Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS 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
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/14—Details; Accessories therefor
  • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
  • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
  • A61J1/2006—Piercing means
  • A61J1/201—Piercing means having one piercing end
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS 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
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/14—Details; Accessories therefor
  • A61J1/1406—Septums, pierceable membranes
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS 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
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/14—Details; Accessories therefor
  • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
  • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
  • A61J1/202—Separating means
  • A61J1/2027—Separating means having frangible parts
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS 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
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/14—Details; Accessories therefor
  • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
  • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
  • A61J1/202—Separating means
  • A61J1/2031—Separating means having openings brought into alignment
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS 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
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/14—Details; Accessories therefor
  • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
  • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
  • A61J1/2048—Connecting means
  • A61J1/2051—Connecting means having tap means, e.g. tap means activated by sliding
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS 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
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/14—Details; Accessories therefor
  • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
  • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
  • A61J1/2048—Connecting means
  • A61J1/2055—Connecting means having gripping means
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS 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
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/14—Details; Accessories therefor
  • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
  • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
  • A61J1/2048—Connecting means
  • A61J1/2065—Connecting means having aligning and guiding means
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS 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
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/14—Details; Accessories therefor
  • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
  • A61J1/2096—Combination of a vial and a syringe for transferring or mixing their contents

Definitions

• the present invention relates to a fluid transfer device 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 powder 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, allowing to insert a solution or to 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 US Patent 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 quantities are metered with precision required by the preparation method or 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 shown in Figure 1, comprises a central channel 11 ending in an orifice which is in the extension of the channel.
• the piercing needle 1 of FIG. 1 is represented in a bottle 2 after having pierced 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 that can reach the top of the bottle (or the bottom of the bottle as it is reversed) and thus recover in the solvent all of the reagent present, including s 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 FIG. 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.
• WO 2009/029010 A1 discloses another needle comprising at least one side opening for emptying a vial completely. Such a perforating needle is shown in FIG. 2.
• the perforating needle 1 comprises a central non-opening channel 11 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 through the lateral opening 8 in the central channel 11.
• the present invention aims to provide a perforating needle which does not have the disadvantages of the state of the art.
• the device of the invention is intended to allow both to optimally inject a liquid in a vial containing a prior product in solid form dispersed on the inner wall or in liquid form to recover it entirely in the liquid and extract the solution or mixture thus formed from the vial by completely draining the liquid into the vial, leaving no residue.
• a first aspect of the present invention relates to a perforating needle, also called “spike”, intended to be introduced into a bottle through a plug or septum for injecting and extracting a fluid, said needle comprising:
• a cylindrical body comprising a central channel through which the fluid can enter and exit the bottle and a side wall comprising at least one lateral orifice, said orifice being in fluid communication with the central channel and the lower end of this orifice being, in use, essentially at the inner face of the plug, said orifice being extended towards the pointed end by a groove whose shape is determined to be substantially tangent to the flow of the fluid in order to channel it along the axis of the needle, characterized in that the lateral wall has two diametrically opposite lateral orifices and disposed on either side of a central island, the central island having a separation stop forming a angle between 15 ° and 60 °, preferably between 20 ° and 30 °.
• the perforating needle is intended to be introduced into a bottle to be pierced to inject and / or extract a fluid.
• the reagent When the reagent must 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 perforating needle is made of rigid plastics material
• the perforating needle is intended to be introduced into a bottle comprising a plug made of elastomer or plastic material;
• the perforating needle comprises a zone of widening of the lateral wall called abutment on which a nut configured to firmly support the needle can be supported on a fluid connection device;
• the perforating needle is also accompanied by a guide accessory configured to be fixed irreversibly on the piercing needle, if necessary by means of a nut, to maintain and guide the bottle;
• the guide accessory comprises hooks for holding the guide accessory on the needle, directly or through a nut;
• the guide accessory has pairs of fins which are configured to hold the bottle irreversibly.
• a first pair of fins is placed in a raised position to hold the vial above the needle before piercing the stopper while a second pair of vane is placed in the down position to hold the vial depressed on the needle after drilling the stopper.
• Figure 1 schematically shows the steps (A, B, C, D) of the operating principle of a perforating needle of the prior art comprising an orifice located in the axis of the channel central. Such a needle does not completely empty the bottle.
• FIG. 2 schematically shows the steps (A, B, C, D) of the operating principle of a perforating needle of the prior art comprising one or more lateral orifices.
• a perforating needle of the prior art comprising one or more lateral orifices.
• Such a needle does not 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.
• FIG 3 shows schematically the steps (A, B, C, D) of the operating principle of a perforating needle according to the invention. After piercing the septum, a solution is introduced in a substantially vertical stream into a vial and the contents of the vial is completely emptied. The needle is shown provided with a nut and capped with a guide accessory of the vial.
• Figure 4 shows a perspective view of an exemplary piercing needle according to the invention.
• Figure 5A shows a side view of the needle shown in Figure 4 and Figure 5B a sectional view of the needle shown in Figure 5A according to Section A-A.
• Figure 6A shows a side view of the needle of the invention rotated at an angle of 90 ° with respect to the device shown in Figure 5A.
• Figure 6B shows a sectional view of the needle shown in Figure 6A in section B-B.
• Figure 6C shows a detailed view of the circled portion of Figure 6B.
• Figure 7 shows an axial view of the piercing needle, the pointed end appearing in the foreground.
• Figure 8 shows two perspective views of a guiding accessory of the vial on the piercing needle of the invention.
• Figure 9 shows two sectional views of the guide accessory shown in Figure 8. These sectional views show pairs of fins holding the vial in high and low positions of the guide accessory.
• Figure 10 shows two views in section of the perforating needle combined with the guide accessory, the left with vial in the upper position before drilling the septum (A) and the right with vial in the lower position after drilling septum (B).
• Figure 11 shows perspective views of the mounting of the piercing needle on a connecting device for introducing a fluid (A), the positioning of a nut (B) against the stop of the needle , the positioning of the guide accessory (C) on the needle provided with a nut and the completed assembly (D) ready to receive the bottle in the inverted position.
• the present invention relates to a perforating needle designed to allow the creation of a substantially vertical jet of solvent in a bottle from one or more side openings which also allow to empty the bottle completely.
• the principle of working in four steps is illustrated in Figure 3.
• the perforating needle 1 is shown in a bottle 2 after piercing the septum 6.
• the lateral orifices are located just above plug, at the same level as the inner face of the latter.
• a first step (step A) 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 in FIG. 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 into two.
• the central channel 11 opens on two lateral orifices 8, each orifice being extended towards 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 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 in Figure 3. This accessory facilitates the vertical insertion of the bottle 2 on the piercing needle 1.
• a nut 19 bears on the stop 4 of the needle allowing secure it firmly to the connecting device.
• the guide accessory is positioned on this nut (see Figure 10).
• the guide accessory 15 comprises hooks 16 which are wedged onto the nut 19. This operation ensures a good alignment of the guide accessory with respect 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 upper position (visible in Figure 9) and to maintain the bottle in the guide accessory before drilling the septum.
• FIG. 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 comprises a central channel 11 which is subdivided into two lateral orifices 8 extending by two flutes 17 opening near the pointed end 5.
• FIG. 5A represents a side view of the needle presented in FIG. 4 in which the lateral orifices 8 are located on either side of the pointed end 5.
• Figure 5B is a sectional view corresponding to Figure 5A according to section A-A.
• 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.
• Figure 6A shows a side view of the needle of the invention rotated at an angle of 90 ° with respect to the device shown in 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.
• Figure 6B shows a sectional view corresponding to 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 constitutes an extension of the side wall 12 in this plane as shown in FIG. Figure 5B.
• Figure 6C shows a detailed view of the circled portion of Figure 6B.
• the angle formed by the separation stop 14 of the central island 13 is between 15 ° and 60 °. For example, it is 24 ° in Figure 6C.
• FIG. 7 represents an axial view of the perforating needle 1. From the first plane towards the last plane, one can see successively: the pointed end 5, the lateral orifices 8, the lateral 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 guiding accessory is shown in 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 by 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. Once the guiding accessory and the piercing needle are assembled on the connecting device, the user only has to insert the vial into the guide accessory and push it to pierce the septum.
• 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 provided with a “luer” connection.
• Female the proximal end 10 of the needle 1 forms a male "luer” fitting that can be fitted to any fluid transfer device provided with a “luer” connection.
• FIG. 11 shows perspective views of the mounting of 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 final assembly, the guide accessory being ready to receive a bottle in the inverted position as shown in FIG.
• the proximal end 10 of the needle may have another type of connection, fluted 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 so as to transfer a fluid from a vial to a syringe or vice versa.

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• 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)

Applications Claiming Priority (2)

Publications (2)

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Family Applications (1)

Country Status (6)

Families Citing this family (6)

Family Cites Families (23)

• 2015
  • 2015-12-03 BE BE2015/5782A patent/BE1023649B1/fr active
• 2016
  • 2016-11-25 WO PCT/EP2016/078876 patent/WO2017093141A1/fr unknown
  • 2016-11-25 EP EP16801495.9A patent/EP3383341B1/de active Active
  • 2016-11-25 CN CN201680070320.1A patent/CN108430429B/zh active Active
  • 2016-11-25 US US15/778,638 patent/US10406070B2/en not_active Expired - Fee Related
  • 2016-11-25 KR KR1020187013850A patent/KR102652130B1/ko active IP Right Grant

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