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WO2008118170A1 - Garde automatique d'aiguille pour stylo médicamenteux - Google Patents

Garde automatique d'aiguille pour stylo médicamenteux Download PDF

Info

Publication number
WO2008118170A1
WO2008118170A1 PCT/US2007/064908 US2007064908W WO2008118170A1 WO 2008118170 A1 WO2008118170 A1 WO 2008118170A1 US 2007064908 W US2007064908 W US 2007064908W WO 2008118170 A1 WO2008118170 A1 WO 2008118170A1
Authority
WO
WIPO (PCT)
Prior art keywords
guard
needle
adapter
boss
slot
Prior art date
Application number
PCT/US2007/064908
Other languages
English (en)
Inventor
Don Millerd
Original Assignee
Visual Connections, 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
Application filed by Visual Connections, Inc. filed Critical Visual Connections, Inc.
Priority to PCT/US2007/064908 priority Critical patent/WO2008118170A1/fr
Publication of WO2008118170A1 publication Critical patent/WO2008118170A1/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
    • A61M5/326—Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
    • 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
    • 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
    • A61M5/326—Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
    • A61M2005/3267—Biased sleeves where the needle is uncovered by insertion of the needle into a patient's body
    • 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
    • A61M5/3202—Devices for protection of the needle before use, e.g. caps
    • 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
    • A61M5/3271—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel with guiding tracks for controlled sliding of needle protective sleeve from needle exposing to needle covering position

Definitions

  • the present invention pertains generally to needle protection devices. More particularly, the present invention pertains to needle protection devices that use a cylindrical guard to extend beyond the needle's tip to prevent contact with the tip.
  • the present invention is particularly, but not exclusively useful as a needle protection device that uses cooperation between a "V" shaped slot and a radially-extending boss to limit relative movement between the guard and the needle.
  • Needles are very common in medical practices, and are frequently used to deliver medications or to draw blood for diagnosis. As a result of their intensive use, it is estimated that some 600,000 to 800,000 accidental needle stick injuries occur every year. Further, there are roughly 8,000,000 healthcare workers in the United States who are at risk of being stuck with a contaminated needle. As the risks involved in providing medical treatment have risen and individual safety and sanitation are taken into consideration, disposable or single-use type of injection devices have become prevalent. While safer than reusable injection devices, these needles must still be handled carefully and the needle tips must be covered before and after use. Although currently there exist various needle protection devices, most require the user to take an affirmative step to cover the needle tip after its use, thereby causing potential risk of contact with the needle. Other devices require specially designed needles, plungers, or medicament chambers.
  • a protective device that can be installed on a needle to ensure there is only a single use of the needle. It is another object of the present invention to provide a protective device having a guard that passively covers and protects the needle after an injection. It is another object of the present invention to provide a protective device that controls movement of the guard relative to the needle. Still another object of the present invention is to provide a protective device that requires an affirmative step to uncover the needle, but automatically covers the needle after an injection. Yet another object of the present invention is to provide a protective device for a needle that is relatively easy to manufacture, reliable and easy to use, and is comparatively cost effective.
  • a needle protection device in accordance with the present invention, includes an adapter for holding a needle.
  • the device also includes a guard having a cylindrical wall that is dimensioned to engage the adapter for relative axial movement therebetween. Such movement is biased by a spring that urges the guard away from the adapter.
  • the guard includes an orifice for selectively passing the needle therethrough.
  • the guard is provided with a "V" shaped slot having a first leg and a second leg with an apex therebetween.
  • the adapter is provided with a radially- extending boss. The boss is received within the slot to limit relative movement between the guard and the adapter.
  • the device is only moveable from a first position to a second position, and from the second position to a third position.
  • the boss In the first position, the boss is in the first leg of the slot and the needle partially extends through the orifice of the guard.
  • the needle In the second position, the needle fully extends through the orifice of the guard and the boss is held at the apex of the slot in response to a force opposing the biasing means.
  • the boss In the third position, the boss is in the second leg of the slot and the needle is retracted into the guard to protect the needle.
  • the boss is provided with an engagement face that is designed to interact with the slot to ensure that the boss moves to the end of the second leg from the apex during movement of the guard from the second position to the third position.
  • the face is inclined toward the second leg, so that contact between the face on the boss and the edge of the slot causes the boss to move toward the end of the second leg.
  • the device may further include a removable shield.
  • the shield includes a hollow portion for receiving the needle.
  • the shield includes a radially extending rib that can be selectively positioned in the orifice of the guard to prevent axial movement of the guard from the first position to the second position.
  • the device may further include a locking mechanism that locks the device in the third position, to thereby prevent further relative movement between the guard and the adapter.
  • the adapter is provided with a shoulder that extends radially outward
  • the guard is provided with an abutment that extends radially inward.
  • FIG. 1A is a perspective view of a needle protection device of the present invention
  • Fig. 1 B is a perspective view of the guard shown in Fig. 1A, illustrating the movement of the boss in the "V" shaped slot;
  • Fig. 2A is a cross section view of the needle protection device of Fig. 1A, as seen along line 2-2 in Fig. 1 B;
  • Fig. 2B is a cross section view of the needle protection device of Fig. 2A with the removable shield rotated for removal in accordance with the present invention;
  • Fig. 3 is a cross section view of the needle protection device of Fig. 2B, as seen along line 3-3 in Fig. 1 B, with the shield removed and the needle inserted into a subject in accordance with the present invention;
  • Fig. 4A is a cross section view of the needle protection device of Fig. 3, as seen along line 4-4 in Fig. 1B, with the needle withdrawn from the subject and the guard advanced to cover the needle tip in accordance with the present invention;
  • Fig. 4B is a cross section view of the needle protection device of Fig. 4A, as seen from a view taken ninety degrees from the view in Fig. 4A;
  • Fig. 5 is a side view of the slot and boss arrangement showing the configuration of the slot and the boss in the first, second and third positions.
  • a needle protection device in accordance with the present invention is shown and generally designated 10.
  • the device 10 covers a needle 12 (shown in phantom) to prevent inadvertent contact with the needle tip 14.
  • the needle 12 defines an axis 16, a proximal direction 15 and a distal direction 17.
  • the device 10 includes a guard 18 having a cylindrical wall 20 that slidingly engages an adapter 22.
  • the wall 20 includes a radially extending "V" shaped slot 24 that corresponds with and receives a boss 26 that extends radially outward from the adapter 22.
  • the slot 24 includes a first leg 28 which meets a longer second leg 30 at an apex 32.
  • the boss 26 is positioned in the first leg 28 of the slot 24.
  • the slot 24 and boss 26 cooperate to guide axial movement of the guard 18 relative to the adapter 22.
  • the guard 18 is shown as including an axially extending orifice 34 that is formed with a long axis 36 and a short axis 38.
  • the device 10 includes a removable shield 40.
  • the shield 40 is shown passing through the orifice 34 and including radially extending grips 42 to facilitate rotation of the shield 40 about the axis 16 as discussed below.
  • the device 10 further includes a spring 44 that biases the guard 18 away from the adapter 22.
  • the boss 26' is positioned in the first leg 28 of the slot 24 (i.e., the first position of the device 10), the boss 26" is positioned at the apex 32 of the slot 24 (i.e., the second position of the device 10), and the boss 26'" is positioned in the second leg 30 of the slot 24 (i.e., the third position of the device 10).
  • movement of the boss 26 between these positions results in rotational movement of the guard 18 about the axis 16 relative to the adapter 22, particularly during movement from boss 26' to boss 26".
  • Figs. 2A and 2B internal components and features of the device 10 can be seen.
  • the adapter 22 includes an axially- extending and substantially cylindrical base member 46 centered about the axis 16. Further, the adapter 22 includes a radially-extending cap member 48. As shown, the adapter 22 has an external surface 50 and an internal surface 52, with the internal surface 52 defining an internal cavity 54. As further shown, the needle 12 passes through an aperture 56 formed in the cap member 48.
  • the cylindrical wall 20 includes an outer side 58 and an inner side 60.
  • the inner side 60 defines a chamber 62 in which the adapter 22 is partially received.
  • the chamber 62 is further bounded by an end member 64 mounted to the cylindrical wall 20 and forming the orifice 34.
  • the spring 44 is positioned in the chamber 62 between the cap member 48 of the adapter 22 and the end member 64 of the guard 18 to bias the guard 18 axially away from the adapter 22.
  • the device 10 includes a removable shield 40 having a hollow portion 66 for receiving the needle 12.
  • the shield 40 includes radially extending ribs 68 that are engaged with the guard 18 and the adapter 22. In the orientation of Fig. 2A, the ribs 68 prevent axial movement of the guard 18 toward the adapter 22.
  • FIG. 2B depicts the shield 40 of Fig. 2A after the shield 40 has been rotated ninety degrees about the axis 16.
  • the ribs 68 are aligned with the long axis 36 of the orifice 34 (see Fig. 1A) and the shield 40 may be removed from the device 10.
  • the device 10 is stored and transported in the orientation shown in Fig. 2A.
  • the shield 40 is rotated as in Fig. 2B and is removed. Regardless of the position of the shield 40, each of Figs. 1A, 2A and 2B depict the device in a first position 70 in which the boss 26 is received within the first leg 28 of the slot 24.
  • the guard 18 may be moved in the proximal direction 15 toward the adapter 22 if a sufficient force is applied thereto. Specifically, if a force greater than the biasing force of the spring 44 is applied.
  • Fig. 3 the result of an application of such a force is shown.
  • the needle 12 has been injected into a subject 72.
  • the force of the subject 72 on the guard 18 has caused the guard 18 to move toward the adapter 22.
  • the device 10 has moved to the second position 74 in which the boss 26 is positioned at the apex 32 of the slot 24.
  • the boss 26 reaches the apex 32, further movement of the guard 18 toward the adapter 22 is prevented by the interaction between the slot 24 and the boss 26.
  • the needle 12 After the needle 12 has injected a fluid 76 into the subject 72, the needle 12 is withdrawn from the subject 72. During withdrawal, the spring 44 pushes the guard 18 away from the adapter 22.
  • the boss 26 moves from the apex 32 to the second leg 30 (as shown in Fig. 4A).
  • the boss 26 is provided with an engagement face 78.
  • the face 78 is inclined toward the second leg 30 so that when the boss 26 moves out of the apex 32 it slides to the end of the second leg 30.
  • Fig. 4A the device 10 is shown in its third position 80 with the boss 26 in the second leg 30. As shown, the guard 18 is extended and fully covers the needle tip 14. In order to prevent any further use of the needle 12, the device 10 is provided with the locking mechanism 82 seen in Fig. 4B.
  • Fig. 4B is a cross section view of the device 10 taken from a view ninety degrees from the view in Fig. 4A. Approximately ninety degrees from the bosses 26 shown in Fig. 4A are two shoulders 84 shown in Fig. 4B that extend radially outward from the adapter 22. As further seen in Fig. 4B, the device 10 includes two corresponding abutments 86 that extend radially inward from the guard 18.
  • the shoulders 84 and abutments 86 are tapered. This construction allows the shoulders 84 to slide in the proximal direction 15 along the inner side 60 of the guard 18 until they pass the abutments 86. Once the shoulders 84 pass the abutments 86, the guard 18 can no longer be moved toward the adapter 22. As a result, the device 10 is locked with the needle 12 protected by the guard 18.
  • the boss 26 is shown in the various stations (indicated by 26', 26", and 26"') it passes through during operation of the device 10. Specifically, the boss 26' is shown in the first leg 28 adjacent the first stop 88 when the device 10 is in the first position 70.
  • the first stop 88 may serve to prevent axial movement of the guard 18 away from the adapter 22.
  • the shield 40 prevents axial movement of the guard 18 toward the adapter 22 when the ribs 68 are positioned between the guard 18 and adapter 22.
  • the spring 44 retains the boss 26' in the first leg 28.
  • the spring 44 forces the guard 18 away from the adapter 22 in the distal direction 17.
  • the boss 26" moves axially away from the apex 32 to its position at boss 26"' in the second leg 30 of the slot 24.
  • the engagement face 78 may contact the edge 90 of the slot 24. Due to the inclination of the engagement face 78 toward the second leg 30 and the slope of the edge 90 of the slot 24, contact between the boss 26 and the edge 90 of the slot 24 causes the boss 26 to move to the second stop 92 of the second leg 30.
  • the boss 26" may move substantially in the proximal direction 15 directly to the second stop 92 of the second leg 30.
  • the spring 44 forces the guard 18 away from the adapter 22 until the boss 26"' contacts the second stop 92 or until further axial movement of the guard 18 away from the adapter 22 is otherwise prevented.
  • the locking mechanism 82 then prevents any further relative movement between the guard 18 and the adapter 22.

Landscapes

  • 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

La présente invention concerne un dispositif de protection sélective d'aiguille qui comprend un adaptateur qui retient l'aiguille et une garde qui s'engage dans l'adaptateur pour y réaliser un mouvement relatif. En outre, le dispositif comprend un moyen de mouvement de guidage entre l'adaptateur et la garde. Structurellement, le moyen de guidage comprend une fente en forme de 'V' dans le capot et une protubérance qui s'étend radialement sur l'adaptateur. Cette protubérance est hébergée dans la fente pour limiter le mouvement relatif entre la garde et l'adaptateur. Spécifiquement, dans une première position du dispositif, la protubérance est dans une première section de la fente et l'aiguille sort partiellement de la garde. Dans une deuxième position, la protubérance est retenue à l'apex de la fente et l'aiguille sort complètement de la garde. Dans une troisième position, la protubérance se situe dans la seconde section de la fente et l'aiguille est rétractée dans la garde pour protéger l'aiguille.
PCT/US2007/064908 2007-03-26 2007-03-26 Garde automatique d'aiguille pour stylo médicamenteux WO2008118170A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/US2007/064908 WO2008118170A1 (fr) 2007-03-26 2007-03-26 Garde automatique d'aiguille pour stylo médicamenteux

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US2007/064908 WO2008118170A1 (fr) 2007-03-26 2007-03-26 Garde automatique d'aiguille pour stylo médicamenteux

Publications (1)

Publication Number Publication Date
WO2008118170A1 true WO2008118170A1 (fr) 2008-10-02

Family

ID=39788780

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2007/064908 WO2008118170A1 (fr) 2007-03-26 2007-03-26 Garde automatique d'aiguille pour stylo médicamenteux

Country Status (1)

Country Link
WO (1) WO2008118170A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016055241A1 (fr) * 2014-10-08 2016-04-14 Carebay Europe Ltd Ensemble de couverture d'aiguille
CN108678396A (zh) * 2018-05-31 2018-10-19 湖北沛函建设有限公司 吊装式建筑支撑装置的基座结构

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4932940A (en) * 1988-06-06 1990-06-12 Walker Cedric F Needle guard device
US5591138A (en) * 1995-08-10 1997-01-07 Vaillancourt; Vincent L. Protected needle assembly
US20010037088A1 (en) * 2000-04-05 2001-11-01 Domici John K. Safety syringe
US20060189933A1 (en) * 2005-02-18 2006-08-24 Becton, Dickinson And Company Safety shield system for a syringe

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4932940A (en) * 1988-06-06 1990-06-12 Walker Cedric F Needle guard device
US5591138A (en) * 1995-08-10 1997-01-07 Vaillancourt; Vincent L. Protected needle assembly
US20010037088A1 (en) * 2000-04-05 2001-11-01 Domici John K. Safety syringe
US20060189933A1 (en) * 2005-02-18 2006-08-24 Becton, Dickinson And Company Safety shield system for a syringe

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016055241A1 (fr) * 2014-10-08 2016-04-14 Carebay Europe Ltd Ensemble de couverture d'aiguille
US10751479B2 (en) 2014-10-08 2020-08-25 Shl Medical Ag Needle cover assembly
CN108678396A (zh) * 2018-05-31 2018-10-19 湖北沛函建设有限公司 吊装式建筑支撑装置的基座结构
CN108678396B (zh) * 2018-05-31 2021-03-26 湖北绿筑装配科技有限公司 吊装式建筑支撑装置的基座结构

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