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
  • A61M5/3145—Filters incorporated in syringes
• • 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
  • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
  • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the 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
  • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
  • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
  • A61M2005/1581—Right-angle needle-type devices
• • 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
  • A61M2005/3103—Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle
• • 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
  • A61M2205/00—General characteristics of the apparatus
  • A61M2205/75—General characteristics of the apparatus with filters
  • A61M2205/7536—General characteristics of the apparatus with filters allowing gas passage, but preventing liquid passage, e.g. liquophobic, hydrophobic, water-repellent membranes
• • 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
  • A61M5/1782—Devices aiding filling of syringes in situ
• • 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
  • A61M5/329—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 characterised by features of the needle shaft
  • A61M5/3291—Shafts with additional lateral openings

Definitions

• the present invention relates to drug delivery devices, and in particular to ambulatory, drug delivery devices.
• Prefilled drug delivery devices are desirable and are being adopted due to the significant advantages they provide over standard drug delivery devices, such as standard syringes that require filling by a health care worker immediately before administration.
• Benefits of such devices include user convenience, and decreased cost.
• the user may administer the drug via the device. This can be done either within a physician's office, hospital, or at home. This results in an increased level of convenience for the user receiving the dosage and significant decrease in health care cost as a health care worker is not necessarily needed to administer the drug via the device.
• the delivery needle associated with such a device typically may include a protective sheath that is removed immediately before use, or may be designed so that the needle is retracted into a protective casing before use.
• Prefilled drug or medication delivery devices must be filled with liquid drug before they can be used.
• the needle sheath shrouds and seals the needle-occupying compartment to prevent contamination. Sealing the needle compartment from ambient also traps air bubbles within its drug-holding compartment or drug reservoir. During priming or filling, air bubbles must be allowed to escape. Otherwise, back pressure will cause incomplete filling of the drug reservoir in the device or will prevent filling altogether.
• the needle sheath must be detached during priming or filling, and then reattached after the priming is completed.
• the needle can be exposed.
• drug is typically filled until a small amount of drug is expelled through the needle. This ensures that 1) the drug reservoir is accurately filled and 2) that no air bubbles remain in the drug reservoir.
• the drug leakage can be problematic as it can undesirably spill over to various components of the device, particularly if the needle end is exposed inside the device, e.g., retracted inside the device housing.
• the leakage of drug during priming or filling is detrimental to the function of the device because the liquid drug may compromise the integrity of the adhesive.
• a preferred aim is to provide an improved needle cover and sheath that is capable of allowing air to pass therethrough but prevents the escape of any drug, thus enabling the drug to remain in the device and be delivered accurately and completely to the user.
• the present invention is drawn to a needle assembly, a sheath thereof, and a method of filling or priming drug delivery device.
• the sheath is attachable to the needle assembly and allows fluid to flow out of the needle and capture any liquid expelled from the needle.
• the sheath comprises a liquid barrier that allows gas to escape but blocks passage of liquid therethrough.
• the needle assembly comprises a needle holder and a sheath.
• a further aspect of the present invention comprises a needle sheath for receiving at least a portion of a length of needle.
• the internal cavity of the sheath is shaped to funnel and hold a volume of liquid drug that flows out of the needle tip during priming or filling.
• Another aspect of the invention is the sheath with a liquid barrier, which can comprise a hydrophobic membrane or the like.
• the needle holder is adapted to hold, or holds, a needle.
• the sheath has a needle compartment that can accommodate the needle, and has a first opening communicating with the needle compartment.
• the sheath is adapted to shroud at least a portion of the needle.
• the liquid barrier is positioned in the first opening and blocks the needle compartment so that the liquid barrier allows gas to escape through the first opening but prevent liquid from leaking through the first opening.
• the sheath can have a second opening, which communicates with the needle compartment, through which a portion of the needle holder is insertable into the sheath.
• the needle holder can have a projection dimensioned and configured to be inserted and frictionally seated into the second opening.
• the sheath can have a recess coaxially arranged with the second opening.
• the recess can seat the projection.
• the sheath can have a wall that closes one end of the compartment. The needle is inserted into the compartment by piercing through that wall.
• the sheath can have a central sheath portion housing the needle compartment and a flange portion extending laterally outwardly from the central sheath portion.
• the central portion is adapted to be inserted into a needle passage formed in a base of a drug delivery device while the flange portion abuts against a liner abutting the base so- that the sheath is removable by removing the liner, which protects an adhesive layer.
• a support with an aperture is provided to support the hydrophobic member substantially concentrically positioned over the aperture. At least the support can be frictionally engaged to a surface of the sheath surrounding the first opening. Alternatively, the support can be seated in the first opening, holding the hydrophobic member in the first opening.
• the sheath for a needle has a central sheath portion adapted to be insertable through an opening of a drug delivery device and engage a portion of the needle, and a flange portion having a dimension larger than the central sheath portion and adapted to abut against an adhesive protector of the drug delivery device. Removing the adhesive protector can automatically remove the sheath from the needle in this embodiment.
• the central sheath portion and the flange portion can be monolithically formed of solid material, such as rubber.
• Another aspect of the invention comprises a method of filling or priming a drug delivery device having a delivery needle, a drug reservoir, and a filling port.
• the method can comprise providing the afore-described sheath and engaging the sheath over the needle so that liquid expelled from the needle is confined within the needle compartment, flowing drug through the filling port to fill the drug reservoir or priming the drug reservoir until the drug flows out through the needle.
• the liquid barrier allows air bubbles to escape into ambient but traps the spilled drug within the needle compartment.
• FIG. 1 is an exploded perspective view of a needle assembly having a sheath according ⁇ the present invention.
• Fig. 2 is a cross-sectional view of the needle assembly of Fig. 1.
• Fig. 3 is another embodiment of the sheath according to the present invention.
• Fig. 4 is another embodiment of the sheath according to another aspect of the present invention.
• Three exemplary embodiments, as shown in Figs. 1-4, serve to illustrate the present invention. In this regard, same or. corresponding elements are labeled with the same or similar reference numerals.
• references are made below to directions in describing the structure, they are made relative to the drawings (as normally viewed) for convenience. The directions, such as left, right, upper, lower, etc., are not intended to be taken literally or limit the present invention in any form.
• the needle assembly 1 comprises a needle holder 10, 10' for holding a needle 20, and a needle sheath 30, 30'.
• the needle holder 10, 10' can be, for instance, a conventional luer lock that can be detachably mounted to a syringe or injection device, or a hub or hub-like body that can be adapted for mounting to a drug delivery device, such as the type disclosed in U.S. Patent No. 5,858,001.
• the needle holder 10, 10' contemplated according to the present invention thus can be any suitable structure, whether it be adapted for a syringe or custom design, that can hold a needle 20 and connect to a drug delivery mechanism.
• the needle holder 10, 10' has a central axial through hole 12 for passage of the needle 20.
• the needle holder 10, 10' can be configured to work with a drug delivery mechanism 100, such as a syringe, to deliver the drug from the upper side 10U of the needle holder 10, 10', as shown in Fig. 2, such as through a port or channel formed in the needle holder 10, 10'.
• a drug delivery mechanism 100 such as a syringe
• the needle holder 10 has a stepped portion that cooperates with the opening of the sheath 30 to sealingly, but detachably hold the sheath 30.
• the stepped portion is formed, for example, by a smaller dimensioned annular projection 14 extending axially downwardly.
• the projection 14 is dimensioned and configured to be inserted and frictionally seated into an opening of the sheath 30 or a twist type mounting mechanism, e.g., bayonet mount, threaded connection.
• the sheath 30, 30' has a hollow and elongated portion, and has a needle compartment 32 for receiving the needle 20.
• the needle compartment is configured to funnel and hold any liquid expelled from the needle 20.
• the sheath 30 has an opening 34 with a recess 36 at one end.
• the opening 34 communicates with the needle compartment 32.
• the recess 36 is dimensioned and configured to sealingly receive the projection 14.
• the second embodiment, Fig. 3 illustrates a needle assembly that is particularly suitable for a drug delivery of the type disclosed in U.S. Patent No. - 5,858,001, the disclosure of which is incorporated herein by reference.
• the needle holder 10' is substantially similar to that of the first embodiment, except that the sheath 30' has a different configuration.
• the needle holder 10' does not matingly and sealingly engage the sheath 30', as occurs in the first embodiment. Instead, the needle 20 itself punctures through a closed upper end or upper wall 30U of the sheath 30'.
• the sheath 30, 30' can be formed of any suitable material, but preferably is made of rubber, such as a bromobutyl rubber, or any other suitable commercial material.
• the sheath 30, 30' has a liquid barrier LB that lets gas, e.g., air bubbles, escape through the sheath 30, 30', while blocking passage of drug therethrough.
• gas e.g., air bubbles
• the drug can be accurately filled by allowing any trapped air bubbles to escape through the needle and through the sheath 30, 30' but confine any liquid expelled from the needle within the -needle compartment 32.
• gas e.g., air bubbles
• no backpressure is developed to enable an accurate dosage.
• the liquid barrier LB comprises a hydrophobic disc or membrane HM positioned inside the sheath 30, 30'.
• the hydrophobic membrane HM is a material, such as a polymer with fine pores, which allows passage of air or gas thereacross or therethrough but repel liquid.
• suitable hydrophobic membrane HM are SUPOR, available from PALL SPECIALTY MATERIAL, IV FILTER available from WHATMAN, and IMMOBILON from MILLIPORE.
• the sheath 30, 30' can have an opening or aperture 38 that communicates with ambient and the needle compartment 32.
• the hydrophobic membrane HM sealingly covers or blocks the opening 38.
• the openirfg 38 can be formed at a lower end of the sheath, below the needle 20, as illustrated in Figs. 1-3.
• the hydrophobic membrane HM should be positioned away from the needle point so that it does not become punctured.
• the sheath is made of rubber or relatively flexible or soft material, it is preferable to support the hydrophobic membrane HM with a relatively rigid support 40, 40', which can be formed of a plastic, for example.
• the sheath could have a closed bottom with an opening. The sheath can be dimensioned to sealingly seat the hydrophobic membrane HM over the opening.
• the first and second embodiments both have the support 40, 40', configured substantially cylindrically, but can have any suitable configuration.
• the support 40, 40' has a central aperture 42, which provides a pathway for gas to escape through the hydrophobic membrane HM.
• the support 40 has a recess 44 for sealingly seating the hydrophobic membrane HM.
• the inner surface 32S of the sheath surrounding the opening 38, or the needle compartment 32 frictionally and sealingly engages the outer periphery of the support 40 to immobilize the support. That is, the support 40 with the hydrophobic membrane HM is inserted or pushed up into the opening 38 or the needle compartment, and frictionally secured thereto.
• the opening 38 is collinear with the needle compartment, but has a larger dimension or diameter (in the case of a cylindrical support).
• the hydrophobic membrane HM is positioned to block the lower end of the needle compartment 32, and is sealingly sandwiched between an upper side 40U of the support 40' and a bottom surface 30B of the opening 38.
• the lower portion of the sheath 30' surrounding the opening 38 is dimensioned larger, forming a flange portion 3 OF.
• the opening 38 can be formed in the flange portion 30F.
• the flange portion 3 OF also includes a lip 30L that extends radially inwardly at the entrance of the opening.
• the support 40' is forced into the opening 38.
• the lip 30L helps to maintain the support 40' securely confined in the opening 38.
• the sheath 30' is configured to protect an adhesion layer 50 typically used for attaching a drug delivery device to a drug delivery site. That is, during priming or filling, overfilling the drug reservoir, for purposes of completely filling the sa ⁇ ie removing any trapped air bubbles, results in spillage.
• the drug can undesirably wet the adhesion layer and make it less effective or completely ineffective.
• the sheath 30' funnels and holds excess liquid drug that flows out of the needle during priming or filling. This design prevents spillage and protects the adhesion layer 50 from exposure to any liquid drug.
• the liner 60 protecting the adhesion layer 50 can be used to remove the sheath 30'.
• the sheath 30' has a central sheath portion 30C that extends through a needle opening 70 formed through a base portion B of the drug deliver device D, and shrouds the needle 20.
• the flange portion 3 OF which is dimensioned larger than the central sheath portion 30C, abuts against the underside of the base portion B. Pulling the liner 60 off the base B forces the sheath 30' to move outwardly off the base, removing the sheath 30' from the drug delivery device D.
• the third embodiment, Fig. 4 is similar to the second embodiment, Fig. 3, except that the sheath 30" is solid, with no needle accommodating compartment.
• the sheath 30" has a central sheath portion 30C" that extends through the needle opening 70 formed through a base portion B of the drug deliver device D and shrouds the needle 20.
• the flange portion 30F which is dimensioned larger than the central sheath portion 30C", abuts against the underside of the base portion B. Pulling the liner 60 off the base B forces the sheath 30" to move outwardly off the base, removing the sheath 30" from the drug delivery device D.
• the needle pierces through the central sheath portion 30" and blocks the needle, preventing the drug from spilling out of the needle.
• the sheath 30" also can be made of rubber, preferably a solid rubber or the like.
• the sheath is placed over the needle before filling take place. If the drug deliver device is provided with a prefilled cartridge, the device is primed while the sheath is placed over the needle. The drug reservoir is filled or primed until the drug spills out through the needle to remove air bubbles. The liquid barrier allows air bubbles to escape into ambient, but traps the spilled drug within the needle compartment.

Landscapes

• Health & Medical Sciences (AREA)
• Vascular Medicine (AREA)
• Engineering & Computer Science (AREA)
• Anesthesiology (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (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)

Applications Claiming Priority (3)

Publications (1)

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ID=22711421

Family Applications (1)

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• 2001
  • 2001-03-28 JP JP2001570312A patent/JP2003527932A/ja active Pending
  • 2001-03-28 EP EP01915519A patent/EP1267967A2/de not_active Withdrawn
  • 2001-03-28 CA CA002402457A patent/CA2402457A1/en not_active Abandoned
  • 2001-03-28 AU AU42608/01A patent/AU4260801A/en not_active Abandoned
  • 2001-03-28 WO PCT/GB2001/001371 patent/WO2001072353A2/en not_active Ceased

Non-Patent Citations (1)

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