EP3383341B1 - Aiguille perforante pour fiole avec septum - Google Patents

Aiguille perforante pour fiole avec septum Download PDF

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Publication number
EP3383341B1
EP3383341B1 EP16801495.9A EP16801495A EP3383341B1 EP 3383341 B1 EP3383341 B1 EP 3383341B1 EP 16801495 A EP16801495 A EP 16801495A EP 3383341 B1 EP3383341 B1 EP 3383341B1
Authority
EP
European Patent Office
Prior art keywords
needle
flask
perforating needle
fluid
stopper
Prior art date
Legal status (The legal status 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 status listed.)
Active
Application number
EP16801495.9A
Other languages
German (de)
English (en)
French (fr)
Other versions
EP3383341A1 (fr
Inventor
Jean-Luc Morelle
Frédéric BAPLUE
Gauthier Philippart
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Trasis SA
Original Assignee
Trasis SA
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 Trasis SA filed Critical Trasis SA
Publication of EP3383341A1 publication Critical patent/EP3383341A1/fr
Application granted granted Critical
Publication of EP3383341B1 publication Critical patent/EP3383341B1/fr
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006Piercing means
    • A61J1/201Piercing means having one piercing end
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/1406Septums, pierceable membranes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/202Separating means
    • A61J1/2027Separating means having frangible parts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/202Separating means
    • A61J1/2031Separating means having openings brought into alignment
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048Connecting means
    • A61J1/2051Connecting means having tap means, e.g. tap means activated by sliding
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048Connecting means
    • A61J1/2055Connecting means having gripping means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048Connecting means
    • A61J1/2065Connecting means having aligning and guiding means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2096Combination of a vial and a syringe for transferring or mixing their contents

Definitions

  • the present invention relates to a device for transferring fluids between a container containing for example a drug or any ingredient (in solid or liquid form) for its preparation and an injection means.
  • the invention relates more particularly to a perforating needle.
  • the ingredients are commonly supplied in containers.
  • the product contained in a vial is transferred by means of a syringe or by pressure difference to the preparation device, for example a syringe or to a specific preparation or synthesis device, in order to constitute the drug or one of its precursors.
  • the product is supplied in liquid form in a vial while in other cases it is in the form of a solid, for example powdered or freeze-dried.
  • a powder When it comes to a powder, it is most often deposited or evaporated on the bottom of the bottle. To recover this powder, a solvent must be introduced into the flask to dissolve the powder. The reconstituted product is then removed from the vial and transferred to the place of use.
  • a hollow perforating needle as known from the state of the art provides a means of fluid communication with the contents of the vial.
  • the tip can pierce the septum, to insert a solution or empty the contents of the vial.
  • a conventional needle is composed of a sharp tip and a hollow access tube allowing a fluid to flow for example from an infusion bag as described in the patent. US 6,261,267 B1 .
  • the solution continues to flow until the meniscus of the fluid in the vial falls below the end of the tip, leaving a certain amount of residual liquid in the vial.
  • the products contained in containers in small quantity are dosed with a precision required by the method of preparation or the clinical indication. This precision can be important. Therefore, failure to recover all of the product contained in the vial may result in variations in the quality of the preparation or the amount transferred.
  • a conventional perforating needle as presented at figure 1 , comprises a central channel 11 ending in an orifice which is in the extension of the channel.
  • the piercing needle 1 of the figure 1 is shown in a bottle 2 after piercing the septum 6.
  • This needle 1 comprises a cylindrical body 3, a stop 4, and a pointed end 5.
  • the cylindrical body 3 extends from a distal end 9 of the needle to a proximal end 10. At its distal end 9 the cylindrical body 3 has a side wall 12 surrounding a central channel 11 terminated by an orifice at the pointed end 5.
  • Such a needle makes it possible to send a vertical jet of solvent which can reach the top of the flask (or the bottom of the flask as it is flipped over) and thus recover all the reagent present in the solvent, even if it is deposited in solid form on all the inner walls of the bottle.
  • a piercing needle does not empty the bottle in its entirety. There will always remain a fraction of unrecoverable fluid 7 below the level of the orifice of the tip 5 (see figure 1D ).
  • the piercing point is eccentric which causes misalignment of the vials with respect to the axis of the needle and is problematic in automated systems. Finally the eccentric points are generally less sharp.
  • the document WO 2009/029010 A1 discloses another needle comprising at least one lateral opening for emptying a vial completely.
  • a perforating needle is represented at figure 2 .
  • the piercing needle 1 has a central channel 11 that does not open and two lateral openings 8 at its distal end 9. The opening is located just above the septum 6 so that all the fluid contained in the bottle can flow to through the lateral opening 8 in the central channel 11.
  • the needle does not make it possible to produce a sufficiently vertical solvent jet to reach the bottom of the bottle and thus recover the entirety of the product deposited on the walls.
  • GB829383 and WO 2009/030788 describe hypodermic perforating needles.
  • the present invention aims to provide a perforating needle which does not have the disadvantages of the prior art.
  • the device of the invention is intended to allow both to optimally inject a liquid in a vial containing a product in solid form dispersed on the inner wall or in liquid form to recover it entirely in the liquid and extracting the solution or mixture thus formed from the vial by completely draining the liquid into the vial, leaving no residue.
  • the perforating needle is intended to be introduced into a flask to be pierced in order to inject and / or extract a fluid.
  • the reagent is to be stored in solid form, it is generally deposited on the walls and more particularly on the bottom of the flask by evaporation or lyophilization techniques known to those skilled in the art.
  • the solid reagent is recovered by introducing a suitable solvent via the piercing needle and then aspirating the solution in which the solid reagent has dissolved or has been entrained. This requires to be able to fully wet the inner surface of the bottle.
  • the present invention relates to a perforating needle designed to allow the creation of a substantially vertical jet of solvent in a vial from one or more lateral ports which also allow the vial to be completely emptied.
  • the principle of working in four stages (A, B, C, D) is illustrated in figure 3 .
  • the perforating needle 1 is shown in a bottle 2 after having pierced the septum 6.
  • the lateral orifices are located just above the cap, at the same level as the internal face of the latter.
  • the needle 1 is used to inject a fluid 7 vertically into the bottle to solubilize the contents, for example in the form of a powder adhering to the walls of the bottle, mainly in the bottom.
  • the bottle is then completely emptied of its contents (steps B, C and D), the solution flowing through the lateral orifices 8 of the needle in the central channel 11.
  • the performance in the essentially vertical injection of liquid is obtained thanks to the particular shape of the flow surfaces of the rising liquid flow.
  • the rising vertical flow can be divided or not.
  • the central channel 11 opens on a lateral orifice 8 extended towards the pointed end 5 by a groove 17 (shown on the figure 4 ).
  • the shape of the groove ensures the flow of fluid to the tip and a substantially vertical jet is obtained along the axis of the piercing needle.
  • the vertical flow is divided in two.
  • the central channel 11 opens on two lateral orifices 8, each orifice being extended to the pointed end 5 by a groove 17.
  • the flow of fluid is channeled around a central island 13 constituting a separation stop 14 (shown in FIG. Figure 6C ) for the rising liquid flow.
  • the fluid 7 follows the central island 13 of substantially convex shape, the surrounding pressure does not allow the fluid to deviate.
  • the needle makes it possible to project the fluid along its substantially vertical axis and to recover it completely via one or more lateral orifices 8.
  • a guide accessory 15 is also shown on the figure 3 .
  • This accessory facilitates the vertical insertion of the bottle 2 on the piercing needle 1.
  • a nut 19 is supported on the stop 4 of the needle for firmly fixing it on the connecting device.
  • the guide accessory is positioned on this nut (see figure 10 ).
  • the guide accessory 15 comprises hooks 16 which are wedged on the nut 19. This operation ensures a good alignment of the guide accessory relative to the needle.
  • the guide accessory 15 also has a pair of lower fins 18a in the lower position for holding the bottle 2 down on the needle after it has pierced the septum. There is also a pair of upper fins 18b in the up position (visible on the figure 9 ) and to maintain the bottle in the guide accessory before drilling the septum.
  • the figure 4 is a perspective representation of the piercing needle according to the invention.
  • This needle 1 comprises a cylindrical body 3, a stop 4, and a pointed end 5.
  • the cylindrical body 3 extends from a distal end 9 of the needle towards a proximal end 10.
  • the cylindrical body 3 has a central channel 11 which is subdivided into two lateral orifices 8 extending by two flutes 17 opening near the pointed end 5.
  • the Figure 5A represents a side view of the needle presented at figure 4 in which the lateral orifices 8 are situated on either side of the pointed end 5.
  • the Figure 5B is a sectional view corresponding to the Figure 5A according to section AA.
  • the cylindrical body 3 comprises a central channel 11 surrounded by a lateral wall 12 which extends from the proximal end of the needle but stops before reaching the distal end 9.
  • the central channel 11 is subdivided at this level into two lateral orifices 8 around a central island 13.
  • the Figure 6A represents a side view of the needle of the invention pivoted at an angle of 90 ° with respect to the device shown in FIG. Figure 5A .
  • a first lateral opening 8 is presented from the front and the other opening 8 is in the background, diametrically opposed to the first.
  • the Figure 6B represents a sectional view corresponding to the Figure 6A according to section BB.
  • the cylindrical body 3 has a central channel 11 surrounded by a side wall 12 which extends from the proximal end 10 of the needle to its distal end 9. Close to the end distal 9, the central channel 11 is divided into two lateral orifices 8 which are separated from each other by a central island 13. This island is disposed at the end of the central channel 11. It begins with a separation stop 14 which divides the incoming liquid flow in two, extends laterally by substantially straight forms and ends with the pointed end 5.
  • the central island 13 is an extension of the side wall 12 in this plane as shown in FIG. Figure 5B .
  • the Figure 6C represents a detailed view of the encircled portion of the Figure 6B .
  • the angle formed by the separation stop 14 of the central island 13 is between 15 ° and 60 °.
  • it is 24 ° on the Figure 6C .
  • the figure 7 is an axial view of the piercing needle 1. From the first plane to the last plane can be seen successively: the pointed end 5, the lateral orifices 8, the side wall 12 of the cylindrical body 3 and the upper part of the stop 4 .
  • a guide accessory 15 may be used. This accessory is configured to be fixed irreversibly on the piercing needle 1, directly or through a nut 19 (see figure 11 ).
  • FIG. 8 An example of a guide accessory is shown at figure 8 .
  • the drawing on the left shows the end of the accessory clinging to the nut 19 of the needle and the drawing on the right shows the end of the accessory through which the bottle 2 is inserted.
  • the guide accessory 15 comprises hooks 16 for attaching to the needle through a nut 19.
  • the hooks 16 are clipped behind the nut 19 enclosing the needle as shown in FIG. figure 10 .
  • the presence of these hooks 16 prevents the guiding accessory 15 from detaching from the needle once it is attached thereto.
  • the figure 10 shows the principle of operation of the pairs of fins 18a, 18b in the presence of a bottle in the inverted position.
  • the left sectional view shows the bottle not yet pierced, held in the upper position by the upper pair of fins.
  • the right sectional view shows the bottle pressed down and held on the needle by the pair of lower fins 18b.
  • the proximal end 10 of the needle 1 forms a male "luer” fitting that can be fitted to any fluid transfer device with a female “luer” connector.
  • the figure 11 represents perspective views of mounting the piercing needle on a connecting device for introducing a fluid therein.
  • the needle 1 comprises a male "luer” fitting attached to a fluid transfer device comprising a female “luer” connector.
  • a nut 19 is introduced on the needle. This nut has a recess of complementary shape (essentially rectangular or square) to the upper part of the stop 4 of the needle so as to keep it firmly in the vertical position.
  • step (C) the guide accessory is positioned on the needle provided with a nut, the hooks 16 of the guide accessory being clipped behind the nut (see figure 10 ).
  • Step (D) shows the finalized mounting, the accessory of guiding being ready to receive a bottle in an inverted position as shown in FIG. figure 10 .
  • the proximal end 10 of the needle may comprise another type of connection, grooved or welded for example. It is through this connection that the fluid enters or leaves.
  • the needle may be used in a reduced pressure injection system to transfer fluid from a vial to a syringe or vice versa.

Landscapes

  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Physics & Mathematics (AREA)
  • Fluid Mechanics (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
EP16801495.9A 2015-12-03 2016-11-25 Aiguille perforante pour fiole avec septum Active EP3383341B1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
BE2015/5782A BE1023649B1 (fr) 2015-12-03 2015-12-03 Aiguille perforante pour fiole avec septum
PCT/EP2016/078876 WO2017093141A1 (fr) 2015-12-03 2016-11-25 Aiguille perforante pour fiole avec septum

Publications (2)

Publication Number Publication Date
EP3383341A1 EP3383341A1 (fr) 2018-10-10
EP3383341B1 true EP3383341B1 (fr) 2019-09-25

Family

ID=55349599

Family Applications (1)

Application Number Title Priority Date Filing Date
EP16801495.9A Active EP3383341B1 (fr) 2015-12-03 2016-11-25 Aiguille perforante pour fiole avec septum

Country Status (6)

Country Link
US (1) US10406070B2 (ko)
EP (1) EP3383341B1 (ko)
KR (1) KR102652130B1 (ko)
CN (1) CN108430429B (ko)
BE (1) BE1023649B1 (ko)
WO (1) WO2017093141A1 (ko)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019084371A1 (en) * 2017-10-26 2019-05-02 Cook Regentec Llc ADAPTER FOR BOTTLES AND SYRINGES
CN213139759U (zh) * 2020-09-04 2021-05-07 汪祥海 一种液体注入器转接头
CN112774746B (zh) * 2020-12-29 2022-11-15 深圳市天林智能科学仪器有限公司 一种有机测试小瓶中废液自动化处理工作站
CN113133941B (zh) * 2021-04-28 2024-04-26 舟山医院 一种医用注射摇液晃瓶装置
USD1008021S1 (en) * 2021-10-25 2023-12-19 Octodent Llc Cap for a medical vial

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Also Published As

Publication number Publication date
KR102652130B1 (ko) 2024-03-29
BE1023649B1 (fr) 2017-06-06
US20190000715A1 (en) 2019-01-03
BE1023649A1 (fr) 2017-06-06
WO2017093141A1 (fr) 2017-06-08
EP3383341A1 (fr) 2018-10-10
US10406070B2 (en) 2019-09-10
CN108430429A (zh) 2018-08-21
KR20180089401A (ko) 2018-08-08
CN108430429B (zh) 2021-05-28

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