WO2001041650A1 - Dispositif de remplissage double direct pour agents de scellement - Google Patents

Dispositif de remplissage double direct pour agents de scellement Download PDF

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Publication number
WO2001041650A1
WO2001041650A1 PCT/US2000/033541 US0033541W WO0141650A1 WO 2001041650 A1 WO2001041650 A1 WO 2001041650A1 US 0033541 W US0033541 W US 0033541W WO 0141650 A1 WO0141650 A1 WO 0141650A1
Authority
WO
WIPO (PCT)
Prior art keywords
connector
hood
recited
container
fluid
Prior art date
Application number
PCT/US2000/033541
Other languages
English (en)
Inventor
Gordon Howard Epstein
Mitchell E. Levinson
Richard Spero
Adam Hagmann
Alan Plyley
Russell James Redmond
Original Assignee
Baxter International Inc.
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
Priority claimed from US09/456,728 external-priority patent/US6488650B1/en
Priority claimed from US09/731,488 external-priority patent/US6575205B2/en
Application filed by Baxter International Inc. filed Critical Baxter International Inc.
Priority to AU19586/01A priority Critical patent/AU1958601A/en
Publication of WO2001041650A1 publication Critical patent/WO2001041650A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00491—Surgical glue applicators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00491—Surgical glue applicators
    • A61B2017/00495—Surgical glue applicators for two-component glue
    • 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
    • A61J1/20—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
    • A61J1/2013—Piercing means having two piercing ends
    • 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
    • A61J1/2058—Connecting means having multiple connecting ports
    • 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 filling device for an applicator which applies multiple fluid sealant components to a work surface and is particularly, although not exclusively, useful for applying tissue sealant components to biological tissue to effect hemostasis or achieve other therapeutic results. More particularly, it relates to a dual compartment enclosed direct filling device for hand-held applicators .
  • tissue sealants and other biological materials are an important emerging surgical technique, well adapted for the operating room or field environments such as the doctor's office or mobile medical units.
  • Preferred sealants include fibrin sealants which are formed from blood plasma components and comprise, on the one hand, a first component containing fibrinogen and Factor XIII and on the other hand a second component which usually includes thrombin, and calcium ions.
  • the fibrinogen is capable of a polymerizing and being cross-linked to form a solid fibrin clot when the components are mixed.
  • the necessary additional factors to simulate relevant portions of the natural blood coagulation cascade are suitably distributed between the fibrinogen and thrombin components .
  • a popular manually operable applicator for such two-component sealants employs a dual syringe construction wherein two syringes, connected by a yoke, each provide a reservoir for one of the components.
  • the sealant components are discharged in separate streams and mixed externally of the applicator.
  • Such applicators are similar in principle to household epoxy glue applicators commonly available in hardware stores.
  • fibrin sealant was not commercially available in the US, therefore use of fibrin sealant was limited to supplies produced within the clinic, which are not subject to FDA control.
  • Figure 13 is a cut away view showing the drawing tube held in place by the guide
  • Figure 14 is an exploded view showing an alternative embodiment of the hood
  • Figure 15 is an elevational section view of the embodiment shown in figure 14
  • Figure 16 is a cut away view showing the hood of the embodiment shown in figure 14 being lowered onto the base during assembly
  • Figure 17 is a partial cross-sectional view of the embodiment shown in figure 14
  • Figure 18 is a frontal view showing a cover of an alternative embodiment of the invention for use with a single vial
  • Figure 19 is a frontal view showing the vial of the embodiment shown in figure 18;
  • Figure 27 is a frontal view showing the assembled system of an alternative embodiment of a single vial system of the invention.
  • Applicator 18 preferably has at least two fluid reservoirs for separately holding and controllably dispensing reactable fluids, each of the fluid reservoirs being connected to a syringe by a fluid conduit.
  • the applicator is of the type primarily used for applying multiple fluid sealant components to biological tissue to effect hemostasis or achieve other therapeutic results.
  • the inventive filling device can be adapted to fit applicators having a wide variety of uses which require the direct filling of fluids into separate reservoirs located within an applicator.
  • Figure la-lb shows an additional embodiment of the direct dual filling device 10a comprising a body 12a, a hood 14a, and a collar 16a which is adapted to fit a syringe-type applicator 18a.
  • the syringe-type applicator 18a preferably has at least two fluid reservoirs 19a and 19b for separately holding and dispensing the retractable fluids.
  • the fluid reservoirs 19a and 19b are connected to the filling device 10a by fluid conduits.
  • the syringe-type applicator 18a is of the type for applying multiple component biological fluids to biological tissue to effect hemostasis or achieve alternative therapeutic results.
  • the filling device 10a comprises the elements of the previous embodiment illustrated in figure 1, however, the collar 16a has been adapted to functionally receive the syringe-type applicator 18a.
  • the collar 16a may be adapted to receive a plurality of syringe-type applicators, including, without limitation, the DuplojectTM syringe-type applicator manufactured by the Baxter Corporation.
  • inlet ports 20 and 21 Located within body 12 are inlet ports 20 and 21 which are adapted to receive syringes 22 and 23 of applicator 18. Rubber O-rings 34 and 35 are positioned within inlet ports 20 and 21 respectively, such that an air tight seal is formed.
  • Inlet ports 20 and 21 are connected to drawing tubes 24 and 25 by transverse channels 26 and 27 respectively, which drawing tubes 24 and 25 extend into bottles 28 and 29.
  • Drawing tubes 24 and 25 should have sufficient length to extract substantially all the liquid contained within the bottle, or conversely they should have a length such that when the system is inverted substantially all of the liquid can be extracted.
  • Drawing tubes 24 and 25 are preferably configured with pointed ends 30 and 31 which have the ability to pierce the protective packaging found on standard medical fluid bottles 28 and 29 and form a seal.
  • Drawing tubes 24 and 25 are preferably formed out of a metallic material, however any suitable material such as thermoplastic may be used. The tubes can also have the ability to be removed from support sleeves 32 and 33 for replacement.
  • Channel 26 allows the fluid contained within right bottle 28 to be drawn through tube 24 and into syringe 22 for deposit within the proper receptacle located within applicator 18 without coming into contact with the fluid contained within bottle 29.
  • channel 27 allows the fluid contained within left bottle 29 to be drawn through tube 25 and into syringe 23 for deposit within the proper receptacle located within applicator 18 without coming into contact with the fluid contained within bottle 28. This allows the simultaneous filling of both sides of the applicator directly from the commercially available containers.
  • Channels 26 and 27 can be formed out of thermoplastic tubing or molded directly into body 12 of the direct filling device 10.
  • hood 14 is placed over said bottles such that pointed tips 30 and 31 are approximately centered on the protective seal covering the bottles.
  • the contoured shape of hood 14 guides the inventive device as the bottles are seated and snap into place within hood 14 by locking members 40.
  • locking members 40 are located within hood 14 such that they move apart when cap 42 of its respective bottle passes by during the insertion of the bottle, then once the bottle has reached the proper location locking members 40 retract under bottle cap 42 to lock or "seat" the bottles in place.
  • the system may be inverted to ensure that all of the fluid is draw out of the bottles.
  • the plunger 19 of applicator 18 is then retracted thereby drawing the fluid contained within bottles 28 and 29 through their respective drawing tubes and channels into the syringes of applicator 18 for deposit within a reservoir.
  • the direct filling device 10 is connected to applicator 18 by a pair of snap fit members 36.
  • Applicator 18 is placed over the filling device such that the syringes are approximately centered over inlet ports 22 and 23, then pressed down until locked in place by snap fit members 36.
  • the novel shaping of the collar 16 allows filling device 10 to mate with applicator 18 in only one orientation, thereby "keying" the fill device to the applicator.
  • the general pentagon shape precisely fits to the applicator body in the same manner as interchangeable applicator tips or heads, which are used for droplet or spray dispensing of sealant.
  • the collar 16 may be adapted to receive and "key" a plurality of applicators, including syringe-type applicators.
  • hood 14 has a recess 44 which aides the user in removal of the bottles. Recess 44 is also useful, if hood 14 is opaque, to view any labels present on the bottle so it can be verified that the proper components are delivered into the proper reservoirs. Also shown is the contoured shape of hood 14. The shape can be varied to allow use of different types and shapes of bottles. The hood can also be modified so that each side allows insertion of a different shaped bottle, thereby keying the bottles to the fill device. This in conjunction with the novel shape of the collar is important in ensuring that the proper components are delivered to the proper reservoirs within the applicator.
  • the direct dual filling device embodiment shown in figures 6-11 is a more detailed embodiment of the invention which includes most of the features shown in the embodiment of figures 1-5 and is suitable for manufacturing from injected molded plastics components. As will be described, several of the parts of the direct dual filling device shown in figures 6-11 embody similar construction and functionality to the components of the embodiment shown in figures 1-5.
  • Hood 102 can be contoured to resemble the shape of the filling device when assembled with agent vials.
  • the shape can also vary to allow use of different types and shapes of bottles.
  • the hood can be modified so that each side allows insertion of a different shaped bottle, thereby keying the bottles to the fill device. This in conjunction with the novel shape of the collar is important in ensuring that the proper components are delivered to the proper reservoirs within the applicator.
  • hood 102 and base 116 are essentially rigid, injected molded components having limited resilience in their thinner sections.
  • Hood 102 is also preferably formed from a clear plastic such as polycarbonate or SAN.
  • fluid conduits 112 and 114 are preferably fabricated from a distinctly elastomeric, resilient molding material such as silicone rubber.
  • hood 102 is configured to snap into the base by use of snap fit members 111.
  • Hood 102 and base 116 are configured such that they may only be assembled in one direction, so in use, the operator cannot assemble the device incorrectly.
  • Base 116 and hood 102 are also color-coded to indicate which side is for the thrombin vial in which side is for the fibrinogen vial.
  • base 116 is labeled with a "T” indicating the side for thrombin, and an "F” indicating the side for fibrinogen.
  • first-half 104 and second half 106 When assembled, the upper portions of first-half 104 and second half 106 combine to form a collar 136, embodying features of collar 16.
  • a pair of channels 137 having inlet ports 140 and 142 are also defined within hood 102. Channels 137 are configured to retain fluid conduits 112 and 114.
  • Drawing tubes 108 and 110 should have sufficient length to extract substantially all the liquid contained within the corresponding vial.
  • Drawing tubes 108 and 110 are preferably configured with a pointed end which has the ability to pierce the protective seal found on standard medical fluid bottles thereby forming a seal.
  • Drawing tubes 108 and 110 generally resemble a needle, and are preferably formed out of a metallic material, however any suitable material such as thermoplastic may be used. Both of the tubes may be of similar diameter, however the tube diameter may differ to accommodate liquids having differing viscosities.
  • Collar 136 is connected to an applicator 18 by a pair of snap fit members 138. Applicator 18 is placed over direct dual filling device 100 such that the syringes of applicator 18 are approximately centered over inlet ports 140 and 142, then pressed down until in place by snap fit members 138. Alternatively, collar 136 may be configured without snap fit members 138. Due to the stability of the device when assembled, applicator 18 can be held in place by a combination of gravity and the friction generated by the tight nature of the seal formed between the syringes and the fluid conduits. The novel shaping of collar 136 allows direct dual filling device 100 to mate with applicator 18 in only one orientation, thereby " keying" the fill device to the applicator.
  • first-half 104 of hood 102 has a central divider 148 which divides the hood into two compartments 150 and 152, which when hood 102 is assembled, house vials 130 and 132 respectively.
  • Compartment 150 has an upper surface 154 which is slanted from its lowest point at divider 148 to its highest point at outer wall 156.
  • compartment 152 has an upper surface and 158 which is slanted from its lowest point at divider 148 to its highest point at outer wall 160.
  • first-half 104 and second-half 106, of hood 102 are configured to be assembled together by snap fit members 105.
  • ultrasonic welding, glue, press fitting or any other method of assembly may be used. All of the components of the inventive device are then sterilized.
  • the operator need only insert the vials and mate the hood onto the base.
  • the agent vials are not sterilized and are unable to be brought into a sterile environment without risk of contamination.
  • the assembly may be brought into a sterile environment for use.
  • the operator assembles the device by sliding the agent vials onto vial supports 126 and 128 such that the necks of the two agent vials are resting on vial support surface 134.
  • the angle at which the outer portion 164 of vial support surface 134 is configured, will cause the two agent vials to slide down into place resting on level central portion 166 of vial support surface 134.
  • the angle is such that friction will not stop the bottle from fully seating on level central portion 166.
  • a vial 130 is properly seated within vial support 126 when the center line 180 of vial 130 is positioned at a point on level central portion 166 further out than pivot fulcrum 182.
  • Pivot fulcrum 182 occurs at the point where level portion 166 transforms into inner support surface 168. This positioning allows vial 130 to be firmly held in place by support 126, while still allowing vile 130 to pivot in the direction of arrow 184. By allowing vial 130 to fully seat within vial support surface 134, vial 130 will maintain a level position during the first part of the insertion of the drawing tube. This allows the needle to properly align with the target area of the vials septum. Since the vials septum has a thin portion in be center which allows needles to puncture, it is desirable to align the drawing tube with this target area, thereby assuring a good seal.
  • Figure 10 depicts the point at which the top portion of vials 130 and 132 comes into contact with upper surfaces 154 and 158.
  • the slanted configuration of upper surface 154 causes agent vial 130 to tilt in the direction of arrow 172.
  • the slanted configuration of upper surface 158 causes agent vial 132 to tilt in the direction of arrow 174.
  • the vials are tilted because the top slanted inner surface of the housing vial cavities are forced down onto the lid of each vial, causing them to tilt to the same angle as the top of the inner cavity.
  • drawing tubes 108 and 110 are driven into the bottom corner of their respective viles.
  • the sharpened tips of the drawing tubes are shaped such that they conform to the shape of the bottom corner of the agent vials so that as much fluid as possible is drawn up.
  • hood assembly Once the hood assembly has been completely lowered onto the base into the fully engaged position of figure 11, it may be locked into place by snap fittings 111.
  • Agent vials 130 and 132 are tilted in such a manner that drawing tubes 108 and 110 are forced into the bottom corner of each respective vial, which has now become the low point for the agent to pool into. This configuration along with the shaping of the drawing tubes allows for minimal waste of the agent contained within the vials.
  • the inventive filling device Once the inventive filling device is assembled, it may be brought into a sterile field.
  • the agent vials are generally not sterile and therefore would not be allowed within a sterile environment for risk of contamination, the hood and base assembly has effectively shrouded the vials within a sterile environment so that they may be brought into a sterile field.
  • Figures 14-17 show an alternative embodiment of the inventive device.
  • hood 102 comprises compliant upper arms 103 and 107 which act as compliant tipping arms. Arms 103 and 107 are vertically positioned and have a resilient flexibility to engage and tip vials 130 and 132 as hood 102 is lowered before the needles bottom out on the vials' convexity and hold vials 130 and 132 in tilted position so as to optimize evacuation of the contents of vials 130 and 132.
  • Base 116 comprises modified vial supports 126' and 128' which are open on either side of vials 130 and 132. Thus, a nurse or other user may load a device without touching the base thus avoiding contaminating the sterile field.
  • hood 102 is provided internally with rounded jaws 131 and 133 (not shown) which firmly clasp the tops of vials 130 and 132.
  • Jaws 131 and 133 suspend vials 130 and 132 in carved rounded recesses 135 and 139 (not shown) .
  • the inside of the jaw has a part circular horizontal ledge where the bottle can sit vertically. Jaws 130 and
  • 132 and recesses 135 and 139 maintain vials 130 and 132 in a vertical position prior to tilting as recesses 135 and 139 prevent tilting until the bottom of each vial is above the recesses.
  • Arms 103 and 107 are vertically positioned and have a resilient flexibility to engage and tip vials 130 and 132 and the vials tilt after the hood clasps the bottoms of the vials.
  • Base 116 is shaped to provide visual guides 117 and 121 to assist the user in visually matching the round and square portion of hood 102 and base 116 for alignment and proper orientation. Once assembled hood 102 is configured to snap into the base by use of snap fit members 111.
  • venting is not usually necessary.
  • most medical personnel are used drawing out a desired volume of liquid from a vial by first injecting the same volume of sterile air into the vial. Then the syringe automatically withdraws the same amount of liquid volume to equalize the pressure in the vial.
  • pressurization may cause problems in that fluids may back up into the needles prematurely. Additionally, this method also causes air bubbles and inaccurate dosages. Accordingly, venting is desirable to prevent such undesired pressurization and release unwanted air while maintaining the sterile field.
  • an oversized piece of hypo tube can be used to provide a collar over the needle which has an inner diameter of .002 in greater than the outer diameter of the needle.
  • the needle pushes against the collar, it makes a gap allowing air to escape between the needle and collar.
  • a pair of dagger-like molded inserts 113 and 115 alongside each needle which is against drawing tubes 108 and 110 which allow air to escape within the sterile field.
  • inserts 113 and 115 may be provided with sharply pointed tips or cutting edges to create a hole alongside the needles which stays open after piercing. The hole allows air but not liquid to escape.
  • adaptation can be easily made to allow the use of three or more, which can directly fill three or more reservoirs contained within the applicator.
  • This adaptation can be accomplished by expanding the hood and adding another inlet port, transverse channel and drawing tube.
  • an alternative embodiment of the inventive device is shown in the form of a single vial, direct filling device 200 having a cover 210 which snaps onto a base 216 thereby enclosing the vial 214 within the structure, allowing device 200 to be brought into a sterile field.
  • This device provides needleless filling of fluids from non-sterile vials inside the sterile field with reduced waste, while maintaining label visibility for application safety.
  • the device consists of a base or bag, cover and a needle. With this device the vial is completely shrouded and can be moved into the sterile field.
  • the device is for single use, but multiple fillings. It is understood that the system may come with a needle for mating with the syringe or the syringe may be attached to a needle retracted within a protective cover so that the needle is only exposed within the sterile environment of the system.
  • Cover 210 has a hole 211 which receives needle 212 and has a tilted side portion 213 which accommodates vial 214 tilting.
  • Base 216 has a curved notch 217 where the neck of vial 214 rests.
  • Vial 214 may be any standard size vial which is used for intravenous medication. Vial 214 is loaded into the device and is suspended by its neck. This arrangement accommodates multiple vial sizes and tilting of vial 214.
  • Figure 21 shows the assembled system 200 with vial 214 sitting in base 216 in vertical ⁇ position . Rib 218 is tilted before engagement.
  • Figure 22 shows the device after it is fully assembled and with rib 218 fully engaged.
  • Cover 210 has a feature that tilts the vial 214 for maximum fluid removal.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

L'invention concerne un dispositif de remplissage (10) et un procédé destinés en particulier à des scellants à deux composants, tels que les scellants de la fibrine, permettant d'injecter deux fluides provenant de deux flacons (28, 29) de stockage, séparément et directement, dans les réservoirs d'un applicateur (18) de fluide à double seringue, lesdits flacons pouvant être des flacons normalisés, étanches et stériles. Le dispositif comprend un raccord (16) en prise avec l'applicateur (18) de fluide, conçu de façon à orienter les réservoirs de fluide de l'applicateur d'une manière prédéterminée et de façon à maintenir les flacons (28, 29) côte-à-côte en alignement avec l'applicateur (18). Deux conduits (26, 27) de fluide, dont les extrémités inférieures peuvent former des pointes (30, 31) permettant de percer les sceaux des flacons (28, 29), s'étendent entre l'applicateur (18) et les flacons (28, 29), pouvant chacun comprendre un élément d'assemblage transversal qui s'adapte aux dimensions des flacons (28, 29). Le dispositif permet d'incliner les flacons (28, 29) de façon que les conduits (26, 27) puissent retirer un maximum de fluide du fond du flacon (28, 29). L'inclinaison peut être effectuée par un mouvement vers le bas du dispositif qui supporte l'applicateur, ce mouvement permettant d'introduire les conduits de fluide dans les flacons. Une enveloppe peut renfermer et étanchéiser les flacons et permettre à l'ensemble appareil et applicateur de fluide d'être introduit dans un environnement stérile. L'invention concerne également d'autres modes de réalisation dans lesquels un seul flacon est utilisé.
PCT/US2000/033541 1999-12-08 2000-12-08 Dispositif de remplissage double direct pour agents de scellement WO2001041650A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU19586/01A AU1958601A (en) 1999-12-08 2000-12-08 Direct dual filling device for sealing agents

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US09/456,728 US6488650B1 (en) 1998-06-03 1999-12-08 Direct dual filling device for sealing agents
US09/456,728 1999-12-08
US09/731,488 2000-12-07
US09/731,488 US6575205B2 (en) 2000-12-07 2000-12-07 Direct dual filling device for sealing agents

Publications (1)

Publication Number Publication Date
WO2001041650A1 true WO2001041650A1 (fr) 2001-06-14

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WO (1) WO2001041650A1 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003088843A1 (fr) * 2002-04-19 2003-10-30 Baxter International Inc. Dispositif de remplissage direct double pour agents de scellement
EP1452140A1 (fr) * 2003-02-03 2004-09-01 Biomet, Inc. Pulvérisateur
WO2010145041A1 (fr) 2009-06-19 2010-12-23 Medmix Systems Ag Dispositif de remplissage d'une seringue multiple ou simple

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5171214A (en) * 1990-12-26 1992-12-15 Abbott Laboratories Drug storage and delivery system
US5266877A (en) 1989-09-14 1993-11-30 Hitachi, Ltd. Apparatus for and method of preparing numerical control data for interactive mounter
WO1996029113A1 (fr) * 1995-03-20 1996-09-26 Medimop Medical Projects Ltd. Dispositif de regulation de fluide
US5585007A (en) 1994-12-07 1996-12-17 Plasmaseal Corporation Plasma concentrate and tissue sealant methods and apparatuses for making concentrated plasma and/or tissue sealant
WO1998046300A1 (fr) 1997-04-14 1998-10-22 Biosurgical Corporation Applicateur de fluide destine a distribuer des quantites mesurees a l'aide d'une aspiration commandee
WO1999017833A1 (fr) * 1997-10-06 1999-04-15 United States Surgical Corporation Applicateur d'agent de scellement fibrineux
WO1999039642A1 (fr) * 1998-02-04 1999-08-12 Omrix Biopharmaceuticals S.A. Dispositif pour stocker une substance medicinale liquide
WO1999062588A1 (fr) * 1998-06-03 1999-12-09 Baxter International Inc. Dispositif a double remplissage direct pour agents d'etancheite

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5266877A (en) 1989-09-14 1993-11-30 Hitachi, Ltd. Apparatus for and method of preparing numerical control data for interactive mounter
US5171214A (en) * 1990-12-26 1992-12-15 Abbott Laboratories Drug storage and delivery system
US5585007A (en) 1994-12-07 1996-12-17 Plasmaseal Corporation Plasma concentrate and tissue sealant methods and apparatuses for making concentrated plasma and/or tissue sealant
WO1996029113A1 (fr) * 1995-03-20 1996-09-26 Medimop Medical Projects Ltd. Dispositif de regulation de fluide
WO1998046300A1 (fr) 1997-04-14 1998-10-22 Biosurgical Corporation Applicateur de fluide destine a distribuer des quantites mesurees a l'aide d'une aspiration commandee
WO1999017833A1 (fr) * 1997-10-06 1999-04-15 United States Surgical Corporation Applicateur d'agent de scellement fibrineux
WO1999039642A1 (fr) * 1998-02-04 1999-08-12 Omrix Biopharmaceuticals S.A. Dispositif pour stocker une substance medicinale liquide
WO1999062588A1 (fr) * 1998-06-03 1999-12-09 Baxter International Inc. Dispositif a double remplissage direct pour agents d'etancheite

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003088843A1 (fr) * 2002-04-19 2003-10-30 Baxter International Inc. Dispositif de remplissage direct double pour agents de scellement
EP1452140A1 (fr) * 2003-02-03 2004-09-01 Biomet, Inc. Pulvérisateur
US7077339B2 (en) 2003-02-03 2006-07-18 Biomet, Inc. Spray applicator
WO2010145041A1 (fr) 2009-06-19 2010-12-23 Medmix Systems Ag Dispositif de remplissage d'une seringue multiple ou simple
US9131930B2 (en) 2009-06-19 2015-09-15 Medmix Systems Ag Devices for filling a multi-use syringe or single-use syringe

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