WO2019027024A1 - 止血弁付留置針および留置針組立体 - Google Patents
止血弁付留置針および留置針組立体 Download PDFInfo
- Publication number
- WO2019027024A1 WO2019027024A1 PCT/JP2018/029139 JP2018029139W WO2019027024A1 WO 2019027024 A1 WO2019027024 A1 WO 2019027024A1 JP 2018029139 W JP2018029139 W JP 2018029139W WO 2019027024 A1 WO2019027024 A1 WO 2019027024A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- end side
- connector
- indwelling needle
- inclined surface
- needle
- Prior art date
Links
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/36—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests with means for eliminating or preventing injection or infusion of air into body
- A61M5/38—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests with means for eliminating or preventing injection or infusion of air into body using hydrophilic or hydrophobic filters
- A61M5/385—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests with means for eliminating or preventing injection or infusion of air into body using hydrophilic or hydrophobic filters using hydrophobic filters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M25/00—Catheters; Hollow probes
- A61M25/0097—Catheters; Hollow probes characterised by the hub
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/06—Body-piercing guide needles or the like
- A61M25/0606—"Over-the-needle" catheter assemblies, e.g. I.V. catheters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M2205/00—General characteristics of the apparatus
- A61M2205/75—General characteristics of the apparatus with filters
- A61M2205/7536—General characteristics of the apparatus with filters allowing gas passage, but preventing liquid passage, e.g. liquophobic, hydrophobic, water-repellent membranes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
- A61M39/0693—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof including means for seal penetration
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/22—Valves or arrangement of valves
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/22—Valves or arrangement of valves
- A61M39/26—Valves closing automatically on disconnecting the line and opening on reconnection thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/165—Filtering accessories, e.g. blood filters, filters for infusion liquids
Definitions
- the present invention relates to an indwelling needle and an indwelling needle assembly to be punctured and indwelled in a blood vessel when performing infusion, blood collection, hemodialysis and the like, and more particularly to a hemostatic valve provided with a hemostasis valve in an internal flow path.
- the present invention relates to an indwelling needle and an indwelling needle assembly.
- an indwelling needle or indwelling needle assembly for example, as described in Japanese Patent No. 5877196 (Patent Document 1) etc., a cannula (catheter 2) which can be inserted into a blood vessel percutaneously is possessed at the distal end side.
- Having a connection connector (catheter hub 3) connectable to an external flow path at the proximal end side, and having a hemostatic valve (valve body 7) disposed inside the connection connector are known.
- the present invention has been made against the background described above, and the problem to be solved is that the hemostatic valve-equipped indwelling needle and indwelling needle assembly having a novel structure capable of discharging the air in the internal flow path To provide.
- the first aspect of the present invention has a cannula on the distal side which is percutaneously inserted into a blood vessel, and a connector on the proximal side, and an internal flow from the cannula to the connector.
- the internal connector is connected to the connection connector to an external space on the cannula side with respect to the hemostatic valve.
- An air vent passage to be communicated is formed, and on the air vent passage, a filter that allows gas to pass but does not allow liquid to pass is mounted in a compressed state.
- the internal flow path from the cannula to the connection connector is in communication with the external space through the air vent passage, so that the internal flow path by reverse blood after puncturing The air inside is pushed out and discharged to the external space through the air vent passage. Since a filter that allows gas to pass but does not allow liquid to pass is provided on the air vent passage, air can be allowed to drain through the air vent passage, and blood can be prevented from leaking.
- the filter is attached to the connector in a compressed state, deformation of the filter is avoided or the amount of deformation is suppressed even if pressure is applied to the filter. Therefore, the occurrence of a gap between the filter and the connector can prevent blood leakage more reliably.
- the second aspect of the present invention has a cannula on the distal side which is percutaneously inserted into a blood vessel, and a connector on the proximal side, and an internal flow from the cannula to the connector.
- a hemostatic valve in which a passage is formed and a hemostatic valve is disposed inside the connection connector, an air vent passage communicated with the external connector through an air outlet opening in the peripheral wall of the connection connector.
- the internal flow path is communicated with the external space through the air vent passage on the cannula side with respect to the hemostatic valve, and the filter is a plurality of rigid members that allow gas to pass but not liquid to pass. It is characterized in that it is sandwiched and disposed on the air vent passage.
- the filter is held stably between the hard members, whereby the filter is stably held on the air vent passage, preventing the blood from being leaked by the filter. Achieved with high reliability.
- the opening to the external space of the air vent passage is an air outlet provided on the peripheral wall of the connection connector, for example, the influence of the internal pressure of the connector on the exhaust of air through the air vent passage Can be reduced to stably discharge the air in the internal flow path.
- a third aspect of the present invention is the indwelling needle with a hemostatic valve according to the second aspect, wherein at least one of the hard members constitutes the connection connector.
- the indwelling needle with a hemostatic valve having a structure according to the present aspect, by using the hard member as a component of the connection connector, the number of parts can be reduced and the structure can be simplified.
- all of the hard members are cylindrical.
- the cylindrical hard member can hold the filter over the entire circumference, enabling more stable holding of the filter. Therefore, blood leakage and the like are more advantageously prevented.
- any one of the hard members comprises an annular support, and the filter is annular.
- the fitting portion is attached to the annular support portion of the hard member in an extrapolation state.
- the filter can be handled together with one hard member by the filter being attached to the cylindrical hard member at the fitting portion in a state of extrapolation. It becomes easy to assemble the filter between the hard members.
- the fitting portion of the filter is radially pinched and compressed between the hard members.
- the filter fitting portion is compressed in the radial direction so that leakage of blood or the like through the radial direction of the hard member is compressed. Is more effectively prevented.
- the hard members are arranged axially adjacent to each other, and the filters are hard It is axially compressed and compressed between the members.
- the axial direction of the hard members is sealed in a fluid tight manner by the filter by the filter being axially compressed between the hard members.
- the passage of blood or the like is prevented between the axial directions of the hard members.
- the hard members disposed adjacent to each other in the axial direction are respectively made cylindrical and the filter is a hard member
- An annular compression rib is formed so as to be compressed over the entire circumference in the axial direction and to be pressed onto the filter over the entire circumference on at least one of the axially facing surfaces of the hard members. It is a thing.
- the filter is sandwiched and compressed over the entire circumference in the axial direction of the cylindrical hard member, and thus the filter is interposed between the hard members.
- the passage of the liquid is more effectively prevented by the filter.
- the compression rib is formed on the hard member so as to protrude, the filter is strongly pressed by the hard member at the formation portion of the compression rib, and the blood flow restriction function resulting from the stable retention of the filter is more advantageous. Can be realized.
- the connection connector in the indwelling needle with a hemostatic valve according to any one of the first to eighth aspects, includes a guide connector having a flow path constituting the internal flow path; And a connector cover to which the leading end of the guide connector is inserted and fixed, a gap is provided between the guide connector and the connector cover, and the air vent passage is formed including the gap. Is configured.
- connection connector is configured to include the guide connector and the connector cover, and the air is released including the gap between the guide connector and the connector cover. Since the passage is configured, the air vent passage can be easily formed in the connection connector by inserting and fixing the tip of the guide connector in the connector cover.
- a tenth aspect of the present invention is the indwelling needle with a hemostatic valve according to the ninth aspect, wherein the filter is inserted and compressed in the radial direction between the guide connector and the connector cover It is being done.
- the filter is mounted in a state of being pinched and compressed in the radial direction between the guide connector and the connector cover. Mounting can be made easy.
- an engagement protrusion projecting to the outer peripheral side is provided on the outer peripheral surface of the guide connector.
- a radially penetrating engagement hole is provided in the peripheral wall of the connector cover, and the tip of the guide connector is inserted into the connector cover so that the engagement projection engages with the engagement hole.
- the guide connector and the connector cover are fixed to each other, and the engagement hole is in communication with the gap between the guide connector and the connector cover.
- the engagement projection provided on the outer peripheral surface of the guide connector engages with the engagement hole provided through the peripheral wall of the connector cover. Since the guide connector and the connector cover are fixed to each other, it is possible to prevent circumferential relative movement (relative rotation) or axial relative movement of the guide connector and the connector cover after their assembly.
- the engagement hole provided on the peripheral wall of the connector cover is in communication with the gap between the guide connector and the connector cover, that is, the air vent passage, the air in the internal flow path passes through the engagement hole. It is discharged to the outside space.
- the engagement hole used for the engagement with the guide connector can be skillfully used as a hole (passage) for air venting, so that the structure can be simplified and the manufacturing efficiency can be improved.
- a concave groove is provided on an inner peripheral surface of the connector cover The opening is covered with the hemostatic valve to form a tunnel-like passage surrounded by the hemostatic valve and the connector cover, and the air venting passage is formed including the tunnel-like passage.
- the opening of the concave groove provided on the inner peripheral surface of the connector cover is covered by the hemostatic valve and is surrounded by the hemostatic valve and the connector cover Since the tunnel-like passage is formed and the air-releasing passage is configured including the tunnel-like passage, the air-releasing passage can be easily formed to the connection connector.
- connection connector and the hemostasis valve By providing a hemostasis valve between the guide connector and the connector cover, for example, by arranging the hemostasis valve at the tip of the guide connector and further covering the connector cover from the tip side, the connection connector and the hemostasis valve It can be assembled, and the assembly of the hemostasis valve to the connection connector and the formation of the air vent passage in the connection connector can be achieved simultaneously and easily.
- the filter is made of a material which allows gas to pass through but absorbs liquid. is there.
- the filter absorbs the blood, thereby preventing the passage of the blood through the filter, and the air is removed by positively holding the blood in the filter. Leakage of blood through the passageway may be prevented.
- an inner needle removable from the proximal end side to the distal end side of the internal flow path It is an indwelling needle assembly characterized in that it is inserted.
- the indwelling needle assembly in which the effects described in any of the first to thirteenth aspects can be produced can be manufactured.
- the elastic valve body and the axially movable pusher are provided on the fluid flow path of the indwelling needle, and the elastic valve body is opened and closed by the movement of the pusher toward the distal end side and the proximal end side.
- an indwelling needle with a hemostatic valve capable of communicating and blocking the passage.
- the applicant has proposed such a hemostatic valve-equipped indwelling needle, for example, in Japanese Patent Application Laid-Open No. 2016-13359 (Patent Document 2).
- the pusher is inserted into the elastic valve body by pushing the external flow path from the base end side of the pusher to move the pusher to the distal end side, and the elastic valve body is pushed open. It is supposed to be.
- the fluid flow channels are communicated to perform infusion, blood collection, and the like.
- the external flow path is removed and the pusher is moved to the base end side by the elastic restoring deformation of the elastic valve body, thereby closing the elastic valve body. And the fluid flow path is shut off. Thereby, the leakage of blood etc. at the time of withdrawal of the external channel is prevented.
- the pusher is moved to the tip end side and inserted into the elastic valve body so that the elastic valve body is pushed open.
- a hemostatic valve-equipped indwelling needle wherein the pusher inserted into the elastic valve body is moved to the base end side by the restoring action of the elastic valve body so that the elastic valve body is closed,
- the outer peripheral surface of the axially intermediate portion is provided with a steeply inclined surface having a larger inclination angle than the distal end side.
- the indwelling needle with a hemostatic valve having a structure according to the present aspect since the steeply inclined surface having a larger inclination angle than the distal end is provided in the insertion region of the pusher into the elastic valve body, the external flow When the path is connected (when the pusher moves to the tip side), the elastic valve body and the steeply inclined surface abut each other, for example, the indwelling needle with a hemostatic valve described in Patent Document 1 (hub with septum member In the restoring force of the elastic valve body exerted on the steeply inclined surface at the time of withdrawal of the external channel, as compared with the case where the insertion region in the pusher is made into a tapered surface with a single inclination angle as in the assembly).
- the axial component can be increased. This makes it possible to stably exert the force for moving the proximal side to the pusher, and the movement of the pusher to the proximal side, that is, the closure of the elastic valve body and the blocking of the fluid flow path are more effective. It can be realized surely.
- movement resistance is small, while when the pusher is returned to the proximal end side, a large force can be obtained to move the pusher to the proximal end side.
- the distal end side inclined surface is provided in a tapered shape on the distal end side of the steeply inclined surface.
- the amount of depression of the external flow path that is, the amount of movement of the pusher toward the tip end is small, and when the external flow path is connected (to the tip end of pusher When the contact amount between the steeply inclined surface and the elastic valve body is small at the time of movement), the tapered shape of the tip-side inclined surface and the elastic valve body abut each other, whereby the external flow passage At the time of withdrawal, the restoring force of the elastic valve body is effectively exerted on the distal side inclined surface, and the pusher can be more stably moved proximally.
- the proximal end inclined surface is provided with a tapered shape on the proximal end side of the steeply inclined surface. is there.
- the indwelling needle with a hemostatic valve structured according to the present aspect for example, even if the amount of depression of the external flow path, that is, the amount of movement of the pusher to the tip side is large, it is exerted on the proximal inclined surface.
- the resilience of the resilient valve body can be used to move the pusher more reliably proximally.
- the steeply inclined surface has a tapered shape.
- the angle change relative to the axial direction in the insertion region of the pusher is reduced as compared with the case where the steeply inclined surface extends in the direction perpendicular to the axis. While the elastic deformation of the valve body is realized more smoothly, the insertion resistance to the elastic valve body can be reduced. In addition, when the pusher moves to the tip side and the elastic valve body is elastically deformed, the possibility that a gap is generated between the steeply inclined surface of the pusher and the elastic valve body is reduced, and the steeply inclined surface and elasticity are reduced. Since a large contact area with the valve body can be secured, the restoring force of the elastic valve body can be more reliably applied to the steeply inclined surface.
- the steeply inclined surface has a constant inclination angle.
- the gap between the steeply inclined surface of the pusher and the elastic valve when the pusher moves to the tip side and the elastic valve elastically deforms. It is also possible to make the contact area between the steeply inclined surface and the elastic valve body large, and to exert the restoring force of the elastic valve body on the steeply inclined surface more reliably.
- a distal inclined side and a proximal end are provided on the distal end side and the proximal end of the steeply inclined surface.
- the inclined surfaces are respectively provided in a tapered shape, and the inclination angle of the distal end side inclined surface is larger than the inclination angle of the proximal end side inclined surface.
- the effects of the sixteenth and seventeenth aspects can be achieved at the same time by providing the tapered end side inclined surface and the proximal end inclined surface. It can be demonstrated. That is, regardless of the magnitude of the amount of depression of the external flow path (the amount of movement of the pusher toward the distal end side), the pusher can be stably moved to the proximal side at the time of removal of the external flow path.
- the inclination angle of the distal end side inclined surface is larger than the inclination angle of the proximal end side inclined surface, the restoring force of the elastic valve body is stably exerted on the distal end side inclined surface, As a result, the axial dimension of the insertion area can be sufficiently ensured.
- a distal inclined side and a proximal end on the distal end side and the proximal end of the steeply inclined surface are each provided with a tapered shape, and the steeply inclined surface, the distal end side inclined surface, and the base end side inclined surface all have a constant inclination angle.
- the insertion region can be formed as a whole in a substantially tapered shape, and the insertion resistance to the elastic valve body can also be reduced.
- the elastic valve body it is also possible to abut the substantially entire insertion area and the elastic valve body without a gap, and to exert the restoring force of the elastic valve body on the pusher more stably. You can also.
- a cylindrical housing in which the elastic valve body and the pusher are accommodated and disposed
- a contact portion is provided on the outer peripheral surface of the pusher on the proximal end side of the insertion region, and an engagement protrusion is provided on the inner peripheral surface of the housing. The movement of the pusher to the proximal end side is restricted by the abutment of the contact portion and the engagement projection.
- a movement restriction mechanism to the proximal end side of the pusher at the time of withdrawal of the external flow channel is provided. That is, the adoption of the fifteenth aspect makes it easy for the pusher to move to the base end side at the time of removal of the external flow path, but the removal of the external flow path is achieved by providing the movement restricting mechanism as in this aspect. The withdrawal of the pusher from the housing at times can be effectively prevented.
- a twenty-third aspect of the present invention is the indwelling needle with a hemostatic valve according to any one of the fifteenth to twenty-second aspects, comprising a cylindrical housing in which the elastic valve body and the pusher are accommodated and disposed.
- the housing includes an outer peripheral housing and an inner peripheral housing which are assembled by being inserted in and out of each other, and a cylindrical support which protrudes to the proximal end on the outer peripheral portion of the elastic valve body.
- a portion is provided, and the elastic valve body is supported by the housing in a compressed state in which the cylindrical support portion is radially interposed between the outer peripheral housing and the inner peripheral housing.
- the elastic valve body is sandwiched between the outer housing and the inner housing as the housing is a divided structure of the outer housing and the inner housing.
- the elastic valve can be easily assembled to the housing.
- the elastic valve body is provided with a cylindrical support projecting to the base end side, and the cylindrical support is supported in a compressed state between the outer peripheral housing and the inner peripheral housing in the radial direction, When the flow path is connected, that is, when the pusher is inserted from the proximal end side to the elastic valve body, removal of the elastic valve body from the housing can be effectively prevented.
- the inclination angle of the steeply inclined surface is set within a range of 25 degrees to 75 degrees. It is a thing.
- the elastic restoring force of the elastic valve body is proximal to the pusher. It can be efficiently applied as a side movement force.
- the outer peripheral surface of the tip portion of the pusher includes the steeply inclined surface.
- a tapered outer peripheral surface is provided, and an axial dimension of a forming portion of the tapered outer peripheral surface in the presser is 4 mm or more.
- the indwelling needle with a hemostatic valve having a structure according to the present aspect by providing a tapered outer circumferential surface having a size equal to or larger than the above-mentioned dimension at the tip end portion of the pusher, for example And / or the proximal inclined surface according to the seventeenth aspect can be formed with sufficient axial dimension, respectively, and the effect according to the sixteenth and / or seventeenth aspects can be made more stable. Can also be demonstrated.
- the filter is mounted in a compressed state on the air venting passage, whereby a stable air venting action is exhibited.
- FIG. 7 is a perspective view showing a specific example of an indwelling needle assembly configured to include the indwelling needle with a hemostatic valve shown in FIG. 1;
- FIG. 8 is a longitudinal sectional view of the indwelling needle assembly shown in FIG.
- FIG. 7 The longitudinal cross-sectional view which expands and shows the principal part in FIG.
- the longitudinal cross-sectional view which expands and shows the principal part in FIG. It is a longitudinal cross-sectional view which expands and shows the principal part in FIG. 10, Comprising: The figure which shows the communication state of an internal flow path.
- the longitudinal cross-sectional view which expands and shows the principal part in FIG. The longitudinal cross-sectional view which expands and shows the principal part further in FIG.
- the longitudinal cross-sectional view which expands and shows the principal part in FIG. The longitudinal cross-sectional view which expands and shows the principal part further in FIG.
- FIGS. 1 to 6 show an indwelling needle 10 with a hemostatic valve according to a first embodiment of the present invention.
- the hemostatic valve-equipped indwelling needle 10 is provided with a cannula 12 as a hollow needle on the distal end side, and a connection connector 14 as a housing to which an external flow path is connected on the proximal end side of the cannula 12.
- the disc valve 16 as a hemostatic valve (elastic valve body) is housed and arranged inside the connection connector 14.
- the internal flow path 18 is comprised including the inside of these cannula 12 and the connection connector 14.
- the cannula 12 is percutaneously inserted into the patient's blood vessel and left in place, whereby infusion and blood collection are performed through the internal flow passage 18, and connection of the external flow passage to the connection connector 14 is performed.
- the disc valve 16 is opened and closed, that is, the communication between the opening and closing of the disc valve 16, that is, the opening and closing of the internal flow passage 18, is switched.
- the axial direction is the central axial direction of each member, substantially corresponding to the needle axial direction of the cannula 12 which is a hollow needle, and means the left-right direction in FIG. 2 which is the longitudinal direction.
- the distal end side refers to the left side in FIG. 2 which is the side to which the cannula 12 is punctured
- the proximal end side refers to the right side in FIG. 2 which is the side operated by the user.
- the cannula 12 is formed of a soft synthetic resin, and the outer peripheral surface of the tip end portion is a tapered outer peripheral surface 20 whose outer diameter dimension gradually decreases toward the tip end side. ing. Further, a plurality of through holes 22 are formed in the peripheral wall of the tip portion of the cannula 12, and blood and the like can easily flow into the cannula 12 through the through holes 22.
- the material of the cannula 12 is not limited to a soft synthetic resin, and may be, for example, metal.
- the proximal end portion of the cannula 12 is fixedly supported by a needle hub 24.
- the needle hub 24 is provided with a substantially cylindrical peripheral wall 26, and is formed of, for example, a hard synthetic resin.
- the cannula 12 is inserted into the needle hub 24 and the proximal end portion of the cannula 12 is fixed to the needle hub 24 by adhesion or welding, whereby the cannula 12 is extended from the needle hub 24 to the tip side. .
- An elastic tube 28 is connected to the proximal end side of the needle hub 24.
- the elastic tube 28 is made of, for example, a soft synthetic resin, and the distal end portion of the elastic tube 28 is pinched by the peripheral wall 26 of the needle hub 24 and the cannula 12 at the proximal end opening of the needle hub 24
- the elastic tube 28 is connected to the proximal end side of the needle hub 24 by adhesion or welding in accordance with the above.
- the cannula 12 and the elastic tube 28 are firmly fixed to the needle hub 24.
- the proximal end portion of the elastic tube 28 is fixed to the distal end portion of the connection connector 14.
- the connector 14 has a generally cylindrical shape as a whole, and the base end portion of the elastic tube 28 is inserted from the opening on the tip side of the connector 14 and adhesion and welding are performed as necessary.
- the elastic tube 28 and the connection connector 14 are connected. That is, the tip portion of the connection connector 14 is a tube connection portion 30 to which the elastic tube 28 is connected.
- the inner flow passage 18 from the cannula 12 to the connector 14 is configured by the inner holes of the cannula 12, the elastic tube 28, and the connector 14 (in particular, a pusher 90 described later provided inside the connector 14). It is done.
- the connector 14 of the present embodiment has a shape in which a connector cover 32 as an outer peripheral housing and a guide connector 34 as an inner peripheral housing, both of which are substantially cylindrical, are mutually connected and fixed in the axial direction. There is. That is, the distal end side of the guide connector 34 is inserted into and assembled at the proximal end side of the connector cover 32 so that the connector cover 32 is fixed to the distal end portion of the guide connector 34 to configure the connection connector 14.
- the peripheral wall 14 is formed of the peripheral wall 36 of the connector cover 32 and the peripheral wall 38 of the guide connector 34. Further, in the peripheral wall 38 of the guide connector 34, a portion on the tip end side which is inserted into the connector cover 32 is a substantially cylindrical insertion portion 40. On the other hand, in the peripheral wall 36 of the connector cover 32, a portion on the base end side into which the insertion portion 40 of the guide connector 34 is inserted is a substantially cylindrical insertion portion 42.
- connection connector 14 is The peripheral wall on the distal end side of the connector cover 32 is formed by the peripheral wall 36 of the connector cover 32, and the peripheral wall on the base end side of the connection connector 14 is formed by the peripheral wall 38 of the guide connector 34.
- the base end portion (inner peripheral surface of the inserted portion 42) 44a in the inner peripheral surface 44 of the connector cover 32 and the distal end portion (outer peripheral surface of the insertion portion 40) 46a of the outer peripheral surface 46 of the guide connector 34 overlap each other.
- the connector cover 32 and the guide connector 34 are connected to form a double-walled portion.
- the connector cover 32 is formed of a hard synthetic resin and includes a substantially cylindrical peripheral wall 36.
- An annular wall portion 48 is formed on the inner circumferential surface 44 at an axially intermediate portion of the circumferential wall 36 so as to protrude to the inner circumferential side.
- the proximal end of the elastic tube 28 inserted from the distal end opening of the connector cover 32 is in contact with the distal end surface of the annular wall 48, and the connector cover 32 has a distal end side with respect to the annular wall 48.
- the tube connection part 30 to which the elastic tube 28 is connected is comprised.
- the inner diameter dimension and the outer diameter dimension are substantially constant over substantially the entire length in the axial direction. Further, in the insertion portion 42 on the proximal end side, the inner diameter dimension and the outer diameter dimension are larger than those of the tube connection portion 30, and are substantially constant over substantially the entire length in the axial direction.
- a pair of engagements penetrating the peripheral wall 36 in the thickness direction (radial direction) on both sides in the radial direction 1 (both sides in the vertical direction in FIG. 2) Holes 50, 50 are formed.
- Each of the engagement holes 50, 50 has a substantially rectangular shape in plan view, and is formed to have a circumferential dimension less than a half circumference.
- An extending notch 54 is formed in the peripheral wall 36 of the connector cover 32.
- a pair of notches 54, 54 are formed with a predetermined width dimension on both sides in the direction orthogonal to the opposing direction of the pair of engagement holes 50, 50 (both sides in the front of the paper in FIG. ing.
- a pair of inclined surfaces 56, 56 is formed in the proximal end opening 52.
- the inclined surfaces 56, 56 are formed in the same direction (both sides in the vertical direction in FIG. 2) as the opposing direction of the engagement holes 50, 50, and the thickness dimension of the peripheral wall 36 gradually increases toward the base end side. It is getting smaller.
- a pair of inclined grooves 58 are formed on the inner peripheral side of the proximal end opening 52 of the connector cover 32 by the inclined surfaces 56, 56 and wall portions on both sides in the circumferential direction of the inclined surfaces 56, 56. 58 are formed.
- the widthwise dimensions of the inclined surfaces 56, 56 are substantially equal to the widthwise dimensions of the engaging holes 50, 50, and the engaging holes 50, 50 and the inclined grooves 58, 58 are peripheral walls of the connector cover 32. At 36, they are formed partially at the corresponding positions on the circumference. That is, the engagement holes 50, 50 are formed on the tip end side of the inclined grooves 58, 58.
- the inner peripheral surface 44 of the connector cover 32 is a concave extending in the radial direction at the proximal end surface 48 a of the annular wall portion 48 and further extending proximally from the proximal end surface 48 a.
- the groove 60 is formed.
- the recessed groove 60 has a substantially rectangular cross section, and is open on the base end side at the proximal end surface 48 a of the annular wall portion 48 and on the inner peripheral side on the inner circumferential surface 44 of the peripheral wall 36. There is.
- each of the recessed grooves 60, 60, 60, 60 is formed to have a predetermined axial dimension.
- the guide connector 34 is formed of a hard synthetic resin, and is provided with a peripheral wall 38 having a diameter smaller than that of the peripheral wall 36 of the connector cover 32.
- the circumferential diameter of the circumferential wall 38 is substantially constant over substantially the entire length in the axial direction, while the lateral diameter varies in the axial direction.
- an annular engagement wall portion 64 as an engagement protrusion is formed to protrude on the inner peripheral side at an axially intermediate portion.
- the tip end side of the engagement wall 64 is a guide surface 66 for guiding the axial movement of the pusher 90 described later, and the inner diameter dimension is substantially constant. It is done.
- the proximal end side of the engagement wall portion 64 is a tapered surface 68 whose inner diameter is gradually increased toward the proximal end.
- the tip end portion 46a of the outer circumferential surface 46 of the guide connector 34 that is, the outer circumferential surface 46a of the insertion portion 40 has a diameter gradually decreasing toward the tip end. That is, on the base end side of the insertion portion 40, a contact portion 70 whose outer diameter size is substantially constant is provided, and the outer diameter size of the contact portion 70 corresponds to the inner diameter size of the insertion portion 42. It is almost equal.
- annular step surface 72 that spreads in the radial direction is formed at an axially intermediate portion. That is, the base end side of the step surface 72 is the contact portion 70, and the tip side of the step surface 72 is the annular support portion 74 whose outer diameter is smaller than the contact portion 70. .
- the annular support portion 74 has a predetermined axial dimension, and an insertion cylindrical portion 76 whose outer diameter is further reduced is formed on the tip end side.
- an engagement protrusion 78 projecting to the outer peripheral side is provided on the outer peripheral surface of the contact portion 70 in the outer peripheral surface 46 a of the insertion portion 40.
- a pair of engagement protrusions 78, 78 are formed on both sides in the radial direction 1 (both sides in the vertical direction in FIG. 2).
- the shapes of these engaging protrusions 78, 78 in a plan view are substantially rectangular shapes substantially corresponding to the engaging holes 50, 50 in the connector cover 32.
- the base end side end face of the engagement projections 78, 78 is made into the inclined surface 80, 80 in which the protrusion height of the engagement projections 78, 78 becomes gradually smaller toward the front end side
- the base end side end face is The vertical surfaces 82, 82 extend substantially in the direction perpendicular to the axis.
- the inclination direction with respect to the axial direction of the inclined surfaces 80 and 80 in the engagement protrusions 78 and 78 is made equal to the inclination direction with respect to the axial direction of the inclined surfaces 56 and 56 in the inclined grooves 58 and 58.
- the inclination angles of the both inclined surfaces 56 and 80 with respect to the axial direction are substantially equal, and the inclined surface 56 and the inclined surface 80 are substantially parallel to each other in the axial direction.
- the number of the engagement protrusions 78 and the engagement holes 50 is not limited to two (a pair), and one or three or more may be provided on the circumference.
- concave portions 83, 83 opened on the outer peripheral side are formed on the tip end side of the engagement protrusions 78, 78.
- These recessed portions 83, 83 have circumferential dimensions substantially equal to the engaging protrusions 78, 78, and are formed over the entire length of the outer peripheral surface of the abutting portion 70 on the tip end side than the engaging protrusions 78, 78. It is done. That is, these recessed parts 83 and 83 are open
- the outer diameter of the contact portion 70 is substantially equal to the inner diameter of the inserted portion 42 except for the positions where the recessed portions 83, 83 are formed.
- the depth dimension (the dimension in the radial direction) of the concave portions 83, 83 is smaller than the inner diameter dimension of the inserted portion 42.
- a pair of positioning projections 84 and 84 having a shape substantially corresponding to the portions 54 and 54 are formed to protrude.
- the proximal end side of the insertion portion 40 extends substantially straight with an outer diameter smaller than that of the insertion portion 40, and the proximal end side opening portion 86 substantially protrudes toward the outer peripheral side.
- An annular flange portion 88 is formed.
- An external thread is formed on the outer peripheral surface of the flange portion 88, and at the time of connection of an external flow path described later, it is possible to connect the external flow path of the luer lock type.
- a cylindrical pusher 90 provided with an inner hole 89 penetrating in the axial direction at the center is accommodated.
- the guide connector 34 A flow passage (inner hole 89 of pusher 90) is provided.
- the inner diameter of the presser 90 is substantially constant over substantially the entire length in the axial direction, while the outer circumferential surface of the presser 90 has an annular step surface (abutment portion) 92 extending in the direction perpendicular to the axial direction. It is formed.
- the tip end side of the step surface 92 is a tapered outer peripheral surface 94 whose diameter gradually decreases toward the tip end, while the base end side of the step surface 92 is substantially constant.
- a straight outer peripheral surface 96 having an outer diameter dimension of The maximum outer diameter of the proximal end portion of the tapered outer peripheral surface 94 is larger than the outer diameter of the straight outer peripheral surface 96.
- the tapered outer peripheral surface 94 provided in the insertion region of the presser 90 into the disc valve 16 is provided with a tapered steeply inclined surface 97 at an axial intermediate portion, and the axis of the sharply inclined surface 97
- the inclination angle with respect to the direction is larger than the inclination angle of the tip end side (tip end side inclined surface) than the steep inclination surface 97 in the tapered outer peripheral surface 94, and is larger than the inclination angle 97 in the tapered outer peripheral surface 94. It is larger than the inclination angle of the proximal end (proximal inclined surface).
- the disc valve 16 is housed and disposed between the connector cover 32 and the guide connector 34 inside the connection connector 14.
- the disc valve 16 has a substantially disc shape, and is formed of an elastic material such as rubber or elastomer.
- the central portion 98 of the disc valve 16 is formed with a slit 100 penetrating in the axial direction.
- the shape of the slits 100 is not limited, in the present embodiment, the slits 100 are radially extended substantially equally (every approximately 120 °) in three directions in the circumferential direction.
- the outer diameter of the disk valve 16 is larger than the inner diameter of the connector cover 32, and the disk valve 16 is assembled by being assembled to the connector 14.
- a pressing force in the radial direction is exerted from the outer peripheral side toward the inner peripheral side, and the slit 100 is stably closed. That is, a pressing portion is provided on the inner peripheral surface of the connection connector 14 for radially pressing the outer peripheral surface of the disc valve 16.
- the outer diameter of the tip portion of the disc valve 16 in the single-piece state is larger than the inner diameter of the connector cover 32, and by being assembled to the connection connector 14, the disc valve 16 is A radial pressing force is exerted toward the inner circumferential side, and the slit 100 is stably closed.
- the outer diameter dimension of the proximal end portion (the proximal end portion of the cylindrical support portion 102 described later) of the disk valve 16 is made smaller than the inner diameter dimension of the connector cover 32 over the entire periphery or on the periphery. ing.
- a light theft portion 101 which is an internal space is provided at the proximal end portion of the disk valve 16, between the disk valve 16 and the connector cover 32 in the radial direction. Therefore, when the disc valve 16 is assembled to the connection connector 14 and the distal end of the disc valve 16 is pressed, the proximal end of the disc valve 16 is deformed even if it is deformed to expand in the radial direction. Since the stealing unit 101 prepares a relief for the compression force, the disc valve 16 can be easily assembled.
- a cylindrical support portion 102 extending to the base end side is provided on the outer peripheral portion of the disc valve 16. Further, on the outer peripheral portion of the proximal end side surface 104 of the disc valve 16, an annular peripheral opening continuously extending on the entire circumference in the circumferential direction on the inner peripheral side relative to the cylindrical support portion 102.
- the groove 106 is formed.
- the connector 14 is configured to include the connector cover 32 and the guide connector 34 structured as described above, and the disc valve 16 and the pusher 90 are assembled inside the connector 14.
- the pusher 90 is inserted and disposed from the front end side opening of the guide connector 34.
- the engaging wall portion 64 provided on the inner peripheral surface 62 of the guide connector 34 and the step surface 92 provided on the outer peripheral surface of the presser 90 abut each other.
- the straight outer peripheral surface 96 of the pusher 90 and the inner peripheral surface of the engagement wall 64 are in contact or slightly separated, and the tapered shape of the pusher 90
- the outer peripheral surface of the proximal end portion of the outer peripheral surface 94 is in contact with or slightly separated from the guide surface 66 of the guide connector 34.
- the pusher 90 is axially movable while being guided by the inner circumferential surface 62 of the guide connector 34.
- the cylindrical support portion 102 of the disk valve 16 is covered and supported at the tip end portion of the guide connector 34. That is, in the circumferential groove 106 provided on the proximal end side surface 104 of the disc valve 16, the distal end portion of the insertion cylindrical portion 76 to be the distal end of the guide connector 34 is inserted.
- the inner and outer peripheral surfaces of the tip end portion of the insertion cylindrical portion 76 are respectively in contact or slightly separated from the inner and outer peripheral surfaces constituting the inner surface of the circumferential groove 106.
- a gap may be provided between the tip end surface of the insertion cylindrical portion 76 and the groove bottom surface of the circumferential groove 106 in the axial direction.
- the inner peripheral surface of the cylindrical support portion 102 of the disc valve 16 is in contact with the outer peripheral surface of the insertion cylindrical portion 76, and the distal end portion of the guide connector 34 is fitted to the proximal end side of the disc valve 16 There is. Further, in the present embodiment, in the supported state of the disc valve 16, the tip end of the pusher 90 is in contact with the proximal end side surface 104 of the disc valve 16, and the pusher 90 engages the disc valve 16 and the engagement wall It is positioned in the axial direction with the portion 64.
- the tip end of the pusher 90 does not necessarily have to abut the proximal end side surface 104 of the disc valve 16, and the tip end of the pusher 90 and the proximal end side 104 of the disc valve 16 are axially separated from each other. It is also good.
- the connector cover 32 is assembled from the tip end side of the disc valve 16. That is, the distal end portion of the guide connector 34 is inserted from the proximal end opening 52 of the connector cover 32 in a state where the disc valve 16 is covered and supported at the distal end, and the engagement projections 78 and 78 of the guide connector 34 are connector cover 32
- the connector cover 32 and the guide connector 34 are connected and fixed in series in the axial direction on substantially the same central axis by engaging with the engagement holes 50, 50 of the second embodiment.
- the inclined surfaces 80, 80 which are the end surfaces of the engagement protrusions 78, 78 and the inner surface 50a of the engagement holes 50, 50 constitute the inner surface. Clearances 108 and 108 are formed in the axial direction between the space 108 and the space 50a.
- the tip end side end surfaces of the engagement protrusions 78, 78 are inclined surfaces 80, 80, fitting of the engagement protrusions 78, 78 into the engagement holes 50, 50 is easy. It is done. Further, since the proximal end surfaces of the engagement projections 78, 78 are the vertical surfaces 82, 82, the engagement projections 78, 78 are pulled out from the engagement holes 50, 50, ie a guide from the connector cover 32. Removal of the connector 34 is prevented.
- the inclined grooves 58, 58 including the inclined surfaces 56, 56 are formed in the proximal end side opening 52 of the connector cover 32, the guide to the connector cover 32 is formed.
- the engagement protrusions 78, 78 are inserted into the inclined grooves 58, 58, so that circumferential relative rotation between the connector cover 32 and the guide connector 34 can be prevented.
- the engaging projections 78, 78 are stably guided to the engaging holes 50, 50 by the guiding action of the inclined surfaces 56, 56, the engaging projections 78, 78 can be more reliably engaged with the engaging holes 50, 50. Can be engaged.
- the positioning projections 84, 84 of the guide connector 34 are inserted into the notches 54, 54 provided in the proximal end opening 52 of the connector cover 32.
- the connector cover 32 and the guide connector 34 can be easily positioned in the circumferential direction so that the engagement protrusions 78, 78 can be engaged with the engagement holes 50, 50 more securely.
- the outer diameter of the contact portion 70 provided in the insertion portion 40 of the guide connector 34 is the same as that of the connector 83 except for the position where the recesses 83 and 83 are formed. Since the inner diameter of the insertion portion 42 of the cover 32 is substantially equal, the connector cover 32 and the guide connector 34 are in contact with each other without a gap. On the other hand, since the outer diameter dimension of the contact portion 70 is reduced at the formation position of the recessed portions 83, 83, the outer peripheral side opening of the recessed portions 83, 83 is covered with the connector cover 32, as shown in FIG. As also shown, axially extending gaps 110, 110 are formed between the connector cover 32 and the guide connector 34 in the radial direction.
- the clearances 110, 110 are communicated at the proximal end thereof with the engagement holes 50, 50, specifically, in communication with the clearances 108, 108 between the engagement projections 78, 78 and the engagement holes 50, 50. It is done. In short, the gaps 110, 110 in the radial direction between the connector cover 32 and the guide connector 34 are communicated with the external space through the engagement holes 50, 50 (gaps 108, 108).
- an annular support portion 74 smaller in outer diameter than the contact portion 70 is formed on the tip end side of the contact portion 70.
- the connector cover 32 and the guide connector 34 are assembled, so that the radial direction between the peripheral wall 36 of the connector cover 32 and the annular support portion 74 is substantially annular.
- a storage area 112 is formed.
- the housing area 112 is in communication with the gaps 110, 110 in the radial direction between the connector cover 32 positioned on the proximal end side and the guide connector 34.
- the housing area 112 is formed to have a predetermined radial width A (see FIG. 6).
- the outer peripheral portion of the disc valve 16 is positioned in the axial direction and the direction perpendicular to the axis between the connector cover 32 and the guide connector 34 assembled to each other.
- the disc valve 16 is assembled in a fitted state in which the disc cover 16 and the guide connector 34 are fitted. That is, the outer peripheral portion of the disc valve 16 is sandwiched axially between the proximal end surface 48 a of the annular wall portion 48 provided on the connector cover 32 and the insertion cylindrical portion 76 which is the tip portion of the guide connector 34.
- the cylindrical support portion 102 protruding to the proximal end side is preferably held in a compressed state between the radial direction of the peripheral wall 36 of the connector cover 32 and the insertion cylindrical portion 76. Furthermore, the disk valve 16 is compressed radially inward by the peripheral wall 36 of the connector cover 32 and assembled. The proximal end surface of the cylindrical support portion 102 in the disc valve 16 and the distal end surface of the filter 120 described later abut in the axial direction with substantially no gap.
- the outer surface of the disc valve 16 is superimposed on the inner peripheral surface 44 of the connector cover 32 to provide the inner peripheral surface 44 of the connector cover 32 as also shown in FIG.
- Tunnel-like passages 116, 116 surrounded by the disc valve 16 and the connector cover 32 with the openings 114, 114, 114, 114 of the recessed grooves 60, 60, 60, 60 covered by the outer surface of the disc valve 16.
- , 116, 116 are formed. That is, the tip end sides of the tunnel-like passages 116, 116, 116, 116 open to the inner peripheral surface of the annular wall portion 48, and communicate with the tip end side (canular 12 side) of the disc valve 16 in the inner flow passage 18 The proximal end side is in communication with the containing area 112.
- the outer peripheral surface of the disk valve 16 is overlapped in a compressed state with the inner peripheral surface 44 of the connector cover 32, so that parts other than the formation positions of the recessed grooves 60, 60, 60, 60 in these overlapped surfaces. But are sealed in a liquid tight manner.
- the space on the tip end side of the disk valve 16 in the internal flow passage 18 is a tunnel-like passage 116 116 116 116, the accommodation area 112, the gap 110 110 between the connector cover 32 and the guide connector 34 and the gap It communicates with the external space through 108,108.
- the air vent passage 118 which communicates the space on the tip end side (the cannula 12 side) of the internal flow passage 18 with respect to the disc valve 16 to the external space is a tunnel-like passage 116, 116,. 116 and 116, a housing area 112, gaps 110 and 110 between the connector cover 32 and the guide connector 34, and gaps 108 and 108.
- the air vent passage 118 is communicated with the external space through the engagement holes 50, 50 opened in the peripheral wall 36 of the connector cover 32 constituting the connection connector 14, and the engagement holes 50, 50 are air flow according to the present embodiment. It is considered an exit.
- a filter 120 is provided in the storage area 112 located on the air vent passage 118.
- the filter 120 is generally cylindrical as a whole, and in the present embodiment, the outer peripheral portion of the tip end surface of the filter 120 is exposed to the air vent passage 118 (tunnel-like passages 116, 116, 116, 116). At the same time, the base end portion of the outer peripheral surface of the filter 120 is exposed to the air vent passage 118 (the gaps 110, 110).
- the filter 120 has a property of passing gas but not passing liquid.
- the filter 120 is not particularly limited as long as it has the above-mentioned properties, but for example, a polymer material such as polyethylene and a material containing a hydrophilic, water-soluble or water-swellable polymer are sintered A sintered porous body, a hydrophobic non-woven fabric, a porous body or the like may be suitably employed.
- a sintered body containing highly water-absorptive polymer (SAP) is employed as the filter 120, gas is allowed to pass through in the initial state before the moisture touches the filter 120, and moisture is When it touches it, it reacts with water (by absorbing water) to prevent passage by swelling, so that the air bleeding and blood leakage prevention effects described later can be exhibited stably.
- the filter 120 of this embodiment is made into the cyclic
- the radial width B (shown by a two-dot chain line in FIG. 6) of the filter 120 before being assembled to the connection connector 14 is larger than the radial width A in the housing area 112. That is, the substantially cylindrical filter 120 is externally inserted on the outer peripheral side of the annular support portion 74 in the guide connector 34, and the distal end portion of the guide connector 34 is inserted into the connector cover 32 so that the filter 120 is a connector cover. 32 and the guide connector 34 are mounted in a state of being radially compressed and compressed. In short, the filter 120 is assembled in a state of being pressed against the radially opposing surface of the outer peripheral surface of the annular support portion 74 and the inner peripheral surface 44 (44a) of the connector cover 32.
- the hard member for holding the filter 120 in the radial direction is constituted by the connector cover 32 and the guide connector 34 that constitute the connection connector 14. Further, the filter 120 is assembled in a state in which it is also in contact with the axially facing surface of the base end surface of the disc valve 16 and the step surface 72 of the guide connector 34. It is assembled in a compressed state. In particular, in the present embodiment, the axially opposite side surfaces and the radially opposite side surfaces of the filter 120 are pressed against the respective pressing surfaces with an area of at least half.
- the disc valve 16 is detached from the guide connector 34 at the time of assembly by assembling the connector cover 32, the guide connector 34, the disc valve 16, the pusher 90, and the filter 120 with the tip end facing upward. And the like can be effectively prevented to improve the assembling efficiency.
- the inner diameter of the portion holding the filter 120 is smaller than the inner diameter of the opening on the proximal end side, and the inclined step surface 121 is formed between the holding portion and the proximal opening.
- the inclined step surface 121 has a tapered shape.
- the filter 120 attached to the guide connector 34 in an externally fitted state is pushed into the inner periphery of the connector cover 32, the filter 120 is guided in contact with the inclined step surface 121 to reduce the diameter of the filter 120. Stabilization of the deformation mode is achieved, and the filter 120 can be disposed in a target sandwiching state.
- the indwelling needle 10 with a hemostatic valve of this embodiment is configured.
- Such an indwelling needle 10 with a hemostatic valve is, for example, an indwelling needle assembly with a hemostatic valve by inserting an inner needle unit including an inner needle including a needle tip with the indwelling needle 10 with a hemostatic valve as an outer needle unit. Used as a solid.
- the cannula 12 is a hollow needle made of metal or the like having a needle tip, the hemostatic valve-equipped indwelling needle 10 can be directly punctured and indwelled in a patient's blood vessel.
- the indwelling needle assembly 122 of this embodiment uses the hemostatic valved indwelling needle 10 as an outer needle unit, and the inner needle unit 124 is inserted from the proximal end toward the distal end into the inner flow path 18 of the outer needle unit 10 It consists of being done.
- the inner needle unit 124 can move in the needle axial direction with respect to the inner needle 128 having the sharp needle tip 126 at the tip, the inner needle hub 130 attached to the proximal end of the inner needle 128 and the inner needle 128 And a needle tip protector 132 attached to the
- the inner needle 128 is a hollow needle and is formed of a known material such as stainless steel, aluminum, titanium or an alloy thereof.
- the needle tip 126 provided at the tip of the inner needle 128 is formed with a blade surface 134 inclined with respect to the needle axial direction, so that puncture to a living body can be performed easily and with low stimulation.
- a large diameter portion 136 whose outer diameter size is increased is formed on the outer peripheral surface of the distal end portion of the inner needle 128, a large diameter portion 136 whose outer diameter size is increased is formed.
- the large diameter portion 136 may be formed over the entire circumference in the circumferential direction by the inner needle 128 being manufactured by centerless processing, but in the present embodiment, the inner needle 128 is crushed.
- a pair is formed on both sides in the radial direction 1 (both sides in the vertical direction in FIG. 8).
- the inner needle hub 130 attached to the proximal end of the inner needle 128 has a substantially cylindrical pedestal 138 to which the proximal end of the inner needle 128 is fixed in an embedded state, and the pedestal 138 from the tip of the pedestal 138
- a substantially cylindrical protector housing portion 140 protruding with an outer diameter larger than that of the base portion 138 and a substantially cylindrical connecting portion 142 protruding from the base end of the pedestal portion 138 are integrally formed of synthetic resin.
- a substantially cylindrical cap housing portion 144 with a larger diameter is formed at the tip of the protector housing portion 140.
- the inner needle cap 146 is detachably assembled to the proximal end opening of the connecting portion 142.
- the inner needle cap 146 is a synthetic resin member having a substantially stepped cylindrical shape in which a stepped portion is provided at a needle axial direction intermediate portion.
- a vent filter (not shown) is provided inside the inner needle cap 146, and the vent filter has a property of transmitting gas but blocking liquid.
- a ventilation filter for example, a material similar to that of the filter 120 provided on the air vent passage 118 inside the connection connector 14 may be employed.
- the proximal end opening of the inner needle hub 130 is covered in a fluid-tight manner, and reverse blood through the inner needle 128 does not leak to the outside. ing.
- the inner needle hub 130 and the inner needle cap 146 are made of a transparent member, it is possible to easily confirm reverse blood flow (flashback).
- the needle tip protector 132 of the inner needle unit 124 is configured to include a substantially cylindrical protector body 148.
- the distal end portion of the protector main body 148 has a diameter larger than that of the proximal end portion, that is, the large diameter cylindrical portion 150 on the distal end side, the small diameter cylindrical portion 152 on the proximal end side, and the large diameter cylindrical portion 150 It is comprised including the taper cylinder part 154 which connects with the small diameter cylinder part 152.
- the proximal end opening (the proximal end opening of the small diameter cylindrical portion 152) of the protector main body 148 is closed by a bottom wall 156 which extends in a direction perpendicular to the axis.
- a proximal needle side insertion hole 158 penetrating in the axial direction of the needle is formed at the center of the bottom wall 156, and a metal locking ring 160 is fixed to the end surface of the bottom wall 156 on the tip side.
- the inner diameter dimension of the proximal end needle insertion hole 158 and the locking ring 160 is smaller than the outer diameter dimension of the large diameter portions 136 and 136 of the inner needle 128, and the large diameter portion 136 of the inner needle 128. , 136 are made larger than the outside diameter size in the portion other than.
- the distal end side opening (the distal end side opening of the large diameter cylindrical portion 150) of the protector main body 148 is closed by assembling a lid 162 having a substantially flat plate shape as a whole.
- An intermediate partial needle insertion hole 164 is formed on the proximal end side of the lid 162 in the needle axial direction, and a distal end side needle insertion hole 166 is formed on the distal end side thereof in the needle axial direction.
- the intermediate partial needle insertion hole 164 and the distal end side needle insertion hole 166 are provided with a predetermined separation distance in the needle axial direction.
- the inner diameter of the intermediate partial needle insertion hole 164 and the distal end side needle insertion hole 166 is larger than the outer diameter of the large diameter portions 136 of the inner needle 128. Also, is the needle axial direction length dimension from the proximal end needle insertion hole 158 to the middle partial needle insertion hole 164 approximately equal to the length dimension from the large diameter portion 136, 136 in the inner needle 128 to the needle tip 126 , Being bigger. Then, the proximal end of the large diameter portion 136, 136 of the inner needle 128 is inserted into the proximal end needle insertion hole 158, the middle partial needle insertion hole 164, and the distal end side needle insertion hole 166 in the needle tip protector 132. The tip protector 132 is extrapolated and attached to the inner needle 128 so as to be movable in the needle axial direction.
- a shielding member 168 and a fixing member 170 are provided on the tip side of the middle partial needle insertion hole 164 in the lid 162, and the shielding member 168 and the fixing member 170 are large diameter cylinders of the needle tip protector 132. It is accommodated and arranged in the part 150.
- the shielding member 168 and the fixing member 170 are each formed in a block shape and provided on both sides of the inner needle 128 in a direction perpendicular to the axis, and the shielding member 168 is provided above the inner needle 128 in FIGS.
- the fixing member 170 is provided below the inner needle 128 in FIGS.
- the shielding member 168 is displaceable in the direction perpendicular to the axis, whereas the fixing member 170 is fixedly attached to the lid 162.
- One of the shielding member 168 and the fixing member 170 is a magnet, and the other is a magnet or a ferromagnetic material such as iron, and a magnetic attraction force is exerted on each other.
- the biasing force for approaching the fixing member 170 is always exerted on the shielding member 168, and the displacement of the shielding member 168 in the direction for approaching the fixing member 170 is restricted by coming into contact with the inner needle 128. ing.
- the protector main body 148 and the lid 162 may be suitably formed of, for example, a hard synthetic resin.
- the proximal end of the inner needle 128 structured as described above is inserted into the pedestal portion 138 of the inner needle hub 130, and the inner needle hub 130 is processed by bonding and welding as necessary.
- the inner needle unit 124 of the present embodiment is configured by fixedly supported on the inner needle 128 and the needle tip protector 132 being extrapolated and attached to the inner needle 128. Then, the inner needle 128 projecting to the distal end side in the inner needle unit 124 is inserted from the proximal end opening of the outer needle unit 10, that is, the proximal end opening 86 of the guide connector 34, and the disc valve 16 and cannula Through 12, the needle tip 126 of the inner needle 128 projects from the tip of the cannula 12.
- connection cap 172 is provided between the guide connector 34 of the outer needle unit 10 and the needle tip protector 132 of the inner needle unit 124.
- the connection cap 172 has a substantially cylindrical shape as a whole, and a substantially annular intermediate wall portion 174 projecting to the inner circumferential side is formed at an axially intermediate portion. That is, the connection cap 172 is provided with a connecting cylindrical portion 176 which opens at the distal end side with the intermediate wall portion 174 as the bottom wall portion, and an engagement cylindrical portion 178 which opens at the proximal end side with the intermediate wall portion 174 as the bottom wall portion ing.
- An internal thread 180 is formed on the inner peripheral surface of the connecting cylindrical portion 176, and can be screwed with an external thread provided on the outer peripheral surface of the flange portion 88 at the proximal end opening 86 of the guide connector 34. . Further, on the inner peripheral side of the connecting cylindrical portion 176, the fitting cylindrical portion 182 protrudes from the inner peripheral edge portion of the intermediate wall portion 174 toward the tip end side.
- the outer diameter dimension of the fitting cylindrical portion 182 is substantially equal to the inner diameter dimension at the proximal end opening 86 of the guide connector 34, and the outer circumferential surface of the fitting cylindrical portion 182 is the inner circumferential surface 62 of the guide connector 34.
- the tapered surface 68 substantially corresponds to the tapered surface 68 in FIG.
- the inner diameter dimension of the fitting cylindrical portion 182 is slightly larger than the outer diameter dimension of the base end portion (straight outer circumferential surface 96) of the presser 90.
- a pair of slits 184, 184 extending toward the distal end side is provided on each of both side portions in the radial direction (both side portions in the vertical direction in FIGS. Is formed.
- the slits 184, 184 are separated from each other by a predetermined distance in the circumferential direction, and between the circumferential direction of the slits 184, 184, that is, in the engagement cylindrical portion 178, portions on both sides in the vertical direction in FIGS.
- the flexible pieces 186, 186 can be bent and deformed in the thickness direction (radial direction).
- locking claws 188, 188 that protrude to the inner peripheral side are provided at substantially the entire length in the circumferential direction at the protruding distal ends (axial direction base ends) of the flexible pieces 186, 186.
- the distance between opposing directions of the locking claws 188 and 188 (vertical distance in FIGS. 8 and 9) is smaller than the outer diameter of the large diameter cylindrical portion 150 of the needle tip protector 132.
- connection cap 172 structured as described above is provided between the guide connector 34 and the needle tip protector 132, and by connecting them to each other, in the indwelling needle assembly 122, the inside of the outer needle unit 10 and the inside A needle unit 124 is mutually connected.
- connection cap 172 is inserted into the proximal end opening 86 of the guide connector 34, and the inner periphery of the connecting cylindrical portion 176 with respect to the male screw provided on the flange portion 88.
- the connection cap 172 is connected to the guide connector 34 by screwing the female screw 180 provided on the surface. Further, the engagement claws 188 and 188 of the flexible pieces 186 and 186 provided on the engagement cylindrical portion 178 are engaged with the tapered cylindrical portion 154 of the needle tip protector 132 from the outer peripheral side, whereby the connection cap 172 and the connection cap 172 The needle tip protector 132 is mutually connected.
- the locking claws 188, 188 are locked to the tapered cylindrical portion 154, the base of the tip end face of the needle tip protector 132 (lid 162) and the intermediate wall 174 of the connection cap 172.
- the end side end faces are in contact with each other.
- the guide connector 34 and the needle tip protector 132 are connected to each other through the connection cap 172, whereby the unintentional removal of the outer needle unit 10 from the inner needle unit 124 is prevented.
- the small diameter cylindrical portion 152 of the needle tip protector 132 is accommodated in the protector accommodating portion 140 of the inner needle hub 130,
- the proximal end of the connection cap 172 (engaging cylindrical portion 178) including the locking claws 188, 188 is accommodated in a cap accommodating portion 144 provided at the tip of the protector accommodating portion 140. That is, the flexible pieces 186, 186 are covered with the cap accommodating portion 144 from the outer peripheral side, and the bending deformation to the outer peripheral side of the flexible pieces 186, 186 is prevented. As a result, unintentional bending deformation of the flexible pieces 186, 186 to the outer peripheral side to release the locking of the locking claws 188, 188 to the tapered cylindrical portion 154 can be prevented.
- the indwelling needle assembly 122 of the present embodiment configured as described above punctures the skin of the patient in a state where the inner needle unit 124 is inserted into the outer needle unit 10 as shown in FIGS. 7-9. Thereafter, by pulling out the inner needle unit 124 from the outer needle unit 10 to the proximal side, the outer needle unit 10 is indwelled in a state of being percutaneously inserted into the blood vessel of the patient.
- the shielding member 168 is displaced in the direction approaching the fixing member 170 according to the biasing force. Thereby, the shielding member 168 is displaced on the needle shaft of the inner needle 128, and the needle tip 126 of the inner needle 128 is protected by the needle tip protector 132.
- connection cap 172 is separated from the cap accommodating portion 144 by the inner needle hub 130 being displaced to the proximal side with respect to the connection cap 172, and the flexible pieces 186, 186 are moved to the outer peripheral side. It is made flexible and deformable.
- the large diameter portions 136 and 136 of the inner needle 128 and the locking ring 160 bottom wall 156) provided at the base end portion of the needle tip protector 132
- the needle tip protector 132 is also displaced proximally with respect to the outer needle unit 10 and the connection cap 172 connected to the outer needle unit 10.
- the large diameter cylindrical portion 150 of the needle tip protector 132 causes the flexible pieces 186, 186 to be bent and spread so as to be pushed outward to the locking claw.
- the locking of 188, 188 to the tapered cylindrical portion 154 is released.
- the needle tip protector 132 is detached from the connection cap 172 in a state where the needle tip 126 of the inner needle 128 is protected, and the inner needle unit 124 is pulled out of the outer needle unit 10.
- the engagement force between the large diameter portions 136 and 136 of the inner needle 128 and the needle tip protector 132 can be improved.
- the user when pulling out the needle tip protector 132 to the base end side, the user can feel a relatively large pull-out resistance until the locking claws 188, 188 get over the large diameter cylindrical portion 150, and the locking claw Since the pullout resistance is substantially zero when 188 and 188 get over the large diameter cylindrical portion 150, the user can grasp that the needle tip protector 132 has been detached from the connection cap 172 only by the touch of the operation. That is, the inner needle unit 124 can be pulled out of the outer needle unit 10 with a good sense of moderation.
- the outer needle unit (the indwelling needle with a hemostatic valve) 10 is indwelled in the blood vessel of the patient in the state shown in FIGS.
- the disk valve 16 is elastically restored and deformed, and the slit 100 is closed.
- the internal flow path 18 of the indwelling needle 10 with a hemostatic valve is blocked by the disc valve 16.
- an external flow path such as a syringe is connected to the proximal end opening (proximal end opening of the guide connector 34) 86 of the connection connector 14 in the indwelling needle 10 with the hemostatic valve, whereby a male luer such as a syringe Pushes the pusher 90 to the distal end side, and while the central portion 98 of the disc valve 16 is pushed out to the distal end side, the slit 100 of the disc valve 16 is opened and the internal flow passage 18 is brought into communication. ing. Thereby, infusion, blood collection, hemodialysis, etc. may be performed through the internal flow passage 18 configured to include the inner hole of the cannula 12, the inner hole of the elastic tube 28, and the inner hole 89 of the pusher 90.
- the indwelling needle 10 with a hemostatic valve when the indwelling needle 10 with a hemostatic valve is indwelled in the patient's blood vessel, the space on the tip end side of the disc valve 16 in the internal flow path 18 of the indwelling needle 10 with a hemostatic valve Because of the communication, blood flows back through the internal flow passage 18 through the cannula 12 and the elastic tube 28. And, the blood in the internal flow passage 18 is pushed out by the blood by flowing back through the internal flow passage 18 in this way, and is discharged to the external space through the air vent passage 118. In this way, it is possible to prevent air remaining in the internal flow passage 18 from being mixed into the body when the external flow passage is connected.
- blood may flow back through the through hole 22 provided in the cannula 12 and the gap between the cannula 12 and the inner needle 128, that is, the inside Exhaust of air in the flow passage 18 may be achieved before the inner needle unit 124 is withdrawn.
- the filter 120 is provided on the air vent passage 118 to prevent the passage of the liquid, the leakage of blood through the air vent passage 118 can be prevented.
- the filter 120 is attached in a compressed state by being pinched by the connector cover 32 and the guide connector 34 in the radial inside and outside, for example, the indwelling needle 10 with a hemostatic valve is indwelled in the artery etc. Even if a relatively strong pressure such as arterial pressure is exerted, deformation of the filter 120 may be effectively suppressed and a gap may be generated between the filter 120 and the connector cover 32 and / or the guide connector 34. Can be reduced. This can prevent blood leakage more reliably.
- the compression of the filter 120 can prevent the passage of blood more effectively, for example, in the case of a sponge filter, because the density of the filter 120 is increased and the space is reduced.
- the air vent passage 118 covers the opening portions 114, 114, 114, 114 of the recessed grooves 60, 60, 60, 60 in the inner peripheral surface 44 of the connector cover 32 with the disc valve 16.
- the connector cover 32 is provided with inclined grooves 58, 58 and notches 54, 54 in the connector cover 32, or by providing the disc valve 16 with the cylindrical support portion 102 so as to cover the guide connector 34.
- the assembling workability of the guide connector 34 and the disc valve 16 is improved, and the manufacturing efficiency of the connection connector 14 having the air vent passage 118 and hence the indwelling needle 10 with hemostatic valve and the indwelling needle assembly 122 is improved. Improvements can be made.
- FIG. 10 shows a hemostatic valve attached indwelling needle 190 according to a second embodiment of the present invention.
- the indwelling needle 190 with a hemostatic valve is provided with a cannula 12 as a hollow needle on the tip end side and a connection connector 192 to which an external flow path is connected on the proximal end side of the cannula 12.
- a disk valve 16 as a hemostatic valve is housed and arranged inside 192.
- connection connector 192 has a shape in which a connector cover 32 and a guide connector 194, both of which have a substantially cylindrical shape, are mutually connected and fixed in the axial direction. That is, the distal end side of the guide connector 194 is inserted into and assembled at the proximal end side of the connector cover 32, whereby the connector cover 32 is fixed to the distal end portion of the guide connector 194, and the connection connector 192 is configured.
- the guide connector 194 is formed of a hard synthetic resin, and as shown also in FIG. 11, includes a peripheral wall 196 whose diameter is smaller than that of the peripheral wall 36 of the connector cover 32.
- the peripheral wall 196 has a structure in which the insertion cylindrical portion 76 inserted into the cylindrical support portion 102 of the disc valve 16 is omitted from the peripheral wall 38 of the embodiment, and the inner diameter dimension is substantially the entire length in the axial direction. The outer diameter dimension changes in the axial direction while being substantially constant throughout.
- a pusher 198 is disposed on the inner circumferential side of the guide connector 194.
- the pusher 198 has a cylindrical shape as a whole and is provided with a flange-like protrusion 200 projecting to the outer periphery at an intermediate portion in the axial direction. Is configured.
- the tip portion of the pusher 198 is formed to be thinner toward the tip side.
- a straight outer peripheral surface 96 is set on the proximal end side of the protrusion 200, and a straight outer periphery extending on the distal end side of the protrusion 200 with a substantially constant outer diameter.
- the surface 202 is set, and the tapered outer peripheral surface 94 is set on the tip side of the straight outer peripheral surface 202.
- the maximum outer diameter of the proximal end portion of the tapered outer peripheral surface 94 is substantially the same as the outer diameter of the straight outer peripheral surface 202 and is larger than the outer diameter of the straight outer peripheral surface 96. There is.
- the inside diameter of the pusher 198 is substantially constant in the axial direction at the proximal end, and is changed to be smaller at the distal end and larger at the proximal end at the distal end, and in the present embodiment,
- the inner circumferential surface 199 of the tip end portion of the presser 198 has a tapered shape which changes in the axial direction at a substantially constant rate of change.
- the valve support member 204 is cylindrical as a whole, and is formed of a hard synthetic resin, metal or the like. Furthermore, the valve support member 204 is provided with a cylindrical insertion cylindrical portion 206, and is provided with an annular fitting portion 208 which protrudes from the proximal end of the insertion cylindrical portion 206 to the outer periphery.
- the insertion tube portion 206 of the valve support member 204 has substantially the same shape as the insertion tube portion 76 of the guide connector 34 in the first embodiment, and the inside diameter dimension is substantially the same as the guide connector 194.
- the end portion protrudes to the inner circumference to be partially reduced in diameter.
- concave grooves 210, 210, 210, 210 opened in the outer peripheral surface are formed to penetrate in the axial direction respectively at four places equally spaced in the circumferential direction. ing.
- annular compression rib 212 continuous in the circumferential direction with a substantially constant cross-sectional shape is protruded and formed.
- the compression rib 212 has a triangular cross section which narrows in the radial direction toward the tip end of the protrusion.
- the insertion cylindrical portion 206 is fitted in the cylindrical support portion 102 of the disc valve 16, and the disc valve 16 is attached to the tip portion of the valve support member 204.
- the valve support member 204 is inserted into the inner periphery of the connector cover 32, and the fitting portion 208 of the valve support member 204 is fixed to the connector cover 32 by being fitted to the peripheral wall 36 of the connector cover 32. There is.
- the disc valve 16 is accommodated on the inner periphery of the connector cover 32 in a state of being supported by the valve support member 204, and is positioned at a predetermined position in the inner peripheral space of the connector cover 32.
- the axis between the connector cover 32 and the valve support member 204 are formed by the recessed grooves 210, 210, 210, 210.
- the distal end portion of the guide connector 194 is inserted into the connector cover 32 more proximal than the valve support member 204. Then, as in the first embodiment, the engagement projections 78 of the guide connector 194 are engaged with the inner surfaces of the engagement holes 50, 50 in the connector cover 32, whereby the connector cover 32 and the guide connector 194 are mutually connected. It is connected. Further, the pusher 198 disposed on the inner periphery of the guide connector 194 has a tip portion protruding from the guide connector 194 inserted into the inner periphery of the valve support member 204 and the tip is a central portion 98 of the disc valve 16. It is located on the more proximal side than the other.
- a substantially annular accommodation area 216 is formed between the peripheral wall 36 of the connector cover 32 and the annular support portion 74 of the guide connector 194.
- the guide connector 194 and the valve support member 204 are arranged axially apart from each other and adjacent to each other, and the containing area 216 is the tip end of the guide connector 194 and the proximal end of the valve support member 204. It is open to the inner circumference in the axial direction.
- the housing area 216 communicates with the radial gaps 110 and 110 between the connector cover 32 located on the base end side and the guide connector 194, and the connector cover 32 and the valve support located on the tip end side It is in communication with the radial gaps 214, 214 in the radial direction of the member 204.
- the space on the tip end side of the disc valve 16 in the internal flow passage 18 is a tunnel-like passage 116 116 116 116, and a gap 214 214 214 214 between the connector cover 32 and the valve support member 204.
- the external space is communicated through the housing area 216, the gaps 110 and 110 and the gaps 108 and 108 between the connector cover 32 and the guide connector 194.
- the air venting passage 218 communicating the space on the tip end side (the cannula 12 side) of the internal flow passage 18 with respect to the disk valve 16 to the external space is a tunnel-like passage 116, 116,.
- the air vent passage 218 communicates with the external space through the engagement holes 50, 50 as air outlets.
- the filter 220 is disposed in the accommodation area 216. Similar to the filter 120 of the first embodiment, the filter 220 has a property of passing gas but not liquid, and may be formed of the same material as the filter 120 of the first embodiment. Further, in the filter 220 of the present embodiment, the fitting portion 222 externally fitted to the guide connector 194 and the inner circumferential protruding portion 224 disposed axially between the guide connector 194 and the valve support member 204 are integrally formed. It is prepared.
- the fitting portion 222 has a substantially cylindrical shape, and the inner diameter dimension is smaller than the outer diameter of the annular support portion 74 of the guide connector 194 in the single state, and the outer diameter dimension is a wall portion of the housing area 216
- the inner peripheral protrusion portion 224 protrudes from the tip end portion of the fitting portion 222 toward the inner periphery, and the axial dimension is between the axially facing surfaces of the tip end surface of the guide connector 194 and the proximal end surface 211 of the valve support member 204.
- the distance is substantially the same or slightly larger.
- the fitting portion 222 is fitted to the distal end portion (annular support portion 74) of the guide connector 194 in a state of being inserted in a state where the inner circumferential protrusion 224 is superimposed on the distal end surface of the guide connector 194.
- the filter 220 is accommodated in the accommodation area 216 and arranged on the air vent passage 218.
- the filter 220 can be handled integrally with the guide connector 194 by the filter 220 being attached to the guide connector 194 in an extrapolated state as described above, arrangement of the filter 220 in the housing area 216 can be It can be completed simultaneously with the assembly of the connector cover 32 and the guide connector 194, and the installation operation of the filter 220 becomes easy.
- connection connector 192 is formed in a state in which the disc valve 16, the pusher 198 and the filter 220 are accommodated.
- the fitting portion 222 of the filter 220 has a thickness dimension in the radial direction corresponding to the inner peripheral surface of the connector cover 32 forming the wall surface of the housing area 216 and the outer periphery of the guide connector 194 in a single-piece state before being assembled to the connection connector 192. It is larger than the radial distance from the surface. Thereby, the fitting portion 222 of the filter 220 is assembled to the connection connector 192 in a state where the fitting portion 222 of the filter 220 is radially pinched and compressed by the connector cover 32 and the guide connector 194.
- an inner and outer rigid member for holding the filter 220 in the radial direction is constituted by the connector cover 32 and the guide connector 194.
- the axial thickness dimension is the same as the projection tip of the compression rib 212 of the valve support member 204 and the tip surface of the guide connector 194. And the axial distance with is greater. Accordingly, the inner peripheral projecting portion 224 of the filter 220 is assembled to the connection connector 192 in a state in which the entire periphery is axially sandwiched and compressed by the guide connector 194 and the valve support member 204.
- a hard member for holding the filter 220 in the axial direction is constituted by the guide connector 194 and the valve support member 204.
- the inner diameter is larger than the inner diameters of the guide connector 194 and the valve support member 204, and the filter 220 is a guide connector. It is designed not to project to the inner periphery from the point 194 and the valve support member 204.
- the filter 220 is assembled to the connection connector 192 in a state where the filter 220 is compressed at the fitting portion 222 and the inner circumferential projection portion 224, so that substantially the entire filter 220 accommodated in the housing area 216 of the connection connector 192. Is in a compressed state, and the filter 220 is stably positioned and held with respect to the connection connector 192.
- the hard member for holding the filter 220 is constituted by the connector cover 32 and the guide connector 194 which constitute the connection connector 192, and the valve support member 204 which supports the disc valve 16, Hard members can be provided without increasing the number of points.
- the entire inner peripheral protruding portion 224 may be compressed by being sandwiched between the guide connector 194 and the valve support member 204 in the axial direction, and the inner peripheral protruding portion 224 presses the compression rib 212. It may be partially sandwiched and compressed by the portion etc.
- the fitting portion 222 may be radially pinched and compressed over the entire length in the axial direction, or may be partially pinched and compressed in the radial direction, for example, this embodiment In the structure of the embodiment, since the tip end portion provided with the inner circumferential protrusion 224 is positioned on the tip end side with respect to the guide connector 194, it may not be compressed in the radial direction.
- the axial dimension of the fitting portion 222 of the filter 220 is smaller than the axial distance between the step surface 72 of the guide connector 194 and the proximal end surface 211 of the valve support member 204 in the single state.
- the fitting portion 222 when the fitting portion 222 is radially pinched and compressed by the connector cover 32 and the guide connector 194, the fitting portion 222 axially extends, and the fitting portion 222 has the step surface 72 and the base end face. It can also be made to be pressed on both of 211.
- the filter 220 may be held by the connector cover 32, the guide connector 194, and the valve support member 204 in a state of being disposed in the housing area 216.
- the filter 220 is held between the hard members does not necessarily mean that the filter 220 is held between the hard members in a compressed state and supported, for example, 0 touch (non-compression contact state to the hard members) ), And is supported in a substantially non-compressed state by a rigid member.
- the filter 220 is a three-dimensional filtration structure (for example, a sponge filter or a sintered body) as exemplified in the embodiment, it is sandwiched and supported in a direction perpendicular to the flow of air.
- the filter 220 does not necessarily have to be supported only by sandwiching with a hard member, and for example, adhesion or welding may be used in combination, or sandwiching with a hard member may be realized via a soft member. .
- the fitting portion 222 of the filter 220 is between the connector cover 32 and the guide connector 194.
- the whole circumference is squeezed and compressed radially.
- the guide connector 194 and the valve support member 204 are both cylindrical at the mounting portion of the filter 220, the inner circumferential projecting portion 224 of the filter 220 is between the guide connector 194 and the valve support member 204. The whole circumference is compressed by being sandwiched in the axial direction.
- the hemostatic valve attached indwelling needle 190 is, as in the first embodiment, indwelling by inserting an inner needle unit (not shown) in the inner flow passage 18.
- a needle assembly is formed, and the skin of the patient is punctured while the inner needle of the inner needle unit is inserted through the cannula 12 as the outer needle.
- the indwelling needle with hemostatic valve 190 is indwelled in a state where the cannula 12 is percutaneously inserted into the patient's blood vessel by pulling out the inner needle unit to the proximal end side from the indwelling needle with hemostatic valve 190 which is an outer needle unit. Be done.
- blood that has flowed back from the blood vessel into the internal flow passage 18 can not pass through the filter 220 disposed on the air vent passage 218, so that leakage to the external space through the air vent passage 218 is prevented. .
- the fitting portion 222 of the filter 220 disposed on the air vent passage 218 is radially compressed between the connector cover 32 and the guide connector 194, the fitting portion 222 of the filter 220 is The prevention of the passage of blood by this is realized more effectively, making it difficult for the blood to leak to the external space.
- the inner peripheral projection 224 of the filter 220 is disposed between the guide connector 194 and the valve support member 204, the passage of blood to the inner peripheral is prevented by the inner peripheral projection 224, and thus the blood is prevented. Is difficult to get in between the guide connector 194 or the valve support member 204 and the pusher 198, and malfunction of the pusher 198 due to blood coagulation is prevented.
- the compression rib 212 protrudes from the base end surface 211 of the valve support member 204, and the compression rib 212 is strongly pressed by the inner peripheral protruding portion 224 of the filter 220. It is greatly compressed in the axial direction. Therefore, in the axial direction between the guide connector 194 and the valve support member 204, stable retention of the filter 220 by compression of the inner circumferential protrusion 224, improvement of the blood passage prevention performance by the filter 220, and the like are achieved. Passage to the inner circumference of the The compression rib 212 may be provided at a portion sandwiching the filter 220 in the axial direction. For example, the compression rib 212 may be provided so as to protrude from the tip end face of the guide connector 194 toward the tip end.
- the connector cover 32, the guide connector 194 and the valve support member 204 for holding the filter 220 are all cylindrical, and the filter 220 is provided between the connector cover 32 and the guide connector 194 and between the guide connector 194 and the valve support Between the members 204, the whole circumference is continuously pinched. As a result, the filter 220 is more stably held in the predetermined mounting state, and thus it is possible to more effectively prevent the blood from leaking to the outer space or the inner circumferential space.
- a syringe 226 or the like is connected to the proximal end of the indwelling needle 10 with a hemostatic valve that is indwelled in the blood vessel of the patient. That is, as shown in FIG. 12, the external flow passage 228 of the syringe 226 is connected to the proximal end opening (the proximal end opening of the guide connector 194) 86 of the connection connector 14 in the hemostatic valve attached indwelling needle 10.
- the male luer 230 of the syringe 226 inserted into the guide connector 194 pushes the pusher 198 distally, and the central portion 98 of the disc valve 16 is pushed forward by the pusher 198.
- the slit 100 is opened.
- the internal flow passage 18 of the indwelling needle 10 with a hemostatic valve is communicated with the external flow passage 228 of the syringe 226, so the inner hole of the cannula 12, the inner hole of the elastic tube 28 and the inner hole 89 of the pusher 198.
- Infusion, blood collection, hemodialysis and the like may be performed through the internal flow path 18 configured to include
- the indwelling needle 310 with a hemostatic valve is provided with a cannula 312 as a hollow needle on the distal end side, and a disc valve (hemostatic valve) 314 as an elastic valve body is accommodated and disposed inside the proximal end side of the cannula 312.
- a needle hub housing (connecting connector) 316 is provided as a housing to be used.
- An internal flow passage 318 is configured including the inside of the cannula 312 and the needle hub housing 316.
- the cannula 312 is percutaneously inserted into the patient's blood vessel and left in place, whereby infusion and blood collection can be performed through the internal channel 318 and the external channel to the needle hub housing 316 With the connection and removal, the opening and closing of the disc valve 314, that is, the communication and closing of the internal flow passage 318 can be switched.
- the axial direction is the central axial direction of each member, substantially corresponds to the needle axial direction of the cannula 312 which is a hollow needle, and means the left-right direction in FIG. 14 which is the longitudinal direction. .
- the distal end side refers to the left side in FIG. 14 where the cannula 312 is punctured, while the proximal end side refers to the right side in FIG. 14 where the user operates.
- the cannula 312 is formed of a soft synthetic resin, and the outer peripheral surface of the tip end portion is a tapered outer peripheral surface 320 whose outer diameter dimension gradually decreases toward the tip end side. ing. Further, a plurality of through holes 322 are formed in the peripheral wall of the tip end portion of the cannula 312, and blood and the like can easily flow into the cannula 312 through the through holes 322.
- the material of the cannula 312 is not limited to a soft synthetic resin, and may be made of metal, for example.
- the proximal end portion of the cannula 312 is fixedly supported by the needle hub 324.
- the needle hub 324 has a substantially cylindrical peripheral wall 326, and is formed of, for example, a hard synthetic resin. Then, the cannula 312 is inserted into the needle hub 324, and the proximal end portion of the cannula 312 is fixed to the needle hub 324 by adhesion, welding or the like, whereby the cannula 312 extends out from the needle hub 324 to the tip side. .
- An elastic tube 328 is connected to the proximal end side of the needle hub 324.
- the elastic tube 328 is formed of, for example, a soft synthetic resin, and the distal end portion of the elastic tube 328 is sandwiched between the peripheral wall 326 of the needle hub 324 and the cannula 312 at the proximal end opening of the needle hub 324.
- the elastic tube 328 is connected to the proximal end side of the needle hub 324 by adhesion or welding in accordance with the above. Thus, the cannula 312 and the elastic tube 328 are firmly fixed to the needle hub 324.
- the proximal end portion of the elastic tube 328 is secured to the distal end portion of the needle hub housing 316.
- the needle hub housing 316 has a generally cylindrical shape as a whole, and the proximal end portion of the elastic tube 328 is inserted from the distal end side opening portion of the needle hub housing 316, and adhesion and welding are performed as necessary. As a result, the elastic tube 328 and the needle hub housing 316 are mutually connected. That is, the tip portion of the needle hub housing 316 is a tube connection portion 330 to which the elastic tube 328 is connected.
- the needle hub is configured to include the needle hub 324, the elastic tube 328, and the needle hub housing 316, and grasps that the needle hub housing 316 is one member constituting the needle hub It can also be done.
- an elastic tube 328 is not essential, and the cannula 312 may extend from the tip of the needle hub housing 316.
- the inside from the cannula 312 to the needle hub housing 316 includes the inner holes of the cannula 312, the elastic tube 328, and the needle hub housing 316 (in particular, the pusher 396 described later provided inside the needle hub housing 316).
- a flow path 318 is configured.
- the needle hub housing 316 has a shape in which an outer peripheral housing (connector cover) 332 and an inner peripheral housing (guide connector) 334, both of which are substantially cylindrical, are inserted in and out of each other and fixed. ing. That is, the distal end portion of the inner peripheral housing 334 is inserted into and assembled at the proximal end side of the outer peripheral housing 332, whereby the outer peripheral housing 332 is axially connected to the distal end portion of the inner peripheral housing 334. Being fixed, the needle hub housing 316 is configured. Therefore, the circumferential wall of the needle hub housing 316 is configured of the circumferential wall 336 of the outer circumferential side housing 332 and the circumferential wall 338 of the inner circumferential side housing 334.
- the portion on the tip end side which is inserted into the outer peripheral side housing 332 is taken as a substantially cylindrical insertion portion 340
- a proximal end portion into which the insertion portion 340 of the side housing 334 is inserted is a substantially cylindrical insertion portion 342.
- the insertion portion 340 and the insertion portion 342 may be provided opposite to each other, and the base end portion of the inner peripheral housing 334 may be inserted into the outer peripheral housing 332 located on the base end side.
- the proximal end of the inner peripheral housing 334 extends toward the proximal end with a predetermined axial dimension than the outer peripheral housing 332. Therefore, the peripheral wall of the needle hub housing 316 has a double-walled structure at the insertion / removal portion between the insertion portion 340 and the insertion portion 342, which are connection portions between the outer peripheral housing 332 and the inner peripheral housing 334
- the peripheral wall at the tip end side of the needle hub housing 316 is formed by the peripheral wall 336 of the outer peripheral side housing 332, and the peripheral wall at the base end side of the needle hub housing 316 is formed by the peripheral wall 338 of the inner peripheral side housing 334.
- the base end portion (inner peripheral surface of the inserted portion 342) 344a in the inner peripheral surface 344 of the outer peripheral side housing 332 and the distal end portion (outer peripheral surface of the insertion portion 340) in the outer peripheral surface 346 of the inner peripheral side housing 334 By being mutually superimposed, the part by which the said outer peripheral side housing 332 and the said inner peripheral side housing 334 are inserted in and out, and is made into the double wall structure is comprised.
- the outer peripheral side housing 332 is formed of hard synthetic resin, and is provided with a substantially cylindrical peripheral wall 336.
- An annular wall portion 348 is formed on the inner circumferential surface 344 at the axially intermediate portion of the circumferential wall 336 so as to protrude to the inner circumferential side.
- the proximal end of the elastic tube 328 inserted from the distal end side opening of the outer peripheral side housing 332 is in contact with the distal end side end face of the annular wall 348 which spreads in the direction perpendicular to the axis.
- the portion more distal than 348 constitutes a tube connection portion 330 to which the elastic tube 328 is connected.
- the base end face of the annular wall 348 extends in the direction perpendicular to the axis, whereby an annular step surface 349 is formed on the inner peripheral surface 344 of the outer peripheral side housing 332.
- the inner diameter dimension is substantially constant over substantially the entire length in the axial direction. Further, in the inserted portion 342 on the proximal end side, the inner diameter dimension is slightly larger than that of the tube connection portion 330, and is substantially constant over substantially the entire length in the axial direction.
- the distal end portion of the inserted portion 342 that is, the portion adjacent to the proximal end side with respect to the annular wall 348, protrudes on the inner circumferential side.
- the pressing rib 350 is partially formed along the entire circumferential length or on the circumference.
- a pair of engagement members penetrating the peripheral wall 336 in the thickness direction (radial direction) on both sides in the radial direction 1 (both sides in the vertical direction in FIG. Joint holes 352, 352 are formed.
- Each of the engagement holes 352, 352 has a substantially rectangular shape in a plan view, and is formed with a circumferential dimension less than a half circumference.
- at a position deviated in the circumferential direction from the pair of engagement holes 352, 352, from the opening edge of the proximal end opening 354 toward the inside in the axial direction (tip side) A notch 356 extending is formed.
- a pair of notches 356, 356 are formed with a predetermined width dimension on both sides in the direction orthogonal to the opposing direction of the pair of engagement holes 352, 352 (both sides in the front and back in FIG. 14). ing.
- the number of the notches 356 is not limited to two (a pair), and one or three or more may be provided on the circumference.
- a pair of inclined surfaces 358 and 358 are formed in the proximal end opening 354.
- the inclined surfaces 358 and 358 are formed in the same direction (both sides in the vertical direction in FIG. 14) as the facing direction of the engagement holes 352 and 352, and the thickness of the peripheral wall 336 toward the proximal opening 354 The dimensions are getting smaller and smaller.
- the inclined surfaces 358 and 358 and the wall portions on both sides in the circumferential direction of the inclined surfaces 358 and 358 allow the base end side opening portion 354 of the outer peripheral side housing 332 to have a pair of inclined grooves 360 opening on the inner peripheral side , 360 are formed.
- the widthwise dimensions of the inclined surfaces 358, 358 are substantially equal to the widthwise dimensions of the engagement holes 352, 352, and the engagement holes 352, 352 and the inclined grooves 360, 360
- the circumferential wall 336 is partially formed circumferentially at corresponding positions on the circumference. That is, the engagement holes 352, 352 are formed on the tip end side of the inclined grooves 360, 360.
- the inner peripheral housing 334 is formed of hard synthetic resin, and includes a peripheral wall 338 smaller in diameter than the peripheral wall 336 of the outer peripheral housing 332.
- the peripheral wall 338 has an inner diameter dimension and an outer diameter dimension that is substantially constant over substantially the entire length in the axial direction.
- annular engagement protrusion (engagement wall portion) 364 is formed to protrude in the inner peripheral side at an axially intermediate portion.
- the tip end side of the engagement protrusion 364 is a guide surface 366 for guiding the axial movement of the pusher 396 described later, and the inner diameter dimension is approximately It is considered constant.
- the proximal end side of the engagement projection 364 is a tapered surface 368 whose inner diameter is gradually increased toward the proximal end.
- the tip portion 346a of the outer circumferential surface 346 of the inner circumferential side housing 334 that is, the outer circumferential surface 346a of the insertion portion 340, has an outer diameter reduced at its most distal end portion.
- a substantially cylindrical support cylindrical portion 370 which protrudes to the tip end side is formed.
- an engagement protrusion 372 that protrudes to the outer peripheral side is provided.
- a pair of engagement protrusions 372 and 372 are formed on both sides in the radial direction 1 (both sides in the vertical direction in FIG. 14).
- the shapes of these engaging protrusions 372 and 372 in a plan view are substantially rectangular shapes substantially corresponding to the engaging holes 352 and 352 in the outer peripheral side housing 332.
- the distal end side end surfaces of the engagement protrusions 372 and 372 are inclined surfaces 374 and 374 in which the protruding heights of the engagement protrusions 372 and 372 gradually decrease toward the distal end side.
- the vertical surfaces 376 and 376 extend substantially in the direction perpendicular to the axis.
- the direction of inclination of the engaging projections 372 and 372 with respect to the axial direction of the inclined surfaces 374 and 374 is equal to the direction of inclination of the inclined surfaces 358 and 358 with respect to the axial direction of the inclined grooves 360 and 360.
- the inclination angles of the both inclined surfaces 358 and 374 with respect to the axial direction are substantially equal, and the inclined surface 358 and the inclined surface 374 are substantially parallel to each other in the axial direction.
- the number of the engagement protrusions 372 and the engagement holes 352 is not limited to two (a pair), and one or three or more may be provided on the circumference.
- cutting on the outer peripheral side housing 332 is performed on both sides in the direction orthogonal to the opposing direction of the pair of engaging protrusions 372, 372 (both sides in the front and back in FIG.
- a pair of positioning projections 378, 378 having a shape substantially corresponding to the notches 356, 356 are formed to protrude.
- the proximal end side of the insertion portion 340 extends substantially straight with an outer diameter dimension substantially equal to or slightly smaller than that of the insertion portion 340, and the proximal end opening 380
- a substantially annular flange portion 382 is formed to protrude to the outer peripheral side.
- An external thread is formed on the outer peripheral surface of the flange portion 382, so that it is possible to connect an external flow path of luer lock type when connecting an external flow path (syringe 414) described later.
- a positioning concave groove 384 extending in the axial direction is formed in a part (upper side in FIG. 14) on the circumference of the flange portion 382.
- the indwelling needle with hemostatic valve 310 of the present embodiment when used as an outer needle unit in combination with an inner needle unit (not shown) as an indwelling needle assembly, the tip side from the inner needle hub constituting the inner needle unit
- the relative positioning between the inner needle unit and the outer needle unit is prevented by inserting the positioning convex portion protruding into the positioning concave groove 384.
- a disc valve 314 is accommodated and disposed between the outer peripheral housing 332 and the inner peripheral housing 334.
- the disc valve 314 has a substantially disc shape, and is formed of an elastic material such as rubber or elastomer.
- the central portion 386 of the disc valve 314 is formed with a slit 388 penetrating in the axial direction.
- the shape of the slits 388 is not limited, but in the present embodiment, the slits 388 extend radially substantially equally (every 120 °) in three directions in the circumferential direction.
- the outer diameter of the disk valve 314 is larger than the inner diameter of the outer housing 332, particularly at the forming position of the pressing rib 350.
- the pressing rib 350 exerts a radial pressing force on the disc valve 314 from the outer peripheral side to the inner peripheral side, and the slit 388 is stably closed. It has become. That is, by the pressing rib 350 provided on the inner peripheral surface 344 (344a) of the outer peripheral side housing 332, the outer peripheral surface of the disc valve 314 is compressed to the inner peripheral side.
- the outer peripheral portion of the disc valve 314 is provided with a cylindrical support portion 390 extending to the base end side.
- a cylindrical support portion 390 extending to the base end side.
- Grooves 394 are formed.
- such a cylindrical support portion 390 is not essential.
- the circumferential groove 394 is not essential, and the circumferential groove 394 may be formed by pushing the tip end of the support cylindrical portion 370 into the proximal end side surface 392 of the disc valve 314.
- a cylindrical pusher 396 is accommodated on the base end side of the disc valve 314, and the central portion of the pusher 396 axially penetrates An inner hole 398 is formed.
- a step surface 400 as an annular contact portion that spreads in the direction perpendicular to the axial direction is formed on the outer peripheral surface of the presser 396 at an axially intermediate portion. That is, the outer diameter dimension of the presser 396 is such that the part adjacent to the distal end side with respect to the step surface 400 is larger in diameter than the part adjacent to the base end side, and the proximal end side than the step surface 400 A straight outer circumferential surface 402 having a substantially constant outer diameter is provided.
- the tip end side of the step surface 400 is a tapered outer circumferential surface 404 whose diameter gradually decreases toward the tip end with the portion adjacent to the tip end side with respect to the step surface 400 as the maximum outer diameter portion.
- the inner peripheral surface 199 of the tip end portion of the pusher 396 is tapered such that the diameter decreases toward the tip, The improvement of the pushability of the disc valve 314 and the small flow resistance in the internal flow path can be achieved in a compatible manner.
- the tip end side of the step surface 400 in the pusher 396 that is, substantially the entire formation portion of the tapered outer peripheral surface 404 is pushed when the external flow path (syringe 414) is connected.
- An insertion area 406 (see FIG. 18) is inserted into the disc valve 314 when the element 396 is moved to the distal end side.
- an insertion area 406 is inserted into the disc valve 314 from the axially intermediate portion of the proximal inclined surface 410 (described later) that constitutes the proximal portion of the tapered outer peripheral surface 404. It is assumed.
- the tapered outer peripheral surface 404 is formed in a tapered shape as a whole, and each of the distal inclined surface 408 and the proximal inclined surface 410, which are tapered, and both inclined surfaces 408, A tapered, steeply-inclined surface 412 is provided, which connects 410 at the axially intermediate portion of the tapered outer peripheral surface 404 (insertion area 406).
- the tapered outer peripheral surface 404 is provided with a tapered end side inclined surface 408 having a relatively small diameter on the front end side with respect to the steeply inclined surface 412 and a proximal end side than the steeply inclined surface 412
- a tapered tapered end-side inclined surface 410 having a relatively large diameter is provided on the.
- the distal end side inclined surface 408, the base end side inclined surface 410, and the steeply inclined surface 412 are each formed as an annular tapered surface extending along the entire circumferential direction.
- the proximal end side inclined surface 410 larger in diameter than the distal end side inclined surface 408, for example, a single inclination angle as described in Patent Document 1 (for example, the same angle as the distal end side inclined surface 408)
- the sealing performance upon insertion of the pusher 396 into the disc valve 314 can also be improved as compared with the case of the tapered outer peripheral surface having only one.
- the inclination angle ⁇ (see FIG. 16) of the steeply inclined surface 412 with respect to the axial direction is larger than the inclination angle ⁇ (see FIG. 16) of the distal-side inclined surface 408 with respect to the axial direction ( ⁇ ⁇ ).
- the inclination angle ⁇ (see FIG. 16) with respect to the axial direction in the proximal end inclined surface 410 is larger ( ⁇ ⁇ ).
- the inclination angle ⁇ of the distal inclined surface 408 with respect to the axial direction is larger than the inclination angle ⁇ of the proximal inclined surface 410 with respect to the axial direction ( ⁇ ⁇ ⁇ ).
- the inclination angle ⁇ of the distal end side inclined surface 408 may be made larger ( ⁇ ⁇ ).
- the inclination angles ⁇ , ⁇ and ⁇ at the distal end side inclined surface 408, the base end side inclined surface 410, and the steep inclined surface 412 are substantially constant in the axial direction, respectively. 412, and the steeply inclined surface 412 and the proximal side inclined surface 410 are connected by smooth curved surfaces, respectively. Thereby, substantially the entire tapered outer circumferential surface 404 is smoothly continuous.
- the distal side inclined surface 408 and the steeply inclined surface 412, and / or the steeply inclined surface 412 and the proximal end inclined surface 410 may be bent and connected.
- the inclination angles ⁇ , ⁇ and ⁇ of the distal end side inclined surface 408, the base end side inclined surface 410 and the steep inclined surface 412 are not limited to any particular ones, but as in the present embodiment, It is preferable that the inclination angle ⁇ be larger ( ⁇ ⁇ , ⁇ ⁇ ) than the inclination angle ⁇ on the distal end side inclined surface 408 and the inclination angle ⁇ on the base end side inclined surface 410. That is, when the inclination angle ⁇ is smaller than the inclination angles ⁇ and ⁇ ( ⁇ ⁇ , ⁇ ⁇ ), the inclination angle is smaller depending on the insertion length of the male luer 416 of the syringe 414 described later into the needle hub housing 316.
- the inclination angles ⁇ , ⁇ , and ⁇ of the distal inclined surface 408, the proximal inclined surface 410, and the steep inclined surface 412 are each set to a tapered shape, that is, within the range of 0 degrees to 90 degrees.
- the inclination angle ⁇ in the proximal end inclined surface 410 exceeds 20 degrees, it is not preferable because the axial dimension of the proximal end inclined surface 410 and hence the insertion area 406 is shortened.
- the inclination angle ⁇ on the steeply inclined surface 412 is more preferably set in the range of 25 degrees to 75 degrees, further preferably 35 degrees to 60 degrees, and is set to 45 degrees in the present embodiment. That is, when the inclination angle ⁇ of the steeply inclined surface 412 exceeds 75 degrees, the elastically deformed disc valve 314 and the sharply inclined surface 412 do not firmly abut each other, and the contact area is reduced.
- the axial dimensions of the distal inclined surface 408, the proximal inclined surface 410, and the steep surface 412 are not limited in any way, but in the present embodiment, the steep surface 412 has a tapered outer periphery.
- the axial-direction dimension of the proximal-side inclined surface 410 is made larger than the axial-direction dimension of the distal-side inclined surface 408, which is provided slightly distal to the center of the surface 404.
- the axial dimension of the formation portion of the steeply inclined surface 412 is 0.2 mm to 0.3 mm.
- the steeply inclined surface 412 is preferably located 1 mm to 3 mm from the tip of the presser 396, more preferably approximately 2 mm, and in the present embodiment, the tip of the steeply inclined surface 412 Is located 1.7 mm from the tip of the pusher 396.
- the axial dimension of the formation portion of the tip side inclined surface 408 is 1.7 mm.
- the axial dimension of the formation part of the taper-shaped outer peripheral surface 404 be 4 mm or more.
- the dimensions in the direction perpendicular to the axis in the distal end side inclined surface 408, the proximal end side inclined surface 410, and the steep inclined surface 412 are set according to the size of the pusher 396 and the disc valve 314, etc.
- the perpendicular dimension H (see FIG. 16) of the steeply inclined surface 412 is It is preferable to set in the range of 0.1 mm to 1.0 mm.
- the needle hub housing 316 is configured to include the outer peripheral housing 332 and the inner peripheral housing 334 configured as described above, and the disc valve 314 and the pusher 396 are housed and arranged inside the needle hub housing 316. It is done.
- the pusher 396 is inserted from the distal end opening of the inner housing 334 and disposed. At that time, at the base end position of the pusher 396, the engaging projection 364 provided on the inner peripheral surface 362 of the inner peripheral side housing 334 and the step surface 400 provided on the outer peripheral surface of the pusher 396 mutually It is defined by contact.
- the straight outer peripheral surface 402 of the pusher 396 and the inner peripheral surface of the engagement protrusion 364 are in contact or slightly separated, and the tapered shape of the pusher 396 Whether the outer peripheral surface of the base end portion of the outer peripheral surface 404 (the base end portion of the proximal inclined surface 410, ie, the maximum outer diameter portion of the tapered outer peripheral surface 404) is in contact with the guide surface 366 of the inner peripheral housing 334 Slightly separated.
- the pushers 396 are axially movable while being guided by the inner circumferential surface 362 of the inner circumferential housing 334.
- the cylindrical support portion 390 of the disc valve 314 is covered and supported at the tip end portion of the inner peripheral side housing 334. That is, in the circumferential groove 394 provided on the proximal end side surface 392 of the disc valve 314, the distal end portion of the support cylindrical portion 370 which is the distal end of the inner peripheral side housing 334 is inserted.
- the inner and outer peripheral surfaces of the tip end portion of the support cylindrical portion 370 are respectively in contact or slightly separated from the inner and outer peripheral surfaces constituting the inner surface of the circumferential groove 394.
- a gap may be provided between the tip end surface of the support cylindrical portion 370 and the groove bottom surface of the circumferential groove 394 in the axial direction.
- the inner peripheral surface of the cylindrical support portion 390 of the disc valve 314 is in contact with the outer peripheral surface of the support cylindrical portion 370, and the tip portion of the inner peripheral housing 334 is fitted into the proximal end of the disc valve 314. It is done. Then, in the present embodiment, in the supported state of the disc valve 314, the tip end of the pusher 396 is in contact with the proximal end side surface 392 of the disc valve 314, and the pusher 396 engages with the disc valve 314. It is positioned in the axial direction with the portion 364.
- the tip end of the pusher 396 does not necessarily have to abut on the proximal end side 392 of the disc valve 314, and the tip end of the pusher 396 and the proximal end side 392 of the disc valve 314 are axially separated from each other. It is also good.
- the outer peripheral housing 332 is assembled from the front end side of the disc valve 314. That is, the distal end portion of the inner housing 334 is inserted from the proximal end opening 354 of the outer housing 332 in a state where the disc valve 314 is covered and supported at the front end, and the engaging protrusion 372 of the inner housing 334, By engaging 372 with the engagement holes 352, 352 of the outer peripheral housing 332, the outer peripheral housing 332 and the inner peripheral housing 334 are inserted in the inside and outside, in series in the axial direction and on substantially the same central axis. Connected fixed.
- the tip end side end surfaces of the engagement protrusions 372 and 372 are the inclined surfaces 374 and 374, fitting of the engagement protrusions 372 and 372 into the engagement holes 352 and 352 is easy. It is done. Further, since the proximal end surfaces of the engagement protrusions 372 and 372 are vertical surfaces 376 and 376, the engagement protrusions 372 and 372 are pulled out from the engagement holes 352 and 352, ie, from the outer peripheral side housing 332. Extraction of the inner circumferential side housing 334 is prevented.
- the inclined grooves 360 and 360 configured to include the inclined surfaces 358 and 358 are formed in the proximal end opening portion 354 of the outer peripheral side housing 332,
- the relative rotation of the outer peripheral side housing 332 and the inner peripheral side housing 334 in the circumferential direction can be prevented by inserting the engaging projections 372 and 372 into the inclined grooves 360 and 360.
- the engaging projections 372 and 372 are stably guided to the engaging holes 352 and 352 by the guiding action of the inclined surfaces 358 and 358, the engaging projections 372 and 372 can be more reliably engaged with the engaging holes 352 and 352. Can be engaged.
- the positioning projections 378, 378 of the inner housing 334 can be formed in the notches 356, 356 provided in the proximal end opening 354 of the outer housing 332.
- the outer peripheral housing 332 and the inner peripheral housing 334 can be easily positioned in the circumferential direction, and the engaging projections 372, 372 can be engaged with the engaging holes 352, 352 more securely.
- the outer peripheral portion of the disc valve 314 extends in the axial direction between the outer housing 332 and the inner housing 334 assembled to each other.
- the disk valve 314 is assembled in a fitted state in which the disc valve 314 is fitted to the outer peripheral housing 332 and the inner peripheral housing 334 by being positioned and held in the direction perpendicular to the axis. That is, the shaft of the step surface 349 which is the end face side end face of the annular wall 348 provided on the outer peripheral side housing 332 and the support cylindrical portion 370 which is the tip end side of the inner peripheral side housing 334 It is sandwiched between directions.
- a cylindrical support portion 390 projecting to the proximal end side is preferably held in a compressed state between the peripheral wall 336 of the outer peripheral side housing 332 and the support cylindrical portion 370 in the radial direction. Further, the disk valve 314 is assembled by being compressed radially inward by the pressing rib 350 of the peripheral wall 336 of the outer peripheral side housing 332, in particular.
- the indwelling needle 310 with a hemostatic valve of this embodiment is obtained. It is configured.
- the indwelling needle with hemostatic valve 310 is, for example, an indwelling needle with indwelling valve by inserting an inner needle unit (not shown) including an inner needle including a needle tip with the indwelling needle with hemostatic valve 310 as an outer needle unit Used as a needle assembly.
- the patient is punctured by the skin of the patient in a state where the inner needle unit is inserted into the outer needle unit (dwelling needle with hemostatic valve) 310, and then the inner needle unit is pulled out from the outer needle unit 310 to the proximal side.
- the outer needle unit 310 is indwelled in a state of being percutaneously inserted into the blood vessel of the patient.
- the hemostatic valved indwelling needle 310 can be directly punctured and indwelled in a patient's blood vessel. In the indwelling state to such a blood vessel, the internal flow path 318 of the indwelling needle 310 with a hemostatic valve is blocked by the disc valve 314.
- a syringe 414 for example, is connected as an external flow path to the proximal end opening (proximal opening of the inner circumferential housing 334) 380 of the needle hub housing 316 in the indwelling needle 310 with a hemostatic valve.
- the male luer 416 such as the syringe 414 pushes the pusher 396 to the distal end side, and the distal end portion of the pusher 396 is inserted into the disk valve 314,
- the slit 388 of the disc valve 314 is opened while the central portion 386 of the valve 314 is pushed forward and the internal flow passage 318 is brought into communication.
- infusion, blood collection, hemodialysis and the like may be performed through the inner flow passage 318 configured to include the inner hole of the cannula 312, the inner hole of the elastic tube 328 and the inner hole 398 of the pusher 396.
- the disc valve 314 can be restored to its initial shape by the elastic restoring action of the disc valve 314 At the same time, it is pushed back to the restored deformed disk valve 314 so that the pusher 396 can be moved to the proximal side to the initial position shown in FIGS. As a result, the slit 388 of the disc valve 314 is closed, and the internal flow passage 318 is shut off.
- the movement of the pusher 396 to the base end side is the step surface 400 provided on the outer peripheral surface of the pusher 396, and the inner peripheral surface of the needle hub housing 316 (inner peripheral housing 334). It is regulated by contact with an engagement projection 364 provided on 362.
- the distal end portion of the pusher 396 when the syringe 414 is connected from the proximal end opening 380 of the needle hub housing 316 and the pusher 396 moves to the distal end side, the distal end portion of the pusher 396, particularly in FIG. As shown in FIG. 19, the distal end side of the axially-proximal portion of the proximal inclined surface 410 is inserted into the disc valve 314, that is, in the present embodiment, the axis of the proximal inclined surface 410. From the direction middle portion to the tip side, an insertion area 406 to be inserted into the disc valve 314 is made.
- the elastic restoring force A is given as an axial component force a x (shown by a thin line in FIG. 19) and a component force a y perpendicular to the axial direction (shown by a thin line in FIG. 19) with respect to the pusher 396 since the act, pusher 396 is adapted to be moved proximally in accordance force component a x in the axial direction with the removal of the syringe 414.
- the tapered outer peripheral surface 404 of the tip end portion of the presser 396 has only a single inclination angle, that is, as shown by a two-dot chain line in FIG.
- the elastic restoring force B of the disc valve 314 (two-dot chain line in FIG. 19) is assumed on the tapered outer peripheral surface 418. (Shown in).
- the elastic restoring force B is a component force b x in the axial direction with respect to the pusher 396 (shown by a two-dot chain line in FIG.
- the axial component of the elastic restoring force by providing a large steep inclined surface 412 of the inclination angle in the tapered outer peripheral surface 404 can be increased.
- the inclination angle of the tapered outer peripheral surface 418 having a single inclination angle, which is illustrated by a two-dot chain line in FIG. 19, is 11.5 degrees.
- the steeply inclined surface 412 having a larger inclination angle than the distal end side inclined surface 408 (for example, the inclination angle is 11.5 degrees) in the insertion area 406 to the disk valve 314 in the presser 396 Can move the pusher 396 more stably to the proximal side at the time of withdrawal of the syringe 414 because the elastic restoring force of the second force can be applied to the pusher 396 more effectively on the proximal side. Can.
- the insertion area of the conventional structure (for example, the patent document 2) has a single taper shape having only a single inclination angle
- the hemostatic valve-equipped indwelling needle 310 according to the present invention has a distal end side in the insertion area 406
- a novel configuration is provided in that a steeply inclined surface 412 having a larger inclination angle is provided.
- the inclination angle ⁇ with respect to the axial direction of the distal end side inclined surface 408 is in the range of 0 degrees to 90 degrees. That is, for example, when the amount of insertion of the male luer 416 into the needle hub housing 316 in the syringe 414, that is, the amount of movement of the pusher 396 to the tip side is small, the contact area between the disc valve 314 and the steep slope 412 Smaller and hence less resilient restoring force of the disc valve 314, making it difficult for the pusher 396 to move proximally.
- the distal end side inclined surface 408 having the above-mentioned inclination angle ⁇ is provided, and when the pusher 396 moves to the distal end side, the distal end side inclined surface 408 and the disc valve 314 abut against each other.
- An effective axial component can be easily obtained from the elastic restoring force.
- the pusher 396 can be stably moved to the proximal end side as the syringe 414 is removed.
- the inclination angle ⁇ with respect to the axial direction of the proximal end inclined surface 410 is in the range of 0 degrees to 90 degrees. That is, for example, when the insertion amount of the male luer 416 into the needle hub housing 316 in the syringe 414, that is, the movement amount of the pusher 396 to the tip side is large, the larger disc is used when pushing the pusher 396 back to the initial position.
- the restoring force of the valve 314 is required, providing the proximal side inclined surface 410 having the above-mentioned inclination angle ⁇ enables effective axial force not only from the steeply inclined surface 412 but also from the proximal side inclined surface 410. You can get it. Thus, even when the amount of movement of the pusher 396 to the distal end side is large, the pusher 396 can be stably moved to the proximal end side as the syringe 414 is removed.
- the needle hub of the male luer 416 can be obtained regardless of whether the amount of insertion of the male luer 416 into the needle hub housing 316 in the syringe 414 is large or small. Regardless of the amount of insertion into the housing 316, the pushers 396 can be stably moved to the proximal side. By the way, it is confirmed that the length of the male luer 416 of the external channel that can be connected to the hemostatic valved indwelling needle 310 currently distributed in the market is various, with a difference of at most 1.7 mm. .
- the disc valve 314 can be made more reliable regardless of the length of the male luer 416. It can be made to abut on the steeply inclined surface 412, and the movement force to the proximal side can be stably obtained with respect to the pusher 396.
- the effective moving force to the proximal end side can be obtained as described above. While being obtained, the axial dimension of the proximal inclined surface 410 and hence the axial dimension of the insertion area 406 into the disc valve 314 can be sufficiently secured. Thus, the pushers 396 can be more reliably inserted into the disc valve 314, and the communication state of the internal flow path 318 can be stably maintained.
- the inclination angle ⁇ with respect to the axial direction of the steeply inclined surface 412 may be, for example, 90 degrees or 90 degrees or more, it has a tapered shape as in the present embodiment, that is, the inclination angle ⁇ ranges from 0 degrees to 90 degrees.
- the space between the distal inclined surface 408 and the proximal inclined surface 410 and the disc valve 314 Since the possibility of the occurrence of gaps in the valve is also reduced, the elastic restoring force of the disc valve 314 can be effectively exerted on the pusher 396 as the moving force to the proximal side.
- the engagement projection 364 is provided on the inner peripheral surface 362 of the needle hub housing 316 (inner peripheral housing 334), and a step surface as an abutting portion on the outer peripheral surface of the pusher 396 400 is provided, and the movement of the pusher 396 to the proximal end side is restricted by the engagement projection 364 and the step surface 400 coming into contact with each other.
- the needle hub housing 316 is configured by inserting and inserting the outer peripheral housing 332 and the inner peripheral housing 334, and between the outer housing 332 and the inner housing 334. Because the disc valve 314 is supported, assembly of the needle hub housing 316 and the disc valve 314 may be facilitated. In particular, since the cylindrical support portion 390 of the disc valve 314 is sandwiched and supported in a compressed state between the outer peripheral housing 332 and the inner peripheral housing 334 in the radial direction, the movement of the presser 396 to the tip end side The disc valve 314 can be prevented from falling out of the needle hub housing 316 also at the time of elastic deformation of the disc valve 314 to the tip side.
- the inner needle unit constituting the indwelling needle assembly is not limited to the one described in the above embodiment, and a conventionally known inner needle unit including an inner needle and an inner needle hub is adopted. It can be done. That is, the shape of the needle point protector is not limited to that of the above embodiment.
- the needle tip protector 132 is not essential, and the connection cap 172 is also not essential.
- the elastic tube 28 is not essential. That is, although the cannula 12 is fixed to and supported by the needle hub 24 in the above embodiment, the cannula 12 may be fixed to and supported by the connection connector 14. In short, the connection connector 14 may have a needle hub function. .
- the recessed groove 60 is provided on the inner peripheral surface 44 of the connector cover 32, and the opening 114 of the recessed groove 60 is covered with the disk valve 16 to configure the air vent passage 118.
- the tunnel-like passage 116 has been configured, it is not limited to such an embodiment. That is, a recessed groove 60 is provided on the outer peripheral surface of the disc valve 16 so that the opening 114 of the recessed groove 60 is covered by the inner peripheral surface 44 of the connector cover 32 so that a tunnel-like passage 116 is formed. It is possible to form grooves on both the inner peripheral surface 44 of the connector cover 32 and the outer peripheral surface of the disc valve 16 and to contact the opening peripheral portions of these grooves with each other to form a tunnel-like passage. May be configured. Although four (two pairs) of recessed grooves 60, 60, 60, 60 are provided in the above embodiment, the present invention is not limited to such an aspect, and for example, one, two (pairs), three The number is not limited at all.
- the air vent passage 118 includes tunnel-like passages 116, 116, 116, 116, and gaps 108, 108, 110, 110 between the connector cover 32 and the guide connector 34.
- the air on the cannula 12 side of the internal flow passage 18 from the disk valve 16 is discharged to the external space through the engagement holes 50 and 50, but the invention is not limited to this aspect. That is, the shape of the air vent passage 118, the opening position to the internal flow passage 18, the opening position to the external space, etc. are not limited at all.
- a through hole may be provided in the peripheral wall 36 of the connector cover 32, and the air vent passage may be configured by the through hole. In such a case, the filter is mounted in a compressed state in the through hole.
- the opening position of the air vent passage to the outer space may be provided, for example, on the inner circumferential surface 62 of the guide connector 34, that is, on the tip end side of the disc valve 16 in the inner flow passage 18 of the hemostatic valve attached indwelling needle 10.
- the space may be in communication with the space proximal to the disc valve 16 through the air vent passage. In such a case, deairing of the space on the distal side of the disc valve 16 in the internal flow passage 18 is achieved through the proximal end opening 86 of the guide connector 34.
- the substantially annular housing area 112 is provided on the air vent passage 118, and the substantially cylindrical filter 120 is disposed in the housing area 112, but the present invention is limited to this aspect. It is not a thing. That is, for example, when the storage area is divided in the circumferential direction into a semi-annular shape, the filter may be formed into a semi-cylindrical shape in accordance with the shape of the storage area, and the shape of the filter 120 is the air vent passage 118 It may be appropriately changed in accordance with the shape of the accommodation area 112.
- the radial width dimension of the filter 120 before assembly is made larger than the radial dimension of the connector cover 32 and the guide connector 34 so that the filter 120 can While being radially compressed by being pinched in the radial direction with the guide connector 34, the present invention is not limited to this aspect. That is, the radial width of the filter 120 before assembly may be approximately equal to or slightly smaller than the radial facing dimension of the connector cover 32 and the guide connector 34.
- the connector cover 32 and the guide connector 34 The filter 120 may be radially compressed by interposing another member in the radial direction, or the filter 120 may be compressed axially between the disc valve 16 and the guide connector 34. As a result, it may expand radially and thereby be compressed between the connector cover 32 and the guide connector 34 in the radial direction.
- connection connector 14 was comprised including the connector cover 32 and the guide connector 34
- a connection connector may be comprised by one member by integral molding.
- these several members may be made into a mere cylindrical body, for example.
- the distal end portion of the guide connector 34 is inserted into the connector cover 32.
- the proximal end portion of the connector cover 32 may be inserted into the guide connector 34.
- the end side opening 52 and the tip side opening of the guide connector 34 may be butted against each other and fixed by adhesion, welding or the like.
- the air flow outlet is constituted by the engagement holes 50, 50 used for positioning the connector cover 32 and the guide connector 34 (194). It is also possible to provide separately, for example, it may be formed so as to open on the tip side of the engagement holes 50, 50 in the peripheral wall 36 of the connector cover 32.
- the hard member sandwiching the filter 120 (220) is configured by the component members of the connection connector 14 (192) and the valve support member 204 that supports the disc valve 16.
- a hard member may be provided separately from the connection connector 14 and the valve support member 204.
- adopting a membrane-like membrane filter it is also considered to employ
- the outer peripheral end of the membrane filter is not only held between the hard member and the connector cover, but the outer peripheral end of the membrane filter is welded to at least one of the hard member and the connector cover Is desirable.
- the filter 220 is orthogonal to the direction through which air flows.
- the mode is shown in which it is inserted in the direction (radial direction and axial direction) and mounted in a compressed state, it may be inserted and compressed in a direction inclined with respect to the radial direction and the axial direction.
- a non-annular curved plate-like filter may be pinched and compressed in the circumferential direction of the hemostatic valve-equipped indwelling needle.
- the arrangement position of the filter is not limited to the aspect of the first embodiment or the second embodiment, and the filter may be arranged anywhere in the air venting path provided in the connection connector. It is possible. Specifically, depending on the configuration of the air vent passage, for example, the filter may be compressed in the radial or axial direction at the outer circumferential side of the hemostatic valve or at any position on the distal end side or the proximal end side of the hemostatic valve. Alternatively, it can be disposed in the air venting passage in a non-compressed state.
- the filter medium for the filter is not particularly limited, and various materials and structures can be adopted.
- a two-dimensional filter structure such as a membrane filter May also be employed.
- filters that allow gas to pass but not liquids are employed, it is of course not limited to filters that have complete liquid tightness in any condition. That is, the filter does not allow the liquid to pass easily, but the liquid impermeability limit of the filter exists, so if the liquid contacts the filter with too much pressure, the liquid impermeability of the filter If the performance limit is exceeded, liquid may pass through the filter.
- the steeply inclined surface 412 has a tapered shape, that is, the inclination angle ⁇ with respect to the axial direction of the sharply inclined surface 412 is set within a range of 0 degrees to 90 degrees.
- the inclination angle ⁇ of the surface 412 may be 90 degrees or more than 90 degrees. That is, when the inclination angle ⁇ of the steep inclined surface 412 is 90 degrees, the steep inclined surface 412 is a step-like surface spreading in the direction perpendicular to the axis.
- the distal inclined surface 408 and the proximal inclined surface 410 are also tapered, that is, the inclination angles ⁇ and ⁇ of the distal inclined surface 408 and the proximal inclined surface 410 with respect to the axial direction are also 0 degrees to 90
- the inclination angles ⁇ and ⁇ of the distal end inclined surface 408 and the proximal end inclined surface 410 may be 0 degrees. That is, the distal end side and / or the proximal end side of the steep inclined surface 412 may be an annular surface which is not inclined with respect to the axial direction (parallel to the axial direction).
- the inclination angle of the front end side inclined surface 408, the base end side inclined surface 410, and the steeply inclined surface 412 was made substantially constant in the axial direction, it is limited to this aspect Instead, for example, it may be a curved surface whose inclination angle gradually changes in the axial direction. That is, for example, the tapered outer peripheral surface 404 provided at the tip portion of the presser 396 may be formed of a curved surface in which the inclination angle changes smoothly over substantially the entire length in the axial direction.
- one annular sharp inclined surface 412 is provided at the axially intermediate portion of the tapered outer peripheral surface 404, but a plurality of acute inclined surfaces 412 which are mutually separated in the axial direction It may be provided. That is, the distal end side and / or the proximal end side of the steep inclined surface 412 may have a portion where the inclination angle changes by bending or curving. In short, the distal end side and / or the proximal end side of the steep slope 412 may be provided with one or more axially extending step-like surfaces, for example, the distal end portion of the pusher 396 may be substantially entirely It may be made into the shape of a step which becomes tapered over.
- the needle hub housing 316 is configured to include the outer peripheral housing 332 and the inner peripheral housing 334, but the needle hub housing 316 may be integrally formed. Further, even when separate members are assembled and fixed to each other, they need not be assembled by insertion as in the embodiment described above, and may be connected in series in the axial direction, for example. Furthermore, the fixing means of the separately formed member is not limited to the locking structure as in the above embodiment, and any conventionally known fixing means such as welding and adhesion may be adopted.
- tip part of the presser 396 was comprised by the taper-shaped outer peripheral surface 404 made into the taper shape as substantially whole, it is not limited to this aspect,
- the outer circumferential surface of the tip end portion of the presser 396 may be provided with a projection having a steeply inclined surface 412 or the like.
- the disc valve 314 abuts on the projection from the proximal side to prevent the movement of the pusher 396 to the proximal side.
- the distal end side from the axially intermediate portion of the proximal inclined surface 410 is the insertion region 406 to be inserted into the disc valve 314.
- the present invention is not limited to such a mode, and it is only required that the disc valve 314 elastically deformed to the tip end be in contact with the steeply inclined surface 412. That is, for example, the distal end side from the sharply inclined surface 412 may be the insertion region 406, and in the present invention, the shape on the proximal end side from the sharply inclined surface 412 is not limited at all.
- the base end portion of the base-side inclined surface 410 is located on the outer peripheral side relative to the straight outer peripheral surface 402, and these base-end side inclined surface 410 and the straight outer peripheral surface
- the step surface 400 is formed between it and 402, such a step surface 400 is not essential, that is, for example, the steeply inclined surface 412 or the base end side inclination continuously to the tip portion of the straight outer peripheral surface 402.
- a face 410 may be formed.
- a lubricant is applied to at least a portion (e.g., the outer peripheral surface of the insertion area 406) on which the elastic valve body (disk valve 314) abuts on the outer peripheral surface of the presser 396 according to the third embodiment.
- a lubricant is applied to the steep surface 412.
- the return to the proximal end side of the pusher 396 at the time of withdrawal of the external flow path becomes smooth. That is, in the pusher 396 according to the present invention, since the inclination angle of the steeply inclined surface 412 is large, the efficiency of the repulsive force by the elastic valve acting in the direction of pushing back the pusher 396 inserted into the elastic valve. But the friction increases.
- the frictional force of the contact surface between the pusher 396 and the elastic valve body with a lubricant, it is possible to further improve the returnability of the pusher 396 to the proximal end side due to the recovery deformation of the elastic valve body. become.
- the specific specifications of the composition and viscosity of the lubricant to be used may be appropriately selected according to the design of the pusher and the elastic valve body, and the method of adhering the lubricant to the pusher 396 is not limited.
- the lubricant is preferably applied to the outer peripheral surface of the presser 396, but may be applied to the surface of the disc valve 314 in addition to or instead of the presser 396.
Landscapes
- Health & Medical Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Anesthesiology (AREA)
- Hematology (AREA)
- Engineering & Computer Science (AREA)
- Veterinary Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Biomedical Technology (AREA)
- Vascular Medicine (AREA)
- Pulmonology (AREA)
- Biophysics (AREA)
- Emergency Medicine (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
- Media Introduction/Drainage Providing Device (AREA)
Abstract
Description
Claims (25)
- 経皮的に血管に挿し入れられるカニューラを先端側に有していると共に、接続コネクタを基端側に備えており、該カニューラから該接続コネクタに至る内部流路が形成されていると共に、該接続コネクタの内部に止血弁が配されている止血弁付留置針において、
前記接続コネクタには前記内部流路を前記止血弁よりも前記カニューラ側において外部空間へ連通させるエア抜き通路が形成されており、該エア抜き通路上に、気体は通過させるが液体は通過させないフィルタが圧縮された状態で装着されていることを特徴とする止血弁付留置針。 - 経皮的に血管に挿し入れられるカニューラを先端側に有していると共に、接続コネクタを基端側に備えており、該カニューラから該接続コネクタに至る内部流路が形成されていると共に、該接続コネクタの内部に止血弁が配されている止血弁付留置針において、
前記接続コネクタには周壁に開口する空気流出口を通じて外部空間へ連通されたエア抜き通路が形成されており、前記内部流路が前記止血弁よりも前記カニューラ側において該エア抜き通路を通じて外部空間へ連通されていると共に、気体は通過させるが液体は通過させないフィルタが複数の硬質部材で挟持されて該エア抜き通路上に配されていることを特徴とする止血弁付留置針。 - 前記硬質部材の少なくとも1つが前記接続コネクタを構成している請求項2に記載の止血弁付留置針。
- 前記硬質部材が何れも筒状とされている請求項2又は3に記載の止血弁付留置針。
- 前記硬質部材の何れか1つが環状支持部を備えていると共に、前記フィルタが環状の嵌着部を備えており、該嵌着部が該硬質部材の該環状支持部に外挿状態で取り付けられている請求項2~4の何れか1項に記載の止血弁付留置針。
- 前記フィルタの前記嵌着部が前記硬質部材の間で径方向に挟まれて圧縮されている請求項5に記載の止血弁付留置針。
- 前記硬質部材が軸方向に隣り合って配されていると共に、前記フィルタがそれら硬質部材の間で軸方向に挟まれて圧縮されている請求項2~6の何れか1項に記載の止血弁付留置針。
- 軸方向に隣り合って配された前記硬質部材がそれぞれ筒状とされて、前記フィルタがそれら硬質部材の軸方向間において全周に亘って圧縮されていると共に、それら硬質部材の軸方向対向面の少なくとも一方には、該フィルタに全周に亘って押し当てられる環状の圧縮リブが突出形成されている請求項7に記載の止血弁付留置針。
- 前記接続コネクタが、前記内部流路を構成する流路を有するガイドコネクタと、該ガイドコネクタの先端部が挿入されて固定されるコネクタカバーとを含んで構成されており、該ガイドコネクタと該コネクタカバーとの間には隙間が設けられて、該隙間を含んで前記エア抜き通路が構成されている請求項1~8の何れか1項に記載の止血弁付留置針。
- 前記ガイドコネクタと前記コネクタカバーとの径方向間において前記フィルタが挟まれて圧縮された状態で装着されている請求項9に記載の止血弁付留置針。
- 前記ガイドコネクタの外周面には外周側に突出する係合突起が設けられている一方、前記コネクタカバーの周壁には径方向で貫通する係合孔が設けられており、該ガイドコネクタの先端部が該コネクタカバーに挿入されることで該係合突起が該係合孔に係合して、該ガイドコネクタと該コネクタカバーが相互に固定されていると共に、該係合孔が該ガイドコネクタと該コネクタカバーとの間の前記隙間に連通されている請求項9又は10に記載の止血弁付留置針。
- 前記コネクタカバーの内周面には凹溝が設けられており、該凹溝の開口部が前記止血弁で覆蓋されることで該止血弁と該コネクタカバーとで囲まれたトンネル状の通路が形成されていると共に、該トンネル状の通路を含んで前記エア抜き通路が構成されている請求項9~11の何れか1項に記載の止血弁付留置針。
- 前記フィルタが、気体は通過させるが液体を吸収する材質で構成されている請求項1~12の何れか1項に記載の止血弁付留置針。
- 請求項1~13の何れか1項に記載の止血弁付留置針に対して抜去可能な内針が前記内部流路の基端側から先端側に向かって挿通されていることを特徴とする留置針組立体。
- 押し子が先端側に移動して弾性弁体に挿入されることで該弾性弁体が押し開かれるようになっていると共に、該弾性弁体に挿入された該押し子が該弾性弁体の復元作用で基端側に移動されることで該弾性弁体が閉塞されるようになっている止血弁付留置針であって、
前記押し子における前記弾性弁体への挿入領域には、軸方向中間部分の外周面において先端側よりも傾斜角度の大きい急傾斜面が設けられていることを特徴とする止血弁付留置針。 - 前記急傾斜面の先端側に先端側傾斜面が先細形状をもって設けられている請求項15に記載の止血弁付留置針。
- 前記急傾斜面の基端側に基端側傾斜面が先細形状をもって設けられている請求項15又は16に記載の止血弁付留置針。
- 前記急傾斜面が先細形状とされている請求項15~17の何れか1項に記載の止血弁付留置針。
- 前記急傾斜面が一定の傾斜角度を有している請求項15~18の何れか1項に記載の止血弁付留置針。
- 前記急傾斜面の先端側と基端側とに先端側傾斜面と基端側傾斜面とがそれぞれ先細形状をもって設けられており、該先端側傾斜面の傾斜角度が、該基端側傾斜面の傾斜角度よりも大きい請求項15~19の何れか1項に記載の止血弁付留置針。
- 前記急傾斜面の先端側と基端側とに先端側傾斜面と基端側傾斜面とがそれぞれ先細形状をもって設けられており、該急傾斜面と該先端側傾斜面と該基端側傾斜面が、何れも一定の傾斜角度を有している請求項15~20の何れか1項に記載の止血弁付留置針。
- 前記弾性弁体と前記押し子とが収容配置される筒状のハウジングを備えている一方、該押し子における前記挿入領域よりも基端側の外周面には当接部が設けられていると共に、該ハウジングの内周面には係合突部が設けられており、これら当接部と係合突部との当接によって該押し子の基端側への移動が規制されている請求項15~21の何れか1項に記載の止血弁付留置針。
- 前記弾性弁体と前記押し子とが収容配置される筒状のハウジングを備えており、該ハウジングが、相互に内外挿されて組み付けられる外周側ハウジングと内周側ハウジングとを含んで構成されている一方、該弾性弁体の外周部分には基端側に突出する筒状支持部が設けられており、該筒状支持部を該外周側ハウジングと該内周側ハウジングとで径方向で挟み込んだ圧縮状態で該弾性弁体が該ハウジングにより支持されている請求項15~22の何れか1項に記載の止血弁付留置針。
- 前記急傾斜面の傾斜角度が25度~75度の範囲内に設定されている請求項15~23の何れか1項に記載の止血弁付留置針。
- 前記押し子の先端部分の外周面には前記急傾斜面を含んで構成される先細形状のテーパ状外周面が設けられており、該押し子における該テーパ状外周面の形成部分の軸方向寸法が4mm以上とされている請求項15~24の何れか1項に記載の止血弁付留置針。
Priority Applications (7)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2019534593A JP7209948B2 (ja) | 2017-08-02 | 2018-08-02 | 止血弁付留置針および留置針組立体 |
CN201880050192.3A CN111356496B (zh) | 2017-08-02 | 2018-08-02 | 带有止血阀的留置针以及留置针组件 |
US16/635,219 US11839752B2 (en) | 2017-08-02 | 2018-08-02 | Hemostasis valve-equipped indwelling needle and indwelling needle assembly |
EP18841085.6A EP3662959A4 (en) | 2017-08-02 | 2018-08-02 | HOME NEEDLE WITH A HEMOSTATIC VALVE, AND HOME NEEDLE ASSEMBLY |
CA3071818A CA3071818A1 (en) | 2017-08-02 | 2018-08-02 | Hemostasis valve-equipped indwelling needle and indwelling needle assembly |
JP2023001335A JP7482382B2 (ja) | 2017-08-02 | 2023-01-06 | 止血弁付留置針および留置針組立体 |
US18/372,770 US20240009406A1 (en) | 2017-08-02 | 2023-09-26 | Hemostasis valve-equipped indwelling needle and indwelling needle assembly |
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2017150204 | 2017-08-02 | ||
JP2017-150204 | 2017-08-02 | ||
JP2017-216744 | 2017-11-09 | ||
JP2017216744 | 2017-11-09 |
Related Child Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US16/635,219 A-371-Of-International US11839752B2 (en) | 2017-08-02 | 2018-08-02 | Hemostasis valve-equipped indwelling needle and indwelling needle assembly |
US18/372,770 Division US20240009406A1 (en) | 2017-08-02 | 2023-09-26 | Hemostasis valve-equipped indwelling needle and indwelling needle assembly |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2019027024A1 true WO2019027024A1 (ja) | 2019-02-07 |
Family
ID=65232883
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/JP2018/029139 WO2019027024A1 (ja) | 2017-08-02 | 2018-08-02 | 止血弁付留置針および留置針組立体 |
Country Status (6)
Country | Link |
---|---|
US (2) | US11839752B2 (ja) |
EP (1) | EP3662959A4 (ja) |
JP (2) | JP7209948B2 (ja) |
CN (1) | CN111356496B (ja) |
CA (1) | CA3071818A1 (ja) |
WO (1) | WO2019027024A1 (ja) |
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2020142019A (ja) * | 2019-03-08 | 2020-09-10 | ニプロ株式会社 | 弁付き針組立体 |
JP2021101771A (ja) * | 2019-12-24 | 2021-07-15 | ニプロ株式会社 | 弁付き針組立体 |
WO2021210484A1 (ja) * | 2020-04-17 | 2021-10-21 | ニプロ株式会社 | 針組立体 |
WO2022214490A1 (en) * | 2021-04-06 | 2022-10-13 | B. Braun Melsungen Ag | Vent device, port assembly and vascular access assembly |
Families Citing this family (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US11338114B2 (en) * | 2019-07-09 | 2022-05-24 | Becton, Dickinson And Company | Magnetic catheter system and methods |
CA3158895A1 (en) * | 2019-11-26 | 2021-06-03 | Benjamin W. Close | Infusion and blood collection devices and methods |
WO2023220845A1 (zh) * | 2022-05-16 | 2023-11-23 | 百仕韦(长汀)医疗器械有限公司 | 带有摆动闸片的血液透析针 |
Citations (9)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5290246A (en) * | 1991-01-18 | 1994-03-01 | Terumo Kabushiki Kaisha | Piercing needle |
JPH114894A (ja) * | 1997-05-02 | 1999-01-12 | Schneider Namic | 止血バルブを備えた医療用挿入機器 |
JP2000279526A (ja) * | 1999-03-30 | 2000-10-10 | Terumo Corp | 留置針組立体および弁体 |
JP2002263197A (ja) * | 2001-03-12 | 2002-09-17 | Medikit Kk | 留置用カテーテル |
JP2012517326A (ja) * | 2009-02-11 | 2012-08-02 | ベクトン・ディキンソン・アンド・カンパニー | 洗浄可能なカテーテルアセンブリを提供するためのシステムと方法 |
WO2015141366A1 (ja) * | 2014-03-20 | 2015-09-24 | テルモ株式会社 | カテーテル組立体 |
JP2016013359A (ja) | 2014-07-03 | 2016-01-28 | ニプロ株式会社 | 隔壁部材付きハブ組立体 |
JP5877196B2 (ja) | 2011-03-28 | 2016-03-02 | テルモ株式会社 | カテーテル組立体 |
US20170119977A1 (en) * | 2015-10-30 | 2017-05-04 | B. Braun Melsungen Ag | Valved catheters and related methods |
Family Cites Families (11)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6749588B1 (en) * | 1998-04-09 | 2004-06-15 | Becton Dickinson And Company | Catheter and introducer needle assembly with needle shield |
JP4344433B2 (ja) | 1999-08-04 | 2009-10-14 | メディキット株式会社 | 留置針 |
DE10307722A1 (de) * | 2002-03-07 | 2003-11-13 | Enomoto Co Ltd | Medizinische Vorrichtung |
US8066669B2 (en) | 2006-11-06 | 2011-11-29 | Becton, Dickinson And Company | Vascular access device housing venting |
US7947018B2 (en) * | 2008-05-05 | 2011-05-24 | Becton, Dickinson And Company | Rotationally activated blood control |
JP5578488B2 (ja) * | 2010-12-22 | 2014-08-27 | ニプロ株式会社 | 留置針組立体 |
JP6050750B2 (ja) * | 2011-07-04 | 2016-12-21 | テルモ株式会社 | イントロデューサ用シース |
CN103842021B (zh) * | 2011-09-28 | 2017-06-27 | 泰尔茂株式会社 | 导管组装体 |
US8758307B2 (en) * | 2012-06-15 | 2014-06-24 | B. Braun Medical Inc. | Self-priming, anti-free flow valve for infusion pumps |
US9717887B2 (en) | 2013-12-04 | 2017-08-01 | B. Braun Melsungen Ag | Catheter assembly blood control device and related methods |
JP6834120B2 (ja) * | 2015-09-11 | 2021-02-24 | ニプロ株式会社 | 医療用コネクタ |
-
2018
- 2018-08-02 CA CA3071818A patent/CA3071818A1/en active Pending
- 2018-08-02 US US16/635,219 patent/US11839752B2/en active Active
- 2018-08-02 CN CN201880050192.3A patent/CN111356496B/zh active Active
- 2018-08-02 EP EP18841085.6A patent/EP3662959A4/en active Pending
- 2018-08-02 JP JP2019534593A patent/JP7209948B2/ja active Active
- 2018-08-02 WO PCT/JP2018/029139 patent/WO2019027024A1/ja unknown
-
2023
- 2023-01-06 JP JP2023001335A patent/JP7482382B2/ja active Active
- 2023-09-26 US US18/372,770 patent/US20240009406A1/en active Pending
Patent Citations (9)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5290246A (en) * | 1991-01-18 | 1994-03-01 | Terumo Kabushiki Kaisha | Piercing needle |
JPH114894A (ja) * | 1997-05-02 | 1999-01-12 | Schneider Namic | 止血バルブを備えた医療用挿入機器 |
JP2000279526A (ja) * | 1999-03-30 | 2000-10-10 | Terumo Corp | 留置針組立体および弁体 |
JP2002263197A (ja) * | 2001-03-12 | 2002-09-17 | Medikit Kk | 留置用カテーテル |
JP2012517326A (ja) * | 2009-02-11 | 2012-08-02 | ベクトン・ディキンソン・アンド・カンパニー | 洗浄可能なカテーテルアセンブリを提供するためのシステムと方法 |
JP5877196B2 (ja) | 2011-03-28 | 2016-03-02 | テルモ株式会社 | カテーテル組立体 |
WO2015141366A1 (ja) * | 2014-03-20 | 2015-09-24 | テルモ株式会社 | カテーテル組立体 |
JP2016013359A (ja) | 2014-07-03 | 2016-01-28 | ニプロ株式会社 | 隔壁部材付きハブ組立体 |
US20170119977A1 (en) * | 2015-10-30 | 2017-05-04 | B. Braun Melsungen Ag | Valved catheters and related methods |
Cited By (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2020142019A (ja) * | 2019-03-08 | 2020-09-10 | ニプロ株式会社 | 弁付き針組立体 |
JP2021101771A (ja) * | 2019-12-24 | 2021-07-15 | ニプロ株式会社 | 弁付き針組立体 |
JP7410453B2 (ja) | 2019-12-24 | 2024-01-10 | ニプロ株式会社 | 弁付き針組立体 |
WO2021210484A1 (ja) * | 2020-04-17 | 2021-10-21 | ニプロ株式会社 | 針組立体 |
WO2022214490A1 (en) * | 2021-04-06 | 2022-10-13 | B. Braun Melsungen Ag | Vent device, port assembly and vascular access assembly |
Also Published As
Publication number | Publication date |
---|---|
US20200254195A1 (en) | 2020-08-13 |
CN111356496A (zh) | 2020-06-30 |
JP7482382B2 (ja) | 2024-05-14 |
JP7209948B2 (ja) | 2023-01-23 |
JP2023026682A (ja) | 2023-02-24 |
EP3662959A4 (en) | 2021-09-29 |
CA3071818A1 (en) | 2019-02-07 |
CN111356496B (zh) | 2023-07-04 |
US20240009406A1 (en) | 2024-01-11 |
JPWO2019027024A1 (ja) | 2020-07-27 |
US11839752B2 (en) | 2023-12-12 |
EP3662959A1 (en) | 2020-06-10 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
WO2019027024A1 (ja) | 止血弁付留置針および留置針組立体 | |
CN109562253B (zh) | 带有阀的针组件以及留置针组件 | |
US9539419B2 (en) | Male connector and transfusion line connection apparatus equipped with male connector | |
US11529474B2 (en) | Valved needle assembly | |
JP6617397B2 (ja) | 隔壁部材付きハブ組立体 | |
CA2597586A1 (en) | Valved fluid connector | |
MX2010012204A (es) | Control de sangre de boton pulsador. | |
EP3226958A1 (en) | Self-sealing catheter valve | |
JP2019527118A (ja) | 安全機能と圧力制御弁体を備えた静脈カテーテル装置 | |
CA2998359C (en) | Safety iv catheter with molded-open blood control valve | |
CN211245180U (zh) | 导管组件 | |
JP2024045522A (ja) | 雄コネクタ | |
JP7134410B2 (ja) | 留置針および留置針組立体 | |
JP2023080198A (ja) | 弁付き針組立体 | |
JP5578488B2 (ja) | 留置針組立体 | |
JP6678379B2 (ja) | 隔壁付きハブ組立体 | |
JP6858942B2 (ja) | 隔壁付きハブ組立体 | |
JPH11332991A (ja) | 留置針組立体 | |
WO2021210484A1 (ja) | 針組立体 | |
JP2019195721A (ja) | 隔壁部材付きハブ組立体 | |
JPWO2020091055A1 (ja) | 留置針組立体および医療用弁 |
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: 18841085 Country of ref document: EP Kind code of ref document: A1 |
|
ENP | Entry into the national phase |
Ref document number: 2019534593 Country of ref document: JP Kind code of ref document: A |
|
ENP | Entry into the national phase |
Ref document number: 3071818 Country of ref document: CA |
|
NENP | Non-entry into the national phase |
Ref country code: DE |
|
ENP | Entry into the national phase |
Ref document number: 2018841085 Country of ref document: EP Effective date: 20200302 |