WO2005011777A1 - Medical needle apparatus - Google Patents

Medical needle apparatus Download PDF

Info

Publication number
WO2005011777A1
WO2005011777A1 PCT/GB2004/003168 GB2004003168W WO2005011777A1 WO 2005011777 A1 WO2005011777 A1 WO 2005011777A1 GB 2004003168 W GB2004003168 W GB 2004003168W WO 2005011777 A1 WO2005011777 A1 WO 2005011777A1
Authority
WO
WIPO (PCT)
Prior art keywords
needle assembly
outer tube
tubular container
safety needle
syringe
Prior art date
Application number
PCT/GB2004/003168
Other languages
French (fr)
Inventor
Barry Peter Liversidge
Original Assignee
Barry Peter Liversidge
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 Barry Peter Liversidge filed Critical Barry Peter Liversidge
Publication of WO2005011777A1 publication Critical patent/WO2005011777A1/en

Links

Classifications

    • 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
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31511Piston or piston-rod constructions, e.g. connection of piston with piston-rod
    • 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
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • 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
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/3243Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/326Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user

Definitions

  • This invention relates to medical needle apparatus, and in particular (but not exclusively) to such apparatus configured to facilitate self-injection of drugs, from within pre-filled syringes.
  • the invention further relates to a procedure for preparing for use such a medical needle apparatus.
  • a well known form of self-injection apparatus is a so-called pen injector where a cartridge of a medicament is held within a pen-like body. A needle is fitted to the forward end of the injector and an appropriate dose is dialled-up on a plunger arrangement at the rear end of the injector.
  • the injection is performed by grasping the body of the injector in the fist and performing a stabbing motion to drive the needle into the injection site, whereafter the plunger arrangement is released or is depressed (as appropriate) by the user's thumb to dispense the drug into the body.
  • pen injectors are well accepted and have been shown to be relatively easy to use by unskilled non-medical personnel. As such, they are widely used for self-injection for example by diabetics but there are of course many other users of such apparatus. It is an aim of the present invention to provide medical needle apparatus which incorporates a safety needle assembly to minimise the likelihood of needle-stick injuries and also to facilitate self-injection, but using a pre-filled syringe of a conventional design.
  • a medical needle apparatus comprising: - a safety needle assembly having an outer sleeve within which is supported a needle slidable out of the sleeve for making an injection; - a tubular container for the safety needle assembly which container is closed at one end and is provided with a seal at the other end removable to release the safety needle assembly therefrom; and - an outer tube within which is located said tubular container, the diameter of the outer tube being reduced at one end and the container fitting in the tube; the outer sleeve of the safety needle assembly, tubular container and the outer tube being configured so that the apparatus is used by: separating the outer tube from the tubular container, removing the seal from the tubular container to gain access to the safety needle assembly, connecting a syringe to the safety needle assembly, withdrawing the safety needle assembly from the tubular container, inserting the safety needle assembly into the
  • This invention extends to a procedure for preparing for use a medical needle apparatus of this invention as described above, said procedure comprising the steps of preparing a medical needle apparatus ready for use to perform an injection, in which the medical needle apparatus comprises a safety needle assembly having an outer sleeve within which is supported a needle slidable out of the sleeve for making an injection, a tubular container for the safety needle assembly which container is closed at one end and is provided with a seal at the other end removable to release the safety needle assembly therefrom, and an outer tube within which is located said tubular container, the diameter of the outer tube being reduced at one end and the container fitting in the tube, said procedure comprises the steps of separating the outer tube from the tubular container, removing the seal from the tubular container to gain access to the safety needle assembly, connecting a syringe to the safety needle assembly, withdrawing the safety needle assembly from the tubular container, inserting the safety needle assembly into the outer tube, and inserting the opened other end of the tubular container into the outer tube so that the closed end
  • FIG 1 is an isometric view of the medical needle apparatus 10 of this invention fully assembled for storage and prior to use, together with a pre-filled syringe 11 having a cylindrical body 12 with a plunger 13 fitted with a piston to expel liquid drug within the body 12.
  • a conventional luer-lock spigot At the forward end of the syringe 11 there is a conventional luer-lock spigot, having a protective cover 14.
  • Figure 2 shows the outer tube 15 of the medical needle apparatus 10 slid away from a tubular container 16 for the safety needle assembly.
  • the outer tube 15 has a reduced diameter portion 17 at one end.
  • the container 16 for the safety needle assembly is closed at one end 18 and is provided with a removable seal 19 at the other end, which maintains the needle assembly within the container in a sterile state.
  • Figure 3 shows the removable seal 19 peeled away from the open end of the container 16, so giving access to the safety needle assembly (not shown) within the container.
  • the cover 14 has been removed from the syringe and the luer-lock spigot thereof has been driven into engagement with the luer-lock socket (not shown) of the safety needle assembly, within its container 16.
  • Figure 4 shows the safety needle assembly 20 having an outer sleeve 21 withdrawn from its container 16 by pulling gently on the syringe 11 connected to that assembly, and then the assembly together with the syringe inserted into the outer tube 15.
  • Figure 5 shows the safety needle assembly 20 lying within the reduced diameter portion 17 of the outer tube so as to project therefrom, the syringe then being located wholly within the outer tube.
  • the safety needle assembly is pulled to this position by grasping the projecting part of the sleeve 21 and the limiting position is defined by a rib 22 ( Figure 4) at the rear end of the sleeve 21 engaging an internal shoulder of the outer tube 15, defined by the reduced diameter portion 17.
  • the internal shoulder may define a groove into which the rib 22 is snap-fitted, by the application of a light force to the sleeve 21 with respect to the outer tube 15.
  • Figure 6 shows the tubular container 16 inserted into the outer tube 15 with the closed end 18 leading, to engage the plunger 13 of the syringe.
  • the outer tube 15 is shown partially cut away for clarity.
  • the medical needle apparatus is now ready for use, by grasping the projecting part of the outer sleeve 21 of the safety needle assembly 20 and the outer tube 15 within a user's fist, in the same manner as is conventionally employed with a pen injector and with the user's thumb over the open end of the tubular container 16.
  • Figure 7 shows the medical needle apparatus partway through an injection cycle.
  • the tubular container 16 has been depressed fully into the outer tube 15, so driving the syringe forward within the safety needle assembly 20 and causing the needle 23 to project from that assembly by a pre-set distance.
  • a spring (not shown) within the safety needle assembly has pulled the needle 23 back into the outer sleeve 21 of that assembly, the syringe also moving rearwardly within the outer tube 15 and so also moving the tubular container 16 rearwardly.
  • the safety needle assembly is locked in its safe condition and it no longer is possible to cause the needle 23 to project from the outer sleeve 21 of that assembly.
  • the entire medical needle apparatus may now be disposed of in an appropriate manner, though it would be possible to retain the outer tube 15 for re-use, should that be required.

Abstract

Medical needle apparatus (10) has a safety needle assembly (20) with an outer sleeve (21) within which is supported a needle (23) slidable out of the sleeve (21) for making an injection. The needle assembly (20) is disposed within a tubular container (16) closed at one end (18) and provided with a removable seal (19) at the other end. The tubular container (16) is located within an outer tube (15) the diameter of which is reduced at one end (17). In use, the outer tube (15) is separated from the tubular container (16), and the seal (19) is removed so that a syringe (11) may connect to the needle assembly (20) and withdraw the assembly (20) from the container (16). The needle assembly (20) is inserted into the outer tube (15) and the tubular container (16) is also inserted into the outer tube (15) so that the closed end (18) of the container (16) contacts the plunger (13) of the syringe.

Description

MEDICAL NEEDLE APPARATUS This invention relates to medical needle apparatus, and in particular (but not exclusively) to such apparatus configured to facilitate self-injection of drugs, from within pre-filled syringes. The invention further relates to a procedure for preparing for use such a medical needle apparatus. A well known form of self-injection apparatus is a so-called pen injector where a cartridge of a medicament is held within a pen-like body. A needle is fitted to the forward end of the injector and an appropriate dose is dialled-up on a plunger arrangement at the rear end of the injector. Then, the injection is performed by grasping the body of the injector in the fist and performing a stabbing motion to drive the needle into the injection site, whereafter the plunger arrangement is released or is depressed (as appropriate) by the user's thumb to dispense the drug into the body. Such pen injectors are well accepted and have been shown to be relatively easy to use by unskilled non-medical personnel. As such, they are widely used for self-injection for example by diabetics but there are of course many other users of such apparatus. It is an aim of the present invention to provide medical needle apparatus which incorporates a safety needle assembly to minimise the likelihood of needle-stick injuries and also to facilitate self-injection, but using a pre-filled syringe of a conventional design. To achieve this, the invention has conceived the assembly of a pen-like injector from certain components which may be used for packaging the safety needle assembly. According to this invention, there is provided a medical needle apparatus comprising: - a safety needle assembly having an outer sleeve within which is supported a needle slidable out of the sleeve for making an injection; - a tubular container for the safety needle assembly which container is closed at one end and is provided with a seal at the other end removable to release the safety needle assembly therefrom; and - an outer tube within which is located said tubular container, the diameter of the outer tube being reduced at one end and the container fitting in the tube; the outer sleeve of the safety needle assembly, tubular container and the outer tube being configured so that the apparatus is used by: separating the outer tube from the tubular container, removing the seal from the tubular container to gain access to the safety needle assembly, connecting a syringe to the safety needle assembly, withdrawing the safety needle assembly from the tubular container, inserting the safety needle assembly into the outer tube, and inserting the opened other end of the tubular container into the outer tube so that the closed end contacts the plunger of the syringe, whereby an injection may be made by a user simultaneously grasping in his fist the outer sleeve of the safety needle assembly and the outer tube, offering the exposed end of the safety needle assembly to the body to be injected, and then pressing on the exposed end of the tubular container to project the needle into the body and to dispense medicament from the syringe through the needle into the body. This invention extends to a procedure for preparing for use a medical needle apparatus of this invention as described above, said procedure comprising the steps of preparing a medical needle apparatus ready for use to perform an injection, in which the medical needle apparatus comprises a safety needle assembly having an outer sleeve within which is supported a needle slidable out of the sleeve for making an injection, a tubular container for the safety needle assembly which container is closed at one end and is provided with a seal at the other end removable to release the safety needle assembly therefrom, and an outer tube within which is located said tubular container, the diameter of the outer tube being reduced at one end and the container fitting in the tube, said procedure comprises the steps of separating the outer tube from the tubular container, removing the seal from the tubular container to gain access to the safety needle assembly, connecting a syringe to the safety needle assembly, withdrawing the safety needle assembly from the tubular container, inserting the safety needle assembly into the outer tube, and inserting the opened other end of the tubular container into the outer tube so that the closed end contacts the plunger of the syringe. Other preferred features of the apparatus are defined in the appended claims. By way of example only, one specific embodiment of medical needle apparatus of this invention will now be described in detail, reference being made to the accompanying drawings. Figure 1 is an isometric view of the medical needle apparatus 10 of this invention fully assembled for storage and prior to use, together with a pre-filled syringe 11 having a cylindrical body 12 with a plunger 13 fitted with a piston to expel liquid drug within the body 12. At the forward end of the syringe 11 there is a conventional luer-lock spigot, having a protective cover 14. Figure 2 shows the outer tube 15 of the medical needle apparatus 10 slid away from a tubular container 16 for the safety needle assembly. The outer tube 15 has a reduced diameter portion 17 at one end. The container 16 for the safety needle assembly is closed at one end 18 and is provided with a removable seal 19 at the other end, which maintains the needle assembly within the container in a sterile state. Figure 3 shows the removable seal 19 peeled away from the open end of the container 16, so giving access to the safety needle assembly (not shown) within the container. The cover 14 has been removed from the syringe and the luer-lock spigot thereof has been driven into engagement with the luer-lock socket (not shown) of the safety needle assembly, within its container 16. Figure 4 shows the safety needle assembly 20 having an outer sleeve 21 withdrawn from its container 16 by pulling gently on the syringe 11 connected to that assembly, and then the assembly together with the syringe inserted into the outer tube 15. Figure 5 shows the safety needle assembly 20 lying within the reduced diameter portion 17 of the outer tube so as to project therefrom, the syringe then being located wholly within the outer tube. The safety needle assembly is pulled to this position by grasping the projecting part of the sleeve 21 and the limiting position is defined by a rib 22 (Figure 4) at the rear end of the sleeve 21 engaging an internal shoulder of the outer tube 15, defined by the reduced diameter portion 17. As shown in Figure 5, the internal shoulder may define a groove into which the rib 22 is snap-fitted, by the application of a light force to the sleeve 21 with respect to the outer tube 15. Figure 6 shows the tubular container 16 inserted into the outer tube 15 with the closed end 18 leading, to engage the plunger 13 of the syringe. The outer tube 15 is shown partially cut away for clarity. The medical needle apparatus is now ready for use, by grasping the projecting part of the outer sleeve 21 of the safety needle assembly 20 and the outer tube 15 within a user's fist, in the same manner as is conventionally employed with a pen injector and with the user's thumb over the open end of the tubular container 16. Figure 7 shows the medical needle apparatus partway through an injection cycle. The tubular container 16 has been depressed fully into the outer tube 15, so driving the syringe forward within the safety needle assembly 20 and causing the needle 23 to project from that assembly by a pre-set distance. The continued pressure on the tubular container 16 pushes the plunger 13 deeper into the syringe so causing the medicament therewithin to be expelled through the needle 23. This injection cycle is performed by offering the forward end 24 of the sleeve 21 to the injection site while grasping the apparatus in the fist of a user, in the manner of a pen injector, and then depressing the tubular container 16 in one movement, which sequentially drives the needle 23 into the body and performs the injection. Figure 8 shows the medical needle apparatus at the completion of an injection cycle. Here, a spring (not shown) within the safety needle assembly has pulled the needle 23 back into the outer sleeve 21 of that assembly, the syringe also moving rearwardly within the outer tube 15 and so also moving the tubular container 16 rearwardly. In this condition, the safety needle assembly is locked in its safe condition and it no longer is possible to cause the needle 23 to project from the outer sleeve 21 of that assembly. The entire medical needle apparatus may now be disposed of in an appropriate manner, though it would be possible to retain the outer tube 15 for re-use, should that be required.

Claims

1. Medical needle apparatus comprising: - a safety needle assembly having an outer sleeve within which is supported a needle slidable out of the sleeve for making an injection; - a tubular container for the safety needle assembly which container is closed at one end and is provided with a seal at the other end removable to release the safety needle assembly therefrom; and - an outer tube within which is located said tubular container, the diameter of the outer tube being reduced at one end and the container fitting in the tube; the outer sleeve of the safety needle assembly, tubular container and the outer tube being configured so that the apparatus is used by: separating the outer tube from the tubular container, removing the seal from the tubular container to gain access to the safety needle assembly, connecting a syringe to the safety needle assembly, withdrawing the safety needle assembly from the tubular container, inserting the safety needle assembly into the outer tube, and inserting the opened other end of the tubular container into the outer tube so that the closed end contacts the plunger of the syringe, whereby an injection may be made by a user simultaneously grasping in his fist the outer sleeve of the safety needle assembly and the outer tube, offering the exposed end of the safety needle assembly to the body to be injected, and then pressing on the exposed end of the tubular container to project the needle into the body and to dispense medicament from the syringe through the needle into the body.
2. Medical needle apparatus as claimed in claim 1 , wherein the outer sleeve of the safety needle assembly is a snap-fit into the reduced diameter end of the outer tube, when the safety needle assembly has been slid mostly through the outer tube to project therefrom.
3. Medical needle apparatus as claimed in claim 1 or claim 2, wherein the syringe is connected to the safety needle assembly when that assembly is still within its tubular container, following removal of the seal therefrom.
4. Medical needle apparatus as claimed in claim 3, wherein the syringe is used to withdraw the safety needle assembly from its tubular container.
5. Medical needle apparatus as claimed in any of the preceding claims, wherein the tubular container is a light friction fit in the outer tube.
6. Medical needle apparatus as claimed in any of the preceding claims, wherein after use the safety needle assembly is withdrawn from the outer tube and is reinserted into its tubular container, for disposal.
7. Medical needle apparatus as claimed in any of the preceding claims, wherein the syringe is of the pre-filled kind, containing a medicament to be injected before being connected to the safety needle assembly.
8. A procedure for preparing a medical needle apparatus ready for use to perform an injection, in which the medical needle apparatus comprises a safety needle assembly having an outer sleeve within which is supported a needle slidable out of the sleeve for making an injection, a tubular container for the safety needle assembly which container is closed at one end and is provided with a seal at the other end removable to release the safety needle assembly therefrom, and an outer tube within which is located said tubular container, the diameter of the outer tube being reduced at one end and the container fitting in the tube, said procedure comprises the steps of separating the outer tube from the tubular container, removing the seal from the tubular container to gain access to the safety needle assembly, connecting a syringe to the safety needle assembly, withdrawing the safety needle assembly from the tubular container, inserting the safety needle assembly into the outer tube, and inserting the opened other end of the tubular container into the outer tube so that the closed end contacts the plunger of the syringe.
PCT/GB2004/003168 2003-07-25 2004-07-20 Medical needle apparatus WO2005011777A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB0317424A GB0317424D0 (en) 2003-07-25 2003-07-25 Medical needle apparatus
GB0317424.0 2003-07-25

Publications (1)

Publication Number Publication Date
WO2005011777A1 true WO2005011777A1 (en) 2005-02-10

Family

ID=27772660

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB2004/003168 WO2005011777A1 (en) 2003-07-25 2004-07-20 Medical needle apparatus

Country Status (2)

Country Link
GB (1) GB0317424D0 (en)
WO (1) WO2005011777A1 (en)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8182475B2 (en) 2003-05-31 2012-05-22 Lumatherm, Inc. Methods and devices for the treatment of skin lesions
US9526846B2 (en) 2009-08-19 2016-12-27 Safety Syringes, Inc. Patient-contact activated needle stick safety device

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR610245A (en) * 1926-01-29 1926-09-01 case for receiving a syringe, a container and tablets
US2571653A (en) * 1950-02-25 1951-10-16 Bastien Victor Gerard Syringe
US3107785A (en) * 1960-10-04 1963-10-22 Brunswick Corp Syringe-container structure
US4390016A (en) * 1981-10-23 1983-06-28 Temp-Trak Inc. Prefillable hypodermic syringe and method of assembling the syringe

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR610245A (en) * 1926-01-29 1926-09-01 case for receiving a syringe, a container and tablets
US2571653A (en) * 1950-02-25 1951-10-16 Bastien Victor Gerard Syringe
US3107785A (en) * 1960-10-04 1963-10-22 Brunswick Corp Syringe-container structure
US4390016A (en) * 1981-10-23 1983-06-28 Temp-Trak Inc. Prefillable hypodermic syringe and method of assembling the syringe

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8182475B2 (en) 2003-05-31 2012-05-22 Lumatherm, Inc. Methods and devices for the treatment of skin lesions
US9526846B2 (en) 2009-08-19 2016-12-27 Safety Syringes, Inc. Patient-contact activated needle stick safety device
US10314985B2 (en) 2009-08-19 2019-06-11 Safety Syringes, Inc. Patient-contact activated needle stick safety device
US11400234B2 (en) 2009-08-19 2022-08-02 Safety Syringes, Inc. Patient-contact activated needle stick safety device

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