hemostatic instruments
The hemostatic device's innovative tube fixing portion design reduces the force needed for tube attachment and detachment, preventing unintended force application and displacement, enhancing surgeon convenience and device stability.
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- TERUMO KK
- Filing Date
- 2022-05-12
- Publication Date
- 2026-07-02
AI Technical Summary
The existing hemostatic devices require significant force to attach or detach the tube portion, which can unintentionally apply external force to the puncture site, potentially causing the expansion member to shift position, and are not designed with surgeon operability in mind.
The hemostatic device features a tube fixing portion with a first and second member, a slit portion, and a tube holding portion, where the first member has a curved surface opposite the second tip surface, allowing for reduced force insertion and removal of the tube portion, and a height difference between members to minimize displacement.
This design reduces the required force for attaching and detaching the tube portion, preventing unintended external force from being applied to the puncture site and minimizing device displacement.
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Abstract
Description
Technical Field
[0001] The present invention relates to a hemostatic device.
Background Art
[0002] As one of the catheter procedures, a procedure is known in which various medical long members are introduced into a blood vessel through a puncture site formed by puncturing a blood vessel in a patient's arm or hand, and treatment or therapy for a lesion site is performed. For example, Patent Document 1 discloses a hemostatic device for hemostatizing a puncture site formed for access to a blood vessel (including the distal radial artery) that runs through the hand.
[0003] The hemostatic device of Patent Document 1 includes an expansion member that applies a compressive force to a puncture site formed in a patient's hand, a fixing member for fixing a pressing member to the patient's hand, a port (connector portion) configured to be able to inject a fluid for expanding the expansion member, a tube portion that connects the connector portion and the lumen of the expansion member, an injection member including the tube portion, and a tube fixing portion that is located in the fixing member and is configured to be able to fix the tube portion.
Prior Art Documents
Patent Documents
[0004]
Patent Document 1
Summary of the Invention
Problems to be Solved by the Invention
[0005] When a practitioner such as a doctor (hereinafter referred to as "practitioner") uses the hemostatic device of Patent Document 1 to hemostatize a puncture site formed in a patient's hand, the hemostatic device can be fixed using each band while the expansion member is arranged at the puncture site formed in the patient's hand and its peripheral portion, thereby preventing the expansion member from being displaced from the puncture site formed in the patient's hand. In addition, the practitioner can reduce the movement of the tube portion following the movement of the patient's hand by fixing the tube portion to the tube fixing portion.
[0006] However, the hemostatic device described in Patent Document 1 may have the following problems.
[0007] In the hemostatic device described in Patent Document 1, a groove is provided in the tube fixing part for fixing the tube. Therefore, when the surgeon attaches or detaches the tube from the tube fixing part, the surgeon needs to deform the tube fixing part (for example, elastically deform) in a direction that expands the groove by applying an external force to the tube. At this time, the force required by the surgeon to deform the tube fixing part in a direction that expands the groove is determined by the mechanical configuration of the tube fixing part, but this configuration may not be designed with the surgeon's operability or convenience in mind.
[0008] For example, if the operator requires a large amount of force to attach or detach the tube from the tube fixing part, the external force (force applied by the operator) may be transmitted to the expansion member via the fixing member on which the tube fixing part is located, potentially causing unintended external force to be applied to the puncture site. Furthermore, the transmission of external force to the fixing member may unintendedly transmit external force to the expansion member, potentially causing the expansion member to shift position away from the puncture site formed on the patient's hand.
[0009] In view of the above problems, the present invention aims to prevent unintended external force from being applied to the puncture site when the surgeon attaches or detaches the tube portion from the tube fixing portion while the hemostatic device is attached to the patient's hand, by transmitting the external force applied by the surgeon to the tube portion to the expansion member via the tube fixing portion and the fixing member, and / or to prevent displacement of the hemostatic device that may occur when the external force applied by the surgeon to the tube portion is transmitted to the fixing member via the tube fixing portion and the expansion member, by unintended external force being applied. [Means for solving the problem]
[0010] The hemostatic device according to the present invention comprises an expansion member configured to compress a site on a patient's limb to be hemostatic, a fixing member configured to fix the expansion member to the patient's limb, an injection member comprising a connector portion configured to inject fluid for expanding the expansion member, a tube portion connecting the connector portion and the lumen of the expansion member, and a tube fixing portion located on the fixing member and configured to fix the tube portion, wherein the tube fixing portion comprises a first member, a second member located on the expansion member side of the first member and facing the first member, a slit portion formed between the first member and the second member and configured to allow insertion of the tube portion, and the first member, the second member, and The first member comprises a tube holding portion surrounded by the slit portion and configured to hold the tube portion, the first member having a first main body portion, a first curved portion curving toward the second member, and a first tip surface located at the tip of the first curved portion, the second member having a second main body portion, a second curved portion curving toward the first member, and a second tip surface located at the tip of the second curved portion and facing the first tip surface across the slit portion, a part of the first member is further away from the expansion member in a direction perpendicular to the virtual plane formed by the slit portion than the second member, and the first tip surface has a first region that does not face the second tip surface across the slit portion, and a second region that faces the second tip surface across the slit portion Direction The first curved portion comprises a second region and a first curved surface that curves toward the second member, and the first curved surface faces the second tip surface with the tube holding portion in between. [Effects of the Invention]
[0011] The hemostatic device configured as described above is designed so that there is a difference in height between the first and second members that constitute the tube fixing portion, thereby reducing the area in which the tip surfaces of the first member (first tip surface) and the second member (second tip surface) face each other across the slit portion. Therefore, when the tube portion is pushed into the tube fixing portion by the surgeon (inserted into the tube fixing portion), the first member is deformed in the direction that expands the slit portion, and then the second member is deformed. As a result, the hemostatic device described above can reduce the force required by the surgeon when inserting the tube portion into the tube fixing portion while it is attached to the patient's hand. Furthermore, the first member of the hemostatic device described above has a first curved surface at a position opposite the second tip surface of the second member, across the tube holding portion. Therefore, when the tube portion is pulled away from the tube fixing portion by the surgeon (removed from the tube fixing portion), it moves from the tube holding portion towards the slit portion using the first curved surface as a guide surface. As a result, the hemostatic device described above can reduce the force required by the surgeon when removing the tube portion from the tube fixing portion. Thus, the above-described hemostatic device can reduce the force required when the operator attaches and detaches the tube portion from the tube fixing portion while it is attached to the patient's hand, thereby preventing unintentional external force from being applied to the puncture site and / or preventing displacement of the hemostatic device that may occur due to unintentional external force being applied to the expansion member. [Brief explanation of the drawing]
[0012] [Figure 1] This figure shows a hemostatic device according to an embodiment, and is a plan view of each band as seen from the outer surface. [Figure 2] This figure shows a hemostatic device according to an embodiment, and is a plan view as seen from the inner surface of each band. [Figure 3] This is a plan view showing a magnified portion of the hemostatic device as seen from the outer surface of each band. [Figure 4] This is a plan view showing a magnified portion of the hemostatic device as seen from the inner surface of each band. [Figure 5] This is a plan view showing a magnified portion of the hemostatic device as seen from the outer surface of each band. [Figure 6] A cross-sectional view of a hemostatic device along arrow 6A-6A shown in FIG. 5, showing the state when the expansion member is expanded. [Figure 7] A cross-sectional view of a hemostatic device along arrow 7A-7A shown in FIG. 5, showing the state when the expansion member is expanded. [Figure 8] A perspective view showing a support member. [Figure 9] A perspective view showing a support member. [Figure 10] A cross-sectional view showing a tube fixing portion, which is a partially enlarged view of FIG. 7. [Figure 11] A view showing the hand (right hand) of a patient to whom the hemostatic device is applied. [Figure 12] A view briefly showing an example of use of the hemostatic device. [Figure 13] A view briefly showing an example of use of the hemostatic device. [Figure 14] A view briefly showing an example of use of the hemostatic device. [Figure 15] A partial cross-sectional view along arrow 15A-15A shown in FIG. 14. [Figure 16] A partial cross-sectional view along arrow 16A-16A shown in FIG. 14. [Figure 17] A plan view showing an enlarged part of a hemostatic device according to Modification 1.
Mode for Carrying Out the Invention
[0013] Hereinafter, embodiments of the present invention will be described with reference to the attached drawings. The following description does not limit the technical scope or the meaning of terms described in the claims. Also, the dimensional ratios in the drawings are exaggerated for the convenience of explanation and may be different from the actual ratios.
[0014] FIGS. 1 to 10 are diagrams for explaining a hemostatic device 100 according to the present embodiment, and FIGS. 11 to 16 are diagrams for explaining an example of use of the hemostatic device 100.
[0015] The hemostatic device 100 can be used, for example, to stop bleeding at a puncture site when removing the sheath tube of the introducer 200 that was placed at a puncture site (for example, each puncture site p1, p2 described later) formed on the hand H located distal to the patient's forearm A, as shown in Figures 11, 14 to 16.
[0016] The specific location of the puncture site targeted for hemostasis by the hemostatic device 100 is not particularly limited, but in this embodiment, the following first puncture site p1 is used as an example.
[0017] The first puncture site p1 is, as shown in Figure 11, a puncture site formed in artery B (hereinafter also referred to as "blood vessel B") located in the snuffbox of the palmar artery that runs along the back of the right hand H1 (hand H) distal to the patient's forearm A. The snuffbox is a cavity in the hand located near the radius when the patient extends the thumb of hand H.
[0018] The second puncture site p2, as shown in Figure 11, is a puncture site formed in the distal radial artery, which is located distal to the snuffbox of the palmar artery running along the dorsal Hb side of the patient's right hand H1. The second puncture site p2 is located distal to the first puncture site p1 on the right hand H1, relative to the extensor pollicis longus tendon t located on the dorsal Hb side of the patient's right hand H1.
[0019] The following provides a detailed description of the hemostatic device 100.
[0020] <Hemostatic device> In general terms, the hemostatic device 100, as shown in Figures 1 to 4 and 14 to 16, comprises an expansion member 110 configured to compress a first puncture site p1 formed on the patient's right hand H1; a fixing member 120 configured to fix the expansion member 110 to the patient's right hand H1; an injection member 180 comprising a connector portion 181 configured to inject fluid for expanding the expansion member 110, and a tube portion 183 connecting the connector portion 181 to the lumen 113 of the expansion member 110; and a tube fixing portion 300 located on the fixing member 120 and configured to fix the tube portion 183.
[0021] <Expansion Member> The expansion member 110 can be composed of a single balloon having a lumen 113 partitioned by a membrane material, as shown in Figures 6 and 7.
[0022] The expansion member 110 can be formed, for example, by joining the edges of two sheet-like membrane materials with a lumen 113 formed between them. Alternatively, the expansion member 110 may be composed of a single membrane material formed in a bag shape with a lumen.
[0023] The expansion member 110 expands when a fluid such as air is supplied to the lumen 113, and contracts when the fluid supplied to the lumen 113 is discharged. Figures 6 and 7 show cross-sectional views of the expansion member 110 when fluid is supplied to it and the expansion member 110 is expanded.
[0024] The membrane material constituting the expansion member 110 can be made of, for example, a resin material having a predetermined thickness. A tube portion 183 (see Figures 1 and 2), which will be described later, is connected to the lumen 113 of the expansion member 110.
[0025] The material of the membrane constituting the expansion member 110 is not particularly limited, but for example, polyolefins such as polyvinyl chloride, polyethylene, polypropylene, polybutadiene, and ethylene-vinyl acetate copolymer (EVA), polyesters such as polyethylene terephthalate (PET) and polybutylene terephthalate (PBT), polyvinylidene chloride, silicone, polyurethane, polyamide elastomer, polyurethane elastomer, polyester elastomer, nylon, nylon elastomer, or any combination thereof (blended resin, polymer alloy, laminate, etc.) can be used.
[0026] As shown in Figures 6, 7, 15, and 16, the expansion member 110 is positioned on the inner surface 130a side of the support member 130 provided by the fixing member 120. The inner surface 130a of the support member 130 is the surface that is positioned on the body surface side of the patient's hand H when the hemostatic device 100 is attached to the patient's hand H. The outer surface 130b of the support member 130 is the surface located on the opposite side of the inner surface 130a.
[0027] The extension member 110 can be directly connected to the inner surface 130a of the support member 130. For connecting the extension member 110 and the support member 130, for example, fusion bonding or adhesive bonding can be used.
[0028] The extension member 110 may also be connected to the inner surface 130a of the support member 130 via other members.
[0029] Furthermore, the expansion member 110 may be composed of a single membrane-like member configured to form a lumen between itself and the inner surface 130a of the support member 130. For example, the expansion member 110 can be configured by directly connecting a single membrane-like member to the inner surface 130a of the support member 130, thereby providing a lumen between the inner surface 130a of the support member 130 and the single membrane-like member.
[0030] The expansion member 110 has a circular shape in the plan view shown in Figures 1 to 5. However, the shape of the expansion member 110 in the plan view is not limited to a circle. Furthermore, there are no particular restrictions on the cross-sectional shape of the expansion member 110 before and after expansion, or on the specific structure of the expansion member 110.
[0031] As shown in Figures 2, 4, 6, 7, 15, and 16, the expansion member 110 is equipped with a marker 115 for aligning the expansion member 110 with the first puncture site p1.
[0032] The marker 115 is positioned on the outer surface of the expansion member 110 opposite to the side on which the support member 130 is located (the surface that is positioned on the body surface side of the patient's hand H when the hemostatic device 100 is attached to the patient's hand H).
[0033] As long as the marker 115 is positioned on the expansion member 110, there are no particular restrictions on its specific placement. The marker 115 may, for example, be positioned on the inner surface of the expansion member 110 opposite to the side on which the support member 130 is positioned (the surface that is positioned on the body surface side of the patient's hand H when the hemostatic device 100 is attached to the patient's hand H).
[0034] As shown in Figure 5, the marker 115 is positioned approximately at the center of the planar direction of the extension member 110. Furthermore, the marker 115 is positioned so as to coincide with the approximately center of the planar direction of the support member 130. Note that the planar direction of the extension member 110 and the planar direction of the support member 130 refer to the direction in which the support member 130 (extension member 110) extends in the plan view shown in Figure 5.
[0035] The marker 115 can be formed, for example, as a rectangular marker with the entire marker 115 formed in color. The shape, size, color, formation method, position, etc., of the marker 115 are not particularly limited. For example, the marker 115 may be provided on the support member 130.
[0036] <Fixing components> As shown in Figure 1, the fixing member 120 includes a support member 130 and a plurality of bands 140, 150, and 160 that are connected to the support member 130 and configured to be wrapped around the patient's hand H.
[0037] <Support member> As shown in Figures 3 to 7, the support member 130 has a first region 131 on which the extension member 110 is arranged, and a second region 132 located outside the first region 131 and configured to allow connection of the first strip 140, the second strip 150, and the third strip 160.
[0038] The support member 130 has a circular shape in the plan view shown in Figure 5.
[0039] The first region 131 is the region where the extension member 110 overlaps in the plan view shown in Figure 5. The second region 132 is the region located outside the first region 131 in the plan view shown in Figure 5.
[0040] The first region 131 can be arbitrarily defined based on the external shape and size of the extension member 110 placed on the support member 130. The second region 132 can be defined based on its relative positional relationship with the first region 131. Therefore, the first region 131 and the second region 132 can be appropriately modified according to the external shape and size of the extension member 110 placed on the support member 130.
[0041] As shown in Figures 6 to 8, the first region 131 is located at the center point R, which is the center point when the first strip 140 and the second strip 150 slide along the second holes 133b and 133c. The center point R is located approximately at the center of the support member 130 in the planar direction. Therefore, as shown in Figures 6 and 7, when the center point R is projected onto the expansion member 110, it is located at a position that overlaps with the marker 115.
[0042] As shown in Figures 5 to 9, the second region 132 has a first hole 133a and a pair of second holes 133b and 133c facing each other with the expansion member 110 in between.
[0043] As shown in Figure 5, the first hole 133a is positioned distal to the hand H (towards the fingertips) of the expansion member 110 when the hemostatic device 100 is attached to the patient's hand H.
[0044] As shown in Figure 5, the second hole 133b and the second hole 133c are positioned with the expansion member 110 in between, in a direction that intersects the straight line connecting the first hole 133a and the expansion member 110 (the straight line connecting the first hole 133a and the tube fixing part 300; this straight line is shown as a dashed line C in Figure 5).
[0045] As shown in Figures 3 to 5, each of the holes 133a, 133b, and 133c is positioned on a virtual circle that follows the outer shape of the support member 130.
[0046] As shown in Figures 3 to 7, the first strip 140 is connected to the second hole 133b. The second strip 150 is connected to the second hole 133c. The third strip 160 is connected to the first hole 133a.
[0047] As shown in Figure 5, the width of one end 141 of the first strip 140 is smaller than the length of the second hole 133b. Therefore, as shown in Figure 8, with one end 141 of the first strip 140 connected to the second hole 133b, the first strip 140 can slide around the expansion member 110 in the second region 132, centered on the center point R of the support member 130.
[0048] As shown in Figure 5, the width of one end 151 of the second strip 150 is smaller than the length of the second hole 133c. Therefore, as shown in Figure 8, the second strip 150 can slide around the second region 132 with its end 151 connected to the second hole 133c, with the center point R as the pivot point.
[0049] The angle (slidable range) in which the first band 140 and the second band 150 can slide around the expansion member 110 with respect to the center point R is not particularly limited, but can be set to, for example, 1° to 75°.
[0050] As shown in Figure 5, the width of one end 161 of the third strip 160 is approximately the same as the length of the first hole 133a. Therefore, when one end 161 of the third strip 160 is connected to the first hole 133a, the sliding movement of the third strip 160 around the center point R is restricted.
[0051] As shown in Figures 8 and 9, in the second region 132 of the support member 130, a first curved region 134a is formed in the portion where the first hole 133a and the tube fixing portion 300 are located, which is curved in a convex shape toward the side away from the expansion member 110 (upper side in Figures 6 and 7).
[0052] Furthermore, as shown in Figures 8 and 9, in the second region 132 of the support member 130, a second curved region 134b is formed in the portion where the second holes 133b and 133c are located, which is curved in a convex shape toward the expansion member 110 side (the lower side in Figures 6 and 7).
[0053] The support member 130 is made of a harder material than each of the strips 140, 150, and 160.
[0054] As constituent materials for the support member 130 having the hardness described above, for example, acrylic resin, polyvinyl chloride (especially rigid polyvinyl chloride), polyethylene, polypropylene, polyolefins such as polybutadiene, polystyrene, poly-(4-methylpentene-1), polycarbonate, ABS resin, polymethyl methacrylate (PMMA), polyacetal, polyacrylate, polyacrylonitrile, polyvinylidene fluoride, ionomer, acrylonitrile-butadiene-styrene copolymer, polyethylene terephthalate (PET), etc. can be used.
[0055] In each of the expansion member 110 and the support member 130, the overlapping portions in the plan view shown in Figures 3 and 4 can be made transparent. When the expansion member 110 and the support member 130 are configured in this way, as shown in Figures 12, 13, and 14, when attaching the hemostatic device 100 to the patient's right hand H1, the operator can more easily visually confirm the position of the marker 115 and / or the first puncture site p1 through the expansion member 110 and the support member 130. Note that the term "transparent" includes colored transparent, colorless transparent, and translucent.
[0056] <Band> As shown in Figures 1, 2, 3, and 4, the first band 140 has one end 141 configured to be connectable to the second hole 133b of the support member 130, a free other end 143 not connected to the support member 130, and a main body 145 extending between the one end 141 and the other end 143.
[0057] As shown in Figures 1 to 5, the second band 150 has one end 151 configured to be connectable to the second hole 133c of the support member 130, a free other end 153 that is not connected to the support member 130, and a main body 155 that extends between the one end 151 and the other end 153.
[0058] The first strip 140 extends from the support member 130 in a predetermined first direction. The second strip 150 extends from the support member 130 in a predetermined second direction different from the first direction.
[0059] As shown in Figures 12, 13, and 14, the first band 140 and the second band 150 can be positioned to wrap around the outer circumference of the right hand H1 when attaching the hemostatic device 100 to the patient's right hand H1.
[0060] As shown in Figures 1 to 5, the third band 160 has one end 161 configured to be connectable to the first hole 133a of the support member 130, a free other end 163 that is not connected to the support member 130, and a main body 165 that extends between the one end 161 and the other end 163.
[0061] The third strip 160 extends from the support member 130 in a third direction different from the first direction in which the first strip 140 extends and the second direction in which the second strip 150 extends.
[0062] As shown in Figure 14, the third band 160 can be positioned so as to hook onto the interdigital space fb located between the thumb and index finger of the patient's right hand H1, with the expansion member 110 positioned at the first puncture site p1.
[0063] The ends 141, 151, and 161 of each strip 140, 150, and 160 can be arranged by inserting them into and wrapping them around the holes 133a, 133b, and 133c of the support member 130. The structure for connecting the ends 141, 151, and 161 of each strip 140, 150, and 160 to the support member 130 is not particularly limited. For example, each end 141 、151、161A member (for example, a hook-and-loop fastener) can be placed therein that can hold and release the wrapped state around each of the holes 133a, 133b, and 133c of the support member 130.
[0064] Furthermore, each of the bands 140, 150, and 160 is provided with a symbol M (including figures and letters) at one end 141, 151, and 161, respectively, to allow identification of each band. In this embodiment, the first band 140 is provided with the number "1" at one end 141, the second band 150 with the number "2" at one end 151, and the third band 160 with the number "3" at one end 161. The numbers provided on each band 140, 150, and 160 correspond to the order in which the surgeon wraps each band 140, 150, and 160 when attaching the hemostatic device 100 to the patient's right hand H1. Therefore, by visually identifying the symbol M, the surgeon can attach each band 140, 150, and 160 to the patient's right hand H1 in the correct order. The size, color, formation method, position, etc., of the symbol M are not particularly limited.
[0065] The constituent materials of each strip 140, 150, and 160 are not particularly limited, but can be made of, for example, polyvinyl chloride resin, amide resin, amide elastomer resin, polyurethane resin, polyester resin, etc. Furthermore, there are no particular restrictions on the shape, length, thickness, etc., of each strip 140, 150, and 160.
[0066] As shown in Figures 1 to 4, the hemostatic device 100 has five fixation points: a first fixation point 171, a second fixation point 172, a third fixation point 173, a fourth fixation point 174, and a fifth fixation point 175.
[0067] As shown in Figures 1 and 3, the first fixing portion 171 is placed on the outer surface of the first strip 140. The second fixing portion 172 is placed on the outer surface of the second strip 150.
[0068] As shown in Figures 2 and 4, the third fixing part 173 is located on the inner surface of the first band 140. The fourth fixing part 174 is located on the inner surface of the second band 150. The fifth fixing part 175 is located on the inner surface of the third band 160.
[0069] The "inner surface" of each band 140, 150, and 160 is the surface that faces the patient's body surface when the hemostatic device 100 is attached to the patient, and the "outer surface" of each band 140, 150, and 160 is the surface located on the opposite side from the inner surface.
[0070] The first fastening portion 171 and the second fastening portion 172 are made up of the male side of the hook-and-loop fastener. The third fastening portion 173, the fourth fastening portion 174, and the fifth fastening portion 175 are made up of the female side of the hook-and-loop fastener. The hook-and-loop fastener in this specification is a fastener that can be attached and detached on a surface, such as Magic Tape® or Velcro®.
[0071] Each fixing point 171, 172, 174, and 175 is used to connect each band 140, 150, and 160 with the hemostatic device 100 positioned on the patient's right hand H1. Furthermore, one end 141, 151, and 161 of each fixing point 173, 174, and 175 is used to connect each band 140, 150, and 160 to the support member 130. The specific structure of each fixing point 171, 172, 174, and 175 is not limited as long as it can secure the support member 130 to the patient's right hand H1. For example, the installation of some fixing points can be omitted, or the position of the fixing points on each band 140, 150, and 160 can be changed as desired. Also, if each fixing point 171, 172, 173, 174, and 175 is constructed with hook-and-loop fasteners, the male and female sides of the hook-and-loop fasteners may be reversed. Furthermore, each fixing part 171, 172, 173, 174, 175 may be composed of, for example, a snap, a button, a clip, or a connecting mechanism having a frame with a hole and an engaged part with a projection that can engage with the frame.
[0072] <Injection material> As shown in Figures 1 and 2, the injection member 180 includes a connector portion 181 configured to allow injection of fluid for expanding the expansion member 110, and a tube portion 183 connecting the connector portion 181 to the lumen 113 of the expansion member 110.
[0073] The connector section 181 incorporates a check valve (not shown). A syringe (not shown) can be connected to the connector section 181.
[0074] A buffer member 182 having an expandable space is positioned between the connector portion 181 and the expansion member 110. The buffer member 182 is made of a flexible, bag-shaped member with a space formed inside. An arrow-shaped marker indicating the direction of syringe insertion into the connector portion 181 may be provided on the buffer member 182.
[0075] A connector portion 181 is connected to one end of the buffer member 182. The lumen of the connector portion 181 is in communication with the space of the buffer member 182. However, while the check valve built into the connector portion 181 is closed, communication between the lumen of the connector portion 181 and the space of the buffer member 182 is blocked.
[0076] A flexible tube portion 183 is connected to the other end of the cushioning member 182. The lumen of the tube portion 183 communicates with the space of the cushioning member 182. In addition, one end of the tube portion 183 connected to the cushioning member 182 and the other end opposite are connected to the expansion member 110. The lumen of the tube portion 183 communicates with the lumen 113 of the expansion member 110.
[0077] When expanding the expansion member 110, the surgeon inserts the tip of a syringe (not shown) into the connector part 181 to open the check valve. With the check valve of the connector part 181 open, the surgeon pushes the plunger of the syringe to inject air from inside the syringe into the lumen 113 of the expansion member 110.
[0078] When air is injected into the lumen 113 of the expansion member 110, the expansion member 110 expands. When the expansion member 110 expands, the buffer member 182, which communicates with the lumen 113 of the expansion member 110 via the tube portion 183, also expands. By visually confirming the expansion of the buffer member 182, the operator can easily confirm that the expansion member 110 has expanded without any air leakage.
[0079] When the surgeon retracts the expansion member 110, he inserts the tip of the syringe into the connector 181 and pulls the plunger of the syringe. By performing the above operation, the surgeon can expel the air from the lumen 113 of the expansion member 110 into the syringe.
[0080] The connector portion 181, the buffer member 182, and the tube portion 183 may be prepared and provided connected to the expansion member 110, or they may be prepared and provided separately from the expansion member 110.
[0081] <Tube fixing part> As shown in Figures 5 and 10, the tube fixing portion 300 includes a first member 310, a second member 320 located on the expansion member 110 side of the first member 310 and facing the first member 310, a slit portion 330 formed between the first member 310 and the second member 320 and configured to allow insertion of the tube portion 183, and a tube holding portion 340 surrounded by the first member 310, the second member 320, and the slit portion 330 and configured to hold the tube portion 183.
[0082] As shown in Figure 10, the first member 310 has a first main body portion 311, a first curved portion 312 that curves toward the second member 320, and a first tip surface 313 located at the tip of the first curved portion 312.
[0083] As shown in Figure 10, the second member 320 has a second main body portion 321, a second curved portion 322 that curves toward the first member 310, and a second tip surface 323 located at the tip of the second curved portion 322 and facing the first tip surface 313 with the slit portion 330 in between.
[0084] As shown in Figure 10, the first main body portion 311 and the second member 320 are oriented substantially perpendicular to the planar direction of the support member 130 and extend from the support member 130 in a direction away from the support member 130. Furthermore, as shown in the enlarged view of the tube fixing portion 300 in Figure 5, the width Z1 of the first main body portion 311 (where "width" refers to the length in the left-right direction in Figure 5) and the width Z2 of the first end surface 313, and the width Z3 of the second main body portion 321 and the width Z4 of the second end surface 323 are set to equal values. Note that the width Z1 of the first main body portion 311, the width Z2 of the first end surface 313, the width Z3 of the second main body portion 321, and the width Z4 of the second end surface 323 are the left-right lengths of the tube fixing portion 300 in Figure 1.
[0085] As shown in Figure 10, the width Y1 (where "width" refers to the length in the left-right direction in Figure 10) of the slit portion 330 formed between the first curved portion 312 and the second curved portion 322 is smaller than the width Y2 of the tube holding portion 340 and smaller than the diameter φ1 of the tube portion 183. Therefore, the hemostatic device 100 can prevent the tube portion 183 inserted into the tube holding portion 340 from unintentionally coming out of the tube fixing portion 300. It is preferable that the width Y2 of the tube holding portion 340 is equal to the diameter φ1 of the tube portion 183. With this configuration, the hemostatic device 100 can prevent the tube portion 183 from moving in the left-right direction in Figure 5 within the tube holding portion 340. It is also preferable that the height (where "height" refers to the length in the up-down direction in Figure 10) of the tube holding portion 340 is equal to the diameter φ1 of the tube portion 183. By configuring it in this way, the hemostatic device 100 can prevent the tube portion 183 from moving in the vertical direction in Figure 10 within the tube holding portion 340. Therefore, the hemostatic device 100 can prevent the tube portion 183 inserted into the tube holding portion 340 from unintentionally coming out of the tube fixing portion 300. Note that the width Y1 of the slit portion 330 and the width Y2 of the tube holding portion 340 are the vertical lengths of the tube fixing portion 300 in Figure 1.
[0086] A portion of the first member 310 (a portion of the first curved portion 312) is further away from the extension member 110 than the second member 320 in a direction perpendicular to the virtual plane S formed by the slit portion 330, and the first tip surface 313 has a first region 313a that does not face the second tip surface 323 with the slit portion 330 in between, and a second tip surface 323 with the slit portion 330 in between. Direction It comprises a second region 313b, and
[0087] The virtual plane S formed by the slit portion 330, as referred to here, means a plane that passes through the upper end surface 324 of the second member 320 and extends toward the first member 310, as shown in Figure 10. For example, the virtual plane S is a plane that passes through the upper end surface 324 of the second member 320 and extends perpendicularly toward the first member 310, as shown in Figure 10.
[0088] The hemostatic device 100 has a height difference between the first member 310 and the second member 320 with respect to a virtual plane S. The upper end surface 314 of the first member 310 is higher than the upper end surface 324 of the second member 320 (away from the expansion member 110). As a result, the hemostatic device 100 is configured such that the area in which the first tip surface 313 and the second tip surface 323 face each other across the slit portion 330 in the height direction of the tube fixing portion 300 (up and down direction in Figure 10) is reduced (the area in which the first tip surface 313 and the second tip surface 323 overlap in a direction perpendicular to the up and down direction in Figure 10). Therefore, when the surgeon pushes the tube portion 183 into the tube fixing portion 300 (inserts the tube portion 183 into the tube fixing portion 300), the hemostatic device 100 can deform the first member 310 in the direction that expands the slit portion 330 due to the external force applied to the tube portion 183, and then, while maintaining the deformation of the first member 310, deform the second member 320 in the direction that expands the slit portion 330. As a result, the hemostatic device 100 can reduce the force required when the surgeon inserts the tube portion 183 into the tube fixing portion 300 while it is attached to the patient's right hand H1, making it easier for the surgeon to insert the tube portion 183 into the tube fixing portion 300.
[0089] Furthermore, as shown in Figures 4, 5, and 10, the hemostatic device 100 (support member 130) has a hole 350 formed between the first member 310 and the second member 320. As shown in Figure 10, the hole 350 is located between the first member 310 and the second member 320 and is a through hole that penetrates between the inner surface 130a and the outer surface 130b of the support member 130. The position of the hole 350 is not particularly limited, as long as it is between the first member 310 and the second member 320 in the plan view shown in Figure 5.
[0090] The support member 130 has a hole 350 between the first member 310 and the second member 320. As a result, when an external force (a force pushing the tube portion 183 in the left-right direction in Figure 5, for example, a force pushing the tube portion 183 from the left to the right in Figure 5 or a force pushing the tube portion 183 from the right to the left in Figure 5) is applied to the hemostatic device 100 while the tube portion 183 is inserted into the tube holding portion 340, a part of the tube portion 183 enters the hole 350, thereby reducing deformation of the tube portion 183 between the connection portion K and the tube fixing portion 300 and preventing it from moving away from the outer surface 130b of the support member 130. Therefore, even when an external force is applied to the tube portion 183 while it is inserted into the tube holding portion 340, the hemostatic device 100 reduces deformation of the tube portion 183 between the connection portion K and the tube fixing portion 300, preventing the operator or others from getting caught on the deformed tube portion 183. In addition, when an external force (a force pushing the tube portion 183 from left to right in Figure 5) is applied to the tube portion 183 while it is inserted into the tube holding portion 340, the hemostatic device 100 prevents the tube portion 183 from moving from left to right in Figure 5 by allowing a part of the tube portion 183 to enter the hole portion 350, thus preventing the connector portion 181 and the cushioning member 182 from sliding away from the tube fixing portion 300. Therefore, when an external force (a force pushing the tube portion 183 from left to right in Figure 5) is applied to the tube portion 183 while the tube portion 183 is inserted into the tube holding portion 340, the hemostatic device 100 reduces the sliding of the connector portion 181 and the cushioning member 182 from left to right in Figure 5, and also prevents the connector portion 181 and the cushioning member 182 from getting caught on components located around the patient, such as a bed. In addition, the hole 350 functions as a hole for removing the mold when molding the first component 310 and the second component 320. Therefore, the hemostatic device 100 can reduce the number of molds used when molding the support member 130 which is formed integrally with the tube fixing portion 300, thereby reducing manufacturing costs.
[0091] Furthermore, the vertical width of the hole 350 (wherein "vertical width" refers to the length in the vertical direction in Figure 5 and the length in the horizontal direction in Figure 10) can be, for example, the width Y2 of the tube holding portion 340. Preferably, the vertical width of the hole 350 is greater than or equal to the diameter φ1 of the tube portion 183. This allows a portion of the tube portion 183 to easily enter the hole 350 when an external force (a force pushing the tube portion 183 in the horizontal direction in Figure 5) is applied to the tube portion 183 while it is inserted into the tube holding portion 340 of the hemostatic device 100. Furthermore, the horizontal width of the hole 350 (wherein "horizontal width" refers to the length in the horizontal direction in Figure 5) can be, for example, the width Z1 of the first main body portion 311 or the width Z3 of the second main body portion 321.
[0092] As shown in Figure 10, the first curved portion 312 has a first curved surface 312a that curves toward the second member 320. The first curved surface 312a is positioned opposite the second end surface 323 and the tube holding portion 340. Therefore, when the surgeon pulls the tube portion 183 away from the tube fixing portion 300 (removes the tube portion 183 from the tube fixing portion 300), the hemostatic device 100 uses the first curved surface 312a as a guide surface to move the tube portion 183 from the tube holding portion 340 toward the slit portion 330. As a result, the hemostatic device 100 can reduce the force required when the surgeon removes the tube portion 183 from the tube fixing portion 300 while it is attached to the patient's right hand H1, making it easier for the surgeon to remove the tube portion 183 from the tube fixing portion 300.
[0093] As shown in Figure 10, the second curved portion 322 has a second curved surface 322a that curves toward the first member 310. When the surgeon removes the tube portion 183 from the tube fixing portion 300, the hemostatic device 100 can be made more accessible to the slit portion 330 by moving the tube portion 183, which is fixed to the tube fixing portion 300, along the first curved surface 312a and / or the second curved surface 322a. This makes it easier for the surgeon to remove the tube portion 183 from the tube fixing portion 300.
[0094] The thickness of the tip portions of the first curved portion 312 and the second curved portion 322 (i.e., the length of the first tip surface 313, which is the sum of the length X2 of the first region 313a and the length X3 of the second region 313b, or the length of the second tip surface 323; here, "length" refers to the vertical length in the enlarged view of the first tip surface 313 in Figure 10) is not particularly limited, but can be set to any thickness that ensures stable molding of the tube fixing portion 300 and reduces the risk of damage when the operator attaches or detaches the tube portion 183 from the tube fixing portion 300. As described above, the tube fixing portion 300 is configured such that the area where the first tip surface 313 and the second tip surface 323 face each other across the slit portion 330 in the height direction of the tube fixing portion 300 (vertical direction in Figure 10) is minimized. As a result, the tube fixing section 300 can be designed with thicker tips for the first curved section 312 and the second curved section 322, while suppressing the force required by the operator to attach and detach the tube section 183 from the tube fixing section 300.
[0095] However, it is preferable that the length X3 of the second region 313b of the first tip surface 313 is smaller than the radius r1 of the tube portion 183. By configuring it in this way, the hemostatic device 100 can reduce the amount of work required when the surgeon moves the tube portion 183 from the slit portion 330 toward the tube holding portion 340 when inserting the tube portion 183 into the tube fixing portion 300 (meaning the amount obtained by multiplying the external force applied by the surgeon to the tube portion 183 by the distance the tube portion 183 moves. Here, "distance" refers to the distance between the first tip surfaces 313 and the second tip surfaces 323 that are opposite each other across the slit portion 330). As a result, the hemostatic device 100 can reduce the force with which the surgeon pushes the tube portion 183 toward the tube holding portion 340, making it easier for the surgeon to insert the tube portion 183 through the tube fixing portion 300.
[0096] As shown in Figure 10, the second tip surface 323 is opposite the first tip surface 313, with the slit portion 330 in between. DirectionThe hemostatic device 100 has a curved portion 323c in a position that allows it to move. By providing the curved portion 323c between the upper end surface 324 and the second tip surface 323 of the second member 320 adjacent to the slit portion 330, the hemostatic device 100 guides the direction of movement of the tube portion 183 toward the curved portion 323c when the tube portion 183 is inserted into the tube fixing portion 300, making it easier for the tube portion 183 held by the tube holding portion 340 to move toward the slit portion 330. As a result, the hemostatic device 100 can reduce the force required when the surgeon inserts the tube portion 183 into the tube fixing portion 300 while it is attached to the patient's right hand H1, making it easier for the surgeon to insert the tube portion 183 into the tube fixing portion 300.
[0097] In this way, the hemostatic device 100 can suppress the force required when the operator attaches and detaches the tube portion 183 from the tube fixing portion 300 while it is attached to the patient's right hand H1. Therefore, the hemostatic device 100 can prevent unintentional external force from being applied to the first puncture site p1 and / or prevent displacement of the hemostatic device 100 that may occur due to unintentional external force being applied to the expansion member 110.
[0098] The tube fixing portion 300 is made of a harder material than the material that makes up the tube portion 183. Also, as shown in Figure 3, the tube fixing portion 300 is located on the outer surface 130b of the support member 130, which is made of a harder material than each of the bands 140, 150, and 160. Therefore, the surgeon can easily attach and detach the tube portion 183 from the tube fixing portion 300 while the hemostatic device 100 is attached to the patient's right hand H1. In addition, because the tube fixing portion 300 is made of a harder material than the tube portion 183, the first main body portion 311 and the second member 320 are less likely to deform under unintentional force, and the tube portion 183 held by the tube fixing portion 300 can be prevented from unintentionally coming out of the tube fixing portion 300. Furthermore, by providing the tube fixing portion 300 on a support member 130 made of a rigid material, it is possible to prevent displacement of the hemostatic device 100 that may occur due to unintentional external force being applied to the expansion member 110 connected to the support member 130. As shown in Figure 3, if the tube fixing portion 300 is located on the outer surface 130b of the support member 130, outside the expansion member 110, it is possible to more reliably prevent displacement of the hemostatic device 100 that may occur due to unintentional external force being applied to the expansion member 110 connected to the support member 130.
[0099] The method for molding the tube fixing portion 300 is not particularly limited, but as shown in Figure 3, it can be molded integrally with the support member 130 and can be made of the same constituent materials as the support member 130.
[0100] Furthermore, the tube fixing part 300 is 100 hemostatic devices As long as the tube portion 183 is positioned in a location that allows for easy attachment and detachment from the tube fixing portion 300 while attached to the patient's right hand H1, its position is not restricted. Therefore, The tube fixing part 300 is The extension member 110 may be provided on the fixing member 120, or it may be provided on any of the bands 140, 150, or 160.
[0101] As shown in Figure 3, the tube fixing portion 300 is located in the first curved region 134a of the support member 130 and is located outside the expansion member 110. The hemostatic device 100 is attached so that the first curved region 134a of the support member 130 does not come into close contact with the body surface of the patient's right hand H1. Therefore, when fixing the tube portion 183 to the tube fixing portion 300, the surgeon can hold the support member 130 of the hemostatic device 100 attached to the patient's right hand H1 by pinching it with two fingers. The surgeon can insert the tube portion 183 into the tube fixing portion 300 with one finger located on the outer surface 130b side of the support member 130, and allow the other finger located on the inner surface 130a side of the support member 130 to absorb the external force applied to the tube portion 183. As a result, the surgeon can fix the tube portion 183 to the tube fixing portion 300 without applying unintended external force to the support member 130. Furthermore, when the surgeon fixes the tube portion 183 to the tube fixing portion 300, they can more reliably prevent the support member 130 from tilting due to external force applied to the tube portion 183 by pinching the support member 130 of the hemostatic device 100 attached to the patient's right hand H1. Therefore, when the surgeon inserts the tube portion 183 into the tube fixing portion 300 while the hemostatic device 100 is attached to the patient's right hand H1, the hemostatic device 100 can prevent unintentional external force from being applied to the first puncture site p1, and / or prevent displacement of the hemostatic device 100 that may occur due to unintentional external force being applied to the expansion member 110 by the transmission of external force to the support member 130.
[0102] As shown in Figure 3, the tube fixing portion 300 is provided in a position opposite the third band 160, with the expansion member 110 in between. As shown in Figures 3 and 4, the connection portion K between the expansion member 110 and the tube portion 183 is positioned on the third band 160 side for the convenience of the operator operating the injection member 180 when adjusting the fluid volume of the expansion member 110. Therefore, by providing the tube fixing portion 300 in a position opposite the third band 160, the excess of the tube portion 183 that may occur between the connection portion K of the tube portion 183 fixed to the tube fixing portion 300 and the tube fixing portion 300 can be reduced. This suppresses the shaking of the end of the tube portion 183 on the connector portion 181 side when the patient moves their right hand H1, and suppresses the unintentional application of external force to the expansion member 110. In addition, when the tube portion 183 is fixed to the tube fixing portion 300, the radius of curvature formed by the tube portion 183 located between the connection portion K and the tube fixing portion 300 becomes larger, thus preventing kinking of the tube portion 183.
[0103] <Examples of hemostatic device use> Next, an example of how to use the hemostatic device 100 will be explained with reference to Figures 12 to 16.
[0104] The example illustrates the procedure for using the hemostatic device 100 to stop bleeding at the first puncture site p1 formed on the patient's right hand H1.
[0105] Figure 12 shows the state after inserting the sheath tube of the introducer 200 into the first puncture site p1 and completing various procedures.
[0106] When the surgeon attaches the hemostatic device 100 to the patient's right hand H1, he positions the support member 130 on top of the back of the patient's right hand H1, as shown in Figure 12. At this time, the surgeon visually confirms the position of the marker 115 placed on the expansion member 110 and positions the marker 115 at the first puncture site p1, thereby appropriately positioning the expansion member 110 at the first puncture site p1.
[0107] Furthermore, after completing the procedure using the introducer 200, the surgeon may withdraw a portion of the introducer 200's sheath tube from the first puncture site p1 formed on the patient's right hand H1 before attaching the hemostatic device 100 to the patient's right hand H1. For example, with the introducer 200's sheath tube still in place in blood vessel B, the surgeon can withdraw the sheath tube about 2-3 cm towards their proximal end before beginning the attachment of the hemostatic device 100.
[0108] As shown in Figures 12 and 13, the surgeon wraps the first band 140 and the second band 150 around the outer circumference of the patient's right hand H1. The surgeon can connect the first band 140 and the second band 150 via the fixation points 171 and 174 by bringing the fourth fixation point 174 (see Figure 2), which is located on the inner surface of the second band 150, into contact with the first fixation point 171 (see Figure 1), which is located on the outer surface of the first band 140.
[0109] As shown in Figure 14, the surgeon passes the third band 160 through the interdigital space fb located between the thumb and index finger of the patient's right hand H1, while positioning a portion of the third band 160 on the palm side of the patient's right hand H1. At this time, the surgeon can connect the second band 150 and the third band 160 via the fixation points 172 and 175 by bringing the fifth fixation point 175 (see Figure 2), located on the inner surface of the third band 160, into contact with the second fixation point 172 (see Figure 1), located on the outer surface of the second band 150.
[0110] The surgeon expands the expansion member 110 by injecting air into it while the syringe is connected to the connector part 181. As shown in Figures 15 and 16, when the expansion member 110 expands, the hemostatic device 100 applies a compressive force to the first puncture site p1 on the patient's right hand H1.
[0111] The surgeon fixes the tube portion 183 to the tube fixing portion 300 (see Figures 3 to 5). The tube fixing portion 300 in this embodiment can reduce the force required by the surgeon when fixing the tube portion 183 to the tube fixing portion 300. In addition, when fixing the tube portion 183 to the tube fixing portion 300, the surgeon can prevent the support member 130 from tilting due to the external force applied by the surgeon to the tube portion 183 by pinching the support member 130 of the hemostatic device 100 attached to the patient's right hand H1. Therefore, the hemostatic device 100 can prevent unintentional external force from being applied to the first puncture site p1 and / or prevent displacement of the hemostatic device 100 that may occur due to unintentional external force being applied to the expansion member 110.
[0112] By following the above procedure, the surgeon can use the hemostatic device 100 to stop bleeding at the first puncture site p1 formed on the patient's right hand H1.
[0113] Furthermore, when using the hemostatic device 100 to stop bleeding at the second puncture site p2 formed on the patient's right hand H1, the surgeon slides each band 140 and 150 around the center point R when wrapping each band 140 and 150 around the patient's right hand H1. By wrapping the slid bands 140 and 150 around the patient's right hand H1 at a position on the forearm A side (proximal side) than the first puncture site p1, the surgeon can stop bleeding at the second puncture site p2 formed on the patient's right hand H1.
[0114] As described above, the hemostatic device 100 according to this embodiment includes an expansion member 110 configured to compress the area of the patient's limb to be hemostatic, a fixing member 120 configured to fix the expansion member 110 to the patient's limb, an injection member 180 comprising a connector portion 181 configured to inject fluid for expanding the expansion member 110, and a tube portion 183 connecting the connector portion 181 and the lumen 113 of the expansion member 110, and a tube fixing portion 300 located on the fixing member 120 and configured to fix the tube portion 183, wherein the tube fixing portion 300 comprises a first member 310, a second member 320 located on the expansion member 110 side of the first member 310 and facing the first member 310, and a slit portion 330 formed between the first member 310 and the second member 320 and configured to allow insertion of the tube portion 183, and the first member 310, second member 320 The first member 310 comprises a first main body portion 311, a first curved portion 312 that curves toward the second member 320, and a first tip surface 313 located at the tip of the first curved portion 312. The second member 320 comprises a second main body portion 321, a second curved portion 322 that curves toward the first member 310, and the tip of the second curved portion 322. It has a first tip surface 313 and a second tip surface 323 that are opposite each other across the slit portion 330, and a part of the first member 310 is further away from the extension member 110 in a direction perpendicular to the virtual plane S formed by the slit portion 330 than the second member 320, and the first tip surface 313 has a first region 313a that is not opposite the second tip surface 323 across the slit portion 330, and a second region that is opposite the second tip surface 323 across the slit portion 330 Direction The first curved portion 312 comprises a second region 313b, and the first curved portion 312 has a first curved surface 312a that curves toward the second member 320, and the first curved surface 312a faces the second end surface 323 with the tube holding portion 340 in between.
[0115] With the hemostatic device 100 configured as described above, a height difference is provided between the first member 310 and the second member 320, so that the area where the first tip surface 313 and the second tip surface 323 face each other across the slit portion 330 is reduced. Therefore, the hemostatic device 100 can reduce the force required when the surgeon inserts the tube portion 183 into the tube fixing portion 300 while it is attached to the patient's right hand H1. In addition, the first curved surface 312a is provided in a position opposite the second tip surface 323 across the tube holding portion 340. Therefore, when the surgeon pulls the tube portion 183 away from the tube fixing portion 300 (removes the tube portion 183 from the tube fixing portion 300), the hemostatic device 100 can use the first curved surface 312a as a guide surface to move the tube portion 183 from the tube holding portion 340 towards the slit portion 330. As a result, the hemostatic device 100 can reduce the force required when the surgeon removes the tube portion 183 from the tube fixing portion 300 while it is attached to the patient's right hand H1. Therefore, the hemostatic device 100 can prevent unintentional external force from being applied to the puncture sites p1 and p2, and / or prevent displacement of the hemostatic device 100 that may occur due to unintentional external force being applied to the expansion member 110.
[0116] Furthermore, the fixing member 120 includes a support member 130 to which the expansion member 110 is fixed, and strips (strips 140, 150, 160) configured to be connectable to the support member 130. The support member 130 is made of a harder material than the material constituting the strips, and the tube fixing portion 300 is made of a harder material than the material constituting the tube portion 183 and is located on the surface (outer surface 130b) of the support member 130.
[0117] With the hemostatic device 100 configured as described above, the surgeon can easily attach and detach the tube portion 183 from the tube fixing portion 300 while the hemostatic device 100 is attached to the patient's right hand H1. Furthermore, because the tube fixing portion 300 is made of a harder material than the tube portion 183, the first main body portion 311 and the second member 320 are less likely to deform due to unintentionally applied force, and the tube portion 183 held by the tube fixing portion 300 can be prevented from unintentionally coming out of the tube fixing portion 300. In addition, because the tube fixing portion 300 is provided on a support member 130 made of a hard material, displacement of the hemostatic device 100 that may occur due to unintentional application of external force to the expansion member 110 connected to the support member 130 can be prevented.
[0118] Furthermore, the support member 130 has a first curved region 134a that curves away from the expansion member 110, and the tube fixing portion 300 is located in the first curved region 134a and is located outside the expansion member 110.
[0119] With the hemostatic device 100 configured as described above, the first curved region 134a of the support member 130 is attached so as not to be in close contact with the body surface of the patient's right hand H1. Therefore, when the surgeon fixes the tube portion 183 to the tube fixing portion 300, the surgeon can hold the support member 130 of the hemostatic device 100 attached to the patient's right hand H1 by pinching it, thereby absorbing the external force applied to the tube portion 183 by the surgeon's fingers. As a result, the surgeon can fix the tube portion 183 to the tube fixing portion 300 without applying unintended external force to the support member 130. In addition, when the surgeon fixes the tube portion 183 to the tube fixing portion 300, the surgeon can more reliably prevent the support member 130 from tilting due to the external force applied to the tube portion 183 by holding the support member 130 of the hemostatic device 100 attached to the patient's right hand H1 by pinching it. Therefore, when the hemostatic device 100 is attached to the patient's right hand H1 and the surgeon inserts the tube portion 183 into the tube fixing portion 300, it prevents unintentional external force from being applied to the puncture sites p1 and p2, and / or prevents displacement of the hemostatic device 100 that may occur due to unintentional external force being applied to the expansion member 110 by the transmission of external force to the support member 130.
[0120] Furthermore, the band comprises a first band 140 extending in a first direction from the support member 130, a second band 150 extending in a second direction different from the first direction from the support member 130, and a third band 160 configured to be positioned between the patient's fingers and extending in a third direction different from the first and second directions from the support member 130. The connection part K between the expansion member 110 and the tube portion 183 is located on the side of the third band 160, and the tube fixing part 300 is located on the surface (outer surface 130b) of the support member 130 facing the third band 160 with the expansion member 110 in between.
[0121] With the hemostatic device 100 configured as described above, the excess of the tube portion 183 that may occur between the connection portion K of the tube portion 183 fixed to the tube fixing portion 300 and the tube fixing portion 300 can be reduced. In addition, when the tube portion 183 is fixed to the tube fixing portion 300, it is possible to prevent the tube portion 183 from kinking between the connection portion K and the tube fixing portion 300.
[0122] Furthermore, the length X3 of the second region 313b of the first tip surface 313 is smaller than the radius r1 of the tube portion 183.
[0123] With the hemostatic device 100 configured as described above, the hemostatic device 100 can reduce the amount of work required when the surgeon inserts the tube portion 183 into the tube fixing portion 300 and moves the tube portion 183 from the slit portion 330 toward the tube holding portion 340. Therefore, the hemostatic device 100 can reduce the force with which the surgeon pushes the tube portion 183 toward the tube holding portion 340 from the slit portion 330, making it easier for the surgeon to insert the tube portion 183 through the tube fixing portion 300. As a result, the hemostatic device 100 can prevent unintentional external force from being applied to the puncture sites p1 and p2, and / or prevent displacement of the hemostatic device 100 that may occur due to unintentional external force being applied to the expansion member 110.
[0124] Furthermore, the second tip surface 323 is opposite the first tip surface 313, with the slit portion 330 in between. Direction It has a curved portion 323c at that position.
[0125] With the hemostatic device 100 configured as described above, when the surgeon inserts the tube portion 183 into the tube fixing portion 300, the hemostatic device 100 guides the direction of movement of the tube portion 183 toward the curved portion 323c, making it easier for the tube portion 183 held by the tube holding portion 340 to move toward the slit portion 330. Therefore, the hemostatic device 100 can reduce the force required when the surgeon inserts the tube portion 183 into the tube fixing portion 300 while it is attached to the patient's right hand H1. As a result, the hemostatic device 100 can prevent unintentional external force from being applied to the puncture sites p1 and p2, and / or prevent displacement of the hemostatic device 100 that may occur due to unintentional external force being applied to the expansion member 110.
[0126] Next, modified examples of the hemostatic device according to the present invention will be described. In the description of the modified examples, explanations of the components and the procedure for using the hemostatic device, etc., which have already been described in the description of the embodiments described above, will be omitted as appropriate. In addition, any content not specifically described in each modified example may be the same as that of the embodiments described above.
[0127] <Variation> Figure 17 shows a magnified view of a portion of the hemostatic device 100A related to a modified example.
[0128] As shown in Figure 17, the tube fixing portion 300A of the modified hemostatic device 100A has a first member 310A and a second member 320A. Furthermore, as shown in the enlarged view of the tube fixing portion 300A in Figure 17, the width ZA2 of the first tip surface 313A is smaller than the width ZA1 of the first main body, and the width ZA4 of the second tip surface 323A is smaller than the width ZA3 of the second main body.
[0129] With the hemostatic device 100A configured as described above, the contact area of the tube fixing portion 300A with respect to the support member 130 can be increased while shortening the width of the first tip surface 313A and the second tip surface 323A that form the slit portion 330. Therefore, the hemostatic device 100A can ensure the strength of the tube fixing portion 300A while reducing the force required when the operator attaches and detaches the tube portion 183 from the tube fixing portion 300A while it is attached to the patient's right hand H1. Thus, the hemostatic device 100A can prevent unintentional external force from being applied to the puncture sites p1 and p2, and / or prevent displacement of the hemostatic device 100A that may occur due to unintentional external force being applied to the expansion member 110. In addition, the hemostatic device 100A can also increase the strength of the tube fixing portion 300A.
[0130] Although the hemostatic device according to the present invention has been described above through embodiments, the present invention is not limited to what has been described in the specification and can be modified as appropriate based on the claims.
[0131] In the description of the embodiment, a hemostatic device for stopping bleeding from a puncture site formed on the back of the right hand and a puncture site formed on the forearm was given as an example. However, the hemostatic device may be configured to stop bleeding from a puncture site formed on the back of the left hand, a puncture site formed on the palm of either the left or right hand, or a puncture site formed on the patient's foot (e.g., the dorsum of the foot, the sole of the foot, etc.).
[0132] The shape and dimensions of each part of the hemostatic device are not particularly limited and can be modified as appropriate, as long as the expansion member can be placed at the site to be hemostatic.
[0133] This application is based on Japanese Patent Application No. 2021-082265, filed on 14 May 2021, the disclosures of which are cited in their entirety by reference. [Explanation of symbols]
[0134] 100, 100A hemostatic devices 110 Expansion member 120 Fixing member 130 Support member 140 First Band 150 Second Band 160 Third Band 180 Injection member 181 Connector section 183 Tube section 300, 300A Tube Fixing Section 310, 310A First member 311 First main body 312 First curved section 313, 313A 1st tip surface 313a First region of the first leading surface 313b Second region of the first leading surface 320, 320A Second member 321 Second main body 322 Second Curve Section 323, 323A 2nd tip surface 323c curved part 330 Slit section 340 Tube holding section A Forearm B Blood vessels (arteries) H hand H1 right hand fb between fingers p1 1st puncture site (puncture site) p2 2nd puncture site (puncture site) R center point
Claims
1. An expandable member configured to compress the area of the patient's limb that needs to be hemostatic, A fixing member configured to fix the aforementioned expansion member to the patient's limb, An injection member comprising a connector portion configured to allow injection of fluid for expanding the expansion member, and a tube portion connecting the connector portion and the lumen of the expansion member, It has a tube fixing part located on the fixing member and configured to fix the tube portion, The tube fixing portion comprises a first member, a second member located on the expansion member side of the first member and facing the first member, a slit portion formed between the first member and the second member and configured to allow insertion of the tube portion, and a tube holding portion surrounded by the first member, the second member, and the slit portion and configured to hold the tube portion. The first member has a first main body portion, a first curved portion that curves toward the second member, and a first tip surface located at the tip of the first curved portion. The second member has a second main body portion, a second curved portion that curves toward the first member, and a second tip surface located at the tip of the second curved portion and facing the first tip surface with the slit portion in between. A portion of the first member is further away from the expansion member in a direction perpendicular to the virtual plane formed by the slit than the second member, The first tip surface comprises a first region that does not face the second tip surface with the slit portion in between, and a second region that faces the second tip surface with the slit portion in between. The first curved portion has a first curved surface that curves toward the second member side, The first curved surface is opposite the second tip surface and the tube holding portion, and is a hemostatic device.
2. The fixing member comprises a support member to which the extension member is fixed, and a band configured to be connectable to the support member. The support member is made of a material that is harder than the material that constitutes the strip. The hemostatic device according to claim 1, wherein the tube fixing portion is made of a material harder than the material constituting the tube portion and is located on the surface of the support member.
3. The support member has a curved region that curves away from the expansion member, The hemostatic device according to claim 2, wherein the tube fixing portion is located in the curved region and is located outside the expansion member.
4. The band comprises a first band extending in a first direction from the support member, a second band extending in a second direction different from the first direction from the support member, and a third band configured to be positioned between the patient's fingers and extending in a third direction different from the first and second directions from the support member. The connection between the expansion member and the tube portion is located on the third band side, The hemostatic device according to claim 2 or 3, wherein the tube fixing portion is located on the surface of the support member facing the third band with the expansion member in between.
5. The hemostatic device according to claim 1, wherein the length of the second region of the first tip surface is smaller than the radius of the tube portion.
6. The hemostatic device according to claim 1, wherein the second tip surface has a curved portion at a position opposite to the first tip surface, with the slit portion in between.
7. The width of the first tip surface is smaller than the width of the first main body. The hemostatic device according to claim 1, wherein the width of the second tip surface is smaller than the width of the second main body.