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
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B2017/00831—Material properties
  • A61B2017/00902—Material properties transparent or translucent
  • A61B2017/00907—Material properties transparent or translucent for light
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B2017/00831—Material properties
  • A61B2017/00946—Material properties malleable

Definitions

• Minimally invasive surgical techniques have emerged as an alternative to conventional surgical techniques to perform a plurality of surgical procedures.
• Minimally invasive procedures differ from conventional surgical procedures in that a plurality of devices may be introduced into the body through a small incision. As a result, trauma to the body is greatly reduced, thereby decreasing the recovery time of the patient.
• Laparoscopic procedures may be used to treat hernias, colon dysfunctions, gastroesophageal reflux disease, gallbladder disorders, etc.
• the patient undergoing the procedures will return home hours after undergoing surgery.
• One challenge presented when performing minimally invasive surgical procedures relates to reducing bleeding at a surgical site when control of bleeding by standard surgical techniques, such as suturing, ligature and cautery, is ineffective or impractical.
• standard surgical techniques such as suturing, ligature and cautery
• the surgeon's access to the site of the incision is greatly reduced during minimally invasive procedures and conventional techniques for hemostasis may be difficult to affect.
• tissue sealants may include fibrin, which is comprised of co-reactive thrombin and fibrinogen materials, although other multiple component materials are available.
• fibrin which is comprised of co-reactive thrombin and fibrinogen materials, although other multiple component materials are available.
• the individual components of the sealant materials are stored in isolated reservoirs. When mixed, these components may coagulate very quickly, yielding a gel within a short period of time, perhaps 10 or 20 seconds.
• the rapid coagulative properties of the tissue sealant are advantageous.
• fast-acting properties of conventional tissue sealants have presented potential problems of fouling or clogging during application through laparoscopic devices, which typically results in the destruction of the device.
• the fibrin sealants used in the above-disclosed procedures are relatively labile and require low temperature storage, such as below about 0 °C, to extend their shelf-life.
• each of the co reactive materials is stored in separate reservoirs, such as syringes, and are only combined after thawing and delivery into the site of the incision to be closed.
• the syringes are glass syringes due to the inertness of glass.
• the syringes are generally similar in size and can be easily mixed-up, so the separate storage of each component in similar syringes can cause difficulties in not only storage, but also in packing, shipping and when configuring them for delivery of the fibrin sealant in a medical facility. It would be advantageous if the syringes of the co-reactive materials could be selected and loaded prior to cooling, storage, and delivery to ensure that they are properly matched.
• a cartridge for storage and delivery of multiple co-reactive materials comprising an elongated holder body having substantially parallel longitudinal voids, multiple hollow cylindrical bodies disposed substantially parallel within the longitudinal voids, the multiple co- reactive materials separately disposed in the multiple hollow cylindrical bodies, wherein the multiple hollow cylindrical bodies have open proximal ends, nozzles at distal ends thereof, and pistons positioned inside, the pistons sealing the open proximal end and slidably moveable within the hollow cylindrical bodies and having no plungers attached.
• the open proximal ends have diameters substantially the same as inner diameters of the hollow cylindrical bodies, and the nozzles have Luer tapers.
• a dispensing device for simultaneous delivery and mixing of multiple co-reactive materials, comprising a cartridge having proximal and distal ends, the cartridge comprising an elongated holder body having substantially parallel longitudinal voids, multiple hollow cylindrical bodies disposed substantially parallel within the longitudinal voids, the multiple co-reactive materials separately disposed in the multiple hollow cylindrical bodies, wherein the multiple hollow cylindrical bodies have open proximal ends, nozzles having Luer tapers at distal ends thereof, and pistons positioned inside, the pistons sealing the open proximal ends and slidably moveable within the hollow cylindrical bodies and having no plungers attached, and a longitudinal housing having proximal and distal ends, structured and arranged to receive the cartridge, having plungers on the proximal end of the longitudinal housing, structured and arranged to contact proximal ends of said pistons.
• the dispensing device further comprises a reactive material receiver having substantially parallel inlet ports a first axial distance apart, located at a distal end of the housing, said inlet ports having co-acting Luer tapers with those of said cylindrical body nozzles.
• the reactive material receiver has substantially parallel exit ports a second axial distance apart and located distal to the inlet ports, and exit nozzles in fluid communication with the exit ports, wherein the second axial distance is different from the first axial distance.
• the dispensing device further comprises a malleable spray or drip mixing tip having a cannula connected to the exit ports of the reactive material receiver, the mixing tip in fluid communication with the multiple hollow cylindrical bodies of the cartridge through channels within the reactive material receiver and the nozzles.
• the malleable spray or mixing tip can be bent up to about 180 degrees without kinking the cannula.
• the longitudinal housing comprises a backbone portion having proximal and distal ends and longitudinal voids on either side of the backbone portion in a side portion of the housing, structured and arranged to accommodate the cartridge between the proximal and distal ends of the housing.
• the longitudinal housing comprises an elongated body, wherein the proximal end of the housing is open to receive the cartridge, and a hinged cover for the open proximal end of the housing, wherein said plungers are slidably captive in said hinged cover.
• the hinged cover further comprises a locking tab structured and arranged to engage the proximal end of the housing and lock the cartridge within the housing.
• the reactive material receiver further comprises substantially parallel inlet ports having Luer tapers which coact with Luer tapers of the nozzles, and the combination of the Luer nut and Luer thread biases the nozzles into a sealing relationship with the inlet ports.
• FIG. 1 is a perspective view of a cartridge according to the present application.
• FIG. 2 is a cross-sectional view of the cartridge of FIG. 1 ;
• FIG. 4A is an exploded view of a combination of a cartridge and a first embodiment of a longitudinal housing for receiving the cartridge;
• FIG. 4B is an assembled view of the cartridge and housing of FIG. 4A;
• FIGS. 4D and 4E depict an alternative design for biasing syringe nozzles according to FIGS. 4A-4C;
• FIG. 5A is a perspective view of a second embodiment of a longitudinal housing for receiving the cartridge of the present application;
• FIG. 5B is an exploded view of a cartridge located proximal to the housing of FIG. 5A;
• FIGS. 5C and 5D are detailed views of the housing.
• FIG. 6 shows an assembled dispensing device with a malleable delivery tip.
• distal refers to that end of a device or component which is closest to the dispensing end.
• proximal refers to that end of a device or component which is furthest away from the dispensing end.
• a cartridge for storage and delivery of multiple co-reactive materials to a surgical site such as an incision requiring sealing.
• the incision site can be one which is difficult to seal by conventional suturing, and instead requires use of a biological sealant.
• One well-known sealant is fibrin, which is formed when fibrinogen and thrombin are combined. While they are naturally occurring in vivo, these two co-reactive materials are commercially available as isolated materials and can be stored and delivered to medical professionals for later mixing and use in sealing incisions, wounds, or the like.
• a cartridge apparatus is provided in which previously matched syringes of the differing materials are inserted and held into the cartridge prior to storage and shipment from the manufacturing facility. The subsequently frozen and delivered cartridge is more easily manipulated in the medical facility, reducing the chance of breakage and mismatching of components.
• the cartridge is structured and arranged to be received in a dedicated dispensing device, from which the co-reactive materials can be dispensed to downstream devices without leakage.
• FIGS. 1-3 illustrate the presently disclosed cartridge 100 which has an elongated holder body 110 having substantially parallel longitudinal voids 120a, 120b, first and second hollow cylindrical bodies 130a, 130b, such as syringes, disposed substantially parallel within the longitudinal voids 120a, 120b.
• Two co-reactive materials e.g. thrombin and fibrinogen
• thrombin and fibrinogen are separately disposed in the first and second syringes 130a, 130b, which have open proximal ends 132, nozzles 134 having Luer tapers at distal ends thereof, and pistons 136 positioned inside, the pistons sealing the open proximal end 132 and slidably moveable within the syringes.
• the cartridge can have removable closure caps 138 sealing the nozzles 134 and a removable rear closure cap 140 having substantially parallel plugs 140a, 140b, fitting into the open proximal ends 132 of the syringes.
• the open proximal ends 132 of the syringes 130a, 130b have diameters substantially the same as inner diameters of the syringes, and the nozzles 134 have Luer tapers.
• the syringes are glass and the co-reactive materials are fibrinogen and thrombin.
• the holder body 110 can have windows 112 in each of side-by-side longitudinal voids 120a, 120b, to facilitate thawing and warming of the co- reactive materials in the syringes, as well as viewing of the contents therein.
• the cartridge 100 is received into one or more dedicated dispensing devices which are structured and arranged specifically to hold the cartridge.
• FIGS. 4A-4C illustrate a top- or side-loading dispensing device 200 for simultaneous delivery and mixing of the two co-reactive materials including a cartridge 100, as described above, and a longitudinal housing 210 including a backbone portion 210a and having proximal and distal ends, the housing being structured and arranged to receive the cartridge 100.
• the dispensing device 200 can be advantageously made from a medically acceptable flexible plastic or polymer, such as polypropylene or polyethylene terephthalate.
• the dispensing device 200 can further comprise a reactive material receiver 212, such as a manifold, either integral with or separate from the longitudinal housing 210.
• the reactive material receiver has substantially parallel inlet ports 214 having Luer tapers which co-act with those of the hollow cylindrical body nozzles 134, located a first axial distance apart at a distal end of the housing 200, into which the cylindrical body Luer nozzles 134 are seated and sealed.
• the reactive material receiver Distal to the inlet ports 214 the reactive material receiver has substantially parallel exit ports 220 a second axial distance apart, wherein the second axial distance is different from the first axial distance, and a Luer nut and thread connector 232 in fluid communication with the exit ports 220.
• the different first and second axial distances between inlet 214 and exit ports 220 of the reactive material receiver can be configured such that the reactive material receiver 212 adapts the co-reactive material flowpaths from the larger axial distance between syringe nozzles 134 to a smaller axial distance between the adapter’s exit ports 220.
• the dispensing device 200 can further include a malleable spray or drip mixing tip 230 connected at the distal end of the reactive material receiver 212 with the Luer nut and thread connector 232, the mixing tip 230 in fluid communication with the first and second hollow cylindrical bodies 130a, 130b, of the cartridge 100 through the various channels within the reactive material receiver 212 and nozzles 134.
• the exit ports 220 can be covered with a cap 225 to seal the unit until use.
• the longitudinal housing 210 has a longitudinal void 215 in a side portion thereof, structured and arranged to accommodate cartridge 100 between the proximal and distal ends of the housing 210.
• the longitudinal housing further includes a clamp 216 to hold the cartridge 100 in the longitudinal void 215 and to bias the cartridge 100 and thereby the nozzles 134 of the syringes 130a, 130b toward the distal end of the housing and tightly against the inlet ports 214 of the reactive material receiver 212 when the clamp is in the engaged position 216a.
• the housing 210 has a fixture 218 at its proximal end which has slidably captive therein substantially parallel plungers 219, structured and arranged to contact the proximal ends of the pistons 136 in the syringes 130a, 130b, held within the cartridge 100.
• the substantially parallel plungers 219 are pushed into the syringe bodies and against pistons 136, such that the liquefied co-reactive materials are forced through the reactive material receiver 212 and into the spray or drip mixing tip 230.
• the distal end of dispensing device 300 has a reactive material receiver 312 with Luer tapered inlet ports 314 which co-act with Luer tapered nozzles 134 of the glass syringes of the cartridge 100.
• the spring member(s) 315b compress the cartridge 100 when the hinged door 315 is closed, forcing nozzles 134 to seat and seal in the inlet ports 314.
• FIG. 6 illustrates an assembled dispensing device 200 having a novel malleable tip 230 that a surgeon could either drip or spray from by changing out the spray tip at the distal end.
• the tips malleability makes it functional to reach challenging anatomy; dripping or spraying option from one tip gives the surgeon an endless amount of options, giving them the ability to create a variable spray based upon pressure applied and distance from the tissue regardless of direction they need to spray.

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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)
• Infusion, Injection, And Reservoir Apparatuses (AREA)

Applications Claiming Priority (2)

Publications (1)

Family

ID=77249854

Family Applications (1)

Country Status (6)

Family Cites Families (4)

• 2021
  • 2021-07-29 AU AU2021319295A patent/AU2021319295A1/en active Pending
  • 2021-07-29 KR KR1020237006476A patent/KR20230044467A/ko unknown
  • 2021-07-29 WO PCT/IB2021/056939 patent/WO2022024043A1/en unknown
  • 2021-07-29 CN CN202180058438.3A patent/CN116096307A/zh active Pending
  • 2021-07-29 EP EP21751878.6A patent/EP4188233A1/de not_active Withdrawn
  • 2021-07-29 IL IL300207A patent/IL300207A/en unknown

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