WO2006059540A1 - Valve body - Google Patents

Valve body Download PDF

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Publication number
WO2006059540A1
WO2006059540A1 PCT/JP2005/021655 JP2005021655W WO2006059540A1 WO 2006059540 A1 WO2006059540 A1 WO 2006059540A1 JP 2005021655 W JP2005021655 W JP 2005021655W WO 2006059540 A1 WO2006059540 A1 WO 2006059540A1
Authority
WO
WIPO (PCT)
Prior art keywords
slit
valve body
auxiliary
slits
present
Prior art date
Application number
PCT/JP2005/021655
Other languages
French (fr)
Japanese (ja)
Inventor
Takayuki Mori
Ryoichi Soba
Shigeki Numata
Hiroshi Yagi
Original Assignee
Terumo Kabushiki Kaisha
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 Terumo Kabushiki Kaisha filed Critical Terumo Kabushiki Kaisha
Publication of WO2006059540A1 publication Critical patent/WO2006059540A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02Access sites
    • A61M39/06Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
    • A61M39/0693Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof including means for seal penetration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06Body-piercing guide needles or the like
    • A61M25/0662Guide tubes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02Access sites
    • A61M39/04Access sites having pierceable self-sealing members
    • A61M39/045Access sites having pierceable self-sealing members pre-slit to be pierced by blunt instrument

Definitions

  • the present invention relates to a valve body having an opening / closing section composed of a plurality of slits that open and close when a long member such as a catheter, a guide wire, or a dilator is inserted or removed.
  • An introducer is used when a long member used for medical treatment such as a catheter or a guide wire is introduced into a living body.
  • a catheter or a guide wire is introduced into a living body.
  • This introducer has a tubular hub, a cap attached to one end of the hub, a sheath having a sheath tube connected to the other end of the hub, and introduction of the sheath into the living body. It is composed of a dilator that is inserted into the sheath and used for easy
  • the cap is provided with an opening communicating with the hollow portion of the hub.
  • a disc-shaped valve body is installed so as to cover the opening, that is, to maintain the liquid-tight state of the hollow portion of the hub.
  • the valve body is formed with two slits that cross in a cross shape. Both slits are in an open state when the long member (tubular body) is inserted into the sheath, and are in a closed state when the long member is removed.
  • An object of the present invention is to provide a valve body in which a slit does not tear when a long member is inserted.
  • the present invention provides:
  • a valve body made of an elastic material and having an opening / closing portion composed of a plurality of slits that open and close as the long member is inserted and removed.
  • the opening / closing part is
  • valve body An internal force of the valve body, a first slit that reaches only the top surface of the valve body;
  • a second slit that reaches only from the inside to the bottom surface of the valve body and intersects the first slit in the inside;
  • the internal force is at least one auxiliary slit that reaches only the bottom surface and intersects the second slit at a position away from the central force of the second slit.
  • the present invention provides:
  • a valve body made of an elastic material and having an opening / closing portion composed of a plurality of slits that open and close as the long member is inserted and removed.
  • the opening / closing part is
  • valve body An internal force of the valve body, a first slit that reaches only the top surface of the valve body;
  • a second slit that reaches only from the inside to the bottom surface of the valve body and intersects the first slit in the inside;
  • the second slit is a valve body characterized by having an auxiliary slit branched into a plurality at the end or in the middle thereof.
  • valve body of the present invention it is preferable that two auxiliary slits are provided.
  • the two auxiliary slits face each other toward the bottom surface of the valve body. It is shaped to approach the heel!
  • the two auxiliary slits face each other toward the bottom surface of the valve body.
  • V is formed so as to be spaced apart!
  • auxiliary slits are provided so as to be substantially equidistant through the central portion! /.
  • the auxiliary slit has a single letter shape in plan view.
  • the auxiliary slit can have a simple shape (configuration), and thus each auxiliary slit (opening / closing portion) can be opened and closed easily and reliably.
  • the auxiliary slit has a V shape in a plan view.
  • the auxiliary slit is formed so as to be inclined with respect to the opening direction of the second slit (in the inserted state) when the elongated member is inserted, so that the auxiliary slit is excessive in the inserted state. Can be prevented.
  • the auxiliary slit intersects the second slit at a valley portion in the V shape, and the valley portion is located on the center portion side. preferable.
  • the auxiliary slits in the inserted state can be opened equally with respect to each other with respect to the second slit.
  • the auxiliary slit has a U-shape in plan view. It is preferable.
  • the auxiliary slit is formed so as to be inclined with respect to the opening direction of the second slit (in the inserted state) when the long member is inserted, and therefore the auxiliary slit is excessive in the inserted state. Can be prevented.
  • the auxiliary slit intersects the second slit at a valley portion in the U-shape, and the valley portion is located on the center portion side. preferable.
  • the auxiliary slits in the inserted state can be opened equally with respect to each other with respect to the second slit.
  • the depth of the auxiliary slit with respect to the valve body is substantially equal to the depth of the second slit with respect to the valve body.
  • the auxiliary slit has a portion whose depth changes with respect to a longitudinal direction of the auxiliary slit.
  • At least one of the first slit and the second slit has a single letter shape in plan view.
  • the slit can be formed into a simple shape (configuration), and thus the slit can be opened and closed easily and reliably.
  • the elongated member is a dilator, a catheter, or a guide mechanism.
  • the elongated member can be introduced into the living body.
  • FIG. 1 is a partial longitudinal sectional view showing an introducer having a valve body of the present invention.
  • FIG. 2 is a perspective view showing a first embodiment of the valve body of the present invention.
  • FIG. 3 is a plan view of the valve body shown in FIG. 2.
  • FIG. 4 is a bottom view of the valve body shown in FIG. 2.
  • FIG. 5 is a plan view showing a state in which a long member is passed through the valve body shown in FIG. 2.
  • FIG. 6 is a bottom view showing a state in which a long member is passed through the valve body shown in FIG. 2.
  • FIG. 7 is a side view showing a second embodiment of the valve body of the present invention.
  • FIG. 8 is a side view showing a third embodiment of the valve body of the present invention.
  • FIG. 9 is a bottom view showing a fourth embodiment of the valve body of the present invention.
  • FIG. 10 is a bottom view showing a fifth embodiment of the valve body of the present invention.
  • FIG. 11 is a bottom view showing a sixth embodiment of the valve body of the present invention.
  • FIG. 12 is a bottom view showing a seventh embodiment of the valve body of the present invention.
  • FIG. 13 is a perspective view showing an eighth embodiment of the valve body of the present invention.
  • FIG. 14 is a perspective view showing a ninth embodiment of the valve body of the present invention.
  • valve body of the present invention will be described in detail based on preferred embodiments shown in the accompanying drawings.
  • FIG. 1 is a partial longitudinal sectional view showing an introducer having the valve body of the present invention
  • FIG. 2 is a perspective view showing the first embodiment of the valve body of the present invention
  • FIG. 3 is shown in FIG.
  • FIG. 4 is a bottom view of the valve body shown in FIG. 2
  • FIG. 5 is a plan view showing a state in which a long member is inserted into the valve body shown in FIG.
  • the figure is a bottom view showing a state in which a long member is passed through the valve body shown in FIG.
  • the upper side in FIGS. 1 and 2 will be described as “upper” or “base end”, and the lower side will be described as “lower” or “tip”.
  • An introducer 1 shown in FIG. 1 is used to introduce a long member used for medical treatment such as a guide wire or a catheter into a living body (for example, a blood vessel or the like). .
  • the introducer 1 includes a hub 2, a tubular sheath tube 4 fixed to the distal end side of the hub 2, a sheath 7 having a sealing means 6, and introduction of the sheath 7 into the living body. It is composed of a dilator (expansion tube) 10 that is inserted into the sheath 7 for easy use.
  • the hub 2 is composed of a tubular body.
  • a side port (connecting portion) 21 protruding sideways is provided on the outer periphery of the hub 2.
  • the side port 21 has a tubular shape, and a hollow portion (inside) 211 communicates with the inside of the hub 2.
  • One end of a flexible tube 8 made of, for example, polyvinyl chloride / vinyl is connected to the side port 21 in a liquid-tight manner.
  • the sheath tube 4 is a member introduced into the living body, and is formed of a thin-walled tubular member.
  • the sheath tube 4 has a proximal end portion fitted into a distal end portion of the hub 2.
  • a sealing means 6 for sealing the inside of the hub 2 is provided at the base end portion of the hub 2.
  • the sealing means 6 is a dilator (expansion tube) 10 or a catheter, or a valve body 61 through which a guide wire can pass, and a bottomed cylindrical shape that supports and fixes the valve body 61 to the sleeve 2 And the lid member 64.
  • the lid member 64 is fitted and attached to the base end outer peripheral portion 22 of the hub 2. At the bottom 641 of the lid member 64, an insertion port 65 through which the dilator 10, catheter or guide wire can be passed is formed.
  • the dilator 10 is composed of a flexible tube (tube).
  • the dilator 10 is inserted into the sheath 7 and inserted (introduced) into the living body while being fixed to the sheath 7. Further, in the dilator 10, for example, in order to facilitate introduction into a blood vessel, the tip portion 101 of the dilator 10 is reduced in diameter by directing the tip.
  • Such a dilator 10 is removed from the sheath 7 after the sheath tube 4 is inserted into the living body (blood vessel). Thereafter, a catheter or guide wire is inserted through the sputum inlet 65.
  • the sealing means 6 has the valve body 61.
  • the valve body 61 is formed of an elastic body having a circular film shape (disk shape).
  • the valve body 61 is fixed in a liquid-tight manner to the hub 2 by being sandwiched between the base end face 23 of the hub 2 and the bottom portion 641 of the lid member 64 (see FIG. 1).
  • the valve body 61 has an opening / closing part 66 that opens and closes as the dilator 10 is inserted and removed (see FIGS. 3 to 6).
  • the opening / closing portion 66 includes a first slit 62, a second slit 63, and two complementary slits. It consists of auxiliary slits 67 and 67.
  • the first slit 62 is formed so that the internal force of the valve body 61 also reaches only the upper surface (top surface) 68 of the valve body 61.
  • the first slit 62 has a single letter shape in plan view (see FIG. 3). As a result, the first slit 62 can have a simple shape (configuration), and thus the first slit 62 (opening / closing portion 66) can be opened and closed easily and reliably.
  • the depth of the first slit 62 is not particularly limited. For example, about 40 to 90% of the thickness of the valve body 61 is preferable, and about 40 to 70% is more preferable.
  • the second slit 63 is formed so that the internal force of the valve body 61 can reach only the lower surface (bottom surface) 69 of the valve body 61.
  • the second slit 63 has a single letter shape in plan view (see FIG. 4). As a result, the second slit 63 can have a simple shape (configuration), and therefore the second slit 63 (opening / closing portion 66) can be easily and reliably opened and closed.
  • the depth of the second slit 63 is not particularly limited.
  • the depth of the valve body 61 is 40-9.
  • About 0% is preferable. About 40 to 70% is more preferable.
  • first slit 62 and the second slit 63 as described above partially intersect with each other inside the valve body 61.
  • the slits 62 and 63 intersect with each other in a cross shape, that is, the crossing angle between the slits 62 and 63 is 90 °.
  • the crossing angle is not limited to 90 °.
  • the length L (see Fig. 2) of the intersection between the first slit 62 and the second slit 63 is not particularly limited, but is, for example, 20 to 50% of the thickness of the valve body 61 About 30 to 40% is preferable.
  • the two auxiliary slits 67 and 67 reach only the lower surface 69 from the inside of the valve body 61, respectively.
  • the auxiliary slits 67 and 67 are formed at substantially the same distance from the central portion 631 of the second slit 63 and intersect only the second slit 63 at that position (FIG. 2, (See Figure 4).
  • each auxiliary slit 67 and the second slit 63 intersect with each other in a cross shape! That is, the intersection angle between each auxiliary slit 67 and the second slit 63 is: 90 ° .
  • both auxiliary slits 67 and 67 are formed so as to be parallel to the first slit 62 and intersect the second slit 63.
  • each auxiliary slit 67 opens and works near the central portion 631 of the second slit 63. It is possible to disperse (relax) the partial stress, and thus it is possible to prevent the second slit 63 (valve element 61) from cracking (cracking) (see FIG. 6).
  • the dilator 10 When the dilator 10 is inserted into the valve body 61 (opening / closing part 66), not only the first slit 62 and the second slit 63 but also the auxiliary slits 67 are opened (see FIG. 6). As a result, the dilator 10 can easily pass through the opening / closing portion 66, that is, the sliding resistance between the outer peripheral surface 102 of the dilator 10 and the valve body 61 is reduced (reduced).
  • each auxiliary slit 67 has a single letter shape in plan view.
  • each auxiliary slit 67 can have a simple shape (configuration), and thus each auxiliary slit 67 (opening / closing portion 66) can be opened and closed easily and reliably.
  • the depth of the auxiliary slit 67 is preferably substantially the same as the depth of the second slit 63, but is not limited to this, for example, the second slit 63 It may be deeper than the depth of 63 or shallower than the depth of the second slit 63.
  • the internal stress can be suitably dispersed, and thus the second slit 63 is torn (cracked). Can be surely prevented.
  • each auxiliary slit 67 is formed such that both end portions 678 and 678 are equal in length from the intersection 677 with the second slit 63.
  • the length is not limited to this, and the lengths may be different.
  • the constituent material of the valve body 61 is not particularly limited.
  • natural rubber isoprene rubber, silicone rubber, urethane rubber, styrene butadiene rubber, fluorine rubber
  • examples include elastic materials such as various synthetic rubbers such as krill rubber, various thermoplastic elastomers such as polyamide and polyester.
  • valve body 61 having such a configuration, liquid tightness is ensured not only when the dilator 10 is not inserted (inserted) into the valve body 61 but also when the dilator 10 is inserted. It is possible to reliably prevent leakage of the liquid (for example, blood) filled in the hub 2.
  • the second and second slits 63 are in close contact with the outer peripheral surface 102 of the dilator 10 from different directions and slide, the liquid tightness is ensured even when the dilator 10 is inserted through the valve body 61. Leakage of blood etc. is effectively prevented.
  • valve body 61 introduction 1
  • valve body 61 When the force is also removed, the valve body 61 is instantly restored to its original shape due to its elasticity, that is, the first slit 62, the second slit 63 and the auxiliary slit 67 are instantly closed and liquid tight. To prevent liquid leakage.
  • the valve body 61 is arranged so that the surface (the lower surface 69) on which the auxiliary slit 67 is formed is located on the base end side.
  • the valve body 61 may be arranged so that the formed surface is located on the tip side.
  • valve body 61 is not limited to the dilator 10, but may be a catheter or a guide wire, for example.
  • FIG. 7 is a side view showing a second embodiment of the valve body of the present invention.
  • This embodiment is the same as the first embodiment except that the formation state of the auxiliary slits is different.
  • the two auxiliary slits 67A and 67A are inclined with respect to the first slit 62, that is, approach each other toward the base end side (lower surface 69 side). It is formed as follows. As a result, the base end side of each auxiliary slit 67A is moved to the central portion 631 of the second slit 63. Therefore, when the dilator 10 is inserted (hereinafter, this state is referred to as “inserted state”), the internal stress near the base end portion (lower surface 69) of the central portion 631 is preferably dispersed. Therefore, it is possible to reliably prevent the second slit 63 from tearing.
  • each auxiliary slit 67A with respect to the first slit 62 (the angle indicated by ⁇ in Fig. 7) is not particularly limited, and is preferably a force of 30 to 70 °, for example. More preferably, it is ⁇ 60 °.
  • the two inclination angles ⁇ are not limited to being equivalent, and may be different from each other.
  • FIG. 8 is a side view showing a third embodiment of the valve body of the present invention.
  • valve body of the present invention will be described with reference to this figure, but the description will focus on differences from the above-described embodiment, and the description of the same matters will be omitted.
  • This embodiment is the same as the first embodiment except that the formation state of the auxiliary slits is different.
  • the two auxiliary slits 67B and 67B are inclined with respect to the first slit 62, that is, separated from each other toward the base end side (the lower surface 69 side). It is formed as follows. As a result, the distance between the auxiliary slits 67B and 67B is increased (widened) along the insertion direction of the dilator 10 (the direction from the upper surface 68 to the lower surface 69). Become.
  • 2 angle is not particularly limited, and is, for example, preferably a force of 30 to 70 °, and more preferably 40 to 60 °.
  • the two inclination angles ⁇ are not limited to being equal, but may be different from each other.
  • FIG. 9 is a bottom view showing a fourth embodiment of the valve body of the present invention.
  • each auxiliary slit 67C has a V-shape in plan view. Accordingly, each auxiliary slit 67C is formed so as to be inclined with respect to the direction in which the second slit 63 opens when the dilator 10 is inserted (the vertical direction in FIG. 9). It is possible to prevent the auxiliary slit 67C from opening excessively.
  • Each auxiliary slit 67C is a valley 671 in the V-shape, intersects with the second slit 63, and the valley 671 is located on the center 631 side of the second slit 63. .
  • each of the auxiliary slits 67C in the inserted state can open the upper part 672 and the lower part 673 in the figure equally with respect to the second slit 63.
  • FIG. 10 is a bottom view showing a fifth embodiment of the valve body of the present invention.
  • the present embodiment is the same as the fourth embodiment except that the formation position of the auxiliary slit is different.
  • each auxiliary slit 67 D intersects the end 63 2 of the second slit 63. That is, the second slit 63 has auxiliary slits 67D and 67D branched into a plurality (two in the present embodiment) at the end 632 (or halfway). As a result, both end portions 632 and 632 can be largely opened in the inserted state, and thus the dilator 10 can easily insert the valve body 61.
  • the auxiliary slit is formed so as to branch into three from the end of the second slit.
  • FIG. 11 is a bottom view showing a sixth embodiment of the valve body of the present invention.
  • valve body of the present invention will be described with reference to this figure. However, the difference from the above-described embodiment will be mainly described, and description of similar matters will be omitted.
  • This embodiment is the same as the first embodiment except that the shape of the auxiliary slit is different. is there.
  • each auxiliary slit 67E has a U-shape in plan view.
  • each auxiliary slit 67E is formed so as to be inclined with respect to the direction in which the second slit 63 opens (the vertical direction in FIG. 9) when the dilator 10 is inserted.
  • Each auxiliary slit 67E can be prevented from opening excessively.
  • Each auxiliary slit 67E is a valley 674 in the U-shape, intersects the second slit 63, and the valley 674 is located on the center 631 side of the second slit 63. .
  • each of the auxiliary slits 67E in the inserted state can open the upper part 675 and the lower part 676 in the figure equally with respect to the second slit 63.
  • FIG. 12 is a bottom view showing a seventh embodiment of the valve body of the present invention.
  • the present embodiment is the same as the sixth embodiment except that the formation positions of the auxiliary slits are different.
  • each auxiliary slit 67 F intersects the end 63 2 of the second slit 63. That is, the second slit 63 has auxiliary slits 67F and 67F branched into a plurality (two in the present embodiment) at the end 632 (or halfway). As a result, both end portions 632 and 632 can be largely opened in the inserted state, and thus the dilator 10 can easily insert the valve body 61.
  • each auxiliary slit is formed so as to be branched into three end forces of the second slit.
  • FIG. 13 is a perspective view showing an eighth embodiment of the valve body of the present invention.
  • each auxiliary slit 67G changes with respect to the longitudinal direction of the auxiliary slit, that is, the depth increases from the end 678 toward the intersection 677. Caro (gradual increase). In the illustrated configuration, the depth of each auxiliary slit 67G is almost zero at the end 678.
  • the auxiliary slit 67G having such a configuration can favorably disperse the internal stress in the inserted state, thereby reliably preventing the second slit 63 from cracking (cracking). That's right.
  • each auxiliary slit 67G is substantially equal to the depth of the second slit 63.
  • FIG. 14 is a perspective view showing a ninth embodiment of the valve body of the present invention.
  • the present embodiment is the same as the first embodiment except that the shape of the auxiliary slit is different.
  • each auxiliary slit 67H changes with respect to the longitudinal direction of the auxiliary slit, that is, the depth gradually decreases partially.
  • the internal stress can be suitably dispersed in the inserted state, and thus it is possible to reliably prevent the second slit 63 from being cracked. That's right.
  • valve body of the present invention has been described above, the present invention is not limited to this, and each part constituting the valve body may be any arbitrary one that can exhibit the same function. It can be replaced with that of the configuration. Moreover, arbitrary components may be added.
  • valve body of the present invention may be a combination of any two or more configurations (features) of the above embodiments! /.
  • the auxiliary slits of the fourth embodiment may be inclined like the auxiliary slits of the second embodiment or the third embodiment, respectively.
  • auxiliary slits of the fifth embodiment are respectively the second embodiment or the It may be inclined like the auxiliary slit of the third embodiment.
  • auxiliary slit of the fifth embodiment may have a single letter shape in plan view like the auxiliary slit of the first embodiment.
  • valve body is not limited to a hollow body such as a pipe body (dilator), and may be, for example, a solid body.
  • auxiliary slits formed is not limited to two, and may be one or three or more, for example.
  • first slit and the second slit are not limited to a single letter shape in plan view, and for example, only the first slit may be a single letter shape. However, only the second slit may have a single letter shape.
  • a valve body shown in FIGS. 2 to 4 was produced using silicone rubber, and a sheath (introducer) shown in FIG. 1 was produced by mounting this valve body.
  • valve body shown in FIG. 9 was produced using silicone rubber, and the sheath shown in FIG. 1 was produced by mounting this valve body.
  • Example 1 Except for omitting the auxiliary slit, a valve body similar to that of Example 1 was prepared, and this valve body was attached to manufacture the sheath shown in FIG.
  • Dilators were inserted into the sheaths produced in each of the examples and comparative examples, and heated in an oven in the state shown in FIG. The heating conditions were 60 ° C x 13 hours.
  • the tubular body introduction device force dilator produced in each of the examples and the comparative examples was removed, and the valve body was removed. Then, for each valve body, the state of the second slit is set. It was confirmed visually.
  • the valve body of the present invention is a valve body made of an elastic material and having an opening / closing part made up of a plurality of slits that open and close as the long member is inserted and removed.
  • Internal force of the valve body A first slit that reaches only the top surface of the valve body, and a second slit that reaches only the bottom surface of the valve body from the inside and intersects the first slit in the inside And at least one auxiliary slit that reaches only the bottom surface from the inside and intersects the second slit at a position away from the central force of the second slit.
  • valve body of the present invention can be used (installed) in a sheath of an introducer that introduces a long member used for medical treatment such as a force tape or a guide wire into a living body. Therefore, the valve body of the present invention has industrial applicability.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Pulmonology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Biophysics (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

A valve body is made of an elastic material and has an opening and closing section having slits that are opened and closed as an elongate member is inserted into and removed from the valve body. The opening and closing section of the valve body has a first slit running from the inside of the valve body only to the top of the valve body, a second slit running from the inside only to the bottom surface of the valve body and intersecting, in the inside, the first slit, and at least one auxiliary slit running from the inside only to the bottom surface and intersecting the second slit at a position away from the central portion of the second slit.

Description

明 細 書  Specification
弁体  Disc
技術分野  Technical field
[0001] 本発明は、例えばカテーテルやガイドワイヤあるいはダイレータ等のような長尺部材 の挿入'抜去に伴って開閉する複数のスリットで構成された開閉部を有する弁体に関 する。  [0001] The present invention relates to a valve body having an opening / closing section composed of a plurality of slits that open and close when a long member such as a catheter, a guide wire, or a dilator is inserted or removed.
背景技術  Background art
[0002] カテーテルやガイドワイヤ等のような医療に用いられる長尺部材を生体内へ導入す るときには、イントロデューサが使用されている。このイントロデューサとしては、例え ば、  [0002] An introducer is used when a long member used for medical treatment such as a catheter or a guide wire is introduced into a living body. As this introducer, for example,
特公平 2— 949号公報に記載されたものが知られている。  What is described in Japanese Patent Publication No. 2-949 is known.
[0003] このイントロデューサは、筒状をなすハブと、ハブの一端部に装着されたキャップと 、ハブの他端部に接続されたシースチューブとを有するシースと、シースの生体内へ の導入を容易にするためシースに挿入して使用されるダイレータとで構成されている[0003] This introducer has a tubular hub, a cap attached to one end of the hub, a sheath having a sheath tube connected to the other end of the hub, and introduction of the sheath into the living body. It is composed of a dilator that is inserted into the sheath and used for easy
。キャップには、ハブの中空部と連通する開口が設けられている。そして、当該開口 を覆うように、すなわち、ハブの中空部の液密状態を維持するように、円盤状をなす 弁体が設置されている。 . The cap is provided with an opening communicating with the hollow portion of the hub. A disc-shaped valve body is installed so as to cover the opening, that is, to maintain the liquid-tight state of the hollow portion of the hub.
[0004] この弁体には、十文字状に交差する 2つのスリットが形成されている。両スリットは、 長尺部材 (管体)がシースに挿入された際には、開いた状態となり、長尺部材がシ一 ス力 抜去された際には、閉じた状態となる。 [0004] The valve body is formed with two slits that cross in a cross shape. Both slits are in an open state when the long member (tubular body) is inserted into the sheath, and are in a closed state when the long member is removed.
[0005] し力しながら、このような弁体は、長尺部材を長期間挿入した状態にしたり、長尺部 材の挿入 ·抜去を頻繁に繰り返したりした場合には、スリットに裂けが生じるおそれが めつに。 [0005] However, when such a valve element is in a state in which a long member is inserted for a long period of time, or when a long member is frequently inserted and removed repeatedly, the slit is split. There is a fear.
[0006] スリットに裂けが生じた場合、たとえ長尺部材を抜去して両スリットが閉じたとしても、 前記裂けにより、弁体 (スリット)の液密性が低下する (損なわれる)ことがあるという問 題があった。  [0006] When tearing occurs in the slit, even if the long member is removed and both slits are closed, the liquid tightness of the valve body (slit) may be reduced (damaged) due to the tearing. There was a problem.
発明の開示 [0007] 本発明の目的は、長尺部材を挿入するに際し、スリットに裂けが生じない弁体を提 供することにある Disclosure of the invention [0007] An object of the present invention is to provide a valve body in which a slit does not tear when a long member is inserted.
上記目的を達成するために、本発明は、  In order to achieve the above object, the present invention provides:
弾性材料で構成され、長尺部材の挿入 '抜去に伴って開閉する複数のスリットで構 成された開閉部を有する弁体であって、  A valve body made of an elastic material and having an opening / closing portion composed of a plurality of slits that open and close as the long member is inserted and removed.
前記開閉部は、  The opening / closing part is
前記弁体の内部力 該弁体の頂面にのみ到達する第 1のスリットと、  An internal force of the valve body, a first slit that reaches only the top surface of the valve body;
前記内部から前記弁体の底面にのみ到達し、前記内部にお 、て前記第 1のスリット と交差する第 2のスリットと、  A second slit that reaches only from the inside to the bottom surface of the valve body and intersects the first slit in the inside;
前記内部力 前記底面にのみ到達し、前記第 2のスリットの中心部力 離れた位置 で該第 2のスリットと交差する、少なくとも 1つの補助スリットとを有することを特徴とする 弁体である。  The internal force is at least one auxiliary slit that reaches only the bottom surface and intersects the second slit at a position away from the central force of the second slit.
[0008] これにより、長尺部材を挿入するに際し、スリットに裂けが生じない。  [0008] Thereby, when inserting the long member, the slit does not tear.
[0009] 上記目的を達成するために、本発明は、 In order to achieve the above object, the present invention provides:
弾性材料で構成され、長尺部材の挿入 '抜去に伴って開閉する複数のスリットで構 成された開閉部を有する弁体であって、  A valve body made of an elastic material and having an opening / closing portion composed of a plurality of slits that open and close as the long member is inserted and removed.
前記開閉部は、  The opening / closing part is
前記弁体の内部力 該弁体の頂面にのみ到達する第 1のスリットと、  An internal force of the valve body, a first slit that reaches only the top surface of the valve body;
前記内部から前記弁体の底面にのみ到達し、前記内部にお 、て前記第 1のスリット と交差する第 2のスリットとを有し、  A second slit that reaches only from the inside to the bottom surface of the valve body and intersects the first slit in the inside;
前記第 2のスリットは、その端部または途中において複数に分岐した補助スリットを 有することを特徴とする弁体である。  The second slit is a valve body characterized by having an auxiliary slit branched into a plurality at the end or in the middle thereof.
[0010] これにより、長尺部材を挿入するに際し、スリットに裂けが生じない。 [0010] Thereby, when inserting the long member, the slit does not tear.
[0011] また、本発明の弁体では、前記補助スリットは、 2つ設けられているのが好ましい。 [0011] In the valve body of the present invention, it is preferable that two auxiliary slits are provided.
[0012] これにより、長尺部材を弁体に挿入したとき、補助スリットが開いて、第 2のスリットの 中心部付近に働く内部応力を分散 (緩和)させることができ、よって、弁体に裂け (亀 裂)が生じるのを防止することができる。 [0012] With this, when the long member is inserted into the valve body, the auxiliary slit is opened, and the internal stress acting near the center of the second slit can be dispersed (relaxed). It can prevent tearing (turtle cracking).
[0013] また、本発明の弁体では、前記 2つの補助スリットは、前記弁体の底面に向って互 ヽに接近するように形成されて!、るのが好ま 、。 [0013] In the valve body of the present invention, the two auxiliary slits face each other toward the bottom surface of the valve body. It is shaped to approach the heel!
[0014] これにより、長尺部材を弁体に挿入したとき、第 2のスリットの中心部付近に働く内部 応力が好適に分散されるため、第 2のスリットに裂けが生じるのを確実に防止すること ができる。 [0014] Thereby, when the long member is inserted into the valve body, the internal stress acting in the vicinity of the center of the second slit is suitably dispersed, so that the second slit is reliably prevented from being cracked. can do.
[0015] また、本発明の弁体では、前記 2つの補助スリットは、前記弁体の底面に向って互 [0015] Further, in the valve body of the present invention, the two auxiliary slits face each other toward the bottom surface of the valve body.
Vヽに離間するように形成されて!、るのが好ま 、。 V is formed so as to be spaced apart!
[0016] これにより、長尺部材を弁体に挿入したとき、第 2のスリットの中心部付近に働く内部 応力が好適に分散されるため、第 2のスリットに裂けが生じるのを確実に防止すること ができる。 [0016] Thereby, when the long member is inserted into the valve body, the internal stress acting near the center of the second slit is suitably dispersed, so that the second slit is reliably prevented from being cracked. can do.
[0017] また、本発明の弁体では、前記補助スリットは、前記中心部を介してほぼ等距離と なるように設けられて 、るのが好まし!/、。  [0017] In the valve body of the present invention, it is preferable that the auxiliary slits are provided so as to be substantially equidistant through the central portion! /.
[0018] これにより、長尺部材を弁体に挿入したとき、補助スリットが開いて、第 2のスリットの 中心部付近に働く内部応力を分散 (緩和)させることができ、よって、弁体に裂け (亀 裂)が生じるのを防止することができる。 [0018] With this, when the long member is inserted into the valve body, the auxiliary slit is opened, and the internal stress acting near the center of the second slit can be dispersed (relaxed). It can prevent tearing (turtle cracking).
[0019] また、本発明の弁体では、前記補助スリットは、その形状が平面視で一文字状をな しているのが好ましい。 [0019] In the valve body of the present invention, it is preferable that the auxiliary slit has a single letter shape in plan view.
[0020] これにより、補助スリットを簡単な形状 (構成)とすることができ、よって、各補助スリツ ト(開閉部)が容易かつ確実に開閉することができる。  [0020] Thereby, the auxiliary slit can have a simple shape (configuration), and thus each auxiliary slit (opening / closing portion) can be opened and closed easily and reliably.
[0021] また、本発明の弁体では、前記補助スリットは、その形状が平面視で V字状をなして いるのが好ましい。 [0021] Further, in the valve body of the present invention, it is preferable that the auxiliary slit has a V shape in a plan view.
[0022] これにより、補助スリットは、長尺部材が挿入されたときに (挿入状態で)第 2のスリツ トが開く方向に対して傾斜するよう形成されるため、挿入状態で補助スリットが過剰に 開くのを防止することができる。  [0022] Thus, the auxiliary slit is formed so as to be inclined with respect to the opening direction of the second slit (in the inserted state) when the elongated member is inserted, so that the auxiliary slit is excessive in the inserted state. Can be prevented.
[0023] また、本発明の弁体では、前記補助スリットは、その V字における谷部で前記第 2の スリットと交差し、かつ、前記谷部が前記中心部側に位置しているのが好ましい。 [0023] Further, in the valve body of the present invention, the auxiliary slit intersects the second slit at a valley portion in the V shape, and the valley portion is located on the center portion side. preferable.
[0024] これにより、挿入状態の補助スリットは、第 2のスリットに対して、対称的に位置する 部位同士が互いに均等に開くことができる。 [0024] Thereby, the auxiliary slits in the inserted state can be opened equally with respect to each other with respect to the second slit.
[0025] また、本発明の弁体では、前記補助スリットは、その形状が平面視で U字状をなし ているのが好ましい。 [0025] In the valve body of the present invention, the auxiliary slit has a U-shape in plan view. It is preferable.
[0026] これにより、補助スリットは、長尺部材が挿入されたときに (挿入状態で)第 2のスリツ トが開く方向に対して傾斜するよう形成されるため、挿入状態で補助スリットが過剰に 開くのを防止することができる。  [0026] Thereby, the auxiliary slit is formed so as to be inclined with respect to the opening direction of the second slit (in the inserted state) when the long member is inserted, and therefore the auxiliary slit is excessive in the inserted state. Can be prevented.
[0027] また、本発明の弁体では、前記補助スリットは、その U字における谷部で前記第 2の スリットと交差し、かつ、前記谷部が前記中心部側に位置しているのが好ましい。 [0027] Further, in the valve body of the present invention, the auxiliary slit intersects the second slit at a valley portion in the U-shape, and the valley portion is located on the center portion side. preferable.
[0028] これにより、挿入状態の補助スリットは、第 2のスリットに対して、対称的に位置する 部位同士が互いに均等に開くことができる。 [0028] Thereby, the auxiliary slits in the inserted state can be opened equally with respect to each other with respect to the second slit.
[0029] また、本発明の弁体では、前記弁体に対する前記補助スリットの深さは、前記弁体 に対する前記第 2のスリットの深さとほぼ同等であるのが好ましい。 [0029] In the valve body of the present invention, it is preferable that the depth of the auxiliary slit with respect to the valve body is substantially equal to the depth of the second slit with respect to the valve body.
[0030] これにより、長尺部材を弁体に挿入したとき、補助スリットが開いて、第 2のスリットの 中心部付近に働く内部応力を好適に分散させることができ、よって、第 2のスリットに 裂け (亀裂)が生じるのを確実に防止することができる。 [0030] With this, when the long member is inserted into the valve body, the auxiliary slit is opened, and the internal stress acting near the center of the second slit can be suitably dispersed, and thus the second slit It is possible to reliably prevent cracks from occurring.
[0031] また、本発明の弁体では、前記補助スリットは、前記深さが前記補助スリットの長手 方向に対して変化して 、る部分を有するのが好ま 、。 [0031] In the valve body of the present invention, it is preferable that the auxiliary slit has a portion whose depth changes with respect to a longitudinal direction of the auxiliary slit.
[0032] これにより、長尺部材を弁体に挿入したとき、補助スリットが開いて、第 2のスリットの 中心部付近に働く内部応力を好適に分散させることができ、よって、第 2のスリットに 裂け (亀裂)が生じるのを確実に防止することができる。 [0032] With this, when the long member is inserted into the valve body, the auxiliary slit is opened, and the internal stress acting near the center of the second slit can be suitably dispersed, and thus the second slit It is possible to reliably prevent cracks from occurring.
[0033] また、本発明の弁体では、前記第 1のスリットおよび前記第 2のスリットの少なくとも 一方の形状が、平面視で一文字状をなして 、るのが好ま 、。 [0033] In the valve body of the present invention, it is preferable that at least one of the first slit and the second slit has a single letter shape in plan view.
[0034] これ〖こより、当該スリットを簡単な形状 (構成)とすることができ、よって、当該スリット が容易かつ確実に開閉することができる。 Thus, the slit can be formed into a simple shape (configuration), and thus the slit can be opened and closed easily and reliably.
[0035] また、本発明の弁体では、前記長尺部材は、ダイレータ、カテーテルまたはガイドヮ ィャであるのが好ましい。 [0035] In the valve body of the present invention, it is preferable that the elongated member is a dilator, a catheter, or a guide mechanism.
[0036] これにより、当該長尺部材を生体内に導入することができる。 [0036] Thereby, the elongated member can be introduced into the living body.
図面の簡単な説明  Brief Description of Drawings
[0037] [図 1]第 1図は、本発明の弁体を有するイントロデューサを示す部分縦断面図である。  FIG. 1 is a partial longitudinal sectional view showing an introducer having a valve body of the present invention.
[図 2]第 2図は、本発明の弁体の第 1実施形態を示す斜視図である。 [図 3]第 3図は、図 2に示す弁体の平面図である。 FIG. 2 is a perspective view showing a first embodiment of the valve body of the present invention. FIG. 3 is a plan view of the valve body shown in FIG. 2.
[図 4]第 4図は、図 2に示す弁体の下面図である。  FIG. 4 is a bottom view of the valve body shown in FIG. 2.
[図 5]第 5図は、図 2に示す弁体に長尺部材が揷通した状態を示す平面図である。  FIG. 5 is a plan view showing a state in which a long member is passed through the valve body shown in FIG. 2.
[図 6]第 6図は、図 2に示す弁体に長尺部材が揷通した状態を示す下面図である。  6 is a bottom view showing a state in which a long member is passed through the valve body shown in FIG. 2. FIG.
[図 7]第 7図は、本発明の弁体の第 2実施形態を示す側面図である。  FIG. 7 is a side view showing a second embodiment of the valve body of the present invention.
[図 8]第 8図は、本発明の弁体の第 3実施形態を示す側面図である。  FIG. 8 is a side view showing a third embodiment of the valve body of the present invention.
[図 9]第 9図は、本発明の弁体の第 4実施形態を示す下面図である。  FIG. 9 is a bottom view showing a fourth embodiment of the valve body of the present invention.
[図 10]第 10図は、本発明の弁体の第 5実施形態を示す下面図である。  FIG. 10 is a bottom view showing a fifth embodiment of the valve body of the present invention.
[図 11]第 11図は、本発明の弁体の第 6実施形態を示す下面図である。  FIG. 11 is a bottom view showing a sixth embodiment of the valve body of the present invention.
[図 12]第 12図は、本発明の弁体の第 7実施形態を示す下面図である。  FIG. 12 is a bottom view showing a seventh embodiment of the valve body of the present invention.
[図 13]第 13図は、本発明の弁体の第 8実施形態を示す斜視図である。  FIG. 13 is a perspective view showing an eighth embodiment of the valve body of the present invention.
[図 14]第 14図は、本発明の弁体の第 9実施形態を示す斜視図である。  FIG. 14 is a perspective view showing a ninth embodiment of the valve body of the present invention.
発明を実施するための最良の形態  BEST MODE FOR CARRYING OUT THE INVENTION
[0038] 以下、本発明の弁体を、添付図面に示す好適実施例に基づいて詳細に説明する。  Hereinafter, the valve body of the present invention will be described in detail based on preferred embodiments shown in the accompanying drawings.
[0039] <第 1実施形態 >  <First embodiment>
第 1図は、本発明の弁体を有するイントロデューサを示す部分縦断面図、第 2図は 、本発明の弁体の第 1実施形態を示す斜視図、第 3図は、第 2図に示す弁体の平面 図、第 4図は、第 2図に示す弁体の下面図、第 5図は、第 2図に示す弁体に長尺部材 が挿通した状態を示す平面図、第 6図は、第 2図に示す弁体に長尺部材が揷通した 状態を示す下面図である。なお、以下では、説明の都合上、第 1図および第 2図中の 上側を「上」または「基端」、下側を「下」または「先端」として説明する。  FIG. 1 is a partial longitudinal sectional view showing an introducer having the valve body of the present invention, FIG. 2 is a perspective view showing the first embodiment of the valve body of the present invention, and FIG. 3 is shown in FIG. FIG. 4 is a bottom view of the valve body shown in FIG. 2, FIG. 5 is a plan view showing a state in which a long member is inserted into the valve body shown in FIG. The figure is a bottom view showing a state in which a long member is passed through the valve body shown in FIG. In the following, for convenience of explanation, the upper side in FIGS. 1 and 2 will be described as “upper” or “base end”, and the lower side will be described as “lower” or “tip”.
[0040] 第 1図に示すイントロデューサ 1は、例えばガイドワイヤやカテーテル等のような医 療に用いられる長尺部材を生体内(例えば、血管等)に導入するのに使用されるもの である。  [0040] An introducer 1 shown in FIG. 1 is used to introduce a long member used for medical treatment such as a guide wire or a catheter into a living body (for example, a blood vessel or the like). .
[0041] このイントロデューサ 1は、ハブ 2と、ハブ 2の先端側に固定された管状のシースチュ ーブ 4と、封止手段 6とを有するシース 7と、シース 7の生体内への導入を容易にする ためにシース 7に挿入して使用されるダイレータ (拡張管) 10とで構成されている。  [0041] The introducer 1 includes a hub 2, a tubular sheath tube 4 fixed to the distal end side of the hub 2, a sheath 7 having a sealing means 6, and introduction of the sheath 7 into the living body. It is composed of a dilator (expansion tube) 10 that is inserted into the sheath 7 for easy use.
[0042] ハブ 2は、管体で構成されている。 [0043] このハブ 2の外周部には、側方に突出するサイドポート (接続部) 21が設けられてい る。サイドポート 21は、管状をなしており、その中空部(内部) 211がハブ 2内と連通し ている。このサイドポート 21には、例えばポリ塩ィ匕ビニル製の可撓性を有するチュー ブ 8の一端が液密に接続される。 [0042] The hub 2 is composed of a tubular body. [0043] On the outer periphery of the hub 2, a side port (connecting portion) 21 protruding sideways is provided. The side port 21 has a tubular shape, and a hollow portion (inside) 211 communicates with the inside of the hub 2. One end of a flexible tube 8 made of, for example, polyvinyl chloride / vinyl is connected to the side port 21 in a liquid-tight manner.
[0044] シースチューブ 4は、生体内に導入される部材であり、薄肉の管状部材で構成され ている。このシースチューブ 4は、その基端部がハブ 2の先端部に嵌入されている。  [0044] The sheath tube 4 is a member introduced into the living body, and is formed of a thin-walled tubular member. The sheath tube 4 has a proximal end portion fitted into a distal end portion of the hub 2.
[0045] ハブ 2の基端部には、ハブ 2内を封止する封止手段 6が設けられている。  [0045] A sealing means 6 for sealing the inside of the hub 2 is provided at the base end portion of the hub 2.
[0046] 封止手段 6は、ダイレータ(拡張管) 10やカテーテルある 、はガイドワイヤが通過可 能な弁体 61と、当該弁体 61をノ、ブ 2に対し支持固定する有底筒状の蓋部材 64とで 構成されている。  [0046] The sealing means 6 is a dilator (expansion tube) 10 or a catheter, or a valve body 61 through which a guide wire can pass, and a bottomed cylindrical shape that supports and fixes the valve body 61 to the sleeve 2 And the lid member 64.
[0047] 蓋部材 64は、ハブ 2の基端外周部 22に嵌合して装着されて 、る。この蓋部材 64の 底部 641には、ダイレータ 10やカテーテルあるいはガイドワイヤが揷通可能な挿入 口 65が形成されている。  The lid member 64 is fitted and attached to the base end outer peripheral portion 22 of the hub 2. At the bottom 641 of the lid member 64, an insertion port 65 through which the dilator 10, catheter or guide wire can be passed is formed.
[0048] ここで、ダイレータ 10について説明する。  [0048] Here, the dilator 10 will be described.
[0049] ダイレータ 10は、可撓性を有する管体 (チューブ)で構成されて ヽる。このダイレー タ 10は、シース 7に挿入され、シース 7に固定された状態で生体内へ挿入 (導入)さ れる。また、ダイレータ 10は、例えば血管への導入を容易にするため、ダイレータ 10 の先端部 101が先端に向力つて縮径している。  [0049] The dilator 10 is composed of a flexible tube (tube). The dilator 10 is inserted into the sheath 7 and inserted (introduced) into the living body while being fixed to the sheath 7. Further, in the dilator 10, for example, in order to facilitate introduction into a blood vessel, the tip portion 101 of the dilator 10 is reduced in diameter by directing the tip.
[0050] このようなダイレータ 10は、シースチューブ 4が生体(血管)内に挿入された後、シ ース 7から抜去される。その後、揷入口 65からカテーテルあるいはガイドワイヤが挿入 される。  [0050] Such a dilator 10 is removed from the sheath 7 after the sheath tube 4 is inserted into the living body (blood vessel). Thereafter, a catheter or guide wire is inserted through the sputum inlet 65.
[0051] さて、前述したように、封止手段 6は、弁体 61を有している。  [0051] As described above, the sealing means 6 has the valve body 61.
[0052] 第 2図に示すように、弁体 61は、円形の膜状(円盤状)をなす弾性体で構成されて いる。この弁体 61は、ハブ 2の基端面 23と蓋部材 64の底部 641とで挟持されること により、ハブ 2に対し液密に固定されている(第 1図参照)。  As shown in FIG. 2, the valve body 61 is formed of an elastic body having a circular film shape (disk shape). The valve body 61 is fixed in a liquid-tight manner to the hub 2 by being sandwiched between the base end face 23 of the hub 2 and the bottom portion 641 of the lid member 64 (see FIG. 1).
[0053] 弁体 61は、ダイレータ 10の挿入.抜去に伴って開閉する開閉部 66を有している( 第 3図〜第 6図参照)。  The valve body 61 has an opening / closing part 66 that opens and closes as the dilator 10 is inserted and removed (see FIGS. 3 to 6).
[0054] 第 2図に示すように、開閉部 66は、第 1のスリット 62と、第 2のスリット 63と、 2つの補 助スリット 67、 67とで構成されている。 [0054] As shown in FIG. 2, the opening / closing portion 66 includes a first slit 62, a second slit 63, and two complementary slits. It consists of auxiliary slits 67 and 67.
[0055] 第 1のスリット 62は、弁体 61の内部力も弁体 61の上面(頂面) 68にのみ到達するよ うに形成されている。また、この第 1のスリット 62は、その形状が平面視で一文字状を なしている(第 3図参照)。これにより、第 1のスリット 62を簡単な形状 (構成)とすること ができ、よって、第 1のスリット 62 (開閉部 66)が容易かつ確実に開閉することができる The first slit 62 is formed so that the internal force of the valve body 61 also reaches only the upper surface (top surface) 68 of the valve body 61. The first slit 62 has a single letter shape in plan view (see FIG. 3). As a result, the first slit 62 can have a simple shape (configuration), and thus the first slit 62 (opening / closing portion 66) can be opened and closed easily and reliably.
[0056] なお、第 1のスリット 62の深さは、特に限定されず、例えば、弁体 61の厚さの 40〜 9 0%程度が好ましぐ 40〜70%程度がより好ましい。 [0056] The depth of the first slit 62 is not particularly limited. For example, about 40 to 90% of the thickness of the valve body 61 is preferable, and about 40 to 70% is more preferable.
[0057] 第 2のスリット 63は、弁体 61の内部力も弁体 61の下面 (底面) 69にのみ到達するよ うに形成されている。また、この第 2のスリット 63は、その形状が平面視で一文字状を なしている(第 4図参照)。これにより、第 2のスリット 63を簡単な形状 (構成)とすること ができ、よって、第 2のスリット 63 (開閉部 66)が容易かつ確実に開閉することができる  The second slit 63 is formed so that the internal force of the valve body 61 can reach only the lower surface (bottom surface) 69 of the valve body 61. The second slit 63 has a single letter shape in plan view (see FIG. 4). As a result, the second slit 63 can have a simple shape (configuration), and therefore the second slit 63 (opening / closing portion 66) can be easily and reliably opened and closed.
[0058] なお、第 2のスリット 63の深さは、特に限定されず、例えば、弁体 61の厚さの 40〜9[0058] The depth of the second slit 63 is not particularly limited. For example, the depth of the valve body 61 is 40-9.
0%程度が好ましぐ 40〜70%程度がより好ましい。 About 0% is preferable. About 40 to 70% is more preferable.
[0059] また、このような第 1のスリット 62と第 2のスリット 63とは、弁体 61の内部において部 分的に交差している。図示の構成では、両スリット 62、 63は、十文字状に交差してい る、すなわち、両スリット 62、 63の交差角度は、 90° となっている力 この交差角度 は、 90° に限定されない。 In addition, the first slit 62 and the second slit 63 as described above partially intersect with each other inside the valve body 61. In the configuration shown in the figure, the slits 62 and 63 intersect with each other in a cross shape, that is, the crossing angle between the slits 62 and 63 is 90 °. The crossing angle is not limited to 90 °.
[0060] なお、第 1のスリット 62と第 2のスリット 63との交差部の長さ L (第 2図参照)は、特に 限定されないが、例えば、弁体 61の厚さの 20〜50%程度が好ましぐ 30〜40%程 度がより好ましい。 [0060] The length L (see Fig. 2) of the intersection between the first slit 62 and the second slit 63 is not particularly limited, but is, for example, 20 to 50% of the thickness of the valve body 61 About 30 to 40% is preferable.
[0061] 2つの補助スリット 67および 67は、それぞれ、弁体 61の内部から下面 69にのみ到 達している。また、両補助スリット 67および 67は、第 2のスリット 63の中心部 631から ほぼ等距離の位置に形成されており、その位置で第 2のスリット 63のみと交差してい る (第 2図、第 4図参照)。  [0061] The two auxiliary slits 67 and 67 reach only the lower surface 69 from the inside of the valve body 61, respectively. The auxiliary slits 67 and 67 are formed at substantially the same distance from the central portion 631 of the second slit 63 and intersect only the second slit 63 at that position (FIG. 2, (See Figure 4).
[0062] 図示の構成では、各補助スリット 67と第 2のスリット 63とは、十文字状に交差して!/ヽ る、すなわち、各補助スリット 67と第 2のスリット 63との交差角度は、 90° となっている 。換言すれば、両補助スリット 67および 67は、それぞれ、第 1のスリット 62と平行とな るように形成され、第 2のスリット 63と交差している。 In the illustrated configuration, each auxiliary slit 67 and the second slit 63 intersect with each other in a cross shape! That is, the intersection angle between each auxiliary slit 67 and the second slit 63 is: 90 ° . In other words, both auxiliary slits 67 and 67 are formed so as to be parallel to the first slit 62 and intersect the second slit 63.
[0063] 以上のような構成の補助スリット 67を設けることにより、ダイレータ 10を弁体 61に挿 入したとき、各補助スリット 67が開いて、第 2のスリット 63の中心部 631付近に働く内 部応力を分散 (緩和)させることができ、よって、第 2のスリット 63 (弁体 61)に裂け (亀 裂)が生じるのを防止することができる (第 6図参照)。  [0063] By providing the auxiliary slit 67 having the above-described configuration, when the dilator 10 is inserted into the valve body 61, each auxiliary slit 67 opens and works near the central portion 631 of the second slit 63. It is possible to disperse (relax) the partial stress, and thus it is possible to prevent the second slit 63 (valve element 61) from cracking (cracking) (see FIG. 6).
[0064] 従って、例えば、シース 7にダイレータ 10を挿通した状態 (第 1図に示す状態。以下 、この状態を「組立状態」という)を、長期間維持したとしても、前述したように弁体 61 に裂けが生じるのが防止されているため、シース 7とダイレータ 10とを組立状態で出 荷 (販売)することができる。  Therefore, for example, even if the state in which the dilator 10 is inserted through the sheath 7 (the state shown in FIG. 1; hereinafter, this state is referred to as “assembled state”) is maintained for a long time, Since tearing of 61 is prevented, the sheath 7 and the dilator 10 can be shipped (sold) in an assembled state.
[0065] また、弁体 61 (開閉部 66)にダイレータ 10を挿入したときには、第 1のスリット 62、第 2のスリット 63のみならず、各補助スリット 67も開く(第 6図参照)。これにより、ダイレー タ 10が開閉部 66を通過し易くなる、すなわち、ダイレータ 10の外周面 102と弁体 61 との摺動抵抗が低減 (軽減)する。  [0065] When the dilator 10 is inserted into the valve body 61 (opening / closing part 66), not only the first slit 62 and the second slit 63 but also the auxiliary slits 67 are opened (see FIG. 6). As a result, the dilator 10 can easily pass through the opening / closing portion 66, that is, the sliding resistance between the outer peripheral surface 102 of the dilator 10 and the valve body 61 is reduced (reduced).
[0066] 第 4図に示すように、各補助スリット 67は、その形状が平面視で一文字状をなして いる。これにより、各補助スリット 67を簡単な形状 (構成)とすることができ、よって、各 補助スリット 67 (開閉部 66)が容易かつ確実に開閉することができる。  [0066] As shown in FIG. 4, each auxiliary slit 67 has a single letter shape in plan view. As a result, each auxiliary slit 67 can have a simple shape (configuration), and thus each auxiliary slit 67 (opening / closing portion 66) can be opened and closed easily and reliably.
[0067] なお、第 2図に示すように、補助スリット 67の深さは、第 2のスリット 63の深さとほぼ 同等であるのが好ましいが、これに限定されず、例えば、第 2のスリット 63の深さより 深くてもよいし、第 2のスリット 63の深さより浅くてもよい。補助スリット 67の深さが第 2 のスリット 63の深さとほぼ同等である場合には、前記内部応力を好適に分散させるこ とができ、よって、第 2のスリット 63に裂け (亀裂)が生じるのを確実に防止することが できる。  [0067] Note that, as shown in FIG. 2, the depth of the auxiliary slit 67 is preferably substantially the same as the depth of the second slit 63, but is not limited to this, for example, the second slit 63 It may be deeper than the depth of 63 or shallower than the depth of the second slit 63. When the depth of the auxiliary slit 67 is substantially equal to the depth of the second slit 63, the internal stress can be suitably dispersed, and thus the second slit 63 is torn (cracked). Can be surely prevented.
[0068] また、第 2図に示すように、各補助スリット 67は、その両端部 678および 678が第 2 のスリット 63との交差部 677からの長さが等しくなるように形成されているのが好まし いが、これに限定されず、前記長さが異なるように形成されていてもよい。  Further, as shown in FIG. 2, each auxiliary slit 67 is formed such that both end portions 678 and 678 are equal in length from the intersection 677 with the second slit 63. However, the length is not limited to this, and the lengths may be different.
[0069] また、弁体 61の構成材料としては、特に限定されず、例えば、天然ゴム、またはイソ プレンゴム、シリコーンゴム、ウレタンゴム、スチレン ブタジエンゴム、フッ素ゴム、ァ クリルゴム等の各種合成ゴム、ポリアミド系、ポリエステル系等の各種熱可塑性エラス トマ一等の弾性材料が挙げられる。 [0069] The constituent material of the valve body 61 is not particularly limited. For example, natural rubber, isoprene rubber, silicone rubber, urethane rubber, styrene butadiene rubber, fluorine rubber, Examples include elastic materials such as various synthetic rubbers such as krill rubber, various thermoplastic elastomers such as polyamide and polyester.
[0070] このような構成の弁体 61を用いることにより、弁体 61にダイレータ 10を揷通(挿入) していないときはもちろんのこと、ダイレータ 10を挿通したときでも、液密性が確保さ れ、ハブ 2内に満たされた液体 (例えば、血液)の漏れを確実に防止することができる  [0070] By using the valve body 61 having such a configuration, liquid tightness is ensured not only when the dilator 10 is not inserted (inserted) into the valve body 61 but also when the dilator 10 is inserted. It is possible to reliably prevent leakage of the liquid (for example, blood) filled in the hub 2.
[0071] 第 5図および第 6図に示すように、ダイレータ 10の挿入に際しては、第 1のスリット 6[0071] As shown in FIGS. 5 and 6, when the dilator 10 is inserted, the first slit 6
2および第 2のスリット 63が、それぞれ、ダイレータ 10の外周面 102に異なる方向から 密着し、摺動するため、弁体 61にダイレータ 10が挿通された状態でも、液密性が確 保され、血液等の漏れ出しが有効に防止される。 Since the second and second slits 63 are in close contact with the outer peripheral surface 102 of the dilator 10 from different directions and slide, the liquid tightness is ensured even when the dilator 10 is inserted through the valve body 61. Leakage of blood etc. is effectively prevented.
[0072] また、第 3図および第 4図に示すように、ダイレータ 10を弁体 61 (イントロデューサ 1Further, as shown in FIGS. 3 and 4, the dilator 10 is replaced with a valve body 61 (introducer 1
)力も抜去したときには、弁体 61は、その弾性により瞬時に元の形状に復元し、すな わち、第 1のスリット 62、第 2のスリット 63および補助スリット 67が瞬時に閉じ、液密性 を発揮して液漏れを防止する。 ) When the force is also removed, the valve body 61 is instantly restored to its original shape due to its elasticity, that is, the first slit 62, the second slit 63 and the auxiliary slit 67 are instantly closed and liquid tight. To prevent liquid leakage.
[0073] なお、イントロデューサ 1では、補助スリット 67が形成された面(下面 69)が基端側に 位置するように弁体 61を配置していたが、それに限定されず、補助スリット 67が形成 された面が先端側に位置するように弁体 61を配置してもよ 、。 [0073] In the introducer 1, the valve body 61 is arranged so that the surface (the lower surface 69) on which the auxiliary slit 67 is formed is located on the base end side. The valve body 61 may be arranged so that the formed surface is located on the tip side.
[0074] また、弁体 61を介して、シース 7内に挿入されるものとしては、ダイレータ 10である のに限定されず、例えば、カテーテル、ガイドワイヤであってもよい。 [0074] Further, what is inserted into the sheath 7 via the valve body 61 is not limited to the dilator 10, but may be a catheter or a guide wire, for example.
[0075] <第 2実施形態 > [0075] <Second Embodiment>
第 7図は、本発明の弁体の第 2実施形態を示す側面図である。  FIG. 7 is a side view showing a second embodiment of the valve body of the present invention.
[0076] 以下、この図を参照して本発明の弁体の第 2実施形態について説明するが、前述 した実施形態との相違点を中心に説明し、同様の事項はその説明を省略する。 Hereinafter, the second embodiment of the valve body of the present invention will be described with reference to this figure, but the description will focus on the differences from the above-described embodiment, and the description of the same matters will be omitted.
[0077] 本実施形態は、補助スリットの形成状態が異なること以外は前記第 1実施形態と同 様である。 [0077] This embodiment is the same as the first embodiment except that the formation state of the auxiliary slits is different.
[0078] 第 7図に示すように、 2つの補助スリット 67A、 67Aは、第 1のスリット 62に対して傾 斜している、すなわち、基端側(下面 69側)に向って互いに接近するように形成され ている。これにより、各補助スリット 67Aの基端側を第 2のスリット 63の中心部 631に 近づけることができ、よって、ダイレータ 10が挿入されたとき(以下、このときの状態を 「挿入状態」という)の中心部 631の基端部(下面 69)付近の内部応力が好適に分散 されるため、第 2のスリット 63に裂けが生じるのを確実に防止することができる。 As shown in FIG. 7, the two auxiliary slits 67A and 67A are inclined with respect to the first slit 62, that is, approach each other toward the base end side (lower surface 69 side). It is formed as follows. As a result, the base end side of each auxiliary slit 67A is moved to the central portion 631 of the second slit 63. Therefore, when the dilator 10 is inserted (hereinafter, this state is referred to as “inserted state”), the internal stress near the base end portion (lower surface 69) of the central portion 631 is preferably dispersed. Therefore, it is possible to reliably prevent the second slit 63 from tearing.
[0079] なお、第 1のスリット 62に対する各補助スリット 67Aの傾斜角度 (第 7図中、 Θ で示 す角度)は、特に限定されず、例えば、 30〜70° であるの力好ましく、 40〜60° で あるのがより好ましい。 [0079] The inclination angle of each auxiliary slit 67A with respect to the first slit 62 (the angle indicated by Θ in Fig. 7) is not particularly limited, and is preferably a force of 30 to 70 °, for example. More preferably, it is ˜60 °.
[0080] また、 2つ傾斜角度 Θ は、同等であるのに限定されず、互いに異なっていてもよい  [0080] Further, the two inclination angles Θ are not limited to being equivalent, and may be different from each other.
[0081] <第 3実施形態 > [0081] <Third Embodiment>
第 8図は、本発明の弁体の第 3実施形態を示す側面図である。  FIG. 8 is a side view showing a third embodiment of the valve body of the present invention.
[0082] 以下、この図を参照して本発明の弁体の第 3実施形態について説明するが、前述 した実施形態との相違点を中心に説明し、同様の事項はその説明を省略する。 Hereinafter, the third embodiment of the valve body of the present invention will be described with reference to this figure, but the description will focus on differences from the above-described embodiment, and the description of the same matters will be omitted.
[0083] 本実施形態は、補助スリットの形成状態が異なること以外は前記第 1実施形態と同 様である。 [0083] This embodiment is the same as the first embodiment except that the formation state of the auxiliary slits is different.
[0084] 第 8図に示すように、 2つの補助スリット 67B、 67Bは、第 1のスリット 62に対して傾 斜している、すなわち、基端側(下面 69側)に向って互いに離間するように形成され ている。これにより、ダイレータ 10の挿入方向(上面 68から下面 69に向う方向)に沿 つて、両補助スリット 67B、 67B間の間隔が大きく(広く)なるため、挿入状態のとき、 開閉部 66が開き易くなる。  [0084] As shown in FIG. 8, the two auxiliary slits 67B and 67B are inclined with respect to the first slit 62, that is, separated from each other toward the base end side (the lower surface 69 side). It is formed as follows. As a result, the distance between the auxiliary slits 67B and 67B is increased (widened) along the insertion direction of the dilator 10 (the direction from the upper surface 68 to the lower surface 69). Become.
[0085] なお、第 1のスリット 62に対する各補助スリット 67Bの傾斜角度 (第 8図中、 Θ で示  [0085] Note that the angle of inclination of each auxiliary slit 67B with respect to the first slit 62 (indicated as Θ in FIG. 8).
2 す角度)は、特に限定されず、例えば、 30〜70° であるの力好ましく、 40〜60° で あるのがより好ましい。  2 angle) is not particularly limited, and is, for example, preferably a force of 30 to 70 °, and more preferably 40 to 60 °.
[0086] また、 2つ傾斜角度 Θ は、同等であるのに限定されず、互いに異なっていてもよい  [0086] Further, the two inclination angles Θ are not limited to being equal, but may be different from each other.
2  2
[0087] <第 4実施形態 > [0087] <Fourth embodiment>
第 9図は、本発明の弁体の第 4実施形態を示す下面図である。  FIG. 9 is a bottom view showing a fourth embodiment of the valve body of the present invention.
[0088] 以下、この図を参照して本発明の弁体の第 4実施形態について説明するが、前述 した実施形態との相違点を中心に説明し、同様の事項はその説明を省略する。 [0089] 本実施形態は、補助スリットの形状が異なること以外は前記第 1実施形態と同様で ある。 Hereinafter, the fourth embodiment of the valve body of the present invention will be described with reference to this figure, but the description will focus on the differences from the above-described embodiment, and the description of the same matters will be omitted. This embodiment is the same as the first embodiment except that the shape of the auxiliary slit is different.
[0090] 第 9図に示すように、各補助スリット 67Cは、その形状が平面視で V字状をなしてい る。これにより、各補助スリット 67Cは、ダイレータ 10が挿入されたときに第 2のスリット 63が開く方向(第 9図中、上下方向)に対して傾斜するよう形成されるため、挿入状 態で各補助スリット 67Cが過剰に開くのを防止することができる。  [0090] As shown in Fig. 9, each auxiliary slit 67C has a V-shape in plan view. Accordingly, each auxiliary slit 67C is formed so as to be inclined with respect to the direction in which the second slit 63 opens when the dilator 10 is inserted (the vertical direction in FIG. 9). It is possible to prevent the auxiliary slit 67C from opening excessively.
[0091] また、各補助スリット 67Cは、その V字における谷部 671で、第 2のスリット 63と交差 し、かつ、谷部 671が第 2のスリット 63の中心部 631側に位置している。これにより、 挿入状態の各補助スリット 67Cは、第 2のスリット 63に対して、図中の上側の部位 672 と下側の部位 673とが互いに均等に開くことができる。  [0091] Each auxiliary slit 67C is a valley 671 in the V-shape, intersects with the second slit 63, and the valley 671 is located on the center 631 side of the second slit 63. . Thereby, each of the auxiliary slits 67C in the inserted state can open the upper part 672 and the lower part 673 in the figure equally with respect to the second slit 63.
[0092] <第 5実施形態 >  [0092] <Fifth Embodiment>
第 10図は、本発明の弁体の第 5実施形態を示す下面図である。  FIG. 10 is a bottom view showing a fifth embodiment of the valve body of the present invention.
[0093] 以下、この図を参照して本発明の弁体の第 5実施形態について説明するが、前述 した実施形態との相違点を中心に説明し、同様の事項はその説明を省略する。  Hereinafter, the fifth embodiment of the valve body of the present invention will be described with reference to this figure, but the description will focus on the differences from the above-described embodiment, and the description of the same matters will be omitted.
[0094] 本実施形態は、補助スリットの形成位置が異なること以外は前記第 4実施形態と同 様である。  [0094] The present embodiment is the same as the fourth embodiment except that the formation position of the auxiliary slit is different.
[0095] 第 10図に示すように、各補助スリット 67Dの谷部 671は、第 2のスリット 63の端部 63 2と交差している。すなわち、第 2のスリット 63は、その端部 632 (または途中)におい て複数 (本実施形態では、 2つ)に分岐した補助スリット 67Dおよび 67Dを有している 。これにより、挿入状態で両端部 632、 632がそれぞれ大きく開くことができ、よって、 ダイレータ 10が容易に弁体 61を挿通することができる。  As shown in FIG. 10, the valley 671 of each auxiliary slit 67 D intersects the end 63 2 of the second slit 63. That is, the second slit 63 has auxiliary slits 67D and 67D branched into a plurality (two in the present embodiment) at the end 632 (or halfway). As a result, both end portions 632 and 632 can be largely opened in the inserted state, and thus the dilator 10 can easily insert the valve body 61.
[0096] なお、前記第 4実施形態では、補助スリットが第 2のスリットの端部から 3つに分岐す るように形成されて ヽるとも言うことができる。  [0096] In the fourth embodiment, it can also be said that the auxiliary slit is formed so as to branch into three from the end of the second slit.
[0097] <第 6実施形態 >  [0097] <Sixth Embodiment>
第 11図は、本発明の弁体の第 6実施形態を示す下面図である。  FIG. 11 is a bottom view showing a sixth embodiment of the valve body of the present invention.
[0098] 以下、この図を参照して本発明の弁体の第 6実施形態について説明するが、前述 した実施形態との相違点を中心に説明し、同様の事項はその説明を省略する。  Hereinafter, the sixth embodiment of the valve body of the present invention will be described with reference to this figure. However, the difference from the above-described embodiment will be mainly described, and description of similar matters will be omitted.
[0099] 本実施形態は、補助スリットの形状が異なること以外は前記第 1実施形態と同様で ある。 [0099] This embodiment is the same as the first embodiment except that the shape of the auxiliary slit is different. is there.
[0100] 第 11図に示すように、各補助スリット 67Eは、その形状が平面視で U字状をなして いる。これにより、各補助スリット 67Eは、ダイレータ 10が挿入されたときに第 2のスリツ ト 63が開く方向(第 9図中、上下方向)に対して傾斜するよう形成されるため、挿入状 態で各補助スリット 67Eが過剰に開くのを防止することができる。  [0100] As shown in Fig. 11, each auxiliary slit 67E has a U-shape in plan view. Thus, each auxiliary slit 67E is formed so as to be inclined with respect to the direction in which the second slit 63 opens (the vertical direction in FIG. 9) when the dilator 10 is inserted. Each auxiliary slit 67E can be prevented from opening excessively.
[0101] また、各補助スリット 67Eは、その U字における谷部 674で、第 2のスリット 63と交差 し、かつ、谷部 674が第 2のスリット 63の中心部 631側に位置している。これにより、 挿入状態の各補助スリット 67Eは、第 2のスリット 63に対して、図中の上側の部位 675 と下側の部位 676とが互いに均等に開くことができる。  [0101] Each auxiliary slit 67E is a valley 674 in the U-shape, intersects the second slit 63, and the valley 674 is located on the center 631 side of the second slit 63. . As a result, each of the auxiliary slits 67E in the inserted state can open the upper part 675 and the lower part 676 in the figure equally with respect to the second slit 63.
[0102] <第 7実施形態 >  [0102] <Seventh embodiment>
第 12図は、本発明の弁体の第 7実施形態を示す下面図である。  FIG. 12 is a bottom view showing a seventh embodiment of the valve body of the present invention.
[0103] 以下、この図を参照して本発明の弁体の第 7実施形態について説明するが、前述 した実施形態との相違点を中心に説明し、同様の事項はその説明を省略する。  [0103] Hereinafter, the seventh embodiment of the valve body of the present invention will be described with reference to this figure, but the description will focus on differences from the above-described embodiment, and the description of the same matters will be omitted.
[0104] 本実施形態は、補助スリットの形成位置が異なること以外は前記第 6実施形態と同 様である。  [0104] The present embodiment is the same as the sixth embodiment except that the formation positions of the auxiliary slits are different.
[0105] 第 12図に示すように、各補助スリット 67Fの谷部 674は、第 2のスリット 63の端部 63 2と交差している。すなわち、第 2のスリット 63は、その端部 632 (または途中)におい て複数 (本実施形態では、 2つ)に分岐した補助スリット 67Fおよび 67Fを有している 。これにより、挿入状態で両端部 632、 632がそれぞれ大きく開くことができ、よって、 ダイレータ 10が容易に弁体 61を挿通することができる。  As shown in FIG. 12, the valley 674 of each auxiliary slit 67 F intersects the end 63 2 of the second slit 63. That is, the second slit 63 has auxiliary slits 67F and 67F branched into a plurality (two in the present embodiment) at the end 632 (or halfway). As a result, both end portions 632 and 632 can be largely opened in the inserted state, and thus the dilator 10 can easily insert the valve body 61.
[0106] なお、前記第 6実施形態では、各補助スリットが第 2のスリットの端部力 3つに分岐 するように形成されて ヽるとも言うことができる。  In the sixth embodiment, it can also be said that each auxiliary slit is formed so as to be branched into three end forces of the second slit.
[0107] <第 8実施形態 >  <Eighth Embodiment>
第 13図は、本発明の弁体の第 8実施形態を示す斜視図である。  FIG. 13 is a perspective view showing an eighth embodiment of the valve body of the present invention.
[0108] 以下、この図を参照して本発明の弁体の第 8実施形態について説明するが、前述 した実施形態との相違点を中心に説明し、同様の事項はその説明を省略する。  Hereinafter, the eighth embodiment of the valve body of the present invention will be described with reference to this drawing. However, the description will focus on the differences from the above-described embodiment, and the description of the same matters will be omitted.
[0109] 本実施形態は、補助スリットの形状が異なること以外は前記第 1実施形態と同様で ある。 [0110] 第 13図に示すように、各補助スリット 67Gは、その深さが補助スリットの長手方向に 対して変化している、すなわち、深さが端部 678から交差部 677に向って増カロ (漸増 )している。また、図示の構成では、各補助スリット 67G深さは、端部 678でほぼ零と なっている。 This embodiment is the same as the first embodiment except that the shape of the auxiliary slit is different. [0110] As shown in FIG. 13, the depth of each auxiliary slit 67G changes with respect to the longitudinal direction of the auxiliary slit, that is, the depth increases from the end 678 toward the intersection 677. Caro (gradual increase). In the illustrated configuration, the depth of each auxiliary slit 67G is almost zero at the end 678.
[0111] このような構成の補助スリット 67Gにより、挿入状態で、前記内部応力を好適に分散 させることができ、よって、第 2のスリット 63に裂け (亀裂)が生じるのを確実に防止す ることがでさる。  [0111] The auxiliary slit 67G having such a configuration can favorably disperse the internal stress in the inserted state, thereby reliably preventing the second slit 63 from cracking (cracking). That's right.
[0112] なお、本実施形態では、各補助スリット 67Gの最大深さが第 2のスリット 63の深さと ほぼ同等となっている。  In the present embodiment, the maximum depth of each auxiliary slit 67G is substantially equal to the depth of the second slit 63.
[0113] <第 9実施形態 >  [0113] <Ninth embodiment>
第 14図は、本発明の弁体の第 9実施形態を示す斜視図である。  FIG. 14 is a perspective view showing a ninth embodiment of the valve body of the present invention.
[0114] 以下、この図を参照して本発明の弁体の第 9実施形態について説明するが、前述 した実施形態との相違点を中心に説明し、同様の事項はその説明を省略する。 Hereinafter, the ninth embodiment of the valve body of the present invention will be described with reference to this figure, but the description will focus on the differences from the above-described embodiment, and the description of the same matters will be omitted.
[0115] 本実施形態は、補助スリットの形状が異なること以外は前記第 1実施形態と同様で ある。 [0115] The present embodiment is the same as the first embodiment except that the shape of the auxiliary slit is different.
[0116] 第 14図に示すように、各補助スリット 67Hは、その深さが補助スリットの長手方向に 対して変化している、すなわち、深さが部分的に漸減している。  As shown in FIG. 14, the depth of each auxiliary slit 67H changes with respect to the longitudinal direction of the auxiliary slit, that is, the depth gradually decreases partially.
[0117] このような構成の補助スリット 67Hにより、挿入状態で、前記内部応力を好適に分散 させることができ、よって、第 2のスリット 63に裂け (亀裂)が生じるのを確実に防止す ることがでさる。  [0117] With the auxiliary slit 67H having such a configuration, the internal stress can be suitably dispersed in the inserted state, and thus it is possible to reliably prevent the second slit 63 from being cracked. That's right.
[0118] 以上、本発明の弁体を図示の実施形態について説明したが、本発明は、これに限 定されるものではなぐ弁体を構成する各部は、同様の機能を発揮し得る任意の構成 のものと置換することができる。また、任意の構成物が付加されていてもよい。  [0118] Although the illustrated embodiment of the valve body of the present invention has been described above, the present invention is not limited to this, and each part constituting the valve body may be any arbitrary one that can exhibit the same function. It can be replaced with that of the configuration. Moreover, arbitrary components may be added.
[0119] また、本発明の弁体は、前記各実施形態のうちの、任意の 2以上の構成 (特徴)を 組み合わせたものであってもよ!/、。  [0119] Further, the valve body of the present invention may be a combination of any two or more configurations (features) of the above embodiments! /.
[0120] 例えば、前記第 4実施形態の補助スリットが、それぞれ、前記第 2実施形態または 前記第 3実施形態の補助スリットのように傾斜して 、てもよ 、。  [0120] For example, the auxiliary slits of the fourth embodiment may be inclined like the auxiliary slits of the second embodiment or the third embodiment, respectively.
[0121] また、前記第 5実施形態の補助スリットが、それぞれ、前記第 2実施形態または前記 第 3実施形態の補助スリットのように傾斜して 、てもよ 、。 [0121] Further, the auxiliary slits of the fifth embodiment are respectively the second embodiment or the It may be inclined like the auxiliary slit of the third embodiment.
[0122] また、前記第 5実施形態の補助スリットが、前記第 1実施形態の補助スリットのよう〖こ 平面視での形状が一文字状をなして 、てもよ 、。 [0122] In addition, the auxiliary slit of the fifth embodiment may have a single letter shape in plan view like the auxiliary slit of the first embodiment.
[0123] また、弁体に挿入 '抜去されるものとしては、管体 (ダイレータ)のような中空のもので あるのに限定されず、例えば、中実のものであってもよい。 [0123] Further, what is inserted into and removed from the valve body is not limited to a hollow body such as a pipe body (dilator), and may be, for example, a solid body.
[0124] また、補助スリットの形成数は、 2つであるのに限定されず、例えば、 1つまたは 3つ 以上であってもよい。 [0124] The number of auxiliary slits formed is not limited to two, and may be one or three or more, for example.
[0125] また、第 1のスリットおよび第 2のスリットは、それぞれの形状が平面視で一文字状を なしているのに限定されず、例えば、第 1のスリットのみ一文字状をなしていてもよい し、第 2のスリットのみ一文字状をなしていてもよい。  [0125] Further, the first slit and the second slit are not limited to a single letter shape in plan view, and for example, only the first slit may be a single letter shape. However, only the second slit may have a single letter shape.
実施例  Example
[0126] 次に、本発明の弁体の具体的実施例について説明する。  Next, specific examples of the valve body of the present invention will be described.
[0127] 1.シース(イントロデューサ)の作製 [0127] 1. Fabrication of sheath (introducer)
(実施例 1)  (Example 1)
シリコーンゴムを用いて、第 2図〜第 4図に示す弁体を作製し、この弁体を装着して 、第 1図に示すシース (イントロデューサ)を作製した。  A valve body shown in FIGS. 2 to 4 was produced using silicone rubber, and a sheath (introducer) shown in FIG. 1 was produced by mounting this valve body.
[0128] (実施例 2) [0128] (Example 2)
シリコーンゴムを用いて、第 9図に示す弁体を作製し、この弁体を装着して、第 1図 に示すシースを作製した。  The valve body shown in FIG. 9 was produced using silicone rubber, and the sheath shown in FIG. 1 was produced by mounting this valve body.
[0129] (比較例) [0129] (Comparative example)
補助スリットを省略した以外は、前記実施例 1と同様の弁体を作製し、この弁体を装 着して、第 1図に示すシースを作製した。  Except for omitting the auxiliary slit, a valve body similar to that of Example 1 was prepared, and this valve body was attached to manufacture the sheath shown in FIG.
[0130] 2.評価 [0130] 2. Evaluation
各実施例および比較例で作製したシースに、それぞれ、ダイレータを挿入し、第 1 図に示す状態で、オーブンで加温した。なお、加温の条件は、 60°C X 13時間とした  Dilators were inserted into the sheaths produced in each of the examples and comparative examples, and heated in an oven in the state shown in FIG. The heating conditions were 60 ° C x 13 hours.
[0131] 加温終了後、各実施例および比較例で作製した管体導入器具力 ダイレータを抜 去し、弁体を取り出した。そして、各弁体について、それぞれ、第 2のスリットの状態を 目視にて確認した。 [0131] After the heating was completed, the tubular body introduction device force dilator produced in each of the examples and the comparative examples was removed, and the valve body was removed. Then, for each valve body, the state of the second slit is set. It was confirmed visually.
[0132] その結果、各実施例の弁体では、いずれも、第 2のスリットの裂けは、認められなか つた o  [0132] As a result, in each of the valve bodies of each of the examples, the second slit was not torn. O
[0133] これに対し、比較例の弁体では、第 2のスリットに明らかな裂けが認められた。  [0133] On the other hand, in the comparative valve body, a clear tear was observed in the second slit.
産業上の利用可能性  Industrial applicability
[0134] 本発明の弁体は、弾性材料で構成され、長尺部材の挿入 '抜去に伴って開閉する 複数のスリットで構成された開閉部を有する弁体であって、前記開閉部は、前記弁体 の内部力 該弁体の頂面にのみ到達する第 1のスリットと、前記内部から前記弁体の 底面にのみ到達し、前記内部において前記第 1のスリットと交差する第 2のスリットと、 前記内部から前記底面にのみ到達し、前記第 2のスリットの中心部力 離れた位置で 該第 2のスリットと交差する、少なくとも 1つの補助スリットとを有する。そのため、長尺 部材を長期間挿入した状態にしたり、長尺部材の挿入 ·抜去を頻繁に繰り返したりし たとしても、スリットに裂けが生じるのを防止することができる。また、例えば、力テーテ ルゃガイドワイヤ等のような医療に用いられる長尺部材を生体内に導入するイントロ デューサのシースに、本発明の弁体を用いる (設置する)ことができる。従って、本発 明の弁体は、産業上の利用可能性を有する。 [0134] The valve body of the present invention is a valve body made of an elastic material and having an opening / closing part made up of a plurality of slits that open and close as the long member is inserted and removed. Internal force of the valve body A first slit that reaches only the top surface of the valve body, and a second slit that reaches only the bottom surface of the valve body from the inside and intersects the first slit in the inside And at least one auxiliary slit that reaches only the bottom surface from the inside and intersects the second slit at a position away from the central force of the second slit. Therefore, even if the long member is inserted for a long period of time or the insertion / extraction of the long member is repeated frequently, it is possible to prevent the slits from tearing. Further, for example, the valve body of the present invention can be used (installed) in a sheath of an introducer that introduces a long member used for medical treatment such as a force tape or a guide wire into a living body. Therefore, the valve body of the present invention has industrial applicability.

Claims

請求の範囲 The scope of the claims
[1] 弾性材料で構成され、長尺部材の挿入 '抜去に伴って開閉する複数のスリットで構成 された開閉部を有する弁体であって、  [1] A valve body having an opening and closing portion made of an elastic material and made up of a plurality of slits that open and close as the long member is inserted and removed.
前記開閉部は、  The opening / closing part is
前記弁体の内部力 該弁体の頂面にのみ到達する第 1のスリットと、  An internal force of the valve body, a first slit that reaches only the top surface of the valve body;
前記内部から前記弁体の底面にのみ到達し、前記内部にお 、て前記第 1のスリット と交差する第 2のスリットと、  A second slit that reaches only from the inside to the bottom surface of the valve body and intersects the first slit in the inside;
前記内部力 前記底面にのみ到達し、前記第 2のスリットの中心部力 離れた位置 で該第 2のスリットと交差する、少なくとも 1つの補助スリットとを有することを特徴とする 弁体。  The valve body having at least one auxiliary slit that reaches only the bottom surface and intersects the second slit at a position away from the central force of the second slit.
[2] 弾性材料で構成され、長尺部材の挿入 '抜去に伴って開閉する複数のスリットで構成 された開閉部を有する弁体であって、  [2] A valve body having an opening and closing portion made of an elastic material and made up of a plurality of slits that open and close as the long member is inserted and removed.
前記開閉部は、  The opening / closing part is
前記弁体の内部力 該弁体の頂面にのみ到達する第 1のスリットと、  An internal force of the valve body, a first slit that reaches only the top surface of the valve body;
前記内部から前記弁体の底面にのみ到達し、前記内部にお 、て前記第 1のスリット と交差する第 2のスリットとを有し、  A second slit that reaches only from the inside to the bottom surface of the valve body and intersects the first slit in the inside;
前記第 2のスリットは、その端部または途中において複数に分岐した補助スリットを 有することを特徴とする弁体。  The valve body, wherein the second slit has an auxiliary slit branched into a plurality at an end portion or in the middle thereof.
[3] 前記補助スリットは、 2つ設けられている請求の範囲第 1項または第 2項に記載の弁 体。 [3] The valve body according to claim 1 or 2, wherein two auxiliary slits are provided.
[4] 前記 2つの補助スリットは、前記弁体の底面に向って互いに接近するように形成され て 、る請求の範囲第 3項に記載の弁体。  [4] The valve body according to claim 3, wherein the two auxiliary slits are formed so as to approach each other toward the bottom surface of the valve body.
[5] 前記 2つの補助スリットは、前記弁体の底面に向って互いに離間するように形成され て 、る請求の範囲第 3項に記載の弁体。 [5] The valve body according to claim 3, wherein the two auxiliary slits are formed so as to be separated from each other toward the bottom surface of the valve body.
[6] 前記補助スリットは、前記中心部を介してほぼ等距離となるように設けられている請求 の範囲第 3項に記載の弁体。 [6] The valve body according to claim 3, wherein the auxiliary slits are provided so as to be substantially equidistant through the central portion.
[7] 前記補助スリットは、その形状が平面視で一文字状をなしている請求の範囲第 1項ま たは第 2項に記載の弁体。 [7] The valve element according to claim 1 or 2, wherein the auxiliary slit has a single letter shape in plan view.
[8] 前記補助スリットは、その形状が平面視で V字状をなしている請求の範囲第 1項また は第 2項に記載の弁体。 [8] The valve body according to claim 1 or 2, wherein the auxiliary slit has a V shape in a plan view.
[9] 前記補助スリットは、その V字における谷部で前記第 2のスリットと交差し、かつ、前記 谷部が前記中心部側に位置している請求の範囲第 8項に記載の弁体。 [9] The valve element according to claim 8, wherein the auxiliary slit intersects the second slit at a valley portion in the V-shape, and the valley portion is located on the center portion side. .
[10] 前記補助スリットは、その形状が平面視で U字状をなしている請求の範囲第 1項また は第 2項に記載の弁体。 [10] The valve element according to claim 1 or 2, wherein the auxiliary slit has a U-shape in plan view.
[11] 前記補助スリットは、その U字における谷部で前記第 2のスリットと交差し、かつ、前記 谷部が前記中心部側に位置している請求の範囲第 10項に記載の弁体。 [11] The valve body according to claim 10, wherein the auxiliary slit intersects the second slit at a valley portion in the U-shape, and the valley portion is located on the center portion side. .
[12] 前記弁体に対する前記補助スリットの深さは、前記弁体に対する前記第 2のスリットの 深さとほぼ同等である請求の範囲第 1項または第 2項に記載の弁体。 12. The valve body according to claim 1 or 2, wherein a depth of the auxiliary slit with respect to the valve body is substantially equal to a depth of the second slit with respect to the valve body.
[13] 前記補助スリットは、前記深さが前記補助スリットの長手方向に対して変化している部 分を有する請求の範囲第 12項に記載の弁体。 13. The valve element according to claim 12, wherein the auxiliary slit has a portion where the depth changes with respect to a longitudinal direction of the auxiliary slit.
[14] 前記第 1のスリットおよび前記第 2のスリットの少なくとも一方の形状が、平面視で一文 字状をなしている請求の範囲第 1項または第 2項に記載の弁体。 14. The valve body according to claim 1 or 2, wherein at least one of the first slit and the second slit has a single letter shape in plan view.
[15] 前記長尺部材は、ダイレータ、カテーテルまたはガイドワイヤである請求の範囲第 1 項または第 2項に記載の弁体。 15. The valve element according to claim 1, wherein the elongated member is a dilator, a catheter, or a guide wire.
PCT/JP2005/021655 2004-12-01 2005-11-25 Valve body WO2006059540A1 (en)

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USD794186S1 (en) 2015-05-12 2017-08-08 Medtronic Vascular, Inc. Cross slit gasket for introducer sheath
US9750925B2 (en) 2014-01-21 2017-09-05 Becton, Dickinson And Company Ported catheter adapter having combined port and blood control valve with venting
US10478609B2 (en) 2013-07-30 2019-11-19 Becton, Dickinson And Company Blood control catheter valve employing actuator with flexible retention arms

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US9101746B2 (en) 2009-02-11 2015-08-11 Becton, Dickinson And Company Systems and methods for providing a flushable catheter assembly
US9114241B2 (en) 2009-02-11 2015-08-25 Becton, Dickinson And Company Systems and methods for providing a flushable catheter assembly
US10118017B2 (en) 2011-10-06 2018-11-06 Becton, Dickinson And Company Activator attachment for blood control catheters
US9126012B2 (en) 2011-10-06 2015-09-08 Becton, Dickinson And Company Intravenous catheter with duckbill valve
US9155863B2 (en) 2011-10-06 2015-10-13 Becton, Dickinson And Company Multiple use stretching and non-penetrating blood control valves
US9155876B2 (en) 2011-10-06 2015-10-13 Becton, Dickinson And Company Port valve of a blood control catheter
US9155864B2 (en) 2011-10-06 2015-10-13 Becton, Dickinson And Company Multiple use blood control valve with center and circumferential slits
WO2013052746A1 (en) * 2011-10-06 2013-04-11 Becton, Dickinson And Company Multiple use blood control valve with center and circumferential slits
US9358364B2 (en) 2011-10-06 2016-06-07 Becton, Dickinson And Company Activator attachment for blood control catheters
US11135399B2 (en) 2011-10-06 2021-10-05 Becton, Dickinson And Company Activator attachment for blood control catheters
WO2013175216A1 (en) * 2012-05-25 2013-11-28 Obrist Closures Switzerland Gmbh A dispensing valve
JP2016509915A (en) * 2013-03-15 2016-04-04 ベー・ブラウン・メルズンゲン・アクチエンゲゼルシャフトB.Braun Melsungen Aktiengesellschaft Catheter assembly with wipeable hemostasis and related methods
US10478609B2 (en) 2013-07-30 2019-11-19 Becton, Dickinson And Company Blood control catheter valve employing actuator with flexible retention arms
US9750925B2 (en) 2014-01-21 2017-09-05 Becton, Dickinson And Company Ported catheter adapter having combined port and blood control valve with venting
US10543351B2 (en) 2014-01-21 2020-01-28 Becton, Dickinson And Company Ported catheter adapter having combined port and blood control valve with venting
US9931489B2 (en) 2015-05-12 2018-04-03 Medtronic Vascular, Inc. Cross slit gasket for introducer sheath
USD794186S1 (en) 2015-05-12 2017-08-08 Medtronic Vascular, Inc. Cross slit gasket for introducer sheath
WO2016183392A1 (en) * 2015-05-12 2016-11-17 Medtronic Vascular Inc. Cross slit gasket for introducer sheath

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