Untitled record

full description

Sister's wallpaper

The current disclosure relates generally to transfer devices for use with medicinal materials. More specifically, detection relates to a pressure controlled valve device.

Blood reflux can lead to the central line and other types of

<p>5 vascular catheters to intraluminal thrombosis, the formation of complete or partial obstruction of a venous access device.</p>

These blockages can interfere with intravenous therapy, provide a nutrient-rich space for pathogenic bacteria, or be separated from the catheter, resulting in venous thrombosis. Even in cases where intraluminal coagulation does not lead to additional health complications,

<p>10 This condition requires catheter replacement, a procedure that can be time consuming and result in injury to the removal site and the new insertion site.</p>

US Patent No. 0264832/2009 - 1A discloses a valve for controlling pressure flow

Operating in an infusion catheter that allows the gravitational flow of fluid through the catheter and into the patient while counteracting the backflow of blood from the patient and into the catheter.

<p>15th International Application No. 00071/90 identified a valve that allows fluid to flow in the first direction and prevents the flow of</p>

Fluid in a second reflux comprising a housing with spaced valves, a plastic valve member positioned longitudinally within an upper section of the housing having two sealing members separated from each other generally equally spaced and generally spaced downward and away from the longitudinal axis of the linear contact substantially sealing plus To grandfather far space mentioned in the sector

20 The above mentioned and the lower sector configured to be paired with the upper sector.

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General description of the invention

The present invention is intended to provide a valve as defined in protection element 1. According to one example, the valve comprises a housing with a first orifice and a second orifice; a plastic member placed in the housing, the elastomer member having a thickness, a continuous circumferential wall protruding from the thickness; A longitudinal incision extending through the

5 Thickness, continuous portion of the circumferential wall that forms a sealable contact continuous with the housing

The housing is divided into an upper section and a lower section, the elastomeric member being designed so that when a differential pressure is formed between the upper section and the lower section of the housing causes either: (i) the circumferential wall to deviate from the housing allowing fluid to flow around the plastic member; or ( 2) Opening the longitudinal slit allowing fluid to flow through the plastic organ

.elastomeric member 10

On one side of the first embodiment, the valve further includes a strut placed in the housing and enclosed in the circumferential wall, the strut being designed to provide fluid communication between the first and the second orifices. In another aspect, alone or in combination with any of the foregoing aspects of the first embodiment, the strut member is received by or is integrated with the housing. On the other hand,

15th Alone or in combination with any of the foregoing aspects of the first embodiment, the abutment member comprises many spaced columns placed around the second aperture, the far ends of the many columns enclosed in a perimeter wall. In another aspect, alone or in combination with any of the foregoing aspects of the first embodiment, the strut member comprises an annular wall placed around the second orifice, the annular wall comprises at least one fluid flow passage providing a connection through

20 The fluid is between the lower section and the second orifice.

On another side, alone or in combination with any of the foregoing aspects of the first embodiment, the second opening includes a duct extending into the housing and enclosed in the perimeter wall. In another aspect, alone or in combination with any of the foregoing aspects of the first embodiment, the portion of the duct extending into the housing is of greater internal diameter than the duct extending outside the housing.

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On the other hand, alone or in combination with any of the foregoing aspects of the first embodiment, a portion of the housing is tapered and the tip of a distal portion of the perimeter wall is in a sealable contact with it.

5 In another aspect, alone or in combination with any of the foregoing aspects of the first embodiment, the upper part of the housing comprises an inner wall, the inner wall comprises one bore channel on

It extends largely along the longitudinal axis of the housing, where the deflection of the perimeter wall from the housing largely corresponds to the position of at least one recessed channel.

In another aspect, alone or in combination with any of the foregoing aspects of the first embodiment, the housing comprises two or more sealing contact components to form an assembly

fluid tight assembly.

In another aspect, alone or in combination with any of the foregoing aspects of the first embodiment, the thickness comprises an upper and a lower surface separated from the upper surface by thickness; The peripheral wall has a second thickness, and the peripheral wall protrudes from the lower surface. On the other hand, alone or in 15 combinations with any of the foregoing aspects of the first embodiment, the thickness of the second is less than the thickness

between the upper and lower surfaces.

In another aspect, alone or in combination with any of the foregoing sides of the first embodiment, the elastomer member further comprises a continuous lateral overhang along the circumferential edge of the thickness, and the housing is designed with a corresponding recess to receive the continuous lateral protrusion and to provide a 20 diagonal stress on the surface of the elastomer . In another aspect, alone or in combination with any of the foregoing aspects of the first embodiment, the elastomer member further comprises one or more vertical protrusions on the upper surface, the housing being designed to provide normal stress on one or more of the vertical protrusions beds.

On the other hand, the thickness is concave, convex, or concave and convex on opposite sides

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On the other hand, alone or in combination with any of the foregoing aspects of the first embodiment, the elastomer member is annular, oval, cylindrical, hemispherical, or cup-shaped. In another aspect, alone or in combination with any of the foregoing aspects of the first embodiment, the elastomeric member is conical frustum-shaped.

<p>5 In another aspect, alone or in combination with any of the foregoing aspects of the first embodiment, the upper surface of the elastomer member comprises one or more fluid channels terminating at the circumferential edge.</p>

On the other hand, alone or in combination with any of the previous aspects of the first embodiment, the longitudinal slit opens at a pressure greater than the threshold pressure required to deviate the circumferential wall 10 from the housing.

On the other hand, alone or in combination with any of the previous sides of the first embodiment, the longitudinal slit is designed, in combination with slot one and slot two, to receive an extended medical device during the overnight stay. In another aspect, alone or in combination with any of the foregoing aspects of the first embodiment, the stent is designed to receive and/or guide an extended medical device during the overnight stay. On the other hand, alone

<p>15th or in combination with any of the foregoing aspects of the first embodiment, the stent is designed in combination with a longitudinal incision to receive and/or guide an extended medical device through the housing.</p>

In a second embodiment, a method is provided for controlling the direction of flow by means of an instrument. The method comprises: creating, in an instrument comprising the valve as defined in any aspect of the first embodiment, a differential pressure between the upper and lower section of the housing; Causing the circumferential wall 20 to deviate from the housing allowing fluid to flow around the elastomer; or, in the alternative form; Causing the opening of the longitudinal fissure allowing the fluid to be suctioned through the elastomer organ; The direction of fluid flow through the tool is controlled.

On a first side, alone or in combination with any of the foregoing aspects of the second embodiment, the differential pressure between the upper and lower section of the housing is formed by a negative pressure

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It is applied to the upper section of the housing or by a positive pressure being applied to the lower section of the housing so that the longitudinal slit allows fluid to flow through it.

In another aspect, alone or in combination with any of the foregoing aspects of the second embodiment, the differential pressure between the upper and lower section of the housing is formed by a positive pressure

<p>5 It is applied to the upper section of the housing so that the circumferential wall allows fluid to flow around the elastomer member.</p>

In another aspect, alone or in combination with any of the foregoing aspects of the second embodiment, the method further comprises introducing a rinse solution into the upper part of the housing through the first orifice; causing, by means of positive pressure, to deflect the perimeter wall from the housing; sweet dates

<p>10 rinsing around the elastomer; Redirect the fluid flow into the lower section of the housing; Clean at least part of the lower section of the housing.</p>

In another aspect, alone or in combination with any of the foregoing aspects of the second embodiment, cleaning additionally includes preventing coagulation within the instrument after suction aspiration of biological fluid through the instrument or preventing bacterial growth within the instrument after suction aspiration. On the other hand, alone or in

<p>15th In combination with any of the foregoing aspects of the second embodiment, the method further includes in-tool reflux prevention.</p>

Brief explanation of the drawings

Figure 1 represents a horizontal projection, with a sectional plane A-A, of a pressure-activated valve embodiment according to the present disclosure;

20 Fig. 2 is an upper projection of Fig. 1 showing segment levels 4a - 4a and 4b - 4b;

Figure 3 is a partial view of the model for Figure 1;

Figure 4a and Figure 4b are representative cross-sectional views of the model for Figure 1 with the sectional levels 4a - 4a and 4b - 4b, respectively;

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Figure 5 is a perspective profile of the upper housing from the model of Figure 1;

Figure 6 is a perspective profile of the lower housing from the model of Figure 1;

Figure 7a and Figure 7b are representative cross-sectional views of the model for Figure 1 with the sectorial levels 4a - 4a and 4b - 4b, respectively, in a first-run and second-run state, at

5 straight;

Figure 8a, 8b, 8c, and 8d represent perspective shapes of the elastomer member according to models specific to the present disclosure;

Figure 9 represents a horizontal projection, in B-B sectoral planes, of another embodiment of a pressure-activated valve according to the present disclosure;

10 Figure 10 is an upper projection of Figure 1 showing sector levels 12a - 12a and 12a - 12a;

Figure 11a and 11b represent segmental view and segmental view, respectively for the model of Fig. 9;

Figure 12a and 12b are representative cross-sectional views of the model for Figure 9 with the 12a - 2a and 12b - 12b sector levels, respectively;

15th Figure 13a and 13b represent a horizontal projection and a perspective profile of the lower housing, respectively, for the model of Figure 9;

Figure 14a and Figure 14b are representative cross-sectional views of the model for Figure 9 with the sectorial levels 12a - 2a and 12b - 12b, respectively, in first run and second run, respectively;

20 Figure 15a, 15b, and 15c are sectional shapes of another model of pressure-activated valve. According to the present disclosure, Figure 15b shows the model for Figure 15a rotated at 90 angles;

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Figure 16a represents a horizontal projection, with sector plane 16b - 16b, of another embodiment of pressure-activated valve according to the present disclosure;

Fig. 16b represents a cross-sectional view with segmental plane 16b - 16b, for the model of Fig. 16a;

5 Figure 17a represents a horizontal projection, with sector plane 17b - 17b, of another embodiment of pressure-activated valve according to the present disclosure;

Fig. 17b represents a cross-sectional view with segmental plane 17b - 17b, for the model of Fig. 17a;

Figure 18a represents a horizontal projection, with a sectional plane 18b-18b, of another embodiment of an energized valve

10 pressing according to the current detection;

Figure 18b represents a cross-sectional view with sectoral plane 18b-18b, for the model of Figure 18a;

Figure 19a represents a horizontal projection, with sector plane 19b - 19b, of another embodiment of pressure-activated valve according to the present disclosure; And

15th Figure 19b represents a cross-sectional view with sectoral plane 19b - 19b, for the model of Fig. 19a.

Detailed description:

The current-detection valve, and valve-containing instruments, reduce or eliminate backflow of blood to the distal end of an angioplasty. Instruments with valves can be used

20 of the present disclosure as a stand-alone replacement only for an open Luer syringe or used with an existing IV valve, even when the IV valve is used alone a backflow of blood will be generated from a negative mass. The valve includes, by design, a directional flow rate

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High injection and high internal fluid mixing, preventing non-rinsable fluid volumes that could lead to bacterial colonization and injection of the catheter related blood stream

CRBSI (infection). These two main benefits are not actually available in the valves and instruments found in the art.

5 The valve currently disclosed which may also be referred to as a “pressure-activated valve” or, alternatively as a “leak opening valve”, is a valve suitable for assembly in an instrument, such as a medical instrument. The valve includes an elastomer member designed to rest in a housing, the elastomer member has a longitudinal slit through the thickness, the elastomer member additionally includes a deflectable circumferential wall in intervening contact with the part

10 The interior of the housing so that a fluid seal is formed and to divide the housing into an upper and a lower part. Each part is connected to a fluid inlet and outlet orifice.

On one side, a valve exposed to a low ground pressure connection allows fluid to flow in one direction through the valve and instrument orifices. This type of fluid delivery is compatible with both continuous intravenous therapy and periodic parenteral or infusion therapy.

15th through the veins. When the fluid is introduced, either through an attached Luer syringe or other infusion device, to the proximal end of an instrument comprising the exposed opening valve, a differential pressure is created between the compartments in the housing. The differential pressure, in one case, deflects the circumferential wall surface of the elastomer member, breaking a fluid-proof seal using the housing. This allows fluid to flow around the elastomer and through this temporary joint, entering the

20 fluid to the other part of the housing separated by the elastomer member.

In a case, for example, a leak, where there is a positive differential pressure formed between the upper and lower parts of the housing, the current-detection valve provides a lower valve fracturing pressure. In addition to the low fracturing pressure, the current-detection valve additionally provides a low flow restriction in the direction of the leak (near to far flow direction) which

25 Valve-containing devices are permitted to be used with existing intravenous infusion systems.

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Still, the low, but not zero, fracturing pressure of the valve described herein prevents air from entering in the direction of the leak when the valve is close to the groove level of the injection site. This is provided, among other things, by arranging the flow around the elastomer member, and by shaping the interior design of the housing so as to aid in portability.

5 The valve is for rinsing while a high flow rate is supported.

In another case, for example, suction suction, where there is a negative differential pressure formed between the upper and lower parts of the housing, the current detection valve provides a cracking pressure of a greater marginal value than in the direction of the leak. This valve modulation currently disclosed prevents, among other things, backflow of blood into the catheter lumen, typically resulting from a median of a temporary void 10 caused by a disconnection of the Luer syringe, an additional infusion device, or a needle free access valve.

As a result of the design and configuration of the valve currently disclosed, and the instrumentation involved, prevention of backflow and the risk of intraluminal coagulation is provided, thus reducing or eliminating bacterial colonization or infection. The fracturing pressure of the valve currently detected in the suction suction direction is designed to remain low enough to allow deliberate fluid withdrawal.

<p>15th Using a syringe or a vacuum tube, as is traditionally done.</p>

Another feature of the presently disclosed valve or its comprising instruments is the valve formation within the instrument that supports high fluid mixing and/or rinsing of surfaces in contact with blood. The fluid volume and/or velocity in the direction of the infusion are controlled so that the fluid mixing is maximized in the instrument section. The high degree of mixing improves valve flushing, eliminating the downstream volume

<p>20 It can lead to the formation of bacterial colonies of the non-rinsed nutrient-rich infusion.</p>

The valve currently disclosed in one embodiment is designed to be attached to one end of a medical device with a lumen, such as a catheter, and is designed, among other things, to prevent backflow of blood or other fluids into the lumen or lumen of the medical device adapted to the opening valve connector. Could

<p>25 Use of valve inclusion, either alone or in a connector, in combination with or integrated with a medical device</p>

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It has a luster, eg, angioplasty, and can be shaped to pair with these tools or shaped for integration during catheter manufacturing, or later, at the point of use.

A feature of the valve presently disclosed and the devices comprising it is that an access device attached to a Luer syringe detaches from a proximal end of an instrument comprising the current valve, or

<p>5 Disconnecting from a free access valve with a needle attached to the proximal end of an instrument comprising the existing valve will not cause blood to backflow into the central line lumen(s). Furthermore, an instrument comprising the current valve will allow fluids, such as blood or other biological fluids, to be withdrawn. By blinking with an access syringe or a vacuum flask (a Vacutainer, for example).</p>

On one side, the valve includes a housing and an elastomer member. On the other hand, the valve 10 includes a housing, an elastomer member, and a strut. The various aspects of the valve are now discussed with reference to illustrations and/or accompanying drawings.

The valve housing may have a single component or be a combination of several components. On one side, the housing comprises an upper section and a lower section which are sealing contact to the upper section to provide a watertight assembly. On the other hand, the housing 15 comprises an upper section of two or more parts that are seamlessly contactable to the lower section to provide a watertight assembly. The housing can be of conventional plastic suitable for medical devices such as polycarbonate, polyester, ABS, cyclic olefinic copolymer, and the like.

The elastomer member is designed to divide the housing into an upper section and a lower section. In general, an elastomeric member can be annular, oval, cylindrical, hemispherical, cup-shaped or elliptic. On one side, the elastomer member can be cup-shaped or elliptical with an internal cavity formed between its base and surface. On one side, a horizontal convex/concave surface can advantageously be used with a circumferential wall protruding from the cup-shaped or elliptical surface. The peripheral wall of this structure can be oval or

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Round, or otherwise, providing a continuous seal against a fluid that can be placed co-operatively with the inner part of the housing and part of the outer surface of the circumferential wall so that the housing is divided into an upper and a lower part, and provides the function of the direction of flow to the valve or instrument . The edge of the perimeter wall can tape off or protrude naturally from the surface from which it protrudes. 5 alternately or in combination with a tapering tip, the outer diameter of the wall can be

Perimeter and/or surface that protrudes from greater than a corresponding inlet diameter of the corresponding part of the housing such that the interface and/or the sealant and/or the housing partition are provided. The angles of the tapering of the circumferential wall can be greater than that of the tape of the inner wall of the housing to provide an interference relationship of an amount capable of facilitating an anti-fluid seal between them and effectively dividing the tool housing into at least two segments. Alternatively or in combination with the above, the thickness of the circumferential wall may be tapering towards the far end of it.

15

On one side, the elastomeric member has the shape of an imperfect cone with a surface, the surface comprising an upper and lower surfaces separated from the upper surface by a first thickness, and a circumferential wall protruding away from the lower surface having a second thickness, the circumferential wall forming a cavity including the lower surface. The second thickness can be less than or equal to the first. Surfaces can be concave and convex on opposite sides or they can be concave or convex on one side only. The upper surface of the elastomer member may include one or more fluid channels terminating at its circumferential edge. Other distinctive features are described below and in the graphics.

<p>20 The elastomer comprises one or more longitudinal slits of such thickness that they open at a differential pressure between the upper and lower segments of the housing, which may be formed, for example, by drawing fluid from either the far ends of an instrument comprising the elastomer. The longitudinal slit of the elastomer member is designed to open at a pressure greater than the threshold pressure required to deviate the perimeter wall from the housing. Accommodation is designed</p>

<p>25 so that the floor space above the elastomer and the inner surface of the upper housing provides sufficient clearance</p>

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To open the longitudinal incision. In a first case, the longitudinal slit is resistant to flow in the direction of near-to-distal flow (for example, infusion) on one side, which, among other things, limits the ability to open the longitudinal slit in this direction of flow. Allow flow in another direction (eg, aspiration) through the slit.

<p>5 On one side, the elastomeric member has a flat top surface generally convex/concave, having an elliptic cone-shaped cavity that includes a bottom surface supported by one or more supports (for example, protruding columns or a wall) that protrudes</p>

Aligned with the longitudinal axis of the housing. The bracket(s) may be integral with the lower housing or may be positioned during manufacture. An adequate overlap is maintained with the lower housing

<p>10 at least from the elastomer member by distinguishing features on either the upper housing components and/or lower housing and/or the elastomeric member. The elastomer member may also be held in place via an annular or protrusion setup with or without the said support(s) to position the elastomer during manufacture and tool use and/or provide a radial compressive stress on the longitudinal slit (for example, to adjust or control the . Longitudinal crack fracturing pressure</p>

<p>15th For example, the elastomer member may have a continuous lateral protrusion along the circumferential edge of its elliptic cone-shaped upper surface, and the housing may be shaped with a corresponding recess to receive a continuous lateral protrusion and to provide an overlap and/or radial stress to the surface of the thickness of the elastomer. Continuous lateral protrusion can be of a thickness equal to or less than the thickness of the surface. In addition to or in combination with, an elastomeric member may comprise one or more</p>

<p>20 From the floor profiles of its ellipse-cone upper surface, the housing is designed and dimensioned to provide normal stress on one or more floor profiles to stabilize the elastomer member during assembly or use.</p>

On one side the elastomer member is part of a valve assembly. The valve assembly can be configured for a variety of housing configurations designed for fluid coupling, such as two-, three-coupling,

<p>25 and four-way. The valve assembly may include the elastomer member and an optional bracket</p>

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Trouble getting into a dormitory. The assembly can be configured to adapt to a two-piece housing structure, comprising either a lower/top housing, a two-piece housing separated along the longitudinal axis, or a combination thereof, eg, a solid lower housing and a two-piece upper housing.

. Fluid intake is restricted through the leakage opening valve (fluid flow from the distal direction to

<p>5 proximal) is lower than the scaling cracking pressure of the longitudinal crack(s) formed through the central axis of the elastomer member. The scaling fracturing pressure is designed to be high enough that the temporary empty medium does not open by detaching the luer syringe, an additional sealant, or a free access valve with a needle attachment, the slit, and thus the valve to flow in that direction.However, the suction is designed to suck in the direction of flow “cracking pressure”</p>

<p>10 To be low enough to allow deliberate fluid withdrawal by syringe or vacuum tube, if needed. The elastomeric member's elastomeric section design and its interlocking with the conical inner part of the housing support unidirectional fluid flow, operable in either direction, the fluid flow control in the housing between its orifices with a leak-free function and ease of use.</p>

<p>15th The valve and instrumentation formed with this valve can be designed to pass a medical instrument eg an insertion device such as a guide wire or other medical instrument. Existing valve-containing designs can support “over the guidewire” placement or replacement technology and remove or prevent backflow of blood or air valves. In one aspect of the present disclosure each of the embodiments are exclusive to spring-actuated valve assemblies, or spring-actuated valve assemblies containing a valve insertion device</p>

<p>20 Inside the valve housing bore, or pressure ring actuated valve assemblies. Of course, these tools can be used in combination with the valve currently being unveiled. The valve models disclosed in this application remove the need for a three-layer design of a slotted slot, followed by a slot, followed by another slot slot, for example. Indeed, in certain respects, the present disclosure is free from narrowing the elastomer organ between the two halves of the housing to support the organ</p>

<p>25 . Elastomer, where, instead, a design specific to the elastomer member is used in a relationship</p>

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Co-operative with the inner wall of the dormitory. Likewise, valve models currently disclosed greatly reduce dead space above and below the valve assembly and/or support effective flushing of any dead space. Furthermore, current valve models avoid problems common to common configurations for pressure actuated valves used in medical devices, such as:

<p>5 1) Fluid leakage through “dome-like” slits with longitudinal slits for bi-directional fluid transport; 2)</p>

Insufficiency in front of gravity feed current through tools containing a “trampoline-shaped” slit between two housing walls; and 3) an inertia to effectively flush the interior of the instrument with valves designed for the flow of two fluids through the longitudinal slit. Supports the valve The current, in contrast, eliminates leakage, the ability to feed by gravity, as well as an improved rinsing of the part

<p>10 The inner part of the device containing the valve. Furthermore, additional benefits of the current-detection valve include directional control of fluid flow through the tool through a passage either through or around the elastomer member, reduced dead space and/or the ability to minimize improved flushing, frequent access to the guidewire without Failures or problems generally associated with known valve systems.</p>

<p>15th The elastomer can be manufactured from conventional thermosetting rubbers (synthetic and non-synthetic). The elastomer is designed between the proximal and distal housings during manufacture. The interface between the conical circumference of the elastomer and the conical part of the proximal housing forms a naturally closed valve This interference permits, among other things, low-pressure fluid passage in one direction.</p>

<p>20 The valve opening/pressure actuated valve design allows a wire or cannula to pass through the central shaft of the tool. This is useful for placement of a PICC or CVC catheter, as well as a short peripheral venous catheter. Hence, the currently detected valve can act as a "bloodless start" deaf, thus minimizing exposure of blood to the clinician when the catheter is placed. Upon insertion, the wire or cannula of the needle can be removed, the longitudinal incision closes automatically when</p>

<p>25 Remove it, and the caregiver is protected from further exposure to blood. This may also preserve the axis</p>

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The catheter is more free of fluid rich in nutrient to further protect the patient from possible infection at the site. The longitudinal slit of the elastomer member can be formed, in conjunction with the first and second slots of the housing, to receive an extended medical device during the housing. The housing can have a stanchion or be designed with an inward-tipped opening

5 It feeds into the second orifice to receive and/or guide an extended medical device through the housing.

The former valve supports a method for creating a differential pressure between the upper section and lower section of a housing comprising the valve that is currently being disclosed. This differential pressure either causes the circumferential wall to deviate from the housing and allows fluid to flow around the elastomer member, or, in an alternative embodiment, causes the longitudinal slit to open allowing fluid to be suctioned through the organ

10 elastomer. In this method, the direction of fluid flow through the tool is controlled. For example, the differential pressure between the upper section and lower section of the housing is formed by negative pressure applied to the upper section of the housing or by positive pressure applied to the lower section of the housing so that the longitudinal slit allows fluid to flow through. In another example, the differential pressure between the upper section and the lower section of the housing is formed by a positive pressure applied

15th Apply it to the upper section of the housing so that the circumferential wall allows fluid to flow around the elastomer member.

The method further comprises introducing a rinse solution into the upper part of the housing through the first orifice and causing, by positive pressure, to deviate the perimeter wall from the housing. This causes the rinse solution to flow around the elastomer, under and into the cavity of the elastomer in which it is located

20 In the shape of an ellipse, with the fluid flow redirected into the lower section of the housing. This provides cleaning of at least part of the lower section of the housing. This cleaning prevents coagulation within the instrument after suction aspiration of biological fluid through the instrument and/or prevents bacterial growth within the instrument after suction suction.

The upper housing and lower housing of all models disclosed in this can be installed

25 Application by ultrasonic welding, bonding with solvent, glue, adhesive, and/or methods

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Heat or other chemical known in art. In at least one aspect of the present disclosure, the housing or its sub-assemblies are designed such that the welding process will trap the elastomer member between the housings, producing a naturally closed seal. The components of the housings can be machined for snap alignment, gluing, spin welding, solvent welding and the like.

5 Any part of the elastomer member and/or the longitudinal incision of the elastomer can be lubricated. On one side, a silicone lubricant can be used. Different lubricants can be used on different surfaces of the elastomer. One or more silicone fluid may be inserted into the elastomer during molding.

The housing and/or supports can be injection molded from a solid, biocompatible, engineering grade 10 resin such as polycarbonate, a cyclic olefinic copolymer.

COC(copolymer), transparent acrylonitrile butadiene styrene MABS, etc. Certain formations of the elastomer organ can be formed using TPE, which is similarly injection molded. Liquid injection molding (LIM) can be used For the elastomer member and/or to form a valve assembly 15. Pressure molding or rotational pressure molding may be used to fabricate the elastomer member. The elastomer material can be silicone, polyurethane for these molding methods.

Forms for the current statement will now be more fully described later in this application with reference to the accompanying drawings, where models for the current statement are displayed. This current disclosure 20 may, however, be included in many different forms and should be construed as being limited to the forms described in this application. Rather, such forms are provided so that such disclosure will be complete and complete, and will fully communicate the scope of the protections to those skilled in the art. Similar numbers refer to similar items throughout the specification.

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Now referring to the figures, Figure 1 is a first-model perspective illustrating Tool 100. Tool 100 includes a 101 rigid upper housing housing to provide a connection to a male luer injector assembly, and a rigid lower housing 102, which supports a connection to a female luer injector assembly. The instrument has a smooth outer surface for patient comfort. Tool 100 has a first hole 101a and a second hole 102a.

5 While the first hole 101a is shown as serrated, it can be machined smooth without tines. Figure 2 is an upper projection of tool 100 showing sector levels further described below.

Figure 3 represents a partial view of the tool 100 illustrating the lower housing, 102

Including the struts 112 supports, the elastomeric member 110 containing the perimeter wall 169 protrudes from the deck 167 towards the lower housing 102. On the deck 10 the 167 is a longitudinal slit 117 slit. The upper housing 101 is designed to create a seal

For fluid with lower housing 102. Upper housing 101 can be machined using 106 female Luer syringe fittings, as shown. The lower housing can be machined using a male luer syringe 107 and a surrounding inner tooth 108, as shown.

Referring now to Figures 4a and 4b, cross-sectional views, separated by an angle of 90, respectively, 15 for the first embodiment the tool 100 is shown in a complex formation.

Figure 4a shows a section of the circumferential wall 169 of the elastomer member 110 containing an interlocking assembly with the inner wall 111 forming a continuous seal with the inner wall 111 of the upper housing 101. The elastomer member 110 divides the tool 100 into an upper section corresponding to the first hole 101a and a lower section corresponding to The second slot 102a. The elastomer member 20 is shown 110 supported by the struts 112. The struts 112 form the slot 109 and provide

Fluid connection between the lower housing 102 and through the second orifice 102a. The elastomer member 110 is shown herein as a normally closed valve, whereby both a longitudinal slot 117 and a continuous seal with inner wall 111 prevent fluid flow between orifices 101a and 102a before activating the tool 100 via a differential pressure. Interface composition can be provided with

25 Between the elastomer member 110 and the inner wall 111 of the housing when installing the upper housing

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101 and lower housing 102 during manufacture eg when joining/welding housing components together, eg at weld joint 114 weld. The elastomer member is supported by struts 112 and the elastomer member is sealing against the inner wall 111 of the upper housing. The fluid shall be capable of flowing between the supports into orifice 109 and through the first orifice 101a 5. The lower housing includes 102 base 102H surrounding a 102C protrusion that protrudes from the base of 102E as part of the second aperture 102A. The deck (or base) 102e extends diagonally toward the taper wall 102d. A portion of the outer diameter of the taper wall 102d is designed for a leak-proof position across the weld joint 114 with an inner diameter of the upper housing 101.

10 Figure 4b shows a side of the first embodiment according to which the fluid channel 115c is provided in the inner wall 111 of the upper housing 101. As shown, the fluid channel 115g generally extends parallel to the longitudinal axis of the tool 100 toward the lower housing 102. The far end is designed from a length of Fluid channel 115c (eg, distal end 115d) such that at least part of the circumferential wall 169 (eg, as shown, distal end 169a) remains at 15 continuously in overlap with the inner wall 111. In one embodiment, tool 100 can be configured without the fluid channel 115 fluid channel (width equal to zero).

On one side, two or more fluid channels 115G are provided in the inner wall 111 of the upper housing 101. On this side, two of the fluid channels 115G may be placed in a parallel configuration with each of their corresponding longitudinal axes closely aligned with the axis 20 Tool longitudinal 100. In one embodiment, the elastomer member has a longitudinal slit 117

Consisting of a single longitudinal slit, the two fluid channels 115c are positioned perpendicular to the longitudinal axis of the 117 single slit. In this configuration, during fluid leakage and the curvature of the circumferential wall 169, radial forces are applied to the surface 167 to facilitate maintaining the closure of a longitudinal fissure 117.

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Figure 5 shows a view of the upper housing 101 showing the fluid channel 115c, as shown, in fluid contact with the first orifice 101a and of length generally parallel to the longitudinal axis of the upper housing 101. The width of the fluid channel 115c can be chosen to be approximately any width equal to a number Greater than zero and less than half the maximum inner circumference of the housing

5 101. In one aspect, the fluid channel width 115g is chosen to be less than the minimum inner diameter of the first orifice 101a so that a focal pressure or force (and/or accelerated fluid velocity) is facilitated on the peripheral wall 169 during infusion and/or 100 flushing of device Figure 6 shows a perspective profile of the lower housing 102 showing several struts 112 placed around the protrusion 102c of the second hole 102a.

10 The struts 112 are positioned diagonally around the overhang 102c with space in between to allow fluid communication between the upper housing 101 first orifice 101a and the lower housing 102 second orifice 102a during infusion. The supports 112 may have remote extrusions 112g designed to contact the bottom surface of the elastomer member 110 and to reduce displacement of the elastomer member 110 within the housing during assembly or use and/or to apply a loading and/or to interpret a stack

15th Components of the upper housing and lower housing.

Figures 7a and 7b are representative cross-sectional views of tool 100 shown in a first case (for example, leakage) and a second case (for example, suction suction), respectively. Arrows 1 and 2 show the direction of fluid flow within tool 100.

Referring to Figure 7a, in a first case, a differential pressure is created between the split housing at 20 Fluid leakage through the first orifice 101a causes the circumference wall 169 to deviate from

The inner wall 111 of the upper housing 101 forms a create a fluid 115 passage and permits contact by fluid between the upper and lower part of the instrument 100 around the elastomer member 110, while maintaining the closure of the longitudinal slit 117, such that a directional fluid flow is provided from The first hole 101a through the second hole 102a. 25 lower housing structures can provide 102 lower housing, for example, 102d tapered wall

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and protrusion 102c, turbulence and/or the direction of fluid flow so as to allow effective rinsing of parts of the elastomer member that have been in contact with bodily fluids (for example, the inner surface of the circumferential wall 169). The circumferential wall 169 is designed, which in various aspects, provides cup-shaped oval, or elliptical cone-shaped, to deviate from and/or inward

<p>5 Towards the central longitudinal axis of the tool 100 when a pressure differential is formed, (eg by introducing the leaking fluid into orifice 101a) with a relatively low leakage fracturing pressure threshold value. 0.0013 H2O MPa (in the counter) to about 0.0089 MPa</p>

(counter), where the term “approximately” includes ± 20% of the stated value).

<p>10 These pressure values, for example, when the IV bag is raised above the height of an insertion point in a patient. In contrast to existing valves to flow “through” the elastomer seal/valve in both the leaky and suction suction states, the valve currently disclosed is designed to flow “around” the valve in the leaking state and through the valve in the suction suction state. The advantage of this current configuration is that it eliminates leakage and “returns” after</p>

<p>15th Aspiration is suction and the desired ability to easily escape the fluid is provided by gravity as described with reference to the illustrative example of Figures 7a and 7b.</p>

Referring to Figure 7b, in a second case, a differential pressure formed upon suction suction of the fluid through the second orifice 102a causes a longitudinal slit opening 117 while the distal end 169a of the circumferential wall 169 is kept in contact with the leak-proof interference continual with

<p>20 The inner wall 111 of the upper housing 101. On one side, the longitudinal slit is designed so that a limit value of the suction suction pressure is required to allow the fluid to pass through the longitudinal slit from the second orifice 102a through the first hole 101a. In one aspect, the limit value of the suction suction pressure is considerably higher than that of the leakage fracturing pressure limit. On one side is the difference between the limit value of the suction pressure</p>

<p>25 . The cut-off value for the suction suction by infusion, which is</p>

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The suction suction LV fracturing pressure is approximately 5 psi (metered) greater than that of the infusion LV fracturing pressure. This difference in the suction LV fracturing pressure can range between about 0.020 MPa (counter) and about 0.048 MPa. (in counter), (where the term “about” includes ± 20% of the value). 5 The formation of the difference in fracturing pressure values ​​to the threshold value can be accomplished by varying the elastic modulus, thickness and/or thickness variation, tapering, cross-linking/processing, material selection and elastomer dimensions 110 as well as the design and layout of the slit longitudinal 117, as discussed above. Additional below. include yee

Additional variables that can be adjusted in relation to the fracturing pressure limit values, number, width, and length of the flow channel 115 g and/or the internal geometries of the upper housing and lower housing components.

10 With reference to Figs 8a, 8b, 8c, and 8d, contrast images from the elastomer member are shown. Figures 8a and 8b, illustrating the elastomer member 110 comprising the formation of a single longitudinal crack 117 and a multiple longitudinal crack 117a. Other slit configurations may be used.

Figures 8c and 8d show elastomeric members 110a and 110b, respectively, having additional characteristic features on the typical elliptic cone-shaped member 110a and 110b, in particular.

15th Prozat 1100 on the surface of a cone-shaped organ minus 110a, or one or more of

Channels 1150 in the surface of the cone-shaped member minus 110b.

Figure 8d further illustrates an embodiment of the elastomeric organ where in the cone-shaped organ minus 110b includes an 1175 stem with a duct (not shown) through which it is surrounded by a circumferential wall 169c, the duct is designed to surround the second opening 102a or

20 Attached to the projection 102c of the lower housing 101. The stem 1175 may be configured as a duct for fluid communication with orifice 102a and longitudinal slit 117. In this formation, the stem 1175 necessarily includes one or more vertically placed slots/slots (with the longitudinal axis of the housing through which (not shown) for fluid passage/rinsing during infusion, longitudinal orifice(s) can be formed to respond to the pressure/force of the compressive infusion and open partially

25 at least allowing fluid to enter orifice 102a, while, during suction suction, it will remain

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The longitudinal orifices/slits, not subject to compressive stress, are closed to greatly facilitate the flow of all fluid through orifice 102a, stem 1175, longitudinal slit 117, upper section of housing and orifice 101a. In this modification of the elastomer organ model described above, all other functional characteristics, as described above for the elastomer organ above, will be preserved.

5 110.

Referring to Figure 9, a second embodiment of the valve now disclosed is shown, showing a perspective of Tool 200, comprising upper housing 201 with first orifice 201a and lower housing 202.

Figure 10 shows a top-down of tool 200 at sector levels 12a - 12a and 12b - 12b.

10 Figures 11a and 11b show a sectional view and a sectional view, respectively for Tool 200. The lower housing 202 of Tool 200 includes 212 annular wall. In this illustrative embodiment, the annular wall 212 provides support for the elastomeric member 210, which is enclosed in the circumferential wall 269. The annular wall 212 can be integral with the lower housing 201 as shown, or it can be molded separately and placed in the housing during assembly. The member includes

15th The elastomer 210 on a lateral annular protrusion 218 from the edge of the surface 267 is shaped to be received by a recess 218a within the inner wall 211 of the upper housing 201. In addition, the elastomer member 210 includes an anchored annular protrusion 2110 from the surface 267 to provide an overlap When assembling the upper housing and lower housing components 201, 202. The surface 267 of the elastomer member includes 210 longitudinal slits.

20 217, passes through the thickness of the deck 267. Different from the previous model, the lower housing is included

202 Tool 200 Tapered slot 202c feeds to second slot 202a. The tapered hole 202c provides guidance for inserting medical devices such as guide wires, ... etc. into a second hole of smaller diameter 201a and prevents bending and/or twisting of these tools.

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Referring now to Figures 12a and 12b, the cross-sectional views, separated by 90 angles, respectively, of the second model tool 200 are shown in a complex formation. Figure 12a shows a portion of the circumferential wall 269 of the elastomer member 210 having an interleaving assembly with the inner wall 211 forming a continuous seal with the inner wall 211 of the upper housing 201.

5 The elastomer member 210 divides the tool 200 into an upper section corresponding to the first hole 201a and a lower section corresponding to the second hole 202a. The elastomer member 210 is shown supported by an annular protrusion 212 that includes fluid passages 209 that provide a fluid contact between the lower housing 202 and through the second orifice 202a. The elastomer member 210 is shown here as a normally closed valve, blocking both a longitudinal slit 217 and a continuous seal with the wall.

10 Internal 211 Fluid flows between orifices 201a and 202a before activating the tool 200 via a differential pressure. The interface composition between the elastomer member 210 and the inner housing wall 211 can be provided when the upper housing 201 and lower housing 202 are attached during manufacture for example, when the housing components are joined/welded together, for example at the weld joint 214. The circumferential wall of the member 269 elastomer 210 fluid-type seal with wall

15th Internal 211. The fluid is capable of flowing through an annular support 212 at orifices 209 and the second orifice 202a. The lower housing includes a deck 202 or base 202e surrounding an annular strut 212 that protrudes from the base of 202e as part of the second slot 202a. The surface or base 202e extends diagonally toward the tapering wall 202d. A portion of the tapered wall's outer diameter 202d shall be designed for a leak-proof position across the weld joint 214 with an inner diameter of the housing.

20 Top 201. Figure 12b shows an aspect of the second embodiment according to which the tip of the inner diameter tapers from an annular support 212 inward to that of the inner diameter of the second hole 202a which also serves as a guide for medical devices that can be inserted through the tool.

In a manner similar to that of the first embodiment, the tool 200 includes an additional fluid channel 215g25 that extends generally parallel to the longitudinal axis of the tool 200 toward the lower housing 202. In one

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Models, any of the devices disclosed herein may be formed without the 215c fluid channel.

Figure 13a shows a profile of the lower housing 202 showing annular support 212 and aisle 209. Figure 13b is a view of the lower housing 202 showing annular support 212 and a taper

5 Terminal 202f feeds to the second slot 202a. An annular support 212 may include distal protrusions 212g designed to contact the bottom surface of the elastomer member 210 and to minimize displacement of the elastomer member 210 inside the housing during assembly or use.

Tool 200 works similarly to that of the first model, as shown in Figures 14a and 14b, which show the cross-sectional views of Tool 200 shown in a first case (on

10 for example, leakage) and a second case (for example, suction suction), respectively. Arrows B1 and B2 show the direction of fluid flow within the tool 200. Referring to Figure 14a, in a first case, a differential pressure is created between the split housing of the tool 200. When fluid leaks through the first orifice 201a causing the circumference wall 269 to deviate from the inner wall 211 of the upper housing 201 forming a fluid passage 215 and allowing connection through

15th Fluid is between the top and bottom of the tool 200 around the elastomer 210, while the longitudinal slit 217 is maintained closed, such that a directional fluid flow is provided from the first orifice 201a through the second orifice 202a. Lower housing structures 202, eg, tapered wall 202d, can provide turbulence and/or direction of fluid flow so that effective rinsing of the parts of the elastomer member that have come into contact with bodily fluids (eg,

20 The inner surface of the circumferential wall 269). The circumferential wall 269 is designed to deflect from and/or reflux toward the central longitudinal axis of the tool 200 when a pressure differential is formed, (eg by introducing the leaking fluid orifice 201a) with a fracturing pressure limit Relatively low leakage as described above for the first model.

Referring to Figure 14b, in a second case, a differential pressure is formed in the split housing on suction

25 By sucking the fluid through the second orifice 202a, causing a longitudinal slit 217 to open while

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Maintain a distal edge 269a of the circumferential wall 269 in continuous contact with the inner wall 211 of the upper housing 201. On one side, the longitudinal slit is designed so that a limit value of the suction suction pressure is required to allow the passage of fluid through the longitudinal slit from the orifice The second 202a through the first hole 201a.

5 Figures 15a and 15b show a third embodiment of the shown tool 300 designed with the upper housing 201 and elastomer 210 from the second model tool 200, while an annular strut 312 with a hole 309 is designed so that it does not come into contact with the lower surface of the elastomer 210. The strut for elastomer 210 alone is provided by a lateral annular protrusion 218 and overlapping a lumen 218a as discussed above. Figure 15c shows Tool 333, which includes an adjustment

10 For the lower housing component of the Tool 300, where the 312 annular support is not entirely present, and the surface or base 302e of the lower housing 302' includes hole 302c for feeding into the second hole 302a.

Figure 16a and 16b represent a perspective and cross-sectional view with the 16b-16b sectional plane of a Model Arba 400 tool showing the implementation of a pressure-activated valve using a lock-housing assembly

15th male luer syringe The piping 401a is attached to the 401 tubing housing, which attaches to the male luer syringe housing 402. The 402 Male luer lock hub c snaps onto the lower housing 402. The functionality and operation of the 400 is similar to that described for the models previously described.

Figure 17a and 17b represent a perspective figure and a cross-sectional view with the sector plane 17b-20 17b, respectively, for a fifth model tool 500 assembled with the upper housing 201. The tool shows

500 How to integrate a pressure-activated valve directly into the axle of an angiogenic catheter 502. A 502a catheter can be a peripheral intravenous catheter, CVC, PICC, or similar.

Figure 18a and 18b represent a perspective figure and a cross-sectional view with the sectional plane 18b-18b, respectively, of a fifth model tool 600 assembled with the upper housing 201 and coupled with a

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Additional with Luer Syringe Male Tool 650. Tool 600 shows how to align a longitudinal incision 217 of the elastomer organ 210 with the 675 medical device inserted through the 602a catheter, guided by a 602e tapered internal conduit.

Figures 19a and 19b represent a perspective shape and a cross-sectional view with the sectional plane 19b-5 and 19b, respectively, of a sixth model device 700. The device 700 shows how to integrate a valve

The pressure activator of the current detection is in direct contact with the luer 701 activated valve. The pressure-activated valve assembly is attached to the injector Luer energized valve assembly at 727. The 701 Luer injector-activated valve is assembled into a 703 female Luer syringe housing and sealed inside at 728. Represents the 700 containing the syringe-activated valve

<p>10 Luer as shown is an example of a single valve, although the pressure-activated valve assembly may be integrated with any number of Luer syringe-actuated valves to support the benefits disclosed herein.</p>

It will be recognized that, although the terms I, II, ...etc. can be used in this application to describe various items, these items should not be identified by these terms.

<p>15th These terms are used only to distinguish one item from another. For example, a first item can be named a second item, and, similarly, a second item can be named a first item, without departing from the scope of the current list. As used herein, the term "and/or" includes any and all combinations of one or more of the related listed items.</p>

Relative terms such as “under,” “above,” “up,” “bottom,” “horizontal,” or 20 “arc” may be used in this application to describe the relationship of one element, one layer, or one area to another,

Another layer or another area as shown in the figures. It will be recognized that these terms are intended to include the different directions of the tool in addition to the direction shown in the figures.

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The technical terms used in this application are intended to describe specific models only and are not intended to limit the present disclosure. As used herein, single images are intended to include plural images as well, unless the context clearly indicates otherwise.

It will be further recognized that the terms “include”, “include”, “include” and/or

<p>5 “Included” when used in this application identifies the presence of distinct features, integers, steps, operations, elements, and/or components mentioned, but does not preclude the presence or addition of one or more features, integers, steps, operations, elements , components, and/or other combinations Unless otherwise defined, all terms (including technical and scientific terms) used in this application have the same meaning as they are commonly understood by an authorized person.</p>

<p>10 Ordinary skill in the art to which this present disclosure belongs. It will be further realized that it should</p>

The terms used in this application have been construed as having a meaning consistent with their meaning in the context of this specification and related art and will not be interpreted in an exemplary or exaggerated formal sense unless clearly defined in this application.

Unless otherwise expressly stated, comparative terms are meant to include quantitative

<p>15th Like "less" and "more", on the concept of equality. For example, 'less' could not only mean 'less' in the arithmetic finer, but also mean, 'less than or equal to'.</p>

The term "fluid" as used herein refers to a liquid, gas, or a combination thereof.

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