Source: https://patents.google.com/patent/JP5162255B2/en
Timestamp: 2020-01-19 23:13:02
Document Index: 514601197

Matched Legal Cases: ['art 71', 'art 68', 'art 40', 'art 40', 'art 153', 'art 71', 'art 72', 'art 109']

JP5162255B2 - Liquid connector with valve - Google Patents
Liquid connector with valve Download PDF
JP5162255B2
JP5162255B2 JP2007555339A JP2007555339A JP5162255B2 JP 5162255 B2 JP5162255 B2 JP 5162255B2 JP 2007555339 A JP2007555339 A JP 2007555339A JP 2007555339 A JP2007555339 A JP 2007555339A JP 5162255 B2 JP5162255 B2 JP 5162255B2
JP2007555339A
JP2008529680A (en
トッド・エム・コロジ
スコット・ピー・ジャーナジン
セオドア・ジェイ・モズラー
2006-02-13 Application filed by インドゥストリー・ボルラ・ソシエタ・ペル・アチオニＩｎｄｕｓｔｒｉｅ Ｂｏｒｌａ Ｓ．ｐ．Ａ． filed Critical インドゥストリー・ボルラ・ソシエタ・ペル・アチオニＩｎｄｕｓｔｒｉｅ Ｂｏｒｌａ Ｓ．ｐ．Ａ．
2008-08-07 Publication of JP2008529680A publication Critical patent/JP2008529680A/en
2013-03-13 Publication of JP5162255B2 publication Critical patent/JP5162255B2/en
The present invention relates to a liquid connector provided with a valve.
As a liquid connector provided with a valve, for example, a male luer connector attached to a female connector device such as a female luer connector is disclosed in order to open a flow path between two devices. Engagement of the connector device provides a safe and efficacious medical fluid flow device that is eagerly desired for use in hospitals, clinics, and laboratories.
The medical male luer connector is standardized by ISO standards 594-1 and 594-2. The outline and usage have not changed much over the years. However, many proposals have been made on the female side of the luer connector due to the appearance of an infectious disease that can be infected when the needle is inserted. Injection positions and standard female lures are often replaced by “needleless connectors”, ie female lures with integral valves. The valve is opened when the male luer is inserted into the device. In terms of health care, the need to reduce the number of needle sticks forced the adoption of needleless devices, which was facilitated by legislation that prevented needle sticks. Another advantage of the needleless device is the reduction or elimination of pointed components and self-closing systems, while maintaining aseptic inspection of the flow path.
In general luer connection, a male luer connector inserted into a female luer connector is used. Since the male luer connector is usually screwed into the corresponding thread of the female luer connector and engaged with each other, the fluid passes between the two without leaking from the connecting portion.
The male luer component is suitable for use in many procedures such as devices and chemotherapy, blood transfusions, and nuclear medicine. During these procedures with conventional lure devices, exposure to fluids such as cytotoxic drugs, blood-borne pathogens, radiopharmaceuticals, etc. may result in exposure to patients, caregivers, housekeeping staff, or other fluids that are likely to come into contact with the fluid. Serious consequences for all. In general, available male luer connectors, if removed from the female connection or if inadvertently disconnected, can lead the substance to the environment, leaking medication or blood, and potentially harming humans. There is a risk of exposure to an environment that exposes certain contents. The current process for disconnecting the male lure from the fluid system is to first clamp (and similar to the IV (Intravenous Infusion) set) so that the fluid does not drip or spill. It is to remove while paying. This process is not automatic and leaves no opportunity for human error, and even if the clamp is successfully used, no action is taken against the possibility of a drop on the male luer tip.
Furthermore, if the connector is detached, the liquid remaining at the tip of the connector can still be harmful, even if fluid does not leak out.
The valved male luer connector described above requires an inner post provided by a special valved female luer (such as an ICU medical clave needleless valve) to project into the male luer with valve. It is said. This greatly limits the ability of devices to operate commercially used multiple female lures and needleless valves.
Also, the aforementioned male luer connector requires multiple valve elements inserted into the male body, and thus the manufacturing process becomes complicated due to the spatial constraints within the male luer tip, There is a risk of restricting the flow rate of the connector below that of a normal male luer.
Some of the male connectors with valves described above utilize metal springs that obscure X-ray and MRI images, and the dynamic energy of the stored springs moves the male luer tip toward the male luer tip. The valve element advances inward of the mold luer and upon release, fluid droplets or mist are expelled from the tip.
The other valved male connector described above comprises an inner valve element downstream of the male connector tip beyond its base. While the flow rates in these devices are acceptable, the male connector tip is exposed to the ambient atmosphere and patients and clinicians can be easily ejected from the internal space of the male connector tip itself. You remain at risk of being exposed to sexual splashes or mists. These designs also provide a number of components that are complex and costly to assemble, and may have metal springs that can obscure X-ray and MRI images. In addition, these designs make it impossible to apply medicine with a cotton swab.
The other self-sealing male connectors described above may limit the presence of needleless valves on the market in terms of their compatibility. For example, some male luer connector designs with valves may be compatible with some female valves (such as smart size) without an inward projecting post. However, the use of a female connector with an inner post geometrically hinders the insertion of the inner post into a smaller inner diameter male tip hole and damages one or both of the devices. Yes, neither can be used. In addition, of some designs of the aforementioned self-sealing male connector, the post protrudes through the elastic member, causing a “squeegee effect” on the inner post of the device, which is detrimental to the chip upon removal. May leave fluid splashes.
In addition, the other self-sealing luer connectors with biased valve plugs described above are not compatible with some needleless valves on the market and are inherently less in flow through the device. There is no charm. These devices are geometrically hindered from being inserted into the inner diameter of the male connector tip, so they are compatible with needleless valves with inner posts (such as ICU medical clave needleless valves). There is no. This may damage one or both devices, and perhaps one or the other will not be usable.
By redesigning the standard male luer connector so that the male connector with valve can completely shut off the flow at the tip of the male connector without restricting inside the male luer itself, The aforementioned problems can be avoided. In addition, if you sterilize the male luer connector sufficiently by swabbing medicine with a cotton swab before or between connections, it can be costly and often use extra components that are often forgotten. All that is needed for the cap to be cut is reduced. Finally, by automatically shutting off upon disengagement, the sterility of the lower flow path is more easily maintained, but otherwise it is exposed to the ambient atmosphere.
Thus, a generally more compatible male connector with a valve is disclosed that generally retains the fluid material contained therein securely when engaged with a standard female luer or needleless connector. Also disclosed is a valved male connection that seals the male connector to protect the connector user from harmful agents that may remain on or within the connector chip when disengaged.
The male connector with valve includes a male connector with valve for engaging a female connector for use in an infusion line (IV), syringe, blood collection, or other fluid type connection.
A tubular member (3,43,73,89,135,163,263) having an adjacent end (7,52,101,137,165) ;
The Cormorant proximal end (the 7,52,101,137,165) covering the elastic member and (5,31,55,75,121,151,251)
The elastic member (5, 31, 55, 75, 121, 151, 251 ) is integrated with a front end integrated with a valve member ( 9, 29, 56, 127, 157) for sealing the adjacent end (7, 52, 101, 137, 165) and a female connector (79, 176). and means for elastically deformed so as contact with front Stories valve member (9,29,56,127,157) is opened (15,53,77,139,177,277,377), the male connector with valve having,
Said means (15,53,77,139,177,277,377), the the adjacent end of the tubular member (3,43,73,89,135,163,263) (7,52,101,137,165) is capable Ri pull Tsu Zhang in the opposite direction,
The valve member (4,105) seals the adjacent end (7,52,101,137,165) of the tubular member (3,43,73,89,135,163,263) when the means (15,53,77,139,177,277,377) is not pulled in the opposite direction. When being pulled , at least a part of the elastic member (5, 31, 55, 75, 121, 151, 251) is elastically deformed to be in an open state .
The valved fluid connector described herein is considered excellent for a number of reasons. The valved fluid connector is a male connector. The valve housed at the end of the male connector with valve self-closes to ensure that little fluid remains on any exposed surface of the connector. When the male connector with valve is disconnected from the appropriate female connector, the male connector is sealed to protect all users from leaking fluid that may be harmful. This ensures that no harmful or toxic drugs such as those used in chemotherapy remain on the surface of the male connector. Body fluids such as blood do not substantially remain on the surface of the connector, and as a result, they are hardly exposed to blood that may be infected. According to the embodiment of the connector with a valve described here, the connector has minute cracks, and the valve members are almost the same height or stretched, so that the medicine is attached to each other or one side with a cotton swab. Is possible.
1 and 2, the male connector with a valve includes a tubular member 3 having a flange 13 and an elastic member 5. A groove 17 is formed by the first stepped region 8 and the second stepped region 10 located in front of the first stepped region. The elastic member covers the adjacent end 7 of the tubular member. The elastic member has a valve member 9 with a seal slit 4 that opens and closes across an adjacent end of the tubular member. The base 6 of the elastic member is adjacent to the flange 13 of the tubular member that forms the lower seal 11. The elastic member 5 includes a laterally extending protrusion 15 located substantially in the middle between the valve member 9 and the lower seal 11, and at least a part thereof is located in front of the groove 17. The protrusion 15 may be annular or any other suitable shape. The groove 17 holds the protrusion 15 when the elastic member is pulled. The protrusion 15 is arranged at a position of about 90 degrees with respect to the direction of the slit 4 in order to assist the slit while urging the slit in the open state. The grooves 17 may be symmetrically or asymmetrically inclined, partially cut, or cut at right angles. The tubular member and the elastic member are fixed to or integrated with the housing member 19. The housing member component 19 secures the lower seal 11 to the base 13 of the tubular member.
Moreover, you may make it attach the elastic member 5 directly to the flange of a tubular member, without a housing member. The attachment may be performed by, for example, adhesion, welding, solvent bonding, or snap fit. The housing member 19 includes a threaded attachment element 21 to engage a compatible female connector and protrusion 22 to limit the depth of insertion of the female connector and / or the passage of the protrusion 15. . The seal 11 is in contact with the base 13 by the protrusion 22.
In FIG. 3, when the male connector with valve described above is engaged with the surface 80 of the female connector 79, the protrusion 15 moves in a direction opposite to the adjacent end, and the side wall 16 of the elastic member (shown by an arrow 20). And so on), the slit 4 of the valve member 9 is opened and held by the annular groove 17 so that fluid flows between the connectors. The repositioned protrusion 15 may provide additional sealing and retention for the two connectors during engagement and use. When the male connector with valve is detached from the female connector, the opening of the valve member 9 of the elastic member 5 is closed and the opening end of the tubular member 3 is sealed.
4 and 5 show a modification of the arrangement of the valve member according to the above-described embodiment. The elastic member 31 is inclined according to the tubular member 3 and covers it. The annular member 3 includes an auxiliary valve member 29. The valve member 29 has an annular region 28 that is slender and inclined to the opposite side, and the annular region 28 extends slightly forward of the adjacent end 7 of the tubular member that forms the gap 30. The inner annular protrusion 42 is located on the inner wall surface 2 of the elastic member 31. With this configuration, the valve member 29 starts to open in contact with the female connector. Upon contact, the valve member 29 of the elastic member 31 moves rearward from the adjacent end of the tubular member 3 and opens the valve member 29 slightly in front of the threaded element of the female connector that engages the protrusion 15. A radially extending tension is applied to the surface to be moved. When fully engaged with the threaded element, this embodiment functions similarly to the previous embodiment.
For example, when a load is applied in the axial direction by engaging with a needleless valve, the pressure acts on the surface 29 of the elastic member 31. Then, the slit 4 starts to open upon receiving the resistance of the protrusion 41 that moves on the adjacent end 7. As a result, the slits 4 expand radially before the adjacent end 7 is fully engaged with the female connector. This design helps the valve to open or otherwise is disturbed by pressure acting between the surface 29 of the elastic member 31 and the mating surface of the needleless valve. The user also experiences touching the seal 41 that detaches from the tip 7, which means engagement of the connector.
FIGS. 6 and 7 show other configurations different from the above-described embodiment of FIG. This embodiment functions in the same way as the embodiment of FIG. 1 except that the threaded attachment element is replaced with a retaining ring on the housing 67 for a “sripple arc” that engages the female housing element 79. The protruding collar 66 in front of the housing 67 is provided with depth limiting means for the female connector. When engaged, the retaining ring 67 moves the protrusion 15 into the groove 17 to allow the user to recognize by tactile sense that it has been properly connected to the device.
8 to 10 show other embodiments of the tubular member and the elastic member. 8 to 10, the tubular member 73 has a stepped region 72 that forms a large-diameter lower portion 68 and a smaller-diameter upper portion 71 that protrudes forward from the lower portion 68. The upper part 71 of the tubular member 73 and at least a part of the lower part 68 are covered with the elastic member 75, and the elastic member 75 is adjacent to the base 13 of the tubular member forming the seal 11. have. The elastic member 75 has a protrusion 77 protruding sideways. The protrusion 77 is at least partially disposed in front of the stepped region 72 and the base 6. The base 6 forms a lower seal 11. The protrusion 77 may be a single annular shape or any other suitable shape. The housing element 89 has a screwing element 83 and a projecting portion 85 facing inward. The protrusion 85 may be configured by a large number of protrusions or a single tubular protrusion. When the female connector is engaged, the surface 80 of the female connector contacts the projection 77 (as indicated by arrow 78), which pulls the elastic member 75 and opens the slit 4 of the valve member 9. The tubular member may optionally include additional stepped areas and grooves (not shown) to hold the protrusions 77 during engagement with the female connector. The protrusion 85 of the housing element 89 may be provided with depth limiting means for the female connector to optimize the opening of the valve member 9 or to prevent tightening or damage of the valve. The stepped region 72 and the large-diameter lower portion 68 engage with the inner surface of the female connector 87, while the small-diameter upper portion 71 is provided with a gap for enabling the elastic member 75 to be pulled. .
Additional embodiments in which the resilient member is not fixed or held to the base of the tubular member are shown in FIGS. The other elastic member 750 that covers the tubular member 73 includes a first stepped side protrusion 377 that functions as a protrusion for pulling the elastic member when engaged with the surface of the female connector, and a second stepped side protrusion. 375. The protrusion 377 may be annular or any other shape. The housing element 289 has an inward protrusion 285 and is located between the first and second stepped protrusions 377 and 375 to secure an elastic member therein and also to the female connector surface 80 and / or Alternatively, it may function as a depth limiting means for extending the elastic member 750. During assembly, the inward protrusion 285 of the housing element 289 may pull the elastic member 750 slightly in advance in order to properly seal between the elastic member and the housing. When engaged by the female connector, the surface 80 moves the second stepped protrusion 377 rearward, pulls the elastic member 750 and activates the valve member 9. The end seal between the elastic member 750 and the tubular member 68 is obtained by interference of the inner surface of the protrusion 377.
FIGS. 13-15 illustrate other embodiments in which the elastic member is not fixed or held to the base of the tubular member. The tubular member 89 has a first stepped region 97 and a second stepped region 96 disposed in front of the first stepped region 97, and a groove 95 and an upper portion are disposed behind the adjacent end 101. 99 and a lower portion 97 are formed. The elastic member 103 covers the upper part of the tubular member 99 and at least a part of the groove 95 that is not fixed or held by the base of the tubular member 89. The slit 105 of the valve member 56 can be sealed to the adjacent end 101 of the tubular member 89 so that it can be restored. The seal portion 107 that interferes with the slide engages with the groove 95 so as to be able to seal and slide while being held by the tubular member 89. The protrusion 53 extends outward from the tubular member 89. The protrusion 53 may have a single annular shape, or may include a number of side protrusions of any suitable shape. The protrusion 53 is arranged at about 90 degrees in the direction of the slit 105 in order to minimize the opening of the slit 105. The protruding element 94 of the housing element 93 fixes the base 91 of the tubular member 89 without fixing or holding the elastic member 103 to the base 91.
When engaging the surface 80 of the female connector 79, the projection 53 moves in the axial direction by the groove 95, is held slidably, pulls the elastic member 103, and has a slit 105 that can be sealed so that it can be returned to its original position. An opening is made to allow fluid to flow between the connectors. Further, the female connector may be frictionally engaged with the outer wall of the elastic member 103 in order to assist the seal, the holding of the female connector, and the opening operation of the slit as appropriate. The housing 93 and the female connector 19 may be appropriately designed as a slitter as described above (without a screwing element not shown). The projecting element 94 and / or the first stepped region 97 is provided with depth limiting means for the projection 53 and the seal portion 107 to minimize the opening of the valve 56 and / or tighten or You may make it prevent damage. At the time of detachment from the female connector, the seal portion 107 comes into contact with the stepped region 96 to stop the movement of the elastic member 55 to the opposite side.
16-19 illustrate other embodiments in which the elastic member is not fixed or held to the base of the tubular member. The tubular member 43 includes a first stepped region 45 and a second stepped region 46 disposed in front of the first stepped region 45, and a groove 50 and an upper portion are disposed behind the adjacent end 52. 103 and the lower part 40 are formed. The lower part 40 has a recessed area 47 in order to hold the protrusion 53 of the elastic member 55. When engaging with the female connector 57, the protrusion 53 moves to the rear of the recessed area 47, pulls the elastic member 55, and opens the slit 105 of the valve member 56. At the time of non-engagement, the projection 109 returns to the original non-pull state, and the slit 105 of the valve member can be closed. The housing element 19 can be fixed to the tubular member 51 and partially includes an elastic member 55.
19 and 20 illustrate another embodiment of a male connector with valve that includes a housing, a tubular member, an elastic member, and a movable annular collar. The elastic member 121 has a front end 123 and a flange 124 disposed at the rear, and is fixed between the lower housing element 129 and the upper housing element 131 and supports the membrane region 141 of the flange 124. The adjacent end 137 of the tubular member 135 is disposed inside the elastic member 121 and is at least partially surrounded. The adjacent end 137 can be sealed to the valve member 127. The annular collar 139 is disposed between the housing 125 and the elastic member 121 and is in contact with the membrane 141. The interference element 120 with the reduced diameter of the upper housing element 131 secures the collar 139 by contacting the laterally extending lip 122 and is provided with depth limiting means for the female connector. The stepped region 321 of the elastic member provides a sealing means during engagement with the female connector. The stepped region 321 also provides improved valve member operation and reseals in a manner similar to the tactile characteristics desired by the user. The gap 184 assists in the operation of the valve member, particularly the engagement by the female connector with posts.
When the female connector 79 engages the male connector with valve, the front surface 80 of the female connector engages the collar 139 and moves the collar rearward. This causes the membrane 141 and elastic member 121 to move to the pulled position (as indicated by arrow 147), open the valve member 127, and conversely seal the adjacent end of the annular member again between the two connectors. Allows fluid flow.
FIGS. 21-25 illustrate other embodiments of a male connector with a valve having a tubular housing, a tubular member with opposing flow paths, an elastic member, and a movable annular collar. The male connector with a valve includes an elastic member 151 having a flange portion 153 that can be fixed by an upper housing element 154, and a lower housing element 156 that supports a membrane portion 180 of the flange 153. The elastic member is a valve member at the front end. 157. The elastic member 151 has a stepped region 322 provided with at least a part of an elastic member having an inner diameter larger than the outer shape of the tubular member. As shown in FIGS. 23 to 24, the elastic member 151 further includes a plurality of laterally located slide seals (158, 159, 160) disposed on the inner surface. The slide seal 158 is disposed so as to be substantially adjacent to the stepped region 322, and the slide seal 159 is disposed behind the slide seal 158. The movable passage 161 is defined by the large-diameter inner surface 172 of the elastic member 151, the seal 159, and the outer surface of the tubular member 163, and means for controlling the fluid flow between the opposing passages is provided. Tubular member 163 includes a distal end 166 and an adjacent end 165 disposed within elastic member 151 and sealably engages valve member 157. In addition, the tubular member includes an inner wall element 167 between the distal end 166 and the adjacent end 165, the adjacent end 165 being opposed upper and lower, generally perpendicular to the upper and lower axial channels (169 and 171 respectively). Channels (173 and 175, respectively) are formed. An annular collar 177 with a lip 178 is disposed between the housing element and the elastic member 151, is adjacent to the elastic member 151, the movable passage 161, contacts the membrane portion 180 of the flange portion 153, and the collar is flanged by the lip 178. It is fixed to the part 153.
As shown in FIG. 24, during engagement with the female connector, the annular collar 177 moves rearward by the surface 155 of the female connector 176, extending the membrane portion 180 and the elastic member 151, and facing the opposing flow. The movable passage 161 is moved over at least a part of the path 175, the wall surface element 167, and at least a part of the upper flow path 173. In this configuration, fluid flow between the opposing and axial passages is provided in a manner similar to passing through the annular member while the valve member 157 is open. Upon disengagement with the female connector 176, the annular collar 177 and the passage 161 move forward by releasing the membrane portion 180 and the elastic member, and fluid between the opposing and axial passages and in the tubular member 163 At the same time, the valve member 157 is closed. The stepped region 322 of the elastic member provides a sealing means during engagement with the female connector.
Alternative embodiments to those shown in FIGS. 21-24 are shown in FIGS. The adjacent end of the tubular member is chamfered with an elastic member 251 extending around the adjacent end to assist in opening the valve member 157. The gap 184 between the valve member 157 and the adjacent end of the tubular member assists in opening the valve member 157 so that the elastic member 151 is contacted by the surface of the female contact. Attachment to a standard male luer connector by a threaded element 302 provides the functionality of a male connector with a valve common to standard male luer devices by using the embodiments described herein. The The annular collar 277 has an inwardly extending annular protrusion 290 and an angled end 292 that contacts the flange to assist in extending the membrane 180 without tearing or penetrating.
In FIGS. 26 and 27, two drawings according to the embodiment of FIG. 25, one of which is rotated 90 degrees along the axis of the connector, show additional or optional elements described below. The notch 181 provides better flow for some female needleless valves by allowing fluid to pass through the opposing surface of the inner needleless valve element during engagement. Ergonomic coreless gripping ribs 185 on the outer surface of the upper housing element 203 assist the user when operating the device. If the inner diameter housing element 203 is stepped, a stronger connection can be achieved by preventing the female connector and the male connector with a valve from being screwed together.
FIGS. 26 and 27 also show additional or optional elements of the previous embodiment. The annular collar 277 has a laterally extending peripheral lip 212 adjacent to the interfering element 183 that preloads the membrane 180 when assembled. Further, the interference element 183 can limit the insertion depth into the female connector and can fix the annular collar 177. An energy director 194 that contacts the flange 153 can assist in sealing and holding the flange 153. The welding interface 195 and flash trap 197 allow for ultrasonic welding assembly of the upper and lower housing elements (325 and 201, respectively).
The simple and basic nature of the embodiments described here allows the integration of multiple devices. 28-30, the valved fluid connector 400 is applicable to a standard male connector with a tubular pocket 260 or IV tubular set (FIG. 28), similar to the syringe tip 250 (FIG. 29). Further, the valved fluid connector 500 can be applied to the blood collection tube adapter 270 (FIG. 30) in the same manner as the female luer as described above. Each of the aforementioned medical devices contain liquids that can be harmful to the patient and / or clinician, limiting or eliminating the use of the various embodiments described herein. In general, this embodiment is applicable to standard male luer connectors to provide the functionality of a male luer with a valve.
The valves described herein are preferably not formed in a compressed state, or do not advance from the interior of the tubular member to seal the end of the tubular member forward from the compressed configuration. The valve member is preferably not formed inside or inward of the tubular member. These preferred embodiments may suppress or eliminate rapid ejection of mist or mist from the valve when not engaged.
The upper inner diameter of the valved tubular member may be similar to the size of a typical male luer, which usually ranges between 0.050 and 0.120. In one or more embodiments, the inner diameter of the valved male tubular member is similar to most other male lures, is interchangeable with almost all female lures and needleless valves, and has an inner post. Including, but not limited to. However, the outer shape of the tubular member may be sufficiently smaller than a general male luer (standardized to ISO-594-1) so that the tubular member can be surrounded by a space for the elastic member. Well, there is a gap between the outer surface of the elastic member, that is, at least the inserted first portion, and the inner diameter of the female connector so that the elastic member can be extended.
The connector housing element is preferably molded from a thermoplastic resin. The housing element may use any known method for assembly, including but not limited to ultrasonic welding, adhesion, adhesion, solvent, snap fit, and the like.
The housing may include a number of retaining elements, for example, to secure and seal the base of the resilient member and maintain the overall assembly of the valved male connector together. Further, the holding element may fix the elastic member in place, minimize it, and suppress or eliminate fluid leakage from the base.
By providing the upper holding ring instead of the screwing element, the male connector with valve becomes a “sripple arc type”. The upper retaining ring may be ultrasonically welded, snapped, glued, or similarly attached to the base of the tubular member, or an elastic member may be sandwiched therebetween. By clamping the base of the elastic member to the base of the tubular member, it is sealed and the elastic member is firmly fixed in place. Also, the retaining ring can stop the interference and in an embodiment holds the elastic member, where the elastic member is not attached to the end base of the tubular member. The retaining ring element is preferably molded from a thermoplastic resin.
In an alternative to the foregoing, by providing a retaining screw hub, the male connector with valve is a “luer fastening type”. The holding screw hub is ultrasonically welded, snapped, bonded, or similarly welded to the base of the tubular member, or the elastic member base is sandwiched between them. May be. By sealing the base of the elastic member with respect to the base of the tubular member, the elastic member is firmly fixed at a predetermined position. Also, the retaining ring can stop interference and retain the elastic member, where the elastic member is not attached to the end base of the tubular member. The screw hub may be formed of a thermoplastic resin.
The tubular member of the male connector with a valve may be a rigid or semi-rigid element that forms a flow path. The terms rigid and semi-rigid include the characteristics of the terms defined in the ISO-594-1 standard. The tubular member also firmly supports the elastic member and the surface for attaching the elastic element or the housing element. The tubular member is preferably formed from a thermoplastic resin. Some needleless female valves may restrict flow through a male connector with valve by blocking fluid flow from the tip of the tubular member. The notch is used to create a flow path in which the cannula is located in order to create a flow path where the cannula is located, despite the suppression of a flat surface, blocking a soft surface, or obstructing a rough surface, and the presence of fluid exiting the tip. You may make it provide in.
In one embodiment, as shown in FIGS. 1-7, the annular groove is disposed approximately midway below the annular member coupled to a protrusion extending laterally from the elastic member. When the female connector pushes the elastic member protrusion down by a predetermined distance, the slit opening is limited to an optimal amount, and the protrusion is lowered or moved into the annular groove so that the tip of the tubular member is slit into the elastic member Is prevented from penetrating. This ensures that the slit remains constant and in an optimal amount of open state, regardless of how hard or deep the male connector is inserted into the female connector or needleless valve. The annular groove is formed in such a size that, when urged by the female connector, the protrusion assists in maintaining the attached state of the female connector.
In other embodiments (not shown), a slidable annular collar element is integrated extending laterally from the elastic member, and the protrusion secures and / or fixes the collar as it moves backwards. A groove or recess is provided to hold the guiding annular collar.
In the various embodiments described herein, as shown in FIGS. 21-27, the tubular member remains in a flow path to withstand high pressure while remaining or in sealing engagement with a female or needleless valve connector. May be designed to limit Thus, the fluid flow is directed from one or more first passages on the side wall of the tubular member to an opposing opening in the tubular member and back to the tubular member via the one or more second passages to the engaged female connector. Head. Both the first and second passages are engaged and disengaged, respectively, and flow in the opposite direction is caused in and out of fluid transmission by the movable passage of the elastic member. With such fluid flow, the connector can apply more pressure than would otherwise be possible with the slidably sealed passages. This causes the connector to be generated by excessive pressure that would otherwise rupture or leak, eg, pressure generated by pressing with a syringe with a sufficiently large force, or by an IV pump. It can withstand pressure. If an annular collar integrated with the elastic member is added, the pressure resistance of the valve is remarkably increased by adopting a rigid or semi-rigid cylindrical structure as a side support for the components of the elastic member. Furthermore, in this embodiment, the tubular member comprises an annular recess and holds the slide seal during extension of the elastic member, providing the user with a tactile sensation that, for example, substantial engagement has occurred.
In the various embodiments described herein, as shown in FIGS. 16-18, the tubular member is positioned in the middle and a stepped shoulder with a recessed region is used in place of the annular groove around the tubular member. It is formed to be. This alternative restricts the portion of the elastic member that contacts the shoulder from moving downwards and concentrates on most of the extension to drive the valve member. The elastic member may be more easily restored by restricting the downward movement of a portion of the elastic member into the opposing region between the shoulders with the stepped portion, when the valve member is not engaged. You may make it re-seal quickly.
The elastic member may be formed of any material that has inherent elasticity, good sealing properties, radiolucency, slit formability, and low compression mounting properties, such as silicon or polyacetal. Examples of such materials include, but are not limited to, natural rubber and synthetic rubber, or synthetic polyisoprene, thermoplastic elastomer, thermosetting rubber, latex free rubber, and the like.
The elastic member may be formed by compression molding, transfer molding, injection molding, reaction injection molding (RIM), liquid injection molding (LIM), or other similar means. The component of the elastic member may be formed with a slit after being molded and before being discharged from the tool or by the following operation. The length of the slit may be in the range between 0.055 not exceeding the entire length across the tip of the male member and extends along both sides of the elastic member, usually such a distance is about 0.160. If it is. The length of the slit is usually sufficiently open to provide adequate flow through the connector. However, the components of the annular member are not required, but may be passed through the slit opening for flow. Also, the slit may traverse the entire chip, allowing the hard component of the male connector to protrude from the inside. The shape of the slit may be a single slit shape, a crossed slit shape, or any other suitable shape. The slit of the valve member may be formed during the assembly of the elastic member or in the assembly process of the post. A lubricant may be added to the material of the elastic member and the material for promoting low friction driving and recovery. Such lubricants include those suitable for medical use, such as medical grade silicone fluid.
The depth limiting means is used to limit the drive depth of the elastic member in order to prevent the tip of the tubular member from protruding through the slit of the elastic member, as shown in FIGS. May be. This may be performed with the annular groove of the tubular member protruding inward or with the shoulder protruding portion of the rigid housing component protruding inward. Due to the depth limitation, the slit opening is of a constant size and is reliably resealed during use, maximizing flow and preventing inadvertent damage.
The elastic member functions to open and close the valve member in a manner similar to sealing the passage of the annular member to eliminate leakage under normal pressure conditions. The elastic member is driven by pulling. For example, in various embodiments, the restoring force of the elastic member may be generated by longitudinal tension or pulling force in the elastic member between the protrusion and the slit. When removing a female connector or needleless valve from a male connector with a valve, the longitudinal tension stored in the component provides the energy required to return the elastic member to the non-tensioned position. As a result, the slit is closed again and all the slide seals are not pulled and can be returned to the sealed closed position.
In other embodiments, the return force of the elastic member is such that, for example, as shown in FIGS. 19-27, the elastic member pulls from either a moving projection, an annular collar and slit, or a pulled membrane and flange. Is substantially generated by When removing a female connector or a needleless valve from a male connector with a valve, the tension stored in this elastic member provides energy to return the elastic member to the position where the previous tension is applied, resulting in slitting. It is closed again and all slide seals can be returned to their sealed closed position under the previous tension.
When initially inserted into the female connector or the needleless valve, the front end of the elastic member may function as a gap fit until it contacts the outward projection or the annular collar. This clearance fit facilitates the slit opening process, acts as a normal male connector tip, and is fit into the standard female connector and needleless valve for the first part of the insertion. You may design. In one or more embodiments, the elastic member has a luer-like slope on the order of 6% such that the elastic member interferes with the female connector that produces the seal during and after engagement.
The elastic member and valved member are designed to be compatible with various needleless valves, including a needleless valve with a post. Such a valve post passes through a slit opening and into a tubular member allowing unrestricted flow.
The opening of the elastic member and the interior of the tubular member typically have a length similar to that of a standard male connector tip, so that the present invention is designed to be accessed by a standard male connector tip. It is possible to sufficiently flow into a needleless valve and a standard female luer.
For example, in FIG. 5, the slit may be initially biased open with axial pressure against the valved member by the top of the swabable needleless valve. When the insertion is completed, the slit is further opened to an arbitrary amount by a protrusion or an annular collar extending to the side.
Both the inside of the tip of the elastic member and the outer edge of the tip of the tubular member may be chamfered. This corresponding chamfer directs the slit opening outward and downward when actuated by the swabable surface of the needleless valve. Furthermore, this corresponding chamfer facilitates opening of the slit during operation as the protrusion or annular collar moves rearward. These chamfers may be in a wide range.
In FIGS. 25, 26 and 27, the notch or groove in the cannula tip of the tubular member allows for improved compatibility and fluid flow in a female connector valve with an inward valve mechanism. Also, the tip of the elastic member (not shown) may include a “duck bill” valve that increases the pressure resistance at the tip. The inclined surface of the duckbill valve may correspond to a surface similar to the inner diameter of the tubular member and supports the opening of the valve member such that they slide relative to each other.
An annular slide seal within the inner diameter of the elastic member is disclosed, for example, in FIGS. 23-24 and 26-27. These seals slidably engage the outer surface of the tubular member. These seals are shown in FIGS. 22-24 and 26-27. In a preferred embodiment, these slide seals (the initial seal is the side wall of the tubular member and is located between the top and base axial passages) are used to increase pressure resistance when disengaged. . When disengaged, the slide seal isolates the base shaft passage from the upper shaft passage and tip of the tubular member, thus resisting reverse pressure generated from various sources, such as syringe pressure, IV pump pressure, and the like. Most seals at the bottom maintain a reverse flow that prevents entry into the space below the flange of the elastic member. The intermediate seal is an initial seal that blocks fluid flow between opposing passages and prevents fluid flow in the tubular member. When the valve is engaged or driven, the intermediate seal moves down the opening of the opposing passage in the base and allows flow between the base and the upper shaft passage and vice versa. The upper seal (closest to the male connector tip) confines the fluid in a predetermined space, forms a movable flow path (movable passage extending sideways) between the upper and intermediate seals, and is tubular between the axial passage It is possible to flow to the member.
In the various embodiments described herein, the elastic member is replaced with a tensioned or stretched shape. Although not based on any theory or belief, the pulling force is more in that it ensures that the resealable valve member returns to the closed shape each time the connector is driven or engaged. More reproducible and predictable. On the other hand, the compression shape usually results in an unacceptable range of bending, compression set, and driving force and / or low restoring force. For this reason, by applying a constant tensile force to the elastic member, a repeated force is generated during driving, unlike bending or compressive loads that occur at different times.
The elastic member is pulled during driving due to the force transmitted from the female connector or via the annular collar. The pullable membrane and / or flange may be secured between the housing retaining element and / or the base of the tubular member and may be used as illustrated in FIGS. During driving, the membrane is pulled and returns elastically.
In the various embodiments described herein and illustrated in FIGS. 1-18, the valved fluid connector comprises a laterally extending protrusion integrated with an elastic member. These protrusions are located approximately in the middle or below and are typically engaged with the lead-in edge and surface of the female connector. When urged rearward by the female connector, the protrusion pulls at least a part of the elastic member between the seal capable of reverse sealing and the protrusion to open the slit. The protrusion may be an annular ring around the elastic member, or may have a number of laterally protruding appearances. In general, these protrusions are compatible with most of all female connectors and needleless valves unless they are designed to not interfere with normal operation. In addition, the protrusions may assist in holding the female connector on the male connector with valve by an interference fit during engagement.
The protrusions extending laterally from the elastic member are arranged approximately 180 degrees apart when viewed from above, and they extend radially outward from the periphery of the tubular member. The protrusion may be placed perpendicular to the slit to maximize the slit opening.
In various embodiments, an annular collar is used, for example, in FIGS. By interposing an annular collar, the pressure resistance imparted by the slide seal may be increased. By retracting or supporting the seal, the blowout resulting from the internal pressure of the seal is eliminated or reduced because the annular collar retains the seal that physically engages the contour of the annular member. Further, the collar allows the female connector to be sufficiently engaged with the fixing screw of the male connector while the elastic member is maintained in a state of being pulled or tensioned during driving / engaging. By including an annular collar in various embodiments, the tensile load is efficiently applied and / or distributed to an elastic member, eg, an integral pullable flange, acting on the entire elastic member. Keep in a letting condition. Furthermore, the friction between the female connector or needleless valve and the annular collar may be less than the female connector engages against the elastomer, reducing the overall friction in the system, Easy to drive by the user. The annular collar may be formed by molding a thermoplastic resin, or may be formed by insert molding a collar as a part of the elastic member. This latter choice reduces one additional assembly step and ensures that the annular collar is held in place. The annular collar may be hooked at a predetermined position in the undercut of the elastic member. Annular collars may have a reverse taper or stepped base that is hooked into the corresponding circular recess or flange undercut to ensure proper collar and flange assembly during use or assembly. Keep in position. The annular collar may be adhered to a predetermined position using an adhesive (UV, cyanoacrylate, etc.) with respect to the circular recess or undercut of the elastic member. Once the parts are assembled, a partially covering shelf is added to both the collar collar and the stationary retaining element, as appropriate, to prevent the collar collar from being removed or forcibly moved. It may be.
In order to simplify the reference numerals of the drawings, the female connector itself is not shown, and only the movement of the components of the male connector is shown. It will be understood that such movement is the result of the engagement of a male / female connector as illustrated in other figures. Similarly, during use, a screw-in or other securing device to hold the male or female connector, or a standard male luer adapter in the housing, is included in all drawings for simplicity. Although not shown, it will be understood that this is the case.
While only some of the above-described examples have been described as some exemplary embodiments of the present invention, modifications may be made to the disclosed embodiments without departing from the scope of the present invention. It will be appreciated by persons skilled in the art that the claims are well limited by the appended claims.
It is a disassembled perspective view of the component which concerns on one Embodiment of the fluid connector with a valve | bulb. It is the disassembled perspective view which removed the side surface of the male connector of FIG. It is side surface sectional drawing similar to FIG. 2 which shows the female connector and the fluid connector with a valve engaged there. FIG. 4 is a perspective view of an elastic member according to an embodiment of the fluid connector with a valve. It is side surface sectional drawing of the component of the tubular member and elastic member which concern on one Embodiment of the fluid connector with a valve | bulb. It is side surface sectional drawing similar to FIG. 5 of the component of the tubular member and elastic member which concern on one Embodiment of the fluid connector with a valve | bulb. It is side surface sectional drawing similar to FIG. 6 which shows a female connector and the fluid connector with a valve | bulb. FIG. 6 is an exploded view of another valved fluid connector with other elastic and tubular member components. It is side surface sectional drawing of the component of the other tubular member and elastic member of FIG. 8 which concern on one Embodiment of the fluid connector with a valve | bulb. FIG. 10 is a side cross-sectional view similar to FIG. 9 showing the female connector and the fluid connector with valve engaged. It is side surface sectional drawing of the component of the other tubular member and elastic member which concern on one Embodiment of the fluid connector with a valve | bulb. It is side surface sectional drawing similar to FIG. 11 which shows the female connector and the fluid connector with a valve | bulb engaged. FIG. 6 is an exploded view of another valved fluid connector with other elastic and tubular member components. It is side surface sectional drawing of the component of the other tubular member and elastic member of FIG. It is side surface sectional drawing similar to FIG. 14 which shows the fluid connector with a valve engaged with the female connector. It is an exploded view of the fluid connector with a valve provided with the component of other tubular members and elastic members. It is a partially broken view which shows the component of another tubular member and an elastic member. FIG. 18 is a view similar to FIG. 17 with the female connector engaged. It is side surface sectional drawing which shows the other fluid connector with a valve | bulb. FIG. 20 is a side sectional view similar to FIG. 19 showing another valved fluid connector and an engaged female connector. It is an exploded view showing an embodiment of another fluid connector with a valve. FIG. 22 is an exploded sectional view similar to FIG. 21 showing an embodiment of another valved fluid connector. It is side surface sectional drawing which shows embodiment of the other fluid connector with a valve | bulb. FIG. 24 is a side cross-sectional view similar to FIG. 23, showing another valved fluid connector embodiment and an engaged female connector. It is an exploded view showing an embodiment of another fluid connector with a valve. It is side surface sectional drawing which shows embodiment of the other fluid connector with a valve | bulb. FIG. 27 is a side cross-sectional view similar to FIG. 26, rotated 90 degrees along the connector axis. FIG. 6 is a side cross-sectional view illustrating an embodiment of a fluid connector with a valve for an IV tubular line. It is a side view which shows embodiment of the fluid connector with a valve provided with the syringe. It is a side view which shows embodiment of the fluid connector with a valve provided with the blood collection adapter.
2 ... inner wall surface 3 ... tubular member 4 ... seal slit 5 ... elastic member 7 ... adjacent end 8 ... first stepped region 9 ... valve member 10 ... second stepped region 11 ... lower side seal 13 ... flange 15 ... projection 16 ... Side wall 17 ... Groove 19 ... Housing member 21 ... Screw mounting element 22 ... Protrusion 28 ... Ring region 29 ... Valve member 30 ... Gap 31 ... Elastic member 41 ... Protrusion 42 ... Ring projection 45 ... First step region 46 ... Second stepped region 47 ... Recessed region 50 ... Groove 51 ... Tubular member 53 ... Projection 55 ... Elastic member 56 ... Valve 57 ... Female connector 66 ... Projection collar 67 ... Housing 68 ... Lower part 71 ... Upper part 72 ... Stepped region 73: tubular member 75 ... elastic member 77 ... projection 79 ... female connector 80 ... surface 83 ... screwing element 85 ... projecting portion 89 ... housing element 91 ... base 93 ... housing element 94 ... projecting required 95 ... Groove 96 ... Second stepped region 97 ... First stepped region 101 ... Adjacent end 103 ... Elastic member 105 ... Slit 107 ... Seal part 109 ... Protrusion 120 ... Interference element 121 ... Elastic member 122 ... Lip 123 ... Front end 124 ... flange 125 ... housing 129 ... lower housing element 135 ... tubular member 137 ... adjacent end 139 ... collar 141 ... membrane region 151 ... elastic member 153 ... flange portion 154 ... upper housing element 156 ... lower housing element 157 ... valve member 159 ... Seal 161, movable passage 163, tubular member 165, adjacent end 166, end 167, inner wall element 169, upper shaft passage 171, lower shaft passage 172, inner surface 173, upper passage 175, lower passage 176, female connector 177, etc. Annular collar 178 ... Lip 180 ... Membrane 183 ... Interference element 184 ... Gap 94 ... Energy director 195 ... Welding interface 197 ... Flash trap 201 ... Lower housing element 203 ... Upper housing element 260 ... Tubular pocket 270 ... Adapter 277 ... Annular collar 285 ... Inward projection 289 ... Housing element 290 ... Annular projection 292 ... Terminal 302 ... Screwing element 321 ... Stepped region 322 ... Stepped region 325 ... Upper housing element 375 ... Projection 377 ... Projection 400 ... Fluid connector 500 with valve ... Fluid connector 750 with valve ... Elastic member
The valve member (4,105) seals the adjacent end (7,52,101,137,165) of the tubular member (3,43,73,89,135,163,263) when the means (15,53,77,139,177,277,377) is not pulled in the opposite direction. A male connector with a valve , wherein when pulled , at least a part of the elastic member (5, 31, 55, 75, 121, 151, 251) is elastically deformed to be opened .
The means is a protrusion (15 , 53 , 77) extending laterally from the elastic member ;
The protrusion (15,53,77), by the engagement of the female connector (79,176) to said resilient member, according to claim 1, wherein the next possible Rukoto which Ri tensile in the opposite direction Male connector with valve.
The tubular member (3) is disposed in front of the first stepped region (8) and the first stepped region (8), and the first stepped region (8) forms a first groove (17). A second stepped region ( 10 ) to be formed,
The elastic member (5) includes an inner surface and an outer surface,
The inner surface is adjacent to the tubular member (3);
The outer surface comprises at least one lateral protrusion (15);
Insertion in a female connector, the protrusion (15) is proceeding enter the first groove (17) is pulled to the opposite direction by elastically deforming at least a portion of the elastic member, the valve member ( male connector with valve according to claim 1, characterized in that the 4) to open.
A housing (129, 131, 154 and 156),
The elastic member (121, 151 , 251) includes a rear end having a flange (124, 153) fixed in the housing (129 , 131 , 154, 156 ),
The distal end of the tubular member (135, 163 , 263) is fixed to the housing (129 , 131 , 154, 156 ),
Said housing (129, 131, 154, 156) comprises a slidable ring-shaped collar (139,177,277,377) between said resilient member (121,151,251),
Said ring-shaped collar (139,177,277,377), by moving to the opposite direction from the adjacent end of the tubular member (127,157), one at least the elastic member I pulling said means (15,53,77,139,177,277,377) in the opposite direction part of elastically deforming, the male connector with valve according to claim 1, characterized in that the open state of the valve member (4,105).
The elastic member (121, 151, 251) further includes a protruding portion ( 141, 180) extending laterally,
Said tubular collar member (139,177,277,377) engages the female connector (176), by Rukoto moving protrusion extending in the lateral and (141,180) in the axial direction, at least a portion of the elastic member (121,151,251) is elastically deformed, the male connector with valve according to claim 4, wherein the open state and to Rukoto the valve member (4,105).
It said elastic member (121,151,251) further includes a wherein during engagement of the female connector (176), with a depth limiting means for limiting the depth of the female connector (176) (322) The male connector with a valve according to claim 5.
Outer surface, an inner surface, engageable with adjacent end the female connector, and a Ruha Ujingu (154,156) which have a tip,
An annular collar (177) disposed between the elastic member (151) and the housing (154, 156) and in contact with a flange region (153) of the elastic member (151);
The tubular member (163) is disposed in the housing (154,156), and the shaft passage (169,171), the outer surface, and the upper and lower shaft passages (169,171) are arranged between the adjacent ends and the tip. An inner wall element (167) for separating,
The elastic member (151) is fixable in a rear end, a housing (154, 156), a flange region (153) disposed at the rear end, and an elastic member adjacent to the outer surface of the tubular member (163) A first laterally projecting slide seal (159) on the inner surface of the tubular member, and an inner surface portion having an outer diameter larger than the outer diameter dimension of the outer surface of the tubular member disposed forward from the first laterally projecting slide seal ( 172), and a movable passage (161) formed by the first laterally projecting slide seal (159), the inner surface portion, and the outer surface of the tubular member (163) ,
Said ring-shaped collar (177) is Ri slidable der between the housing (154, 156) and elastic member (151), when said elastic member (151) is not elastically deformed, the valve member (4) is The adjacent end of the annular member (163) is sealed, and the flange region (153) is pressed, so that at least a part of the elastic member (151) is elastically deformed to be in an open state. Item 2. A male connector with a valve according to Item 1.
Wherein the first lateral protrusion sliding seal of the elastic member (151) (159), before the engagement of the female connector (176), to prevent fluid flow between the lower and upper shaft passage (169 and 171) The male connector with a valve according to claim 7, wherein the male connector is arranged as described above.
The movable passage (161) of the elastic member (151) is arranged so that fluid can flow between the lower and upper shaft passages (169, 171) during engagement with the female connector (176). The male connector with a valve according to claim 7.
The first laterally projecting slide seal (159) of the elastic member (151) does not pull the elastic member (151) during engagement with the female connector (176), so that the lower and upper shaft passages ( valved male connector of claim 7, characterized in that it is arranged to prevent fluid from flowing between the 169 and 171).
By engaging the female connector (176) with the elastic member (151), the annular collar (177) is moved in the opposite direction from the adjacent end of the tubular member (163), and at least the elastic member (151) 8. The valve member (4) is opened by elastically deforming a part thereof , and the female connector (176) and the movable passage (161) of the annular collar (177) are communicated with each other. Male connector with valve as described.
When the female connector (176) is engaged with the elastic member (151) and the elastic member (151) is elastically deformed, the tubular member is straddled across the inner wall element (167) by the movable passage (161). The male die with a valve according to claim 11, wherein the passage (169) located on the adjacent end side of (163) and the passage (171) located on the opposite side of the adjacent end can communicate with each other. connector.
When the female connector (176) is engaged with the elastic member (151), by moving the annular collar (177) in the opposite direction, at least a part of the elastic member (151) is elastically deformed. 8. The male connector with a valve according to claim 7, wherein the valve member is opened and the passage (169) and the passage (171) are in communication with each other .
The first laterally projecting slide seal (159) contacts at least a part of the inner wall element (167) of the tubular member (163) before engaging the female connector (176) with the elastic member (151). The male connector with a valve according to claim 8, wherein the passage (169) and the passage (171) are in a non-communication state .
The first laterally projecting slide seal (159) is separated from the inner wall element (167) of the tubular member (163) when the female connector (176) is engaged with the elastic member (151), and the passage (169) The male connector with a valve according to claim 9, wherein a communication state is established between the pipe and the passage (171) .
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