WO1997038744A1 - Point d'injection sans aiguille - Google Patents

Point d'injection sans aiguille Download PDF

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Publication number
WO1997038744A1
WO1997038744A1 PCT/US1996/005383 US9605383W WO9738744A1 WO 1997038744 A1 WO1997038744 A1 WO 1997038744A1 US 9605383 W US9605383 W US 9605383W WO 9738744 A1 WO9738744 A1 WO 9738744A1
Authority
WO
WIPO (PCT)
Prior art keywords
injection site
proximal end
housing
adapter
aperture
Prior art date
Application number
PCT/US1996/005383
Other languages
English (en)
Inventor
Bruno Franz P. Mayer
Original Assignee
Critical Device Corporation
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Critical Device Corporation filed Critical Critical Device Corporation
Priority to AU55550/96A priority Critical patent/AU5555096A/en
Priority to PCT/US1996/005383 priority patent/WO1997038744A1/fr
Publication of WO1997038744A1 publication Critical patent/WO1997038744A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites

Definitions

  • the present application is a continuation-in-part of United States Application Serial No. 08/262,994 entitled NEEDLELESS INJECTION SITE filed June 20, 1994, the disclosure of which is expressly incorporated herein by reference.
  • the present invention relates generally to the medical arts, and more particularly to a needleless injection site for use in relation to intravenous infusions.
  • an injection site is fluidly coupled within the tubing intermediate the introducer needle and the solution bag.
  • the injection site typically has a Y-shaped configuration and comprises a tubular main body portion having a tubular side arm portion in fluid communication therewith.
  • the distal end of the side arm portion is fluidly connected to the solution bag via an upper segment of the tubing, with the bottom end of the main body portion being fluidly connected to the introducer needle via a lower segment of the tubing.
  • the top end of the main body portion is itself covered by a diaphragm which is typically fabricated from rubber or a similar resilient material.
  • injection site within the tubing allows various medications to be selectively infused into the blood vessel of the patient by the addition thereof to the solution flowing from the solution bag into the blood vessel via the upper tubing segment, injection site, lower tubing segment nd introducer needle.
  • This supplemental infusion is typically accomplished through the utilization of a conventional syringe, the needle of which pierces and is extended through the diaphragm disposed on the top end of the main body portion of the injection site.
  • the needle is retracted out of the main body portion of the injection site, with the aperture created in the diaphragm due to the passage of the needle therethrough being substantially closed upon such retraction due to the resiliency of the diaphragm.
  • the incorporation of the injection site within the tubing allows various medications to be intravenously administered to the patient through the existing infusion site within the blood vessel, thus eliminating the need to subject the patient to additional needle sticks.
  • the injection sites constructed in accordance with the prior art possess certain deficiencies which detract from their overall utility.
  • the use of such injection sites typically requires that the needle of the conventional syringe be extended through (i.e., puncture) the diaphragm attached to the top end of the main body portion of the injection site.
  • the necessity of having to utilize a syringe with a needle to facilitate the introduction of the medication into the solution flow is undesirable due to the risk of inadvertent needle sticks.
  • needleless injection sites which incorporate a diaphragm adapted to assume open and closed configurations without having a needle inserted thereinto.
  • a needleless injection site comprising a housing which defines an interior chamber and a central opening which communicates with the interior chamber.
  • a housing which defines an interior chamber and a central opening which communicates with the interior chamber.
  • the housing further defines an elongate, proximally extending dilator projection portion which is coaxially aligned with the central opening, and an elongate, distally extending adapter portion.
  • the dilator projection and adapter portions define a continuous fluid passage.
  • the needleless injection site further comprises a reseal member which is disposed within the central opening and the interior chamber of the housing.
  • the reseal member includes an elastically openable and closable aperture formed therein, and normally resides in the first position within the housing wherein the aperture is in a closed configuration.
  • the dilator projection portion of the housing extends into the reseal member.
  • the reseal member is deformable such that the application of distally directed pressure thereto will cause the reseal member to distally advance within the housing to a second position wherein the aperture assumes an open configuration and communicates with the fluid passage.
  • the reseal member comprises an elongate, resilient body defining a distal end, a proximal end having inner and outer surfaces, and an aperture extending between the inner and outer surfaces of the proximal end.
  • Partially encapsulated within the body is a radial leaf spring defining a base portion and a plurality of leaf portions. The leaf portions are adapted to apply a radially inward biasing force to the proximal end of the body which maintains the aperture in the closed configuration when no distally directed pressure is applied to the outer surface of the proximal end.
  • the body and radial leaf spring define a bore which extends longitudinally from the distal end of the body to the inner surface of the proximal end.
  • the dilator projection portion of the housing is received into the bore, with the application of distally directed pressure to the outer surface of the proximal end causing the radial leaf spring to be distally advanced over the dilator projection portion.
  • the resultant outward flexion of the leaf portions facilitates the radial expansion of the aperture to the open configuration.
  • the removal of the distally directed pressure from the outer surface causes the radial leaf spring to be proximally withdrawn from over the dilator projection portion, thus facilitating the return of the aperture to the closed configuration.
  • the body portion of the reseal member is preferably fabricated from silicone and comprises a generally frusto-conical proximal portion defining the proximal end and a generally cylindrical distal portion defining the distal end. Formed between the proximal and distal portions is a beveled shoulder. The diameter of the distal portion preferably exceeds the maximum diameter of the proximal portion.
  • the body of the reseal member includes a lip which is formed about and extends radially outward from the proximal end thereof, and has a diameter which slightly exceeds the diameter of the central opening of the housing.
  • the outer surface of the proximal end of the body is preferably arcuately contoured, with the inner surface of the proximal end having a generally semi-spherical configuration.
  • the aperture extends axially between the arcuately outer surface and the apex of the semi-spherical inner surface.
  • the inner surface of the proximal end may further include a duck-bill style check valve formed at the apex thereof, with the aperture extending through the check valve.
  • both the shoulder and the distal end of the body are abutted against the housing in a manner wherein a slight compression force is applied to the distal portion.
  • the body further defines an annular flange which is disposed within the bore of the reseal member and abutted against the dilator projection portion when the same is extended into the bore.
  • the adapter portion of the housing may comprise an elongate spike having a tapered outer surface and a beveled distal tip.
  • Slidably extensible and frictionally maintainable on the spike is a tubular adapter sleeve which has a tapered outer surface and a tapered bore extending longitudinally therethrough.
  • the tapered bore is complimentary to the outer surface of the spike for facilitating the frictional retention of the adapter sleeve thereon.
  • the spike further includes an elongate rib formed on the outer surface thereof, with the bore of the adapter sleeve defining at least one elongate slot therewithin which is sized and configured to receive the rib when the adapter member is slidably advanced over the spike. The receipt of the rib into the slot is operable to prevent the rotation of the adapter sleeve upon the spike.
  • the housing may further define a distal lock region for facilitating the connection of the housing to an annular, externally threaded surface.
  • the lock region may define a plurality of Luer thread pitch barbs therewithin.
  • the adapter portion of the housing may alternatively define a tapered outer surface with a blunt distal tip, with the distal lock region of the housing circumventing the adapter portion and comprising an internally threaded lock member which is rotatably connected to the adapter portion.
  • the housing comprises an upper section defining the central opening and a lower section attached to the upper section, with the upper and lower sections defining the interior chamber when attached to each other.
  • the housing constructed in accordance with the first embodiment comprises an adapter member which includes a flange portion having the dilator projection portion extending proximally from one side thereof and the adapter portion extending distally from the other side thereof.
  • the flange portion of the adapter member is captured between the upper and lower sections of the housing, with at least a portion of the adapter member residing within the interior chamber of the housing.
  • the adapter portion preferably has a tapered outer surface and a beveled distal tip, with the lower section of the housing defining the distal lock region for facilitating the connection of the housing to an annular, externally threaded surface.
  • the housing comprises an upper section which defines the central opening and a lower section which is attached to the upper section and defines the dilator projection portion and the adapter portion.
  • the upper and lower sections define the interior chamber when attached to each other.
  • the adapter portion of the lower section may comprise a spike having a tapered outer surface and a beveled distal tip.
  • the adapter portion may have a tapered outer surface, with the lower section further defining the distal lock region which circumvents the adapter portion for facilitating the connection of the housing to an annular, externally threaded surface.
  • a method of fabricating a reseal member comprising the step of advancing a radial leaf spring having a base portion and a plurality of leaf portions over a core which is sized to cause the leaf portions be flexed outwardly when the radial leaf spring is advanced thereover.
  • the preferred method further comprises the steps of molding a body about the radial leaf spring and core in a manner wherein the radial leaf spring is partially encapsulated by the body, and removing the core from within the radial leaf spring and body.
  • the molded body defines a distal end, a proximal end having inner and outer surfaces, and an aperture extending through the proximal end between the inner and outer surfaces thereof.
  • the removal of the core from within the radial leaf spring and body facilitates the formation of a bore which extends longitudinally from the distal end to the inner surface of the proximal end. Such removal also allows the leaf portions of the radial leaf spring to return to an unflexed orientation which results in the application of a radially inward biasing force to the proximal end for maintaining the aperture in a closed configuration.
  • Figure 1 is a side elevational view of a needleless injection site constructed in accordance with a first embodiment of the present invention, further illustrating an introducer device which may be used in conjunction therewith;
  • Figure 2 is a top perspective view of a radial leaf spring incorporated into a reseal member of the needleless injection site shown in Figure 1;
  • Figure 3 is a side elevational view of the radial leaf spring shown in Figure 2;
  • Figure 4 is a partial cross-sectional view illustrating the preferred manner of forming the reseal member;
  • Figure 5 is a partial cross-sectional view illustrating an alternative method of forming a portion of the reseal member;
  • Figure 6 is a cross-sectional view of the reseal member
  • Figure 7 is a partial top perspective view of the reseal member
  • Figure 8 is a cross-sectional view taken along line 8-8 of Figure 6;
  • Figure 9 is a cross-sectional view of the needleless injection site shown in Figure 1, illustrating the reseal member thereof in a first, closed position;
  • Figure 10 is a cross-sectional view of the needleless injection site shown in Figure 1, illustrating the reseal member thereof as deformed into a second, open position;
  • Figure 10a is a cross-sectional view of an adapter sleeve which may be used with the needleless injection site shown in Figures 1, 9 and 10; and Figure 11 is a cross-sectional view of a needleless injection site constructed in accordance with a second embodiment of the present invention.
  • Figure 1 illustrates a needleless injection site 10 constructed in accordance with a first embodiment of the present invention.
  • medications are typically introduced into the injection site 10 via a needleless introducer device 12 such as a syringe which includes a reduced diameter tip
  • the injection site 10 comprises a hollow housing 16.
  • the housing 16 itself comprises an upper section 18 which defines a reduced diameter proximal portion 20 having Luer threads 22 formed on the outer surface thereof.
  • the housing 16 comprises a sleeve ⁇ like lower section 24 which is insertible into and attachable to the upper section 18.
  • the upper and lower sections 18, 24, when attached to each other, define an interior chamber 26 of the housing 16, with the proximal half of the interior chamber being defined by the upper section 18, and the distal half of the interior chamber 26 being defined by the lower section 24.
  • the proximal portion 20 of the upper section 18 defines a tapered central opening 28 which communicates with the interior chamber 26, and in particular the proximal half thereof.
  • the locking tabs 30 are formed in a manner wherein the pitch barbs 32 are oriented radially inward from and extend in generally parallel relation to the inner surface of the lower section 24. The use of the locking tabs 30 and associated pitch barbs 32 will be discussed in more detail below.
  • the housing 16 comprises an adapter member 34 which includes a central, circularly configured flange portion 36. Extending proximally from the flange portion 36 is an elongate dilator projection portion 38 which is coaxially aligned with the central opening 28 of the upper section 18. Extending distally from the flange portion 36 is an elongate adapter portion 40 which is itself coaxially aligned with the dilator projection portion 38.
  • the adapter portion 40 has a tapered outer surface and includes a beveled distal end which defines a piercing tip 42.
  • the dilator projection and adapter portions 38, 40 define a continuous fluid passage 44.
  • the adapter member 34 is attached to the remainder of the housing 16 via the rigid capture of the peripheral region of the flange portion 36 between the upper and lower sections 18, 24.
  • the housing 16 may further comprise a tubular adapter sleeve 46 which is selectively attachable to the adapter portion 40 of the adapter member 34.
  • the adapter sleeve 46 has a tapered outer surface 48 and includes a tapered bore 50 extending longitudinally therethrough which is complimentary to the tapered outer surface of the adapter portion 40.
  • Disposed within the side wall of the bore 50 are a plurality of equidistantly spaced slots 52 which extend longitudinally from the end of the adapter sleeve 46 of greater diameter to a depth which is approximately one-fourth the total length of the adapter sleeve 46.
  • the adapter sleeve 46 In attaching the adapter sleeve 46 to the remainder of the housing 16, the same is slidably advanced over the adapter portion 40. Since the outer surface of the adapter portion 40 and the bore 50 of the adapter sleeve 46 have mutually tapered configurations, the adapter sleeve 46 is frictionally maintained on the adapter portion 40 subsequent to being slidably advanced thereover.
  • Each of the slots 52 of the adapter sleeve 46 is sized and configured to slidably receive an elongate rib 54 which is formed on the outer surface of the adapter portion 40 and extends longitudinally from the flange portion 36 along approximately one-third of the length of the adapter portion 40.
  • the advancement of the adapter sleeve 46 over the adapter portion 40 is terminated when the rib 54 is fully received into a respective slot 52.
  • the receipt of the rib 54 into a respective slot 52 prevents any rotation of the adapter sleeve 46 upon the adapter portion 40.
  • the end of the adapter sleeve 46 opposite that including the slots 52 has a blunt configuration.
  • the injection site 10 constructed in accordance with the first embodiment of the present invention further comprises a reseal member 56 which is disposed within the central opening 28 and interior chamber 26 of the housing 16.
  • the reseal member 56 comprises an elongate, resilient body 58 having a generally frusto-conical proximal portion 60 which defines a proximal end 62, and a generally cylindrical distal portion 64 which defines a distal end 66.
  • a beveled shoulder 68 Formed between the proximal and distal portions 60, 64 is a beveled shoulder 68. The diameter of the distal portion 64 exceeds the maximum diameter of the proximal portion 60.
  • the proximal portion 60 resides within the central opening 28, with the distal portion 64 and shoulder 68 residing within the interior chamber 26.
  • the proximal end 62 of the body 58 defines an arcuately contoured outer surface 70 and a generally semi-spherical inner surface 72. Extending axially through the proximal end 62 from the outer surface 70 to the apex of the inner surface 72 is an aperture 74. Additionally, formed about and extending radially outward from the proximal end 62 is a continuous lip 76 having a diameter which slightly exceeds the diameter of the central opening 28.
  • the body 58 is preferably fabricated from silicone, though the same may alternatively be fabricated from a similar resilient material such as rubber.
  • the reseal member 56 further comprises a radial leaf spring 78 which is partially encapsulated within the body 58.
  • the radial leaf spring 78 comprises a beveled base portion 80 having three (3) identically configured, equidistantly spaced leaf portions 82 extending therefrom.
  • the leaf portions 82 are separated from each other by three (3) longitudinally extending slots 84 which extend into the base portion 80.
  • the radial leaf spring 78 is partially encapsulated within the body 58 in a manner wherein the proximal portion 60 of the body 58 extends along the outer surfaces of the leaf portions 82, with the inner surface 72 of the proximal end 62 bulging inwardly into the opening defined by the ends of the leaf portions 82.
  • the base portion 80 extends through the distal portion 64 of the body 58, with the peripheral region of the base portion 80 extending radially outward from the outer surface of the distal portion 64 adjacent the shoulder 68.
  • the reseal member 56 further includes a bore 86 which is defined by the body 58 and radial leaf spring 78, and extends longitudinally from the distal end 66 to the inner surface 72 of the proximal end 62.
  • the body 58 defines an annular flange 88 which is formed within the bore 86 in close proximity to the leaf portions 82 of the radial leaf spring 78.
  • formed in the inner surfaces of the leaf portions 82 adjacent the ends thereof are grooves 90.
  • the radial leaf spring 78 is encapsulated within the body 58 in a manner wherein portions of the proximal end 62, and in particular the inner surface 72 thereof, are received into the grooves 90.
  • the radial leaf spring 78 is preferably fabricated from polysulfone or polycarbonate, though similar rigid materials with memory may be utilized as an alternative.
  • the aperture 74 extending through the proximal end 62 is elastically openable and closeable.
  • the reseal member 56 normally resides in a first position within the housing 16 (shown in Figure 9) wherein the aperture 74 is in a closed configuration, and is deformable such that the application of distally directed pressure thereto will cause the reseal member 56 to distally advance within the housing 16 to a second position (shown in Figure 10) wherein the aperture 74 assumes an open configuration and communicates with the fluid passage 44 of the adapter member 34.
  • the removal of the distally directed pressure from the reseal member 56 will cause the same to resiliently return to the first position wherein the aperture 74 reassumes the closed configuration.
  • the dilator projection portion 38 of the adapter member 34 is fully extended into the bore 86 of the reseal member 56, with the proximal end of the dilator projection portion 38 extending to approximately the leaf portions 82 of the radial leaf spring 78.
  • the annular flange 88 formed within the bore 86 is abutted against the outer surface of the dilator projection portion 38 in close proximity to the proximal end thereof.
  • the outer surface 70 of the proximal end 62 is substantially flush with the rim of the proximal portion 20 of the upper section 18, with the peripheral edge of the lip 76 formed about the proximal end 62 being abutted against the side wall of the central opening 28.
  • the beveled shoulder 68 of the body 58 is abutted against a complimentary beveled ramp 92 which defines the transition between the central opening 28 and interior chamber 26 of the housing 16, with the distal end 66 of the body 58 being abutted against the flange portion 36 of the adapter member 34.
  • the distance separating the ramp 92 from the flange portion 36 of the adapter member 34 slightly exceeds the length of the body 58 excluding the proximal portion 60 thereof.
  • the distal portion 64 of the body 56 is slightly compressed between the ramp 92 and flange portion 36, thus applying a pre-load thereto which causes the same to bulge slightly outwardly as shown in Figure 9.
  • the leaf portions 82 of the radial leaf spring 78 apply a radially inward biasing force to the proximal end 62 of the body 58 which maintains the aperture 74 in the closed configuration.
  • the application of the radially inward biasing force is assisted by the abutment of the ramp 92 against the shoulder 68 of the body 58 which also applies a radially inward force to the leaf portions 82.
  • the application of distally directed pressure to the outer surface 70 of the proximal end 62 by the tip 14 of the introducer device 12 causes the radial leaf spring 78 to be distally advanced over the dilator projection portion 38.
  • Such advancement removes the shoulder 68 out of its abutting contact with the ramp 92 and facilitates the compression of the distal portion 64 of the body 58, thus causing the same to bulge outwardly.
  • the camming action of the dilator projection portion 38 against the inner surfaces of the leaf portions 82 causes the same to be flexed outwardly, thus facilitating the radial expansion of the aperture 74 to the open configuration.
  • the removal of the distally pressure from the outer surface 70 of the proximal end 62 causes the radial leaf spring 78 to be proximally withdrawn from over the dilator projection portion 38, thus facilitating the return of the reseal member 56 to the first position and resultant collapse of the aperture 74 to the closed configuration.
  • the injection site 10 is coupled to a standard tubular fluid line 94 defining a hollow lumen 96.
  • the connection of the injection site 10 to the fluid line 94 is accomplished by the slidable advancement of the adapter portion 40 into the lumen 96, with the adapter portion 40 being frictionally maintained therewithin.
  • medication may be passed from the introducer device 12 into the lumen 96 of the fluid line 94 via the flow path defined by the open aperture 74 and fluid passage 44 of the adapter member 34.
  • the injection site 10 is shown in Figures 9 and 10 as being connected to the fluid line 94, it will be recognized that the same may also be selectively coupled to other infusion components such as a Luer connector, Y-injection site or bottle through the utilization of the locking tabs 30.
  • the adapter sleeve 46 will be attached to the adapter portion 40 in the aforementioned manner.
  • a needled introducer device in an emergency situation medication may be passed into the fluid passage 44 via a needled introducer device rather than through the non-needled introducer device 12 previously described.
  • the reseal member 56 will not be moved to the second position to facilitate the opening of the aperture 74. Rather, the needle of the needled introducer device is simply forced through the closed aperture 74 and into the fluid passage 44 of the dilator projection portion 38.
  • any medication dispensed therefrom will still flow into the fluid passage 44, and will be prevented from flowing into the interior chamber 26 by the seal created by the abutment of the flange 88 against the outer surface of the dilator projection portion 38.
  • the ends of the leaf portions 82 being embedded in the inner surface 72 of the proximal end 62 as a result of the same being partially received in the grooves 90, the plug created by the protrusion of the inner surface 72 into the opening defined by the leaf portions 82 is maintained during the removal of the needled introducer device from within the aperture 74.
  • the injection site 100 comprises a housing 102 which itself comprises an upper section 104 having a reduced diameter proximal portion 106.
  • the proximal portion 106 includes Luer threads 108 formed on the outer surface thereof, and defines a tapered central opening 110.
  • the housing 102 comprises a lower section 112 which is attached to the upper section 104 and includes a bottom wall 114 and a continuous side wall 116. Extending proximally from the bottom wall 114 is a dilator projection portion 118 which is coaxially aligned with the central opening 110.
  • an adapter portion 120 Extending distally from the bottom wall 114 is an adapter portion 120 which is itself coaxially aligned with the dilator projection portion 118.
  • the dilator projection and adapter portions 118, 120 define a continuous fluid passage 122.
  • the upper and lower sections 104, 112, when attached to each other, define an interior chamber 124 of the housing 102. In this respect, the central opening 110 of the upper section 104 communicates with the interior chamber 124.
  • the adapter portion 120 defines a tapered outer surface and a blunt distal end 128. Formed in the outer surface of the adapter portion 120 in close proximity to the bottom wall 114 is a continuous groove 130.
  • Rotatably connected to the adapter portion 120 is an internally threaded lock member 132 which includes a radially inwardly extending flange portion 134.
  • the rotatable connection of the lock member 132 to the adapter portion 120 is facilitated by the receipt of the flange portion 134 into the groove 130.
  • the injection site 100 further comprises a reseal member 56a which is identical to the previously described reseal member 56 and is disposed within the interior chamber 124 and central opening 110 of the housing 102.
  • the proximal portion 60a of the reseal member 56a is disposed within the central opening 110, with the distal portion 64a being slightly compressed between an annular ramp 136 defining the transition between the central opening 110 and interior chamber 124, and the bottom wall 114 of the lower section 112.
  • the shoulder 68a of the body 58a is abutted against the ramp 136, with the distal end of the body 58a being abutted against the bottom wall 114.
  • the distance separating the ramp 136 from the bottom wall 114 slightly exceeds the length of the body 58a excluding the proximal portion 60a thereof, thus facilitating the compression of the distal portion 64a.
  • the reseal member 56a is shown in Figure 11 in the first position wherein the aperture 74a of the body 58a is in the closed configuration.
  • the movement of the reseal member 56a to the second position wherein the aperture 74a assumes the open configuration occurs in the same manner as previously described in relation to the injection site 10.
  • a needled introducer may be used in conjunction with the injection site 100 by extending the needle through the closed aperture 74a and into the fluid passage 122.
  • the injection site 100 is adapted for use with a Luer connector, with the internally threaded lock member 132 being threadably engageable to the Luer threads of the Luer connector subsequent to the insertion of the adapter portion 120 thereinto.
  • the adapter portion 120 has an external configuration which is substantially identical to that of the adapter portion 40 of the previously described injection site 10 subsequent to the slidable advancement of the adapter sleeve 46 thereover.
  • the housings 16, 102 of the injection sites 10, 100 are adapted to be connectible to infusion components such as a Luer connector, a Y- injection site, a standard tubular fluid line, and a bottle.
  • any housing with which the reseal member 56, 56a is utilized need only be configured so that the reseal member 56, 56a is movable from the first to the second positions to create a continuous fluid passage from the introducer device into the infusion component in the previously described manner.
  • the preferred method of fabricating the reseal member 56 comprises the step of advancing the radial leaf spring 78 over a solid core 200 which is sized to cause the leaf portions 82 of the radial leaf spring 78 to be flexed outwardly when the radial leaf spring 78 is advanced over the core 200.
  • Formed in the proximal end of the core 200 is an arcuately contoured, generally semi-circular recess 202.
  • the radial leaf spring 78 is advanced over the core 200 to a position whereat the grooves 90 formed in the ends of the leaf portions 82 are disposed immediately adjacent the recess 202.
  • the core 200 having the ra.dial leaf spring 78 positioned thereon is then placed into a mold 204 having a cavity which approximates the shape of the body 58.
  • the mold 204 includes a pin 206 which extends perpendicularly through the cavity into contact with the apex of the recess 202 formed in the proximal end of the core 200.
  • the body 58 is injection molded about the radial leaf spring 78 and core 200 in a manner wherein the radial leaf spring 78 is partially encapsulated by the body 58 in the previously described manner.
  • the silicone from which the body 58 is preferably formed flows into the slots 84 of the radial leaf spring 78 during the molding process, thus facilitating the positive engagement between the proximal portion 60 and leaf portions 82.
  • the core 200 further includes a continuous channel 208 circumventing the outer surface thereof which facilitates the formation of the flange 88 within the body 58.
  • the flow of the silicone into the recess 202 of the core 200 during the molding process facilitates the formation of the inner surface 72 of the proximal end 62 with the semi-spherical configuration, with the flow of the silicone into the grooves 90 facilitating the positive engagement between the proximal end 62 and leaf portions 82 for the reasons previously described.
  • the same (along with the integral radial leaf spring 78) is removed from within the mold 204.
  • the withdrawal of pin 206 of the mold 204 from within the proximal end 62 of the body 58 facilitates the formation of the aperture 74.
  • the core 200 is removed from therewithin, thus facilitating the formation of the bore 86.
  • the reseal member 56 may alternatively be formed through the utilization of a core 200a which is identical to the previously described core 200, but further includes a conically shaped notch 210 formed in the apex of the semi-spherical recess 202a disposed in the proximal end thereof.
  • the pin 206a of the mold 204a is provided with a pin point 212 which extends to the apex of the notch 210.
  • the body formed through the utilization of the core 200a and accompanying pin 206a will include a duck-bill style check valve 300 which is formed at the apex of the semi-spherical inner surface thereof.
  • the check valve 300 may be provided with the reseal member 56 for purposes of preventing any medication from back flowing into the introducer device 12. It will be recognized that the check valve 300 may also be formed with alternative configurations.

Abstract

L'invention porte sur un point d'injection sans aiguille (10) comportant une enceinte (16) délimitant une chambre intérieure (26) et une ouverture centrale (28) communiquant avec la chambre intérieure. L'enceinte comporte par ailleurs une saillie (38) de dilatation s'étendant proximalement coaxialement avec l'ouverture centrale, et un adaptateur (34) s'étendant distalement. La saillie de dilatation et l'adaptateur forment un passage continu pour le fluide. Un élément refermable (56) placé dans l'ouverture centrale et dans la chambre intérieure comporte une ouverture (24) s'ouvrant et se fermant par élasticité. L'élément refermable (56) se trouve normalement dans une première position à l'intérieur de l'enceinte, l'ouverture étant alors obstruée. L'élément refermable (56) étant déformable lorsqu'on lui applique une pression dirigée dans le sens distal, on le fait progresser distalement dans l'enceinte vers une deuxième position où l'ouverture est libre et communique avec le passage du fluide.
PCT/US1996/005383 1996-04-17 1996-04-17 Point d'injection sans aiguille WO1997038744A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
AU55550/96A AU5555096A (en) 1996-04-17 1996-04-17 Needleless injection site
PCT/US1996/005383 WO1997038744A1 (fr) 1996-04-17 1996-04-17 Point d'injection sans aiguille

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US1996/005383 WO1997038744A1 (fr) 1996-04-17 1996-04-17 Point d'injection sans aiguille

Publications (1)

Publication Number Publication Date
WO1997038744A1 true WO1997038744A1 (fr) 1997-10-23

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1996/005383 WO1997038744A1 (fr) 1996-04-17 1996-04-17 Point d'injection sans aiguille

Country Status (2)

Country Link
AU (1) AU5555096A (fr)
WO (1) WO1997038744A1 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1033143A1 (fr) * 1999-02-26 2000-09-06 F. Hoffmann-La Roche Ag Appareil pour l'administration de médicaments
DE20105379U1 (de) * 2001-03-27 2001-08-23 Mednet Gmbh Schutzkappe für nadelfreie Injektionssysteme
US7947032B2 (en) 2001-12-07 2011-05-24 Becton, Dickinson And Company Needleless luer access connector

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