WO2012175082A1 - Dispositif d'injection pour injection d'un médicament - Google Patents

Dispositif d'injection pour injection d'un médicament Download PDF

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Publication number
WO2012175082A1
WO2012175082A1 PCT/DK2011/050231 DK2011050231W WO2012175082A1 WO 2012175082 A1 WO2012175082 A1 WO 2012175082A1 DK 2011050231 W DK2011050231 W DK 2011050231W WO 2012175082 A1 WO2012175082 A1 WO 2012175082A1
Authority
WO
WIPO (PCT)
Prior art keywords
housing
slide
injection device
slide member
injection
Prior art date
Application number
PCT/DK2011/050231
Other languages
English (en)
Inventor
Michael Perthu
Original Assignee
Union Medico Aps
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 Union Medico Aps filed Critical Union Medico Aps
Priority to PCT/DK2011/050231 priority Critical patent/WO2012175082A1/fr
Publication of WO2012175082A1 publication Critical patent/WO2012175082A1/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
    • A61M5/3287—Accessories for bringing the needle into the body; Automatic needle insertion
    • 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
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/587—Lighting arrangements

Definitions

  • the present invention relates to an injection device comprising a slide member, which can be displaced in relation to a housing from a re- tracted position to an injection position, where the slide member comprises a slide portion situated within the housing and a syringe holder portion situated outside the housing, the slide member being preten- sioned toward the injection position.
  • MS Multiple sclerosis
  • MS is an inflammatory disease characterized by progressive deterioration of the nervous system that is accompanied by a broad spectrum of symptoms.
  • treatments currently available that can relieve the symptoms and/or slow the progression of the disease.
  • drugs are delivered to the patient by means of intra muscu- lar injections. The delivery process is advantageously carried out by the patient in order to allow more personal freedom to the patient and reduce costs of the treatment.
  • a device for intramuscular delivery of a drug is known from US 4,512,767, which discloses an injection device comprising a large num- ber of springs used for syringe actuation.
  • a stop member permits to predetermine the degree of penetration of the syringe needle.
  • the inherently complex actuation mechanism of the device renders its manufacture difficult and expensive.
  • US 2001/0005781 discloses an autoinjector for subcutaneous injection providing a fully automated process of drug delivery.
  • the autoinjecting device comprises a penetration mechanism and an injection mechanism, both being spring driven.
  • the device further comprises a syringe holder situated entirely in the interior of the device.
  • the syringe itself is also situated in the interior of the device.
  • the sequential process of drug delivery includes a penetration phase and an injection phase.
  • the penetration phase comprises a spring-driven simultaneous operation of the penetration and the injection mechanisms providing a movement of the syringe such that, at the end of the phase, the syringe needle has penetrated the skin.
  • the injection phase comprises a spring- driven operation of the injection mechanism on the syringe plunger whereby the drug is injected .
  • a damper is arranged between the penetration mechanism and the injection mechanism such that damping only takes place when the injection mechanism moves relative the penetra- tion mechanism, normally after completed penetration .
  • the purpose of the damping is to absorb energy d uring injection phase.
  • EP 1154811 d iscloses an injection device comprising a slide member which can be d isplaced a predetermined distance from a re- tracted position to an injection position, where the slide member comprises a slide portion situated within the housing of the injection device and a syringe holder portion situated outside of the housing and being adapted to, in use, receive a hypodermic syringe which also is situated outside the housing .
  • a compression spring arranged inside the housing actuates the movement of the slide member.
  • the injection device disclosed therein is potentially ridden with one drawback.
  • the design of the injection device of EP 1154811 entails that the slide member, and thus the syringe, moves with the same velocity throughout its movement from the retracted to the injection position .
  • the muscle tissue into which the d rug is to be delivered may, due to the d isease, atrophy considerably without the patient taking notice thereof.
  • a patient not taking into account effects of muscu- lar atrophy may choose a hypodermic syringe with a needle having an inappropriate length . And if the chosen syringe need le is too long , the fast moving syringe needle will penetrate throug h the muscle and may end up striking a bone causing considerable discomfort to the patient.
  • the present invention therefore aims at providing an injection device with improved control of the injection dept.
  • the injection device is characterized in that during at least a portion of a d isplacement of the slide member from the retracted position towards the injection position air com- pressed inside an air chamber of the housing attenuate the d isplacement of the slide member.
  • the slide member By damping the d isplacement of the slide member for at least a portion of the movement from the retracted position to the injection position it is possible control the injection of a need le into a muscle and prevent a need le of a syringe mounted in the syringe holder portion from being injected into a bone. Since the slide member is pretensioned towards the injection position it wil l, when released from the retracted position, move with a relatively high speed towards the injection position, because the pretensioning is configured so that a needle of a syringe po- sitioned in the syringe holder portion will penetrate through the skin of a patient, and subseq uently enter a muscle of the patient.
  • an air chamber attenuating the movement of the slide member ensures that needle slowly penetrates into the muscle after having penetrated the skin .
  • the provision of an air chamber wherein air is compressed during displacement of the slide member, i .e. the size of the air chamber is reduced in volume during d isplacement from the retracted position to the injection position has the advantage of being a mechan ically simple construction acting on the slide member so that the displacement of the slide member comprises a skin penetration phase and an attenuated muscle penetration phase, wherein air compressed in the air chamber acts on the slide member against the force pretensioning the slide member towards the injection position .
  • the need le of a syringe positioned in the syringe holder portion will have an impact velocity sufficiently high to penetrate the skin of a patent and enter a muscle, however, the air compressed in the air chamber during displacement of the slide member will ensure that the impact velocity is reduced in the muscle penetrating phase to prevent the needle from being injected into a bone.
  • the injection device may be configured with length of displacement allowing the injection device to be used for subcutaneous injections as well.
  • the injection device according to the invention may be provided as a disposable injection device, which is adapted to only provide one injection, i.e. the slide member may only once be displaced from the retracted position to the injection position.
  • the injection device may be configured so the slide member only once can be displaced from the injection position to the retracted position or it may be supplied with the slide member in the retracted position.
  • an inner surface of the housing and the slide portion from the air chamber. This is advantageous as it reduces the number of parts required for attenuating the displacement of the slide member and hence makes the injection device easy to assemble.
  • a guide member guiding the slide portion being arranged inside the housing, and an inner surface of the housing, the slide portion from an air chamber and an outer surface of the guide member form the air chamber.
  • At least a portion of the slide portion is pressed towards the inner surface of the housing du r- ing at least a portion of the d isplacement of the slide member from the retracted position towards the injection position .
  • the slide portion comprises a sealing element positioned between the inner surface of the housing and a body part of the slide portion .
  • the sealing element ensures that air will be compressed in the air chamber so that the displacement of the slide member is attenuated .
  • a portion of the sealing element is funnel-shaped with an edge portion being at least partly biased towards the inner surface of the housing during at least a portion of the d isplacement of the slide member from the retracted position to- wards the injection position .
  • the funnel shape makes it possible to vary the thickness of the seal ing element at the edge portion so that it is pressed against the inner surface of the housing when air is compressed in the air chamber.
  • the sealing element is releasably connected to the main body of the slide portion . This allows the injection device to be assembled in smaller pieces before put together in a fully assembled injection device. Moreover, it allows the sealing element to be replaced in case of wear.
  • the slide portion of the injection device is configured to provide fluid communication between the air chamber and the ambient air outside the housing during retraction of the slide member from the injection position to the retracted position .
  • the housing may be provided with a valve or outlet providing fluid communication of compressed air from the air chamber to the ambient air surrounding the housing. This provides for a very smooth and well controlled attenuation of the slide member by letting compressed air in the air chamber slow to the ambi- ent outside of the injection device, and provides not only penetration of the skin without the risk of anchoring a needle of a syringe in a bone, but also allows for at controlled positioning of the needle to the correct position in the muscle where the drug is to be delivered .
  • an air outlet provides fluid communication between the air camber and the ambient air outside the housing .
  • the slide portion comprises an air outlet.
  • the slide member being pretensioned toward the injection position by a spring situated within the housing .
  • the housing forms a cylindrical chamber, preferably at least a portion said cylin- drical chamber is tapered.
  • the cylindrical chamber may have sections with different diameters so that for a first section the inner surface of the housing and the slide portion form an air chamber not allowing air to be compressed to attenuate the displacement of the slide member, and a second section with a smaller diameter allowing the inner surface of the housing and the slide portion to form an air chamber, wherein air is compressed the move- ment of the slide member is attenuated during the remaining part of the displacement of the slide member towards the injection position.
  • the housing forms a cylindrical chamber with an end wall forming a stop member, on which stop member the slide portion abuts in the injection position .
  • the inner surface of the housing defines a cylinder wall and an end wall of the cylinder chamber.
  • the end wall of the cylinder chamber then defines the length of the displacement from the retracted position to the injection position .
  • the inner surface of the housing may advantageously form part of the air chamber, wherein air is compressed during movement of the slide member.
  • the guide member extends coaxially within a cylind rical chamber of the housing and the slide portion is guided on an outer surface of the guide member. This allows the guide member to be fixed to the at least one end wall formed by the inner surface of the housing and provides a very stable guidance of the slide portion .
  • the length of displacement of the slide member between the retracted position and the injection position is approximately 20 mm to 60 mm, prefera bly about 40 mm .
  • the air compressed inside the air chamber d uring the displacement of the slide member acts on the slide portion for approximately 10 mm to 30 mm, preferably about 20 mm, of the total d isplacement of the slide member.
  • Fig . la, lb and lc shows long itud inal cross-sectional side view of an injection device accord ing to a preferred embod iment of the invention
  • Fig . 2a is a perspective view of a slide member provided with a seal ing element according to the invention
  • Fig . 2b is another perspective view of the slide member according to Fig . 2a having the sealing element removed,
  • Fig . 3 is top side view of the slide member of Fig . 2a
  • Fig. 4 is a cross sectional side view along the line IV-IV of Fig.
  • Fig. 5 is a cross sectional side view according to Fig . 4 of the sealing element taken alone,
  • Fig. 1 shows an injection device 1 with a tubular housing 3, which forms a guide for a slide member 2 on which a hypodermic syringe can be mounted in a syringe holder portion 5 of the slide member 2. Then injection device 1 can be used to guide a hypodermic syringe, in particular for intramuscular injections, as the needle for such injection is essentially long and therefore rather unpleasant to enter manually.
  • the slide member 2 comprises a tubular exterior portion 13, the inside diameter of which corresponds to the outside diameter of the housing 3 such that the tubular exterior portion 13 can glide on the outside of the outer surface of the housing 14.
  • the exterior portion of the slide mem- ber 2 is connected to an interior slide portion 4, which in this preferred embodiment is tubular with an outside diameter that corresponds to the inside diameter defined by the inner surface 9 of the housing 3 so that the slide portion 4 can slide along the inner surface 9 of the housing 3.
  • the interior slide portion 9 is through a longitudinal groove 15 in a wall 16 of the housing 3 connected to the exterior portion of the slide member 2.
  • the slide portion 4 is provided with an axial bore 40 (cf. Fig. 2b) and mounted on a guide member 7 positioned axially in the tubular housing 3.
  • the guide member 7 and the in- terior of the housing 3 comprises an injection mechanism, preferably operated by a spring 12, which cooperates with a release button 30 positioned at one end of the housing 2 and adapted for digitally operation by the user of the injection device 1.
  • the injection device 1 is provided with a lamp assembly 61, which may be activated when a push bottom 72 is pressed against the skin of a patient so that a lamp of the lamp assembly can illuminate both the syringe and the skin area during injection of a needle.
  • the injection device 2 comprises an obliquely cut tube section 70 extending next to and parallel with the housing 2.
  • the injection mechanism and the lamp assembly position in the opposite end of the housing are preferably both implemented in a manner known per se from applicant's granted patent EP 1 154 811 Bl .
  • the slide member 2 is positioned in a retracted position where it is held by the injection mechanism until released by the release button 30.
  • the spring 12 is compressed and the slide member 2 is pretensioned by a force of the spring 12.
  • the release button 30 is activated, the slide member 2 is displaced by the force of the compressed spring 12 towards an injection position shown in Fig . lc.
  • the slide member 3 is generally biased by the spring 12 towards the injection position as shown in Fig . lc.
  • a syringe is mounted in the syringe holder portion 5 with the needle pointing towards the tube section 70.
  • the push button 60 is pressed against the skin covering a muscle wherein a drug comprised in the syringe is to be injected .
  • the slide member 2 is released from the retracted position and displaced to the injection position under the force of the compressed spring 12, and the needle penetrates the skin during the displacement of the slide member 2 from the retracted position to the injection position .
  • the needle of the syringe penetrates into the muscle.
  • the slide portion 4 of the slide member 2 abuts an end wall 13 of an air chamber 6 defined by the inner surface of the housing 3.
  • the end wall 13 serves as a stop member defining the length of displacement of the slide member 2.
  • the wall 16 of the housing 3 forms a cylindrical guide for both the interior and exterior portion of the slide member 2.
  • the wall 16 of the housing 3 forms a cylindrical guide for both the interior and exterior portion of the slide member 2.
  • the slide member 2 is guided without slack even when the outer surface of the slide portion 4 is not is not guided closely along the inner surface 9 of the wall 16. Therefore the slide member 2 may move relatively unhindered under the force of the compressed spring 12 and thereby the needle of a syringe mounted on the syringe holder portion 5 will penetrate the skin.
  • lb is shown an interme- diate position between the retracted position and the injection position.
  • the diameter of the circumferential wall 16 starts to narrow to a smaller diameter, and therefore there gap 17 will reduce as the slide portion 4 reaches a tapered section 18 of the wall 16.
  • Fig . lb shows a position where a part of the slide portion 4 has reached the more narrow part of the wall 16. From this point the outer surface of the slide portion 4 is guided closely along the inner surface 9 of the housing 3. Thereby the inner surface 9 of the housing 3 and the slide portion 4 forms an air chamber 6, wherein air is compressed when the slide portion 4 is moved towards the injec- tion position and the size of the air chamber is reduced.
  • the slide member 2 This attenuates the remaining part of the displacement of the slide member 2 towards the injection position to a smooth sliding movement under the force of the spring 12, where the needle is guided into the muscle.
  • the movement of the slide member is attenuated so that is allows the needle to penetrate the muscle. If the needle strikes a bone it will not penetrate the bone and become anchored to discomfort of the user, because the impact velocity of the needle is attenuated so that the impact force only allows the needle to slide into the muscle.
  • the slide member 2 will move slowly to the end wall 13 where it reaches the injection position. At this point the user of the injection device 1 will manually operate the plunger of the syringe to deliver the drug into the muscle.
  • the total displacement of the slide member 2 is 40.8 mm whereof the movement is damped for 22.8 mm.
  • the injection device is adapted to provide fluid communication of compressed air inside the air chamber 6 and the surroundings of the injection device.
  • This may for instance be achieved by adapting the slide portion 4 to provide fluid communication between the air chamber 6 and the surroundings as the size of the air chamber is reduced, e.g . through the longitudinal groove 15.
  • the slide portion 4 may be provided with a sealing element 8 having a section that allows a small amount of compressed air to flow from the air chamber 6 to the surroundings as the slide member 2 is pressed towards the injection position by the compressed spring 16.
  • the outer surface of the slide portion 4 may be provided with a groove allowing compressed air to flow from the air chamber 6 to the surroundings.
  • the slide portion 4 may be provided with a through-going bore 11.
  • the housing 3 may be provided with a valve allowing compressed air to flow from the air chamber 6 to the surroundings.
  • the guide member 7 is mounted to the end wall 13 with a sealing that prevents compressed air in the air chamber 6 to flow into the in- terior of the guide member 7, where part of the injection mechanism according to a preferred embodiment is located and therefore in fluid communication with the surroundings.
  • the sealed part of the air chamber 6 is formed by the inner surface 9 of the housing and an outer surface of the guide member 7.
  • the end wall 13 that serves as stop member is a part of the inner surface.
  • Fig. 2a is a perspective view of the slide member 2 provided with a sealing element 8.
  • the slide portion 4 of the slide member 2 has a through-going bore 40 (cf. Fig. 2b) for mounting the slide portion 4 on a guide member 7 coaxially mounted in the tubular housing 3 of an injec- tion device 1.
  • the sealing element 8 is mounted on the slide portion 4 by means of a circumferential groove 42.
  • the tubular shaped slide portion extends into an arm 43 with a reception means 41 for receiving a syringe holder portion 5.
  • the syringe holder portion comprises a pair of clamps, but other holding devices are possible.
  • the reception means allows the syringe holder portion to be replaced so that the injection device 1 may be provided with different holding devices, hence allowing different types of syringes to be used in connection with the injection device.
  • Fig. 3 is a top side view of the slide member 2 of Fig. 2a show- ing the sealing element 8 positioned at one of the slide portion 4.
  • the sealing element 8 form a part of the outer surface of the slide portion 4, which outer surface is guided along the inner surface 9 of the housing 3.
  • the sealing element is tubular shaped and tapered in a direction .
  • Fig . 5 is shown a cross- sectional view of the sealing element 8.
  • the sealing element 8 is slightly frusto-conical and has inner cylinder wall provided with a circumferential protrusion 50 adapted for cooperating with the circumferential groove 42 of the slide portion 4.
  • a marginal portion of the sealing element 8's side wall has a reduced thickness.
  • the sealing element 8 is preferably made of flexible material such as rubber or silicone ensuring that the air is compressed in the air chamber 6.
  • the reduced thickness of the margin portion 51 is slightly biased toward the inner surface 9 of the housing 3. When air is compressed inside the air chamber 6 the margin portion 51 is further pressed towards the inner surface 9.
  • the margin portion is flexible it may bend away from the inner surface 9 when the slide member 2 is displaced from the injection position to the retracted posi- tion, hence instead of momentarily introducing a vacuum, the slide member 2 may be moved to the retracted position only by overcoming the force of the spring 12.
  • the bore 11 allows a flow of air compressed inside the air chamber 6 to the surroundings, however, the size of the bore, which in a preferred embodiment is about 1 mm 2 , may be adjusted to obtain the desired degree of attenuation of the slide member 2. More specifically, the size of the bore must be selected with a view to among others the size of the air chamber and the force applied to the slide member 2 by the spring 12.
  • the through-going bore 40 is adapted to fit tightly around the guide member 7.
  • the injection device according to the invention is configured so that at least during a portion of the displacement of the slide member from the retracted position to the injection position, the movement of the slide member is attenuated by air compressed in the air chamber formed by at least the inner surface of the housing and a portion of the slide member.

Abstract

La présente invention concerne un dispositif d'injection (1) comprenant un composant coulissant (2), qui peut être déplacé par rapport à un boîtier (3) d'une position rétractée vers une position d'injection, le composant coulissant comprenant une partie coulissante (4) située dans le boîtier et une partie de porte-seringue (5) située à l'extérieur du boîtier, le composant coulissant étant prétendu vers la position d'injection, et pendant au moins une partie d'un déplacement du composant coulissant de la position rétractée vers la position d'injection, de l'air comprimé à l'intérieur d'une chambre à air (6) du boîtier atténue le déplacement du composant coulissant.
PCT/DK2011/050231 2011-06-22 2011-06-22 Dispositif d'injection pour injection d'un médicament WO2012175082A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/DK2011/050231 WO2012175082A1 (fr) 2011-06-22 2011-06-22 Dispositif d'injection pour injection d'un médicament

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/DK2011/050231 WO2012175082A1 (fr) 2011-06-22 2011-06-22 Dispositif d'injection pour injection d'un médicament

Publications (1)

Publication Number Publication Date
WO2012175082A1 true WO2012175082A1 (fr) 2012-12-27

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/DK2011/050231 WO2012175082A1 (fr) 2011-06-22 2011-06-22 Dispositif d'injection pour injection d'un médicament

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019158426A1 (fr) * 2018-02-13 2019-08-22 Union Medico Aps Dispositif d'injection et adaptateur

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4512767A (en) 1982-03-30 1985-04-23 Raymond Denance Apparatus for performing intradermal, subcutaneous of intramuscular injections
WO2000024441A1 (fr) * 1998-10-26 2000-05-04 Pharmacia Ab Injecteur automatique
WO2001041837A1 (fr) * 1999-12-08 2001-06-14 Union Medico Dispositif d'injection

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4512767A (en) 1982-03-30 1985-04-23 Raymond Denance Apparatus for performing intradermal, subcutaneous of intramuscular injections
WO2000024441A1 (fr) * 1998-10-26 2000-05-04 Pharmacia Ab Injecteur automatique
US20010005781A1 (en) 1998-10-26 2001-06-28 Thomas Bergens Autoinjector
WO2001041837A1 (fr) * 1999-12-08 2001-06-14 Union Medico Dispositif d'injection
EP1154811A1 (fr) 1999-12-08 2001-11-21 Union Medico Dispositif d'injection
EP1154811B1 (fr) 1999-12-08 2004-09-01 Union Medico Dispositif d'injection

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019158426A1 (fr) * 2018-02-13 2019-08-22 Union Medico Aps Dispositif d'injection et adaptateur
US11679207B2 (en) 2018-02-13 2023-06-20 Union Medico Aps Injection device and adaptor

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