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WO2005060679A2 - Dispositif de protection pour aiguilles medicales - Google Patents

Dispositif de protection pour aiguilles medicales Download PDF

Info

Publication number
WO2005060679A2
WO2005060679A2 PCT/US2004/042560 US2004042560W WO2005060679A2 WO 2005060679 A2 WO2005060679 A2 WO 2005060679A2 US 2004042560 W US2004042560 W US 2004042560W WO 2005060679 A2 WO2005060679 A2 WO 2005060679A2
Authority
WO
WIPO (PCT)
Prior art keywords
needle
shield
hub
medical
retention element
Prior art date
Application number
PCT/US2004/042560
Other languages
English (en)
Other versions
WO2005060679A3 (fr
Inventor
Mark F. Ferguson
Donald Solomon
Roy Barrus
Jeremy Snow
Original Assignee
Specialized Health Products, Inc.
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
Priority claimed from US10/739,868 external-priority patent/US7413562B2/en
Application filed by Specialized Health Products, Inc. filed Critical Specialized Health Products, Inc.
Publication of WO2005060679A2 publication Critical patent/WO2005060679A2/fr
Publication of WO2005060679A3 publication Critical patent/WO2005060679A3/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
    • A61M5/3205—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
    • A61M5/3273—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel freely sliding on needle shaft without connection to syringe or needle

Definitions

  • the present disclosure generally relates to safety shields for medical needles, and more particularly, to safety shields that protect a needle point of a medical needle. 2. Description of the Related Art Problems associated with inadvertent needle sticks are well known in the art of blood sampling, percutaneous medication injection and other medical procedures involving use of medical needles. Significant attention has been focused on needle stick problems due to the contemporary sensitivity of exposure to AIDS, Hepatitis and other serious blood-borne pathogen exposures. Procedures for removing a needle from a patient commonly require a technician to use one hand to place pressure at the wound site where the needle is being withdrawn, while removing the needle device with the other hand.
  • a medical needle shield apparatus in accordance with the principles of the present disclosure.
  • the medical needle shield apparatus includes a needle hub having an outer needle cannula extending therefrom to a distal end.
  • An inner needle is disposed for slidable movement with the outer needle cannula.
  • At least one shield is extensible from a retracted position to an extended position to enclose a distal end of the inner needle.
  • the shield includes a binding member disposed within the shield and defines binding surfaces that form an aperture configured for slidable receipt of the inner needle between the retracted position and the extended position.
  • the binding member includes at least one drag inducing member such that the member engages the inner needle during slidable receipt of the inner needle to create a drag force with the inner needle.
  • the drag force facilitates inclination of the binding member relative to a longitudinal axis of the inner needle such that the binding surfaces engage the inner needle to prevent slidable movement of the inner needle in the extended position of the shield.
  • the binding member further includes a retainer extending therefrom such that the retainer is engageable with the inner needle to prevent inclination of the binding member prior to the extended position.
  • the binding member may be inclinable, relative to a longitudinal axis of the inner needle, between a non-binding orientation whereby the inner needle is slidable relative to the binding member and a binding orientation whereby the binding surfaces engage the inner needle to prevent slidable movement of the inner needle in the extended position of the at least one shield.
  • the binding member may include one or more outwardly arcuate arms that extend to the needle-communicating surface.
  • the inner needle can be attached to a handle for manipulation thereof.
  • the needle hub may define a hub slot configured for receipt of a retention element.
  • the needle hub may be releasably mountable with a housing of the at least one shield.
  • the medical needle shield apparatus may further include a plurality of shields.
  • the at least one drag inducing member may define a cavity that is substantially aligned with the aperture.
  • the cavity is configured for slidable receipt of the needle to create the drag force with the needle.
  • the binding member may include a substantially planar aperture plate that includes the binding surfaces that form the aperture.
  • the at least one drag inducing member may include a pair of arms extending from the aperture plate. The arms can have curled end portions spaced apart from the aperture plate.
  • the arms can include deflectable members.
  • the shield can include a housing that defines at least one blocking member extending from an interior surface thereof. The at least one blocking member can be engageable with the binding member for urging the binding member to a binding orientation.
  • the aperture plate is axially movable for engagement with the at least one blocking member that causes inclination of the binding member to a binding orientation.
  • the medical needle shield apparatus may further include an outer housing that encloses the at least one shield.
  • the outer housing supports the at least one shield for relative rotational movement therewith.
  • the at least one shield can be supported for relative rotational movement by the outer housing by at least one bearing.
  • the shield also includes a sheath retention element extending therefrom.
  • the sheath retention element has a releasable fit with a sheath such that disengagement of the sheath with the sheath retention element does not disengage the retention element engaged between the shield and the hub.
  • the sheath retention element can be configured for press fit, snap fit or threaded fit with the sheath, for example.
  • a hub retention element is formed with the shield and configured for releasable engagement with a shield retention element formed with the needle hub.
  • the shield includes a binding member disposed within the shield.
  • the binding member defines binding surfaces that form an aperture configured for slidable receipt of the outer needle cannula between the retracted position and the extended position.
  • the binding member includes at least one drag inducing member which engages the outer needle cannula during slidable receipt of the outer needle cannula to create a drag force with the outer needle cannula.
  • the drag force facilitates inclination of the binding member relative to a longitudinal axis of the outer needle cannula such that the binding surfaces engage the outer needle cannula to prevent slidable movement of the outer needle cannula in the extended position of the shield.
  • the binding member further includes a retainer exitending therefrom such that the retainer is engageable with the outer needle cannula to prevent inclination of the binding member.
  • the present disclosure provides a medical needle shield apparatus including a needle hub and a needle disposed with the hub.
  • the needle hub includes a magnifier section configured for viewing fluid flashback exiting the needle.
  • At least one shield is extensible from a retracted position to an extended position to enclose a distal end of the needle.
  • a binding member is disposed within the shield and defines binding surfaces that form an aperture configured for slidable receipt of the inner needle between the retracted position and the extended position.
  • the magnifier includes a curved section defining a viewing area that refracts light from a smaller focal area for magnified viewing thereof.
  • the medical needle shield apparatus according to this embodiment can be configured for use with particular hubs known in the art such as, for example, one- wall introducer needle hubs, biopsy needle hubs, spinal hubs or epidural hubs.
  • the medical needle shield as described herein can be adapted for use with a
  • FIGURE 1 is a perspective view of one particular embodiment of a medical needle shield apparatus in accordance with the principles of the present disclosure
  • FIGURE 2 is a perspective view of a needle device for insertion through the needle device shown in FIGURE 1
  • FIGURE 3 is a perspective view of the needle device shown in FIGURE 2 inserted into the needle device shown in FIGURE 1
  • FIGURE 4 is a cross-sectional perspective view of the medical shield apparatus as shown in FIGURE 3
  • FIGURE 5 is an enlarged cutaway perspective view of the medical shield apparatus as shown in FIGURE 3
  • FIGURE 6 is a perspective view of the needle device shown in FIGURE 3 with the shield apparatus in the extended position
  • FIGURE 7 is a cross-sectional perspective view of the medical shield apparatus as shown in FIGURE 6
  • FIGURE 8 is an enlarged cutaway perspective view of the medical shield apparatus as
  • the exemplary embodiments of the medical needle shield apparatus and methods of operation disclosed are discussed in terms of medical needles for infusion of intravenous fluids, medication infusion or fluid collection, guiding of other needles, e.g., biopsy, and more particularly, in terms of needle shield apparatus employed with a needle cannula that prevent hazardous exposure to the needle tip, including, for example, inadvertent needle sticks. It is envisioned that the present disclosure, however, finds application to a wide variety of cannula needles and devices for the infusion of preventive medications, medicaments, therapeutics, etc.
  • a subject such as, for example, epidural needles, spinal needles, biopsy needles, chiba needles, potts cournand needles, coaxial introducer needles, Y-sites, etc.
  • a subject such as epidural needles, spinal needles, biopsy needles, chiba needles, potts cournand needles, coaxial introducer needles, Y-sites, etc.
  • the present disclosure may be employed for collection of body fluids and/or tissues, including those collected during procedures relating to soft tissue biopsy, bone biopsy, phlebotomy, digestive, intestinal, urinary, veterinary, etc.
  • the medical needle shield apparatus may be utilized with other medical needle applications including, but not limited to, fluid infusion, fluid collection, catheters, catheter introducers, guide wire introducers, biopsy needle introducers, spinal and epidural, biopsy, aphaeresis, dialysis, blood donor, Neress needles, Huber needles, etc.
  • proximal refers to a portion of a structure that is closer to a clinician
  • distal refers to a portion that is further from the clinician.
  • the term “subject” refers to a patient that receives infusions or has blood, fluid and/or tissue collected therefrom using the medical needle shield apparatus.
  • the term "clinician” refers to an individual administering an infusion, performing fluid or tissue collection, installing or removing a needle cannula from a medical needle shield apparatus and may include support personnel.
  • the following discussion includes a description of the medical needle shield apparatus, followed by a description of the method of operating the medical needle shield apparatus in accordance with the present disclosure.
  • the medical needle shield apparatus includes a shield 46 that is extensible from a retracted position (FIGURES 1 and 3) to an extended position (FIGURE 6) to enclose a distal end 50 of inner needle 51.
  • shield 46 In the retracted position, shield 46 is disposed adjacent to a needle hub 45 of outer needle 43.
  • inner needle 51 in FIGURES 1-8 is shown as an epidural needle point, it is envisioned that shield 46 may be used with any needle tip.
  • the needle assembly includes a hollow outer needle 43.
  • Inner needle 51 is slideably and concentrically disposed with outer needle 43 for employment therewith during a medical needle application, as will be discussed.
  • a handle 52 is comiected to inner needle 51 to facilitate manipulation thereof.
  • a binding member 47 is disposed within shield 46 and defines binding surfaces 60. Binding surfaces 60 form an aperture 62 configured for slidable receipt of inner needle 51 and outer needle 43 between the retracted position and the extended position of shield 46. Binding member 47 includes a drag inducing member, such as, for example, friction members 64 extending therefrom. Binding member 47 has a retainer 57 that is engageable with outer needle 43 and inner needle 51 to prevent inclination of binding member 47. Friction members 62 are configured for slidable engagement with outer needle
  • binding member 47 moves to a binding position (FIGURES 7 and 8).
  • the force created by blocking members 48 and/or 55 acts in a direction opposite to the drag force. This causes a force couple, which moves binding member 47 to the binding position.
  • binding member 47 moves to the binding position. Inclination of binding member 47 is no longer opposed by engagement with inner needle 51 at retainer 57.
  • binding member 47 is subject to inclination into the binding position.
  • binding member 47 causes binding surfaces 60 to frictionally engage inner needle 51 to prevent movement thereof.
  • Blocking members 48 and/or 55 cause binding member 47 to move to the binding position as forces imposed on shield 46 cause relative movement thereof in either direction along longitudinal axis x. This maintains inner needle 51 within shield 46 to avoid hazardous exposure to distal end 51.
  • retainer 57 may include ribs, projections, cavities, etc. for engagement with inner needle 51 or that a portion of retainer 57 engages inner needle 51.
  • Shield 46 includes a housing 66 that encloses binding member 47. In the illustrative embodiment, housing 66 may comprise two separate sections.
  • housing sections may be variously configured and dimensioned such as, for example, rectangular, spherical, etc. It is further envisioned that the housing sections may be joined by any appropriate process such as, for example, snap fit, adhesive, solvent weld, thermal weld, ultrasonic weld, screw, rivet, etc.
  • housing 66 may be monolithically formed or integrally assembled of multiple housing sections and may be substantially transparent, opaque, etc. Housing 66 may include ribs, ridges, etc. to facilitate manipulation of the medical needle shield apparatus. It is contemplated that binding surfaces 60 may include sharp edges to increase frictional engagement.
  • the binding friction force may be created and varied by one or more altering factors, such as, for example, aperture 62 configuration and dimension, inner needle 51 configuration and dimension, binding member 47 thickness, the dimension from blocking members 48, 55 contact point to the centerline of inner needle 51, and the coefficient of friction between aperture 62 and inner needle 51 depending on the particular requirements of a needle application.
  • friction members 64 may be configured so as to vary the drag force with variation of the inclination of the binding member 47, this variation in drag force may be accomplished by geometric changes in the shape of the friction members 64, such as wedge shapes or the inclusion of notches to engage inner needle 51.
  • This variation in drag force may also be accomplished through the selective application of friction modifying materials or coatings such as oils, jells, greases, or coatings which increase friction.
  • an introducer needle such as outer needle 43
  • inner needle 51 having a smaller diameter which is placed within and concentric to the outer needle 43.
  • the inner needle 51 is inserted through the outer needle 43 fo ⁇ ning a co-axial assembly 49.
  • the co-axial assembly 49 may be removed all together and intact from the patient as illustrated in FIGURE 3.
  • the safety shield 46 is extended from the retracted position adjacent to hub 45, beyond the point 44 of outer needle 43, and out to the sharp point 50 of inner needle 51. Since the inner needle 51 is through outer needle 43, the binding member 47 cannot pivot to lock to the point 44 of outer needle 43. Binding member 47 must continue to be advanced to the sharp point 50 of inner needle 51 where retainer 57 senses the end of the device (i.e., sharp point 50) and binding member 47 moves into a binding orientation on inner needle 51 as previously described. The outer needle point 44 is protected by the inner needle 51 that is through the bore of outer needle 43.
  • an embodiment of the medical needle shield apparatus includes means for releasably retaining the safety shield to the hub of a medical needle.
  • the hub 101 includes a safety shield retention element 102, which interacts with a hub retention element on the safety shield 104. This interaction retains the safety shield 104 to the hub 101 until intentionally removed.
  • the interaction may include, for example, a bayonet fitting, ramp, detents (see e.g., FIGURE 6 showing detent 68 and corresponding slot 70 in hub 45), snaps deformable geometry, friction fitting suction, magnets or any suitable removable retention configurations kno i in the art.
  • the safety shield may be released from the retention element 118 by overcoming the interaction method.
  • One configuration shown in FIGURES 12 - 17 includes a bayonet fitting. This fitting is overcome, for example, by rotating the safety shield 104 and then extending the safety shield 104 distally. Other such fittings and interaction methods are similarly overcome.
  • This configuration also provides a safety shield 104 with an external grip element 110. The external grip element may be used to facilitate actuation of the safety shield 104.
  • a safety shield 104 based on a binding component as described herein, is adapted for use with external grip element 110.
  • the external grip element can include, for example, wings, tabs, buttons, annular rims, and the like. Selected textures such as ribs, grips contours and the like may also be provided on the safety shield surface to aid griping.
  • FIGURES 18 - 20 depicted is another means for releasably retaining the safety shield to the hub of a medical needle.
  • Safety shield 104 includes a safety shield retention element 118, which interacts with hub 101 via a friction fit at surface 105. This interaction retains the safety shield 104 to the hub 101 until intentionally removed.
  • the interaction between retention element 118 and hub 101 may also serve as an alignment feature for safety shield 104 relative to the hub 101.
  • the safety shield may be released from the retention element 118 by overcoming the friction fit at surface 105. It is envisioned that one or more retention elements 118 may be utilized.
  • FIGURE 20 shows another embodiment of retention element 118 for releasably retaining the safety shield to the hub of a medical needle.
  • Retention element 118 includes an extended surface, which interacts with hub 101 via a friction fit at surface 105. This interaction retains the safety shield 104 to the hub 101 until intentionally removed.
  • retention element 118 may also serve as an alignment feature for safety shield 104 relative to the hub 101.
  • the safety shield may be released from the retention element 118 by overcoming the friction fit at surface 105.
  • one or more retention elements 118 may be utilized.
  • a particular configuration shown in FIGURES 21 - 23 includes a sheath 120 fitting to safety shield 104 by means of a sheath retention element 121.
  • the sheath retention element may be coupled with safety shield retention element 102 such that removal of the sheath 120 does not interfere or dislodge the safety shield 104.
  • the sheath retention element 121 may include, for example, friction fit, press fit, suction, bayonet fitting, detents, deformable geometry, snaps and the like.
  • FIGURES 24 - 26 another particular embodiment of the medical safety shield apparatus according to the present disclosure includes a hub 201 having a magnifier section 202 for viewing fluid flashback therein.
  • Hub 201 includes a magnifier section 202 formed or installed with the hub 201 for viewing fluid flashback directly after the flashback exits needle 203.
  • Viewing area 204 of the magnifier section 202 as shown in FIGURE 25 is larger than a focal area 205 of the magnifier section 202.
  • a clinician is thereby allowed to view a small section of flashback area 206 through a larger viewing area 204 to more easily view fluid flashback and thereby decrease response time to certain medical procedures.
  • Magnifier section 202 on hub 201 enhances viewing of focal area 205 by refracting light from focal area 205 to the clinician's viewing area 204.
  • FIGURE 26 illustrates refraction of light from focal area 205 through the magnifier section 202 as the light passes through curved section 207 of viewing area 204 from focal area 205.
  • the focal area 205 is thereby magnified when viewed from viewing area 204 and visual detection of fluid flashback is thereby enhanced.
  • the size and location of focal area 205 and the amount of magnification are dependent on the curvature of curved section 207.
  • Focal area 205, curved section 207 and viewing area 204 can be adapted to better suit a specific application.
  • adaptations include, but are not limited to, large and smaller focal areas 205, more or less magnification, and larger or smaller viewing areas 2O4.
  • magnifier section 202 can be constructed from any of a large number of transparent materials such as, for example, polycarbonate, polystyrene, acrylic, PNC, glass or the like. It is further contemplated that magnifier section 202 may be formed integrally with hub 201, for example, wherein hub 201 is constructed from a substantially transparent material.
  • the invention of the present disclosure may be embodied in other specific forms without departing from the spirit or essential characteristics thereof.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Environmental & Geological Engineering (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne un dispositif de protection pour aiguilles médicales comprenant un embout d'aiguille à partir duquel s'étend un tube d'aiguille. Au moins un dispositif de protection peut passer d'une position rétractée à une position déployée de manière à recouvrir une extrémité distale de l'aiguille. Le dispositif de protection comprend un élément de liaison disposé à l'intérieur du dispositif de protection, comportant des surfaces de liaison formant une ouverture conçue pour recevoir l'aiguille de manière coulissante. L'élément de liaison comprend au moins un élément de retenue conçu pour entrer en prise avec l'aiguille lorsqu'elle est introduite dans le dispositif de protection pour créer une force de résistance. La force de résistance facilite l'inclinaison de l'élément de liaison, les surfaces de liaison entrant en prise avec l'aiguille pour éviter que le dispositif de protection ne glisse de l'aiguille. Le dispositif de protection comprend au moins un élément de retenue pouvant entrer en prise entre le dispositif de protection et l'embout d'aiguille.
PCT/US2004/042560 2003-12-18 2004-12-17 Dispositif de protection pour aiguilles medicales WO2005060679A2 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US10/739,868 US7413562B2 (en) 2001-03-15 2003-12-18 Safety shield for medical needles
US10/739,868 2003-12-18
US62919704P 2004-11-18 2004-11-18
US60/629,197 2004-11-18

Publications (2)

Publication Number Publication Date
WO2005060679A2 true WO2005060679A2 (fr) 2005-07-07
WO2005060679A3 WO2005060679A3 (fr) 2005-10-20

Family

ID=34713875

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2004/042560 WO2005060679A2 (fr) 2003-12-18 2004-12-17 Dispositif de protection pour aiguilles medicales

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WO (1) WO2005060679A2 (fr)

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7654735B2 (en) 2005-11-03 2010-02-02 Covidien Ag Electronic thermometer
US7731692B2 (en) 2005-07-11 2010-06-08 Covidien Ag Device for shielding a sharp tip of a cannula and method of using the same
US7828773B2 (en) 2005-07-11 2010-11-09 Covidien Ag Safety reset key and needle assembly
US7905857B2 (en) 2005-07-11 2011-03-15 Covidien Ag Needle assembly including obturator with safety reset
US8357104B2 (en) 2007-11-01 2013-01-22 Coviden Lp Active stylet safety shield
US8834417B2 (en) 2005-06-06 2014-09-16 Covidien Ag Needle assembly with removable depth stop
US8844112B2 (en) 2005-04-18 2014-09-30 Specialized Health Products, Inc. Methods of manufacturing safety shields for medical needles and related manufacturing devices

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5423766A (en) * 1994-08-26 1995-06-13 Becton, Dickinson And Company Safety shield having spring tether
US6117108A (en) * 1997-08-20 2000-09-12 Braun Melsungen Ag Spring clip safety IV catheter

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8844112B2 (en) 2005-04-18 2014-09-30 Specialized Health Products, Inc. Methods of manufacturing safety shields for medical needles and related manufacturing devices
US8834417B2 (en) 2005-06-06 2014-09-16 Covidien Ag Needle assembly with removable depth stop
US7731692B2 (en) 2005-07-11 2010-06-08 Covidien Ag Device for shielding a sharp tip of a cannula and method of using the same
US7828773B2 (en) 2005-07-11 2010-11-09 Covidien Ag Safety reset key and needle assembly
US7905857B2 (en) 2005-07-11 2011-03-15 Covidien Ag Needle assembly including obturator with safety reset
US7976498B2 (en) 2005-07-11 2011-07-12 Tyco Healthcare Group Lp Needle assembly including obturator with safety reset
US8162889B2 (en) 2005-07-11 2012-04-24 Covidien Ag Safety reset key and needle assembly
US8348894B2 (en) 2005-07-11 2013-01-08 Covidien Lp Needle assembly including obturator with safety reset
US7654735B2 (en) 2005-11-03 2010-02-02 Covidien Ag Electronic thermometer
US8357104B2 (en) 2007-11-01 2013-01-22 Coviden Lp Active stylet safety shield

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