巴西专利BR112013019057B1 connector

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专利摘要:
CONNECTOR WITH FIRST AND SECOND DOORS. The present invention relates to a connector having a housing having a fluid path from the first port through an internal cavity to the second port. The connector also includes a plug that has a first and a second position within the inner cavity, where the plug blocks the fluid path between the first port and the inner cavity when in the first position. The plug has a diaphragm that separates the internal cavity in a first volume that is ventilated and a second volume that includes the fluid path. The plug also includes a guiding element which is arranged within the first volume and which launches the plug towards the first position. Moving the plug from the first position to the second position opens the fluid path and increases the second volume.
公开号:BR112013019057B1
申请号:R112013019057-4
申请日:2012-01-27
公开日:2020-12-08
发明作者:George Michel Mansour；Tyler Devin Panian
申请人:Carefusion 303, Inc；
IPC主号:

专利说明:

[0001] This application is a continuation in part of applicationNo. 12 / 204,941 deposited on September 5, 2008, now pending. BACKGROUND Field
[0002] The present description in general refers to medical connectors used in fluid sending applications and more specifically to connectors having a low starting volume and a low positive displacement at disconnection. Otherwise, the present description relates to a Luer-activated neonatal medical connector. Description of the Related Art
[0003] Medical connections are widely used in fluid delivery systems such as those used in connection with intravenous fluid lines, blood access, hemodialysis, peritoneal dialysis, enteral feeding, drug vial access, etc. Many aseptic medical connectors of the prior art employ an arrangement to puncture an elastomeric diaphragm or septum, which has one side in contact with the fluid, with a sharp hollow hypodermic needle. The use of these hypodermic needles has been gradually reduced as a result not only of safety considerations but also of costs associated with infectious disease acquired from a needle stick. These connectors have been replaced with Luer-activated connectors that do not require hypodermic needles, but instead use an activator such as a Luer at the end of a syringe or intravenous (IV) line to create a fluid path through a valve in a connector. Removing the connector causes the valve to close when the line is disconnected. Said system is described in US Patent No. 5,569,235 to Ross et al, for example.
[0004] Typical connectors and valves of this type, as described by Ross, have many attributes that are not ideal in medical applications for fluid delivery. First, said devices can have large starting volumes, that is, the connector can have a large chamber associated with a valve element that must be filled with the fluid being sent before that fluid is actually sent into the patient's line. and the patient. For very low flow coefficients (for example, 0.1 milliliters per hour or 0.05 milliliters per hour), as is common for neonatal or child care as well as other types of care, such as a large starting volume can cause a delay of as long as several hours before the intended therapy reaches the patient.
[0005] Second, fluid displacement can always occur when the connection is produced between two closed fluid systems. When the connection, such as a Luer or hypodermic needle, is inserted into an intravenous connector or fluid tube, fluid displacement occurs. Because the intravenous fluid is incompressible, a fluid volume equal to Luer or needle volume is displaced out of the intravenous tube and into the patient's blood vessel. Said fluid displacement from the intravenous tube into the patient's blood vessel is referred to as anterograde flow. Similarly, when the connection is removed, an equivalent volume of blood will be drawn, usually through the catheter, into the intravenous tube. Said retrograde flow can be harmful when blood directed into the catheter tip remains stagnant for a long period of time. Stagnant blood tends to decant, and can begin to clot, thereby restricting flow through the catheter and possibly requiring the insertion of a new intravenous catheter into the patient. Connector systems providing negative, or retrograde, displacement at insertion and positive flow, or anterograde flow at removal, are much more desirable in medical applications.
[0006] Third, most connectors use a septum, or permeable membrane in the connection field. These membranes must be penetrated at the insertion of the connector and therefore promote the development of bacteria inside the connector. Said septum is also susceptible to leakage when there is back pressure in the system. Connector systems that have cleanable surfaces to allow cleaning and that prevent leakage under back pressure are preferable. SUMMARY
[0007] A connector having a low starting volume would allow an introduced therapy to reach the patient more quickly, even at low flow coefficients.
[0008] One embodiment of a connector is described having a valve housing defining an inlet port, and an outlet port, the valve housing additionally including a fluid path from the inlet port to the outlet port. The connector additionally includes an operable valve plug to seal the inlet port when the connector is in a non-actuated state thereby closing the fluid path through the connector, and a diaphragm in a valve housing, the diaphragm separating a plug from valve from an internal volume in a valve housing and the diaphragm sealing the internal volume, so that with the actuation of the connector a valve plug deforms the diaphragm in the internal volume thereby eliminating the entrance door seal and opening the fluid path through the connector.
[0009] The mode of a method of operating a connector for medical fluids is also described. The method includes triggering the connector by pressing a valve plug on the connector when inserting a male Luer into a connector inlet port, pressing a valve plug opening a fluid path through the connector, deforming a diaphragm under pressure from of a valve plug, the diaphragm defining and sealing an internal volume within a valve housing of the connector, where the deformation of the diaphragm causes the connector to exhibit negative displacement of fluid with the drive, and closing the connector by removing the Male Luer from the intake port, where removal of the male Luer causes a valve plug to reseal the connector and diaphragm to return to an undeformed state, where the return of the diaphragm to the undeformed state causes that the connector exhibits positive fluid displacement with disconnection.
[00010] In another embodiment of the connector described here, the connector includes a valve housing having a valve housing base and a valve cover, a valve housing defining an inlet port, and an outlet port, a valve additionally including a fluid path from the inlet to the outlet port, the fluid path including a channel formed in an inner wall of a valve housing. The connector also includes a valve insertion device in a valve housing, the valve insertion device defining a concavity element and a diaphragm in a valve housing and sealing the valve insert device concavity element, the element sealed cavity forming an internal volume in a valve housing. A valve plug is operable to seal the inlet port when the connector is in a non-actuated state by closing the fluid path through the connector, and where the diaphragm contacts a valve plug and applies force to a valve plug to maintain a valve plug in the non-actuated state. With the actuation of the connector, a valve plug deforms the diaphragm in the internal volume, thus eliminating the sealing of the inlet port and opening the fluid path through the connector.
[00011] In another embodiment of the connector described here, the connector includes a housing having an internal cavity with first and second ports and a fluid path from the first port through the internal cavity to the second port. The connector also includes a plug having first and second positions within the internal cavity. The plug is configured to block the fluid path between the first port and the internal cavity when in the first position. The plug comprises a diaphragm configured to separate the internal cavity in a first volume that is vented and a second volume that includes the fluid path, and a guide element disposed within the first volume, the guide element configured to launch the plug in direction of the first position. Moving the plug from the first position towards the second position opens the fluid path and increases the second volume.
[00012] Certain embodiments described here comprise a medical device comprising a connector that includes a housing having an internal cavity with a first and a second port and a fluid path from the first port through the internal cavity to the second port. The connector also includes a plug having a first and a second position within the internal cavity. The plug is configured to block the fluid path between the first port and the internal cavity when in the first position. The plug comprises a diaphragm configured to separate the internal cavity in a first volume that is vented and a second volume that includes the fluid path, and a guide element disposed within the first volume, the guide element configured to launch the plug in direction of the first position. Moving the plug from the first position towards the second position opens the fluid path and increases the second volume.
[00013] Certain embodiments described here comprise a connector having a housing having an internal cavity with first and second ports, with a flow path from the first port through the internal cavity to the second port. The connector also includes an insertion device having a hollow element with the insertion device disposed within the internal cavity of the housing. The connector also includes a flexible valve that is partially arranged within the hollow element, the valve also having a diaphragm sealed to the edge of the hollow element, forming an air space sealed with the hollow element. The connector also includes a ventilation path from the air space through the insertion device which is coupled to a ventilation path from the internal cavity through the housing to the external environment. BRIEF DESCRIPTION OF THE DRAWINGS
[00014] The attached drawings, which are included to provide additional understanding and are incorporated and constitute a part of the present specification, illustrate the described modalities and together with the description serve to explain the principles of the described modalities. In the drawings:
[00015] FIG. 1 is a perspective view of a Luer-activated medical connector according to the concepts described here;
[00016] FIG. 2 is a side view of the medical connector shown in FIG. 1.
[00017] FIG. 3 is an exploded side view of the medical connector shown in FIG. two.
[00018] FIG. 4 is a sectional view of the medical connector shown in FIG. two.
[00019] AsFIGS. 5A-5D are side views of the medical connector shown in FIG. 2, shown in several operational states.
[00020] AsFIGS. 6A-6D are side views of the medical connector shown on the FIG. 2, illustrating examples of various alternative modalities.
[00021] FIGS. 7A-7D are cross sections of the components of a medical connector according to certain aspects of the description.
[00022] FIG. 7E is the cross section of the medical connector assembled according to certain aspects of the description.
[00023] FIG. 8 illustrates the air space and ventilation path of the medical connector of FIG. 7E according to certain aspects of the description.
[00024] FIG. 9 illustrates the liquid flow path of the medical connector of FIG. 7E according to certain aspects of the description.
[00025] FIG. 10 illustrates the connector as the connector is partially mismatched according to certain aspects of the description.
[00026] FIG. 11 illustrates a connector that includes another embodiment of the plug according to certain aspects of the description. DETAILED DESCRIPTION
[00027] According to the concepts described here, a medical device with no needle access that combines a low starting volume, positive displacement disconnection, and a surface capable of being cleaned for disinfection between uses is described.
[00028] In the following detailed description, numerous specific details are determined to provide a complete understanding of the present description. It will be apparent, however, to those skilled in the art that the modalities of the present description can be practiced without some of the specific details. In other cases, well-known structures and techniques have not been shown in detail so as not to obscure the description.
[00029] The method and system described here are presented in terms of a connector adapted for use that sends medical fluid to a patient, particularly a child. It will be apparent to those skilled in the art that the concepts described can be applied to a variety of applications where the same characteristics of a low starting volume, positive displacement disconnection, and a surface capable of being cleaned for disinfection between uses are of value. . Nothing in the present description is to be interpreted, unless specifically determined as such, to limit the application of any method or system described herein to neonatal medical applications.
[00030] According to the concepts described here, a medical device with no needle access that combines a low starting volume, positive displacement disconnection, and a surface capable of being cleaned for disinfection between uses is described.
[00031] Returning to FIGS. 1 and 2, a low starting volume Luer-activated connector modality 100 according to the concepts described here is shown in perspective and side views respectively. The Luer-activated connector 100 is formed by valve housing 101 and valve cover 102. Valve cover 102 is attached to a valve housing 101 using conventional means, such as solvent connection, ultrasonic, rotation welding, etc. . The valve inlet port 103 is sealed by the top of the valve plug 107 which forms a cleanable surface that can be cleaned between uses. The valve inlet port 103 accepts a driver that pushes valve plug 107 into valve housing 101 to create a fluid path through connector 100 as will be described below. The inlet port of valve 103 includes threads that allow connector 100 to be securely connected to a syringe or other fluid dispensing mechanism.
[00032] Housing ribs 106 provide structural support to valve housing 101 and also provide gripping surfaces to allow connector 100 to be held firmly while attaching another device. As will be described below, in certain described modalities, a channel is formed inside one of the ribs that provides a low starting volume fluid path through connector 100. Actuator 104 allows the connector to be connected to the inlet port of another device, such as an IR tube or tube.
[00033] With reference now to FIG. 3, a connector modality 200 according to the concepts described here is shown in an exploded side view illustrating the various components of connector 200. The connector modality 200 shown here includes valve housing 201, valve cover 202, valve plug 207, valve insert 208, and diaphragm 209. As described with reference to FIGS. 1 and 2, valve cover 202 has inlet port 203 with threads 205 which receives a driver from a fluid dispenser or other device. Inner chamber 222 is formed by valve cover 202 and valve housing 201 when matched together and is designed to receive valve plug 207.
[00034] Valve plug 207 is generally cylindrical in shape to slide into inner chamber 222 formed by valve cap 202 and valve housing 201. The valve plug includes a main shoulder seal 219 adapted to be in contact with the valve base 220 of valve cover 202. Valve plug 14 also includes drying seal 218 that engages the inner surface of throat 217 of valve cover 202. As will be described below, the sealing of drying 218 acts to remove any fluid from throat 217 of valve cap 202 when a driver is disengaged from connector 200. Valve plug 207 can also include a chamfer 216. Chamfer 216 facilitates plug deformation of valve 207 when under pressure from a Luer actuator. Deformation of valve plug 207 creates a fluid path through connector 200.
[00035] Preferred embodiments of connector 200 also include valve insertion device 208 and diaphragm 209. Valve insertion device 208 includes a hollow element 211. When diaphragm 209 is matched with valve insertion device 208 an air pocket is formed in the hollow element 211. The air pocket in the hollow element 211 provides a back pressure to the diaphragm 209 during the fluid flow and works to ensure a negative displacement of fluid during insertion and a positive displacement of fluid during disconnection as will be explained. Support ribs 214 provide structural rigidity to valve insertion device 208 and help support diaphragm 209 within the air pocket of hollow element 211 when the diaphragm is in an extended or stretched position.
[00036] The valve insertion device 208 and diaphragm 209 perform several functions in connector 200. First, they occupy a space that would otherwise be filled by the fluid, thereby minimizing the starting volume necessary to achieve the flow of fluid through connector 200. Second, they provide the mechanism by which connector 200 achieves the proper fluid flow characteristics, that is, the positive displacement of fluid during disconnection. Additionally, diaphragm 209 deforms under back pressure in the system, deforming to accept the fluid inserted into the connector during back pressure and then positively displacing that fluid out of the connector when the back pressure has been reduced. The hollow element 211 also provides a volume for the valve plug 207 to move inward when the valve plug 207 is moved by a driver inserted in the inlet port 203. Diaphragm 209 extends into the hollow element 211 under the strength of the valve plug 207, but only to the extent necessary, thereby minimizing the starting volume. Diaphragm 209 also provides a counter force against valve plug 207, helping to push valve plug 207 back into chamber 222 when the driver is removed, thereby resealing inlet port 203 of connector 200.
[00037] Stem 215 of valve insert 208 extends into outlet port 223 of valve housing 201 further reducing the internal volume of connector 200 and thereby minimizing the starting volume for fluids flowing through the connector 200. Valve insertion device 208 slides tightly into valve housing 201 creating a tight connection between the outer walls of valve insertion device 208 and the inner walls of valve housing 201. A single flow channel is formed on one of the ribs 206 on the inner side wall of the valve housing 201 and also on the base wall of the housing 201. The stem 215 is dimensioned so that when inserted into the outlet port 223 of the connector 200, the cross section of the flow volume of outlet port 223 will be equivalent to the volume of flow through the channel in the side wall of valve housing 201.
[00038] Valve housing 201 also includes Luer male 204 and female threads 224. The connection that is created by Luer male 204 and threads 224 is a common standardized connection for medical fluid sending devices and is the counterpart to the connection formed through the entrance door 203 and male threads 205.
[00039] With reference now to FIG. 4, a cross section of a connector mode according to the concepts described here is shown assembled. A preferred embodiment of connector 300 again includes valve housing 301, valve cover 302, valve insertion device 308, valve plug 307 and diaphragm 309. Valve insertion 308 and diaphragm 309 fit tightly within valve housing 301 and are held in place by valve cover 302 which is firmly attached to valve housing 301 by soldering or other means. A flange 313 on diaphragm 309 fits into a groove 312 created by valve cover 302 and valve insertion device 308. Flange 313 and groove 312 hold diaphragm 309 firmly in place and prevent diaphragm 309 from moving when it deforms within the hollow element 311.
[00040] Valve plug 307 fits into chamber 322 formed when valve cap 302 is fitted into valve housing 301 with valve inserter 308 and diaphragm 309 inserted. In the closed position shown, the shoulder seal 319 of valve plug 307 rests tightly against the base of valve 320, preventing any flow of fluid through connector 300. Additionally, drying seal 318 seals the entrance to the inlet port. 303 by providing a seal around the inner throat wall 317 of valve cover 302. Drying seal 318 also acts to remove any fluid from the throat 317 by forcing any fluid in the throat 317 up and out of the connector 300 when valve plug 307 transitions from an open position to the closed position shown in FIG. 4. Chamfer 316 of valve plug 307 is used to control deformation of valve plug 307 under pressure from a driver (not shown) inserted in connector 300.
[00041] Although connector 300 is shown in a closed position in FIG. 4 with the upper portion of the fluid path closed by the drying seal 318 and particularly the shoulder seal 319, the lower portion of the fluid path 310 through connector 300 is shown. Fluid path 310 includes chamber 325 formed by the open portion of valve cover 302 and diaphragm 309. Chamber 325 is in communication with the hindered channel in one of the ribs 306 of valve housing 301. Although connector 300 is shown with a single fluid path channel, channels in other valve housing ribs 301 can be used in connector 300 to increase flow volume. Also the size of the channel for the fluid path 310 can be changed to change the flow characteristics of the device. It should be noted that by increasing the size of the channel or adding additional channels, the starting volume of the device can be increased.
[00042] Fluid path 310 continues from the channel in rib 306 within a channel in the valve housing base 301. The fluid path then enters outlet port 323 on male Luer 304 of valve housing 301. A stem 315 is dimensioned so that the remaining open space at outlet port 323 matches the flow path characteristics of fluid 310 through the rest of valve housing 301. As determined, stem 315 occupies the space at outlet port 323 that would otherwise be part of the starting volume for connector 300.
[00043] The male Luer 304 of the valve housing 301 allows the connector 300 to be inserted into another device such as a pipe, IV line connector or any other device with a female connector of the universal type. Threads 324 allow connector 300 to be held in place when connected via male Luer 304. As described, the top surface 326 of valve plug 307 is flush with the top of valve cap 302, and the drying seal 318 removes the fluids from inlet port 303 of connector 300 when the connector is disengaged from another device. Said arrangement provides the connector 300 with a cleanable entry surface that can be cleaned and disinfected between uses. Other connecting devices that use a slit in a septum allow fluids to collect under the septum and are not able to be easily disinfected between uses.
[00044] During use the male Luer portion of another device forces the valve plug down into the connector 300. Diaphragm 309 is deformed within the hollow element 311 by valve plug 307 and the shoulder seal 319 separates at from the base of the valve 320, thereby opening the fluid path 310 through the connector 300. The chamfer 316 in the valve plug 307 controls the deformation of the valve plug 307 and allows it to bend inside the connector 300 ensuring that the valve plug 307 squeezes sufficiently into connector 300 to allow a good connection to the device being inserted. The diaphragm 309 and the air pocket in the hollow element 311 provide positive pressure in the valve plug 307, thereby ensuring that the valve plug 307 sits properly with the removal of the drive device.
[00045] Additionally, with the actuation, the compression of the valve plug 307 in the diaphragm 309 creates a larger open volume inside the connector 300, thus dragging downstream the fluid inside the connector 300 providing the desired negative displacement in the connection. The return of a valve plug 307 and diaphragm 309 back into the non-extended position after disconnection reduces the internal volume of connector 300. As the shoulder seal 319 of valve plug 307 prevents fluid from being propelled out of the inlet port 303, the fluid in the hollow element 311 is driven out of the outlet port 323 with the removal of the drive device, thereby providing the desired positive displacement at disconnection.
[00046] With the internal volume of connector 300 being occupied by valve insertion device 308, diaphragm 309 and valve plug 307, it can be easily seen that the internal volume, which is also the starting volume of connector 300, is minimized . Minimizing the starting volume can be important in a variety of applications, but it can be particularly important in applications involving a low dose of medication or in neonatal applications where very low flow coefficients are maintained. In preferred embodiments of a connector according to the concepts described here, a low starting volume can be considered a starting volume of 70 microliters or less, although larger starting volumes may be appropriate for other applications and still fall within the scope of the concepts described here.
[00047] With reference now to FIGS. 5A to 5D, various aspects of a preferred embodiment of a connector 400 are described. Each of the connectors shown includes valve housing 401, valve cover 402, valve plug 407, valve insertion device 408 and diaphragm 409 as described with reference to FIGS. 1 to 4.
[00048] FIG. 5A shows connector 400 in its closed position with valve plug 407 sealing connector 400 and preventing any fluid from passing through connector 400. Diaphragm 409 is in its normal condition for the closed configuration. FIG. 5B illustrates the fluid path portion 410 after the valve plug 407. As the valve plug 407 is in its closed position the fluid path 410 is closed by a valve plug 407 as described with reference to FIG. 4.
[00049] FIG. 5C shows the connector 400 under return pressure through the outlet port 423. The fluid entering the outlet port 423 runs along the fluid path 410 shown in FIG. 5B and is blocked by valve plug 407 preventing the outlet of connector 400. Instead, the fluid causes diaphragm 409 to expand within the hollow element 411 creating a space for a fluid volume between valve plug 407 and the diaphragm 409. Additionally, valve plug 407 is held in place by back pressure, thereby reinforcing the seals between valve plug 407 and valve cap 402 and ensuring that connector 400 does not leak under back pressure conditions . When the back pressure condition ends, the elasticity of the diaphragm 409 and the pressure from the air pocket in the hollow element 411 forces the fluid that entered the connector under return pressure to exit through the outlet port 423.
[00050] FIG. 5D shows the connector 400 in an open state or with a male Luer compressing the valve plug 407 inside the body of the connector 400. The valve plug 407 causes the diaphragm 409 to expand inside the concavity element 411 creating a space for the valve plug 407 and opening the fluid path through the device. Diaphragm 409 and valve plug mass 407 minimize the volume inside connector 400 in the actuated state, thereby minimizing the starting volume required by connector 400.
[00051] With reference now to FIGS. 6A to 6D, several alternative embodiments of a valve plug and diaphragm in a connector are described. Each of the shown connectors operates essentially as described with reference to FIGS. 1 to 5.
[00052] FIG. 6A shows a beveled valve plug 609a in its driven state with diaphragm 609a in its expanded state as described above. The chamfer allows the valve plug 607a to deform in a desired mode with the actuation by a male Luer. FIG. 6B shows a diaphragm 609b having a socket 630 and a corresponding recess 629 in valve plug 607b. The socket and recess allow diaphragm 609b and valve plug 607b to deform in a desired manner.
[00053] FIG. 6C shows a diaphragm 609c having a recess 632 and a corresponding recess 631 in valve plug 607c. As before, the recess and recess allow diaphragm 609c and valve plug 607c to deform in a desired manner. FIG. 6D shows a diaphragm 609d having chamfer 633 and a corresponding inclination 634 in valve plug 607d. The inclination and chamfer allow diaphragm 609d and valve plug 607d to deform in a desired manner. Although certain alternative modalities have been explicitly shown, those skilled in the art can observe that many other alternative modalities can be envisaged that could have the same or similar functions and are still within the scope of the concepts described here.
[00054] FIGS. 7A-7D are cross sections of the components of a medical connector according to certain aspects of the description. FIG. 7A is the upper housing 700 with an input 702 configured to accept, in the present embodiment, a male Luer connector 800 shown in FIGS. 8 and 9. There is an inner cavity 704 with a rib 706 surrounding the opening of the inner cavity 704. Rib 706 is an "energy driver" that guides the ultrasonic energy used to fuse the upper shell 700 to the inner pocket 704 during assembly, as described in more detail with reference to FIG. 7E. Inlet 702 is connected to inner cavity 704. There is at least one channel 708 formed in the inner wall of outer shell 700 which is discussed in more detail with reference to FIG. 7E.
[00055] FIG. 7B is a plug 710 that is provided with a face 712 that is sized to fit within opening 702 and is smooth so as to avoid cracks and corners that could house bacteria and be difficult to disinfect. Below face 712 is a neck 714 having, in the present embodiment, a chamfer 716 which causes the neck 714 to bend preferably in the direction of chamfer 716 when compressed. Below the neck is a shoulder 718 which is connected to a diaphragm 720 which is connected to a sealing ring 722. Below the sealing ring 722 is a guiding element 724 which, in the present embodiment, has four notches 726 which make it that the guiding element 724 preferably bends within a coil configuration when compressed. In certain embodiments, there are fewer than four notches 726. Guiding element 724 is attached to shoulder 718 within diaphragm 720 as seen in the cross section of FIG. 7E.
[00056] FIG. 7C illustrates the base 730 with an outlet 736 inside the socket 734 which, in the present configuration, is a male Luer connector. A threaded cavity 739 surrounds the male Luer connector 734. The top surface of the base 730 having a rib 738 is a "power driver" that directs the ultrasonic energy used to fuse the base 730 to the inner pocket 704 during assembly, as described in more details with reference to FIG. 7E. There is a ventilation channel 754A from the upper surface 738 to the threaded cavity 739. There are, in the present embodiment, two locating pins 732 which are discussed in more detail with reference to FIG. 7D.
[00057] FIG. 7D is the inner pocket 740 with an inner cavity 752A, that is, a hollow element, with a bottom 744 and is surrounded at the open end by a shoulder 746. A ventilation path 754B connects the inner cavity 752A to the bottom surface 748 In the present embodiment, two location pockets 756 are provided which are configured to accept location pins 732 from base 730.The interaction of pins 732 and location pockets 756 is discussed in more detail with reference to FIG. 7E.
[00058] FIG. 7E is the cross section of the medical connector 750 assembled according to certain aspects of the description. The connector 750 is mounted by positioning the plug 710 inside the upper housing 700. The neck 714 of the plug 710 is located inside the internal cavity 704 so that the face 712 is flush with and sealed to the opening 702. The inner pocket 740 is then inserted in the upper shell 700 over the plug 710 until the rib 706 is in contact with the inner pocket 740, with which the inner pocket 740 is, in the present embodiment, ultrasonically welded to the upper shell 700. The outer circumferential surface of the inner pocket 740 is a pressure fitting with the inner circumferential surface of cavity 704 and forms a fluid-tight flow channel over channel 708 that is formed in the wall of cavity 704. Base 730 is then attached to inner pocket 740 when align the alignment pins 732 with the location pockets 756 and then bring the rib 738 of the base 730 into contact with the bottom surface 748 of the inner pocket 740. In the present embodiment, the base 730 is last welded internal pocket 740.In the present configuration, the ventilation paths 754A and 754B are aligned and form a continuous ventilation path 754 from the internal cavity 752A to the threaded cavity 739.
[00059] When completely assembled, the sealing ring 722 of the plug 710 is compressed between the upper housing 700 and the shoulder 746 of the inner pocket 740. The diaphragm 720 and the walls of the inner pocket 740 form a sealed inner cavity 752 with a path of ventilation 754 to the environment through the threaded cavity 739. A second internal cavity 758 is formed by the diaphragm 720 and the inner wall of the upper housing 700 and the sealed perimeter of the face 712 of the plug 710. The channel 708 formed between the inner wall of the housing upper 700 and the outer wall of the inner pocket 740 forms a fluid path from the inner cavity 758 to the outlet 736. The operation and function of the two inner cavities 752, 758 are discussed in more detail with reference to FIGS. 8 and 9.
[00060] FIG. 8 illustrates air space 752 and ventilation path 754 of medical connector 750 of FIG. 7E according to certain aspects of the description. In this view, connector 750 was activated by inserting a corresponding connector element which, in the present mode, is a male Luer connector 800. The connector 800 has a central light 802 and a tip 804. As the connector 800 enters at entrance 702 of housing 700, tip 804 contacts the face of the plug 712 and moves the plug 710 in the distal direction. When the connector 800 is fully inserted, the neck 714 deviates according to the chamfer 716 so that the face of the plug 712 tilts away from the tip 804, as can be seen in figure 8. The bypass of the plug 710 stretches the diaphragm 720 as the neck 714 descends into the internal cavity 752. As the internal cavity 752 remains sealed by the diaphragm 720, the air in the internal cavity 752 escapes through the ventilation path 754.
[00061] FIG. 9 illustrates the liquid flow path of the medical connector of FIG. 7E according to certain aspects of the description. The connector configuration 750 in FIG. 9 is identical to the configuration shown in FIG. 8. In FIG. 9, the second internal cavity 758 was filled with liquid entering from connector 800 through light 802. As can be seen in FIG. 9, with connector 800 in place, there is a fluid path from the light 802 ahead of the sloping face 712 and through the internal cavity 758 along channel 708 to outlet 736 so that fluid can flow through the corresponding connectors 750 800.
[00062] FIG. 10 illustrates connector 750 insofar as connector 800 is partially mismatched according to certain aspects of the description. As the connector 800 is removed from the connector 750, the elastic nature of the diaphragm 720 and the guide element 724 both push the plug 710 upwards and maintain the contact between the tip 804 and the face 712. The volume of the internal cavity 758 has decreased compared to the volume of the fully matched configuration of FIG. 9. The neck 714 has rotated as the displacement of the plug 710 is reduced and the face 712 is now sealing through the tip 804 and blocking the flow through the light 802. As the internal cavity volume 758 decreases, the fluid from internal cavity 758 flows through channel 708 and out through outlet 736. This is the "positive displacement" function of connector 750, in which the fluid is forced towards the patient, that is, out through from outlet 736, with disconnection of connector 800 from connector 750. The benefit of positive displacement is that it prevents retrograde flow, that is, drawing blood from the patient into the IV tube (not shown) towards the connector 750. When blood is drawn into the IV tube and not immediately directed back into the patient, there is a risk that blood may clot and block the IV tube, requiring either manual routing or IV set replacement. As the internal cavity 76 contracts and expels the fluid, the internal cavity 752 expands and draws air through the ventilation path 754.
[00063] FIG. 11 illustrates a connector 750A that includes another embodiment of plug 710A according to certain aspects of the description. In the present embodiment, shoulder 718A protrudes outward and protrudes over diaphragm 720. Shoulder 718A comes into contact with outer shell 700 and separates inner cavity 758 in a first volume 758 A above shoulder 718A and a second volume 758B below the 718A shoulder. There is a gap 719 between the bottom and the top edge of shoulder 718A that passes through the point of contact between shoulder 718A and the upper housing 700. In the case of back pressure introduced through outlet 736 when connector 750A is not activated , pressure will increase in the 758B internal volume. A positive pressure differential between the internal volume 758B and 758A causes slit 719 to open, thereby allowing the internal cavity pressure 758A to increase to the internal volume pressure 758B. Pressure on internal volume 758A is applied upwardly to the neck 714 of the plug 710 to create a tighter seal between face 712 and the inlet 702 of the upper housing 700 and to prevent leakage from the inlet 702.
[00064] In short, the connector described provides a surface that can be cleaned on the exposed face of the unmatched connector so that the interface can be sterilized before matching the connector halves. The connector is self-sealed so that liquid does not drip from the connector after decoupling. The connector also, in certain modalities, positively displaces fluid during the decoupling process to avoid retrograde flow. In certain embodiments, the connector has a displacement close to zero so that the fluid is neither expelled from nor dragged into the connector during the decoupling process.
[00065] The present description is provided to allow those skilled in the art to practice the various aspects described here. Although the aforementioned has described what are considered the best modes and / or other examples, it is understood that several changes to these aspects will be readily apparent to those skilled in the art, and that the generic principles defined here can be applied to other aspects. Thus, the claims are not intended to be limited to the aspects shown here, but it must be agreed that a broad scope consistent with the language of the claims, where reference to an element in the singular is not intended to mean "one and only one" unless specifically so determined, but instead "one or more." Unless specifically stated otherwise, the terms "a set" and "some" refer to one or more. Male pronouns (e.g., his) include feminine and gender neutral (e.g., saddle and yours, yours) and vice versa. Headings and sub-headings, if any, are used for convenience only and do not limit the present invention.
[00066] It is understood that the specific order or hierarchy of steps in the described processes is an illustration of examples of approaches. Based on design preferences, it is understood that the specific order or hierarchy of steps in the processes can be rearranged. Some of the steps can be performed simultaneously. The accompanying method claims the elements present from the various steps in a sample order, and should not be seen as being limited to that specific order or hierarchy presented.
[00067] Terms such as "top," "bottom," "front," "rear" and the like as used in the present description are to be understood as referring to an arbitrary reference structure, rather than to a reference structure gravitational ordinary. Thus, a top surface, a bottom surface, a front surface, and a rear surface can extend upwards, downwards, diagonally, or horizontally in a gravitational reference structure.
[00068] The term "slit" refers to any passage through an object, including a single flat separation as well as passages having other cross-sectional profiles such as an "X." Passages can be closed in one configuration and opened in a second configuration.
[00069] The phrase as an "aspect" does not imply that that aspect is essential for the technology in question or that that aspect applies to all configurations of the technology in question. An aspect-related description can apply to all configurations, or one or more configurations. The phrase as an aspect can refer to one or more aspects and vice versa. The phrase as a "modality" does not imply that said modality is essential for the technology in question or that said modality applies to all configurations of the technology in question. A description relating to a modality can apply to all modalities, or to one or more modalities. The phrase the referred modality can refer to one or more modalities and vice versa.
[00070] The term "exemplary" is used here to mean "serve as an example or illustration." Any aspect or design described here as "exemplary" should not necessarily be construed as preferred or advantageous over other aspects or designs.
[00071] All functional and structural equivalents for the elements of the various aspects described throughout the present description that are known or that will later become known to those skilled in the art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Furthermore, none of what is described here is intended to be dedicated to the public regardless of whether that description is explicitly recited in the claims. No claimed element shall be constructed under the provision of 35 USC §112, sixth paragraph, unless the element is expressly recited using the phrase "means for" or, in the case of a method claim, the element is recited using the phrase "step to". In addition, to the extent that the term "include," "has," or the like is used in the description or in the claims, it is intended that the term be inclusive in a similar way to the term "comprises" as "comprising" is interpreted when used. as a transitional term in a claim.
[00072] All the elements, parts and steps described here are preferably included. It should be understood that any of the aforementioned elements, parts and steps can be replaced by other elements, parts and steps or eliminated all together as will be obvious to those skilled in the art.
[00073] Briefly, what has been written has at least the following: a connector is described which has a housing having a fluid path from a first port through an internal cavity to the second port. The connector also includes a plug that has a first and a second position within the inner cavity, where the plug blocks the fluid path between the first port and the inner cavity when in the first position. The plug has a diaphragm that separates the internal cavity in a first volume that is ventilated and a second volume that includes the fluid path. The plug also includes a guiding element which is disposed within the first volume and which launches the plug towards the first position. Moving the plug from the first position towards the second position opens the fluid path and increases the second volume. CONCEPTS
[00074] What was written described at least the following concepts.
[00075] Concept 1. A connector comprising: a housing having an internal cavity with first and second ports and a fluid path from the first port through the internal cavity to the second port; and a plug having first and second positions within the inner cavity, the plug configured to block the fluid path between the first port and the inner cavity when in the first position, the plug comprising: a diaphragm configured to separate the inner cavity in a first volume that is ventilated and a second volume that includes the fluid path; and a guiding element disposed within the first volume, the guiding element configured to launch the plug towards the first position; wherein the displacement of the plug from the first position towards the second position opens the fluid path and increases the second volume.
[00076] Concept 2. The Concept 1 connector, in which fluid is drawn into the second volume through the second port when the plug moves towards the second position.
[00077] Concept 3. The Concept 2 connector, in which fluid is expelled from the second volume through the second port when the plug moves towards the first position.
[00078] Concept 4. The connector of Concept 1, in which the plug has a smooth surface that is flush with the first port when the plug is in the first position.
[00079] Concept 5. The Concept 1 connector, where the second volume is less than 70 microliters.
[00080] Concept 6. The Concept 1 connector, in which the guiding element has at least one chamfer configured to cause the guiding element to deform in a controllable manner when the plug is compressed.
[00081] Concept 7. The Concept 6 connector, in which the guiding element has a plurality of notches configured to make the guiding element deform in a controllable manner in a serpentine format when the plug is compressed.
[00082] Concept 8. The connector of Concept 1, in which the plug additionally comprises: a shoulder that comes into contact with the housing and separates the second volume into a third volume between the first door and the shoulder and a fourth volume between the shoulder and the second door; and a passage from the fourth volume through the plug to the third volume, where the passage is opened when the pressure in the fourth volume is greater than the pressure in the third volume, and the passage is closed when the pressure in the fourth volume is not. is greater than the pressure in the third volume.
[00083] Concept 9. The Concept 1 connector, where the first port is configured as a female Luer connector.
[00084] Concept 10. The Concept 1 connector, in which the second port is configured as a male Luer connector.
[00085] Concept 11. A self-sealing connector without a needle with a low starting volume and generating a positive displacement of fluid with the decoupling, the connector comprising: a housing having an internal cavity with a volume and first and second ports, in which the first port is configured to correspond with a male Luer connector; and a valve assembly disposed within the internal cavity, the valve assembly having a first configuration when no connector is matched to the first port and a second configuration when a male Luer connector is matched to the first port, the valve assembly configured to seal the first port when in the first configuration and to allow fluid to flow from the corresponding male Luer connector inside the first port and through the internal cavity and out of the second port when in the second configuration; wherein the valve assembly displaces the first and second volumes when in the first and second configurations, respectively; wherein the internal cavity has respective first and second volumes of liquid which are the volume of the internal cavity minus the respective first and second volumes displaced by the valve assembly, respectively; wherein the second volume of liquid is less than 70 microliters; and wherein the second volume of liquid is greater than or equal to the first volume of liquid.
[00086] Concept 12. The Concept 11 connector, in which the valve assembly comprises an air space that is separated from the volume of liquid in the internal cavity.
[00087] Concept 13. The Concept 12 connector, in which: the valve assembly comprises a first ventilation channel that is connected to the air space; the housing comprises a second ventilation channel that is connected to the external environment; and the second ventilation channel is sealably matched with the first ventilation channel so that the air space is continuously connected to the external environment and separated from the liquid volume of the internal cavity.
[00088] Concept 14. The Concept 12 connector, wherein the valve assembly comprises: a valve insertion device having a shoulder hollow element; a cap neck having the face; an elastic diaphragm attached to the cap neck and sealed to the shoulder of the concavity element; and a guide element coupled to the neck of the plug and disposed within the hollow element, the guide element configured to urge the neck of the plug to move away from the hollow element; wherein the plug neck is configured so that the face is aligned with the first port when the valve assembly is in the first configuration; and wherein the volume enclosed by the concavity element and the diaphragm form the air space of the valve assembly.
[00089] Concept 15. The Concept 14 connector, in which the guiding element comprises an elastic material and at least one bevel that causes the guiding element to deform into a serpentine shape when the valve assembly is in the second configuration .
[00090] Concept 16. The Concept 14 connector, in which the cap neck comprises an elastic material and at least one chamfer which causes the cap neck to bend so that the face is inclined with respect to the first door when the valve assembly is in the second configuration.
[00091] Concept 17. The Concept 14 connector, in which: the corresponding male Luer connector has an inclined central nose and a fixing cover with internal threads; the first port comprises an internal inclined hole configured to correspond with the central inclined nose of the male Luer connector and an external thread configured to correspond with the internal threads of the fixing cover; and the valve assembly is moved from the first configuration to the second configuration by the tilted central nose of the corresponding male Luer connector by displacing a portion of the valve assembly as the male Luer connector is matched with the first port.
[00092] Concept 18. A connector comprising: a housing having an internal cavity with first and second ports, with a flow path from the first port through the internal cavity to the second port; an insertion device having a hollow element, the insertion device disposed within the internal cavity of the housing; a flexible valve that is partially arranged within the hollow element, the valve also having a diaphragm sealed to the edge of the hollow element, forming an air space sealed with the hollow element; and a ventilation path from the air space through the insertion device which is coupled to a ventilation path from the internal cavity through the housing to the external environment.
[00093] Concept 19. The Concept 18 connector, in which: the internal cavity has the volume of fluid which is the total volume of the internal cavity minus the volume occupied by the insertion device and valve; and the fluid volume when a male Luer connector is inserted is greater than the fluid volume when no male Luer connector is inserted.
[00094] Concept 20. The Concept 18 connector, in which the flexible valve comprises a valve face without a slot that is configured to be flush with the first port when no male Luer connector is inserted.

权利要求:
Claims (9)
[0001]
1. Connector characterized by the fact that it comprises: a housing (700, 730, 740) having an internal cavity with first and second ports (702, 736) and a fluid path from the first port through the internal cavity to the second door; and a plug (710) having a first and a second position within the inner cavity, the plug configured to block the fluid path between the first port and the inner cavity when in the first position, the plug comprising: a configured diaphragm (720) to separate the internal cavity in a first volume (752) that is ventilated and a second volume (758) that includes the fluid path; a guiding element (724) disposed within the first volume, the guiding element configured to launch the plug towards the first position; a shoulder (718.718A) that contacts the housing and separates the second volume into a third volume (758A) between the first door and the shoulder and a fourth volume (758B) between the shoulder and the second door; and a passage (719) from the fourth volume (758B) through the plug to the third volume (758A), where the passage is opened when a pressure in the fourth volume is greater than the pressure in the third volume and the passage is closed when the pressure in the fourth volume is not greater than the pressure in the third volume, in which the displacement of the plug from the first position towards the second position opens the fluid path and increases the second volume (758).
[0002]
2. Connector according to claim 1, characterized in that the fluid is attracted into the second volume (758) through the second port (736) when the plug moves towards the second position.
[0003]
3. Connector according to claim 2, characterized in that the fluid is expelled from the second volume (758) through the second port (736) when the plug moves towards the first position.
[0004]
4. Connector according to claim 2, characterized in that the plug (710) has a smooth surface that is flush with the first port (702) when the plug is in the first position.
[0005]
5. Connector according to claim 1, characterized by the fact that the second volume (758) is less than 70 microliters.
[0006]
6. Connector according to claim 1, characterized in that the guiding element (724) has at least one chamfer configured to cause the guiding element to deform in a controllable manner when the plug is compressed.
[0007]
7. Connector according to claim 6, characterized in that the guiding element (724) has a plurality of notches configured to cause the guiding element to deform controllably in a serpentine shape when the plug is compressed.
[0008]
8. Connector according to claim 1, characterized by the fact that the first port (702) is configured as a female Luer connector.
[0009]
9. Connector according to claim 1, characterized by the fact that the second port (736) is configured as a male Luer connector.

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同族专利:

公开号 | 公开日

WO2012103518A2|2012-08-02|

CA2825052C|2016-08-09|

US8511638B2|2013-08-20|

US20110130724A1|2011-06-02|

WO2012103518A3|2012-10-26|

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EP2667927A4|2018-08-01|

BR112013019057A2|2016-10-04|

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法律状态:
2018-12-18| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

2019-10-01| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

2020-08-25| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

2020-12-08| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 27/01/2012, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

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US13/016,883|2011-01-28|

US13/016,883|US8511638B2|2008-09-05|2011-01-28|Neonatal Luer-activated medical connector|

PCT/US2012/023028|WO2012103518A2|2011-01-28|2012-01-27|Connector with first and second ports|

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