TWI603752B - Needleless access connector and method of controlling fluid - Google Patents

Description

Needle-free connector and method for controlling fluid

Field of invention

The present invention relates to needleless connectors, and more particularly to positive displacement needleless connectors having small priming volumes.

Background of the invention

Modern medical treatment often relies on medical professionals to introduce fluids into or extract fluid from patients. For example, a patient may need to rely on a medical professional to separately take urine from the urethra or to draw blood from a vein. Conversely, a medical professional may need to introduce a drug or nutrient into the patient's vein (ie, intravenously). In order to create a path for fluid to flow into or out of a patient, there is a method in which a medical practitioner needs to use a catheter, wherein one end of the catheter is inserted into the patient. The other end of the catheter is connected to the IV bag (IV bag) through an IV wire. The needle-free connector uses several valves that allow medical practitioners to remove or add devices (such as IV bags) from the catheter without using a needle. An example of a needleless connector is shown in Figures 1A and 1B.

Figure 1A is a cross-sectional view of the prior art needleless connector 100. The needleless connector 100 includes a female luer fitting 101, a male luer connector 102, and a valve 103. When used, the male Luer connector 102 series Connected to, for example, a catheter or female luer, and the female luer 101 is attached to a fluid reservoir, such as an IV bag or male luer. The female luer connector 101 is coupled to the fluid reservoir via a second male luer 106 having a hollow member (as shown in FIG. 1B) and inserted through the top of the female luer connector 101 . The insertion of the male luer 106 folds the valve 103 into the volume 104 to break the seal and create a fluid flow path. Figure 1B shows the collapsible valve 103 in the folded position after the male luer 106 is inserted into the female luer 101. The male luer 106 transfers fluid flowing around the valve 103 from, for example, an IV bag, into the passage in the male luer connector 102 and into the conduit or female luer.

A gap (or spacing, not shown) filled with air is provided in the valve 103. The needleless connector 100 is a positive displacement device such that when a new connection is made at the female luer connector 101, the device 100 pulls fluid from the male side of the valve (i.e., the side adjacent the male luer connector 102). When the disconnection is made at the female luer connector 101, the device 100 pushes in fluid from the female side (i.e., the side near the top of the female luer connector 101). An advantage of the positive displacement is that when the disconnection is generated, the device 100 removes fluid from the male luer 102 and effectively flushes the catheter. Conversely, some devices on the market today have a negative displacement such that when a male luer (e.g., male luer 106) is disconnected, the devices draw a small amount of liquid from the male luer 102 side. When the fluid is drawn from the male Luer 102 side of the catheter attached to the patient's vein, blood can be drawn into the lumen of the catheter, and if the blood remains in the lumen of the catheter, it can clot and cause health problems in the patient. . The positive displacement connector avoids this problem by pushing the fluid out when the male luer (e.g., male luer 106) is disconnected from the needleless connector and its collapsible valve is moved from its collapsed state to its unfolded state. Help prevent by fluid cleaning of the positive displacement connector Blood enters the tip of the catheter, preventing blood clots/contamination and thus preventing bloodstream infection.

In operation, when the female end of the needle-free connector 100 is accessed by a male luer (Fig. 1B), the valve 103 is sufficiently resilient to bend out of the passage to allow flow, and thereafter in the female When the end is disconnected, it returns to its original shape. Thus, the needle-free connector 100 reseas itself and forms a flat surface that can be sterilized with alcohol gauze at the top surface 110.

The needleless connector 100 has a partially annular valve body because it has a weak point on either side of the duckbill 105. The duckbill 105 promotes folding of the collapsible valve 103. In addition, the needleless connector 100 is included in the valve body, even at the duckbill 105 and around it, with a uniform wall thickness.

The needle-free connector 100 will contain some air before the needle-free connector 100 is used to connect the device to, for example, a catheter. This air is removed before the use of the needle-free connector 100 and the catheter, as otherwise the air may be inflicted into the patient and cause injury to the patient. Typically, to remove this air, the medical practitioner will invert the needleless connector and attach a syringe containing the salt to the needleless connector. The salt is then squeezed through the needleless connector to remove air from the connector (this process is called priming, and the minimum liquid required to remove all air from the needleless connector) The volume is called the priming volume). Some medical practitioners prefer a needleless connector with a small priming volume to reduce the delay in drug delivery.

After the needle-free connector is used, medical practitioners usually The female end 102 is connected to a conduit (not shown). The medical practitioner connects the male luer to the needleless connector from the IV bag (not shown). For example, a medical practitioner would connect the end of the syringe 106 to the female luer connector 101 as shown in Figure 1B.

The above discussion of the preferences of medical practitioners with needle-free connectors is significant, especially in view of the fact that some of these medical practitioners, such as nurses, must have a needle-free connector connection during the day's work. Very many facts.

Summary of invention

The present disclosure is directed to a positive displacement needleless connector having a small priming volume. One embodiment of the present invention is a foldable valve for use in a needleless connector. The collapsible valve includes a first portion having at least one smile cut, the at least one smile cut being in a section of the first portion. The collapsible valve has a length of from 0.62 to 0.82 inches. In addition, the collapsible valve is adapted to provide a positive displacement. Another embodiment of the present invention is a positive displacement needleless connector that includes a housing and a collapsible valve disposed in the housing. The collapsible valve has a length of from 0.62 to 0.82 inches. A device in accordance with an embodiment of the present invention is a positive displacement needleless connector that includes a housing and a collapsible valve disposed in the housing. The housing and the valve cooperate such that the volume of liquid required to remove air from the needleless connector is about 0.17 to 0.19 milliliters.

Another embodiment of the present invention is a positive displacement needleless connector that includes a housing and a collapsible valve disposed in the housing. A method according to an embodiment of the present invention is to use a pinless connector to be a first The medical device is coupled to a second medical device. The method includes inserting the male luer of the needleless connector into the female luer of the second medical device. The method further includes inserting a male luer portion of the first medical device into the female luer of the needleless connector. The needleless connector is a positive displacement needleless connector that includes a housing and a collapsible valve disposed in the housing. The collapsible valve has a length of from 0.62 to 0.82 inches.

The above features and technical advantages of the present invention have been fairly broadly described in order to make the details of the present invention more readily understood. Additional features and advantages of the invention will be set forth in the description of the appended claims. It will be appreciated by those skilled in the art that the concept and specific embodiments disclosed herein may be readily utilized as a basis for modification or design of other structures for the same purpose. It is also to be understood by those skilled in the art that the structure of the invention is not limited by the spirit and scope of the invention as set forth in the appended claims. These novel features which are believed to be characteristic of the present invention, such as its organization and method of operation, as well as further objects and advantages, will be readily understood from the following description and the accompanying drawings. It is to be understood, however, that the claims of the claims

100, 300‧‧‧ Needle-free connector

101‧‧‧Female Luer connector

102‧‧‧Male Luer connector

103‧‧‧Valve

104‧‧‧ volume

105‧‧‧ duckbill

106‧‧‧Gold Ruhr

110‧‧‧ top surface

200, 201, 202‧‧‧Foldable valve

200A, 202A‧‧‧ first part

200B, 201B, 202B‧‧‧ second part

200C, 202C‧‧‧ third part

200D, 202D‧‧‧ smile incision

200E, 202E‧‧‧ hole

301‧‧‧ Shell

302‧‧‧Top thread

303‧‧‧Gold Ruhr

304‧‧‧Foldable valve

304A‧‧‧ first part

304B‧‧‧ smile incision

304C‧‧‧ Part II

304D‧‧‧Part III

305‧‧‧ hole

306‧‧‧ openings

307‧‧‧ shoulder

308‧‧‧ catheter

309‧‧‧Gold Ruhr

401‧‧‧ flow channel

D1‧‧‧ diameter of the first part

D2‧‧‧ diameter of the second part

D3‧‧‧ diameter of the third part

In order to provide a more complete understanding of the present invention, the following description is incorporated by reference to the accompanying drawings, wherein: FIGS. 1A and 1B are cross-sectional views of conventional needleless connectors.

Figure 2A shows three exemplary collapsible valves used to test needleless connectors.

2B and 2C are cross-sectional and top views of different exemplary configuration valves in accordance with embodiments of the present invention.

3A and 3B illustrate different views of an exemplary needleless connector in accordance with an embodiment of the present invention.

4A and 4B are diagrams showing flow passages in an outer casing of an exemplary needleless connector in accordance with an embodiment of the present invention.

5A-5C illustrate different views of an outer casing of an exemplary needleless connector in accordance with an embodiment of the present invention.

Detailed description of the preferred embodiment

In order to solve the problem of reducing the priming volume, the present invention discloses a valve of a different configuration for a needleless connector. It has performed a number of tests to establish operability and the priming volume for each positive displacement needleless connector. The priming volume is used to purify the minimum liquid volume of the air from the needleless connector. The tests were carried out on three needleless connectors each containing a different collapsible valve. The configuration of these three different collapsible valves is shown in Figure 2A. The number and size of the duckbills can be observed, which is an important part of some collapsible valves in the prior art, and the length of the collapsible valve is reduced compared to conventional valves, which affects the needleless Pick up the priming volume of the connector.

In one of the duckbills being completely removed from the collapsible valve (valve 200), and the valve is reduced from the typical length of the conventional valve 0.92吋 to In the 0.72 测试 test, it was observed that the priming volume for this valve was lower than the other two valves - valve 201 and valve 202, the valve 201 has several small duckbill shapes, and the valve 202 has several large duckbill shapes Things. It should be noted that reducing the compression valve length from 0.92 0.7 to 0.72 吋 will allow the overall device length to be reduced from 1.32 1.1 to 1.12 吋. Some test results are shown in Table 1 below.

The results of these tests indicate that the priming volume of the needleless connector using the configuration of the valve 200 (a portion of the outer surface that is substantially annular) can have an priming volume of approximately 0.175 milliliters, with Good flow rates are tolerated, although various embodiments may have different priming volumes. For example, the priming volume can range from 0.17 to 0.19 milliliters.

Different configurations of the collapsible valve 200 can have an annular outer surface. For example, the collapsible valve 200 includes a first portion 200A, a second portion 200B, and a third portion 200C. The first portion 200A does not have a significant annular outer surface because it has a smile cut 200D interrupting the annular characteristic. Conversely, both the second portion 200B and the third portion 200C have a circumferential outer surface. Fig. 2B shows a plane x of the second portion 200B which is cut along the vertical plane y. The annular outer surface with respect to the plane y shown in Fig. 2B is circular. Figure 2C shows another possible annular outer surface. It should be noted that the axial length of the annular outer surface does not include portions of the outer surface having folding aids such as a smile cut and a duckbill. For example, the collapsible valve 201 is interrupted by the ring The duckbill on the second portion 201B of the sex has less axial length than the collapsible valve 200. The collapsible valve 202 has less axial length of the annular surface by virtue of the duckbill shape that governs the second portion 202B.

Figure 2A illustrates an exemplary embodiment of the present invention. The collapsible valves 200 to 202 can be used for microvalves in needleless connectors. The foldable valves 200 to 202 have smile cuts 200D to 202D in the first portions 200A to 202A, respectively. The collapsible valves 200-202 have an axial height of 0.72 inches, but may range from 0.62 to 0.82 inches in various embodiments. The collapsible valves 200-202 are partially adapted to provide a positive displacement by the holes 200E to 202E. The holes 200E to 202E contain air before the foldable valves 200 to 202 of the needleless connector are installed and used.

2A illustrates that in various embodiments of the invention, the annular portion of the outer surface of the collapsible valve spans from about 30% to about 66% of the total axial length of the collapsible valve. The collapsible valves 200 to 202 have a total axial length of 0.72 inches. The amount of axial length of the annular surface changes in valves 200-202 as a function of the amount and size of the folding assist structures in the valves of the valves. Each of the valves of the valves has a smile cut in the first portions 200A-202A that cause the axial length portions of the valves 200-202 to have no annular outer surface. In other words, the axial lengths of the first portions 200A through 202A do not have an annular outer surface. The first portions 200A-202A have an axial length of about 0.25 或 or about 34% of the total axial length of the valves 200-202. Therefore, due to the smile cuts 200D to 202D, at least 34% of the axial length of the valves 200 to 202 does not have an annular outer surface.

Considering valve 200, second part 200B and third part 200C There is a ring outer surface. These annular portions represent the other 66% of the axial length of the valve 200 (separate from the first portion 200A) having an annular outer surface. In particular, the second portion 200B has an axial length of about 0.4 或 or about 56% of the total axial length of the valve 200. The third portion 200C has an axial length of about 0.07 Torr or about 10% of the total axial length of the valve 200.

Because of the plurality of duckbill shapes in the second portions 201B and 202B, the collapsible valves 201 and 202 have fewer outer annular surfaces than the collapsible valve 200. Taking the collapsible valve 202 as an example, having a larger duckbill shape may result in an annular outer surface spanning about 30% of the axial length of the valve 202 (i.e., 20% from the second portion 202B, and 10%) Provided by the third portion 202C).

3A is a cross-sectional view of an exemplary needleless connector in accordance with an embodiment of the present invention. The needleless connector 300 includes a housing 301. The outer casing 301 may be a material including polycarbonate, polystyrene, and acrylonitrile butadiene styrene. The outer casing 301 includes a top threaded portion 302. It should be noted that the configuration of the top threaded portion 302 is in accordance with the ISO 594 standard in certain embodiments. Likewise, the configuration of the male luer 303 located on the base of the needleless connector 300 is in accordance with the ISO 594 standard in some embodiments. The foldable valve 304 is disposed within the outer casing 301.

The collapsible valve 304 can be made of an elastic material such as silicone, which is deformable and biocompatible. Because the collapsible valve 304 is made of a deformable material, it folds when sufficient force is applied. The collapsible valve 304 includes a first portion 304A that is disposed within the top threaded portion 302 when the valve 304 is in the folded condition as depicted in FIG. 3A. The first portion 304A can be substantially cylindrical in shape and can contain variations in the shape of the cylinder, such as a smile cut 304B. The collapsible valve 304 also includes a second portion 304C disposed in the cavity 305 of the outer casing 301. Unlike the prior art depicted in Figure 1, the second portion does not have any other variation of the duckbill or its shape, i.e., the outer surface of portion 304 is annular. Specifically, in one embodiment, the second portion 304C is cylindrical and has a larger diameter d2 than the diameter d1 of the first portion 304A. The collapsible valve 304 can also include a third portion 304D. The third portion 304D can have a larger diameter d3 than the diameter d2 of the second portion 304C.

The collapsible valve 304 controls the flow of fluid through the needleless connector 200 and thereby provides a means of connecting the device to a conduit. In its unfolded state, as shown in Fig. 3A, the collapsible valve 304 seals the top threaded portion 302. A further seal is provided on the shoulder 307 of the collapsible valve 304. When the male luer 303 is coupled to the conduit 308, a seal is created at the opening 306 and the shoulder 307, and the collapsible valve 304 also seals the conduit 308. To attach another device, such as an IV bag, to the conduit 308, the male luer 309 is inserted into the opening 306 as shown in Figure 3B. The collapsible valve 304 is folded by the force imparted by the male luer 309, and thereby allows fluid to flow from the male luer 309 through the needleless connector 300, around the valve 304 and into the conduit 308, as shown in Fig. 3B Show.

In certain embodiments of the invention, the outer casing 301 includes a flow channel 401 as shown in Figures 4A and 4B. When the collapsible valve 304 is in the collapsed state, the flow channel 401 helps fluid flow around the collapsible valve 304 and into the conduit. As indicated in FIG. 4A, the flow channel 401 can be disposed in the upper portions of the outer casing 401. Figures 4A and 4B show six flow channels 401 located inside the outer casing 301. In some embodiments, the width of the flow channel 401 is half the width of the flow channel in a typical needleless connector.

5A-5C show the appearance of an exemplary needleless connector in accordance with an embodiment of the present invention. It should be noted that the specific values given above are for exemplary embodiments and other embodiments that may have slightly different values. Other configurations having different sizes and shapes are within the scope of the embodiments. In fact, any type of positive displacement device (and/or valve) can be adapted to the concepts illustrated in the above examples.

While the invention and its advantages are described in detail, it is understood that the various modifications, alternatives, and modifications of the invention may be made without departing from the spirit and scope of the invention as defined by the appended claims. In addition, the scope of the present invention is not limited to such specific embodiments of the processes, machines, manufactures, compositions, compositions, components and steps described in the specification. Those skilled in the art will readily appreciate that the processes, machines, manufactures, compositions, components, methods, or steps disclosed herein are presently present or later developed to perform substantially the same function or the corresponding embodiments described herein. Substantially the same result, the corresponding embodiments described herein are utilized in accordance with the present invention. Accordingly, the scope of the accompanying claims is intended to be within the scope of the invention, including, for example, a process, a machine, a manufacture, a material composition, a component or a step.

Broadly speaking, this description proposes at least the following: a collapsible valve for use in a needleless connector for reducing the priming volume of a needleless connector. A needleless connector having a small priming volume. A method of connecting a first medical device and a second medical device with a needleless connector having a small priming volume.

Invention concept

The following broad inventive concepts are disclosed in this specification.

Concept 1. A needleless connector for connecting a medical device, the connector comprising: a foldable valve comprising: a first portion having at least one of the segments of the first portion a smile cut; a second portion that is foldable and provides a positive displacement; wherein the collapsible valve has an axial length from 0.62 to 0.82.

Concept 2. The connector of Concept 1, wherein the second portion has an axial length that is longer than the first portion.

Concept 3. The connector of Concept 1, wherein the second portion of the collapsible valve has an annular outer surface that spans between 30% and 66% of the axial length of the foldable valve.

Concept 4. The connector of Concept 3, wherein the annular surface is cylindrical.

The connector of any one of aspects 1 to 4, wherein the collapsible valve comprises an elastic material.

The connector of any one of the aspects 1 to 5, further comprising: a casing, wherein the collapsible valve is disposed in the casing; wherein the first portion of the collapsible valve is in the casing A mouth is created at a first opening.

Concept 7. The connector of Concept 6, wherein the housing further comprises: a male Luer connector at one end; and a female Luer connector at the other end.

Concept 8. The connector of Concept 6 or 7, wherein the foldable valve folds When stacked, the outer casing contains a plurality of channels adapted to allow fluid to flow therethrough.

The connector of any one of aspects 6-8, wherein the needleless connector has a length of 1.02 to 1.13 inches.

The connector of any one of aspects 6 to 9, wherein the outer casing and the valve cooperate to each other such that a volume of liquid required to remove air from the connector is 0.17 to 0.19 ml.

The connector of any one of aspects 6 to 10, wherein the outer casing is made of polycarbonate, polystyrene, or acrylonitrile butadiene styrene.

Concept 12. A method for connecting a first medical device to a second medical device, the method using the connector of any one of concepts 7 to 11, comprising the step of: one of the first medical devices A male luer is inserted into the female luer of the connector; and the male luer of the connector is inserted into the female luer of the second medical device.

Concept 13. The method of Concept 12, wherein the first medical device comprises an IV bag and the second medical device comprises a catheter.

300‧‧‧ Needle-free connector

301‧‧‧ Shell

302‧‧‧Top thread

303‧‧‧Gold Ruhr

304‧‧‧Foldable valve

304A‧‧‧ first part

304C‧‧‧ Part II

304D‧‧‧Part III

305‧‧‧ hole

306‧‧‧ openings

307‧‧‧ shoulder

D1‧‧‧ diameter of the first part

D2‧‧‧ diameter of the second part

D3‧‧‧ diameter of the third part

Claims (20)

A needleless connector includes: a housing and a foldable valve disposed in the housing, the foldable valve comprising: a first portion having at least one smile cut on an outer surface thereof The second axial length is coupled to the first portion, the second portion includes a second axial length, and a third portion coupled to the second portion The third portion includes a third axial length; wherein the second and third portions comprise an annular outer surface of the valve, the annular outer surfaces having a fourth axial length when joined Wherein the fourth axial length is less than the combined second axial length and the third axial length; wherein the outer casing and the foldable valve are assembled for positive displacement upon actuation. The needle-free connector of claim 1, wherein the fourth axial length is 30% to 66% of the combined first axial length, second axial length, and third axial length. The needleless connector of claim 1, wherein an outer surface of one of the second portions comprises a smile cut or a duckbill. The needleless connector of claim 1, wherein the combined first axial length, second axial length, and third axial length are between 0.62 and 0.82. The needleless connector of claim 1, wherein the first axial length is 0.22 to 0.28 。. The needleless connector of claim 1, wherein the first axial length is a combination of a first axial length, a second axial length, and a third axial length of 34%. The needleless connector of claim 1, wherein the second axial length is 56% of the length of the valve shaft. The needleless connector of claim 1, wherein the outer casing and the collapsible valve have an priming volume of 0.17 to 0.19 milliliters. The needleless connector of claim 1, wherein the outer casing and the collapsible valve have an priming volume of 0.175 milliliters. The needle-free connector of claim 1, wherein the outer casing includes passages extending along the second and third axial lengths, the passages being adapted to allow fluid to be folded when the foldable valve is folded Flow between the outer casing and the collapsible valve. The needle-free connector of claim 1, wherein the housing comprises a male connector at a first end and a female connector at a second end of the first end. A needleless connector as claimed in claim 11 wherein the male and female connectors comprise Luer connectors. The needle-free connector of claim 1, wherein: the outer casing includes an opening; the first portion includes an end portion that extends into the opening when the collapsible valve is in an unfolded state ; The end of the first portion has a first diameter; and an outer surface of the second portion has a second diameter that is greater than one of the first diameters. A method of controlling a fluid comprising the steps of: providing a needleless connector as claimed in claim 1; and actuating the valve in the housing. The method of claim 14, wherein the fourth axial length is 30% to 66% of the combined first axial length, second axial length, and third axial length. The method of claim 14 further comprising the step of providing a smile cut or duckbill on an outer surface of one of the second portions. The method of claim 14, wherein the combined first axial length, second axial length, and third axial length are between 0.62 and 0.82. The method of claim 14, wherein the first axial length is a combination of a first axial length, a second axial length, and a third axial length of 34%. The method of claim 14, wherein the outer casing and the collapsible valve have an priming volume of 0.17 to 0.19 milliliters. The method of claim 14, further comprising the step of providing a channel extending along the second and third axial lengths, the channels being adapted to allow fluid to be in the outer casing when the collapsible valve is folded Flow between the collapsible valves.