US2836942A - Method of encasing and sterilizing needles - Google Patents

Method of encasing and sterilizing needles Download PDF

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US2836942A
US2836942A US392246A US39224653A US2836942A US 2836942 A US2836942 A US 2836942A US 392246 A US392246 A US 392246A US 39224653 A US39224653 A US 39224653A US 2836942 A US2836942 A US 2836942A
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needle
casing
sections
recess
collar
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US392246A
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John J Miskel
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Pfizer Inc
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Pfizer Inc
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/002Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; 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
    • A61M5/3202Devices for protection of the needle before use, e.g. caps
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S264/00Plastic and nonmetallic article shaping or treating: processes
    • Y10S264/76Processes of uniting two or more parts
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T29/00Metal working
    • Y10T29/49Method of mechanical manufacture
    • Y10T29/49826Assembling or joining
    • Y10T29/49893Peripheral joining of opposed mirror image parts to form a hollow body

Definitions

  • This invention relates to encased needles, and more particularly, to a hypodermic syringe needle which is encased in a protective casing of plastic material, and to methods for manufacturing the same.
  • hypodermic syringe needles prior to use presents many problems, due to the delicate nature of the needles and the need for maintaining them in a sterile condition free from contamination.
  • long thin cannula or tube of stainless steel having at least one sharpened end for injection purposes, and an enlarged portion or hub intermediate its ends for affixing the needle to a medicament ampule or syringe.
  • both ends are sharpened to facilitate insertion of the needle into the resilient stoppers or diaphragms employed for sealing such medicament ampules.
  • these needles are extremely delicate and do not readily lend themselves to the rugged treatment which is sometimes demanded, as in the Armed Forces.
  • Fig. 1 shows one form of a hypodermic syringe needle which may be employed in accordance with the invention
  • Fig. 2 shows one of the two longitudinal preformed sections employed in the manufacture of the encased needle of this invention
  • Fig. 3 is an elevation partly in longitudinal section showing the completed casing with a needle therewithin
  • Fig. 4 is a section along line 44 of Fig. 3.
  • element 1 is a conventional stainless steel needle provided with sharpened ends and a metallic collar or hub 2, the outer periphery of which is knurled, as indicated at 3.
  • the collar is also provided with a threaded portion 4 to facilitate attachment of the needle to the barrel of a hypodermic syringe not shown.
  • the needle and collar may be constructed of a variety of materials and may assume other configurations, as will be apparent to those skilled in the art.
  • the casing or sheath which is to surround the needle structure is fabricated from two matching preformed,
  • the usual hypodermic needle consists of a longitudinal sections. of a thermosetting plastic material, one form of which is shown in Fig. 2.
  • This preformed section consists of an elongated body, generally indicated at 5, having a longitudinal recess 6 in the central portion thereof and running substantially the length of the preform.
  • the purpose of the recess 6 is to accommodate the needle 1.
  • an enlarged recess 7 is also provided to accommodate the collar 2 on the needle.
  • the body 5 is provided with an area of reduced cross-section, or a scored portion, 8 in circumferential relationship to recess 7 which accommodates the needle collar.
  • This point of reduced cross-sectional area is preferably situated in the central portion of recess 7 so that the needle may later be retained firmly in one portion of the ruptured casing while the section of the needle exposed by removal of the other portion of the ruptured casing is inserted into a syringe ampulc.
  • the completed article is formed by placing the needle between two of the matching preformed sections described above, and subjecting the same to heat and pressure in a mold under suitable conditions to effect curing of the thermosetting plastic material and thereby completely seal the needle therewithin.
  • the product so obtained is illustrated in Fig. 3 and the corresponding sectional view of Fig. 4.
  • the needle is completely encased between the two sections 5, which are fused together along the dividing line 9 originally separating the same.
  • the needle is readily prepared for use by rupturing the casing along the scored portion 8. This is accomplished by firmly grasping the casing on each side of the scored portion and twisting one side with respect to the other.
  • the scored portion is preferably molded in contact with the knurled portion 3 of the collar in order to retain the needle and prevent undesirable movement thereof with respect to the casing.
  • the dimensions of the needle recess 6 with respect to the needle are preferably such that a slight tolerance, say 0.5 to 1.0 mm.,. exists between the outer periphery of the needle and the recess walls to permit the casing to be readily withdrawn from the needle and to obviate the sticking of any plastic material thereto.
  • the casing is slidably spaced from the outer periphery of the needle. Only a relatively thin barrier of plastic material is necessary or desirable about the collar portion of the needle.
  • the thickness of the casing surrounding the needle should be substantially greater, say at least twice its thickness about the'collar, in order to insure adequate protection of the needle.
  • the cross-section of recess 6 may assume any convenient configuration, such as the rectangular configuration shown in Fig. 4, or it may be circular.
  • Various indicia may be applied to the outside of the casing during the molding operation or inscribed thereon after said operation, and the entire casing may be coated wtih a lacquer or other suitable coating to improve its appearance and render it further impervious to moisture.
  • thermosetting'plastic material is 'preferablymolded at relatively lowtemp'eratures for a time sufiicientto efiect only partial curing or polymerization.
  • the plastic material maybe cold molded without polymerization taking. place.
  • thelowerthetemperature the greater'will be the timer'e'quired to completethe curing of the plastic material and'to effect the desired'sterilizati'on.
  • 'Inmost 'cases a temperature "of 400 F. for one-half hour providescompletetcurihg and at'tne'same time, complete sterilization.
  • the preform operation is advantageously conducted at a temperature of about 320 F.
  • the molding pressures for'both thepreform and final molding operation may vary considerably. However, a pressure of from 1.000 to 2000pou'n ds per square inch is usually sufficientin'preparing the preform,whereas a somewhat higher pressure; such'as from 3000 to 4000'pounds'per square inch, is employed during the final molding operation.
  • the encased needles are, of course, stored and trans- 'ported in a sealed'conditio'n.
  • the casing When it is desired to use a needle, the casing is grasped and twisted as indicated above in order to 'causea transverse rupture in theregion
  • Theexp'os'ed'p'or'tion 'of the needle generally the barrel in which the ampule is contained.
  • the stopper or diaphragm of the medicament ampule may be sterilized, if necessary, before inserting the needle therein.
  • the product obtained in accordance with this invention is sterile and impervious to moisture, as well as other contaminants, including the various pathogenic microorganisms. Th'eneedles-so encased are 'sufiiciently rugged to stand up underthe severest conditions which may be encountered in the field.
  • a method for encasing a hypodermic syringe needle ina sterile protecti-ve casing ofiplastic material which 'comprises preformin'gitwo sections'of thermosetting "plastic materiaL each section being-provided with a'thin longitudinal recess to accommodate aneedle and an enlarged recess to accommodate a n'ee'dlecollar, placing between said sections a-'needle-havingan enlarged collar portion thereon intermediate its-ends, and hermetically sealing the combination at a temperature and pressure suflicient to cure said-plastic and sterilize said needle and providing an integral protective-casing thereabout.
  • a method-forencasing-a'hypodermic syringe needle in-a sterile; protective casing of rubber which comprises formingtwopa'rtiallyvulcanized sections of rubber in a mold,-each section-being provided with a thin longitudi- "nal recess to accommodate a needle and an enlarged -recess to accommodate aneedle collar, placing between said sections a needle having an enlarged collar portion thereon intermediate 'its ends, and hermetically sealing the combination at a temperature and pressure sufiicientto completevulcanizationof said rubber and sterilize said needle and providing an integral protective casing of rubber thereabout.

Description

'June 3, 1958 J. J. MISKEL 2,836,942
METHOD OF ENCASING AND STERILIZING NEEDLES Filed NOV. '16, 1953 .JoHN .J. -MI5KEL Hi5 AT TORNEYE 1N VEN TOR.
i atented June 3, 1958 fine METHOD OF ENCASING AND STERILIZING NEEDLES John J. Miskel, Brooklyn, N. Y., assignor to Chas. Pfizer & Co., Inc, Brooklyn, N. Y., a corporation of Delaware Application November 16, 1953, Serial No. 392,246
2 Claims. (CI. 53-25) This invention relates to encased needles, and more particularly, to a hypodermic syringe needle which is encased in a protective casing of plastic material, and to methods for manufacturing the same.
The distribution, storage and handling of hypodermic syringe needles prior to use presents many problems, due to the delicate nature of the needles and the need for maintaining them in a sterile condition free from contamination. long thin cannula or tube of stainless steel having at least one sharpened end for injection purposes, and an enlarged portion or hub intermediate its ends for affixing the needle to a medicament ampule or syringe. Frequently both ends are sharpened to facilitate insertion of the needle into the resilient stoppers or diaphragms employed for sealing such medicament ampules. Obviously, these needles are extremely delicate and do not readily lend themselves to the rugged treatment which is sometimes demanded, as in the Armed Forces.
While numerous attempts have been made to meet these problems through various protective sheaths, covers, strip packages, and the like, such measures have not been demonstrated to'be satisfactory under all practical conditions of use. Difiiculties are frequently encountered with breakage of the seal about the needle and a resulting contamination thereof. Furthermore, many protective covers which might otherwise be suitable are not properly adapted for the task of inserting the needle into a medicament ampule. In addition, the problem of providing hypodermic syringe needles with a satisfactory protective cover is further complicated by a number of manufactoring difficulties.
In accordance with the present invention, however, the above problems are obviated by enveloping the hypodermic syringe needle completely Within a protective casing of thermosetting plastic material which is molded about the needle under such conditions that it will effect complete sterilization of the needle therein contained. For a better understanding of the invention, reference is made to the accompanying drawings, wherein Fig. 1 shows one form of a hypodermic syringe needle which may be employed in accordance with the invention; Fig. 2 shows one of the two longitudinal preformed sections employed in the manufacture of the encased needle of this invention; Fig. 3 is an elevation partly in longitudinal section showing the completed casing with a needle therewithin; and Fig. 4 is a section along line 44 of Fig. 3.
Referring to Fig. 1 of the drawings, element 1 is a conventional stainless steel needle provided with sharpened ends and a metallic collar or hub 2, the outer periphery of which is knurled, as indicated at 3. The collar is also provided with a threaded portion 4 to facilitate attachment of the needle to the barrel of a hypodermic syringe not shown. The needle and collar may be constructed of a variety of materials and may assume other configurations, as will be apparent to those skilled in the art. The casing or sheath which is to surround the needle structure is fabricated from two matching preformed,
The usual hypodermic needle consists of a longitudinal sections. of a thermosetting plastic material, one form of which is shown in Fig. 2. This preformed section consists of an elongated body, generally indicated at 5, having a longitudinal recess 6 in the central portion thereof and running substantially the length of the preform. The purpose of the recess 6 is to accommodate the needle 1. In addition, an enlarged recess 7 is also provided to accommodate the collar 2 on the needle. in order to facilitate a clean transverse rupture of the casing after encasement of the needle is completed, the body 5 is provided with an area of reduced cross-section, or a scored portion, 8 in circumferential relationship to recess 7 which accommodates the needle collar. This point of reduced cross-sectional area is preferably situated in the central portion of recess 7 so that the needle may later be retained firmly in one portion of the ruptured casing while the section of the needle exposed by removal of the other portion of the ruptured casing is inserted into a syringe ampulc.
The completed article is formed by placing the needle between two of the matching preformed sections described above, and subjecting the same to heat and pressure in a mold under suitable conditions to effect curing of the thermosetting plastic material and thereby completely seal the needle therewithin. The product so obtained is illustrated in Fig. 3 and the corresponding sectional view of Fig. 4. As indicated therein, the needle is completely encased between the two sections 5, which are fused together along the dividing line 9 originally separating the same. The needle is readily prepared for use by rupturing the casing along the scored portion 8. This is accomplished by firmly grasping the casing on each side of the scored portion and twisting one side with respect to the other. The scored portion is preferably molded in contact with the knurled portion 3 of the collar in order to retain the needle and prevent undesirable movement thereof with respect to the casing. However, the dimensions of the needle recess 6 with respect to the needle are preferably such that a slight tolerance, say 0.5 to 1.0 mm.,. exists between the outer periphery of the needle and the recess walls to permit the casing to be readily withdrawn from the needle and to obviate the sticking of any plastic material thereto. In other words, the casing is slidably spaced from the outer periphery of the needle. Only a relatively thin barrier of plastic material is necessary or desirable about the collar portion of the needle. On the other hand, the thickness of the casing surrounding the needle should be substantially greater, say at least twice its thickness about the'collar, in order to insure adequate protection of the needle. The cross-section of recess 6 may assume any convenient configuration, such as the rectangular configuration shown in Fig. 4, or it may be circular. Various indicia may be applied to the outside of the casing during the molding operation or inscribed thereon after said operation, and the entire casing may be coated wtih a lacquer or other suitable coating to improve its appearance and render it further impervious to moisture.
The manufacture of a needle completely protected by a casing of molded plastic material is obviously complicated if ordinary molding techniques are employed. 'For instance, if a body of molten plastic material is permitted to come in direct contact with the needle, much of the material will stick to the needle, and more serious, clogging of the needle is apt to result. The provision of a protective stylus within the needle does not obviate the danger of such occurrences. While such a stylus can be employed with the subject invention, the provision of a stylus is rendered unnecessary by employing preformed sections of plastic material as described. The flow of plastic material is thereby substantially reduced, and the final melding operation can be accomplished without =3 clogging'the needles or having the material adhere thereto.
-A'-wide variety of"therrnosetting plastic materials are useful'in this invention, including vulcanite or vulcanized rubber, phenol-aldehyde resins, glyptal or glycerol-phthal- 'ic anyhydride resins, "melamine formaldehyde resins and the synthetic rubbers, such as butadiene=acrylonitrile ("Buna N), buta'dienestyrene (BunaS') neoprene" and butyl "rubber. "Irrthecase of rubber, variouswulcanizingagents, 'suchas sulphur, are employed to advantage. Natural "rubber'ispreferred for reasons 'of economy. 'lthas been found that'thetherrnosetting plastics, i.'e., plastics which harden when heated, "are less aptto cause undesirable 'stickingand/ or clogging with respect to the needle than are thether'm'oplasti'cs. In particular, the "thermos'etting plastics may be maintained 'at "sterilization conditions withoutseriousdanger of'encountering these adverse etfects.
In preparing the aforesaid'preformed sections, the thermosetting'plastic material is 'preferablymolded at relatively lowtemp'eratures for a time sufiicientto efiect only partial curing or polymerization. Alternatively, however,
the plastic material maybe cold molded without polymerization taking. place. During the final molding operation a temperature of "from'about 360to 450 F. at conventional moldingpressuresfor aperiod of about I'Sminutes 'to one hour'is generally adequate for most purposes. Of course, thelowerthetemperature, the greater'will be the timer'e'quired to completethe curing of the plastic material and'to effect the desired'sterilizati'on. 'Inmost 'cases a temperature "of 400 F. for one-half hour providescompletetcurihg and at'tne'same time, complete sterilization. 'Whennatural rubber is employed, the preform operation is advantageously conducted at a temperature of about 320 F. for-ten minutes to eifect partial vulcanization, while the final'vulcanization of the completed casing'is accomplished at approximately the same temperature for about twenty minutes. The molding pressures for'both thepreform and final molding operation may vary considerably. However, a pressure of from 1.000 to 2000pou'n ds per square inch is usually sufficientin'preparing the preform,whereas a somewhat higher pressure; such'as from 3000 to 4000'pounds'per square inch, is employed during the final molding operation.
The encased needles are, of course, stored and trans- 'ported in a sealed'conditio'n. When it is desired to use a needle, the casing is grasped and twisted as indicated above in order to 'causea transverse rupture in theregion The shorter section protecting amen: ampulefis' removed and discarded while grasping -the othersect'idmofthe casing firmly, preferably near the point of separation'between the two sections at the'needle collar. Theexp'os'ed'p'or'tion 'of the needle, generally the barrel in which the ampule is contained. The other sec- -tion of the needle-easing is then removed, leaving the needle in condition for an injection without need for any sterilization except at'the site of the injection. Of course, the stopper or diaphragm of the medicament ampule may be sterilized, if necessary, before inserting the needle therein.
The product obtained in accordance with this invention is sterile and impervious to moisture, as well as other contaminants, including the various pathogenic microorganisms. Th'eneedles-so encased are 'sufiiciently rugged to stand up underthe severest conditions which may be encountered in the field.
Resort fmay be'ha'dto'such modifications and equivalents as fall within the spirit of the invention and the scope of the appendedblaims.
1 claim:
1. A method for encasing a hypodermic syringe needle ina sterile, protecti-ve casing ofiplastic material which 'comprises preformin'gitwo sections'of thermosetting "plastic materiaL each section being-provided with a'thin longitudinal recess to accommodate aneedle and an enlarged recess to accommodate a n'ee'dlecollar, placing between said sections a-'needle-havingan enlarged collar portion thereon intermediate its-ends, and hermetically sealing the combination at a temperature and pressure suflicient to cure said-plastic and sterilize said needle and providing an integral protective-casing thereabout.
2. A method-forencasing-a'hypodermic syringe needle in-a sterile; protective casing of rubber which comprises formingtwopa'rtiallyvulcanized sections of rubber in a mold,-each section-being provided with a thin longitudi- "nal recess to accommodate a needle and an enlarged -recess to accommodate aneedle collar, placing between said sections a needle having an enlarged collar portion thereon intermediate 'its ends, and hermetically sealing the combination at a temperature and pressure sufiicientto completevulcanizationof said rubber and sterilize said needle and providing an integral protective casing of rubber thereabout.
References'Cited' in the'file of this patent UNITED STATES PATENTS 7

Claims (1)

  1. 2. A METHOD FOR ENCASING A HYPODERMIC SYRINGE NEEDLE IN A STERILE, PROTECTIVE CASING OF RUBBER WHICH COMPRISES FORMING TWO PARTIALLY VULCANIZED SECTIONS OF RUBBER IN A MOLD, EACH SECTION BEING PROVIDED WITH A THIN LONGITUDINAL RECESS TO ACCOMMODATE TO NEEDLE AND AN ENLARGE RECESS TO ACCOMODATE A NEDDLE COLLAR, PLACING BETWEEN SAID SECTIONS A NEEDLE HAVING AN ENLARGED COLLAR PORTION
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US2938238A (en) * 1954-05-04 1960-05-31 Baxter Laboratories Inc Plastic collar secured to a member and method of attaching same
US2998880A (en) * 1958-06-19 1961-09-05 Bard Parker Company Inc Sterile surgical instrument and assembly
US3073307A (en) * 1959-10-28 1963-01-15 Brunswick Corp Needle hub and sheath structure
US3074540A (en) * 1959-07-31 1963-01-22 American Hospital Supply Corp Package for sterile articles
US3075639A (en) * 1960-03-07 1963-01-29 Baxter Laboratories Inc Hypodermic needles in blister package
US3127892A (en) * 1960-07-13 1964-04-07 Baxter Laboratories Inc Blood handling apparatus
US3217710A (en) * 1963-03-25 1965-11-16 Abbott Lab Blood collection and sampling apparatus provided with separable coupling means
US3294089A (en) * 1960-12-14 1966-12-27 Richard A Brookfield Hypodermic needle
US3376689A (en) * 1962-04-04 1968-04-09 Continental Can Co Packaging apparatus and method of utilizing the same
US4710180A (en) * 1986-10-06 1987-12-01 Johnson Gerald W Lipoject needle
US4845923A (en) * 1987-08-06 1989-07-11 Donovan Dennis M Contaminated sharp object disposal method
US4872552A (en) * 1988-11-16 1989-10-10 Mid-South Products Engineering, Inc. Safety packaging for hypodermic syringes with needles and the like
US4886071A (en) * 1983-10-28 1989-12-12 Becton, Dickinson And Company Package including syringe and needle
US4955580A (en) * 1986-01-28 1990-09-11 Coopervision Optics Limited Contact lens mold
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US5439453A (en) * 1994-03-25 1995-08-08 Kashanchi; Behnam Hypodermic needle storage apparatus
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US20010039401A1 (en) * 1999-11-04 2001-11-08 Safety Syringe Corporation Safety shield for medical needles
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US6780169B2 (en) 1999-08-23 2004-08-24 Becton, Dickinson And Company Safety shield assembly
US6796968B2 (en) 1999-11-04 2004-09-28 Tyco Healthcare Group Lp Reaccessible medical needle safety devices and methods
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US7029461B2 (en) 1999-11-04 2006-04-18 Tyco Healthcare Group Lp Safety shield for medical needles
US7144389B2 (en) 2001-03-14 2006-12-05 Tyco Healthcare Group, Lp Safety shield for medical needles
US20070016222A1 (en) * 2005-07-05 2007-01-18 Alcon, Inc. Handpiece tip assembly
US20070106224A1 (en) * 2001-07-09 2007-05-10 Becton, Dickinson And Company Needle shield assembly having hinged needle shield and flexible cannula lock
US7220249B2 (en) 2001-06-06 2007-05-22 Becton, Dickinson And Company Hinged needle shield assembly having needle cannula lock
US20070239117A1 (en) * 2006-03-21 2007-10-11 Chelak Todd M Passive latch ring safety shield for injection devices
US7300423B2 (en) 2003-02-14 2007-11-27 Tyco Healthcare Group Lp Safety device with trigger mechanism
US7320682B2 (en) 1999-11-18 2008-01-22 Tyco Healthcare Group Lp Safety device
US20080208138A1 (en) * 2007-02-26 2008-08-28 Becton, Dickinson & Company Syringe having a hinged needle shield
US7553296B2 (en) 2003-02-14 2009-06-30 Tyco Healthcare Group Lp Safety device with trigger mechanism
US7615033B2 (en) 2004-08-16 2009-11-10 Becton, Dickinson And Company Flashback blood collection needle
US20100298739A1 (en) * 2007-04-26 2010-11-25 Tyco Healthcare Group Lp Multifunctional Medical Access Device
US8172809B2 (en) 1999-11-04 2012-05-08 Tyco Healthcare Group Lp Safety shield apparatus and mounting structure for use with medical needle devices
US20140364887A1 (en) * 2013-06-10 2014-12-11 Facet Technologies, Llc Intra-mold sterilization of plastic-embedded needle

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