this reason, since each finger is not covered by the covering member <NUM> when the hemostatic device <NUM> is attached to the right hand H1, the patient can freely move the finger while hemostasis is performed.

By proceeding with an attaching operation according to a procedure described with reference to <FIG>, the operator, etc. can use the first arm portion <NUM> and the second arm portion <NUM> to easily attach the hemostatic device <NUM> to the patient in a short time. Further, the hemostatic device <NUM> can secure the covering member <NUM> to the right hand H1 of the patient using the securing members <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, and <NUM> disposed on the respective arm portions <NUM> and <NUM>. Therefore, the hemostatic device <NUM> can reduce a burden on the skin of the patient during attachment when compared to a hemostatic device secured to the right hand H1 or the forearm A of the patient using a seal member, etc. provided with an adhesive material.

Further, since the hemostatic device <NUM> includes the first inflatable portion <NUM> as a member that applies a compressive force to the puncture site t1, the compressive force can be easily adjusted by adjusting the internal pressure of the first inflatable portion <NUM>. Further, in the hemostatic device <NUM>, even when the first inflatable portion <NUM> is deformed to change the internal pressure following movement of the right hand H1 when the patient moves the right hand H1, the deformable second inflatable portion <NUM> mitigates the change in the internal pressure of the first inflatable portion <NUM>. Therefore, the first inflatable portion <NUM> has a high following property to movement of the right hand H1 of the patient, and compression on the puncture site t1 by the first inflatable portion <NUM> can be appropriately maintained.

Further, the hemostatic device <NUM> is configured to cover only a part of the right hand H1 of the patient by the covering member <NUM>, and is not configured to cover the entire right hand H1. For this reason, when the patient moves the right hand H1 in a state where the hemostatic device <NUM> is attached to the right hand H1 of the patient, it is possible to prevent movement of the right hand H1 of the patient from being transmitted to the entire hemostatic device <NUM>. Therefore, the hemostatic device <NUM> can suppress position shift from the right hand H1 of the patient when the patient moves the right hand H1 in the state where the hemostatic device <NUM> is attached to the right hand H1 of the patient.

The hemostatic device <NUM> can be attached to the left hand H2 of the patient, for example, without changing the configuration of the hemostatic device <NUM>. Hereinafter, a description will be given of an example of a procedure for attaching the hemostatic device <NUM> to the left hand H2 of the patient on which the puncture site t1 is formed. Note that description of content overlapping with the above-mentioned example of the procedure for attaching the hemostatic device <NUM> to the right hand H1 will be omitted.

As illustrated in <FIG>, the operator, etc. disposes the main body <NUM> of the covering member <NUM> so as to overlap the side of the dorsal side Hb of the right hand H2.

Subsequently, as illustrated in <FIG>, the operator, etc. wraps the inclined portion (the first inclined portion 141a and the second inclined portion 141b) <NUM> of the second arm portion <NUM> along the left hand H2 of the patient while wrapping the convex portion 133a of the first arm portion <NUM> around the left hand H2 of the patient. In this instance, the operator, etc. secures the convex portion 133a and the second arm portion <NUM> via the respective securing members <NUM> and <NUM> by bringing the fifth securing member <NUM> (female side of the surface fastener) disposed on the inner surface of the inclined portion <NUM> into contact with the first securing member <NUM> (male side of the surface fastener) disposed on the outer surface of the convex portion 133a of the first arm portion <NUM> on the palm Hp side of the left hand H2 of the patient.

Subsequently, as illustrated in <FIG>, the operator, etc. disposes the second arm portion <NUM> on the side of the dorsal side Hb of the left hand H2 of the patient. In this instance, the operator, etc. secures the first arm portion <NUM> and the second arm portion <NUM> via the respective securing members <NUM> and <NUM> on the side of the dorsal side Hb of the left hand H2 by bringing the fifth securing member <NUM> (female side of the surface fastener) disposed on the inner surface of the inclined portion <NUM> into contact with the first securing member <NUM> (male side of the surface fastener) disposed on the outer surface of the inclined portion <NUM> of the first arm portion <NUM> on the side of the dorsal side Hb of the left hand H2 of the patient.

Subsequently, as illustrated in <FIG>, the operator, etc. passes the second arm portion <NUM> between the thumb f1 and the index finger f2 of the left hand H2 of the patient, and disposes the second arm end portion <NUM> on the palm Hp side of the left hand H2 of the patient. In this instance, the operator, etc. secures the first inclined portion 141a and the second arm end portion <NUM> via the respective securing members <NUM> and <NUM> by bringing the sixth securing member <NUM> (female side of the surface fastener) disposed on the inner surface of the second arm end portion <NUM> into contact with the second securing member <NUM> (male side of the surface fastener) disposed on the outer surface of the inclined portion <NUM> on the palm Hp side of the left hand H2 of the patient.

The operator, etc. can secure the hemostatic device <NUM> to the left hand H2 of the patient by the above procedure.

Hereinafter, the effects of the present embodiment will be described.

The hemostatic device <NUM> according to the present embodiment includes the covering member <NUM> disposed to cover the puncture site t1 on the right hand H1 (or left hand H2) of the patient, the plurality of securing members <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, and <NUM> that is configured to secure the covering member <NUM> in a state where the covering member <NUM> covers the puncture site t1, and the inflatable member <NUM> connected to the covering member <NUM> and configured to be inflated by injection of a fluid. The covering member <NUM> has the main body <NUM> to which the inflatable member <NUM> is connected, the first arm portion <NUM> protruding from the main body <NUM>, and the second arm portion <NUM> protruding from the main body <NUM> while forming an obtuse angle with the longitudinal direction of the first arm portion <NUM>. Further, the first arm portion <NUM> has the convex portion 133a protruding in the width direction of the first arm portion <NUM> at the end portion <NUM> of the first arm portion <NUM>. Furthermore, the second arm portion <NUM> is longer than the first arm portion <NUM> and is configured to be secured to the convex portion 133a and secured to the second arm portion <NUM> by passing between the fingers f1 and f2 of the patient in a state where the second arm portion <NUM> is wrapped around the limb of the patient.

In the hemostatic device <NUM> configured as described above, it is possible to secure the main body <NUM> in which the inflatable member <NUM> is disposed to the limb by disposing a part of the second arm portion <NUM> between the adjacent fingers f1 and f2 of the patient and connecting the convex portion 133a and the second arm portion <NUM> while wrapping the first arm portion <NUM> and the second arm portion <NUM> around the limb of the patient. The first arm portion <NUM> and the second arm portion <NUM> are fastened to the limb by connecting the convex portion 133a and the second arm portion <NUM>, and the main body <NUM> is secured to the limb. Further, by disposing the second arm portion <NUM> between the adjacent fingers f1 and f2 of the patient, it is possible to suppress position shift of the inflatable member <NUM> disposed in the main body <NUM> with respect to the puncture site t1. Further, the hemostatic device <NUM> has a simple securing structure capable of tightening the inflatable member <NUM> to the hand H1 of the patient by connecting the two arm portions <NUM> and <NUM> protruding from the main body <NUM>. For this reason, the hemostatic device <NUM> can reduce the number of arm portions installed for securing the inflatable member <NUM>. Therefore, the hemostatic device <NUM> can suppress an increase in arm portions that may interfere with a medical device such as the introducer <NUM> when the hemostatic device <NUM> is attached to the hand H1 of the patient, and it is possible to easily remove the medical device from the puncture site t1 even after the hemostatic device <NUM> is attached. Further, a movable range of the right hand H1 (or the left hand H2) increases from the wrist side to the fingertip side of the right hand H1. In the hemostatic device <NUM>, the first arm portion <NUM> and the second arm portion <NUM> extend from the fingertip side to the wrist side of the right hand H1 while forming an obtuse angle, so that the first arm portion <NUM> and the second arm portion <NUM> can be connected on the wrist side of the right hand H1 of the patient. Therefore, in the hemostatic device <NUM>, the first arm portion <NUM> and the second arm portion <NUM> can be secured on the wrist side where the movable range is small, and thus the main body <NUM> can be secured to the limb while maintaining the movable range on the fingertip side of the right hand H1. Note that an outer circumference of the right hand H1 becomes larger from the wrist side to the fingertip side of the right hand H1 in a state where the right hand H1 is spread. Therefore, since the first arm portion <NUM> and the second arm portion <NUM> extend in a direction opposite to a direction in which the outer circumference of the right hand H1 becomes larger, the first arm portion <NUM> and the second arm portion <NUM> can be reliably connected on the wrist side of the right hand H1 in the state where the hemostatic device <NUM> is attached. Furthermore, in the hemostatic device <NUM>, even in the case where the patient moves the hand H with the inflatable member <NUM> inflated, when the first arm portion <NUM> and the second arm portion <NUM> are secured in a state of being tightened to the limb of the patient, it is possible to prevent rising of the distal side (fingertip side) of the main body <NUM> to which the inflatable member <NUM> is connected, and to appropriately maintain the compressive force of the inflatable member <NUM> on the puncture site t1 formed on the dorsal side Hb of the hand H1 of the patient.

Further, the main body <NUM> has first regions 121a and 121b and the second region <NUM> in which the inflatable member <NUM> is disposed unlike the first regions 121a and 121b. The first region 121a is disposed between the second region <NUM> and the first arm portion <NUM>, and the first region 121b is disposed between the second region <NUM> and the second arm portion <NUM>. Further, the second region <NUM> includes the support member <NUM> having a higher rigidity than that of the first regions 121a and 121b. Therefore, the hemostatic device <NUM> can prevent the inflatable member <NUM> from rising from the dorsal side Hb of the hand H of the patient by the support member <NUM> while hemostasis is performed. As a result, the hemostatic device <NUM> can suitably apply a compressive force from the inflatable member <NUM> to the puncture site t1 while being attached to the right hand H1 of the patient.

Further, the support member <NUM> has the curved portion 125a formed on the distal side of the main body <NUM>. For this reason, in the support member <NUM>, when the inflatable member <NUM> is inflated, a direction in which the inflatable member <NUM> applies a compressive force to the right hand H1 of the patient is directed in an oblique direction toward the puncture site t1. For this reason, the hemostatic device <NUM> can more effectively apply a compressive force to the puncture site t1. Further, the curved portion 125a of the support member <NUM> directs the compressive force of the inflatable member <NUM> toward the center side of the support member <NUM> by wrapping the end portion of the inflatable member <NUM> on the distal side when the inflatable member <NUM> inflates, and thus the compressive force of the inflatable member <NUM> is inhibited from escaping to the outside of the support member <NUM>. For this reason, the hemostatic device <NUM> can suppress a decrease in the compressive force to the puncture site t1 by the inflatable member <NUM>, and thus can appropriately maintain the compressive force of the inflatable member <NUM> to the puncture site t1.

Further, the inflatable member <NUM> has the first inflatable portion <NUM> and the deformable auxiliary member <NUM> having a smaller outer shape than that of the first inflatable portion <NUM>, and the auxiliary member <NUM> is disposed to overlap the first inflatable portion <NUM> on the distal side of the main body <NUM>. In the hemostatic device <NUM> configured as described above, when the first inflatable portion <NUM> inflates, the second inflatable portion <NUM> inhibits the first inflatable portion <NUM> from rising from the body surface of the patient. Therefore, when the first inflatable portion <NUM> inflates, the first inflatable portion <NUM> can effectively apply the compressive force to the puncture site t1. Further, when the patient bends a finger (for example, the thumb f1) or the wrist downward (to the palm Hp side of the hand H), the hemostatic device <NUM> maintains a state in which the auxiliary member <NUM> is deformed by following movement of the finger or the wrist and the auxiliary member <NUM> applies the compressive force to the puncture site t1.

Further, the auxiliary member is the second inflatable portion <NUM> configured to be inflated by injection of a fluid, and the lumen <NUM> of the second inflatable portion <NUM> communicates with the lumen <NUM> of the first inflatable portion <NUM>. Since the auxiliary member <NUM> includes the second inflatable portion <NUM> which is inflatable, it is possible to improve the following property of the second inflatable portion <NUM> to movement of the right hand H1. Further, since the lumen <NUM> of the first inflatable portion <NUM> and the lumen <NUM> of the second inflatable portion <NUM> communicate with each other, the first inflatable portion <NUM> and the second inflatable portion <NUM> can be easily inflated.

In addition, the second inflatable portion <NUM> is disposed to have bilateral symmetry with respect to the center line d3 of the first inflatable portion <NUM>, and the securing members <NUM> and <NUM> for securing the second arm portion <NUM> are disposed on the outer surface of the first arm portion <NUM> and the outer surface of the second arm portion <NUM> opposing to each other with the main body <NUM> interposed therebetween. For this reason, when the hemostatic device <NUM> is attached to the right hand H1 of the patient, the operator, etc. can secure the second arm portion <NUM> to the convex portion 133a through the respective securing members <NUM> and <NUM> while disposing the first inflatable portion <NUM> on the puncture site t1 so that the puncture site t1 is located on the center line d3 of the auxiliary member <NUM>. Similarly, when the hemostatic device <NUM> is attached to the left hand H2 of the patient, the operator, etc. can secure the second arm portion <NUM> to the convex portion 133a through the respective securing members <NUM> and <NUM> while disposing the first inflatable portion <NUM> on the puncture site t1 so that the puncture site t1 is located on the center line d3 of the auxiliary member <NUM>. Therefore, the operator, etc. can attach the hemostatic device <NUM> to both the right hand H1 and the left hand H2 of the patient.

Further, the convex portion 133a protrudes toward the distal side of the main body <NUM> in a direction intersecting the extending direction of the first arm portion <NUM>. Therefore, when the second arm portion <NUM> is secured to the convex portion 133a, the operator, etc. can confirm the position of the convex portion 133a disposed on the palm Hp side of the hand H and the shape of the convex portion 133a by the hand feel, etc., and thus the second arm portion <NUM> can be easily secured to the convex portion 133a.

Further, the second arm portion <NUM> has the inclined portion <NUM> and the second arm end portion <NUM> which is continuously formed with the inclined portion <NUM> and forms an end portion of the second arm portion <NUM>, and the width of the inclined portion <NUM> is larger than the width of the second arm end portion <NUM>. Therefore, when the second arm portion <NUM> is secured to the convex portion 133a, by wrapping the inclined portion <NUM> around the hand H of the patient, the operator, etc. can more reliably dispose the inclined portion <NUM> with respect to the convex portion 133a, and easily secure the second arm portion <NUM>.

Further, the hemostatic device <NUM> has the injection portion <NUM> for injecting a fluid into the inflatable member <NUM>. The cushioning member <NUM> having an inflatable space is disposed between the injection portion <NUM> and the inflatable member <NUM>. In the hemostatic device <NUM>, when the patient moves the right hand H1 while the hemostatic device <NUM> is attached to the patient, the inflatable member <NUM> (the first inflatable portion <NUM> and the second inflatable portion <NUM>) that compresses the puncture site t1 on the right hand H1 is deformed. When the inflatable member <NUM> is deformed, if there is no escape place for air in the lumen of the inflatable member <NUM> (the lumen <NUM> of the first inflatable portion <NUM> and the lumen <NUM> of the second inflatable portion <NUM>), deformation of the inflatable member <NUM> is hindered. For this reason, the patient has a limited movable range for the right hand H1. The cushioning member <NUM> included in the hemostatic device <NUM> allows air to move from the lumen of the inflatable member <NUM> to the cushioning member <NUM> when the patient moves the right hand H1. For this reason, the patient can prevent the movable range from being restricted by the inflatable member <NUM> when the right hand H1 is moved. Note that when the patient returns the right hand H1 from the deformed state to the original state, air moves from the cushioning member <NUM> to the inflatable member <NUM>, and thus the compressive force can be effectively applied to the puncture site t1 from the inflatable member <NUM>.

Next, a description will be given of a modification of the hemostatic device according to the first embodiment described above. In description of the modification, detailed description of the configuration, etc. previously described in the first embodiment will be omitted. In addition, content not particularly described in the description of the modification can be regarded as the same as that in the first embodiment.

<FIG> is a plan view of a hemostatic device 100A seen from the outer surface side of the main body <NUM> of the covering member <NUM>, and <FIG> is a cross-sectional view of the hemostatic device 10A taken along arrow <NUM>-<NUM> illustrated in <FIG>.

In the hemostatic device 100A according to the modification, the inflatable member <NUM> includes only the first inflatable portion <NUM>. That is, the inflatable member <NUM> does not include the second inflatable portion <NUM>. Further, in the hemostatic device 100A, as illustrated in <FIG>, the end portion <NUM> of the first inflatable portion <NUM> on the distal side included in the inflatable member <NUM> is directly fixed to the inner surface of the covering member <NUM>. Other configurations of the hemostatic device 100A are substantially the same as those of the hemostatic device <NUM> described above.

In the hemostatic device 100A according to the modification, similarly to the hemostatic device <NUM> described above, position shift of the inflatable member <NUM> disposed on the main body <NUM> with respect to the puncture site t1 can be suppressed by connecting the convex portion 133a wrapped around the limb of the patient and the second arm portion <NUM>, and securing a part of the second arm portion <NUM> passed between the fingers f1 and f2 of the patient to the second arm portion <NUM>. Further, since the hemostatic device 100A has a simple securing structure capable of tightening the inflatable member <NUM> to the right hand H1 of the patient by connecting the two arm portions <NUM> and <NUM> protruding from the main body <NUM>, the hemostatic device 100A can reduce the number of arm portions installed for securing the inflatable member <NUM>. Therefore, the hemostatic device 100A can suppress an increase in arm portions that may interfere with a medical device such as the introducer <NUM> when the hemostatic device 100A is attached to the hand H1 of the patient, and it is possible to easily remove the medical device from the puncture site t1 even after the hemostatic device 100A is attached. Further, a movable range of the right hand H1 (or the left hand H2) of the patient increases from the wrist side to the fingertip side of the right hand H1. In the hemostatic device 100A, the first arm portion <NUM> and the second arm portion <NUM> extend from the fingertip side to the wrist side of the right hand H1 while forming an obtuse angle, so that the first arm portion <NUM> and the second arm portion <NUM> can be connected on the wrist side of the right hand H1 of the patient. Therefore, in the hemostatic device 100A, the first arm portion <NUM> and the second arm portion <NUM> can be secured on the wrist side where the movable range is small, and thus the main body <NUM> can be secured to the limb while maintaining the movable range on the fingertip side of the right hand H1. Note that the outer circumference of the right hand H1 becomes larger from the wrist side to the fingertip side of the right hand H1 in a state where the right hand H1 is spread. Therefore, since the first arm portion <NUM> and the second arm portion <NUM> extend in a direction opposite to a direction in which the outer circumference of the right hand H1 becomes larger, the first arm portion <NUM> and the second arm portion <NUM> can be reliably connected on the wrist side of the right hand H1 in the state where the hemostatic device 100A is attached. Furthermore, in the hemostatic device 100A, even in the case where the patient moves the right hand H1 with the inflatable member <NUM> inflated, when the first arm portion <NUM> and the second arm portion <NUM> are secured in a state of being tightened to the limb of the patient, it is possible to prevent rising of the distal side (fingertip side) of the main body <NUM> to which the inflatable member <NUM> is connected, and to appropriately maintain the compressive force of the inflatable member <NUM> on the puncture site t1 formed on the dorsal side Hb of the right hand H1 of the patient.

Next, a description will be given of a hemostatic device according to a second embodiment of the invention. In description of the second embodiment, detailed description of the configuration, etc. previously described in the first embodiment will be omitted. In addition, content not particularly described in the description of the second embodiment can be regarded as the same as that in the first embodiment.

<FIG> is a plan view of a hemostatic device 100B seen from the outer surface side of the main body <NUM> of the covering member <NUM>, and <FIG> is a plan view of the hemostatic device 100B seen from the inner surface side of the main body <NUM> of the covering member <NUM>. <FIG> and <FIG> are diagrams briefly illustrating a usage example of the hemostatic device 100B.

As illustrated in <FIG> and <FIG>, in the hemostatic device 100B according to the second embodiment, the first arm portion <NUM> does not include the convex portion 133a (see <FIG> and <FIG>). In this respect, the second embodiment differs from the hemostatic device <NUM> according to the first embodiment.

The end portion <NUM> of the first arm portion <NUM> of the hemostatic device 100B is continuously connected to the inclined portion <NUM>, and extends linearly along a direction substantially the same as the extending direction of the inclined portion <NUM>.

As illustrated in <FIG>, a first securing member <NUM> is disposed on a part of the outer surface of the first arm portion <NUM> on the distal side. Further, as illustrated in <FIG>, a fourth securing member <NUM> is disposed on a part of the inner surface of the first arm portion <NUM> on the distal side.

<FIG> illustrates a state before the hemostatic device 100B is attached to the limb of the patient, and <FIG> illustrates a state in which the hemostatic device 100B is attached to the limb of the patient. The hemostatic device 100B can be attached to the right hand H1 or the left hand H2 of the patient on which the puncture site t1 is formed by substantially the same procedure as the attachment procedure of the hemostatic device <NUM> according to the first embodiment described above. The procedure for attaching the hemostatic device 100B to the right hand H1 of the patient will be outlined below.

As illustrated in <FIG>, the operator, etc. disposes the main body <NUM> of the covering member <NUM> so that the main body <NUM> overlaps the side of the dorsal side Hb of the right hand H1. Subsequently, the operator, etc. wraps the inclined portion (the first inclined portion 141a and the second inclined portion 141b) <NUM> of the second arm portion <NUM> along the right hand H1 of the patient while wrapping the end portion <NUM> of the first arm portion <NUM> around the right hand H1 of the patient. In this instance, the operator, etc. secures the end portion <NUM> and the second arm portion <NUM> via the respective securing members <NUM> and <NUM> by bringing the fifth securing member <NUM> (female side of the surface fastener) disposed on the inner surface of the inclined portion <NUM> into contact with the first securing member <NUM> (male side of the surface fastener) disposed on the outer surface of the end portion <NUM> of the first arm portion <NUM> on the palm Hp side of the right hand H1 of the patient.

Subsequently, the operator, etc. passes the second arm portion <NUM> between the thumb f1 and the index finger f2 of the right hand H1 of the patient, and disposes the second arm end portion <NUM> on the side of the dorsal side Hb of the right hand H1 of the patient. In this instance, the operator, etc. secures the first inclined portion 141a and the second arm end portion <NUM> via the respective securing members <NUM> and <NUM> by bringing the sixth securing member <NUM> (female side of the surface fastener) disposed on the inner surface of the second arm end portion <NUM> into contact with the second securing member <NUM> (male side of the surface fastener) disposed on the outer surface of the inclined portion <NUM> on the side of the dorsal side Hb of the right hand H1 of the patient.

By the above procedure, as illustrated in <FIG>, the operator, etc. can secure the hemostatic device <NUM> to the right hand H1 of the patient.

As described above, the hemostatic device 100B according to the second embodiment includes the covering member <NUM> disposed to cover the puncture site t1 on the right hand H1 (or left hand H2) of the patient, the plurality of securing members <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, and <NUM> that is configured to secure the covering member <NUM> in a state where the covering member <NUM> covers the puncture site t1, and the inflatable member <NUM> connected to the covering member <NUM> and configured to be inflated by injection of a fluid. Further, the covering member <NUM> has the main body <NUM> to which the inflatable member <NUM> is connected, the first arm portion <NUM> protruding from the main body <NUM>, and the second arm portion <NUM> protruding from the main body <NUM> while forming an obtuse angle with the longitudinal direction of the first arm portion <NUM>. Further, the inflatable member <NUM> has the first inflatable portion <NUM> and the deformable auxiliary member <NUM> which has a smaller outer shape than that of the first inflatable portion <NUM> and is biased toward the distal side (one end side) of the first inflatable portion <NUM>. In the covering member <NUM>, the first arm portion <NUM> and the second arm portion <NUM> can be connected by the securing members <NUM> and <NUM> in a state where the covering member <NUM> is wrapped around the limb of the patient, and the auxiliary member <NUM> is disposed between the first arm portion <NUM> and the second arm portion <NUM>.

In the hemostatic device 100B configured as described above, since the first arm portion <NUM> and the second arm portion <NUM> protrude from the main body <NUM> so as to form an obtuse angle, when the hemostatic device 100B is attached to the right hand H1 of the patient, the arm portions <NUM> and <NUM> can be connected so that the entire finger of the patient is not covered by the covering member <NUM>. For this reason, the patient is less likely to be restricted in movement of the right hand H1 even when the hemostatic device 100B is attached, and thus a degree of freedom on the fingertip side can be increased. Further, since the hemostatic device 100B has the deformable auxiliary member <NUM> located on the distal side of the first inflatable portion <NUM>, when the first inflatable portion <NUM> is inflated, the auxiliary member <NUM> presses the first inflatable portion <NUM> against the limb of the patient to inhibit the first inflatable portion <NUM> from rising in a direction away from the puncture site t1 on the right hand H1 of the patient. As a result, the hemostatic device 100B can maintain an appropriate compressive force on the puncture site t1 while increasing the degree of freedom on the fingertip side. Furthermore, in the hemostatic device 100B, since the first arm portion <NUM> and the second arm portion <NUM> extend from the fingertip side to the wrist side of the right hand H1 while forming an obtuse angle, the first arm portion <NUM> and the second arm portion <NUM> can be secured on the wrist side where the movable range is small. Therefore, the main body <NUM> can be appropriately secured to the limb while maintaining the movable range on the fingertip side of the right hand H1. Further, in the hemostatic device 100B, since the first inflatable portion <NUM> can be secured to the puncture site t1 by the two arm portions including the first arm portion <NUM> and the second arm portion <NUM> and the auxiliary member <NUM>, it is unnecessary to add different arm portions between the first arm portion <NUM> and the second arm portion <NUM>. Therefore, the operator, etc. can easily remove the medical device such as the introducer <NUM> after attaching the hemostatic device 100B. Further, since the first arm portion <NUM> and the second arm portion <NUM> are connected in a state of being wrapped around the right hand H1 of the patient, the first arm portion <NUM> and the second arm portion <NUM> are pressed against the right hand H1 of the patient while pulling the main body <NUM> located therebetween toward the both side portion sides (vertical direction in <FIG>). Since the auxiliary member <NUM> is located between the first arm portion <NUM> and the second arm portion <NUM>, the inflatable member <NUM> can be reliably pressed against the body surface of the right hand H1 by connection of the first arm portion <NUM> and the second arm portion <NUM>. Therefore, the hemostatic device 100B can press the first inflatable portion <NUM> against the limb of the patient by the auxiliary member <NUM>, and reliably inhibit the first inflatable portion <NUM> from rising in the direction away from the puncture site t1 on the right hand H1 of the patient. In this way, the hemostatic device 100B can reliably press the first inflatable portion <NUM> against the right hand H1 of the patient and maintain an appropriate compressive force on the puncture site t1 while increasing the degree of freedom on the fingertip side during attachment of the hemostatic device 100B.

Further, the main body <NUM> has the first regions 121a and 121b and the second region <NUM> in which the inflatable member <NUM> is disposed unlike the first regions 121a and 121b. The first region 121a is disposed between the second region <NUM> and the first arm portion <NUM>, and the first region 121b is disposed between the second region <NUM> and the second arm portion <NUM>. Further, the second region <NUM> includes the support member <NUM> having a higher rigidity than that of the first regions 121a and 121b. Therefore, the hemostatic device 100B can prevent the inflatable member <NUM> from rising from the dorsal side Hb of the hand H of the patient by the support member <NUM> while hemostasis is performed. As a result, the hemostatic device <NUM> can suitably apply a compressive force from the inflatable member <NUM> to the puncture site t1 while being attached to the hand H of the patient.

Further, the support member <NUM> has the curved portion 125a formed on the distal side of the main body <NUM>. For this reason, in the support member <NUM>, when the inflatable member <NUM> is inflated, a direction in which the inflatable member <NUM> applies a compressive force to the right hand H1 of the patient is directed in an oblique direction toward the puncture site t1. For this reason, the hemostatic device <NUM> can more effectively apply a compressive force to the puncture site t1. Further, when the curved portion 125a of the support member <NUM> wraps the end portion of the inflatable member <NUM> on the distal side, the inflatable member <NUM> directs the compressive force toward the central side of the support member <NUM>, and thus the compressive force of the second inflatable portion <NUM> is inhibited from escaping to the outside of the support member <NUM>. In this way, even in the case where a gap is generated between the first arm portion <NUM> and the right hand H1 of the patient, when the curved portion 125a presses the second inflatable portion <NUM> against the skin of the right hand H1 of the patient, it is possible to prevent the first inflatable portion <NUM> from rising, and it is possible to prevent a decrease in the compressive force applied to the puncture site t1 by the inflatable member <NUM>.

Further, the second arm portion <NUM> is longer than the first arm portion <NUM>, and is configured to be secured to the second arm portion <NUM> by passing between the fingers f1 and f2 of the patient in a state where the second arm portion <NUM> is wrapped around the limb of the patient. For this reason, the hemostatic device 100B can secure the main body <NUM> in which the inflatable member <NUM> is disposed to the limb by disposing a part of the second arm portion <NUM> between the adjacent fingers f1 and f2 of the patient and connecting parts of the second arm portion <NUM> to each other while wrapping the first arm portion <NUM> and the second arm portion <NUM> around the limb of the patient. The first arm portion <NUM> and the second arm portion <NUM> are fastened to the limb by connecting the parts of the second arm portions <NUM> to each other, and the main body <NUM> is secured to the limb. By disposing the second arm portion <NUM> between the adjacent fingers f1 and f2 of the patient, it is possible to effectively suppress position shift of the inflatable member <NUM> disposed on the main body <NUM> with respect to the puncture site t1.

In addition, the second inflatable portion <NUM> is disposed to have bilateral symmetry with respect to the center line d3 of the first inflatable portion <NUM>, and the securing members <NUM> and <NUM> for securing the second arm portion <NUM> are disposed on the outer surfaces of the first arm portion <NUM> and the second arm portion <NUM> opposing to each other with the main body <NUM> interposed therebetween. For this reason, when the hemostatic device <NUM> is attached to the right hand H1 of the patient, the operator, etc. can secure the respective arm portions <NUM> and <NUM> through the respective securing members <NUM> and <NUM> while disposing the first inflatable portion <NUM> on the puncture site t1 so that the puncture site t1 is located on the center line d3 of the auxiliary member <NUM>. Similarly, when the hemostatic device <NUM> is attached to the left hand H2 of the patient, the operator, etc. can secure the respective arm portions <NUM> and <NUM> through the respective securing members <NUM> and <NUM> while disposing the first inflatable portion <NUM> on the puncture site t1 so that the puncture site t1 is located on the center line d3 of the auxiliary member <NUM>. Therefore, the operator, etc. can attach the hemostatic device <NUM> to both the right hand H1 and the left hand H2 of the patient.

Further, the second arm portion <NUM> has the inclined portion <NUM> and the second arm end portion <NUM> which is continuously formed with the inclined portion <NUM> and forms an end portion of the second arm portion <NUM>, and the width of the inclined portion <NUM> is larger than the width of the second arm end portion <NUM>. Therefore, when the inclined portion <NUM> is wrapped around the hand H of the patient, the operator, etc. can more reliably dispose the inclined portion <NUM> on the second arm end portion <NUM>, and easily secure the second arm portion <NUM>.

Further, the hemostatic device 100B has the injection portion <NUM> for injecting a fluid into the inflatable member <NUM>. The cushioning member <NUM> having an inflatable space is disposed between the injection portion <NUM> and the inflatable member <NUM>. In the hemostatic device 100B, when the patient moves the right hand H1 while the hemostatic device 100B is attached to the patient, the inflatable member <NUM> (the first inflatable portion <NUM> and the second inflatable portion <NUM>) that compresses the puncture site t1 on the right hand H1 is deformed. When the inflatable member <NUM> is deformed, if there is no escape place for air in the lumen of the inflatable member <NUM> (the lumen <NUM> of the first inflatable portion <NUM> and the lumen <NUM> of the second inflatable portion <NUM>), deformation of the inflatable member <NUM> is hindered. For this reason, the patient has a limited movable range for the right hand H1. The cushioning member <NUM> included in the hemostatic device 100B allows air to move from the lumen of the inflatable member <NUM> to the cushioning member <NUM> when the patient moves the right hand H1. For this reason, the patient can prevent the movable range from being restricted by the inflatable member <NUM> when the right hand H1 is moved. Note that when the patient returns the right hand H1 from the deformed state to the original state, air moves from the cushioning member <NUM> to the inflatable member <NUM>, and thus the compressive force can be effectively applied to the puncture site t1 from the inflatable member <NUM>.

Even though the hemostatic device according to the invention has been described above through the embodiments, the invention is not limited to content described in this specification, and can be appropriately modified based on description of the scope of claims.

The auxiliary member is not limited to the inflatable member described in each embodiment. For example, the auxiliary member may include a member made of a resin material such as plastic, gel, etc., a member containing gel whose moisture content decreases over time to gradually reduce a compressive force, an elastic material such as a sponge-like substance, an aggregate of fibers such as cotton, metal, a member having a predetermined three-dimensional shape (sphere, ellipsoid, triangular pyramid, etc.), an appropriate combination thereof, etc..

In addition, the shape and dimensions of each portion of the hemostatic device are not particularly limited as long as the inflatable member can be disposed at the puncture site while wrapping the first arm portion and the second arm portion around the limb, and changes can be made as appropriate.

Claim 1:
A hemostatic device (<NUM>, 100A, 100B) comprising:
a covering member (<NUM>) configured to be disposed to cover a site (t1) where bleeding is to be stopped on a hand (H) of a patient;
a securing member (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>) configured to secure the covering member (<NUM>) in a state where the covering member (<NUM>) covers the site (t1) where bleeding is to be stopped; and
an inflatable member (<NUM>) connected to the covering member (<NUM>) and configured to be inflated by injection of a fluid,
wherein the covering member (<NUM>) includes a main body (<NUM>) to which the inflatable member (<NUM>) is connected, a first arm portion (<NUM>) protruding from the main body (<NUM>), and a second arm portion (<NUM>) protruding from the main body (<NUM>) while forming an obtuse angle (θ1) with a longitudinal direction of the first arm portion (<NUM>),
the first arm portion (<NUM>) has a convex portion (133a) protruding in a width direction of the first arm portion (<NUM>) at an end portion (<NUM>) of the first arm portion (<NUM>), and
the second arm portion (<NUM>) is longer than the first arm portion (<NUM>) and is configured to be secured to the convex portion (133a) and secured to the second arm portion (<NUM>) by passing between fingers of the patient in a state where the second arm portion (<NUM>) is wrapped around a limb of the patient,
characterized in that
the inflatable member (<NUM>) has a first inflatable portion (<NUM>) and a deformable auxiliary member (<NUM>) having a smaller outer shape than an outer shape of the first inflatable portion (<NUM>), and
the auxiliary member (<NUM>) is disposed to overlap the first inflatable portion (<NUM>) on a distal side of the main body (<NUM>).