Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
  • A61B17/132—Tourniquets
  • A61B17/135—Tourniquets inflatable
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
  • A61B17/132—Tourniquets
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
  • A61B17/132—Tourniquets
  • A61B17/1322—Tourniquets comprising a flexible encircling member
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
  • A61B17/132—Tourniquets
  • A61B17/1322—Tourniquets comprising a flexible encircling member
  • A61B17/1325—Tourniquets comprising a flexible encircling member with means for applying local pressure
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B2017/00477—Coupling
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B2017/00831—Material properties
  • A61B2017/00858—Material properties high friction or non-slip
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B2017/00831—Material properties
  • A61B2017/00902—Material properties transparent or translucent
  • A61B2017/00907—Material properties transparent or translucent for light

Definitions

• the present invention relates to a hemostatic device.
• Patent Document 1 discloses a hemostasis device that stops bleeding at a puncture site formed to allow access to blood vessels (including the distal radial artery) running through the hand.
• the hemostasis device of Patent Document 1 includes an expansion member that applies pressure to a puncture site formed on a patient's hand, a fixing member that secures the pressing member to the patient's hand, and a fluid that expands the expansion member.
• an injection member comprising a port (connector part) configured to be able to inject the same, a tube part that connects the connector part and the inner lumen of the expansion member, and a tube located on the fixing member and configured to be able to fix the tube member.
• an operator such as a doctor (hereinafter referred to as "operator”) uses the hemostatic device of Patent Document 1 to stop bleeding at a puncture site formed on a patient's hand
• the operator hereinafter referred to as "operator” inserts the expansion member into the patient's hand.
• the hemostatic device By fixing the hemostatic device using each band while disposed at the puncture site and its surrounding area, it is possible to prevent the expansion member from shifting from the puncture site formed on the patient's hand.
• the tube member to the tube fixing portion, the operator can suppress the tube member from moving in accordance with the movement of the patient's hand.
• the hemostasis device described in Patent Document 1 may have the following problems.
• a groove portion for fixing the tube member is provided in the tube fixing portion. Therefore, when the operator attaches and detaches the tube member from the tube fixing part, the operator needs to apply an external force to the tube member to deform (for example, elastically deform) the tube fixing part in the direction of widening the groove. At this time, the force required for the operator to deform the tube fixing part in the direction of widening the groove is determined by the mechanical configuration of the tube fixing part, but the configuration depends on the operator's operability and convenience. It may not be designed with this in mind.
• Patent Document 1 discloses a hemostasis device having a structure in which a port capable of injecting a fluid for expanding the expansion member is directly connected to the expansion member.
• the port directly connected to the expansion member is arranged to protrude from the outer surface side of the cover member opposite to the body surface. Therefore, when the surgeon expands the expansion member and connects a fluid supply device such as a syringe to the port, the pushing force at the time of connection is transmitted to the entire hemostatic device, causing the hemostatic device to shift or tilt. There is a possibility that it will be placed. If the hemostatic device is displaced or placed at an angle as described above, there is a possibility that the expansion member will be displaced or the direction of pressure applied by the expansion member to the puncture site may change to an unintended direction. There is.
• the present invention has been made based on the above-mentioned problems, and it is possible to easily fix an injection member for injecting fluid into an expansion member to a cover member, and when fixing the injection member to the cover member, It is an object of the present invention to provide a hemostatic device that can prevent misalignment of the hemostatic device and expansion member.
• a hemostasis device includes a cover member configured to cover a puncture site formed on a patient, and an expansion member connected to the cover member and configured to press the puncture site.
• an injection member connected to the expansion member and configured to be able to inject fluid into the expansion member; and a fixing member configured to be able to fix the injection member to the cover member, the injection member , a connector portion, and a tube member connected to the expansion member, and the fixing member includes a main body portion connecting the connector portion and the tube member, and a main body portion connected to the main body portion toward the expansion member side.
• the claw portion includes a claw portion extending in parallel, and a connecting portion configured to allow insertion of the cover member between the main body portion and the claw portion and connecting the main body portion and the claw portion, the claw portion is smaller than the width of the main body at a position where the claw and the main body overlap in plan view.
• a hemostasis device includes a cover member configured to cover a puncture site formed on a patient, and an expansion member connected to the cover member and configured to press the puncture site.
• an injection member connected to the expansion member and configured to be able to inject fluid into the expansion member; and a fixing member configured to be able to fix the injection member to the cover member, the injection member , a connector portion, and a tube member connected to the expansion member, and the fixing member includes a main body portion connecting the connector portion and the tube member, and a main body portion connected to the main body portion toward the expansion member side.
• the main body has a claw portion extending in parallel, and a connecting portion configured to allow the cover member to be inserted between the main body portion and the claw portion, and connecting the main body portion and the claw portion.
• the above-mentioned hemostasis device can be configured such that the injection member is fixed by inserting the cover member between the main body portion and the claw portion in a state where the main body portion of the fixing member connects the connector portion and the tube member. can be fixed to the cover member.
• the surgeon should move the fixing member closer to the cover in a direction substantially parallel to the plane of the cover to close the gap between the main body and the claw.
• a cover member can be inserted into. Therefore, when fixing the injection member to the cover member, the operator can prevent unnecessary force from being applied in the direction of pressing the hemostatic device toward the surface of the patient's body.
• the hemostasis device can prevent the hemostatic device attached to the patient's body from shifting or the expansion member from shifting. Furthermore, for example, the cover member may curve following the movement of the patient's body when the hemostasis device is attached to the patient.
• the width of the claw portion is smaller than the width of the main body portion at the position where the claw portion and the main body portion overlap in plan view. Therefore, in the above-mentioned hemostasis device, the cover member can be smoothly inserted between the main body portion and the claw portion even when the cover member is curved following the patient's movement.
• the cover member is inserted between the main body and the claw part to cover the injection member. It can be fixed to a member.
• the surgeon should move the fixing member closer to the cover in a direction substantially parallel to the plane of the cover to close the gap between the main body and the claw.
• a cover member can be inserted into. Therefore, when fixing the injection member to the cover member, the operator can prevent unnecessary force from being applied in the direction of pressing the hemostatic device toward the surface of the patient's body.
• the hemostasis device can prevent the hemostatic device attached to the patient's body from shifting or the expansion member from shifting.
• the above-mentioned hemostatic device is configured such that the main body portion has an inclined portion that slopes toward the claw portion. Further, at least a portion of the inclined portion of the main body portion is configured to be located at a position closer to the proximal end than the distal end of the claw portion in the main body portion. Therefore, the above-mentioned hemostasis device is configured such that when the operator inserts the cover member between the main body part and the claw part, the inclined part guides the cover member to a position closer to the connecting part than the tip of the claw part. Ru. Therefore, when inserting the cover member between the main body part and the claw part, the surgeon guides the cover member along the inclined part to adjust the shape of the cover member and to insert the cover member between the main body part and the claw part. The cover member can be smoothly inserted into.
• FIG. 3 is a diagram showing the hemostasis device according to the first embodiment, and is a plan view seen from the outer surface side of each band portion. It is a figure showing the hemostasis device concerning a 1st embodiment, and is a top view seen from the inner surface side of each band body part. It is an enlarged view showing a part of the hemostasis device as seen from the outer surface side of the main body portion of the cover member. It is an enlarged view showing a part of the hemostasis device as seen from the inner surface side of the main body portion of the cover member. It is an enlarged view showing a part of the hemostasis device as seen from the outer surface side of the main body portion of the cover member. FIG.
• FIG. 6 is a partial cross-sectional view of the hemostasis device taken along arrows 6A-6A shown in FIG. 5, showing the state when the expansion member is expanded.
• FIG. 6 is a partial cross-sectional view of the hemostasis device taken along arrow 7A-7A shown in FIG. 5, showing the state when the expansion member is expanded.
• It is a top view of a support member.
• FIG. 3 is a perspective view of the support member viewed from the lower end side.
• FIG. 3 is a perspective view showing the inner surface of the support member.
• FIG. 11 is a cross-sectional view of the main body of the injection member taken along arrow 12A--FIG. 12A shown in FIG. 11.
• FIG. 13 is a side view of the injection member seen from the direction of arrow 13A shown in FIG. 12.
• FIG. 13 is a bottom view of the injection member viewed from the direction of arrow 14A shown in FIG. 12.
• FIG. It is a figure which shows the situation when inserting a cover member between the main body part of a fixing member, and a claw part. It is a figure which shows the situation when inserting a cover member between the main body part of a fixing member, and a claw part. It is a figure for explaining the effect of a fixing member. It is a figure for explaining the effect of a fixing member.
• FIG. 2 is a diagram showing a patient's hand (right hand) on which the hemostasis device according to the first embodiment is used.
• FIG. 23 is a partial cross-sectional view taken along arrow 23A-23A shown in FIG. 22.
• FIG. 23 is a partial cross-sectional view taken along arrow 24A-24A shown in FIG. 22.
• FIG. It is a figure which illustrates the fixed position of an injection member. It is a figure which illustrates the fixed position of an injection member. It is a figure which illustrates the fixed position of an injection member. It is a figure which illustrates the fixed position of an injection member.
• FIG. 7 is a side view of an injection member according to modification example 1. 29 is a partial cross-sectional view taken along arrow 29A-29A shown in FIG. 28.
• FIG. FIG. 7 is a side view of an injection member according to modification example 2;
• FIG. 7 is a side view of an injection member according to modification example 3;
• FIG. 7 is a diagram schematically showing an example of use of a hemostasis device according to modification 4.
• FIG. 7 is a diagram schematically showing an example of use of a hemostasis device according to modification 4.
• FIG. 7 is a perspective view showing a fixing member according to a second embodiment. 35 is a side view of the fixing member viewed from the direction of arrow 35A shown in FIG. 34.
• FIG. It is a figure which simply shows the example of use of the fixing member based on 2nd Embodiment.
• ⁇ First embodiment> 1 to 18 are diagrams for explaining a hemostasis device 10 according to this embodiment.
• 19 to 27 are diagrams for explaining usage examples of the hemostasis device 10.
• the hemostasis device 10 has a first puncture site formed on the hand H located on the distal side (fingertip side) of the patient's forearm Ar.
• first puncture site p1 When removing the sheath tube 610 of the introducer 600 that has been placed in p1, it can be used to stop bleeding at the puncture site (hereinafter also referred to as "first puncture site p1").
• first puncture site p1 and a second puncture site p2 are illustrated.
• the first puncture site p1 is a snuff box Sb of the palmar artery running on the back side of the right hand H1 located distal to the patient's forearm Ar. This is the puncture site formed in the distal radial artery (hereinafter also referred to as "blood vessel V1") located on the distal side. Further, the first puncture site p1 is located at a predetermined position between the metacarpal bone B1 of the index finger and the metacarpal bone B2 of the thumb, and avoiding the metacarpal bone B1 of the index finger and the metacarpal bone B2 of the thumb. To position. Note that the snuff box Sb is a cavity in the hand located near the radius when the patient spreads the thumb of the hand H.
• the second puncture site p2 is a puncture site formed in the artery V2 located in the snuff box Sb of the palmar artery running on the back side of the right hand H1.
• the second puncture site p2 is located closer to the patient's forearm Ar side (proximally) than the first puncture site p1, and includes the extensor pollicis longus tendon T1 and the pollicis brevis located on the back of the patient's right hand H1.
• the second puncture site p2 is located at a predetermined position avoiding the position of the metacarpal bone B1 of the index finger and the position of the metacarpal bone B2 of the thumb.
• the hemostasis device 10 has a puncture site formed in the patient's left hand at a position corresponding to the first puncture site p1 illustrated in the patient's right hand H1, and a second puncture site formed in the patient's left hand at a position corresponding to the first puncture site p1 illustrated in the patient's right hand H1. It is also possible to apply it to hemostasis at a puncture site formed at a position corresponding to p2.
• hemostasis device 10 will be explained in detail.
• the hemostasis device 10 includes a cover member 100 configured to cover the first puncture site p1 and a cover member 100, as shown in FIGS. 1, 2, 11, 22, 23, and 24. an expansion member 150 connected to the expansion member 150 and configured to press the first puncture site p1; an injection member 200 connected to the expansion member 150 and configured to be able to inject fluid into the expansion member 150; A fixing member 230 configured to be fixable to the cover member 100.
• the expansion member 150 includes a lumen 150a into which fluid can be injected.
• the expansion member 150 is configured to expand as fluid is injected into the lumen 150a, and contract as the fluid injected into the lumen 150a is discharged.
• the fluid used to expand the expansion member 150 is, for example, a gas such as air.
• 6 and 7 show cross-sectional views of the expansion member 150 in an expanded state.
• a tube member 220 (see FIGS. 1 and 2) is connected to the lumen 150a of the expansion member 150.
• the expansion member 150 can be constructed of, for example, a membrane-like member (sheet material) connected to the sheet material 120 that constitutes the main body portion 110 of the cover member 100.
• the expansion member 150 can be arranged to form a lumen 150a between the expansion member 150 and the lower surface area 132 of the holding portion 130 formed by the sheet material 120.
• the outer peripheral edge of the membrane-like member constituting the expansion member 150 constitutes an edge 151 of the expansion member 150.
• Edges 151 of expansion member 150 can be connected to sheet material 120 by, for example, fusing or gluing.
• the membrane-like member constituting the expansion member 150 can be made of, for example, a resin material having a predetermined thickness.
• the material of the membrane member constituting the expansion member 150 is not particularly limited, and examples thereof include polyvinyl chloride, polyethylene, polypropylene, polybutadiene, polyolefin such as ethylene-vinyl acetate copolymer (EVA), and polyethylene terephthalate (PET). ), polyesters such as polybutylene terephthalate (PBT), various thermoplastic elastomers such as polyvinylidene chloride, silicone, polyurethane, polyamide elastomer, polyurethane elastomer, polyester elastomer, nylon, nylon elastomer, or any combination of these (blends) (resin, polymer alloy, laminate, etc.) can be used.
• the cover member 100 which will be described later, can be made of, for example, the same materials as those exemplified above.
• the expansion member 150 is arranged on the inner surface 110a side of the main body portion 110 of the cover member 100, as shown in FIGS. 6 and 7.
• the inner surface 110a of the main body part 110 is configured with a surface disposed on the body surface side of the right hand H1 in the lower surface area 132 of the holding part 130 (see FIGS. 23 and 24).
• the outer surface 110b of the main body section 110 is formed of the surface of the upper surface region 131 of the holding section 130 that faces the outside.
• FIG. 8 shows a plan view of the support member 300 viewed from the outer surface 300b side.
• FIG. 8 shows the positional relationship between the expansion member 150, the support member 300, and the holding part 130 in a contracted state.
• the expansion member 150 and the holding part 130 are shown by two-dot chain lines.
• the expansion member 150 has a vertical width wa passing through the center c1 of the expansion member 150 in a contracted state, and a horizontal width wb passing through the center c1 of the expansion member 150 while being orthogonal to the vertical width wa.
• the center c1 of the expansion member 150 is located at the center of the outer shape shown in the plan view of FIG.
• the expansion member 150 can be formed, for example, so that the horizontal width wb is shorter than the vertical width wa.
• the expansion member 150 has a substantially oval shape that is rotationally symmetrical with respect to the center c1, as shown in the plan view of FIG.
• the expansion member 150 can be arranged such that the center c1 of the expansion member 150 is located closer to the lower end 302 of the support member 300 than the center of gravity G1 of the outer shape of the support member 300.
• the expansion member 150 has a marker portion 160 for aligning the expansion member 150 with the first puncture site p1, as shown in FIGS. 20, 21, and 22.
• the marker portion 160 is located at a position overlapping the center c1 of the expansion member 150, as shown in FIG.
• the marker section 160 can be composed of a transparent center section surrounding the center c1 and a colored circular frame section surrounding the center section.
• the marker portion 160 is arranged on the outer surface of the expansion member 150, as shown in FIGS. 6 and 7. Note that the marker portion 160 may be arranged on the inner surface of the expansion member 150 facing the inner cavity 150a.
• the marker section 160 may be configured with, for example, a circular marker entirely colored, a marker composed of a transparent center and a rectangular frame, a rectangular marker entirely colored, or the like. can.
• the planar shape of the expansion member 150 is not limited to an oval shape.
• the expansion member 150 may be configured to have a planar shape such as a circle, an ellipse, or a rectangle, for example.
• the specific configuration of the expansion member 150 is not particularly limited.
• the expansion member 150 may be formed, for example, by joining one sheet-like member to the edge of the other sheet-like member, with the inner cavity 150a formed between the two sheet-like members. good. In such a case, the surface of one sheet-like member of the expansion member 150 is connected to the sheet material 120 that constitutes the main body portion 110 of the cover member 100.
• the expansion member 150 can also be configured by, for example, a single bag-shaped member shaped to have a lumen 150a inside. In such a case, a part of the surface of the bag-shaped member of the expansion member 150 is connected to the sheet material 120 that constitutes the main body portion 110 of the cover member 100.
• a first band portion 410 extending in the direction
• a second band portion 420 extending from the main body 110 in a second direction different from the first direction
• a third band portion 430 is provided which faces each other and extends from the main body portion 110 in a third direction different from the first direction and the second direction.
• the main body portion 110 includes a support member 300 made of a harder material than the expansion member 150, as shown in FIGS. 5, 6, and 7.
• the support member 300 is configured to overlap the expansion member 150 in plan view shown in FIGS. 4 and 5.
• the main body section 110 has a two-layer structure and includes a holding section 130 that holds the support member 300.
• the holding portion 130 includes an upper surface region 131 located on the outer surface 300b side of the support member 300, a lower surface region 132 located on the inner surface 300a side of the support member 300 and facing the upper surface region 131 with the support member 300 in between, and the support member 300. It has a curved region 133 that connects the upper surface region 131 and the lower surface region 132 on the base end side of the support member 300 (lower end 302 side of the support member 300).
• the curved region 133 is formed by folding a part of the main body portion 110 toward the first band portion 410 side.
• the holding part 130 having the insertion part g into which the support member 300 can be inserted is configured by folding back a part of the sheet material 120 constituting the main body part 110 from the base end side to the distal end side of the main body part 110. has been done.
• the first end 121 located on the tip side of the folded portion of the sheet material 120 is connected to the sheet material 120 at a position closer to the tip than the upper end 301 of the support member 300, as shown in FIGS. 5 and 6. ing.
• the base end 122 of the cover member 100 made of a portion of the sheet material 120 is located in the curved region 133.
• the insertion portion g of the holding portion 130 is closed between the first end portion 121 and the curved region 133 in the vertical width wa direction of the expansion member 150 (see FIG. 11). Further, as shown in FIG. 7, the holding portion 130 has an insertion portion g external to the second band portion 420 side and the third band portion 430 side in the width wb direction of the expansion member 150 (see FIG. 11). It communicates with
• each of the band parts 410, 420, and 430 can be connected to any position in the area surrounding the holding part 130 in the main body part 110. Further, each of the band members 410, 420, and 430 can be connected to a surface disposed on the body surface side of the right hand H1 in the above region. Each of the band portions 410, 420, and 430 can be connected to the main body portion 110 by, for example, fusing or adhesion. In addition, each band body part 410, 420, 430 may be comprised integrally with the main body part 110.
• FIG. 1 As shown in FIG. 1, FIG. 2, FIG. 4, and FIG. It has an end portion 412 and a main body portion 413 extending between one end portion 411 and the other end portion 412.
• the first band portion 410 is designed to be hooked onto the inter-finger portion fb located between the thumb and index finger of the patient's right hand H1 with the expansion member 150 disposed at the first puncture site p1. can be placed in
• FIG. 1 As shown in FIG. 1, FIG. 2, FIG. 4, and FIG. It has an end portion 422 and a main body portion 423 extending between one end portion 421 and the other end portion 422.
• FIG. 1 As shown in FIG. 1, FIG. 2, FIG. 4, and FIG. It has an end portion 432 and a main body portion 433 extending between one end portion 431 and the other end portion 432.
• the second band part 420 and the third band part 430 can be arranged so as to be wrapped around the outer circumference of the patient's right hand H1 when the hemostasis device 10 is attached to the patient's right hand H1. .
• each band body part 410, 420, 430 is not particularly limited, but may be composed of, for example, vinyl chloride resin, polyurethane resin, polyester resin, etc. Further, there are no particular limitations on the shape, length, thickness, etc. of each band body portion 410, 420, 430.
• Each band body part 410, 420, 430 has four fixing parts: a first fixing part 510, a second fixing part 520, a third fixing part 530, and a fourth fixing part 540, which enable fixing the cover member 100 to the right hand H1. Fixed areas are located.
• a first fixing portion 510 is arranged on the outer surface of the main body portion 423 of the second band portion 420.
• a second fixing portion 520 is arranged on the outer surface of the main body portion 433 of the third band portion 430.
• a third fixing portion 530 is arranged on the inner surface of the main body portion 423 of the second band portion 420.
• a fourth fixing portion 540 is arranged on the inner surface of the main body portion 413 of the first band portion 410.
• the first fixing part 510 and the second fixing part 520 are formed on the male side of the hook and loop fastener.
• the third fixing part 530 and the fourth fixing part 540 are formed on the female side of the hook and loop fastener.
• the hook-and-loop fastener in this specification is a fastener that can be detached from the surface, and is, for example, Magic Tape (registered trademark) or Velcro (registered trademark).
• the second band portion 420 and the third band portion 430 have a third fixing portion 530 located on the inner surface of the main body portion 423 of the second band portion 420 and a third fixing portion 530 located on the outer surface of the main body portion 433 of the third band portion 430. It is configured to be detachable via the second fixing portion 520.
• the first band portion 410 and the second band portion 420 also have a fourth fixing portion 540 located on the inner surface of the main body portion 413 of the first band portion 410 and an outer surface of the main body portion 423 of the second band portion 420. It is configured to be detachable via the first fixing portion 510 located at .
• each of the fixing parts 510, 520, 530, and 540 fixes the cover member 100 to the right hand H1 by connecting the band parts 410, 420, and 430 with each other while the hemostasis device 10 is placed on the right hand H1.
• the specific structure is not limited as long as it is possible. For example, it is possible to omit the installation of some of the fixing parts or to change the position of the fixing parts in each of the band parts 410, 420, 430, etc. as desired.
• each of the fixing parts 510, 520, 530, and 540 is configured with a hook-and-loop fastener, the male side and female side of the hook-and-loop fastener may be swapped.
• Each of the fixing parts 510, 520, 530, and 540 includes, for example, a frame part in which a snap, button, clip, or protrusion is formed, and an engaged part in which a hole part that can be engaged with the frame part is formed. It may also be configured with a connecting mechanism or the like.
• FIGS. 8-10 A support member 300 is shown in FIGS. 8-10.
• Arrows X1-X2 in the figure indicate the vertical direction of the support member 300 (same direction as the longitudinal width wa direction of the expansion member 150), and arrows Y1-Y2 indicate the width direction of the support member 300 (same direction as the width wb direction of the expansion member 150).
• arrows Z1-Z2 indicate the thickness direction of the support member 300.
• the support member 300 can be placed within the insertion section g of the holding section 130.
• the support member 300 has an upper end portion 301 located on the first band portion 410 side and forming an end of the support member 300, and an upper end portion 301 on the opposite side to the upper end portion 301. It has a lower end part 302 forming an end part, and a pair of side parts 303 and 304 connecting the upper end part 301 and the lower end part 302.
• the upper end portion 301 can be placed on the fingertip side (distal end side) of the finger when the hemostatic device 10 is attached to the patient's right hand H1.
• the lower end portion 302 can be placed on the forearm Ar side (base end side) in a state where the hemostatic device 10 is attached to the patient's right hand H1. Note that the upper end portion 301 forms a distal end portion of the support member 300, and the lower end portion 302 forms a base end portion of the support member 300.
• the upper end portion 301 of the support member 300 has a linear flat portion 301a in a plan view shown in FIG.
• the flat portion 301a extends substantially linearly between the corner portions 306c and 306d located on the upper end portion 301 side.
• the lower end portion 302 of the support member 300 has a linear flat portion 302a in a plan view shown in FIG.
• the flat portion 302a extends substantially linearly between corner portions 306a and 306b located on the lower end portion 302 side.
• the support member 300 has an intermediate portion 305 located between an upper end portion 301 and a lower end portion 302 in a plan view shown in FIG.
• the intermediate portion 305 is located in the middle in the vertical direction connecting the upper end portion 301 and the lower end portion 302.
• the outer surface 300b of the support member 300 is curved toward the second band portion 420 and the third band portion 430, as shown in FIGS. 7 and 9.
• the radius of curvature of the outer surface 300b of the support member 300 can be formed to be substantially constant at each portion of the support member 300 in the longitudinal direction, for example.
• the support member 300 has a position that is the center of gravity G1 of the outer shape of the support member 300 in a plan view shown in FIG.
• the width w1 of the upper end portion 301 is larger than the width w2 of the lower end portion 302 so that the center of gravity G1 is located closer to the upper end portion 301 than the intermediate portion 305.
• the support member 300 has a substantially trapezoidal shape in which the width w1 of the upper end 301 is larger than the width w2 of the lower end 302. Therefore, the center of gravity G1 of the support member 300 is located at a position shifted by a predetermined distance from the middle portion 305 of the support member 300 toward the upper end portion 301 side (the lower base side of the trapezoidal shape).
• the width w1 of the upper end portion 301 of the support member 300 is defined as the width w1 of the widest portion of the region located closer to the upper end portion 301 than the intermediate portion 305 of the support member 300 ( maximum width).
• the width w2 of the lower end portion 302 of the support member 300 can be defined by the length of a straight line connecting the boundary between the side surface portion 303 and the corner portion 306a and the boundary between the side surface portion 304 and the corner portion 306b. .
• the boundary between the side surface portion 303 and the corner portion 306a is the position where the tangent to the side surface portion 303 starts changing into a curved shape.
• the boundary between the side surface portion 304 and the corner portion 306b is the position where the tangent to the side surface portion 304 starts changing into a curved shape.
• the inner surface 300a of the support member 300 is curved toward the second band portion 420 and the third band portion 430 side. In other words, the inner surface 300a of the support member 300 is curved in a convex manner in a direction away from the expansion member 150, as shown in FIGS. 7 and 10.
• the radius of curvature of the inner surface 300a of the upper end 301 of the support member 300 can be smaller than the radius of curvature of the inner surface 300a of the lower end 302 of the support member 300, for example.
• the support member 300 is configured such that the thickness t1 of the side surfaces 303 and 304 connecting the upper end 301 and the lower end 302 becomes thinner from the upper end 301 to the lower end 302. There is. Therefore, in the cross-sectional view shown in FIG. 6 and the cross-sectional view shown in FIG. There is.
• Each of the corner portions 306a, 306b, 306c, and 306d located at the four corners of the support member 300 is formed in a rounded and curved shape.
• the hemostasis device 10 includes a portion of the expansion member 150 where the marker portion 160 is provided, a portion of the cover member 100 that overlaps with the marker portion 160 (an upper surface region 131 and a lower surface region 132 of the holding portion 130), and a marker portion of the support member 300. It is preferable that the overlapping portion of 160 and 160 be transparent.
• transparent in this specification includes colored transparent, colorless transparent, and translucent.
• examples of the material of the support member 300 include acrylic resin, polyvinyl chloride (especially hard polyvinyl chloride), polyolefin such as polyethylene, polypropylene, and 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.
• acrylic resin polyvinyl chloride (especially hard polyvinyl chloride), polyolefin such as polyethylene, polypropylene, and polybutadiene, polystyrene, Poly-(4-methylpentene-1), polycarbonate, ABS resin, polymethyl methacrylate (PMMA), polyacetal, polyacrylate, polyacrylonitrile, polyvinylidene fluoride,
• the injection member 200 includes a connector portion 210 and a tube member 220 connected to the connector portion 210 and the expansion member 150, as shown in FIGS. 1, 2, and 11.
• the connector section 210 has a port section 211 disposed outside the fixing member 230 and a valve section 213 disposed inside the main body section 231 of the fixing member 230.
• the valve portion 213 is shown simply in each figure, and is omitted from some drawings.
• a fluid supply device for supplying fluid to the lumen 150a of the expansion member 150 can be connected to the connector portion 210.
• a syringe (not shown in the drawings in this specification) can be used as the fluid supply tool.
• the valve portion 213 can be configured with a check valve, for example.
• the valve portion 213 maintains a closed state when the front barrel portion of the syringe is not inserted into the connector portion 210.
• the valve portion 213 blocks communication between the inner cavity of the tube member 220 and the outside of the connector portion 210 when the valve portion 213 is in the closed state.
• the valve portion 213 opens when the front barrel portion of the syringe is inserted into the connector portion 210.
• the valve portion 213 is opened, the inner cavity of the tube member 220 and the inside of the front cylinder portion of the syringe communicate with each other via the internal space 231a (see FIG. 12) of the main body portion 231 where the valve portion 213 is located.
• one end of the tube member 220 is connected to the expansion member 150.
• the other end of the tube member 220 is connected to a main body 231 of the fixing member 230.
• the other end of the tube member 220 is located in the internal space 231a of the main body 231 of the fixing member 230.
• the inner cavity of the tube member 220 communicates with the internal space 231a of the main body portion 231 via the other end of the tube member 220. Therefore, the lumen 150a of the expansion member 150 communicates with the internal space 231a of the main body portion 231 of the fixing member 230 via the lumen of the tube member 220.
• the operator When expanding the expansion member 150, the operator inserts the tip of a syringe (not shown) into the connector portion 210 and opens the valve portion 213. The operator injects the air in the syringe into the lumen 150a of the expansion member 150 by pushing the pusher of the syringe with the valve portion 213 open. Expandable member 150 expands when air is injected into lumen 150a.
• the operator When contracting the expansion member 150, the operator inserts the front barrel part of the syringe into the connector part 210, and then pulls the pusher of the syringe. By performing the above operation, the operator can discharge the air in the lumen 150a of the expansion member 150 to the syringe.
• ⁇ Fixed member> 11 to 14 show drawings of the fixing member 230 viewed from various directions.
• 15 and 16 show how the fixing member 230 is fixed to the cover member 100.
• 17 and 18 show a state in which the fixing member 230 is fixed to the cover member 100.
• the fixing member 230 includes a main body part 231 that connects the connector part 210 and the tube member 220, and a claw part 233 that extends parallel to the main body part 231 toward the expansion member 150 side. , 234, and connecting portions 236, 237 configured to allow the cover member 100 to be inserted between the main body portion 231 and the claw portions 233, 234, and connecting the main body portion 231 and the claw portions 233, 234.
• the other end of the tube member 220 is connected to the main body 231.
• the side to which the other end of the tube member 220 is connected is referred to as the "distal side”
• the side of the fixing member 230 on which the port part 211 is arranged is referred to as the "proximal end side”.
• the main body portion 231 has two claw portions 233 and 234, as shown in FIGS. 11 and 12.
• the claw portion 233 will be referred to as the “first claw portion 233” and the claw portion 234 will be referred to as the “second claw portion 234”.
• the first claw part 233 and the second claw part 234 extend parallel to each other.
• a gap g2 into which the cover member 100 can be inserted is formed between the first claw part 233 and the main body part 231 and between the second claw part 234 and the main body part 231.
• the width w3 of the first claw part 233 and the second claw part 234 is such that the width w3 of the first claw part 233 and the second claw part 234 is such that the width w3 of the first claw part 233 and the second claw part 234 is such that the first claw part 233 and the second claw part 234 overlap the main body part 231, width w4.
• the above-mentioned plan view means a plan view seen from the bottom side shown in FIG. 14 or a plan view seen from the top side opposite to the bottom side.
• the main body portion 231 has two claw portions 233 and 234.
• the width w3 of the first claw part 233 and the second claw part 234 is the width w3 of each of the first claw part 233 and the second claw part 234 farthest from the center position of the main body part 231, as shown in FIGS. It is defined as the distance between the outermost circumferential positions of the claws 233 and 234.
• the fixing member 230 can be fixed to the cover member 100 by inserting the cover member 100 between the claws 233, 234 and the gap g2.
• the operator inserts the cover member 100 into the gap g2 by moving the claws 233 and 234 closer to the cover member 100 along a direction substantially parallel to the surface direction of the cover member 100. can be easily inserted.
• the operator can inadvertently apply force in the direction of pressing the cover member 100 against the body surface side of the patient's right hand H1 to the hemostatic instrument 10 when fixing the fixing member 230 to the cover member 100. can be prevented from being added to
• the width w3 of the first claw portion 233 and the second claw portion 234 of the fixing member 230 is smaller than the width w4 of the main body portion 231, the following effects are achieved.
• the cover member may curve following the movement of the patient's right hand H1.
• the cover member 100 is curved concavely toward the main body 231 as shown in FIG. 17, or curved convexly toward the main body 231 as shown in FIG. 18.
• the radius of curvature of the cover member (the radius of curvature when the shape of the cover member in front view is assumed to be a circular arc) becomes too small, when the cover member is inserted into the gap g2, When this occurs, the cover member tends to interfere with the claw portion.
• the width w3 of the first claw part 233 and the second claw part 234 is equal to the width w4 of the main body part 231 at the position where the first claw part 233 and the second claw part 234 overlap the main body part 231 in a plan view. smaller than Therefore, even when the cover member 100 is curved convexly toward the main body 231 as described above, the hemostasis device 10 has the first claw part 233 and the second claw part 233 when inserting the cover member 100 into the gap g2. Interference between the claw portion 234 and the cover member 100 can be suppressed.
• the main body portion 231 has an inclined portion 232 that slopes toward the claw portions 233 and 234.
• the inclined portion 232 is configured such that at least a portion of the inclined portion 232 is located at a position closer to the proximal end than the distal ends 233a, 234a of the claw portions 233, 234.
• the inclined portion 232 extends from a position on the distal end side of each distal end 233a, 234a of each claw section 233, 234 to a position on the proximal end side of each distal end 233a, 234a of each claw section 233, 234. It extends to the position.
• the operator when inserting the cover member 100 into the gap g2, the operator inserts the cover member 100 into the gap g2 from a position closer to the distal end than the tips 233a and 234a of each of the claws 233 and 234. move it towards.
• the inclined portion 232 guides the cover member 100 toward the gap g2 along the inclined portion 232 while adjusting the shape of the cover member 100.
• the inclined portion 232 extends from a position on the distal side of each of the distal ends 233a, 234a of each of the claws 233, 234 to a position on the proximal side of each of the distal ends 233a, 234a of each of the claws 233, 234.
• the cover member 100 can be efficiently guided along the inclined portion 232 to the positions of the respective tips 233a and 234a of the respective claw portions 233 and 234.
• the inclined portion 232 assists in inserting the cover member 100 into the gap g2 by guiding the movement of the cover member 100. Therefore, the operator can smoothly insert the cover member 100 into the gap g2.
• the main body portion 231 can be configured to have a cylindrical outer shape.
• the main body part 231 can be configured to have a circular cross-sectional shape in a direction perpendicular to the direction in which the main body part 231 extends.
• the fixing member 230 may be subjected to various external forces when the cover member 100 is inserted into the gap g2.
• the main body portion 231 of the fixing member 230 has a circular cross-sectional shape. Therefore, when an external force is applied to the main body part 231, the fixing member 230 can deflect the external force along the outer surface of the main body part 231.
• the fixing member 230 is formed with a cross-sectional shape such as a square, when an external force is applied to the main body part 231 as described above, the external force is sufficiently deflected along the outer surface of the main body part 231. I can't. Therefore, when an external force is applied to the main body portion 231, the hemostasis device 10 may be displaced or tilted.
• the cover member 100 may be curved concavely toward the main body 231 as shown in FIG. 17, or as shown in FIG. Even when the cover member 100 has a convexly curved shape toward the main body 231 side, interference between the main body 231 and the cover member 100 can be suitably prevented.
• the main body part 231 has a cross-sectional shape such as a rectangle with corners
• the cover member 100 is curved as shown in FIGS. 17 and 18, the cover member 100 is inserted into the gap g2. At this time, the cover member 100 interferes with the corner of the main body portion 231, making it impossible to smoothly insert the cover member 100 into the gap g2.
• the main body portion 231 can exhibit the effect of deflecting the external force described above. Therefore, from the viewpoint of exhibiting the effect of deflecting the external force, it is preferable that the main body portion 231 be formed with a circular or elliptical cross-sectional shape.
• each claw portion 233, 234 has a cylindrical outer shape.
• Each of the claw parts 223 and 234 has a part of the cover member 100 in a flat shape with the cover member 100 inserted between the main body part 231 and each of the claw parts 233 and 234 on the upper surface of the main body part 231 side.
• the flat portions 233b, 234b are configured to maintain the same.
• the flat portions 233b and 234b extend linearly in a side view shown in FIG. 13.
• Each of the flat portions 233b and 234b extends substantially parallel to the extending direction of the main body portion 231, and faces the main body portion 231 with a gap g2 formed between the flat portions 233b and 234b.
• the connecting portions 236 and 237 are curved from the main body portion 231 toward the tips 233a and 234a of the respective claw portions 233 and 234.
• the connecting portion 236 has approximately the same shape as the connecting portion 237, and like the connecting portion 237, the first claw The portion 233 is curved toward the tip 233a side.
• the operator can attach the hemostasis device 10 to the patient with the fixing member 230 fixed to the cover member 100.
• the hemostasis device 10 since each of the connecting portions 236 and 237 has a curved shape as described above, when the hemostatic device 10 is attached to a patient with the fixing member 230 connected to the cover member 100, each of the connecting portions 236 and 237 Even if 237 comes into contact with the body surface of the patient's right hand H1, pain etc. can be prevented from being caused to the patient.
• the hemostasis device 10 since the hemostasis device 10 has each of the connecting portions 236 and 237 curved as described above, the patient places his or her right hand H1 on a table stand or the like while fixing the fixing member 230 to the cover member 100. It is possible to prevent the connecting portions 236 and 237 from digging into the skin when such operations are performed.
• the tips 233a, 234a of the claws 233, 234 can be formed into rounded shapes, as shown in FIG. Since the fixing member 230 has rounded tips 233a and 234a of the claws 233 and 234, there is no possibility that the claws 233 and 234 may unintentionally come into contact with the expansion member 150. This can prevent the expansion member 150 from being damaged if the expansion member 150 is damaged. In addition, since the fixing member 230 has rounded tips 233a and 234a of the claw parts 233 and 234, when the fixing member 230 is attached to the cover member 100, the tips 233a and 234a of the claw parts 233 and 234 Even if the patient accidentally hits the patient's body surface, the pain felt by the patient can be reduced.
• the fixing member 230 has two cylindrical claws 233 and 234. As will be explained in the later-described modification (see FIGS. 28 and 29), there are no particular restrictions on the number or shape of the claws 233, 234 arranged on the fixing member 230. However, when the claw part is formed in a cylindrical shape, as shown in this embodiment, it is preferable that the claw part is composed of two or more claw parts 233 and 234 with a predetermined distance between them. This is due to the following reasons. For example, if the fixing member 230 is configured to have one cylindrical claw, the contact area between the cover member 100 and the claw becomes excessively small when the cover member 100 is inserted into the gap g2.
• each claw portion 233 and 234 can be connected to the main body.
• the cover member 100 can be stably supported between the portions 231.
• the claw portion is preferably configured so that the cover member 100 inserted between the main body portion 231 and the claw portion can maintain a flat shape.
• the cover member 100 inserted between the main body part 231 and the claw part can maintain a flat shape, the operability when inserting and removing the claw part from the cover member 100 is improved.
• the claw parts are arranged with a predetermined distance between them, for example, like the two claw parts 233 and 234 shown in this embodiment. It is preferable.
• the fixing member 230 supports the cover member 100 over a wider range in the direction in which the two claw parts 233 and 234 are arranged side by side by providing a predetermined distance between the two claw parts 233 and 234. be able to. Thereby, the fixing member 230 can maintain the cover member 100 in a flat shape between the main body part 231 and each of the claw parts 233 and 234.
• the position where the fixing member 230 is fixed to the cover member 100 is not particularly limited.
• the fixing member 230 is located at a position where a gap is formed between the cover member 100 and the body surface of the right hand H1 in which the claws 233 and 234 of the fixing member 230 can be placed when the expansion member 150 is expanded. can be fixed to.
• Such positions include a portion of the main body portion 110 located between the first band portion 410 and the second band portion 420 (see FIG. 22), and a portion of the cover member 100 located on the second band portion 420 side. The portion near the proximal end 122 (see FIG. 25) can be selected.
• the position where the fixing member 230 is connected to the cover member 100 is not particularly limited as long as it is a position where the tube member 220 is not forcibly pulled when the expansion member 150 is expanded.
• the fixing member 230 may be fixed to the first band portion 410 as shown in FIG. 27, or the fixing member 230 may be fixed to the second band portion 420 as shown in FIG.
• FIG. 20 shows a state in which various procedures have been performed using the sheath tube 610 of the introducer 600 inserted into the first puncture site p1.
• the operator When attaching the hemostasis device 10 to the patient's right hand H1, the operator places the expansion member 150 and the support member 300 so as to overlap at the first puncture site p1, as shown in FIG. 20. At this time, the operator visually confirms the position of the marker section 160 arranged on the expansion member 150 and places the marker section 160 at the first puncture site p1, thereby moving the expansion member 150 and the support member 300 to the first puncture site p1. 1 puncture site p1.
• the operator can place the support member 300 so as to overlap the metacarpal bone B1 of the index finger and the metacarpal bone B2 of the thumb.
• the distance between the metacarpal bone B1 of the index finger and the metacarpal bone B2 of the thumb gradually narrows from the fingertip side toward the forearm Ar side (see FIG. 19).
• the width of the support member 300 decreases from an upper end 301 located on the fingertip side to a lower end 302 located on the forearm Ar side (see FIG. 8). Therefore, the operator places the supporting member 300 so as to overlap the metacarpal bone B1 of the index finger and the metacarpal bone B2 of the thumb from the back side of the patient's right hand H1.
• the support member 300 can be placed along the hand bone B2. By placing the support member 300 along the metacarpal bone B1 of the index finger and the metacarpal bone B2 of the thumb, the operator can connect the expansion member 150 placed on the inner surface 300a side of the support member 300 with the right hand H1. It is possible to prevent a gap from being formed in between.
• the operator wraps the second band section 420 and the third band section 430 along the outer periphery of the patient's right hand H1.
• the operator attaches the third fixation site 530 (see FIG. 2) placed on the inner surface of the second band portion 420 to the second fixation site 520 (see FIG. 1) placed on the outer surface of the third band portion 430. ), the second band portion 420 and the third band portion 430 can be connected via the fixing portions 520 and 530.
• the operator connects each band body part 420, 430 to the right hand H1 by connecting each band body part 420, 430 with the supporting member 300 superimposed on the metacarpal bone B1 of the index finger and the metacarpal bone B2 of the thumb. It can be wrapped tightly around the outer circumference of the
• the outer surface 300b of the support member 300 is curved toward the second band portion 420 side (side surface portion 303 side) and the third band portion 430 side (side surface portion 304 side) (FIGS. 5, 7, and 7). 9). Therefore, the operator wraps the second band part 420 and the third band part 430 along the patient's right hand H1 as shown in FIG. In this way, the support member 300 can be pressed against the right hand H1 from the outer surface 300b side. Therefore, the hemostasis device 10 can increase the fixing force of the support member 300 and the expansion member 150 to the patient's right hand H1.
• the operator passes a part of the first band part 410 onto the patient while passing the first band part 410 through the inter-finger area fb located between the thumb and index finger of the patient's right hand H1. Place it on the palm side of the right hand H1.
• the operator connects the first fixing part 510 (see FIG. 1) arranged on the outer surface of the second band part 420 to the fourth fixing part 540 (see FIG. 1) arranged on the inner surface of the first band part 410. 2), the first band portion 410 and the second band portion 420 can be connected via the respective fixing portions 510 and 540.
• each part of the patient's right hand H1 for example, around the snuff box Sb (see FIG. 19).
• the shape of the inclined portion of the right hand H1 depends on individual differences among patients. For example, if the inner surface of the support member is formed in a flat shape, it is difficult to arrange the support member along the inclined portion of the right hand H1.
• the inner surface 300a of the support member 300 is curved in a convex shape in a direction away from the expansion member 150 (see FIGS. 7 and 24).
• the hemostatic device 10 can place the support member 300 overlapping the first puncture site p1, regardless of the patient's dominant hand or the operator's placement. Therefore, the hemostasis device 10 can appropriately arrange the support member 300 at a desired position near the first puncture site p1.
• the operator connects the syringe to the port portion 211 with the hemostatic device 10 attached to the patient's right hand H1 in the above procedure.
• the operator operates a syringe to inject air into the expansion member 150, thereby expanding the expansion member 150.
• the expansion member 150 applies compressive force to the first puncture site p1.
• the support member 300 made of a material harder than the expansion member 150 presses the expansion member 150 against the patient's right hand H1 when the expansion member 150 is expanded with the hemostatic device 10 attached to the patient's right hand H1. . Thereby, the hemostatic device 10 can prevent the expansion member 150 from lifting off from the patient's right hand H1.
• the operator can, for example, strongly tighten the first band portion disposed at the inter-finger region fb in order to increase the fixing force of the support member to the patient's right hand H1. .
• the operator can securely fix the support member to the patient's right hand H1 even if the support member is unstablely placed on the patient's right hand H1. can.
• the hemostasis device is arranged so that the inner surface of the support member is inclined with respect to the body surface of the patient's right hand H1.
• the hemostatic device is arranged with the support member tilted such that the distance between the inner surface of the support member and the body surface of the patient's right hand H1 gradually narrows from the upper end of the support member toward the lower end.
• the hemostasis device 10 is configured such that the thickness t1 of the side portions 303 and 304 of the support member 300 becomes thinner from the upper end 301 to the lower end 302.
• the first band portion 410 configured to be placed in the inter-finger portion fb located between the patient's fingers extends from the upper end 301 side of the support member 300, and extends from the upper end 301 side of the support member 300.
• the portion 301 side is configured to be pressed against the patient's right hand H1.
• the expansion member 150 starts expanding with the support member 300 and the expansion member 150 fixed to the patient's right hand H1
• the expansion member 150 moves to the upper end 301 of the support member 300. Apply force to nearby areas.
• the upper end 301 side of the support member 300 is lifted by the force applied by the expansion member 150.
• the inner surface 300a of the support member 300 is arranged substantially parallel to the body surface of the patient's right hand H1, as shown in FIG. Therefore, when the expansion member 150 expands, the hemostasis device 10 can apply a compressive force in the vertical direction to the first puncture site p1.
• the inner surface 300a of the support member 300 is curved toward the second band portion 420 side and the third band portion 430 side (see FIG. 7). As shown in FIG. 24, the hemostasis device 10 is arranged such that the inner surface 300a of the support member 300 is along the body surface of the patient's right hand H1 when the expansion member 150 is expanded. When the expansion member 150 expands, the hemostasis device 10 presses the expansion member 150 along the body surface of the patient's right hand H1 by the inner surface 300a of the support member 300.
• each side surface portion 303, 304 located at the center side of the inner surface 300a of the support member 300 in the width direction and at both ends of the inner surface 300a of the support member 300 in the width direction A compressive force is applied from the side toward the first puncture site p1. Therefore, the hemostasis device 10 effectively increases the compressive force that the expansion member 150 applies to the first puncture site p1, compared to the case where the inner surface 300a of the support member 300 is formed in a flat surface shape. be able to.
• the operator After expanding the expansion member 150, the operator removes the sheath tube 610 of the introducer 600 from the first puncture site p1, as shown in FIG. 22. The operator confirms that there is no bleeding from the first puncture site p1 while performing hemostasis using the hemostatic device 10. The operator can adjust the amount of air injected into the expansion member 150 when there is bleeding from the first puncture site p1.
• the operator can stop the bleeding at the first puncture site p1 formed in the patient's right hand H1 using the hemostatic instrument 10.
• the operator can fix the fixing member 230 to the cover member 100 as shown in FIG. 22 with the expansion member 150 expanded.
• the operator can prevent the tube member 220 from moving following the movement of the patient's right hand H1 while the hemostasis device 10 is attached.
• the operator can fix the fixing member 230 to the cover member 100 in advance before expanding the expansion member 150, and then expand the expansion member 150 after attaching the hemostasis device 10 to the patient's right hand H1. .
• the hemostasis device 10 includes the cover member 100 configured to cover the first puncture site p1, and the cover member 100 configured to be connected to the cover member 100 and press the first puncture site p1.
• an injection member 200 connected to the expansion member 150 and configured to be able to inject fluid into the expansion member 150; and a fixing member 230 configured to be able to fix the injection member 200 to the cover member 100;
• Equipped with Injection member 200 includes a connector portion 210 and a tube member 220 connected to expansion member 150.
• the fixing member 230 includes a main body part 231 that connects the connector part 210 and the tube member 220, claw parts 233 and 234 that extend parallel to the main body part 231 toward the expansion member 150 side, and a main body part 231 and the claw parts 233 and 234.
• the cover member 100 is configured to be insertable between the connecting portions 236 and 237 that connect the main body portion 231 and the claw portions 233 and 234.
• the width w3 of the claw parts 233, 234 is smaller than the width w4 of the main body part 231 at the position where the claw parts 233, 234 and the main body part 231 overlap in plan view.
• the cover member 100 is inserted between the main body 231 and the claws 233 and 234 with the main body 231 of the fixing member 230 connecting the connector 210 and the tube member 220.
• the injection member 200 can be fixed to the cover member 100.
• the operator moves the fixing member 230 close to the cover member 100 along a direction substantially parallel to the surface direction of the cover member 100.
• the cover member 100 can be inserted between the main body portion 231 and the claw portions 233 and 234.
• the operator can prevent unnecessary force from being applied in the direction of pressing the hemostatic device 10 toward the body surface of the patient's right hand H1. Therefore, when fixing the injection member 200 to the cover member 100, the hemostasis device 10 can prevent the hemostatic device 10 attached to the patient's right hand H1 from shifting, and the expansion member 150 from shifting. Further, for example, the cover member 100 may curve following the movement of the body when the hemostasis device 10 is attached to the patient.
• the width w3 of the claw parts 233, 234 is larger than the width w4 of the main body part 231 at the position where the claw parts 233, 234 and the main body part 231 overlap, and the cover member 100 is curved, the main body part 231 When inserting the cover member 100 between the claw parts 233 and 234, the claw parts 233 and 234 tend to interfere with the cover member 100.
• the width w3 of the claws 233, 234 is smaller than the width w4 of the main body 231 at the position where the claws 233, 234 and the main body 231 overlap in plan view. Therefore, in the hemostasis device 10 described above, even when the cover member 100 curves following the movement of the patient's right hand H1, the cover member 100 can be smoothly inserted between the main body portion 231 and the claw portions 233 and 234. can.
• the hemostasis device 10 also includes a cover member 100 configured to cover the first puncture site p1, and an expansion member connected to the cover member 100 and configured to press the first puncture site p1.
• Injection member 200 includes a connector portion 210 and a tube member 220 connected to expansion member 150.
• the fixing member 230 includes a main body part 231 that connects the connector part 210 and the tube member 220, claw parts 233 and 234 that extend parallel to the main body part 231 toward the expansion member 150 side, and a main body part 231 and the claw parts 233 and 234.
• the cover member 100 is configured to be insertable between the connecting portions 236 and 237 that connect the main body portion 231 and the claw portions 233 and 234.
• the main body part 231 has an inclined part 232 that slopes toward the claw parts 233 and 234, and at least a part of the inclined part 232 is located closer to the base of the main body part 231 than the tips 233a and 234a of the claw parts 233 and 234. It is configured to be located at an end position.
• the cover member 100 is inserted between the main body 231 and the claws 233 and 234 with the main body 231 of the fixing member 230 connecting the connector 210 and the tube member 220.
• the injection member 200 can be fixed to the cover member 100.
• the operator moves the fixing member 230 close to the cover member 100 along a direction substantially parallel to the surface direction of the cover member 100.
• the cover member 100 can be inserted between the main body portion 231 and the claw portions 233 and 234.
• the hemostasis device 10 can prevent the hemostatic device 10 attached to the patient's right hand H1 from shifting, and the expansion member 150 from shifting. Further, the hemostasis device 10 is configured such that the main body portion 231 has an inclined portion 232 that slopes toward the claw portions 233 and 234.
• the inclined portion 232 of the main body portion 231 is configured to be located at a position closer to the proximal end than the tips 233a, 234a of the claw portions 233, 234 in the main body portion 231. Therefore, in the hemostatic instrument 10, when the operator inserts the cover member 100 between the main body part 231 and the claw parts 233, 234, the inclined part 232 pushes the cover member 100 further than the tips 233a, 234a of the claw parts 233, 234. It is configured to be guided to a position on the side of the connecting portions 236 and 237.
• the operator guides the cover member 100 along the inclined portion 232 to adjust the shape of the cover member 100 while adjusting the shape of the cover member 100.
• the cover member 100 can be smoothly inserted between the main body part 231 and the claw parts 233 and 234.
• the main body portion 231 has an inclined portion 232 that slopes toward each of the claw portions 233 and 234.
• the inclined portion 232 extends from a position on the distal end side of each of the distal ends 233a, 234a of each of the claw portions 233, 234 to a position on the proximal end side of each of the distal ends 233a, 234a of each of the claw portions 233, 234.
• the inclined portion 232 when inserting the cover member 100 into the gap g2, the inclined portion 232 efficiently moves the cover member 100 to the positions of the tips 233a and 234a of the claw portions 233 and 234. I will guide you to.
• the inclined portion 232 assists the insertion of the cover member 100 into the gap g2 when the cover member 100 is inserted into the gap g2. Therefore, the operator can smoothly insert the cover member 100 into the gap g2.
• the main body portion 231 can be configured to have a circular or elliptical cross-sectional shape.
• the fixing member 230 can deflect the external force along the outer surface of the main body 231. Therefore, when an external force is applied to the main body portion 231, the hemostasis device 10 can be prevented from being displaced or tilted. Furthermore, even when the cover member 100 has a concavely curved shape toward the main body 231 side, or when the cover member 100 has a convexly curved shape toward the main body 231 side, the cover member 100 It is possible to suitably prevent the main body portion 231 and the cover member 100 from interfering with each other when the cover member 100 is inserted into the gap g2.
• the claw parts 233 and 234 are flat parts configured to maintain a part of the cover member 100 in a flat shape when the cover member 100 is inserted between the main body part 231 and each of the claw parts 233 and 234. It has portions 233b and 234b. Each of the flat parts 233b and 234b faces the main body part 231 with a gap g2 formed between the main part 231 and each of the claw parts 233 and 234 interposed therebetween.
• the hemostasis device 10 when fixing the fixing member 230 to the cover member 100, the operator places the cover member 100 along the flat parts 233b, 234b of each claw part 233, 234. can be easily inserted into and removed from the gap g2. Therefore, the operator can easily fix the fixing member 230 to the cover member 100.
• Each connecting portion 236, 237 has a shape curved from the main body portion 231 toward the tips 233a, 234a of each claw portion 233, 234.
• each connecting portion 236, 237 is connected to the body surface of the patient's right hand H1. Even if the patient comes into contact with the patient, pain etc. can be prevented.
• the hemostasis device 10 since the hemostasis device 10 has each of the connecting portions 236 and 237 curved as described above, the patient places his or her right hand H1 on a table stand or the like while fixing the fixing member 230 to the cover member 100. It is possible to prevent the connecting portions 236 and 237 from digging into the skin when such operations are performed.
• the cover member 100 includes a main body part 110 in which the expansion member 150 is located, a first band part 410 that is configured to be placed between the patient's fingers and extends in a first direction from the main body part 110; A second band portion 420 extends from the main body portion 110 in a second direction different from the first direction, and a first band portion 410 extends from the main body portion 110 and faces the second band portion 420 with the expansion member 150 in between. and a third band portion 430 extending in a direction different from the second band portion 420.
• the claw portions 233 and 234 connect any one of the main body portion 110, the first band portion 410, the second band portion 420, and the third band portion 430 of the cover member 100 with the connecting portions 236 and 237. Configured to be insertable.
• the fixing member 230 can be fixed to any position of the cover member 100 included in the hemostatic device 10 configured to be attachable to the right hand H1. Therefore, the convenience of the hemostasis device 10 is improved.
• FIG. 28 is a side view of a fixing member 230A according to modification 1.
• FIG. 29 is a cross-sectional view taken along arrow 29A-29A shown in FIG. 28.
• the fixing member 230A includes a claw portion 233A.
• the claw portion 233A includes a flat portion 233b configured to maintain a portion of the cover member 100 in a flat shape when the cover member 100 is inserted between the main body portion 231 and the claw portion 233A.
• the flat portion 233b extends parallel to the direction in which the main body portion 231 extends. Further, the flat portion 233b extends linearly in a side view shown in FIG. 28.
• the flat portion 233b faces the main body portion 231 with a gap g2 formed between the main body portion 231 and the claw portion 233A.
• the fixing member 230A includes one claw portion 233A.
• the claw portion 233A is connected to the main body portion 231 via a connecting portion 236A.
• the claw portion 233A has a rectangular shape when viewed from the front.
• the flat portion 233b forms the upper surface of the claw portion 233A located on the main body portion 231 side.
• the flat portion 233b of Modification 1 forms a plane extending linearly in the width direction of the claw portion 233A. Therefore, the claw portion 233A can maintain a portion of the cover member 100 in a flat shape over a relatively wide range while the cover member 100 is inserted between the main body portion 231 and the claw portion 233A.
• the claw portion 233A extends substantially linearly toward the tip 233a.
• the connecting portion 236A can be configured to extend substantially linearly between the main body portion 231 and the claw portion 233A.
• the width w3' of the claw part 233A is smaller than the width w4' of the main body part 231 at the position where the claw part 233A and the main body part 231 overlap when viewed from the front. Note that the above-mentioned relationship in width in a front view is the same as in a plan view of the fixing member 230A.
• the claw portion 233A of the fixing member 230A according to Modification 1 includes a linear flat portion 233b that faces the main body portion 231 with a gap g2 formed between the main body portion 231 and the claw portion 233A.
• the claw portion 233A of the fixing member 230A has a simple structure that extends linearly.
• FIG. 30 is a side view of a fixing member 230B according to modification example 2.
• the fixing member 230B according to the second modification includes a first protrusion 238a formed on the main body portion 231 and a second protrusion 238b formed on the claw portion 233A.
• the first convex portion 238a protrudes from the main body portion 231 toward the gap g2.
• the second convex portion 238b protrudes from the claw portion 233A toward the gap g2.
• the first protrusion 238a can be arranged, for example, at a position closer to the proximal end of the fixing member 230B than the second protrusion 238b. Further, the second convex portion 238b can be arranged at the tip 233a of the claw portion 233A.
• each of the protrusions 238a and 238b contacts the cover member 100 when the cover member 100 is inserted into the gap g2. Therefore, it becomes difficult for the cover member 100 to come out from the gap g2.
• the fixing member 230B there are no particular restrictions on the number, position, cross-sectional shape, etc. of the protrusions arranged on the fixing member 230B. Further, it is also possible to arrange a convex portion on the fixing member 230 that includes the claw portions 233 and 234 having the structure shown in the first embodiment. Further, the convex portion may be placed only on the main body portion 231 or only on the claw portion.
• FIG. 31 is a side view of a fixing member 230C according to modification 3.
• a plurality of protrusions 239 are arranged on the main body portion 231 of the fixing member 230C according to the third modification.
• the plurality of protrusions 239 function to prevent slippage when the operator grasps the main body 231 with his or her fingers. Therefore, the operator can more smoothly fix the fixing member 230C to the cover member 100.
• the main body portion 231 of the fixing member 230C may be made of a material that does not easily slip.
• the fixing member 230C can exhibit the same effect as described above also when configured in this way.
• the fixing member 230 can also be applied to, for example, a hemostasis device 10A configured to be attached to a patient's arm.
• the hemostasis device 10A includes a band-shaped cover member 810 configured to be able to be fixed while being wrapped around a patient's arm, and an expansion member 820 disposed on the cover member 810.
• the tube member 220 is connected to the expansion member 820 .
• the tube member 220 is connected to a main body portion 231 of the fixing member 230.
• the hemostatic devices of Modifications 1 to 4 described above are provided with an inclined portion 232 on the main body of the fixing member (FIG. 28, FIG. 30, FIG. , see Figure 32).
• the inclined portion 232 provided in each modification is inclined toward the claw portion side. Further, at least a portion of the inclined portion 232 is configured to be located at a position closer to the proximal end than the tip of the claw portion in the main body portion.
• FIGS. 34, 35, and 36 show a fixing member 700 according to the second embodiment.
• the fixing member 700 according to the second embodiment is configured to be detachable from the tube member 220.
• the hemostasis device includes a cover member 100 configured to cover the first puncture site p1, and a cover member 100 that is connected to the cover member 100 and configured to press the first puncture site p1.
• an injection member 900 connected to the expansion member 150 and configured to be able to inject fluid into the expansion member 150; and a fixing member 700 configured to be able to fix the injection member 900 to the cover member 100. And prepare.
• the injection member 900 includes a connector portion 901 and a tube member 903 that connects the connector portion 901 and the expansion member 150.
• a buffer member 902 having an expandable space is arranged between the tube member 903 and the connector portion 901.
• the buffer member 902 is a flexible bag-shaped member with a space formed inside. Note that the buffer member 902 may be provided with an arrow-shaped marker indicating the insertion direction of the syringe into the connector portion 901.
• the expansion member 150 expands.
• buffer member 902 which communicates with lumen 150a of expansion member 150 via tube member 903, expands.
• the fixing member 700 includes a main body part 710 in which a groove part 711 capable of fixing the tube member 903 is formed, a first claw part 720 extending from the main body part 710, and a first claw part 720. and a second claw part 730 that extends parallel to the first claw part 720 and forms a gap g3 between which the cover member 100 can be inserted.
• the fixing member 700 can connect the tube member 903 to the main body portion 710 by pushing the tube member 903 into the groove portion 711 along the direction shown by arrow D in FIG.
• the fixing member 700 can be fixed to the cover member 100 by inserting the cover member 100 into the gap g3 between the first claw part 720 and the second claw part 730.
• the first claw portion 720 has a root portion 721 connected to the main body portion 710 and a tapered portion 724 extending toward the distal end side of the root portion 721.
• the tapered portion 724 is configured such that the thickness thereof gradually decreases toward the distal end side of the first claw portion 720.
• the second claw portion 730 has a root portion 731 connected to the main body portion 710 and a tapered portion 734 extending toward the distal end side of the root portion 731.
• the tapered portion 734 is configured such that the thickness thereof gradually decreases toward the distal end side of the second claw portion 730.
• the tip of the tapered portion 734 of the second claw portion 730 is located further away from the main body portion 710 than the tip of the tapered portion 724 of the first claw portion 720 . That is, the second claw part 730 has a longer length in the extending direction than the first claw part 720.
• the fixing member 700 When inserting the cover member 100 into the gap g3, the fixing member 700 is guided to be inserted into the gap g3 along the tapered part 734 of the second claw part 730. Therefore, the operator can smoothly insert the cover member 100 into the gap g3.
• the fixing member 700 is connected to a hemostatic device via the tube member 903 by fitting the tube member 903 into the groove 711. Therefore, when the tube member 903 is not fitted into the groove 711, the fixing member 230 is separated from the hemostatic device.
• the fixing member 700 can be packed together with the hemostasis device in a state where it is separated from the hemostasis device before the hemostasis device is used (transported or stored).
• the operator can connect the tube member 903 to the fixing member 700 when starting hemostasis using the hemostatic device.
• the operator can fix the fixing member 700 connected to the tube member 903 at any position on the cover member 100, as shown in FIG.
• the operator can prevent the tube member 903 from moving following the movement of the patient's right hand H1 while the hemostatic device is attached to the patient's right hand H1. . Furthermore, when connecting the fixing member 700 to the cover member 100, the fixing member 700 is fixed to the cover member 100 by moving the fixing member 700 close to the cover member 100 along a direction substantially parallel to the surface direction of the cover member 100. can do. Therefore, when fixing the fixing member 700 to the cover member 100, it is possible to prevent a force from being applied to the hemostasis device 10 in the direction of pressing the expansion member 150 against the body surface of the patient's right hand H1.
• hemostatic device according to the present invention has been described above through a plurality of embodiments and modified examples, the present invention is not limited to only the contents explained in the specification, and can be modified as appropriate based on the description of the claims. It is possible to do so.
• each part of the hemostasis device are not particularly limited and can be changed as appropriate as long as the expansion member placed at the puncture site can compress the puncture site to stop bleeding.
• the specific shapes (planar shape and cross-sectional shape) of the expansion member and the support member are not limited to the shapes illustrated in the embodiments.
• the fixing member may be partially or entirely made of a flexible material in order to reduce the load on the body of the patient wearing the hemostasis device or to provide good skin contact when wearing the device.
• the fixing member may be configured to include a clip structure that allows the distance between the claw portion and the main body portion to be varied by utilizing the elastic force of the elastic member or the like.

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• Molecular Biology (AREA)
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• 2023
  • 2023-03-09 EP EP23770622.1A patent/EP4487793A4/en active Pending
  • 2023-03-09 WO PCT/JP2023/008987 patent/WO2023176666A1/ja not_active Ceased
  • 2023-03-09 CN CN202380027488.4A patent/CN118922137A/zh active Pending
  • 2023-03-09 JP JP2024507823A patent/JPWO2023176666A1/ja active Pending
• 2024
  • 2024-09-13 US US18/884,340 patent/US20250000518A1/en active Pending

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