WO2014137901A1 - Adaptateurs intradermiques à adjonction latérale - Google Patents

Adaptateurs intradermiques à adjonction latérale Download PDF

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Publication number
WO2014137901A1
WO2014137901A1 PCT/US2014/019907 US2014019907W WO2014137901A1 WO 2014137901 A1 WO2014137901 A1 WO 2014137901A1 US 2014019907 W US2014019907 W US 2014019907W WO 2014137901 A1 WO2014137901 A1 WO 2014137901A1
Authority
WO
WIPO (PCT)
Prior art keywords
needle cannula
skin contact
adapter
needle
contact guide
Prior art date
Application number
PCT/US2014/019907
Other languages
English (en)
Inventor
Izrail Tsals
Original Assignee
Sid Technologies, Llc
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 Sid Technologies, Llc filed Critical Sid Technologies, Llc
Priority to CN201480012347.6A priority Critical patent/CN105246533B/zh
Publication of WO2014137901A1 publication Critical patent/WO2014137901A1/fr

Links

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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3287—Accessories for bringing the needle into the body; Automatic needle insertion
    • 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/50—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile
    • 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3245—Constructional features thereof, e.g. to improve manipulation or functioning
    • A61M2005/3247—Means to impede repositioning of protection sleeve from needle covering to needle uncovering position
    • A61M2005/325—Means obstructing the needle passage at distal end of a needle protection sleeve
    • 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/42—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for desensitising skin, for protruding skin to facilitate piercing, or for locating point where body is to be pierced
    • A61M5/425—Protruding skin to facilitate piercing, e.g. vacuum cylinders, vein immobilising means

Definitions

  • the invention pertains to intradermal adapters in general and side merge intradermal adapters in particular.
  • ID adapters for facilitating intradermal injection of diagnostic and therapeutic agents, vaccines and other compounds.
  • Some ID adapters are intended for use with conventional syringes including a permanently fixed needle cannula.
  • Typical syringes include inter alia BD PLASTIPAK syringes with 1 ml volume, 0.5" long needle cannula and a needle cannula gauge 28.
  • ID adapters are intended for use with a needle cannula assembly with an integral needle cannula and a drug delivery device, for example, a syringe with a Luer connector, for connection to the needle cannula assembly.
  • the needle cannula assemblies are typically formed with a female Luer connector for axial connection of a male Luer lock connection of a typical syringe thereto.
  • WO 2008/131440 Figures 1 to 6 disclose an ID adapter 100 having a longitudinal adapter centerline defining a longitudinal adapter plane, and an elongated opening 1 11 for initial sliding insertion of a conventional syringe into the ID adapter in a radial direction to form an intradermal injection assemblage with the syringe and the ID adapter in preferably co-axial arrangement.
  • the syringe is subsequently urged along the longitudinal adapter centerline from its initial loading position to a subsequent loaded position in which the syringe's needle is inserted into a cone opening 109.
  • the needle cannula is in a non- protruding position relative to the ID adapter in the loaded position such that placement of the intradermal injection assemblage onto an injection site does not lead to needle cannula insertion at the injection site.
  • the intradermal injection assemblage is applied to and held in intimate contact at an injection site and thereafter the syringe is manually slid forward relative to the stationary ID adapter for protruding the needle cannula through a needle cannula opening for needle cannula insertion into a patient's dermis at the injection site.
  • Intradermal insertion is performed while maintaining manual pressure on the ID adapter. The pressure might be slightly reduced for allowing more dermis distention during injection.
  • the syringe may be withdrawn from the stationary ID adapter before removal of the ID adapter from the injection site.
  • the intradermal injection assemblage may be removed intact from the injection site.
  • FIG. 7 to 14 disclose an ID adapter 200 similar to the Figures 1 to 6 ID adapter 100 for use with a syringe with an annular undercut 94 to enable syringe capture.
  • the ID adapter 200 additionally includes a safety ring 230 for permanently shielding a needle cannula after use.
  • WO 2008/131440 Figures 17 to 23 disclose a needle assembly 300 with a female Luer connector 332 and an ID adapter 310 similar to the Figures 1 to 6 ID adapter.
  • the needle assembly 300 additionally includes a safety clip 360 for retaining the relative positions of an ID adapter component on the needle cannula assembly 300 during storage and during the attachment of a drug delivery device to the needle cannula assembly.
  • WO 2008/131440 Figures 24 to 28 disclose an alternative needle assembly embodiment with a skin interface of an ID adapter component similar to that of the Figures 1 to 6 ID adapter and additionally including an arrangement for preventing distal motion of a needle cannula assembly relative to the ID adapter component on axial attachment of a syringe to the ID needle cannula assembly.
  • WO 2008/131440 Figures 29 to 34 disclose yet another embodiment of an ID needle assembly with a skin interface of the ID adapter component similar to that of the Figures 1 to 6 ID adapter and additionally including an arrangement for detecting placement of the adapter on an injection site.
  • angular tolerance from a needle base to its distal free needle cannula tip forms a cone of positional uncertainty increasing in its radial extent in a linear manner from a needle cannula base to its distal free needle cannula tip.
  • WO 2010/077596 discloses ID adapters similar to the aforesaid WO
  • WO 2010/077596 ID adapters include an adapter body 1 10 having a first body portion 120 and a second body portion 122 pivotal on the first body portion 120 along a pivot axis parallel to the longitudinal ID adapter centerline.
  • WO 2010/077596 additionally discloses several support arrangements for providing intermediate support for a needle cannula between its needle cannula base to its distal free needle cannula tip which in effect aligns and stiffens a needle cannula, thereby aligning the needle and reducing its tendency to
  • WO 2010/077596 also describes that by virtue of the intermediate support affording enhanced stiffness of a needle cannula, a smaller diameter and therefore more flexible needle cannula can be used.
  • WO 2008/131440 ID adapters disclose a so-called side merge ID adapter which differs from the WO 2008/131440 ID adapters insofar as the WO 201 1/011697 Figures 1 to 10 ID adapter is intended for sideways sliding
  • the WO 201 1/011697 intradermal injection assemblage is intended to be smoothly slid along a patient's skin for needle cannula insertion at an injection site. Furthermore, it affords user safety during sideways sliding merger as the syringe needle is positioned in front of a user's hands.
  • UNISEF has fully endorsed and implemented the use of Auto-Disable Syringes in Immunization services as recommended in the WHO-UNICEF-UNFPA Joint Statement of 2003.
  • Auto-disable syringes include a permanently fixed needle cannula and become automatically disabled by virtue of the presence of an internal one-way valve or other mechanism to prevent re -use after they have been used once.
  • UNICEF also employs a bundling policy such that sufficient numbers of AD syringes, reconstitution syringes and safety boxes must be ensured for each vaccine dose. Since ID adapters are liable for contamination by skin contact and/or bodily fluids during use, there is a valid concern regarding the unintended and improper re-use of ID adapters.
  • the so-called side merge ID adapters of the present invention can be optionally provisioned with auto-disable features for preventing their re-use with a second auto-disable syringe after being used with a first auto-disable syringe to prevent cross contamination between patients and the spread of infection.
  • the present invention is directed towards side merge intradermal adapters (hereinafter abbreviated to "SMID adapters") for use with conventional syringes with permanently fixed needle cannulas and/or needle cannula assemblies for mounting on syringes with luers.
  • SMID adapters side merge intradermal adapters
  • the description hereinbelow refers to the use of the SMID adapters of the present invention with a syringe having a permanently fixed needle cannula.
  • the SMID adapters of the present invention are similar in construction as the aforesaid WO 201 1/01 1697 Figures 1 to 10 side merge ID adapter insofar they have a longitudinal adapter centerline defining a vertical longitudinal adapter plane, an elongated open sided main adapter body with a leading skin contact guide, and a trailing skin contact guide.
  • the SMID adapters of the present invention differ from the aforesaid WO 201 1/01 1697 Figures 1 to 10 side merge ID adapter 10 insofar their trailing skin contact guides are manually pivotal from an initial unciamping position to a final clamping position about a transverse pivot axis perpendicular to the vertical longitudinal adapter plane.
  • the initial unciamping position of the trailing skin contact guide enables side merging of a first unused syringe into the SMID adapter.
  • the SMID adapters of the present invention include a clamping arrangement for intentionally bending a needle cannula as it passes through an elongated throughgoing needle cannula aperture defined thereby in a final clamping position of a trailing skin contact guide for correctly aligning an exposed distal needle cannula section protruding beyond the throughgoing needle cannula aperture with a leading skin contact guide.
  • the exposed distal needle cannula section has an exposed length in the range of from about 3 mm to about 6 mm available for intradermal insertion at an injection site.
  • the exposed distal needle cannula section is aligned at about 0.75 mm separation between an underside surface of the leading skin contact guide and the needle cannula centerline.
  • the SMID adapters of the present invention can be optionally provisioned with auto-disable features for preventing their re-use with a second syringe after being used with a first syringe to prevent cross contamination between patients and the spread of infection.
  • One auto-disable ID adapter feature is that the clamping arrangement for clamping the trailing skin contact guide onto the main body is designed not to be opened after clamping such that a user trying to replace a used syringe by a fresh replacement syringe faces the difficulty of having to insert the fresh replacement syringe's needle cannula through the relatively small throughgoing needle cannula aperture.
  • Another auto-disable ID adapter feature is the provision of an upright needle blocking member resiliently flexibly mounted on the trailing skin contact guide for blocking passage of a needle cannula of a fresh syringe through the throughgoing needle cannula aperture in the final clamping position of the trailing skin guide contact.
  • Yet another auto-disable ID adapter feature is the provision of a pair of opposite side walls for enclosing a cavity proximal to the clamping arrangement and the throughgoing needle cannula aperture. This pair of opposite side walls further poses difficulties for inserting a needle cannula of a fresh syringe through the throughgoing needle cannula aperture in the final clamping position of the trailing skin contact guide.
  • Fig. 1 corresponds to commonly owned WIPO International Publication No. WO 2011/011697 Figure 1 showing a so-called side merge ID adapter and a conventional syringe with a permanently fixed needle cannula;
  • FIG. 2 is a front perspective view of a first embodiment of a side merge intradermal adapter (hereinafter abbreviated to "SMID adapter”) in an initial undamped state and a conventional syringe with a permanently fixed needle cannula;
  • SMID adapter side merge intradermal adapter
  • FIG. 3 is a front perspective view of the Figure 2 SMID adapter in its initial undamped state
  • FIG. 4 is a longitudinal cross section of the Figure 2 SMID adapter in its initial undamped state along line A-A in Figure 3;
  • FIG. 5 is a front perspective view of the Figure 2 SMID adapter in its final clamped state
  • Fig. 6 is a longitudinal cross section of the Figure 2 SMID adapter in its final clamped state along line A-A in Figure 5;
  • FIG. 6A is a front elevation view of the Figure 6 SMID adapter
  • FIG. 7 is a side elevation view of an intradermal injection assemblage of the Figure 2 SMID adapter in its initial undamped state and the syringe;
  • Fig. 8 is a side eievation view of the Figure 7 intradermal injection assemblage in a partially closed state prior to its final clamped state;
  • FIG. 9 is a side elevation view of the Figure 7 intradermal injection assemblage in a final clamped state
  • FIG. 9A is a front elevation view of the Figure 9 intradermal injection assemblage
  • FIG. 10 is a front perspective view of the Figure 2 SMID adapter in a final clamped state and an attempted insertion of a fresh syringe thereinto;
  • Fig. 1 1 is a front perspective view of a second embodiment of a side merge intradermal adapter (hereinafter abbreviated to "SMID adapter”) in an initial unclamping position;
  • SMID adapter side merge intradermal adapter
  • FIG. 12 is a rear perspective view of the Figure 1 1 SMID adapter in its initial unclamping position
  • FIG. 13 is a front perspective view of the Figure 1 1 SMID adapter in a final clamping position
  • FIG. 14 is a rear perspective view of the Figure 1 1 SMID adapter in its final clamping position.
  • Figure 1 corresponds to WO 2011/011697 Figure 1 showing a so-called side merge ID adapter 10 and a conventional syringe 12.
  • the syringe 12 includes a cannula 14 with a cannula tip 14a, a syringe barrel 44 with a hollow cavity 44a, and a plunger 46 with a piston 46a.
  • the adapter 10 includes a side opening 22 that extends along an entire length of the adapter 10 generally parallel to a longitudinal axis 18.
  • the ID adapter 10 includes a central portion 24 having a cannula channel 26 extending therethrough extending generally parallel to the longitudinal axis 18.
  • the side opening 22 permits insertion of the syringe 12 into the ID adapter 10 whereby the cannula tip 14a is spaced distally relative to a cannula channel edge 26a.
  • demarcation plane 27 is defined where the cannula 14 extends over the channel edge 26a, is generally perpendicular to the longitudinal axis 18 and intersects the longitudinal axis 18.
  • the ID adapter 10 includes a distal portion 30 which extends generally parallel to the longitudinal axis 18 from the central portion 24.
  • the distal portion 30 includes a sloped distal nose 32 that curves away from the longitudinal axis 1 8.
  • the distal portion 30 is generally transparent distally relative to a demarcation plane 27 such that the cannula 14 can be viewed therethrough during insertion of cannula at an injection site.
  • FIGS 2 to 10 show the construction and use of a side merge intradermal adapter 200 (hereinafter abbreviated to SMID adapter 200") similar in construction as the side merge ID adapter 10.
  • SMID adapter 200 is described for use with a conventional auto-disable syringe 100 commercially available from BD, Helm, and the like.
  • the SMID adapter 200 can equally be used with a syringe which is not auto disabled.
  • the SMID adapter 200 can also equally be used with a needle cannula assembly with a luer for mounting on a syringe or other device with a luer.
  • the syringe 100 is necessarily pre-filled with liquid contents before being side merged with the SMID adapter 200 as described hereinbelow.
  • the syringe 100 has a longitudinal syringe centerline 101 and includes a syringe barrel 102 with a plunger 103 and a piston 104.
  • the syringe barrel 102 includes an annular syringe barrel shoulder 106 and a needle hub 107.
  • the syringe barrel 102 has a leading end 102a towards the annular syringe barrel shoulder 106.
  • the needle hub 107 has fins 108 for interference fitting of a needle shield (not shown).
  • the needle hub 107 supports a permanently fixed needle cannula 109 having a needle cannula base 1 1 1 and a distal free needle cannula tip 112 respectively proximate and distal the syringe barrel 102.
  • Figure 2 shows a representative cone 113 of the positional uncertainty of the needle cannula 109 due to manufacturing tolerances, post manufacturing deformations, and the like.
  • the SMID adapter 200 includes a longitudinal adapter centerline 201 defining a vertical longitudinal adapter plane 202.
  • the SMID adapter 200 is preferably formed from suitable regulatory approved materials for medical devices, for example, polycarbonate, and the like.
  • the SMID adapter 200 includes an elongated main body 203 with an open-sided generally tubular trailing section 204, a needle shield section 206 and a leading skin contact guide 207.
  • the leading skin contact guide 207 has an underside surface 207A preferably perpendicular to the vertical longitudinal adapter plane 202 and transparent for enabling visualization of a needle cannula insertion at an injection site.
  • the open sided generally tubular trailing section 204 includes a barrel section 208 and a hub section 209 and an abutment shoulder 21 1 at the juncture therebetween.
  • the syringe 100 is side merged into the SMID adapter 200 in a radial direction relative to the longitudinal adapter centerline 201 as denoted by arrow A such that the annular syringe barrel shoulder 106 abuts against the abutment shoulder 21 1, the barrel section 208 snugiy receives the syringe barrel 102 and the barrel's leading end 102a and adapter hub section 207 encloses the needle hub 107.
  • the SMID adapter 200 includes a trailing skin contact guide 213 pivotal on the open-sided generally tubular trailing section 204 about a transverse pivotal axis 214 perpendicular to the vertical longitudinal adapter plane 202 and distally extending along the longitudinal adapter centerline 201.
  • the trailing skin contact guide 213 has a proximate trailing skin contact guide end 213A and a distal trailing skin contact guide end 213B correspondingly proximate and distal relative to the open-sided generally tubular trailing section 204.
  • the distal trailing skin contact guide end 213B has an underside needle cannula contact surface 216 for assisting in the alignment of the needle cannula 109.
  • the underside needle cannula contact surface 216 is preferably perpendicular to the vertical longitudinal adapter plane 202 in the final clamping position of the trailing skin contact guide 213.
  • the trailing skin contact guide 213 can be pivotal on the open-sided generally tubular trailing section 204 by means of a living hinge 217 such that the main body 203 and the trailing skin contact guide 213 are a unitary body.
  • the trailing skin contact guide 213 can be a discrete component for hinged connection to a main body 203.
  • the trailing skin contact guide 213 is preferably swung through an activation angle in the order of 15° from its initial unclamping position (see Figure 7) to its final clamping position (see Figure 9).
  • the SMID adapter 200 includes a clamping arrangement 218 for intentionally permanently clamping the distal trailing skin contact guide end 213B at a juncture 219 between the needle shield section 206 and the leading skin contact guide 207 such that the trailing skin contact guide 213 is manually pivotal from an initial unclamping position to a final clamping position corresponding to an initial undamped state and a final clamped state of the SMID adapter 200.
  • the juncture 219 effectively defines a transition of the needle cannula 109 from a proximal shielded needle cannula section 1 14 under the needle shield section 206 to a distal exposed needle cannula section 1 16 under the leading skin contact guide 207.
  • the clamping arrangement 218 is formed with a topside needle cannula contact surface 222 preferably perpendicular to the vertical longitudinal adapter plane 202 and therefore parallel to the leading skin contact guide's underside surface 207A. Accordingly, the underside needle cannula contact surface 216 and the topside needle cannula contact surface 222 are opposite and parallel in the final clamping position of the trailing skin contact guide 213.
  • the clamping arrangement 218 is constituted by a first clamp arrangement component 218A at the juncture 219 and a second clamp arrangement component 218B at the distal trailing skin contact guide end 213B.
  • the first clamp arrangement component 218A is in the form a spaced apart clamp member pair 221 A facing the trailing skin contact guide 213 on opposite sides of the longitudinal adapter centeriine 201.
  • the second clamp arrangement component 218B is in the form of a spaced apart clamp member pair 22 IB on opposite sides of the underside needle cannula contact surface 216 for clamping onto the spaced apart clamp member pair 221A.
  • the spaced apart clamp pair 22 IB are in the form of rearward facing hooks deployed on either side of the underside needle cannula contact surface 216.
  • the clamp arrangement 218 is designed such that an attempt to open it will lead to snapping of one or more of the clamp member pair 221 A and the clamp member pair 22 I B thereby precluding re- clamping the clamp arrangement 218.
  • a needle cannula 109 may contact the topside needle cannula contact surface 222 on side merging the syringe 100. In some instances, depending on the degree of deflection and deployment of a syringe 100 in a SMID adapter 200, a needle cannula 109 may not contact the topside needle cannula contact surface 222.
  • the syringe 100 and the SMID adapter 200 are so matched that in the final clamping position of the trailing skin contact guide 213, the underside needle cannula contact surface 216 deflects the needle cannula 109 to a lesser or greater degree on its being clamped parallel and opposite to the topside needle cannula contact surface 222 for assuring capture of the needle cannula 109 and parallel alignment of the exposed distal needle cannula section 116 with the leading skin contact guide's underside surface 207A.
  • the SMID adapter 200 and the syringe 100 are matched lengthwise such that on fully side merging the syringe 100 into the SMID adapter 200 such that the annular syringe barrel shoulder 107 abuts the abutment shoulder 211, the distal free needle cannula tip 109 is disposed midway along the leading skin contact guide 207.
  • the distal free needle cannula tip 109 is typically disposed in the range of 3 mm to 6mm beyond the distal trailing skin contact guide end 213B.
  • the distal exposed needle cannula section 116 defines a separation S of about 0.75 mm between leading skin contact guide's underside surface 207A and a needle cannula centerline. This arrangement precludes aspiration of liquid contents into an empty syringe 100 after it is merged in the SMID adapter 200.
  • the leading skin contact guide 207 contacts the patient's skin before the trailing skin contact guide 213.
  • the trailing skin contact guide 213 can be provisioned with a needle blocking member 224 as an auto-disable feature for preventing the insertion of a fresh unused syringe 100 after the use of the SMID adapter 200 to avoid cross
  • the needle blocking member 224 is resiliently flexibly mounted on the trailing skin contact guide 213 towards the distal trailing skin contact guide end 213B and facing towards the needle shield section 206.
  • the needle blocking member 224 includes a needle blocking member base 224A mounted on the trailing skin contact guide 213 and a free needle blocking member end 224B disposed toward the needle shield section 206 as shown in Figure 6.
  • Figure 7 shows the free needle blocking member end 224B does not interfere with side merging the syringe 100 into the SMID adapter 200.
  • the free needle blocking member end 224B is typically about 1mm beneath the needle cannula 109 on side merging the syringe 100 into the SMID adapter 200.
  • Figure 8 shows the free needle blocking member end 224B contacts the needle cannula 109 on partial closing of the trailing skin contact guide 213 prior to its final clamping position.
  • Figure 9 shows that on clamping the trailing skin contact guide 213 into its final clamping position, the needle cannula 109 deflects the needle blocking member 224 towards the trailing skin contact guide 213 such that the free needle blocking member end 224B is closer to the trailing skin contact guide 213 than in comparison to the SMID adapter 200 being in its final clamped state without an installed syringe 100 (see Figure 6).
  • Figure 10 shows the needle blocking member 224 blocks an attempted insertion of a syringe's needle cannula 109 through the throughgoing needle cannula aperture 223 in the SMID adapter 200's final clamped state.
  • the needle blocking member 224 precludes the user from merging a fresh syringe 100 into the used SMID adapter 200.
  • FIGS 1 1 to 14 show a side merge intradermal adapter 300 (hereinafter abbreviated to "SMID adapter 300").
  • SMID adapter 300 is similar in construction and operation to the SMID adapter 200 and therefore similar parts are likewise numbered.
  • the SMID adapter 300 has a different clamp arrangement 301 than the clamp arrangement 218 and is provisioned with additional auto-disable features in addition to the needle blocking member 224.
  • the clamping arrangement 301 is constituted by a first clamp arrangement component 301 A at the juncture 219 and a second clamp arrangement component 30 IB at the distal trailing skin contact guide end 213B.
  • the first clamp arrangement component 301A is in the form spaced apart parallel and opposite clamp member side slots 302A on opposite sides of the longitudinal adapter centerline 201 .
  • the second clamp arrangement component 301B is in the form of a spaced apart clamp member pair 302B on opposite sides of the longitudinal adapter centerline 201 for clamping into the spaced apart parallel and opposite clamp member side slots 302A.
  • the spaced apart clamp member pair 302B are in the form of inward directed hooks.
  • the clamp arrangement 301 is designed such that an attempt to open it will lead to snapping of one or both of the clamp member pair 302B thereby precluding re-clamping the clamp arrangement 301.
  • the SMID adapter 300 includes a side wall pair 306 for effectively forming an enclosed cavity in its final clamped state through which the needle cannula 109 passes before protruding through the throughgoing needle cannula aperture 223.
  • the needle shield section 206 includes a first side wall 306 A disposed toward the trailing skin contact guide 213 and the trailing skin contact guide 213 includes a second side wall 306B opposite the first side wall 306A and disposed towards the needle shield section 206.
  • the side wall pair 306 discourages a user even attempting to pry open the trailing skin contact guide 213 from the main body 203 to remove a used syringe 100 from a used ID adapter 300 without massively damaging same thereby preventing its re-use with a fresh syringe 100. Moreover, the side wall pair 306 together with the needle blocking member 224 prevent sliding out a used syringe 100 from the SMID adapter 300 and trying to replace it with a fresh syringe 100 by also sliding it in axially.

Abstract

L'invention concerne des adaptateurs intradermiques à adjonction latérale (200) comprenant une ligne centrale d'adaptateur longitudinale (201) définissant un plan d'adaptateur longitudinal vertical et comprenant un guide de contact avec la peau postérieur (203) pouvant pivoter manuellement sur un axe de pivot transversal (214) perpendiculaire au plan d'adaptateur longitudinal vertical entre une position initiale desserrée et une position finale serrée. Le guide de contact avec la peau postérieur (203) s'aligne sur une canule d'aiguille (116) et la rigidifie dans sa position serrée finale. Les adaptateurs intradermiques à adjonction latérale (200) destinés à être utilisés dans les pays en développement peuvent être munis d'éléments auto-destructibles pour empêcher le rechargement avec une seconde seringue pré-remplie avec une canule d'aiguille fixée en permanence après utilisation avec une première seringue pré-remplie (12).
PCT/US2014/019907 2013-03-04 2014-03-03 Adaptateurs intradermiques à adjonction latérale WO2014137901A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN201480012347.6A CN105246533B (zh) 2013-03-04 2014-03-03 侧合并皮内适配器

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201361772264P 2013-03-04 2013-03-04
US61/772,264 2013-03-04

Publications (1)

Publication Number Publication Date
WO2014137901A1 true WO2014137901A1 (fr) 2014-09-12

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WO2017019631A1 (fr) * 2015-07-25 2017-02-02 Nano Precision Medical, Inc. Applicateur sous-cutané
US10525248B2 (en) 2015-01-26 2020-01-07 Nano Precision Medical, Inc. Apparatus and method for promoting fluid uptake into an implant

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EP0457477A1 (fr) * 1990-05-09 1991-11-21 Safety Syringes, Inc. Seringue de sécurité à usage unique
WO2008131440A1 (fr) 2007-04-23 2008-10-30 Sid Technologies, Llc Procédés et dispositifs pour injection intradermique
WO2010077596A1 (fr) 2008-12-08 2010-07-08 Sid Technologies, Llc Alignement d'une aiguille dans un dispositif d'injection intradermique
WO2011011697A1 (fr) 2009-07-23 2011-01-27 Sid Technologies, Llc Adaptateur d'injection intradermique
WO2011112916A1 (fr) * 2010-03-12 2011-09-15 Sid Technologies, Llc Ensemble à utiliser avec une seringue

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10525248B2 (en) 2015-01-26 2020-01-07 Nano Precision Medical, Inc. Apparatus and method for promoting fluid uptake into an implant
WO2017019631A1 (fr) * 2015-07-25 2017-02-02 Nano Precision Medical, Inc. Applicateur sous-cutané

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