WO2019208714A1 - Instrument hémostatique - Google Patents

Instrument hémostatique Download PDF

Info

Publication number
WO2019208714A1
WO2019208714A1 PCT/JP2019/017708 JP2019017708W WO2019208714A1 WO 2019208714 A1 WO2019208714 A1 WO 2019208714A1 JP 2019017708 W JP2019017708 W JP 2019017708W WO 2019208714 A1 WO2019208714 A1 WO 2019208714A1
Authority
WO
WIPO (PCT)
Prior art keywords
expansion member
recess
hemostatic device
hand
expansion
Prior art date
Application number
PCT/JP2019/017708
Other languages
English (en)
Japanese (ja)
Inventor
相馬　克明
和田　哲
正子 宮下
Original Assignee
テルモ株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by テルモ株式会社 filed Critical テルモ株式会社
Priority to JP2020515576A priority Critical patent/JP7295848B2/ja
Publication of WO2019208714A1 publication Critical patent/WO2019208714A1/fr

Links

Images

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/132—Tourniquets
    • A61B17/135—Tourniquets inflatable

Definitions

  • the present invention relates to a hemostatic device.
  • the patient's arm blood vessel for example, radial artery
  • various medical elongated bodies are introduced into the blood vessel through the puncture site formed in the patient's arm blood vessel.
  • a technique for performing treatment or treatment on a site is known (see Patent Document 1 below).
  • a catheter procedure using the radial artery is called a transradial approach.
  • the radial artery running on the human arm is connected to the palmar artery that bypasses the hand. Therefore, as a new technique of the transradial artery approach, there is a catheter technique by dTRA (distral transradial approach) that punctures the palmar artery (including the distal radial artery) located in the hand and performs treatment through the puncture site. has been tried.
  • dTRA neutral transradial approach
  • Blood vessels such as palm arteries located in the hand are located in places where there are many movable parts such as fingers. Therefore, when a surgeon stops blood from a puncture site of a blood vessel located in a hand after a catheter procedure, it may be difficult to follow the movement of the hand with an existing arm or leg hemostasis device. Therefore, there is a need for a hemostatic device that can effectively perform hemostasis on a puncture site of a blood vessel located in a hand.
  • the hemostatic device that stops the puncture site of the blood vessel of the hand has a pressing member (such as an expansion member) that applies a compressive force to the puncture site as compared to the hemostasis device for the puncture site of the blood vessel of the arm or leg. It is necessary to arrange so as not to be displaced from the puncture site.
  • a gap is likely to be generated between the pressing member and the puncture site. Therefore, it is also important for a hemostatic device for hemostasing a puncture site of a hand to appropriately maintain pressure on the puncture site even when hand movement or the like occurs.
  • the present invention can maintain the pressing force of the pressing member to the site to be hemostasized even when hand movement or the like occurs during hemostasis.
  • An object is to provide a hemostatic device.
  • the hemostasis device has a pressing member that can be arranged at a site where hemostasis of a patient's hand is to be stopped, and the pressing member includes a first recess that is recessed toward a central axis in a longitudinal direction of the pressing member, A second recess that is disposed at a position facing the first recess and is recessed toward the central axis in the longitudinal direction of the pressing member, and the first recess and the second recess are: It is located in the central region in the longitudinal direction of the pressing member.
  • the hemostasis device is caused by the movement of the patient's hand when the patient's hand moves in a state where the pressing member is arranged to apply a compression force to the site where the patient's hand should be hemostatic.
  • the concentrated force concentrates on the first recess and the second recess.
  • the pressing member is deformed so as to follow the movement of the patient's hand with the first recess and the second recess as the base points, and the displacement of the pressing member with respect to the site where the hand should be hemostatic can be suppressed. Therefore, the hemostatic device can maintain the pressing force to the site where the pressing member should be hemostatic even if hand movement or the like occurs during the hemostasis.
  • FIG. 3 is a cross-sectional view of the expansion member along line 3A-3A shown in FIG. It is a figure for demonstrating the usage example of the hemostatic device which concerns on 1st Embodiment, Comprising: It is a perspective view which shows the state by which the medical elongate body was inserted in the blood vessel of a patient's hand.
  • FIG. 8 is a cross-sectional view for explaining the operation of the hemostatic device according to the first embodiment, and is a partial cross-sectional view taken along the line 8A-8A shown in FIG.
  • FIG. 8 is a cross-sectional view for explaining the operation of the hemostatic device according to the first embodiment, and is a partial cross-sectional view taken along the line 8A-8A shown in FIG.
  • It is a perspective view which shows the hemostatic device which concerns on the modification of 1st Embodiment. It is a top view of the hemostatic device concerning a 2nd embodiment.
  • FIG. 12 is a cross-sectional view of the expansion member taken along line 11A-11A shown in FIG.
  • FIG. 14 is a cross-sectional view for explaining the action of the hemostatic device according to the second embodiment, and is a partial cross-sectional view taken along the line 14A-14A shown in FIG.
  • FIG. 14 is a cross-sectional view for explaining the action of the hemostatic device according to the second embodiment, and is a partial cross-sectional view taken along the line 14A-14A shown in FIG. It is a top view of the hemostatic device concerning a 3rd embodiment.
  • FIG. 17 is a cross-sectional view taken along line 17A-17A shown in FIG.
  • FIG. 1 to 3 are diagrams for explaining the hemostatic device 100
  • FIGS. 4 to 9 are diagrams for explaining an example of use of the hemostatic device 100.
  • FIG. 1 to 3 are diagrams for explaining the hemostatic device 100
  • FIGS. 4 to 9 are diagrams for explaining an example of use of the hemostatic device 100.
  • the hemostatic device 100 includes a radial artery side of the palmar artery (deep palm artery) that runs on the instep Hb side of the hand H located on the finger side of the patient's forearm A (
  • a medical long body (equivalent to a “site to be hemostatic”) placed in a puncture site t1 (corresponding to “site to be hemostatic”) formed in an artery around the snuff box or a distal radial artery that runs on the fingertip side from the snuff box.
  • the puncture site t1 can be used for hemostasis.
  • FIG. 1 to 3 show a hemostatic device 100 having a pressing member 110.
  • the pressing member 110 is preferably an expansion member 110 that can freely adjust the degree of compression to the puncture site t1 by injecting fluid.
  • 1 to 3 show the hemostatic device 100 in a state where the expansion member 110 made of the pressing member 110 is expanded and deformed.
  • the hemostatic device 100 includes an expansion member 110 that can be disposed at the puncture site t1 of the patient's hand H, an injection portion 130 that communicates with the lumen 119 of the expansion member 110 and can inject fluid into the expansion member 110, Have
  • the expansion member 110 has a central axis in the longitudinal direction of the expansion member 110 (the left-right direction in FIG. 2) in a state before the expansion member 110 is expanded and a state after the expansion member 110 is expanded.
  • positioned in the position facing 1st recessed part 115a, and recessed toward the central axis c1 of the longitudinal direction of the expansion member 110 are included. .
  • the expansion member 110 includes a first region 111, a second region 112, and a central region 113 disposed between the first region 111 and the second region 112 in the longitudinal direction of the expansion member 110. ,have.
  • the first region 111 is formed in a certain range on the one end 111a side of the expansion member 110.
  • the first region 111 has a curved shape so as to protrude in the width direction of the expansion member 110 (the vertical direction in the figure and the direction perpendicular to the central axis c1). .
  • the second region 112 is formed in a certain range on the other end 112a side of the expansion member 110. Similar to the first region 111, the second region 112 has a curved shape so as to protrude in the width direction of the expansion member 110 in the plan view shown in FIG. 2.
  • a first recess 115a and a second recess 115b are arranged in the central region 113.
  • the central region 113 forms a constricted portion in which the dimension in the width direction of the expansion member 110 gradually decreases from the first region 111 side and the second region 112 side by arranging the first recess 115a and the second recess 115b. ing.
  • the central region 113 means a region where the first concave portion 115 a and the second concave portion 115 b are formed, and the first region 111 and the second region 112 mean arbitrary regions other than the central region 113. To do. That is, the positional relationship between the regions 111, 112, and 113 on the expansion member 110 is not strictly limited to the illustrated positional relationship.
  • the injection part 130 has a front tube part 131 inserted into the lumen 119 of the expansion member 110 and a connection part 133 led out of the expansion member 110. Yes.
  • a check valve (not shown) is arranged in the front tube part 131 of the injection part 130.
  • the surgeon or the like inserts the distal end portion (not shown) of the syringe from the connection portion 133 and opens the check valve disposed in the front tube portion 131.
  • An operator injects the air in the syringe into the lumen 119 of the expansion member 110 by pressing the pusher of the syringe with the check valve opened.
  • the expansion member 110 expands and deforms when air is injected into the lumen 119 of the expansion member 110.
  • the operator or the like When contracting the expansion member 110, the operator or the like inserts the distal end portion of the syringe into the connection portion 133 and pulls the pusher of the syringe to discharge air from the lumen 119 of the expansion member 110.
  • the surgeon can adjust the compression force by the expansion member 110 according to the patient's condition by contracting the expansion member 110 and adjusting the compression force during the hemostasis using the hemostatic device 100. Occlusion of blood vessels (for example, the distal radial artery of the hand) can be suppressed.
  • the fluid used to expand the expansion member 110 is not limited to air.
  • the expansion member 110 is, for example, a sheet-like member that forms the bottom surface 110a of the expansion member 110 (the surface on the side facing the patient's hand H) and the top surface 110b of the expansion member 110 (the surface facing the patient's hand H). And a sheet-like member forming a surface opposite to the side surface) (see FIG. 3).
  • one surface 110a of the expansion member 110 is the bottom surface and the other surface 110b of the expansion member 110 is the top surface, but these names are expansions when the hemostatic device 100 is used.
  • the direction of the member 110 is not limited.
  • the upper surface 110b may be disposed so as to face the patient's hand H.
  • Each sheet-like member forming the expansion member 110 is joined by being fused at a position where the outer edge portion 118 of the expansion member 110 is formed. That is, at the outer edge portion 118 of the expansion member 110, the respective sheet-like members forming the expansion member 110 are overlapped and joined. Therefore, the outer edge part 118 of the expansion member 110 is harder than the part which is not joined in each sheet-like member. Thereby, in each part of the first region 111, the second region 112, and the central region 113, the portion where the outer edge portion 118 is formed is harder than the portion where the outer edge portion 118 is not formed, and expansion deformation and contraction deformation. It is hard to do.
  • the outer edge portion 118 of the expansion member 110 is formed to be harder than the unbonded portion of each sheet-like member by overlapping the respective sheet-like members forming the expansion member 110 and bonding them with an adhesive or the like. May be.
  • the injection part 130 is liquid-tight with respect to the expansion member 110 in a state of being sandwiched between the sheet-like members of the expansion member 110 so that a part of the front tube part 131 is inserted into the lumen 119 of the expansion member 110. Can be fixed to.
  • adhesion can be employed as a method for connecting the injection portion 130 to the expansion member 110.
  • the expansion member 110 has a marker portion 116 provided in the central portion 117 between the first recess 115 a and the second recess 115 b.
  • the central portion 117 of the expansion member 110 is near the center located between the first recess 115a and the second recess 115b in the plan view shown in FIG. As shown in FIG. 3, the marker portion 116 is formed at a position overlapping the central portion 117 on the inner surface of the bottom surface 110 a of the expansion member 110.
  • the marker portion 116 is preferably composed of a transparent center portion and a colored linear frame portion surrounding the center portion.
  • the surgeon can place the marker portion 116 at the puncture site t1 while confirming the puncture site t1 via the transparent center portion of the marker portion 116. Therefore, the surgeon can easily arrange the central portion 117 of the expansion member 110 at the puncture site t1 using the marker portion 116.
  • the marker 116 is not particularly limited as long as it can be used by the surgeon to place the central portion 117 of the expansion member 110 at the puncture site t1.
  • the marker part 116 does not have a frame part, but may be formed only with a colored center part.
  • the specific shape and color of the marker portion 116, the method of forming the expansion member 110, etc. are not particularly limited.
  • the part which overlaps with the marker part 116 in planar view in the expansion member 110, and its periphery are translucent or colored transparent. Accordingly, the surgeon can visually recognize the puncture site t1 from the upper surface 110b side of the expansion member 110 even in a state where the marker portion 116 is superimposed on the puncture site t1 (see FIG. 5).
  • the marker part 116 can also be arrange
  • each sheet-like member forming the expansion member 110 is fused at the outer edge portion 118.
  • the center part 117 located closer to the center side of the expansion member 110 than the outer edge part 118 is not joined by fusion or the like. Therefore, in the expansion member 110, the outer edge portion 118 that forms the first concave portion 115 a and the second concave portion 115 b of the expansion member 110 is harder than the central portion 117 of the expansion member 110.
  • expansion member 110 examples include polyvinyl chloride, polyethylene, polypropylene, polybutadiene, polyolefin such as ethylene-vinyl acetate copolymer (EVA), and polyethylene terephthalate (PET).
  • PET polyethylene terephthalate
  • Polyesters such as polybutylene terephthalate (PBT), polyvinylidene chloride, silicones, polyurethanes, polyamide elastomers, polyurethane elastomers, polyester elastomers and other thermoplastic elastomers, or any combination thereof (blend resins, polymer alloys, A laminate or the like can be used.
  • the expansion member 110 may include a drug part containing a hemostatic material on the outer surface of the bottom surface 110a on the side that contacts the back Hb of the hand H where the puncture site t1 is formed.
  • the drug part is preferably disposed in the central region 113 of the bottom surface 110a of the expansion member 110 on the side in contact with the puncture site t1 so as to contact the puncture site t1 when the hemostatic device 100 is mounted.
  • the hemostatic material promotes hemostasis of the puncture site t1, and can efficiently stop hemostasis at the puncture site t1, so that the time required for hemostasis of the puncture site t1 can be shortened.
  • the drug part is preferably transparent so that the operator can confirm the position of the puncture site t1 through the expansion member 110.
  • the drug part may be formed by dispersing a hemostatic material in a transparent material.
  • the drug part is not particularly limited as long as it can be disposed on the outer surface of the expansion member 110.
  • the drug part can be formed of a viscous liquid, a sheet-like member, or the like.
  • the hemostatic material is not particularly limited as long as it can treat the puncture site t1 of the living tissue.
  • the hemostatic material may be thromboplastin, thrombin, menadione sodium bisulfite, acetomenaphton, ⁇ -aminocaproic acid, tranexamic acid, sodium carbazochrome sulfonate, adrenochrome monoaminoguanidine methanesulfonate, and the like.
  • the hemostatic material may be a surgical hemostatic agent such as Sandai Kasei Kogyo's Matsudite (registered trademark).
  • the operator or the like can use a predetermined fixing member 120 when fixing the hemostatic device 100 to the back Hb of the patient's hand H.
  • a fixing member 120 for example, a seat main body 121 disposed so as to cover part or all of the expansion member 110, an inner surface side (back Hb side of the hand H) of the seat main body 121, and a seat A sheet material including an adhesive layer 122 that fixes the main body 121 to the back Hb of the patient's hand H can be used.
  • the color of the sheet body 121 is not particularly limited.
  • the seat body 121 allows the operator to place the hemostatic device 100 while confirming the position of the hemostatic device 100 with respect to the puncture site t1, and the operator fixes the hemostatic device 100 to the back Hb of the patient's hand H.
  • the portion that overlaps the marker portion 116 in plan view and the periphery thereof in a state where the sheet main body portion 121 is disposed so as to cover the expansion member 110 It is preferably transparent.
  • the operator attaches the fixing member 120 to the hemostatic device 100 while confirming the position of the hemostatic device 100 with respect to the puncture site t1.
  • the surgeon can visually recognize the puncture site t1 from the outer surface side of the fixing member 120 even when the hemostatic device 100 is fixed to the back Hb of the patient's hand H by the fixing member 120 (see FIG. 7). reference).
  • the size and shape of the sheet main body 121 and the size, shape and arrangement of the adhesive layer 122 are not particularly limited as long as the hemostatic device 100 can be fixed to the patient's hand H.
  • the sheet main body 121 may have a length that can be wound once or a plurality of times in the circumferential direction of the patient's hand H.
  • the adhesive layer 122 is disposed at a position that does not overlap the expansion member 110 when the hemostatic device 100 is fixed to the patient's hand H by the fixing member 120.
  • the adhesive layer 122 may be disposed on the entire inner surface of the sheet main body 121.
  • the adhesive layer 122 is transparent at a position where it overlaps the marker portion 116 in plan view and its peripheral portion.
  • the fixing member 120 may have a peeling member or the like arranged so as to cover the adhesive layer 122 in a state before the adhesive layer 122 is attached to the patient's hand H.
  • the sheet body 121 for example, a plastic sheet, cloth, various laminated papers, non-woven fabrics, and other various sheet-like materials can be used.
  • the sheet body 121 is preferably formed of a stretchable material such as a cloth material using polyurethane elastic fibers.
  • the sheet main body 121 having elasticity is affixed to the body surface around the puncture site t1 after application.
  • the puncture site t1 can be efficiently pressed by the hemostatic device 100.
  • the adhesive layer 122 for example, a silicone adhesive, an acrylic adhesive, a natural rubber adhesive, a vinyl adhesive, or the like can be used.
  • the expansion member 110 has a first concave portion in a direction in which a length L1 of a straight line connecting the end portion 111 a and the center portion 117 in the longitudinal direction of the expansion member 110 intersects the longitudinal direction of the expansion member 110. It is formed to have a length L2 or less of a straight line connecting 115a and the second recess 115b.
  • the one end 111a that defines the length L1 is an expandable end of the expansion member 110 (a position excluding the outer edge 118).
  • the length L2 is a length of a straight line connecting the expandable position of the first recess 115a (position excluding the outer edge 118) and the expandable position of the second recess 115b (position excluding the outer edge 118). That's it.
  • the expansion member 110 includes the central portion 117 of the lumen 119 of the expansion member 110 by forming the length L1 with a length L2 or less (length L2 ⁇ length L1). In the vicinity of the central region 113, a space capable of holding a certain amount of fluid for expanding the expansion member 110 is defined. Therefore, as shown in FIG. 3, when the fluid flows into the lumen 119 of the expansion member 110, the central region 113 in which the first recess 115 a and the second recess 115 b are formed is the first region 111 and the second region 112.
  • the expansion member 110 can be expanded and deformed in the thickness direction of the expansion member 110 (vertical direction in FIG. 3). Accordingly, the hemostatic device 100 can effectively apply a compression force from the central portion 117 to the puncture site t1 by arranging the central portion 117 at the puncture site t1 with the expansion member 110 expanded. (See FIGS. 8 and 9).
  • the expansion member 110 can be formed such that the length L1 shown in FIG. 2 when the expansion member 110 is expanded is, for example, 10 mm to 15 mm. Further, the expansion member 110 can be formed such that the length L2 shown in FIG. 2 when the expansion member 110 is expanded is, for example, 11 mm to 20 mm.
  • the expansion member 110 can be formed such that the expansion dimension (thickness dimension) ha of the central region 113 shown in FIG. 3 when the expansion member 110 is expanded is, for example, 12 mm to 20 mm. Further, the expansion member 110 can be formed such that the expansion dimension (thickness dimension) hb of the second region 112 shown in FIG. 3 when the expansion member 110 is expanded is, for example, 5 mm to 13 mm. Further, the expansion member 110 can be formed such that the expansion dimension (thickness dimension) hc of the first region 111 shown in FIG. 3 when the expansion member 110 is expanded is, for example, 5 mm to 13 mm.
  • the expansion dimension (thickness dimension) of the expansion member 110 is a dimension at the time of maximum expansion when the puncture site t1 of the expansion member 110 is stopped.
  • the expansion member 110 when the expansion member 110 is expanded, the first concave portion 115a and the second concave portion 115b are compressed by the fluid in the lumen 119 of the expansion member 110. Therefore, the central region 113 of the expansion member 110 is expanded and deformed so that the central portion 117 of the expansion member 110 protrudes in the thickness direction of the expansion member 110 as the amount of fluid injected into the expansion member 110 increases. Therefore, the compression by the expansion member 110 against the body surface with which the expansion member 110 is in contact is distributed near the central portion 117 of the expansion member 110 when the pressure of the lumen 119 of the expansion member 110 is low.
  • the central portion 117 of the expansion member 110 is compressed into the lumen 119 of the expansion member 110 when the expansion member 110 is pressed against the body surface with which the expansion member 110 is in contact. Is expanded and deformed so as to protrude in the thickness direction of the expansion member 110 than in the case where the pressure of the expansion member 110 is low. Therefore, the expansion member 110 is locally concentrated on the central portion 117 (the compression force applied to the body surface by the expansion member 110 is high). Part is locally formed in the central part 117 of the expansion member 110). Thereby, the surgeon can adjust the compression force by the expansion member 110 to the puncture site t1 more appropriately by adjusting the expansion degree of the expansion member 110.
  • the sheath tube 210 of the introducer 200 is inserted into the distal radial artery via the puncture site t1 formed on the back Hb of the patient's hand H, and various procedures are completed, and the sheath is started from the puncture site t1.
  • the state which pulled out a part of tube 210 is shown.
  • the operator or the like arranges the expansion member 110 of the hemostatic device 100 so as to overlap the puncture site t1 as shown in FIG. Specifically, the operator or the like overlaps the central portion 117 of the expansion member 110 with the puncture site t1.
  • the hemostatic device 100 is arranged so that the connection part 133 (see FIG. 1) of the injection part 130 faces the forearm A side of the patient. It is also possible to arrange the hemostatic device 100 so that the part 133 faces the finger side of the patient.
  • the surgeon or the like uses the fixing member 120 to fix the hemostatic device 100 to the back Hb of the patient's hand H as shown in FIG.
  • the surgeon or the like expands the expansion member 110 using the injection unit 130 and a syringe (not shown).
  • the hemostatic device 100 applies a compressive force to the puncture site t1 from the central region 113 including the central portion 117 when the expansion member 110 expands.
  • the surgeon or the like may expand and deform the expansion member 110 in advance prior to disposing the expansion member 110 at the puncture site t1.
  • the surgeon or the like removes the sheath tube 210 of the introducer 200 from the puncture site t1 while maintaining the state in which the expansion member 110 applies a compressive force to the puncture site t1.
  • the hemostatic device 100 suitably applies a compression force to the puncture site t1 by maintaining the expanded state of the expansion member 110 even after the sheath tube 210 is removed from the puncture site t1.
  • the expansion member 110 can be deformed so as to follow the movement of the patient's hand H when the patient's hand H moves while applying hemostatic pressure to the puncture site t1. .
  • the force generated by the movement of the patient's hand H is the first recess 115a and It concentrates near the central region 113 where the second recess 115b is formed.
  • the expansion member 110 is deformed so that the central region 113 follows the shape of the patient's hand H. For example, as shown in FIG.
  • the force generated by the movement of the patient's hand H is the first force. It concentrates in the vicinity of the central region 113 where the recess 115a and the second recess 115b are formed. Thereby, the expansion member 110 is deformed so that the central region 113 follows the shape of the patient's hand H. As described above, the expansion member 110 absorbs the force applied to the expansion member 110 by deforming the central region 113 so as to follow the movement of the patient's hand H when the patient moves the hand H. . Therefore, the position shift of the expansion member 110 with respect to the puncture site t1 can be suppressed while hemostasis is performed using the hemostasis device 100.
  • the hemostatic device 100 includes the pressing member 110 (expansion member 110) that can be disposed at the puncture site t1 of the patient's hand H.
  • the pressing member 110 is disposed at a position facing the first recess 115a that is recessed toward the central axis c1 in the longitudinal direction of the pressing member 110 (expansion member 110), and the first recess 115a, and A second recess 115b that is recessed toward the central axis c1 in the longitudinal direction of the pressing member 110 (expansion member 110).
  • the first recess 115a and the second recess 115b are formed on the pressing member 110 (expansion member 110). Located in the central region 113 in the longitudinal direction.
  • the patient's hand H is moved in a state where the pressing member 110 (expansion member 110) is arranged to apply a compression force to the puncture site t1 of the patient's hand H.
  • the force generated by the movement of the patient's hand H concentrates on the first recess 115a and the second recess 115b.
  • the pressing member 110 (expansion member 110) is deformed so as to follow the movement of the patient's hand H from the first recess 115a and the second recess 115b, and the pressing member 110 against the puncture site t1 of the hand H.
  • the positional deviation of the (expansion member 110) can be suppressed. Therefore, the hemostatic device 100 can maintain the pressing force on the puncture site t1 of the pressing member 110 (expansion member 110) even when the hand H moves or the like during the hemostasis. it can.
  • the pressing member 110 (expansion member 110) has a marker portion 116 provided in a central portion 117 between the first recess 115a and the second recess 115b. Therefore, when an operator or the like places the pressing member 110 (expansion member 110) at the puncture site t1, the operator confirms the position of the marker portion 116, whereby the central portion 117 between the first recess 115a and the second recess 115b. Can be easily aligned with the puncture site t1.
  • the pressing member 110 is an expansion member 110 that can be expanded and contracted.
  • the first recess 115a and the second recess 115 of the expansion member 110 are more than the central portion 117 between the first recess 115a and the second recess 115b of the expansion member 110.
  • the outer edge 118 that forms the recess 115b is harder. Therefore, when the expansion member 110 is expanded, the outer edge portion 118 is not easily expanded and deformed. Thereby, when the expansion member 110 expands, the expansion member 110 is difficult to expand and deform in the surface direction of the expansion member 110 (direction parallel to the hand H). For this reason, when the expansion member 110 expands, the expansion member 110 increases the amount of expansion deformation in the thickness direction (direction perpendicular to the hand H) of the expansion member 110, and more effectively compresses the puncture site t1. Can be granted.
  • the hemostatic device 100 also has a fixing member 120 for fixing the pressing member 110 (expansion member 110) to the patient's hand H.
  • the fixing member 120 has an adhesive layer 122 that can be fixed to the patient's hand H. Therefore, an operator or the like can fix the hemostatic device 100 to the patient's hand H by a simple operation of attaching the adhesive layer 122 of the fixing member 120 to the patient's hand H.
  • the hemostatic device 100 is an expansion member 110 that can be expanded and contracted by the pressing member 110 and connects the longitudinal end portion 111a of the expansion member 110 and a central portion 117 between the first recess 115a and the second recess 115b.
  • the length L1 of the straight line is formed to be equal to or shorter than the length L2 of the straight line connecting the first recess 115a and the second recess 115b in the direction intersecting the longitudinal direction of the expansion member 110. Therefore, in the expansion member 110, a space capable of holding a certain amount of fluid for expanding the expansion member 110 is partitioned in the vicinity of the central region 113 including the central portion 117 of the lumen 119 of the expansion member 110.
  • the expansion member 110 when the fluid flows into the lumen 119 of the expansion member 110, the expansion member 110 has a central portion 117 located in the central region 113 in which the first concave portion 115 a and the second concave portion 115 b are formed except for the central portion 117. It is formed so that it can be expanded and deformed in the thickness direction of the expansion member 110 rather than the portion. Therefore, the hemostatic device 100 can effectively apply a compression force from the central portion 117 to the puncture site t1 by arranging the central portion 117 at the puncture site t1 in a state where the expansion member 110 is expanded. .
  • the hemostatic device 100 is an expansion member 110 that allows the pressing member 110 to expand and contract, and has an injection portion 130 that communicates with the lumen 119 of the expansion member 110 and can inject fluid into the expansion member 110. Therefore, the surgeon or the like operates the supply of the fluid to the lumen 119 of the expansion member 110 and the discharge of the fluid from the lumen 119 of the expansion member 110, whereby the expansion member 110 is applied to the puncture site t1.
  • the pressing force to be adjusted can be easily adjusted.
  • FIG. 10 (Modification of the first embodiment)
  • the use condition of the hemostatic device which concerns on a modification is shown.
  • the description of the modification the description of the members already described in the first embodiment is omitted.
  • configurations and the like not particularly mentioned can be configured in the same manner as in the first embodiment.
  • the hemostatic device according to the modified example is different from the hemostatic device 100 according to the first embodiment described above in the configuration of the injection unit 140.
  • the injection unit 140 communicates with the first connector 141 communicating with the lumen 119 of the expansion member 110, the flexible tube 142 communicating with the internal space of the first connector 141, and the lumen of the tube 142. It has the bag part 143 arrange
  • the distal end of a syringe (not shown) is inserted into the second connector 144, the check valve of the second connector 144 is opened, the pusher of the syringe is pressed, and the syringe The air inside is injected into the lumen 119 of the expansion member 110.
  • the expansion member 110 is expanded by the above operation, the bag portion 143 communicating with the lumen 119 of the expansion member 110 is expanded through the tube 142.
  • An operator or the like can easily visually confirm that the expansion member 110 can be pressurized without air leakage by confirming the expansion of the bag portion 143.
  • the surgeon or the like connects a syringe to the second connector 144 when contracting the expansion member 110.
  • An operator or the like can contract the expansion member 110 by operating the syringe to discharge the air in the lumen 119 of the expansion member 110.
  • (Second Embodiment) 11 to 15 show a hemostatic device 300 according to the second embodiment.
  • the description of the members and the like already described in the first embodiment will be omitted as appropriate.
  • configurations and the like not particularly mentioned can be configured in the same manner as in the first embodiment.
  • the hemostatic device 300 includes a first support member (corresponding to a “support member”) 310 and a second support member (corresponding to a “support member”) 320 disposed on the expansion member 110. ing.
  • the first support member 310 is disposed on the outer surface of the upper surface 110b of the first region 111 of the expansion member 110.
  • the second support member 320 is disposed on the outer surface of the upper surface 110 b of the second region 112 of the expansion member 110.
  • the first support member 310 is a plate-like member arranged so as to protrude from the first region 111 of the expansion member 110 by a predetermined length in the width direction (vertical direction in the drawing). It consists of.
  • the second support member 320 is a plate arranged so as to protrude from the second region 112 of the expansion member 110 by a predetermined length in the width direction (vertical direction in the drawing). It is comprised with the shape-shaped member.
  • the first support member 310 and the second support member 320 have a substantially rectangular shape in cross section (the cross section shown in FIGS. 14 and 15) along the longitudinal direction of the expansion member 110.
  • the cross-sectional shapes of the first support member 310 and the second support member 320 may be formed, for example, in a curved shape along the outer surface of the upper surface 110b of the expansion member 110.
  • first support member 310 and the second support member 320 are not particularly limited and can be changed as appropriate.
  • the first support member 310 and the second support member 320 can be made of a material harder than the expansion member 110.
  • the first support member 310 and the second support member 320 include acrylic resin, polyvinyl chloride (particularly hard polyvinyl chloride), polyolefin such as polyethylene, polypropylene, 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), polybutylene terephthalate (PBT) Fluorine resins such as polyester, butadiene-styrene copolymer, aromatic or aliphatic polyamide, and polytetrafluoroethylene can be used.
  • the first support member 310 can be fixed to the outer surface of the upper surface 110b of the first region 111 of the expansion member 110 by adhesion or the like, for example.
  • the second support member 320 can be fixed to the outer surface of the upper surface 110b of the second region 112 of the expansion member 110 by, for example, adhesion.
  • each of the support members 310 and 320 covers a part or all of the support members 310 and 320 by the fixing member 120 when the hemostatic device 300 is fixed to the back Hb of the patient's hand H.
  • the hemostatic device 300 As shown in FIGS. 14 and 15, the hemostatic device 300 according to the present embodiment has a central region 113 of the expansion member 110 when the patient's hand H moves during hemostasis by the expansion member 110. It is deformed so as to follow the movement of the hand H. Therefore, in the hemostatic device 300, as in the hemostatic device 100 according to the first embodiment, during the hemostasis using the hemostatic device 300, the displacement of the expansion member 110 with respect to the puncture site t ⁇ b> 1 occurs. Can be suppressed.
  • the hemostatic device 300 is an expansion member 110 that can be expanded and contracted by the pressing member 110.
  • the expansion member 110 includes a first region 111, a second region 112, a first region 111, and a second region. And a central region 113 disposed between the first region 111 and the second region 112, and support members 310 and 320 are disposed on the outer surfaces of the upper surfaces 110 b of the first region 111 and the second region 112. Therefore, when the expansion member 110 applies a compression force to the puncture site t1, the hemostatic device 300 is expanded in the direction away from the body surface of the back Hb of the hand H by the first support member 310 and the second support member 320. Can be prevented from expanding. Thereby, the hemostatic device 300 can more effectively apply a compression force to the puncture site t1 of the hand H when the expansion member 110 is expanded and deformed.
  • first support member 310 is disposed in the first region 111 of the expansion member 110
  • second support member 320 is disposed in the second region 112 of the expansion member 110. Therefore, when the patient moves the hand H, the central region 113 of the expansion member 110 is deformed so as to follow the movement of the patient's hand H without being deformed by the support members 310 and 320. Can do.
  • hemostatic device 300 according to the second embodiment can also be configured to include the injection unit 140 according to the modification shown in FIG.
  • FIG. 16 and 17 show a hemostatic device 400 according to the third embodiment.
  • the description of members and the like already described in the first embodiment and the second embodiment will be omitted as appropriate.
  • configurations and the like not particularly mentioned can be configured in the same manner as in the first embodiment and the second embodiment.
  • the hemostatic device 400 according to the third embodiment is different from the hemostatic device 300 according to the second embodiment in the configuration of the fixing member 420.
  • the configuration of the hemostatic device 400 other than the fixing member 420 is substantially the same as the hemostatic device 300 according to the second embodiment.
  • the fixing member 420 is formed of a sheet-like member.
  • the fixing member 420 includes an outer edge 421, an adhesive layer 422 disposed on the inner surface of the outer edge 421 (the surface on the back Hb side of the hand H), a window 423 disposed so as to cover the expansion member 110, have.
  • the window 423 is preferably transparent, for example. Thereby, the operator can visually recognize the marker portion 116 and the puncture site t1 from the upper surface 110b side of the expansion member 110 even in a state where the window portion 423 is superimposed on the puncture site t1.
  • the outer edge portion 421 can be formed of, for example, a transparent material, a colored transparent material, or a material having a predetermined coloring.
  • the window part 423 and the outer edge part 421 are fixed.
  • Each support member 310, 320 is fixed to the expansion member 110.
  • the window 423 and the support members 310 and 320 are fixed. Therefore, in the hemostatic device 400, the expansion member 110, the support members 310 and 320, and the fixing member 420 are integrally attached. Note that the fixing of the window portion 423 and the outer edge portion 421 and the fixing of the window portion 423 and the support members 310 and 320 can be performed by a method such as fusion or adhesion.
  • the fixing member 420 may have a peeling member or the like disposed so as to cover the adhesive layer 422 in a state before the adhesive layer 422 is attached to the patient's hand H.
  • the outer edge portion 42 for example, a material such as a plastic sheet, a cloth, various laminated papers, and a nonwoven fabric can be used.
  • the outer edge portion 421 is preferably formed of a stretchable material such as a cloth material using polyurethane elastic fibers.
  • the adhesive layer 422 for example, a silicone adhesive, an acrylic adhesive, a natural rubber adhesive, a vinyl adhesive, or the like can be used.
  • the window portion 423 for example, polyurethane, polyethylene, polypropylene, vinyl chloride, or the like can be used.
  • the expansion member 110 and the fixing member 420 are integrally configured. Therefore, when hemostasis using the hemostatic device 400 is performed, the hemostatic device 400 is attached to the patient's hand H. The work of fixing to the upper Hb can be easily performed.
  • hemostatic device 100 according to the first embodiment and the hemostatic device according to the modified example may be provided with the fixing member 420 described in the third embodiment.
  • the hemostatic device according to the present invention has been described through the embodiments.
  • the present invention is not limited only to the contents described in the specification, and can be appropriately changed based on the description of the claims. is there.
  • the hemostatic device for hemostasis of the puncture site formed on the back of the left hand is illustrated, but the hemostatic device is formed on the puncture site formed on the back of the right hand, the palm of the right hand, and the palm of the left hand. It can also be used to stop the puncture site.
  • the expansion member only needs to have at least the first concave portion and the second concave portion, and the specific outer shape, cross-sectional shape and the like are not limited to those illustrated by the drawings.
  • the hemostatic device does not need to be provided with the injection part.
  • the expansion member can be prepared in a state of being expanded to a predetermined size before being used for hemostasis.
  • the fixing member may be made of a material other than the sheet material provided with the adhesive layer.
  • the fixing member can be configured to have a belt portion arranged to wrap the expansion member around the patient's hand and a hook-and-loop fastener attached to the belt portion.
  • the expansion member is not limited to a structure in which a plurality of sheet-like members are joined.
  • the expansion member may be constituted by, for example, a single bag-shaped member having a lumen formed therein.
  • the pressing member is not limited to the expansion member (balloon) described in each embodiment.
  • the pressing member is composed of, for example, a mechanical member whose amount of pressing into the hand can be changed by an external operation such as rotation, a resin material such as plastic that is pressed into the hand so as to apply a surface pressure, a gel, or the like.
  • a member having a predetermined three-dimensional shape (spherical, ellipsoidal, triangular pyramid, etc.), or a combination of these may be used.
  • 100, 300, 400 hemostatic device 110 expansion member (pressing member), 110a bottom surface (surface facing the hand), 110b Top surface (surface opposite to the surface facing the hand), 111 first region, 111a one end, 112 second region, 112a the other end, 113 central region, 115a first recess, 115b second recess, 116 Marker part, 117 Central part, 118 outer edge, 119 lumen, 120, 420 fixing member, 121 seat body, 122 adhesive layer, 130, 140 injection part, 200 Introducer, 210 sheath tube, 310 first support member (support member), 320 second support member (support member), A forearm, H hand, Hb back of the hand, c1 the central axis in the longitudinal direction of the expansion member, t1 Puncture site (site to be hemostatic).

Abstract

Le problème décrit par la présente invention est de fournir un instrument hémostatique qui, même lorsqu'un mouvement de la main ou similaire se produit pendant l'hémostase, est apte à maintenir une force de compression d'un élément de pression contre un site devant être soumis à une hémostase. La solution selon l'invention porte sur un instrument hémostatique (100) qui comprend un élément de pression (110) apte à être disposé au niveau d'un site de perforation (t1) d'une main (H) d'un patient. L'élément de pression a une première partie en creux (115a) en retrait vers un axe central (c1) dans la direction longitudinale de l'élément de pression, et une seconde partie en creux (115b) disposée à une position faisant face à la première partie en creux, et en retrait vers l'axe central dans la direction longitudinale de l'élément de pression, et la première partie en creux et la seconde partie en creux sont situées dans une région centrale (113) dans la direction longitudinale de l'élément de pression.
PCT/JP2019/017708 2018-04-26 2019-04-25 Instrument hémostatique WO2019208714A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2020515576A JP7295848B2 (ja) 2018-04-26 2019-04-25 止血器具

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2018085367 2018-04-26
JP2018-085367 2018-04-26

Publications (1)

Publication Number Publication Date
WO2019208714A1 true WO2019208714A1 (fr) 2019-10-31

Family

ID=68294049

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2019/017708 WO2019208714A1 (fr) 2018-04-26 2019-04-25 Instrument hémostatique

Country Status (2)

Country Link
JP (1) JP7295848B2 (fr)
WO (1) WO2019208714A1 (fr)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0747073A (ja) * 1993-08-04 1995-02-21 Sumitomo Rubber Ind Ltd 圧迫止血ベルト
JP2005521464A (ja) * 2002-03-27 2005-07-21 データスコープ・インヴェストメント・コーポレイション 傷を圧迫するための装置および方法
WO2016163326A1 (fr) * 2015-04-07 2016-10-13 テルモ株式会社 Garrot

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0747073A (ja) * 1993-08-04 1995-02-21 Sumitomo Rubber Ind Ltd 圧迫止血ベルト
JP2005521464A (ja) * 2002-03-27 2005-07-21 データスコープ・インヴェストメント・コーポレイション 傷を圧迫するための装置および方法
WO2016163326A1 (fr) * 2015-04-07 2016-10-13 テルモ株式会社 Garrot

Also Published As

Publication number Publication date
JPWO2019208714A1 (ja) 2021-05-20
JP7295848B2 (ja) 2023-06-21

Similar Documents

Publication Publication Date Title
JP6806669B2 (ja) 止血器具
JP6936223B2 (ja) 止血器具
JP6740232B2 (ja) 止血器具
JP6893206B2 (ja) 止血器具
JP6885941B2 (ja) 止血器具
JP7041056B2 (ja) 止血器具
JP6783083B2 (ja) 止血器具
JP6959219B2 (ja) 止血器具
JP6730137B2 (ja) 止血器具
JP6725343B2 (ja) 止血器具
WO2020111184A1 (fr) Instrument hémostatique
JP7018281B2 (ja) 止血器具
JP6859345B2 (ja) 止血器具
JP7236439B2 (ja) 止血器具
JP2020018686A (ja) 止血器具
JP2020116313A (ja) 止血器具、および被覆部材
JP2017047039A (ja) 止血器具
JP7236440B2 (ja) 止血器具
WO2019208714A1 (fr) Instrument hémostatique
JP2004201829A (ja) 止血器具
JP2020116314A (ja) 止血器具
JP2004041599A (ja) 止血器具
JP2022035819A (ja) 止血器具
WO2023189408A1 (fr) Dispositif hémostatique et procédé de production d'élément d'expansion
WO2020067164A1 (fr) Instrument hémostatique

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 19792967

Country of ref document: EP

Kind code of ref document: A1

ENP Entry into the national phase

Ref document number: 2020515576

Country of ref document: JP

Kind code of ref document: A

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 19792967

Country of ref document: EP

Kind code of ref document: A1