Luer connector, syringe cap, intravenous catheter, medical syringe and component for vascular access system

Abstract

The application relates to a Luer connector, a syringe cap, an intravenous catheter, a medical syringe and a component for a vascular access system. A medical device incorporates a four-lead threaded male or female luer connector, also referred to as a four-start threaded luer connector. The luer connector includes an integrally molded polymeric tubular body having inner and outer wall circumferential surfaces and a four-lead helical thread formed on one of the wall circumferential surfaces. The helical threads circumscribe nested, concentrically aligned, frustoconical, luer tapered mating surfaces. The four-lead threaded configuration reduces the axial cross-sectional area of each thread compared to a conventional two-lead threaded Luer connector, which facilitates more uniform mold filling and cooling, more uniform finished products and material savings when injection-molding medical devices.

Description

Technical Field

[0001] The present disclosure generally relates to medical devices incorporating threaded Luer connectors. More specifically, the present disclosure relates to medical devices with male or female Luer connectors having four leads (also known as four-start helical thread patterns). Background Art

[0002] A Luer connector is a connecting collar that is a standard way to attach medical devices such as syringes, catheters, hubbed needles, IV tubes, etc. to each other. A Luer connector consists of a male and female interlocking tube that tapers slightly to better hold together, even if it is just a simple press / twist fit. Some Luer connector embodiments include an additional threaded outer rim, allowing them to be more securely connected to a mating threaded connector (sometimes called a locking Luer connector or Luer lock connector, or simply a Luer lock). The Luer connector male end is typically incorporated into the distal end of the syringe and can be interlocked and connected to the female end located on a vascular access device (VAD) (e.g., an intravenous catheter or hub), or to a needle hub. Syringe caps with female Luer connectors are often used to seal syringes by connecting to the male Luer connector of the syringe to maintain sterility and prevent fluid leakage. Typically, Luer connectors and related medical devices are manufactured by injection molding of plastic polymers.

[0003] ISO 80369-7:2016 defines the specifications of a standard Luer connector including a 6% taper between the distal and proximal ends. The male standard Luer connector increases from the distal open end to the proximal end. The female standard Luer connector decreases from the proximal open end to the distal end. According to ISO 80369-7:2016, the outer cross-sectional diameter of the male standard Luer connector measured from 0.75mm at the distal end of the tip is between 3.970mm and 4.072mm. The length of the male standard Luer taper is between 7.500mm and 10.500mm. The outer cross-sectional diameter measured from 7.500mm at the distal end of the tip is between 4.376mm and 4.476mm. As used herein, the phrases "male standard Luer connector" and "female standard Luer connector" shall refer to connectors having the dimensions described in ISO 80369-7, which is incorporated herein by reference as a whole.

[0004] Male or female Luer lock connectors conforming to ISO 80369-7 have a helical thread with alternating ribs and grooves with a two-start or two-lead trapezoidal profile. The relevant ISO specifications for Luer taper diameter and thread rib outer diameter require relatively thick tubular wall construction, which complicates the injection molding of medical devices incorporating Luer connectors. Typically, thicker wall constructions of injection molded plastic parts require longer mold injection and cooling times. During injection molding of the connector, local variations in radial thickness of known Luer lock connectors further exacerbate variations in molten plastic flow and subsequent cooling due to large dimensional variations between thread ribs and grooves along the axial length of the connector. A particular location of concern for Luer connectors is the uniformity of the tapered Luer engagement surface. Local flow and cooling variations during the injection molding process may result in higher rejection rates for final molded Luer components that do not meet dimensional quality standards. Local variations in Luer component wall thickness are more apparent in the following description of known medical devices incorporating ISO-compliant Luer connectors.

[0005] FIG. 1 depicts a known syringe 20 with a male syringe Luer lock connector 22 conforming to ISO 80369-7 and a known matching syringe cap 24 with a similarly conforming female Luer lock connector. The known syringe cap 24 is shown in FIGS. 2-4 and is marketed under the registered trademark The syringe cap 24 has an integrally molded polymer tubular body 26 having a distal end 28 and a proximal end 30. An annular gripping surface 32 is bonded to the distal end 28 and extends axially to a hub portion 33. The hub portion 33 traverses the interior of the tubular body 26, which isolates the gripping surface 32 from a female Luer lock connector 34 extending axially to the proximal end 30 of the tubular body 26. The annular gripping surface 32 defines circumferential walls of respective inner circumferential walls 36 and outer circumferential walls 38 and a localized gripping wall thickness t therebetween. G Circumferentially oriented gripping tabs 40 extend radially and axially from the outer circumferential wall 38 .

[0006] In the known syringe cap 24, the female Luer lock connector 34 defines respective inner and outer circumferential walls 42, 44 defining a varying local wall thickness therebetween; wherein the two wall thicknesses are shown as t C1 and t C2 The outer circumferential wall 44 of the Luer lock connector 34 defines a two-pitch or two-start helical external thread 46, which is shown as 46 in FIG. LT1 and 46 LT2The external threads 46 each include a first side portion 48 and a second side portion 50, a bridging crown 52, and a root 54. The root 54 and the first side portion 48 and the second side portion 50 define a spiral groove 56, while the crown 52 and the first side portion and the second side portion define a spiral rib 58. The spiral groove 56 and the spiral rib 58 have a trapezoidal axial cross-sectional profile. Figures 2 and 3 show various sizes of the Luer connector 34. Major diameter D MAJ Corresponding to the spiral rib height / thread depth 60 at the thread crown 52, the minor diameter D MIN Corresponds to the diameter of the outer circumferential wall 44. The root width 62, crown width 64, thread angle 66, helix angle α and pitch P1 are indicated by dimension arrows. The thread lead is defined as the pitch P1 multiplied by the number of thread starts (the syringe cap 24 has two thread starts).

[0007] As shown in FIG. 3 , the inner circumferential wall 42 of the Luer connector 34 forms the circumferential surface of the female Luer mating cavity 68. The hub 33 forms a closed axial distal end 70 of the female Luer mating cavity 68. The proximal open end 71 of the female Luer mating cavity 68 communicates with the proximal end 30 of the tubular body 26. The axial length L of the cavity 68 is measured between its axial distal end 70 and its axial open end 71. The hub 33 includes a molding gate 72 with a distal end 74 that protrudes toward the axial distal end 28 of the tubular body 26.

[0008] The syringe cap 24 is typically injection molded in a mold whose cavity conforms to the outer surface contour of the tubular body 26 of the cap. The molten plastic is introduced into the mold through the area of ​​the mold that forms the distal end 74 of the molding gate 72, and radially expands into the area that forms the hub 33. Thereafter, the molten plastic travels axially and radially along the annular portion of the mold that forms the gripping surface 32 and the female Luer lock 34. The radial thickness of the annular gripping surface portion 32 of the cap 24 is relatively uniform and is less than the radial thickness of the corresponding Luer connector portion 34, which is the thickness measured between the inner circumferential surface 42 and the outer circumferential surface 44 of the corresponding Luer connector portion plus the additional thickness and material volume occupied by the ribs 58 of the two helical threads 46. The annular gripping surface portion 32 of the cap 24 cools faster than the corresponding Luer connector portion 34; therefore, the Luer connector portion 34 requires additional cooling time.

[0009] Table 1 details selected typical axial cross-sectional dimensions, in millimeters and degrees, of the luer connector portion 34 of the known syringe cap 24. The manufacturing tolerances for these specific dimensions of this known syringe cap 24 vary by approximately + / - 0.07 mm.

[0010] Table 1

[0011]

[0012] The relatively large axial cross-sectional area of ​​each spiral rib 58 is about 0.79 mm 2 , and the total axial cross-sectional area of ​​all about five spiral ribs represents about 16.6% of the comparable total axial cross-sectional area of ​​the entire tubular wall of the Luer connector 34. The different tubular and spiral rib thicknesses within the Luer connector 34 increase the risk of discontinuities and uneven surface contours of the female Luer mating cavity 68 during injection molding of the syringe cap 24. Summary of the invention

[0013] The medical device incorporates a four-lead threaded Luer connector (also known as a four-start threaded Luer connector). The axial cross-sectional area of ​​these four-start / lead threaded Luer connectors is significantly smaller than the axial cross-sectional area of ​​known Luer connectors that comply with ISO80369-7. The Luer connector of the present disclosure includes an integrally molded polymer tubular body having an inner wall circumferential surface and an outer wall circumferential surface and a four-lead helical thread formed on one of the wall circumferential surfaces. The helical thread circumscribes nested, concentrically aligned, frustoconical, Luer-tapered mating surfaces. Compared to conventional two-lead threaded Luer connectors, the four-lead thread configuration reduces the axial cross-sectional area of ​​each thread, which contributes to more uniform mold filling and cooling when injection molding medical devices, more uniform finished products (especially along the mating Luer surface of the connector), and material savings. Some medical device embodiments of the present disclosure (e.g., syringe caps and intravenous catheters) incorporate a four-lead threaded female Luer connector. Other embodiments of the present disclosure (e.g., syringes) incorporate a male Luer connector.

[0014] The lead thread with four starts significantly reduces the cross-sectional area of ​​each individual helical thread and also reduces the overall average wall thickness of the Luer connector, which contributes to more consistent molding quality of injection molded parts. The thinner cross-sectional threads provide an excellent fluid seal between mating male and female Luer connectors because there are twice as many abutting sealing surfaces in the Luer connector of the present disclosure as compared to known two-start helical thread Luer connectors.

[0015] One aspect of the present disclosure is directed to a Luer connector comprising an integrally molded polymer tubular body having inner and outer wall circumferential surfaces and a four-lead helical thread formed on one of the wall circumferential surfaces, the helical thread circumscribing nested, concentrically aligned, frusto-conical, Luer-tapered mating surfaces.

[0016] Another aspect of the present disclosure relates to a component for a vascular access system, the component including an integrally molded polymer body forming a female Luer connector defining an axial centerline. The connector has an inner wall circumferential surface and an outer wall circumferential surface concentric with the axial centerline, which define the connector wall thickness therebetween relative to the axial centerline. The connector has a four-lead male external helical thread on the outer wall circumferential surface. Each helical thread has a corresponding local axial cross-section around the outer wall. The helical threads circumscribe nested, concentrically aligned, frustoconical, Luer-tapered female mating surfaces formed in the inner wall circumferential surface. In some embodiments, the total local cross-sectional area of ​​all threads aligned along any axial cross-section along the axial centerline of the connector is less than twelve percent (12%) of the corresponding local axial cross-sectional area of ​​the connector wall. One or more aspects include a patient vascular port.

[0017] Yet another aspect of the present disclosure relates to a syringe cap incorporating an integrally molded polymer tubular body defining an axial centerline. The tubular body incorporates an annular bite surface on an axial distal end and a female Luer connector on a proximal end. Relative to the axial centerline of the tubular body, the corresponding inner wall circumferential surface and outer wall circumferential surface of the bite surface define a bite wall thickness, and the corresponding inner wall circumferential surface and outer wall circumferential surface of the female Luer connector define a connector wall thickness therebetween. The outer wall circumferential surface of the female Luer connector defines a four-pitch male external helical thread. Each helical thread has a corresponding local axial cross-section around the outer wall. A female mating surface of a coaxially aligned, frustoconical, Luer-conical shape is formed in the inner wall circumferential surface of the female Luer connector, nested with the helical thread. The total local cross-sectional area of ​​all threads aligned along any axial cross-section along the axial centerline of the connector is less than twelve percent (12%) of the corresponding local axial cross-sectional area of ​​the connector wall.

[0018] In one aspect, a Luer connector includes an integrally molded polymer tubular body having inner and outer wall circumferential surfaces and a four-lead helical thread formed on one of the wall circumferential surfaces, the helical thread circumscribing nested, concentrically aligned, frusto-conical, Luer-tapered mating surfaces.

[0019] In one aspect, the Luer connector further comprises a female Luer connector, the four-lead helical threads formed on the outer wall circumferential surface and the tubular body circumscribing a nested, concentrically aligned, frusto-conical, Luer-tapered female mating surface formed in the inner wall circumferential surface.

[0020] In one aspect, the syringe cap incorporates a Luer connector.

[0021] In one aspect, the intravenous catheter incorporates a Luer connector.

[0022] In one aspect, the Luer connector further comprises a male Luer connector, the four-lead helical threads formed on the inner wall circumferential surface of the tubular body circumscribing a nested, concentrically aligned, frustoconical, Luer-tapered male mating surface formed on the first axial end of the tubular body.

[0023] In one aspect, a medical syringe incorporates a Luer connector.

[0024] In one aspect, a component for a vascular access system, the component comprising an integrally molded polymer body forming a female Luer connector defining an axial centerline, the connector having an inner wall circumferential surface and an outer wall circumferential surface concentric with the axial centerline, defining a connector wall thickness relative to the axial centerline between the inner wall circumferential surface and the outer wall circumferential surface; four-lead male external helical threads on the outer wall circumferential surface, each helical thread having a corresponding local axial cross-section about the outer wall, the helical threads circumscribing nested, concentrically aligned, frustoconical, Luer-tapered, female mating surfaces formed in the inner wall circumferential surface; and wherein the total local cross-sectional area of ​​all threads aligned along any axial cross-section along the axial centerline of the connector is twelve percent less than the corresponding local axial cross-sectional area of ​​the connector wall.

[0025] In one aspect, the components further include a syringe cap.

[0026] In one aspect, the component further comprises: each of the four-lead male external helical threads has the following local dimensions relative to the axial centerline, in millimeters and degrees:

[0027] 11.98 degree helix angle;

[0028] 46 degree thread angle;

[0029] 0.43 thread depth;

[0030] 0.53 root axial width;

[0031] 0.37 crown axial width;

[0032] A thread lead of 5.08; and

[0033] 1.27 thread pitch.

[0034] In one aspect, the component further comprises a patient vascular port.

[0035] In one aspect, a syringe cap comprises:

[0036] an integrally molded polymeric tubular body defining an axial centerline, the tubular body incorporating an annular gripping surface on an axial distal end thereof and incorporating a female Luer connector on a proximal end of the tubular body;

[0037] The respective inner and outer circumferential surfaces of the annular gripping surface define a gripping wall thickness therebetween relative to the axial centerline, and the respective inner and outer circumferential surfaces of the female Luer connector define a connector wall thickness therebetween relative to the axial centerline;

[0038] four-lead male external helical threads on a circumferential surface of the outer wall of the female Luer connector, each helical thread having a respective partial axial cross-section around the outer wall; and

[0039] a frusto-conical, Luer-tapered female mating surface formed in the inner wall circumferential surface of the female Luer connector nesting with and coaxially aligned with the helical threads;

[0040] Wherein a total local cross-sectional area of ​​all threads aligned along any axial cross-section along the axial centerline of the connector is less than twelve percent (12%) of a corresponding local axial cross-sectional area of ​​the connector wall.

[0041] In one aspect, the syringe cap further comprises: each of the four-lead male external helical threads has the following local dimensions relative to the axial centerline, in millimeters and degrees:

[0042] 11.98 degree helix angle;

[0043] 46 degree thread angle;

[0044] 0.43 thread depth;

[0045] 0.53 root axial width;

[0046] 0.37 crown axial width;

[0047] A thread lead of 5.08; and

[0048] 1.27 thread pitch. BRIEF DESCRIPTION OF THE DRAWINGS

[0049] Exemplary embodiments of the present disclosure are further described in the following detailed description in conjunction with the accompanying drawings, in which:

[0050] FIG. 1 is an isometric view of one embodiment of a prior art medical syringe and a prior art syringe cap, each with mating two-lead threads of respective male and female Luer connectors;

[0051] FIG. 2 is a front view of the prior art syringe cap of FIG. 2 ;

[0052] FIG3 is an axial cross-sectional view of the prior art syringe cap of FIG2;

[0053] FIG4 is an isometric view of the Luer connector of the prior art syringe cap of FIG2, showing the two-lead helical threads thereof;

[0054] Figure 5 is a front view of a syringe cap incorporating a four-lead helical threaded Luer connector of the present disclosure;

[0055] Figure 6 yes Figure 5 An axial cross-sectional view of a syringe cap;

[0056] Figure 7 yes Figure 5 An isometric view of the Luer connector of a syringe cap showing its four-lead helical threads;

[0057] Figure 8 is a partial axial cross-sectional view of a syringe with a male Luer lock incorporating a four-lead helical threaded Luer connector of the present disclosure; and

[0058] Fig. 9 is an isometric view of an intravenous catheter incorporating a four-lead helical threaded female Luer connector of the present disclosure.

[0059] To facilitate understanding, identical reference numerals have been used, where possible, to designate identical elements that are common to the figures. The figures are not drawn to scale. DETAILED DESCRIPTION

[0060] The medical device incorporates a four-lead threaded Luer connector (also known as a four-start threaded Luer connector). The Luer connector includes an integrally molded polymer tubular body having an inner wall circumferential surface and an outer wall circumferential surface and a four-lead helical thread formed on one of the wall circumferential surfaces. The helical thread circumscribes nested, concentrically aligned, frustoconical, Luer-tapered mating surfaces. Compared to conventional two-lead threaded Luer connectors, the four-lead thread configuration reduces the axial cross-sectional area of ​​each thread, which contributes to more uniform mold filling and cooling, more uniform finished products and material savings when injection molding the medical device. Some embodiments of the medical device (e.g., syringes) incorporate a four-lead threaded male Luer connector. Other embodiments of the medical device (e.g., syringe caps and intravenous catheters and hubs) incorporate a four-lead threaded female Luer connector.

[0061] In this disclosure, where generally applicable, the convention is generally followed where the distal end of the device is the end closest to the patient and the proximal end of the device is the end away from the patient and closest to the clinician or other physician. However, for better understanding of the context in this disclosure, the outwardly facing axial end of the Luer connector is sometimes explicitly referred to as the "distal end of the Luer connector" that is intended to be paired with a complementary Luer connector (e.g., male to female or female to male). As used herein, the use of "a", "an", and "the" includes both the singular and the plural.

[0062] As previously mentioned, the term "Luer connector" refers to a connecting collar that is a standard way to attach syringes, catheters, collared needles, IV tubing, etc. to each other. Also as previously mentioned, ISO 80369-7:2016 defines the specifications for standard Luer connectors. The phrases "male Luer connector," "female Luer connector," "male standard Luer connector," "female standard Luer connector," "male Luer lock connector," and "female Luer lock connector" shall refer to connectors having the dimensions described in ISO 80369-7, which is incorporated herein by reference in its entirety.

[0063] As will be readily appreciated by those skilled in the relevant art, although descriptive terms such as "tip," "hub," "thread," "protrusion / insert," "tongue," "slope," "wall," "top," "side," "bottom," and other terms (as applicable) are used throughout this specification to facilitate understanding, they are not intended to limit any components that may be used in combination or alone or to require specific spatial orientations to implement the various aspects of the embodiments of the present disclosure.

[0064] Before describing several exemplary embodiments of the present disclosure, it should be understood that the present disclosure is not limited to the details of construction or process steps set forth in the following description. The present disclosure is capable of other embodiments or can be practiced or implemented in many ways. For example, where the Luer connector disclosed herein has a first mating accessory portion and a second mating accessory portion shown in one configuration (e.g., a mating male connection and a female connection), in other embodiments, the positions and orientations of the mating accessory portions are reversed.

[0065] The contents of the examples in this specification are provided to help fully understand the exemplary embodiments of the present disclosure. Therefore, those of ordinary skill in the art will recognize that various changes and modifications may be made to the embodiments described herein without departing from the scope and spirit of the present disclosure. Moreover, for the sake of clarity and brevity, descriptions of well-known functions and configurations are omitted.

[0066] Overall reference Figure 5-Figure 7, a first embodiment of a Luer connector is a female Luer lock connector incorporated into a syringe cap 124. The syringe cap 124 has an integrally molded polymer tubular body 126 having a distal end 128 and a proximal end 130. An annular biting surface 132 is incorporated on the distal end 128 and extends axially to a hub portion 133. The hub portion 133 traverses the interior of the tubular body 126, which isolates the biting surface 132 from a female Luer lock connector 134 extending axially to the proximal end 130 of the tubular body 126. The annular biting surface 132 defines respective inner circumferential walls 136 and outer circumferential walls 138 and a localized biting wall thickness t therebetween. G Circumferentially oriented gripping tabs 140 extend radially and axially from the outer circumferential wall 138 .

[0067] In the syringe cap 124, the female Luer lock connector 134 defines respective inner and outer circumferential walls 142, 144 defining varying local wall thicknesses therebetween; wherein the two wall thicknesses are shown as t C1 and t C2 The outer circumferential wall 144 of the Luer lock connector 134 defines a four-pitch or four-start thread helical external thread 146, which is Figure 7 is shown as 146 LT1 , 146 LT2 , 146 LT3 and 146 LT4 . Four external threads 146 start from the axial proximal end 130 of the syringe cap 124 and are arranged circumferentially in a clock-like manner at a 90-degree angle. Compared with a two-start thread Luer lock, the four-start threads arranged in a clock-like manner at 90 degrees are more easily engaged with a mating male Luer lock component. Each of the individual spiral threads 146 includes a first side portion 148 and a second side portion 150, a bridging crown 152 and a root 154. The root 154 and the first side portion 148 and the second side portion 150 define a spiral groove 156, while the crown 152 and the first side portion and the second side portion define a spiral rib 158. The spiral groove 156 and the spiral rib 158 have a trapezoidal axial cross-sectional profile. Figure 5 and Figure 6 Various sizes of Luer connectors 134 are shown. Major diameter D MAJ Corresponding to the spiral rib height / thread depth 160 at the thread crown 152, the minor diameter D MIN Corresponds to the diameter of the outer circumferential wall 144. The root width 162, crown width 164, thread angle 166, helix angle α and pitch P2 are indicated by dimension arrows. The thread lead is defined as the pitch P2 multiplied by the number of thread starts (the syringe cap 224 has four thread starts).

[0068] like Figure 6As shown, the inner circumferential wall 142 of the Luer connector 134 forms the circumferential surface of the female Luer mating cavity 168. The hub 133 forms a closed axial distal end 170 of the female Luer mating cavity 168. The proximal open end 171 of the female Luer mating cavity 168 communicates with the proximal end 130 of the tubular body 126. The axial length L of the cavity 168 is measured between its axial distal end 170 and its axial open end 171. The hub 133 includes a molding gate 172 with a distal end 174 that protrudes toward the axial distal end 128 of the tubular body 126.

[0069] The syringe cap 124 is typically injection molded in a mold whose cavity conforms to the outer surface contour of the tubular body 126 of the cap. The molten plastic is introduced into the mold through the area of ​​the mold that forms the distal end 174 of the molding gate 172, and radially expands into the area that forms the hub 33. Thereafter, the molten plastic travels axially and radially along the annular portion of the mold that forms the gripping surface 132 and the female Luer lock 134. The radial thickness of the annular gripping surface portion 132 of the cap 24 is relatively uniform and less than the radial thickness of the corresponding Luer connector portion 134, which is the additional volume occupied by the ribs 158 of the four helical threads 146 between the inner circumferential surface 142 and the outer circumferential surface 144 of the Luer connector portion. However, as described below, the pitch P2 of the four-start thread is half the pitch of the similar two-thread start cap 24 of FIG. 3, and both cap designs have a common thread lead size. This results in a significantly smaller axial cross-sectional area for each threaded rib 158 compared to the axial cross-sectional area of ​​the known two-thread start cap 24. Although the annular gripping surface portion 132 of the cap 124 cools faster than the corresponding Luer connector portion 134, the smaller axial cross-sectional area of ​​each threaded rib 158 compared to the axial cross-sectional area of ​​the Luer connector portion 34 of the known syringe cap 24 of FIGS. 1-4 reduces the overall cooling time and increases mold filling efficiency.

[0070] When the syringe cap 124 is coupled to the corresponding syringe male Luer lock, the first threaded side portion 148 and the second threaded side portion 150 of the cap abut against the corresponding side portion of the male Luer lock in a sealing engagement, which prevents fluid from leaking from the syringe. Doubling the pitch P2 of the four-thread starting point, the syringe cap 124 doubles the number of the first threaded side portion 148 and the second threaded side portion 150 of the cap 124 compared to the known cap 24, which further reduces the possibility of fluid leaking from the syringe.

[0071] Table 2 details the local dimensions, including selected typical axial cross-sectional dimensions, in millimeters and angles, of the Luer connector portion 134 of the syringe cap 124. The manufacturing tolerances for these specified dimensions vary by approximately + / - 0.07 mm. The pitch P2 thread crown width 164 of the syringe cap 124 is different from that of the known syringe cap 24, but the remaining dimensions are the same and conform to the existing ISO 80369-7:2016 standard.

[0072] Table 2

[0073]

[0074] Compared to the size of the known two-start thread syringe cap 24, the relatively small axial cross-sectional area of ​​each spiral rib 158 of the four-start thread syringe cap 124 of the present disclosure is approximately 0.24 mm 2 The ratio (R) / (W) of the total axial cross-sectional area (R) of all about ten spiral ribs 158 to the similar total axial cross-sectional area (W) of the entire tubular wall of the Luer connector 134 is about 11%. A similar dimension of the syringe cap 24 is about 0.79 mm 2 axial cross-sectional area, and 16.6% of the total axial cross-sectional area of ​​its entire tubular wall. Therefore, the four-start threaded syringe cap 124 of the present disclosure reduces the axial cross-sectional area of ​​each spiral rib 158 by approximately 66% compared to the axial cross-sectional area of ​​the spiral rib 58 of the known two-start syringe cap 24. The syringe cap 124 also reduces the (R) / (W) ratio of the total axial cross-sectional area of ​​the spiral rib 158 to the total axial cross-sectional area of ​​the entire tubular wall of the Luer connector 134 to 11%, compared to the 16.6% (R) / (W) ratio of the known syringe cap 24: the material volume ratio is reduced by approximately 33%.

[0075] In a computational mold flow analysis comparison of a known syringe cap 24 and the syringe cap 124 of the present disclosure, during an injection molding simulation, the cap 124 exhibited more uniform local temperatures of the injected plastic and cooled more quickly than the known cap 24. Based on past manufacturing experience, greater uniformity of local temperatures within the mold and faster cooling times increase the overall uniform quality of the injection molded parts and reduce the number of parts that are scrapped due to failure to meet manufacturing specifications. The reduction in the axial cross-sectional area of ​​each spiral rib 158 of the syringe cap 124 of the present disclosure also reduces the volume of plastic material required to manufacture the part, which contributes to lower manufacturing costs and lower environmental impacts associated with the production and disposal of used plastic caps.

[0076] Figure 8A male Luer lock embodiment of a Luer connector of the present disclosure is shown incorporated within a syringe 220. The male Luer lock 222 has an integrally molded polymer tubular body 226 with an axial proximal end 228, an axial distal end 230, an inner circumferential wall 242, and an outer circumferential wall 244. Four-start internal helical threads 246 are formed in the inner circumferential wall 242; they circumscribe a tubular male Luer mating surface 248. A syringe lumen 250 and a syringe outlet 252 are formed within the tubular male Luer mating surface 248.

[0077] Fig. 9 An intravenous (IV) catheter 320 is shown incorporating a female Luer lock connector 324 of the present disclosure. The Luer connector 324 has a tubular body 326, the proximal end 328 of which incorporates a female Luer lock cavity 368. The female Luer lock cavity 368 is circumscribed by a four-start helical thread 346 that defines ribs and grooves as described with respect to the syringe cap 134. The axial distal end 330 of the tubular body 326 is coupled to a flexible cannula 350. Details of the trocar are not shown.

[0078] In various embodiments, the cap 124, syringe male Luer lock 222, IV catheter 320, and other medical devices including the four-start Luer connector of the present disclosure are constructed of any of a variety of types of plastic materials, such as polycarbonate, polypropylene, polyethylene, glycol-modified polyethylene terephthalate, acrylonitrile-butadiene-styrene, or any other injection moldable medical grade plastic material for medical devices.

[0079] Various aspects of the present disclosure include a patient vascular port.

[0080] References throughout the specification to "one embodiment," "certain embodiments," "various embodiments," "one or more embodiments," or "an embodiment" mean that a particular feature, structure, material, or characteristic described in conjunction with the embodiment is included in at least one embodiment of the present disclosure. Thus, the appearance of phrases such as "in one or more embodiments," "in certain embodiments," "in various embodiments," "in one embodiment," or "in an embodiment" in various places throughout the specification are not necessarily referring to the same embodiment of the present disclosure. Furthermore, the particular features, structures, materials, or characteristics may be combined in any suitable manner in one or more embodiments.

[0081] Although the disclosure herein has been described with reference to specific embodiments, it should be understood that these embodiments are merely illustrations of the principles and applications of the present disclosure. It will be apparent to those skilled in the art that various modifications and variations may be made to the present disclosure without departing from the spirit or scope of the present disclosure. Therefore, the present disclosure is intended to include modifications and variations within the scope of the appended claims and their equivalents.

Claims

1. A Luer connector, characterized in that: The Luer connector includes an integrally molded polymer tubular body having inner and outer wall circumferential surfaces and a four-lead helical thread formed on one of the wall circumferential surfaces, the helical thread circumscribing nested, concentrically aligned, frusto-conical, Luer-tapered mating surfaces.

2. The Luer connector according to claim 1, characterized in that Further comprising a female Luer connector, the four-lead helical threads formed on the outer wall circumferential surface and the tubular body circumscribing a nested, concentrically aligned, frusto-conical, Luer-tapered female mating surface formed in the inner wall circumferential surface.

3. The Luer connector according to claim 1, characterized in that: Further comprising a male Luer connector, the four-lead helical threads formed on the inner wall circumferential surface of the tubular body circumscribing a nested, concentrically aligned, frustoconical, Luer-tapered male mating surface formed on the first axial end of the tubular body.

4. A syringe cap, characterized in that: The syringe cap incorporates the Luer connector of claim 2.

5. An intravenous catheter, characterized in that: The intravenous catheter incorporates a Luer connector according to claim 2.

6. A medical syringe, characterized in that: The medical syringe incorporates the Luer connector according to claim 5.

7. A component for a vascular access system, characterized in that: The component includes an integrally molded polymer body forming a female Luer connector defining an axial centerline, the connector having an inner wall circumferential surface and an outer wall circumferential surface concentric with the axial centerline, defining a connector wall thickness relative to the axial centerline between the inner wall circumferential surface and the outer wall circumferential surface; four-lead male external helical threads on the outer wall circumferential surface, each helical thread having a corresponding local axial cross-section about the outer wall, the helical threads circumscribing nested, concentrically aligned, frustoconical, Luer-tapered, female mating surfaces formed in the inner wall circumferential surface; and wherein the total local cross-sectional area of ​​all threads aligned along any axial cross-section of the axial centerline of the connector is less than 12% of the corresponding local axial cross-sectional area of ​​the connector wall.

8. The component according to claim 7, characterized in that Further included is a syringe cap.

9. The component according to claim 8, characterized in that Further including: Each of the four-lead male external helical threads has the following local dimensions relative to the axial centerline, in millimeters and degrees: 11.98 degree helix angle; 46 degree thread angle; 0.43 thread depth; 0.53 root axial width; 0.37 crown axial width; A thread lead of 5.08; and 1.27 thread pitch.

10. The component according to claim 7, characterized in that A patient vascular port is further included.

11. A syringe cap, characterized in that: The syringe cap comprises: an integrally molded polymeric tubular body defining an axial centerline, the tubular body incorporating an annular gripping surface on an axial distal end thereof and incorporating a female Luer connector on a proximal end of the tubular body; The respective inner and outer circumferential surfaces of the annular gripping surface define a gripping wall thickness therebetween relative to the axial centerline, and the respective inner and outer circumferential surfaces of the female Luer connector define a connector wall thickness therebetween relative to the axial centerline; four-lead male external helical threads on a circumferential surface of the outer wall of the female Luer connector, each helical thread having a respective partial axial cross-section around the outer wall; and a frusto-conical, Luer-tapered female mating surface formed in the inner wall circumferential surface of the female Luer connector nesting with and coaxially aligned with the helical threads; wherein a total local cross-sectional area of ​​all threads aligned along any axial cross-section of the axial centerline of the connector is less than 12% of a corresponding local axial cross-sectional area of ​​the connector wall.

12. The syringe cap according to claim 11, characterized in that Further including: Each of the four-lead male external helical threads has the following local dimensions relative to the axial centerline, in millimeters and degrees: 11.98 degree helix angle; 46 degree thread angle; 0.43 thread depth; 0.53 root axial width; 0.37 crown axial width; A thread lead of 5.08; and 1.27 thread pitch.

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