Abstract
Two embodiments of a normally closed tapered fitting valve are disclosed. Each tapered fitting valve comprises a single molded incompressible, but supple part and a skeletal support whereby the tapered fitting valve is opened by insertion into a female tapered fitting. Use of the valve specifically targets use with medical luer fittings. The preferred embodiment of an actuator portion of the valve is preferably elliptical in shape. The valve opens by compressing a slit which is disposed along a major elliptical axis as it is advanced through a tapered circular duct. A stand-alone male adapter comprising the tapered fitting valve is disclosed. Also, a syringe barrel comprising a skeletal support structure for a securely affixed valve to thereby provide a syringe barrel with an integrally affixed male adapter is disclosed.
Claims
1. A normally-closed male valve which is opened upon insertion into a tapered female fitting of circular cross section, said valve comprising: (i) a valve part comprising a) a distally disposed planar surface; b) a tapered asymmetric valve core section comprising a distal end, a proximal end and a planar slit there between; c) an extended, hollow body, comprising a comparable tapered asymmetric shape as said valve core section, proximally affixed to said proximal end of said valve core section, and d) an anchor ring integrally affixed at the proximal end of the extended body; said valve core section comprising an exterior surface which comprises the same relative circumferential dimensions as an internal surface of the tapered female fitting, when fully disposed therein, said slit having a width dimension which, when opened by radial compression of said valve core section, defines a fluid pathway of predetermined flow capacity but when closed by relaxation of uncompressed material maintains closure of said valve; and said extended body comprises an exterior surface which is increased in size to match the surface taper of the fitting cross section, when fully inserted therein; and (ii) a tapered internal support which is displaced into said hollow body to provide structural support, said support further comprising: a) an elongated stem comprising a tapered circular cross section which is displaced into said hollow body to reform the asymmetric shape of said hollow body to a conforming, close fitting, circular cross section comparable to that of the tapered fitting and further comprising a distal end structure by which fluid and fluid pressure is communicated to deter valve opening under force of upstream pressure.
2. A male valve according to claim 1 wherein said distally disposed planar surfaces fits within a circle of 0.158 inches.
3. A male valve according to claim 1 wherein said asymmetric valve core section comprises an elliptically shaped exterior surface.
4. A male valve according to claim 1 wherein said extended hollow body comprises an elliptical shape and a body wall of constant thickness.
5. A male valve according to claim 3 wherein said anchor ring is elliptically shaped with exterior dimensions which are proportional to those of said valve core section.
6. A male valve according to claim 3 wherein said elongated stem comprises distal end structure which is beveled to thereby provide a fluid pathway to gaps associated with a major axis of said elliptical shape.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0045] FIG. 1 is a perspective of a preferred embodiment of an asymmetric valve part which is compressively opened according to the instant invention, the valve part being preferably molded from incompressible, elastic material.
[0046] FIG. 1A is a perspective of another embodiment of an asymmetric valve part which is compressively opened according to the instant invention, the valve part being preferably molded from incompressible, elastic material.
[0047] FIG. 2 is a perspective of the valve part seen in FIG. 1 with shading removed for a clearer view of planes disposed to identify crosscuts of the valve part at predetermined sites.
[0048] FIG. 2A is a perspective of the valve part seen in FIG. 1A with shading removed for a clearer view of planes disposed to identify crosscuts of the valve part at predetermined sites.
[0049] FIG. 3 is a cross section of a preferred embodiment of the valve part, seen in FIG. 1, in a first radial orientation.
[0050] FIG. 3A is a cross section of the valve part seen in FIG. 3, but rotated ninety degrees about a longitudinal axis.
[0051] FIG. 3b is an elevation of the distal end of the valve part seen in FIG. 3A.
[0052] FIG. 4 is a cross section of an insertion support which is an integral part of a tapered fitting valve made according to the present invention.
[0053] FIG. 4A is an elation of the proximal face of the insertion support seen in FIG. 4.
[0054] FIG. 5 is a cross section of the insertion support seen in FIG. 4 fully inserted, in a first rotational orientation, into the valve part seen in FIG. 3.
[0055] FIG. 5A is a cross section of the inserted support and valve part combination seen in FIG. 5, but rotated ninety degrees in a second orientation about a longitudinal axis.
[0056] FIG. 5B is a cross section of the valve part, seen in FIG. 9, at a plane of intersection between the inserted support and valve part.
[0057] FIG. 5C is a magnified cross section of the circled portion of FIG. 5A.
[0058] FIG. 6 is a cross section of a valve part which is similar to the valve part seen in FIG. 3, but comprising a modified distal front end.
[0059] FIG. 6A is a cross section of the valve part seen in FIG. 6, but rotated ninety degrees about a longitudinal axis.
[0060] FIG. 6b is an elevation of the distal end of the valve part seen in FIG. 6.
[0061] FIG. 7 is a cross section of an insertion support which is an integral part of a tapered fitting valve made with the valve part seen in FIG. 6.
[0062] FIG. 7A is a cross section of tha insertion support seen in FIG. 7, but rotated ninety degrees about a longitudinal axis.
[0063] FIG. 7B is an elation of the distal face of the insertion support seen in FIG. 7.
[0064] FIG. 8 is a cross section of the valve part seen in FIG. 6 with an insertion support as seen in FIG. 7 disposed therein.
[0065] FIG. 8A is a cross section of the inserted support and valve part seen in FIG. 8, rotated ninety degrees about a longitudinal axis.
[0066] FIG. 8B is a cross section at a plane of intersection between interfacing portions of the insertion support and an asymmetric portion of the assembled valve
[0067] FIG. 9 is a cross section of an assembled tapered fitting valve, as seen in FIG. 5, inserted into a female luer fitting.
[0068] FIG. 9A is a cross section of the assembled tapered fitting valve inserted into a female luer fitting as seen in FIG. 9, but rotated ninety degrees about a longitudinal axis.
[0069] FIG. 9B is a cross section of the valve part, seen in FIG. 9, at a plane of intersection between the insertion support and valve part.
[0070] FIG. 10 is a cross section of an assembled tapered fitting valve, as seen in FIG. 6, inserted into a female luer fitting.
[0071] FIG. 10A is a cross section of the assembled tapered fitting valve inserted into a female luer fitting as seen in FIG. 10, but rotated ninety degrees about a longitudinal axis.
[0072] FIG. 10B is a cross section of the valve part, seen in FIG. 10, at a plane of intersection between the insertion support and valve part.
[0073] FIG. 11 is a cross section of a male adapter which utilizes parts of the assembled valve seen in FIG. 5.
[0074] FIG. 11A is a cross section of the male adapter seen in FIG. 19, but rotated ninety degrees about a longitudinal axis.
[0075] FIG. 12 is an exploded view of parts (with portions in cross section) which when assembled combine to provide a medical syringe with an integrally affixed male adapter.
[0076] FIG. 13 is a magnified view of a circled portion of parts seen in FIG. 12.
[0077] FIG. 14 is an exploded view of the parts seen in FIG. 21 with a first valve part affixed to a medical syringe which has an insertion support integrally molded therewith.
[0078] FIG. 14A is a magnified view of a circled portion of the parts seen in FIG. 14.
[0079] FIG. 15 is a side elevation, with portions in cross section, of a completely assembled medical syringe and integrally affixed male adapter.
[0080] FIG. 15A is a magnified view of a circled portion of the parts seen in FIG. 15.
[0081] FIG. 16 is a side elevation, with a portion in cross section, of a male adapter with a cap disposed to cover and protect an otherwise exposed portion of a male adapter.
[0082] FIG. 17 is a cross section of a cap disposed as about an exterior of a male luer lock portion of a male adapter device comprising a preferred embodiment valve part.
[0083] FIG. 18 is a cross section of a cap and a male adapter before the cap is fully engaged about a luer lock portion of the adapter.
[0084] FIG. 18A is a cross section of parts which are similar to parts seen in FIG. 18 with a cap fully engaged and affixed to the male adapter.
[0085] FIG. 18B is a frontal elevation of a cap for a plurality of male luer lock fittings such as those, for example, seen in FIGS. 17, 18 and 18A, the interior surface of the male luer lock fitting contacting portion of the cap formed as an ellipse to match a similarly shaped luer lock fitting exterior and. thereby, provide instructing orientation for affixing the cap to the luer lock fitting.
[0086] FIG. 19 is a cross section at a plane of intersection between a valve part and an insertion support of a prior first valve part as disclosed in Thorne 343.
[0087] FIG. 19A is a schematic of the prior first valve part seen in FIG. 17 after being inserted into and compressed by a female luer fitting.
DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS
[0088] While the instant inventions disclosed herein are applicable to a wide variety of tapered male/female insertion type fluid connectors, the detailed description provided herein is focused upon examples of medical devices. Reference is now made to the embodiments illustrated in FIGS. 1-19B wherein like numerals are used to designate like parts throughout and primes of numbers generally indicate parts which are similar in shape and/or function of those numbers, but not exactly the same.
Valve Part 10 (Preferred Embodiment)
[0089] Reference is now made to FIGS. 1 and 2 wherein an asymmetric valve part 10 is seen. As seen in FIG. 1, valve part 10 comprises two sections, an asymmetric, tapered body 20 and a proximally disposed asymmetric anchor ring 30.
[0090] As seen in FIG. 2, at a distal end 35, a first reference orthogonal plane 40 is disposed to provide a cross reference definition. A second reference orthogonal dissecting plane 50 is disposed proximally from plane 50 to provide a second plane of definition. Plane 40 is disposed to define a distal end of a valve core 100 (details of which are not seen in FIG. 2, but seen in FIGS. 3 and 3A). Valve core 100 comprises a slit valve 102 formed by a planar slit 104 which is opened by radial compression of a planar slit 110.
[0091] Plane 50, as seen in FIGS. 3 and 3A, is disposed at the proximal end of valve core 100. Body 20, being elliptical in this example, is seen to be smaller in cross section in FIG. 3, which depicts a view about the minor axis 120 of the ellipse, than in FIG. 3A which depicts a view about the major axis 130 of the aforementioned ellipse. Each axis varies in length along a horizontal axis of part 10 as defined by taper of a fitting into which part 10 is displaced to open valve 102.
[0092] As seen in FIG. 3A, valve core 100 comprises a pair of beveled edges, commonly numbered 132, proximally disposed relative to plane 40. It should be noted, as seen in FIG. 3, that valve core 100 comprises a pair of sharp edges 134. The purposes for contour of edges 132 and 134 are explained in detail hereafter. As seen in FIG. 3, slit 110 forms a pair of lips 136 and 138.
[0093] Valve core 100 and body 20 combine to form a blind hole 140 which is also elliptically dimensioned as seen in FIGS. 3, 3A and 3B. Radial dimensions of hole 140 is defined by an exterior surface 150 of body 20, an interior surface 152 and at wall thickness 154. Exterior surface 150 is dimensioned to have a comparable circumference to the tapered fitting into which part 10 is inserted along the entire length of insertion. Wall thickness 154 is constant, the measurement of which is determined by dimensional limitations of the selected tapered fitting, as disclosed in detail hereafter.
Valve Insert Support 200
[0094] A valve insert support 200 is seen in FIGS. 4 and 4A. Support 200 basically has three functions. First, support 200 provides a fluid communicating through flow pathway 210 for fluid communication to valve core 100 once support 200 is inserted into valve part 10. Second, support 200, once inserted, provides physical support for valve part 10 when both part 10 and support 200 are further inserted into the associated fitting. As valve part 10 is generally made from material which is subject to deformation such support is required. Third, support 200 comprises an insertion stem 212, which comprises an elongated circular structure 214 which is sized and shaped to reform that portion 220 of body 20 (see FIGS. 3 and 3A) into which stem 212 is inserted from elliptical to circular (i.e. to match structure of a female tapered fitting). Valve support 200 has yet one other very important function. At a distal end 222, where valve support 200 interfaces with valve core 100, valve stem 212 comprises a beveled end 224, which provides a reduction in stress about surface 152 where stem 212 and valve core 100 merge.
Valve Assembly 300
[0095] Reference is now made to FIGS. 5 and 5A wherein an assembled valve 300 is seen. Insertion of support 200 transforms a surrounding body portion 220 of valve part 10 from an elliptical to a circular cross section. Support stem 212 is sized to engage the inner surface 152 of body portion 220 in a fluid tight relationship, as seen in FIGS. 5 and 5A.
[0096] When so assembled and not inserted into a tapered fitting which opens valve 100 by radially directed ellipse deformation, valve part 10 must remain closed to fluid flow in both directions. When upstream pressure is less than ambient surrounding pressure, valve 100 performs as a conventional duckbill valve, remaining closed due to externally existing atmospheric pressure.
[0097] When upstream pressure is greater than ambient, it is well understood by those skilled in fluid dynamics that body portion 220 could expand and such expansion could part lips 136 and 138 with resultant valve opening. It should be noted that insertion of stem 212 into body 20 should result in a very tight fit about the minor elliptical axis 112 of body 20 as seen in FIG. 5.
[0098] Such is not the case about the major elliptical axis 120 near valve 100. As seen in FIG. 5A, insertion of stem 212 into body portion 220 also reforms wall 154 to be circular in cross section. However, the length of the major axis of the ellipse is greater than the diameter of the stem at the interface between valve 100 and stem 212. The result is a pair of open gaps 320 and 320, seen in FIG. 5A and better seen by magnification in FIG. 5C. By providing a fluid communicating pathway into gaps 320 and 320, body 20 tends to expand about major elliptical axis 120. Such expansion tightens the fit about minor axis 112 (see FIG. 5) while such expansion lengthens body 20 along major axis 120 (see FIG. 3A) and thereby tightens contact between lips 136 and 138 acting to keep valve 100 closed.
[0099] To provide a fluid pathway which communicates fluid and associated pressure via hole 124 to gaps 320 and 320, a pattern of grooves, generally numbered 330, are disposed in the proximal surface portion 322 of valve 100, as seen in FIG. 5B. Note that groove pattern 330 (seen in FIGS. 3, 5 and 5B) is disposed to communicate with pathway 210 (denoted by dashed lines in FIG. 5B). the location of which is defined by a dashed line circle 332.
Valve Part 10
[0100] Reference is now made to FIGS. 1A and 2A wherein an asymmetric valve part 10 is seen. Valve part 10 comprises three general sections, a distal insertion end and transition zone 340, an elliptically shaped body 20 and an anchor ring 30.
[0101] As seen in FIG. 2A, a first reference orthogonally dissecting plane 40 is disposed proximally from zone 340. A second reference dissecting plane 50 is disposed proximally from plane 40. Plane 40 is proximally disposed relative to section 340 at a site which defines a proximal end 342 of a transition section 350 between end 342 which is the distal end of a valve 100 (not seen in FIG. 2A, but seen in FIGS. 6 and 6A).
[0102] Distal portions of a slit 104 which cleaves through end 342 and valve core 100 (to form a pair of lips 136 and 138 as seen in FIG. 6) is seen to extend on opposite sides of a blind hole 352 which is circular at end 360, see FIG. 2A, and diminishes linearly to closure along slit 104 at plane 40 between lips 136 and 138, as seen in FIG. 6. Plane 50 is disposed to reference the proximal end 122 of valve 100, which is also the proximal end of two back-to-back slit (duckbill valves), numbered 362 and 362 as seen in FIGS. 6 and 6A.
[0103] Generally, the proximal exterior surface 150 of valve core body 20 is shaped to form an ellipse which is tapered proximally to conform with the 3 taper of a luer fitting. Because end 360 is circular, section 340 (see FIG. 2A) provides a linear transition from a circle to the shape of the ellipse of the rest of body 20 of part 10, while keeping cross sectional surface circumference of section 340 equal to an inner surface circumference of a corresponding surface of a female luer fitting into which part 10 is fully inserted. From plane 40, to the proximal end 364 of part 10, the exterior surface 150 of body 20, as disclosed supra, is elliptical and conforms to a 3 taper. Such a smooth contour is uniquely different than embodiments of similar valves disclosed in U.S. patent applications from which this application continues. Other marked differences are two blind slits, numbered 370 and 372, also disposed in valve core 100.
[0104] A blind, tapered hole 140 which opens through proximal end 374 ends at valve core 100, as seen in FIGS. 6 and 6A. Blind hole 140 is sized to be proportionally smaller than surface 150 to provide a constant wall thickness 154 along the length of blind hole 140 through body 20. The elliptical shape of hole 140 is maintained in proximal end anchor ring 30, as seen in FIGS. 6 and 6A.
[0105] Distal portions of slit 104 which cleaves through valve core 100 (to form lips 136 and 138) is seen to extend on opposite sides of a blind hole 352 which is circular at end 360, see FIGS. 2A and 6B, and diminishes linearly to closure at slit 104 at plane 40 between lips 136 and 138, as seen in FIGS. 6 and 6A. Form and structure at end 360 is seen in FIG. 6B. Blind hole 352 is terminated at Plane 40 along slit 104. Plane 50 is disposed to reference the proximal end 354 of valve core 100.
Valve Insert Support 200
[0106] A valve insert support 200 is seen in FIGS. 7. 7A and 7B. Support 200 basically has the same three functions as support 200, but relative to part 10, disclosed supra. Repeating, first, support 200 provides a fluid communicating through pathway 210 for fluid communication to valve core 100 once support 200 is inserted into valve part 10. Second, support 200, once inserted, provides physical support for valve part 10 when both part 10 and support 200 are further inserted into an associated tapered fitting. As valve part 10 is generally made from material which is subject to deformation such support is required. Third, support 200 comprises an insertion stem 212, which comprises an elongated circular structure 214 which is sized and shaped to reform that portion 220 of body 20 (see FIGS. 6 and 6A) into which stem 212 is inserted from elliptical to circular (i.e. to match structure of a female tapered fitting). Valve support 200 has yet one other very important function. At a distal end 222 (see FIG. 4), where valve support 200 interfaces with valve core 100, valve stem 212 comprises a beveled end 224, which provides a reduction in stress about surface 152 where stem 212 and valve core 100 merge and an open notch 361 thereat, which is also seen in FIG. 7B.
Valve Assembly 300
[0107] Reference is now made to FIGS. 8 and 8A wherein an assembled valve 300 is seen. Insertion of support 200 transforms a surrounding body portion 220 of valve part 10 from an elliptical to a circular cross section. Support stem 212 is sized to engage the inner surface 152 in a fluid tight relationship, as seen in FIGS. 8 and 8A.
[0108] When so assembled and not inserted into a tapered fitting which opens valve 100 by radially outward directed deformation, valve part 10 must remain closed to fluid flow in both directions. When upstream pressure is less than ambient surrounding pressure, valve 100 performs as a conventional duckbill valve, remaining closed due to externally existing atmospheric pressure.
[0109] When upstream pressure is greater than ambient, it is well understood by those skilled in fluid dynamics that body portion 220 could expand and such expansion could part lips 136 and 138 with resultant valve opening. It should be noted that insertion of stem 212 into body 20 should result in a very tight fit about the minor elliptical axis 112 of body 20 as seen in FIGS. 8 and 8A. In the case of assembled valve 300, the tight fit operates to displace blind slits 362 and 372 (see FIG. 8B) to an open state creating blind cavities 376 and 378 as seen in FIG. 8.
[0110] As seen in FIGS. 7 and 7A, stem 212 comprises open end notch 361 which permits fluid and fluid pressure to communicate with cavities 376 and 378. Such communication of fluid pressure places the same pressure about lips 136 and 138 resulting in no additional valve opening forces.
Inserting Valves 300 and 300 into a Female Luer Fitting
[0111] Reference is now made to FIGS. 9, 9A and 9B wherein a valve 300, as an example, is disposed within a female luer fitting 400. It should be noted that support 200 should be constrained to remain within valve part 10. However, in FIGS. 9 and 9A constraining members are not shown to reduce complicating structures and permit a clearer presentation of valve 300 performance within a female luer fitting. Examples of devices, each employing valve 300 and a constrained support 200, are provided hereafter.
[0112] Fitting 400 is a conventional tapered luer fitting having a circular cross section. As shown in FIGS. 9 and 9A, fitting 400 compresses valve core 100 to open a through hole (which is then a continuation of pathway 210 and, therefore, given the same number. A fluid tight fit is assured by constructing each linear circumferential segment of valve 300 to have the same circumference as the corresponding inner surface 402 of fitting 400. Exemplary geometry of pathway 210 which is opened between lips 136 and 138 is seen in FIG. 9B. Note, that associated parting of lips 136 and 138 also displaces groove pattern 330 away from pathway 210. Assurance of opening of pathway 210 thereat is provided by a medially disposed slit 110.
[0113] Evidence of lack of enablement of fittings disclosed in prior U.S. patent applications from which this U.S. patent application continues-in-part is provided in FIGS. 19 and 19A. FIG. 19 discloses a proximal end 500 of a valve core 510, similar in desired operation to valve core 100 of the present invention. However, the prior applications taught a molded cavity 520 disposed to provide fluid pressure upon a slit, numbered 530 in this example. It was anticipated that cavity 520 would close upon radially directed compression occurring when disposed in a female luer fitting. But is was discovered that, rather than being compressively closed, structure 532 about cavity 520 was distorted as seen, by example, in FIG. 19A. Such distortion effectively kept slit 530 from opening.
[0114] As seen in FIGS. 10, 10A and 10B, a valve 300 is inserted into female luer fitting 400. Note, in FIGS. 10A and 10B, that slits 362 and 372 are closed. Flow path 210 is extended by parting lips 136 and 138.
Critical Dimensions of Valve Part 10 (and 10)
[0115] Dimensions of major and minor axes of part 10 ellipse are dependent upon the diameter of a fluid pathway 210 formed by radial compression when part 10 is inserted into a conventional luer fitting 400 (see FIGS. 9 and 9A). As an example, if a fluid pathway 210 has a predetermined diameter and the distance along lips 136 and 138 (valve length) is of the order of 0.110 inches. In the case of part 10, transition section 340 (see FIG. 2A) transition length may be 0.050 inches, although not of consideration in this example. With the aforementioned dimensions, the following calculated parameters (in inches) of part 10 apply:
TABLE-US-00001 For a.050 For a 0.60 Item dia. hole dia. hole Valve length 0.110 0.110 Total body 20 length 0.400 0.400 Calculated slit 110 width 0.079 0.094 Slit width extended for open orifice 0.083 0.099 anomalies Stem pathway 210 hole diameter 0.050 0.060 Support stem 212 dist end diameter 0.109 0.109 Support stem 212 distal end wall thickness 0.030 0.025 Support stem 212 bevel radius 0.025 0.025 Major (A) axis (at plane 40-with extended 0.196 0.201 slit) Minor (B) axis (at plane 40-with extended 0.109 0.099 slit) Ellipse A axis (at plane 50-with extended 0.207 0.213 slit) Ellipse B axis (at plane 50-with extended 0.119 0.109 slit) Ellipse A axis (at proximal end of body 20) 0.251 0.257 Ellipse B axis (at proximal end of body 20) 0.161 0.151
[0116] Calculations of A and B axes are made at reference plane 50 as follows:
half axis b=ILFRHR
B axis2*b
half axis a=Sqrt(2*HR.sup.2b.sup.2)
A axis=2*a
Where:
[0117] A is major ellipse axis and a is major half axis
[0118] B is minor ellipse axis and b is minor half axis [0119] Note: A and B axes are thus calculated to provide a circumference equal to the internal circumference of a female luer fitting at a site at which part 10 is fully inserted. In other words, the female luer diameter which correlates to plane 50 is 0.176 inches with a circumference of 0.552 inches; the female luer diameter which correlates to plane 60 is 0.193 inches with a circumference of 0.605. inches.
[0120] ILFR is internal luer fitting at reference plane radius
[0121] SL is actual slit length
[0122] HR is desired pathway 210 hole radius
[0123] Sqrt is square root
[0124] As mentioned supra, slit 104 width can be calculated as one-half pi times desired hole diameter, but a differential circumference from that calculated for a circular hole resulting from shape variations at slit 110 ends suggests an small increase to slit length be added. In the calculations above, a five percent increase to calculated slit length has been added.
[0125] An additional calculation to assure meeting pathway 210 desired orifice size of the above listed parameters (i.e. ellipse area against area of fitting at a common plane shows the following:
TABLE-US-00002 Area (at plane 40) 0.0187 0.0184 Percent less than area of fitting at plane 5 7 Area (at plane 50) 0.0213 0.210 Percent less than area of fitting at plane 5 6 Area (at proximal end of body 20) 0.0337 0.333 Percent less than area of fitting at plane 4 5
Thus, with the parameters provided supra, a larger pathway 210 cross section can be generated than hole size specified.
[0126] As mentioned supra, one of the critical issues associated with luer fitting design according to the present invention is meeting ISO standards. For this reason, distal end 35 must be consistent with a limited circular orifice and, therefore, limited to a circular insertion diameter of 0.158 inches. Therefore edges 132 and 134 see FIG. 3A) to meet ISO standards.
Male Adapter 600 Utilizing Elements of Valve Assembly 300 (i.e. Valve Part 10 and a Stem 212)
[0127] An exemplary male adapter 600 which employs inventive elements of valve assembly 300 (see FIGS. 8 and 8A) is seen two rotational modes in FIGS. 11 and 11A. Adapter 600 comprises a valve part 10, a female luer fitting 610 which comprises an integrally molded stem 212 and a male luer lock fitting 620. Fittings 610 and 620 are joined along a common interface 640 by compression, adhesion, welding or threading (all commonly used in medical device construction) to capture anchor ring 30 (see FIG. 2). As such adapter 600 meets or exceeds all requirements for a self-closing fitting for medical applications.
Syringe Application for Valve Part 10
[0128] A syringe system 700 which employs a valve part 10 (and assembly 300) in place of a conventional male luer fitting is seen in various stages of assembly in FIGS. 12-15A. As seen in exploded format in FIG. 12, syringe system 700 comprises a conventional medical syringe 710 which is modified for interface with a valve part 10 and a retaining ring 720.
[0129] As seen in magnified circled reproduction 730 of a portion 740 of syringe 710, syringe 710 comprises an integrally molded stem 212 in place of a conventional male luer. Valve part 10 is affixed about stem 212 as seen in FIGS. 14 and 14A. As a final assembly step, retaining ring 720 is affixed to provide compressive, secure engagement as seen in FIGS. 15 and 15A.
Caps
[0130] A variety of caps which can be used to protect a fitting made according to the present invention are seen in FIGS. 15-18B. As seen in FIG. 26, a simple conventional female luer cap 800 can also be used. However, such a cap must grip body 20 (or 20) at a site which maintains valve part 10 in an open state.
[0131] Cap 810, seen in FIG. 17) comprises internal structure 812 which is sized and shaped to compress valve lips 136 and 138 closed. For cap 810 and another cap 820 (disclosed hereafter) to be safely and efficaciously used, exterior wall 814 of associated luer fitting 816 must be formed to radially orient caps 810 and 820. An example, of such is seen in FIG. 18B where wall 814 is seen to be asymmetric (e.g. elliptical).
[0132] The cap 820 which is designed to maintain closure pressure upon a thinned or minor axis portion of valve core 100 is seen in FIGS. 18 and 18A. Cap 820 is made from a substantially incompressible yet flexible material. As seen in FIG. 18, cap 820 comprises a pair of internally disposed leaflets 822 and 822. As cap 820 is disposed about a male luer lock fitting 816, leaflets 822 and 822 are forced inward by collision with distal structure 824 of the male luer fitting 816 to engage and apply pressure upon valve core 100 as seen in FIG. 18A. Note in FIG. 18A, a pair of flanges 826 and 828 are added to cap 820 to facilitate engagement with and removal from fitting 816. As mentioned supra, for cap 820 to be used, proper orientation is necessary.
[0133] Inventions disclosed herein may be embodied in other specific forms without departing from the spirit or essential characteristics thereof. The present embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the inventions being indicated by the appended claims rather than by the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein.
