Cryotherapy delivery device
阅读说明:本技术 冷冻疗法输送装置 (Cryotherapy delivery device ) 是由 艾登·B·贝蒂 马丁·L·福德里 皮特·M·麦肯纳 索菲·A·甘农 莎拉·J·卡拉吉 于 2018-07-16 设计创作,主要内容包括:一种用于小瓶中的生物材料无菌输送的装置,包括管状桶、过滤器组件和分散漏斗组件。管状桶包括在管状桶内接收小瓶的至少一部分的接收端,以及与接收端相对的分散端。过滤器组件流体连接至管状桶的分散端。分散漏斗组件配置为连接至小瓶,并至少部分地设置在管状桶内。分散漏斗组件具有打开形态和闭合形态,在打开形态下,小瓶中的生物材料分散到在分散漏斗组件和过滤器组件之间的管状桶中;在闭合形态下,当分散漏斗组件朝向管状桶的分散端移动时迫使分散的生物材料通过过滤器组件。(An apparatus for the sterile transport of biological material in vials comprises a tubular barrel, a filter assembly, and a dispersion funnel assembly. The tubular barrel includes a receiving end that receives at least a portion of the vial within the tubular barrel, and a dispensing end opposite the receiving end. The filter assembly is fluidly connected to the dispensing end of the tubular barrel. The dispersion funnel assembly is configured to be connected to a vial and disposed at least partially within the tubular barrel. The dispersion funnel assembly has an open configuration in which the biological material in the vial is dispersed into the tubular barrel between the dispersion funnel assembly and the filter assembly; in the closed configuration, the dispersed biological material is forced through the filter assembly as the dispersion funnel assembly moves toward the dispersing end of the tubular barrel.)
1. A device for the sterile delivery of biological material in vials, the device comprising:
a tubular barrel comprising a receiving end within the tubular barrel to receive at least a portion of the vial, and a dispensing end opposite the receiving end;
a filter assembly fluidly connected to the dispensing end of the tubular barrel; and
a dispersion funnel assembly configured to be connected to the vial and disposed at least partially within the tubular barrel, the dispersion funnel assembly having an open configuration in which biological material in the vial is dispersed into the tubular barrel between the dispersion funnel assembly and the filter assembly, and a closed configuration in which dispersed biological material is forced through the filter assembly as the dispersion funnel assembly moves toward the dispersion end of the tubular barrel.
2. The device of claim 1, wherein the filter assembly comprises a filter media, the filter assembly being selectable between an open state in which the filter media prevents passage of the biological material through the filter assembly, but allows passage of liquid through the filter assembly, a bypass state, and optionally a closed state; in the bypass state, the biological material may pass through the filter assembly to transport the biological material; in the closed state, no liquid or biological material can pass through the filter assembly.
3. The device of claim 2, wherein the filter assembly is selectable only from the closed state to the open state and from the open state to the bypass state.
4. The apparatus of claim 2, wherein the filter assembly further comprises:
a first output port in fluid communication with the dispensing end of the tubular barrel when the filter assembly is in the open state; and
a second output port in fluid communication with the dispersion end of the tubular barrel when the filter assembly is in the bypass state.
5. The apparatus of any one of claims 1 to 4, wherein the dispersion funnel assembly comprises:
an inner funnel comprising a first plurality of openings through the inner funnel;
an outer funnel comprising a second plurality of openings through the outer funnel, the inner funnel coaxial with and nested in the outer funnel such that the first plurality of openings are aligned with the second plurality of openings; and
a compressible seal disposed between the inner funnel and the outer funnel,
wherein in the open configuration the compressible seal allows fluid connection between the inner and outer funnels and in the closed configuration the compressible seal is compressed between the inner and outer funnels to prevent the fluid connection between the inner and outer funnels.
6. The apparatus of claim 5, wherein:
the inner funnel further comprises:
a first tubular portion; and
a first conical portion coaxial with and projecting away from the first tubular portion, the first conical portion defining a first opening angle and the first plurality of openings; and is
The outer funnel further comprises:
a second tubular portion; and
a second conical portion coaxial with and projecting away from the second tubular portion, the second conical portion defining a second opening angle and the second plurality of openings, the second opening angle being substantially equal to the first opening angle.
7. The apparatus of claim 5 or 6, further comprising a dispersion funnel retention device configured to engage a portion of the outer funnel extending from the receiving end of the tubular barrel to prevent movement of the dispersion funnel assembly toward the dispersing end of the tubular barrel until the dispersion funnel assembly is in the closed configuration.
8. The apparatus of any one of claims 1 to 7, further comprising a vial engagement assembly connected to the tubular barrel at the receiving end configured to selectively engage a plurality of threads along a portion of the length of the vial.
9. A system for the sterile storage and delivery of biological material, the system comprising:
a vial, comprising:
a tubular body comprising the biological material prior to delivery;
a vial input port; and
a pressure activated vial output port; and
the delivery device of any one of claims 1 to 8.
10. A method of aseptically delivering a biological material in a sterile frozen and concentrated state within a vial using a delivery device, the method comprising:
thawing the biological material contained within the vial;
connecting the vial to the delivery device to transfer thawed biological material into the delivery device;
dispersing the thawed biological material within the delivery device; and
forcing the dispersed biological material out of the delivery device and into an intravascular device coupled to the delivery device.
11. The method of claim 10, wherein connecting the vial to the transfer device comprises:
connecting the vial output port to an input port of an inner funnel of the dispersion funnel assembly;
inserting the inner funnel into an outer funnel of the dispersion funnel assembly within a tubular barrel of the delivery device, at least one projection on the inner funnel engaging an axially extending slot within the outer funnel to align a first plurality of openings in the inner funnel with a second plurality of openings in the outer funnel; and
moving the vial to push the inner funnel through the outer funnel until at least one cantilevered lug on the inner funnel engages at least one first recess in the outer funnel to place the dispersing funnel assembly in an open configuration.
12. The method of claim 11, wherein dispersing the biological material within the delivery device comprises:
connecting a liquid source to a vial input port;
flowing the liquid into the vial to force the biological material out of the vial, into the inner funnel, through the first plurality of openings, into the outer funnel, through the second plurality of openings, and into the tubular barrel, at least one of the first plurality of openings or the second plurality of openings sized to allow the liquid and dispersed biological material to pass through the dispersion funnel assembly and to prevent undispersed biological material from passing through the dispersion funnel assembly; and
flowing the liquid through a filter assembly connected to the dispensing end of the tubular barrel, the filter assembly including filter media sized to prevent the passage of dispensed biological material through the filter assembly, but allow the liquid to pass through the filter assembly.
13. The method of claim 12, wherein forcing dispersed biological material out of the delivery device and into an intravascular device coupled to the delivery device comprises:
moving the vial to push the inner funnel through the outer funnel, disengaging the at least one cantilevered lug from the at least one first recess and subsequently engaging at least one second recess in the outer funnel, forcing the seal between the inner funnel and the outer funnel closed to place the dispersing funnel assembly in a closed configuration, thereby preventing the liquid or dispersed biological material from passing back into the dispersing funnel assembly;
selecting the filter assembly to be in a bypass state such that the liquid and dispersed biological material can bypass the filter media;
disengaging a dispersion funnel retention device configured to prevent sliding of the outer funnel along the tubular barrel by engaging a portion of the outer funnel extending from a receiving end of the tubular barrel; and
moving the vial to push the connected dispersion funnel assembly to slide along the tubular barrel toward the dispersion end of the tubular barrel, the dispersion funnel assembly forcing the biological material through the filter assembly and into the intravascular device connected to the delivery device.
14. The method of claim 13, further comprising removing a retaining sleeve disposed about a portion of the vial prior to moving the vial, the retaining sleeve configured to prevent moving the vial to push the inner funnel through the outer funnel to disengage the at least one cantilevered lug from the at least one first recess.
15. The method of any one of claims 11 to 14, wherein the connection between the vial and the dispersion funnel assembly is a rotatable connection, and moving the vial comprises:
engaging the threaded portion of the tubular body with a vial engagement assembly connected to the tubular barrel; and
rotating the vial to pass the vial through the vial engagement assembly and move the vial relative to the transport device.
Technical Field
The present invention relates to systems, devices and methods for storing and delivering biological material to a patient. More particularly, the present invention relates to systems, devices and methods for storing and delivering cryotherapy biological materials to a patient.
Background
Biomaterials for cell therapy, such as allogeneic or autologous transplant cells, are typically produced by aspiration of stem cells from a donor or patient, respectively, followed by isolation and differentiation of the stem cells. The differentiated stem cells are then expanded to produce a quantity of differentiated stem cells sufficient for cell therapy. Prior to storage, differentiated stem cells are washed and suspended in a solution comprising proteins and a cryoprotectant, such as dimethyl sulfoxide (DMSO). The suspended cells are then transferred to bags or vials and frozen with liquid nitrogen at a slow, controlled rate.
The frozen suspension cells were transferred to the clinic and kept frozen until ready for use. The cells are thawed in the bag and then transferred from the bag to a dedicated device for washing. Washing removes the cryoprotectant, which, if not removed, can increase some of the side effects of cell therapy. In some cases, the equipment must be operated by specially trained professionals using specialized reagents. The cost of using specialized equipment, professionals, and reagents is high. In other cases, the apparatus may use an inexpensive saline solution instead of a dedicated reagent, but requires centrifugation of the cells. Centrifugation can damage and clump the cells together, thereby reducing the activity of the cells and the efficacy of the cell therapy.
Once the cryoprotectant in the transplanted cells is washed away, the transplanted cells are transferred from the dedicated device into a syringe or catheter for delivery to the patient. Each of the transfer steps, such as from the bag to the washing apparatus and from the washing apparatus to the syringe, exposes the cells to the atmosphere and introduces an increased risk of contamination and infection, particularly in high risk immunodeficiency patients.
Disclosure of Invention
Example 1 is a device for the sterile delivery of biological material in vials. The apparatus includes a tubular barrel, a filter assembly, and a dispersion funnel assembly. The tubular barrel includes a receiving end that receives at least a portion of the vial within the tubular barrel, and a dispensing end opposite the receiving end. The filter assembly is fluidly connected to the dispensing end of the tubular barrel. The dispersion funnel assembly is configured to be connected to a vial and disposed at least partially within the tubular barrel. The dispersion funnel assembly has an open configuration to disperse the biological material in the vial into the tubular barrel between the dispersion funnel assembly and the filter assembly, and a closed configuration to force the dispersed biological material through the filter assembly as the dispersion funnel assembly moves toward the dispersing end of the tubular barrel.
Example 2 is the apparatus of example 1, wherein the filter assembly comprises a filter media, the filter assembly being selectable between an open state in which the filter media prevents passage of biological material through the filter assembly, but allows passage of liquid through the filter assembly, a bypass state, and optionally a closed state; in the bypass state, the biological material may pass through the filter assembly to transport the biological material; in the closed state, no liquid or biological material can pass through the filter assembly.
Example 3 is the apparatus of example 2, wherein the filter assembly is selectable only from the closed state to the open state and from the open state to the bypass state.
Example 4 is the apparatus of example 2, wherein the filter assembly further comprises a first output port and a second output port. The first output port is in fluid communication with the dispensing end of the tubular barrel when the filter assembly is in the open state. The second output port is in fluid communication with the dispensing end of the tubular barrel when the filter assembly is in the bypass state.
Example 5 is the apparatus of any one of examples 1 to 4, wherein the dispersion funnel assembly comprises an inner funnel, an outer funnel, and a compressible seal. The inner funnel includes a first plurality of openings through the inner funnel. The outer funnel includes a second plurality of openings through the outer funnel. The inner funnel is coaxial with and nested within the outer funnel such that the first plurality of openings is aligned with the second plurality of openings. A compressible seal is disposed between the inner funnel and the outer funnel. In the open configuration, the compressible seal allows fluid connection between the inner and outer funnels. In the closed configuration, the compressible seal is compressed between the inner and outer funnels to prevent a fluid connection between the inner and outer funnels.
Example 6 is the apparatus of example 5, wherein the inner funnel further comprises a first tubular portion and a first conical portion coaxial with and protruding away from the first tubular portion. The first conical portion defines a first opening angle and a first plurality of openings. The outer funnel further comprises a second tubular portion and a second conical portion coaxial with and protruding away from the second tubular portion. The second conical portion defines a second opening angle and a second plurality of openings. The second opening angle is substantially equal to the first opening angle.
Example 7 is the apparatus of any one of examples 5 or 6, further comprising a dispersion funnel retention device configured to engage a portion of the outer funnel extending from the receiving end of the tubular barrel to prevent movement of the dispersion funnel assembly toward the dispersing end of the tubular barrel until the dispersion funnel assembly is in the closed configuration.
Example 8 is the apparatus of any one of examples 1 to 7, further comprising a vial engagement assembly coupled to the tubular barrel at the receiving end configured to selectively engage the plurality of threads along a portion of the length of the vial.
Example 9 is a system for sterile storage and delivery of biological material. The system includes a vial and a delivery device. The vial includes a tubular body for containing biological material prior to delivery, a vial inlet port, and a pressure activated vial outlet port. The delivery device is according to any one of examples 1 to 8.
Example 10 is a method of aseptically delivering a biological material in a state of aseptically freezing and concentrating inside a vial using a delivery device. The method includes thawing the biological material contained within the vial; connecting the vial to a transfer device to transfer thawed biological material into the transfer device; dispersing the thawed biological material within a transport device; and forcing the dispersed biological material out of the delivery device and into an intravascular device coupled to the delivery device.
Example 11 is the method of example 10, wherein connecting the vial to the transfer device comprises connecting a vial output port to an input port of an inner funnel of the dispersion funnel assembly; inserting an inner funnel into an outer funnel of a dispersion funnel assembly within a tubular barrel of a delivery device, at least one protrusion engaged on the inner funnel with an axially extending slot within the outer funnel to align a first plurality of openings in the inner funnel with a second plurality of openings in the outer funnel; and moving the vial to push the inner funnel through the outer funnel until the at least one cantilevered lug on the inner funnel engages the at least one first recess in the outer funnel to place the dispersing funnel assembly in the open configuration.
Example 12 is the method of example 11, wherein dispersing the biological material within the delivery device includes connecting a liquid source to the vial input port; flowing a liquid into the vial to force the biological material out of the vial, into the inner funnel, through the first plurality of openings, into the outer funnel, through the second plurality of openings, and into the tubular barrel; and flowing the liquid through a filter assembly connected to the dispensing end of the tubular barrel. At least one of the first plurality of openings or the second plurality of openings is sized to allow liquid and dispersed biological material to pass through the dispersion funnel assembly and to prevent undispersed biological material from passing through the dispersion funnel assembly. The filter assembly includes a filter media. The filter media is sized to prevent the dispersed biological material from passing through the filter assembly, but to allow liquid to pass through the filter assembly.
Example 13 is the method of example 12, wherein forcing the dispersed biological material out of the delivery device and into an intravascular device coupled to the delivery device comprises moving a vial to push an inner funnel through an outer funnel; disengaging the at least one cantilevered lug from the at least one first recess and subsequently engaging the at least one second recess in the outer funnel; forcing the seal between the inner funnel and the outer funnel closed to place the dispersion funnel assembly in a closed configuration to prevent the liquid or dispersed biological material from passing back into the dispersion funnel assembly; selecting the filter assembly to be in a bypass state such that the liquid and dispersed biological material can bypass the filter media; disengaging a dispersion funnel retention device configured to prevent sliding of the outer funnel along the tubular barrel by engaging a portion of the outer funnel extending from the receiving end of the tubular barrel; and moving the vial to push the attached dispersion funnel assembly to slide along the tubular barrel and toward the dispersion end of the tubular barrel, the dispersion funnel assembly forcing the biological material through the filter assembly and into an intravascular device attached to the delivery device.
Example 14 is the method of example 13, further comprising removing a retaining sleeve disposed around a portion of the vial prior to moving the vial, the retaining sleeve configured to prevent the vial from moving to push the inner funnel through the outer funnel to disengage the at least one cantilevered lug from the at least one first recess.
Example 15 is the method of any one of examples 11 to 14, wherein the connection between the vial and the dispersion funnel assembly is a rotatable connection, and moving the vial includes engaging a threaded portion of the tubular body with a vial engagement assembly connected to the tubular barrel, and rotating the vial to pass the vial through the vial engagement assembly and move the vial relative to the transport device.
Example 16 is an apparatus for sterile delivery of biological material in a vial. The apparatus includes a tubular barrel, a filter assembly, and a dispersion funnel assembly. The tubular barrel includes a receiving end within the tubular barrel that receives a portion of the vial, and a dispensing end opposite the receiving end. The filter assembly is fluidly connected to the dispensing end of the tubular barrel. The dispersion funnel assembly is configured to be connected to a vial and disposed at least partially within the tubular barrel. The dispersion funnel assembly has an open configuration for dispersing biological material from the vial into the tubular barrel between the dispersion funnel assembly and the filter assembly, and a closed configuration for forcing the dispersed biological material through the filter assembly as the dispersion funnel assembly moves toward the dispersing end of the tubular barrel.
Example 17 is the apparatus of example 16, wherein the filter assembly comprises a filter media, the filter assembly selectable between an open state in which the filter media prevents passage of biological material through the filter assembly, but allows passage of liquid through the filter assembly, a bypass state, and optionally a closed state; in the bypass state, the biological material may pass through the filter assembly to transport the biological material; in the closed state, no liquid or biological material can pass through the filter assembly.
Example 18 is the apparatus of example 17, wherein the filter assembly is selectable only from the closed state to the open state and from the open state to the bypass state.
Example 19 is the apparatus of example 17, wherein the filter assembly further comprises a first output port and a second output port. The first output port is in fluid communication with the dispensing end of the tubular barrel when the filter assembly is in the open state. The second output port is in fluid communication with the dispensing end of the tubular barrel when the filter assembly is in the bypass state.
Example 20 is the apparatus of any one of examples 16 to 19, wherein the dispersion funnel assembly comprises an inner funnel, an outer funnel, and a compressible seal. The inner funnel includes a first plurality of openings through the inner funnel. The outer funnel includes a second plurality of openings through the outer funnel. The inner funnel is coaxial with and nested within the outer funnel such that the first plurality of openings is aligned with the second plurality of openings. A compressible seal is disposed between the inner funnel and the outer funnel. In the open configuration, the compressible seal allows fluid connection between the inner and outer funnels. In the closed configuration, the compressible seal is compressed between the inner and outer funnels to prevent a fluid connection between the inner and outer funnels.
Example 21 is the apparatus of example 20, wherein the inner funnel further comprises a first tubular portion and a first conical portion coaxial with and protruding away from the first tubular portion, and the outer funnel further comprises a second tubular portion and a second conical portion coaxial with and protruding away from the second tubular portion. The first conical portion defines a first opening angle and a first plurality of openings. The second conical portion defines a second opening angle and a second plurality of openings. The second opening angle is substantially equal to the first opening angle.
Example 22 is the apparatus of any one of examples 20 or 21, further comprising a dispersion funnel retention device configured to engage a portion of the outer funnel extending from the receiving end of the tubular barrel to prevent movement of the dispersion funnel assembly toward the dispersing end of the tubular barrel until the dispersion funnel assembly is in the closed configuration.
Example 23 is the apparatus of any one of examples 16 to 22, further comprising a vial engagement assembly connected to the tubular barrel at a receiving end. The vial engagement assembly is configured to selectively engage the plurality of threads along a portion of the vial length.
Example 24 is a system for sterile storage and delivery of biological material. The system includes a vial and a delivery device. The vial includes a tubular body for containing biological material prior to delivery, a vial inlet port, and a pressure activated vial outlet port. The delivery device is configured to be connected to a vial for delivering biological material. The delivery device includes a tubular barrel, a filter assembly, and a dispersion funnel assembly. The tubular barrel includes a receiving end for receiving at least a portion of the vial including the output port within the tubular barrel, and a dispensing end opposite the receiving end. The filter assembly is fluidly connected to the dispensing end of the tubular barrel. The dispersion funnel assembly is configured to be connected to the vial output port. The dispersion funnel assembly is configured to be at least partially disposed within the tubular barrel. The dispersion funnel assembly has an open configuration for dispersing biological material from the vial into the tubular barrel between the dispersion funnel assembly and the filter assembly, and a closed configuration for forcing the dispersed biological material through the filter assembly as the dispersion funnel assembly moves toward the dispersing end of the tubular barrel.
Example 25 is the system of example 24, wherein the filter assembly comprises filter media. The filter assembly is selectable between an open state in which the filter media prevents passage of biological material through the filter assembly, a bypass state, and optionally a closed state, but permits passage of liquid through the filter assembly; in the bypass state, the biological material may pass through the filter assembly to transport the biological material; in the closed state, no liquid or biological material can pass through the filter assembly.
Example 26 is the system of any one of examples 24 or 25, wherein the dispersion funnel assembly comprises an inner funnel, an outer funnel, and a compressible seal. The inner funnel includes a first plurality of openings through the inner funnel. The outer funnel includes a second plurality of openings through the outer funnel. The inner funnel is coaxial with and nested within the outer funnel such that the first plurality of openings is aligned with the second plurality of openings. A compressible seal is disposed between the inner funnel and the outer funnel. In the open configuration, the compressible seal allows fluid connection between the inner and outer funnels. In the closed configuration, the compressible seal is compressed between the inner and outer funnels to prevent a fluid connection between the inner and outer funnels.
Example 27 is the system of example 26, wherein the inner funnel further comprises a first tubular portion and a first conical portion coaxial with and protruding away from the first tubular portion. The outer funnel further comprises a second tubular portion and a second conical portion coaxial with and protruding away from the second tubular portion. The first conical portion defines a first opening angle and a first plurality of openings. The second conical portion defines a second opening angle and a second plurality of openings. The second opening angle is substantially equal to the first opening angle.
Example 28 is the system of any one of examples 26 or 27, wherein the conveyance device further comprises a dispersion funnel retention device configured to engage a portion of the outer funnel extending from the receiving end of the tubular barrel to prevent movement of the dispersion funnel assembly toward the dispersing end of the tubular barrel until the dispersion funnel assembly is in the closed configuration.
Example 29 is the system of any one of examples 24 to 28, wherein a portion of the length of the tubular body of the vial comprises a plurality of threads, and the transfer device further comprises a vial engagement assembly coupled to the tubular barrel at the receiving end configured to selectively engage the plurality of threads.
Example 30 is a method for sterile delivery of a biological material in a sterile frozen and concentrated state within a vial. The method includes thawing the biological material contained within the vial; connecting the vial to a transfer device to transfer thawed biological material into the transfer device; dispersing the thawed biological material within a transport device; and forcing the dispersed biological material out of the delivery device and into an intravascular device coupled to the delivery device.
Example 31 is the method of example 30, wherein connecting the vial to the transfer device comprises connecting a vial output port to an input port of an inner funnel of the dispersion funnel assembly; inserting an inner funnel into an outer funnel of a dispersion funnel assembly within a tubular barrel of a conveyor apparatus; at least one projection on the inner funnel engages an axially extending slot in the outer funnel to align the first plurality of openings in the inner funnel with the second plurality of openings in the outer funnel; and moving the vial to push the inner funnel through the outer funnel until the at least one cantilevered lug on the inner funnel engages the at least one first recess in the outer funnel to place the dispersing funnel assembly in the open configuration.
Example 32 is the method of example 31, wherein dispersing the biological material within the delivery device includes connecting a liquid source to the vial input port; flowing a liquid into the vial to force the biological material out of the vial, into the inner funnel, through the first plurality of openings, into the outer funnel, through the second plurality of openings, and into the tubular barrel; and flowing the liquid through a filter assembly connected to the dispensing end of the tubular barrel. The filter assembly includes a filter media. The filter media is sized to prevent the dispersed biological material from passing through the filter assembly, but to allow liquid to pass through the filter assembly. At least one of the first plurality of openings or the second plurality of openings is sized to allow liquid and dispersed biological material to pass through the dispersion funnel assembly and to prevent undispersed biological material from passing through the dispersion funnel assembly.
Example 33 is the method of example 32, wherein forcing the dispersed biological material out of the delivery device and into an intravascular device coupled to the delivery device comprises moving a vial to push an inner funnel through an outer funnel; disengaging the at least one cantilevered lug from the at least one first recess and subsequently engaging the at least one second recess in the outer funnel; forcing the seal between the inner funnel and the outer funnel closed to place the dispersion funnel assembly in a closed configuration to prevent the liquid or dispersed biological material from passing back into the dispersion funnel assembly; selecting the filter assembly to be in a bypass state such that the liquid and dispersed biological material can bypass the filter media; disengaging a dispersion funnel retention device configured to prevent sliding of the outer funnel along the tubular barrel by engaging a portion of the outer funnel extending from the receiving end of the tubular barrel; and moving the vial to push the attached dispersion funnel assembly to slide along the tubular barrel and toward the dispersion end of the tubular barrel, the dispersion funnel assembly forcing the biological material through the filter assembly and into an intravascular device attached to the delivery device.
Example 34 is the method of example 33, further comprising removing a retaining sleeve disposed around a portion of the vial prior to moving the vial, the retaining sleeve configured to prevent moving the vial to push the inner funnel through the outer funnel to disengage the at least one cantilevered lug from the at least one first recess.
Example 35 is the method of any one of examples 31 to 34, wherein the connection between the vial and the dispersion funnel assembly is a rotatable connection, and moving the vial comprises engaging a threaded portion of the tubular body with a vial engagement assembly connected to the tubular barrel, and rotating the vial to pass the vial through the vial engagement assembly and move the vial relative to the transport device.
While multiple embodiments are disclosed, other embodiments of the present invention will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the invention. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not as restrictive.
Drawings
Fig. 1 is a perspective view of a system for the sterile storage and delivery of biological material according to some embodiments of the present invention.
Fig. 2 is a perspective view of the vial of fig. 1, according to some embodiments.
Fig. 3 is an enlarged perspective view of a portion of the vial of fig. 2, according to some embodiments.
Fig. 4 is an exploded perspective view of a dispersion funnel assembly of the delivery device of fig. 1, according to some embodiments.
Figures 5A and 5B are perspective views of a portion of the dispersion funnel assembly of figure 4 in an open configuration and a closed configuration, respectively, according to some embodiments.
Fig. 6 is a side view of a portion of the system of fig. 1, showing an interface between a vial and a transfer device, according to some embodiments.
Fig. 7 is a perspective view of a portion of the system of fig. 1, showing a dispersion funnel retention device, according to some embodiments.
Fig. 8 is an exploded perspective view of a portion of the system of fig. 1, showing a filter assembly, according to some embodiments.
Fig. 9 is a perspective view of a portion of the filter assembly shown in fig. 8, according to some embodiments.
Fig. 10 is a perspective view of another portion of the filter assembly shown in fig. 8, according to some embodiments.
Fig. 11A-11C are views of a vial engagement assembly of the transfer device of fig. 1, according to some embodiments.
Fig. 12 is a schematic cross-sectional view further illustrating the system of fig. 1 and a method for sterile storage and delivery of biological material, in accordance with an embodiment of the present invention.
Fig. 13 is another schematic cross-section further illustrating the system of fig. 12 and a method for sterile storage and delivery of biological material, in accordance with an embodiment of the present invention.
Fig. 14 is a perspective view of a portion of the system of fig. 1, according to some embodiments.
Fig. 15 is another schematic cross-section further illustrating the system of fig. 13 and a method for sterile storage and delivery of biological material, in accordance with an embodiment of the present invention.
While the invention is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. However, the invention is not limited to the specific embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the scope of the invention as defined by the appended claims.
Detailed Description
Embodiments of the invention include systems for the sterile storage and delivery of biological materials, such as transplanted cells for cell therapy. Embodiments may provide a closed sterile system that begins after production of the transplanted cells and is maintained by freezing, transferring, storing, thawing, washing, and delivering to the patient.
Fig. 1 is a perspective view of a
The transfer device 14 may include a tubular barrel 26 (shown transparent), a
The
The
In the closed configuration, when attached
Once the dispersed biological material and liquid are ready for delivery to the patient, the
In the embodiment shown in fig. 1, the
Fig. 2 is a perspective view of
In some embodiments, after the biological material is washed and suspended in a solution comprising proteins and a cryoprotectant, such as dimethyl sulfoxide (DMSO), the biological material may be centrifuged and the supernatant aspirated to produce a concentrated cell pellet in the form of a "pellet. The biological material in
Fig. 4 is an exploded perspective view of the
A plurality of
In the embodiment shown in FIG. 4, the
In the embodiment shown in fig. 4, each of the first plurality of
In other embodiments, the first plurality of
Fig. 5A and 5B are perspective views of the
Fig. 6 is a side view of a portion of the
Fig. 7 is a perspective view of a portion of the
Fig. 8 is an exploded perspective view of a portion of the
Fig. 9 is a perspective view of the
Fig. 10 is a perspective view of the rotating
Considering fig. 8-10 together,
Thus, the
The
In other embodiments, the
Fig. 11A-11C are views of the
FIG. 11B is an exploded top view of the
Fig. 11C is a top view of the
Fig. 12 is a schematic cross-sectional view further illustrating the
Fig. 13 is another schematic cross-section further illustrating the
Once in the open configuration, the biological material C may be dispensed by applying a pressurized flow of liquid F to the vial inlet port 18 (fig. 1) to open the
Leakage of liquid flow F is prevented by first O-
Fig. 14 is a perspective view of a portion of the
The
Fig. 15 is another schematic cross-section further illustrating the
Once in the closed configuration, the
Various modifications and additions may be made to the exemplary embodiments discussed without departing from the scope of the present invention. For example, although the embodiments described above refer to specific features, the scope of the present invention also includes embodiments having different combinations of features and embodiments that do not include all of the described features. Accordingly, the scope of the present invention is intended to embrace all such alternatives, modifications and variances which fall within the scope of the appended claims, and all equivalents thereof.
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