WO2014137986A2 - Appareil et procédés pour hydrater un produit stérile sans compromettre la stérilité - Google Patents

Appareil et procédés pour hydrater un produit stérile sans compromettre la stérilité Download PDF

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Publication number
WO2014137986A2
WO2014137986A2 PCT/US2014/020146 US2014020146W WO2014137986A2 WO 2014137986 A2 WO2014137986 A2 WO 2014137986A2 US 2014020146 W US2014020146 W US 2014020146W WO 2014137986 A2 WO2014137986 A2 WO 2014137986A2
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WIPO (PCT)
Prior art keywords
inner volume
actuator
configuration
package
sterilization
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Application number
PCT/US2014/020146
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English (en)
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WO2014137986A3 (fr
Inventor
David Reed Markle
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David Reed Markle
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 David Reed Markle filed Critical David Reed Markle
Publication of WO2014137986A2 publication Critical patent/WO2014137986A2/fr
Publication of WO2014137986A3 publication Critical patent/WO2014137986A3/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L9/00—Disinfection, sterilisation or deodorisation of air
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor

Definitions

  • Embodiments described herein relate to apparatus and methods for hydrating a sterile product and more specifically to hydrating a product after sterilization without compromising the sterility of the product.
  • some known medical products are disposed in a hydrating solution prior to use.
  • medical sensors are often hydrated for a period of time (e.g., several minutes to several days) prior to insertion into the body.
  • some such medical products that are hydrated prior to use can be sensitive to sterilization techniques that allow a product to be hydrated during sterilization such as, for example, gamma irradiation or autoclaving.
  • sterilization techniques such as, for example, ethylene oxide (ETO) sterilization and then hydrated after sterilization.
  • the sterilized medical products are shipped in a dry state and, prior to use, are removed from a sterile packaging and disposed in a hydrating solution.
  • the sterility of the medical product can be compromised during the hydration period.
  • complex hydration systems have been designed to hydrate a medical product while being disposed in a sterile environment.
  • the cost of some such systems is prohibitive to wide-spread adoption.
  • the change of rupturing a sterile barrier and thereby compromising the sterility of the medical product can be relatively high.
  • a package defines an inner volume configured to be filled with a sterilizing gas.
  • the package is configured to house, at least temporarily, a first element and a second element.
  • the first element defines an inner volume that stores, at least temporarily, a medical product.
  • the first element includes an actuator that is movable between a first configuration wherein the actuator defines a flow path configured to place the inner volume of the first element in fluid communication with the inner volume of the package such that the sterilizing gas sterilizes the medical product and a second configuration wherein the inner volume of the first element is fluidically isolated from the inner volume of the package.
  • the second element defines an inner volume that contains, at least temporarily, a sterile hydrating solution.
  • the second element includes an actuator that is movable between a first configuration wherein the sterile hydrating solution is maintained within the inner volume of the second element and a second configuration wherein the actuator defines a flow path within which the sterile hydrating solution can flow from the inner volume of the second element into the inner volume of the first element.
  • the actuator of the first element and the actuator of the second element configured to be moved from the first configuration to the second configuration when a portion of the hydrating solution is disposed within the inner volume of the first element.
  • FIG. 1 is a schematic illustration of a hydrating device according to an embodiment.
  • FIG. 2 is a side view of an illustration of a hydrating device according to an embodiment.
  • FIG. 3 is a perspective view of a first element included in the hydrating device of FIG. 2.
  • FIG. 4 is a perspective view of a second element included in the hydrating device of FIG. 2.
  • FIG. 5 is a side view of the hydrating device of FIG. 2 in use.
  • a package defines an inner volume configured to be filled with a sterilizing gas.
  • the package is configured to house, at least temporarily, a first element and a second element.
  • the first element defines an inner volume that stores, at least temporarily, a medical product.
  • the first element includes an actuator that is movable between a first configuration wherein the actuator defines a flow path configured to place the inner volume of the first element in fluid communication with the inner volume of the package such that the sterilizing gas sterilizes the medical product and a second configuration wherein the inner volume of the first element is fluidically isolated from the inner volume of the package.
  • the second element defines an inner volume that contains, at least temporarily, a sterile hydrating solution.
  • the second element includes an actuator that is movable between a first configuration wherein the sterile hydrating solution is maintained within the inner volume of the second element and a second configuration wherein the actuator defines a flow path within which the sterile hydrating solution can flow from the inner volume of the second element into the inner volume of the first element.
  • the actuator of the first element and the actuator of the second element configured to be moved in sequence from the first configuration to the second configuration to facilitate moving a portion of the hydrating solution to the inner volume of the first element.
  • a product can be a sensor (such as for sensing pH, temperature, blood gas(es), pressure, lactate and/or any other analyte), biological tissues (such as collagen-based tissue grafts), and/or any other suitable product.
  • a sensor such as for sensing pH, temperature, blood gas(es), pressure, lactate and/or any other analyte
  • biological tissues such as collagen-based tissue grafts
  • any other suitable product can be a sensor (such as for sensing pH, temperature, blood gas(es), pressure, lactate and/or any other analyte), biological tissues (such as collagen-based tissue grafts), and/or any other suitable product.
  • the methods described herein can be used on or with any suitable product.
  • the discussion herein is not meant to limit the use of the embodiments and methods to medical products.
  • FIG. 1 is a schematic illustration of a hydrating device 100 according to an embodiment.
  • the hydrating device 100 can be used, for example, to hydrate a product 160 after sterilization using ethylene oxide (ETO) while maintaining the sterility of the product 160.
  • ETO ethylene oxide
  • the product 160 can be any suitable medical product 160 such as, for example, a medical sensor or the like.
  • product 160 can have sensitivity to hydrated sterilization techniques such as, for example, gamma irradiation and/or autoclaving.
  • the hydrating device 100 includes a sterilization element 1 10 (i.e., a first element), a hydration element 130 (i.e., a second element), and a package 150 (i.e., a third element). As shown in FIG. 1 , the sterilization element 1 10 and the hydration element 130 are each disposed within an inner volume defined by the package 150, as described in further detail herein.
  • the sterilization element 1 10 can be any suitable shape, size, or configuration.
  • the sterilization element 1 10 can be a substantially gas impermeable tube such as a glass or polymer tube or the like.
  • the sterilization element 1 10 can be substantially inert such that the sterilization element 1 10 substantially does not chemically interact with a gas, liquid, and/or solid.
  • the sterilization element 1 10 includes a set of walls that define an inner volume configured to house, at least temporarily, the product 160.
  • the sterilization element 1 10 includes and/or is coupled to an actuator (not shown in FIG. 1) that can be moved between a first configuration and a second configuration. More specifically, the actuator of the sterilization element 1 10 can be a valve that can be moved between an open configuration (e.g., the first configuration) and a closed configuration (e.g., the second configuration). In some embodiments, the arrangement of the actuator is such that when in the non-actuated configuration (e.g., the first configuration) the actuator defines a flow path that places the inner volume defined by the sterilization element 1 10 in fluid communication with the inner volume defined by the package 150.
  • an actuator not shown in FIG. 1
  • the actuator of the sterilization element 1 10 can be a valve that can be moved between an open configuration (e.g., the first configuration) and a closed configuration (e.g., the second configuration).
  • the arrangement of the actuator is such that when in the non-actuated configuration (e.g., the first configuration) the actuator defines a flow path that places the inner volume defined by the steriliz
  • the actuator can be actuated (e.g., moved to the second configuration) and then remain in the second configuration (e.g., the actuator does not automatically return to the first configuration) to fiuidically isolate the inner volume of the sterilization element 1 10 from the inner volume of the package 150, as described in further detail herein.
  • the sterilization element 1 10 can include any suitable coupling and/or sealing device (not shown) disposed at the end portions of the sterilization element 1 10.
  • the sterilization element 1 10 can be a substantially cylindrical tube that includes end portions that are substantially open.
  • the end portions can be coupled to a coupling device such as, for example, a Luer Lok ® or the like.
  • the sterilization element 1 10 can include an end portion that is coupled to a mechanism configured to advance the product 160 in a distal direction relative to the sterilization element 1 10 to dispose the product 160 in a cannula or the like that is inserted into the body of a patient, thereby delivering the product 160 to the patient (as described in further detail herein).
  • the end portion of the sterilization element 1 10 can be coupled to a Tuohy- Borst device (e.g., a device including a valve that can be opened and closed and also including an advancement mechanism that can be manipulated to advance a product through the valve).
  • a Tuohy- Borst device e.g., a device including a valve that can be opened and closed and also including an advancement mechanism that can be manipulated to advance a product through the valve.
  • the hydration element 130 is disposed within the inner volume defined by the package 150.
  • the hydration element 130 can be any suitable shape, size, or configuration.
  • the hydration element 130 can include at least a syringe and an actuator (not shown in FIG. 1).
  • the syringe can define an inner volume that at least temporarily contains and/or houses a hydrating solution.
  • the syringe can include a plunger that forms a substantially fluid tight seal with an inner surface of the syringe thereby defining the inner volume.
  • the actuator can be fiuidically coupled to the syringe and can be moved between a first configuration and a second configuration.
  • the actuator can be a valve configured to move between a closed configuration (e.g., the first configuration) and an open configuration (e.g., the second configuration).
  • the actuator can be, for example, a spring loaded actuator.
  • an actuation force can be applied to a portion of the actuator (e.g., by pressing on a portion of the actuator) to move the actuator to the second configuration and once the force is removed, the actuator can automatically return to the first configuration.
  • One suitable actuator is a TracTM in-line valve manufactured by Quosina having part number QOS5402597N.
  • the actuator of the hydration element 130 is physically and fluidically coupled to the sterilization element 1 10.
  • the actuator can be coupled to the end portion (e.g., the end portion opposite the Tuohy-Borst device) of the sterilization element 1 10 via a Luer Lok ® or the like.
  • the arrangement of the actuator can be such that when in the first configuration (e.g., the closed configuration), the inner volume of the hydration element 130 (e.g., defined by the syringe) is fluidically isolated from the inner volume of the sterilization element 1 10.
  • the actuator defines a flow path that places the inner volume of the hydration element 130 in fluid communication with the inner volume of the sterilization element 1 10.
  • the hydration element 130 can include an activation portion.
  • the plunger of the syringe can be coupled to or in contact with an energy storage device such as a spring, compressed gas (e.g., compressed carbon dioxide C0 2 ), etc.
  • an energy storage device such as a spring, compressed gas (e.g., compressed carbon dioxide C0 2 ), etc.
  • the hydration element 130 can be activated such that the potential energy stored in the energy storage member is converted to work applied to the hydrating solution (e.g., the spring expands or the compressed gas is released).
  • the hydration element 130 can be moved to expel the hydrating solution disposed therein, as described in further detail herein.
  • the package 150 defines the inner volume configured to house the sterilization element and the hydration element 130. More specifically, the package 150 can be a substantially gas impermeable tray that is coupled to a substantially gas permeable lid.
  • the package 150 can include a thermo formed tray that is coupled to a lid formed of, for example, Tyvek ® (flashspun nonwoven high-density polyethylene fibers). In this manner, the tray and lid can be coupled to form a gas permeable package suitable for ETO sterilization yet capable of preventing biological contamination of the inside of the package from the contaminating agents outside the package.
  • the hydrating device 100 can be sterilized and the product 160 can be hydrated without compromising the sterility of the product prior to shipping or being inserted into the body of a patient. More specifically, with the product 160 disposed within the sterilization element 1 10, the hydration element 130 can be substantially sterilized using standard sterilization techniques such as gamma irradiation and/or autoclaving prior to the hydration element 130 being disposed within the package 150. In this manner, with the hydrating solution disposed within the inner volume (as described above), the sterility of the hydrating solution is maintained regardless of the sterility of a portion of the hydration element 130 other than the inner volume. Similarly stated, the hydration element 130 can be disposed within an unsterile environment while maintaining the sterility of the inner volume.
  • the sterilization element 1 10 and the hydration element 130 are disposed within the package 150 and the lid is coupled to the tray.
  • the package 150 can be placed in a chamber and a vacuum can be applied to evacuate the package 150.
  • the lid can be formed of a material that is gas permeable but liquid impermeable. One suitable material is Tyvek ® .
  • ETO gas can be pumped into the chamber and thence into the package 150 through the gas permeable lid.
  • the process of evacuation and filling with ETO can be repeated any suitable number of times as is known in common ETO sterilization processes.
  • the arrangement of the actuator included in or coupled to the sterilization element 1 10 is such that a valve disposed within the actuator is in a substantially open configuration (e.g., the first configuration).
  • the ETO can flow through the actuator and into the inner volume of the sterilization element 1 10 to sterilize the product 160 disposed therein.
  • the ETO can sterilize substantially all remaining portions of the hydrating device 100 disposed within the inner volume of the package 150.
  • the ETO gas can be evacuated from the chamber and thence from the inner volume and a air can be pumped into the chamber and thence into the inner volume of the package 150.
  • the package 150 can then be removed from the chamber. In this manner, with the package 150 being substantially liquid impermeable and with the tray forming a seal with the lid, the inner volume of the package is substantially isolated from contaminants that could compromise the sterility of the package 150 and thus, the sterility of the product 160 is maintained.
  • the actuator of the hydration element 130 can be manipulated to move from its first configuration (e.g., the closed configuration) to its second configuration (e.g., the open configuration). In this manner, the flow path defined by the actuator is placed in fluid communication with the inner volume of the hydration element 130 (e.g., the inner volume of the syringe) and in fluid communication with the inner volume of the sterilization element 1 10.
  • the movement of the actuator of the hydration element 130 can substantially correspond to an activation of the hydration element 130 (e.g., the expansion of a spring and/or the release of a compressed gas).
  • the movement of the actuator to the open configuration can decrease a pressure within the inner volume of the hydration element 130. Therefore, the decrease in pressure within the inner volume is such that a reaction force exerted to resist the energy storage member is reduced, thereby allowing the energy storage member to move to a second configuration (e.g., allowing a spring to move from a compressed configuration to an expanded configuration).
  • the activation of the hydration element 130 can, for example, move the plunger of the syringe relative to the body of the syringe to expel the hydrating solution from the inner volume.
  • the actuator in the open configuration e.g., the second configuration
  • the hydrating solution can flow within the flow path defined by the actuator and into the inner volume of the sterilization element 1 10.
  • the flow of the hydrating solution into the inner volume of the sterilization element 1 10 can urge a portion of the air within the inner volume of the sterilization element 1 10 to flow through the actuator of the sterilization element 1 10 and into the inner volume of the package 150.
  • the hydrating solution can fill at least a portion of the inner volume of the sterilization element 1 10.
  • a verification of the inner volume being sufficiently filled can be performed by visually inspecting the sterilization element 1 10 through the package 150.
  • the pressure within the inner volume of the sterilization element 1 10 can be monitored to provide an indication of a desired fill pressure.
  • the inner volume of the hydration element 130 can be filled with a predetermined amount of hydrating solution such that substantially all the hydrating solution flows within the flow path defined by the actuator of the hydration element 1 10 to fill the inner volume of the sterilization element 1 10 to a desired fill volume.
  • the actuator of the hydration element 130 can be maintained in the second configuration for at least a predetermined time period that is sufficient for substantially all of the hydrating solution to be expelled from the hydration element 130 into the sterilization element 1 10.
  • the actuator of the sterilization element 1 10 can be manipulated to move the actuator from the first configuration to the second configuration.
  • the valve disposed therein is in the closed configuration.
  • the actuator of the hydration element 130 can be allowed to return to its first configuration (e.g., the closed configuration), such as by releasing the manual force applied through the lid to the actuator.
  • the inner volume of the sterilization element 1 10 is fluidically isolated from a volume outside of the sterilization element 1 10. Therefore, the product 160 can be stored substantially within the hydrating solution prior to use without compromising the sterility of the product 160.
  • a user e.g., a physician, nurse, technician, clinician, etc.
  • the sterilization element 1 10 can be decoupled from the hydration element 130.
  • the end portion of the sterilization element 1 10 can be moved to a second configuration (e.g., the Tuohy-Borst device can be manipulated to open the valve) and the product 160 can be removed from the sterilization element 1 10.
  • the product 160 can then be inserted into an indwelling cannula and can be advanced in the distal direction to place the product 160 within a portion of the body of the patient.
  • the hydrating device 200 can be used, for example, to hydrate a product 260 after sterilization using ethylene oxide (ETO) while maintaining the sterility of the product 260.
  • ETO ethylene oxide
  • the product 260 can be any suitable medical product 260 such as, for example, a medical sensor or the like.
  • product 260 can have sensitivity to hydrated sterilization techniques such as, for example, gamma irradiation and/or autoclaving.
  • the hydrating device 200 includes a sterilization element 210 (i.e., a first element), a hydration element 230 (i.e., a second element), and a package 250 (i.e., a third element). As shown in FIG. 2, the sterilization element 210 and the hydration element 230 are each disposed within an inner volume 253 defined by the package 250, as described in further detail herein.
  • the sterilization element 210 can be any suitable shape, size, or configuration.
  • the sterilization element 210 can be a substantially gas impermeable cylindrical tube such as a glass tube or the like.
  • the sterilization element 210 can be substantially inert such that the sterilization element 210 substantially does not chemically interact with a gas, liquid, and/or solid.
  • the sterilization element 210 includes a body portion 21 1 that defines an inner volume 215 configured to house, at least temporarily, the product 260.
  • the sterilization element 210 is coupled to an actuator 216 that can be moved between a first configuration and a second configuration. More specifically, the actuator 216 includes and inlet portion 218 (FIG. 3) that is physically and fluidically coupled to the sterilization element 210 and an outlet portion 219 that is in fluid communication with the inner volume 253 of the package 250. While not shown in FIGS. 2-5, the actuator 216 can include a valve that can be moved between an open configuration (e.g., the first configuration) and a closed configuration (e.g., the second configuration) when an activation portion 217 of the actuator 216 is moved relative to the actuator 216.
  • an open configuration e.g., the first configuration
  • a closed configuration e.g., the second configuration
  • the arrangement of the actuator 216 is such that when in the non-actuated configuration (e.g., the first configuration wherein the activation portion 217 is in a first position relative to the actuator 216), the actuator 216 defines a flow path that places the inner volume 215 defined by the sterilization element 210 in fluid communication with the inner volume 253 defined by the package 250. Similarly stated, when in the first configuration the actuator 216 defines a flow path from the inlet portion 218 to the outlet portion 219. Conversely, the actuator 216 can be actuated (e.g., the activation portion 217 moved to a second position relative to the actuator 216) to fluidically isolate the inlet portion
  • the actuator 216 when the actuator 216 is in the in second configuration, the inner volume 215 of the sterilization element 210 is fluidically isolated from the inner volume 253 of the package 250, as described in further detail herein.
  • the actuator 216 can be configured to remain in the second configuration once actuated (e.g., the actuator 216 does not automatically return to the first configuration).
  • the body portion 21 1 of the sterilization element 210 includes a first end portion 212 and a second portion 213.
  • the first end portion 212 can include any suitable coupling device such as, for example, a Luer Lok ® or the like.
  • the sterilization element 210 can be physically and fluidically coupled to the hydration element 230, as described in further detail herein.
  • the second end portion 213 is coupled to a mechanism 214 that is movable between a first configuration (e.g., sealed) and a second configuration (e.g., unsealed).
  • the mechanism 214 can be placed in the second configuration (e.g., after hydration) to remove the product 260 from the sterilization element 210 and to dispose the product 260 in a cannula or the like that is inserted into the body of a patient, thereby delivering the product 260 to the patient (as described in further detail herein).
  • the mechanism 214 can be similar to or the same as known Tuohy-Borst devices (described above).
  • the hydration element 230 includes a syringe 231 , an actuator 240, and an activation portion 234.
  • the syringe 231 includes a body portion 232 that defines and inner volume 237 (FIGS. 2 and 5) configured to movably receive a plunger 233. More specifically, the plunger 233 includes an outer surface (not shown) that is in frictional contact with an inner surface of the body 232 of the syringe 231.
  • the plunger 233 and the body 232 of the syringe 231 form a substantially fluid tight seal that fluidically isolates the inner volume 237 of the syringe 231 from a volume that is disposed on an opposite side of the plunger 233 than the inner volume 237.
  • the inner volume 237 is configured to at least temporarily store a hydrating solution.
  • the actuator 240 is physically and fluidically coupled to the syringe 231.
  • the actuator 240 includes an inlet portion 242 that is physically and fluidically coupled to an end portion of the syringe 231 and an outlet portion 243 that is physically and fluidically coupled to the first end portion 212 of the sterilization element 210, for example, via a Luer Lolt or the like (FIGS. 2 and 5).
  • the actuator 240 can be moved between a first configuration and a second configuration.
  • the actuator 240 can include a valve (not shown) that can be moved between a closed configuration (e.g., the first configuration) and an open configuration (e.g., the second configuration) when an activation portion 241 of the actuator 240 is moved relative to the actuator 240.
  • the arrangement of the actuator 240 is such that when in the non-actuated configuration (e.g., the first configuration wherein the activation portion 241 is in a first position relative to the actuator 240), the actuator 240 can fluidically isolate the inlet portion 242 of the actuator 240 from the outlet portion 243 of the actuator 240.
  • the actuator 240 when the actuator 240 is in the first configuration, the inner volume 237 of the syringe 231 is fluidically isolated from the inner volume 215 of the sterilization element 210. Conversely, the actuator 240 can be actuated (e.g., the activation portion 241 is moved to a second position relative to the actuator 240) to define a flow path that places the inlet portion 242 of the actuator 240 in fluid communication with the outlet portion 243 of the actuator 240. Thus, when the actuator 240 is in the second configuration the inner volume 237 defined by the syringe 231 is placed in fluid communication with the inner volume 215 defined by the sterilization element 210.
  • the actuator 240 can automatically return to the first configuration once actuated (e.g., the actuator 240 can be spring loaded). For example, a force can be applied to the activation portion 241 to place the actuator 240 in the second configuration and when the force is removed, the actuator 240 can automatically return to the first configuration, as described in further detail herein.
  • the activation portion 234 of the hydration element 230 is coupled to the syringe 231.
  • the plunger 233 of the syringe 231 is coupled to or in contact with a spring 236.
  • a backstop 235 can be fixedly coupled to the body 232 of the syringe 231 such that when the plunger 233 is disposed within the inner volume 237 of the syringe 231 , the spring 236 is disposed between the plunger 233 and the backstop 235.
  • the arrangement of the hydration element 230 is such that prior to activation, the spring 236 is in a compressed configuration and exerts a force on the plunger 233 and the backstop 235.
  • the backstop 235 fixed coupled to the body 232 of the syringe 231 and with the actuator 240 in the first configuration (e.g., the closed configuration) the hydrating solution (i.e., a non-compressible fluid) and the backstop 235 exert a reaction force that maintains the spring 236 in the compressed configuration without moving the plunger 233 relative to the body 232 of the syringe 231.
  • the hydrating solution i.e., a non-compressible fluid
  • the hydration element 230 can be activated such that the potential energy stored in the spring 236 is converted to work (e.g., the spring 236 expands) and the plunger 233 can be moved relative to the body 232 of the syringe 231 to expel the hydrating solution disposed in the inner volume 237, as described in further detail herein.
  • the package 250 defines the inner volume 253 configured to house the sterilization element 210 and the hydration element 230.
  • the package 250 can be any suitable shape, size, or configuration. For example, while shown and being substantially rectangular in other embodiments, the package 250 can be any suitable shape.
  • the surfaces of the package 250 are shown as being substantially linear, in other embodiment, the surfaces can be curvilinear and/or can include one or more surface features such as, for example, detents, protrusions, partial perforations, and/or the like.
  • the package 250 includes a substantially gas impermeable tray 251 that is coupled to a substantially gas permeable lid 252.
  • the package 250 can include a thermo formed tray 251 that is coupled to a Tyvek ® lid 252. In this manner, the tray 251 and lid 252 can be coupled to isolate the inner volume 253 defined by the package 250 from contaminants outside of the package 250.
  • the hydrating device 200 can be sterilized and the product 260 can be hydrated without compromising the sterility of the product 260 prior to shipping or being inserted into the body of a patient. More specifically, with the product 260 disposed within the sterilization element 210, the hydration element 230 can be substantially sterilized using standard sterilization techniques such as gamma irradiation and/or autoclaving prior to the hydration element 230 being disposed within the package 250.
  • the hydration element 230 can be disposed within an unsterile environment while maintaining the sterility of the inner volume 237 and, thus, the hydrating solution.
  • the sterilization element 210 and the hydration element 230 are disposed within the package 250 and the lid 252 is coupled to the tray 251 (e.g., via ultrasonic welding, adhesive, thermal coupling, and/or the like).
  • the package 250 can be placed in a chamber and a vacuum can be applied to evacuate the chamber and thence the inner volume 253 of the package 250.
  • a vacuum can be applied to evacuate the chamber and thence the inner volume 253 of the package 250.
  • Tyvek® the lid 252 is gas permeable while remaining liquid impermeable. In this manner, air within the inner volume 253 of the package 250 is removed.
  • ETO gas can be pumped into the chamber and thence into the package 250 through the gas permeable lid 252.
  • the process of evacuation and filling with ETO can be repeated any suitable number of times as is known in common ETO sterilization processes.
  • the inner volume 253 of the package 250 can be sterilized.
  • the arrangement of the sterilization element 210 is such that the actuator 216 is in the substantially open configuration (e.g., its first configuration).
  • the ETO can flow into the outlet portion 219, through the flow path defined by the actuator 216, and out of the inlet portion 218 to enter the inner volume 215 of the sterilization element 210.
  • the product 260 disposed within the inner volume 215 is exposed to the ETO and sterilized.
  • the actuator 240 in the closed configuration (e.g., its first configuration), the ETO the actuator 240 fluidically isolates the inner volume 215 of the sterilization element 210 from the inner volume 237 of the hydration element 230. Therefore, the hydrating solution is not exposed to the ETO. However, with the hydrating solution previously sterilized the ETO can sterilize substantially all remaining portions of the hydrating device 200 that are disposed within the inner volume 253 of the package 250.
  • the ETO gas can be evacuated from the chamber and thence from inner volume 253 and air can be pumped into the chamber and thence into the inner volume 253 of the package 250.
  • the package 250 can then be removed from the chamber. In this manner, with the package 250 being substantially liquid impermeable and with the tray forming a seal with the lid, the inner volume 253 of the package 250 is substantially isolated from potential contaminants outside of the package 250 and thus, the sterility of the product 260 is maintained.
  • the actuator 240 of the hydration element 230 can be manipulated to move from its first configuration (e.g., the closed configuration) to its second configuration (e.g., the open configuration).
  • the activation portion 241 of the actuator 240 is disposed adjacent to the lid 252 such that a force can be applied to the lid 252 directly above the activation portion 241 of the actuator 240 (e.g., by a user, manufacturing personnel, or by a machine during manufacturing).
  • a minimal amount of force can be applied to the lid 252 to move the actuator 240 from its first configuration to its second configuration.
  • the activation portion 241 is moved to its second position relative to the actuator 240 and the flow path defined by the actuator 240 is placed in fluid communication with the inner volume 237 of the syringe 231 and in fluid communication with the inner volume 215 of the sterilization element 210.
  • the movement of the actuator 240 to its second configuration substantially corresponds to an activation of the hydration element 230 (e.g., the activation portion 234 moves from its first configuration to its second configuration).
  • the movement of the actuator 240 to the open configuration decreases the pressure within the inner volume 237 of the syringe 231. Therefore, with the backstop 235 fixedly coupled to the body 232 of the syringe 231 , the decrease in pressure within the inner volume 237 is such that the reaction force exerted to resist the expansion of the spring 236 is reduced, thereby allowing the spring 236 to move to a second configuration (i.e., expand to the second configuration), as indicated by the arrow BB in FIG. 5.
  • the activation of the hydration element 230 moves the plunger 233 of the syringe 231 relative to the body 232 to expel the hydrating solution from the inner volume 237.
  • the actuator 240 in the open configuration e.g., the second configuration
  • the hydrating solution flows within the flow path defined by the actuator 240 and into the inner volume 215 of the sterilization element 210, as indicated by the arrow CC in FIG. 5.
  • the flow of the hydrating solution into the inner volume 215 of the sterilization element 210 can urge a portion of the air within the inner volume 215 of the sterilization element 210 to flow through the actuator 216 of the sterilization element 210 and into the inner volume 253 of the package 250.
  • the hydrating solution can exert a pressure on an area of the air to force at least a portion of the air into the inlet portion 218 of the actuator 216, through the outlet portion 219 of the actuator 216, and into the inner volume 253 of the package 250.
  • the hydrating solution can fill at least a portion of the inner volume 253 of the sterilization element 210.
  • a verification of the inner volume 215 being sufficiently filled can be performed by visually inspecting the sterilization element 210 through the package 250.
  • the pressure within the inner volume 253 of the sterilization element 210 can be monitored to provide an indication of a desired fill pressure.
  • the inner volume 237 of the syringe 231 can be filled with a predetermined amount of hydrating solution such that substantially all the hydrating solution flows within the flow path defined by the actuator 240 to fill the inner volume 215 of the sterilization element 210 to a desired fill volume.
  • the actuator 240 of the hydration element 230 can be maintained in the second configuration for at least a predetermined time period that is sufficient for substantially all of the hydrating solution to be expelled from the syringe 231 into the inner volume 215 of the sterilization element 210.
  • the actuator 216 of the sterilization element 210 can be manipulated to move the actuator 216 from the first configuration to the second configuration.
  • the activation portion 217 of the actuator 216 can be disposed adjacent to the lid 252 such that a force can be applied to the lid 252 to move the activation portion 217 to its second position relative to the actuator 216, thereby moving the actuator 216 from its first configuration to its second configuration, as indicated by the arrow DD in FIG. 5.
  • the valve disposed therein is in the closed configuration.
  • the actuator 216 can remain in the second configuration once actuated.
  • the actuator 240 of the hydration element 230 can be returned to the first configuration (e.g., the closed configuration).
  • the actuator 240 can include a bias member (not shown) configured to return the activation portion 241 to it first position relative to the actuator 216 when a force is remove from the activation portion 241 such that the actuator 240 is returned to its first configuration.
  • the inner volume 215 of the sterilization element 210 is fluidically isolated from a volume outside of the sterilization element 210. Therefore, the product 260 can be stored substantially within the hydrating solution prior to use without compromising the sterility of the product 260.
  • a user e.g., a physician, nurse, technician, clinician, etc.
  • the sterilization element 210 can be decoupled from the hydration element 230.
  • the mechanism 214 disposed at the end portion 213 of the sterilization element 210 e.g., the Tuohy-Borst device
  • the product 260 can then be inserted into an indwelling cannula and can be advanced in the distal direction to place the product 260 within a portion of the body of the patient.
  • a portion of the mechanism 214 can be rotated relative to the sterilization element 210 to open a valve. In this manner, the product 260 can be moved through the valve to insert the product 260 into the cannula.

Landscapes

  • Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)

Abstract

L'invention concerne un appareil, qui comprend un emballage définissant un volume interne configuré pour recevoir un gaz de stérilisation. L'appareil comprend également un premier élément disposé à l'intérieur du volume interne de l'emballage configuré pour définir un volume interne qui stocke au moins temporairement un produit médical, et comporter un actionneur. L'appareil comprend également un second élément disposé à l'intérieur du volume interne défini par l'emballage. Le second élément est configuré pour définir un volume interne qui contient au moins temporairement une solution d'hydratation stérile, et comporter un actionneur couplé fluidiquement au premier élément.
PCT/US2014/020146 2013-03-04 2014-03-04 Appareil et procédés pour hydrater un produit stérile sans compromettre la stérilité WO2014137986A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201361772221P 2013-03-04 2013-03-04
US61/772,221 2013-03-04

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WO2014137986A2 true WO2014137986A2 (fr) 2014-09-12
WO2014137986A3 WO2014137986A3 (fr) 2015-02-19

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Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4863016A (en) * 1988-07-25 1989-09-05 Abbott Laboratories Packaging for a sterilizable calibratable medical device
US5178267A (en) * 1990-12-20 1993-01-12 Abbott Laboratories Packaging system for a sterilizable calbratable medical device
US6991096B2 (en) * 2002-09-27 2006-01-31 Medtronic Minimed, Inc. Packaging system

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