Devices, systems, and methods for combining and / or delivering injectable materials

Abstract

Devices, systems, and methods for combining and / or delivering injectable materials to a patient. The vial adapter is configured to fluidly couple and facilitate fluid exchange between at least the first chamber and the separate chamber, and to vent material from the separate chamber as it is withdrawn. The first chamber may be defined in a multi-chamber device that also defines a second chamber. The vial adapter also defines a purge reservoir into which excess material and / or air can be purged from the second chamber. For example, when material is ejected from a first chamber into a separate chamber, a determined amount of material may be purged from a second chamber into a purge reservoir.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority to U.S. Provisional Application No. 62 / 462,119, filed April 26, 2023, the entire disclosure of which is incorporated herein by reference for various purposes. Technical Field

[0003] This disclosure generally relates to the field of devices, related systems, and methods for delivering materials (such as injectable materials) to patients. More specifically, this disclosure relates to devices, related systems, and methods for combining components of injectable materials. Background Technology

[0004] Various forms of cancer and other diseases are treated with locally applied radiation therapy. However, radiation therapy can come with a range of risks. Since the concept of conformal radiation therapy was introduced, doctors have been concerned with the radiation dose delivered to the target and surrounding tissues. Researchers have been able to correlate side effects with the amount of tissue receiving a given radiation dose. However, time, distance, and shielding affect the delivered dose. The shorter the time an area is exposed to radiation, the lower the delivered dose. The greater the distance from radiation, the lower the delivered dose. Filler materials can be injected into the treatment area to provide shielding for the tissues surrounding the target of radiation therapy. For example, many men are diagnosed with prostate cancer each year. Traditionally, treatment options include interstitial implantation, surgery, and external beam radiation therapy. While the optimal treatment remains controversial, treatments for prostate cancer with implantation and radiation therapy have become less toxic.

[0005] Various systems deliver filler materials to the treatment site to reduce radiation dose to surrounding tissues (e.g., shielding the rectum during prostate cancer radiotherapy). These filler materials are typically reactive and therefore often assembled / mixed immediately before or even during delivery to the patient. Various systems are known for assembling / mixing (e.g., in vitro) filler materials injected into the radiotherapy area. However, most of these systems comprise numerous sub-components, are complex to assemble, and are prone to filler mixing errors before delivery to the patient. The various challenges posed by such mixing systems can lead to errors and accidents, resulting in unnecessary increases in procedure time and costs. Addressing these and other issues through the assembly and delivery of injectable materials is welcome in the art. Summary of the Invention

[0006] The summary is provided to present, in a simplified form, the selected concepts described in further detail below. The summary is not necessarily intended to identify key or essential features of the claimed subject matter, nor is it intended to help determine the scope of the claimed subject matter. Those skilled in the art will understand that in some cases, each of the aspects and features of this disclosure may be advantageously used alone, or in other cases, in combination with other aspects and features of this disclosure, whether or not described in the summary. The inclusion or exclusion of elements, components, etc., in the summary does not imply a limitation on the scope of the claimed subject matter.

[0007] According to various principles of this disclosure, a vial adapter has a proximal end configured for fluid connection with a material transfer device defining a first chamber of a multi-chamber system; a distal end configured for fluid connection with an independent chamber of the multi-chamber system; and a fluid exchange system defined between the proximal and distal ends of the vial adapter. In some aspects, the fluid exchange system has a fluid exchange lumen extending through the distal end of the vial adapter to fluidly communicate with the independent chamber fluidly connected to the distal end of the vial adapter and the first chamber fluidly connected to the proximal end of the vial adapter; and a vent lumen extending through the distal end of the vial adapter to ventilate the independent chamber fluidly connected to the distal end of the vial adapter, wherein the vent lumen is fluidly isolated from the fluid exchange lumen and fluidly communicates with an inlet of the vent lumen defined in the wall of the vial adapter.

[0008] In some aspects, the proximal end of the vial adapter defines a first port configured to receive and fluidly communicate with a first nozzle of a material transfer device defining a first chamber of a multi-chamber system, thereby fluidly communicating a fluid exchange lumen with the first chamber of the multi-chamber system via the first port of the vial adapter and the first nozzle of the material transfer device; and the distal end of the vial adapter defines a vial receiving chamber configured to receive a vial, thereby defining an independent chamber of the multi-chamber system. In some aspects, a fluid exchange lumen and a venting lumen are defined in the base of the vial adapter; and the vial receiving chamber extends distally from the base of the vial adapter to define a vial receiving chamber sized to receive a vial body thereby defining an independent chamber. In some aspects, the vial adapter further includes a fluid exchange device having a fluid exchange device base; a fluid exchange trocar extending distally from the fluid exchange device base and defining a fluid exchange lumen therethrough, the distal end of the fluid exchange lumen extending through the fluid exchange trocar to be positioned within a vial receiving chamber, the proximal end of the fluid exchange lumen extending through the fluid exchange device base; and a distal extension extending distally from the fluid exchange device base and defining a ventilation lumen therethrough, the ventilation outlet being located at the distal end of the fluid exchange lumen in the fluid exchange trocar. In some aspects, the vial adapter base defines a fluid exchange passage forming a base fluid exchange lumen with the fluid exchange device base, and a ventilation passage forming a base ventilation lumen with the fluid exchange device base; the base fluid exchange lumen is in fluid communication with the fluid exchange lumen and a first port defined at the proximal end of the vial adapter; and the base ventilation lumen is in fluid communication with the ventilation lumen and the ventilation lumen inlet. In some aspects, the distal extension of the fluid exchange device has a sharp distal end for piercing a stop of a vial defining an independent chamber to facilitate fluid exchange through the vial stop and into the independent chamber, and a vent outlet of the distal extension of the fluid exchange device is defined in the distal end of the sharp distal end of the distal extension of the fluid exchange device. In some aspects, the vial adapter further includes a fluid exchange nozzle and a vent nozzle, the vent nozzle extending distally from the distal end of the vial adapter and configured to be fluidly connected to a fluid exchange port and a vent port, respectively, defined in a stop of a vial received in a vial receiving chamber; a fluid exchange lumen extends through the fluid exchange nozzle to be in fluid communication with the independent chamber; and a vent lumen extends through the vent nozzle to be in fluid communication with a distal extension extending distally beyond the fluid exchange port in the vial stop within the independent chamber.

[0009] In some aspects, the proximal end of the vial adapter defines a second port configured to receive and fluidly communicate with a second nozzle of a material transfer device; and the vial adapter further includes a purification reservoir fluidly communicating with the second port, whereby material from a second chamber defined in the material transfer device can fluidly communicate with the purification reservoir via the second nozzle and the second port. In some aspects, the purification reservoir is defined in the base of the vial adapter and fluidly isolated from the fluid exchange lumen and the vent lumen. In some aspects, the vial adapter also includes a reservoir cap positioned near the proximal end of the vial adapter and enclosing the purification reservoir within the vial adapter; and the purification reservoir is fluidly isolated from the fluid exchange lumen and the vent lumen.

[0010] According to various principles of this disclosure, a multi-chamber assembly and / or delivery system includes a material transfer device defining a first chamber therein; and a vial adapter defining a vial receiving chamber. In some aspects, the vial adapter has a proximal end defining a first nozzle port; the multi-chamber assembly has a first nozzle configured to be fluidly connected to the nozzle port of the first vial adapter; the vial adapter has a distal end defining a fluid exchange lumen in fluid communication with the nozzle port of the first vial adapter and the nozzle of the first multi-chamber assembly; and the distal end of the vial adapter further defines a vent lumen fluidly isolated from the fluid exchange lumen, the vent lumen extending from a vent lumen inlet defined in the wall of the vial adapter to the distal end of the vial adapter.

[0011] In some aspects, the system also includes a fluid exchange device having a fluid exchange device base; a fluid exchange trocar extending distally from the fluid exchange device base and defining a fluid exchange lumen therethrough, the distal end of the fluid exchange lumen extending through the fluid exchange trocar to be positioned within a vial receiving chamber, the proximal end of the fluid exchange lumen extending through the fluid exchange device base to be in fluid communication with a first vial adapter nozzle port; and a distal extension extending distally from the fluid exchange device base and defining a venting lumen therethrough, the venting outlet being located within a vial receiving chamber at the distal end of the fluid exchange lumen in the fluid exchange trocar.

[0012] In some aspects, the system further includes a vial body having an open end and a vial stop located within the open end of the vial body. In some aspects, the vial body defines a separate chamber that can be positioned within a vial receiving chamber defined by a vial adapter; the vial stop defines a fluid exchange port and a vent port therethrough, in fluid communication with the separate chamber defined within the vial body; the vial adapter further includes a fluid exchange nozzle extending distally from a distal end of the vial adapter and configured to be in fluid communication with the separate chamber via the fluid exchange port of the vial stop, and a vent nozzle extending distally from a distal end of the vial adapter and configured to be in fluid communication with the separate chamber via the vent port of the vial stop; and the vial stop further includes a distal extension extending within the separate chamber, which is positioned distal to the fluid exchange port of the vial stop and within an empty space within the separate chamber when the vial is inverted and material is removed therefrom through the fluid exchange port of the vial stop.

[0013] In some aspects, the proximal end of the vial adapter further defines a second nozzle port; the multi-chamber device further defines a second chamber therein; and the multi-chamber device has a second nozzle configured to be fluidly connected to the second vial adapter nozzle port. In some aspects, the vial adapter also defines a purification reservoir fluidly connected to the second vial adapter nozzle port, the second multi-chamber device nozzle, and the second chamber, and fluidly isolated from the vial adapter fluid exchange lumen, the first vial adapter nozzle port, the first multi-chamber device nozzle, and the first chamber.

[0014] According to various principles of this disclosure, a method combines a first material contained in a first chamber of a multi-chamber system with a second material contained in an independent chamber. In some aspects, the method includes fluidly communicating the first chamber and the independent chamber via a vial adapter; drawing material from the independent chamber into the first chamber through a fluid exchange lumen defined by the vial adapter; and venting the independent chamber while material is being withdrawn from it to balance the pressure within the independent chamber via a venting lumen defined by the vial adapter. In some aspects, the fluid exchange lumen extends from its distal end into the fluid communicating with the first chamber; and the venting lumen is fluidly communicating with a venting lumen inlet defined through a wall of the vial adapter and has an outlet extending beyond the distal end of the fluid exchange lumen, the outlet being located within the empty space when material is withdrawn from the independent chamber.

[0015] In some aspects, the method further includes injecting a first material from a first chamber through a fluid exchange lumen defined in a vial adapter into an independent chamber. In some aspects, the vial adapter includes a fluid exchange device having a fluid exchange puncture and a distal extension defining a vial adapter fluid exchange lumen via the fluid exchange puncture and a vial adapter venting lumen via the distal extension. In some aspects, the method further includes extending the fluid exchange puncture of the fluid exchange device through a stop in the vial opening defining the independent chamber to extend a distal end of the fluid exchange lumen defined in the fluid exchange puncture into the independent chamber; and extending the distal extension further into the independent chamber, rather than extending the distal end of the fluid exchange lumen into the independent chamber, to provide fluid communication to the venting lumen defined by the empty space created in the independent chamber when material is withdrawn from the independent chamber.

[0016] In some aspects, the method further includes fluidly connecting a fluid exchange nozzle extending distally from the distal end of the vial adapter to a fluid exchange port defined in a stop at the open end of the vial defining an independent chamber; fluidly connecting a vent nozzle extending distally from the distal end of the vial adapter to the independent chamber via a vent port defined in the vial stop; and fluidly connecting the vent nozzle to an empty space within the vial via an extension extending from the vial stop into the independent chamber toward a closed end of the vial opposite the open end of the vial.

[0017] In some aspects, the first chamber is defined in a multi-chamber device that defines a second chamber; and the method further includes purging material or air from the second chamber into a purge reservoir contained within a vial adapter.

[0018] These and other features and advantages of this disclosure will become apparent from the following detailed description, the scope of which is set forth in the appended claims. While the following disclosure is presented according to aspects or embodiments, it should be understood that each aspect may be claimed individually or in combination with aspects and features of that embodiment or any other embodiment. Attached Figure Description

[0019] Non-limiting embodiments of the present disclosure are described by way of example with reference to the accompanying drawings, which are schematic and not intended to be drawn to scale. The drawings are for illustrative purposes only, and the dimensions, positions, orders, and relative sizes reflected in the drawings may vary. For example, the device may be enlarged to make details clear, but its size may be reduced to facilitate injection into a patient. For clarity and simplicity, not every element is labeled in every figure, nor is every element shown in every embodiment, where no description is necessary to allow those skilled in the art to understand the disclosure. Furthermore, reference numerals may indicate elements in some figures that are shown in other figures, and for brevity, description is based solely on reference to those other figures.

[0020] The detailed description will be better understood in conjunction with the accompanying drawings, in which the same reference numerals denote the same elements, as shown below:

[0021] Figure 1 A perspective view is shown of an embodiment of a multi-chamber system for combining and / or delivering injectable materials to a patient, formed according to various principles of the present disclosure.

[0022] Figure 2 Showing Figure 1 Exploded perspective view of a multi-chamber assembly and / or delivery system.

[0023] Figure 3 It shows, as Figure 1 The diagram shows a perspective view of a multi-chamber assembly and / or delivery system, but the vial is fluidly connected to an injectable material transfer device.

[0024] Figure 4 It shows along Figure 1 Cross-sectional view of line IV-IV of the system shown.

[0025] Figure 5 It shows along Figure 3 Cross-sectional view of the VV line of the system shown.

[0026] Figure 6 Showing along Figure 3 Cross-sectional view of the VI-VI line of the system shown.

[0027] Figure 7 As shown Figures 1-6 A perspective view of one embodiment of a vial adapter for a multi-chamber combination and / or delivery system shown.

[0028] Figure 8 A perspective view of another embodiment of a multi-chamber assembly and / or delivery system formed according to various principles of the present disclosure is shown, the system having a protective cap located within a vial adapter.

[0029] Figure 9Showing along Figure 8 The cross-sectional view of the IX-IX line of the system shown.

[0030] Figure 10 As shown Figure 8 The diagram shows a perspective view of a multi-chamber combination and / or delivery system, but the system has a vial located within a vial adapter and fluidly connected to an injectable material transfer device, rather than a protective cap.

[0031] Figure 11 It shows Figure 10 The system shown is a cross-sectional view along line XI-XI.

[0032] Figure 12 Showing along Figure 10 The cross-sectional view of the XII-XII line of the system shown.

[0033] Figure 13A Showing Figure 10 The medicine bottle in Figure 8 A perspective view of the injectable material transfer device of the multi-chamber combination and / or delivery system before connection.

[0034] Figure 13B Showing Figure 13A A perspective view of the medicine bottle after the protective cap has been removed.

[0035] Figure 14A An example of an embodiment of a valve seal in a sealed position is shown.

[0036] Figure 14B It shows the location of the purification process. Figure 14A Valve seals.

[0037] Figure 15A An example of an embodiment of a valve seal in a sealed position is shown.

[0038] Figure 15B It shows the location of the purification process. Figure 15A Valve seals.

[0039] Figure 16A An example of an embodiment of a valve seal in a sealed position is shown.

[0040] Figure 16B It shows the location of the purification process. Figure 16A Valve seals. Detailed Implementation

[0041] The following detailed description should be read with reference to the accompanying drawings depicting illustrative embodiments. It should be understood that this disclosure is not limited to the specific embodiments described, as these embodiments can vary. All apparatuses, systems, and methods discussed herein are examples of apparatuses and / or systems and / or methods implemented according to one or more principles of this disclosure. Each example of an embodiment is provided by way of explanation and is not the only way to implement these principles, but merely an example. Therefore, references to elements or structures or features in the drawings must be understood as references to embodiments of this disclosure and should not be construed as limiting this disclosure to the specific elements, structures, or features shown. Other examples of ways of implementing the disclosed principles will arise in those skilled in the art upon reading this disclosure. In fact, those skilled in the art will understand that various modifications and variations can be made to this disclosure without departing from the scope or spirit of the subject matter. For example, features shown or described as part of an embodiment may be used with another implementation to produce yet another embodiment. Therefore, this subject matter is intended to cover modifications and variations within the scope of the appended claims and their equivalents.

[0042] It should be understood that this disclosure is set forth in various levels of detail. In some cases, details that are not necessary for a person of ordinary skill in the art to understand the contents of this disclosure, or details that make other details difficult to perceive, may have been omitted. The terminology used herein is for describing particular embodiments only and is not intended to limit the scope beyond the appended claims. Unless otherwise defined, the technical terms used herein should be understood as those commonly understood by a person of ordinary skill in the art to which this disclosure pertains. All devices and / or methods disclosed and claimed herein can be made and performed without excessive experimentation based on this disclosure.

[0043] As used herein, “proximal end” refers to the direction or location closest to the user (medical professional, clinician, technician, operator, or physician, etc.; these terms are used interchangeably herein and are not intended to be limiting, including automated control systems or others), such as when using the device (e.g., introducing the device into a patient, or during implantation, placement, or delivery), and / or closest to the delivery device, while “distal end” refers to the direction or location furthest from the user, such as when using the device, for example, during introduction of the device into a patient, or during implantation, placement, or delivery, and / or closest to the delivery device. “Longitudinal” refers to extending along the longer or larger dimension of the element. “Longitudinal axis” extends along the longitudinal direction of the element, but is not necessarily straight, and does not necessarily maintain a fixed configuration if the element is bent or kinked; “axial” generally refers to along the longitudinal axis. However, it should be understood that references to the axial or longitudinal movement of the aforementioned system or its elements need not be strictly limited to axial and / or longitudinal movement along the longitudinal axis or central axis of the reference element. "Center" means at least substantially bisecting the center point and / or substantially equidistant from the periphery or boundary. "Central axis" means a line that, relative to the opening, at least substantially bisects the center point of the opening, extending longitudinally along the length of the opening when the opening comprises, for example, a tubular element, channel, cavity, or orifice. As used herein, "cavity," "channel," "orifice," or "access" is not limited to a circular cross-section. As used herein, "free end" of an element means the terminal beyond which the element does not extend. It should be understood that, unless otherwise stated, terms such as "at or on or near an end" or "along a terminal" may be used interchangeably herein without limitation and are intended to indicate general relative spatial relationships rather than precisely limited locations.

[0044] Various medical procedures involve the delivery (e.g., injection) of injectable materials into the body before, during, or after surgery. Preferably, the injectable material is biocompatible and optionally biodegradable. Injectable materials can be used for a variety of purposes, including, but not limited to, distinguishing tissues (e.g., differentiating anatomical areas by creating “bubbles” or other raised or swollen areas), separating anatomical structures from one another, or influencing (e.g., shielding, coating, covering, altering, etc.) anatomical structures. It should be understood that the term “tissue” is a broad term encompassing a part of the body or a site within the body: for example, a group of cells, a group of cells and interstitium, an organ, a part of an organ, an anatomical part of the body such as the rectum, ovary, prostate, nerve, cartilage, bone, brain, or parts thereof. Furthermore, the term “target” may be used herein to refer to the area in the patient’s body to which surgery will be performed. However, it should be understood that this reference is broadly understood and is not intended to be limited to tissues or specific procedures. Finally, you can refer to target tissue, target location, target part, target tissue part, anatomical part, delivery site, deployment site, injection site, treatment site, etc., including their combinations and other grammatical forms, which are interchangeable and unintentionally restrictive.

[0045] Certain specific aspects of this disclosure relate to the preparation of injectable materials for placement between target tissue and other tissues. For convenience and without limitation, reference is made to an injectable material, such as a filler, including but not limited to gel compositions. The injectable material can be delivered within a patient to displace tissue relative to tissue to be treated by a treatment procedure or other means (e.g., not necessarily therapeutic). The injectable material can exchange and / or shield tissue to protect tissue from potential side effects of treatment of the target tissue, such as those involving radiation or cryotherapy. In some aspects, the injectable material can displace anatomical tissue and / or increase the distance between the target tissue and other tissues. For example, if the target tissue is to be irradiated, the injectable material can separate other tissues from the target tissue, exposing the other tissues to less radiation and / or shielding them from radiation. In some aspects, the injectable material can be injected as a filler into the space between tissues. The first tissue can then be treated by radiation, while the injectable material reduces the pathway of radiation through the second tissue. The first tissue can be irradiated, while the second tissue separated by the injectable material receives less radiation than it would without the injectable material. An effective amount of injectable material can be injected into the space between the primary tissue to be treated and a secondary tissue that may be an extremely sensitive organ. For example, in the treatment of prostate cancer, injectable material can be injected into the Denonvilliers space (the area between the rectum and the prostate) to create additional space between the rectum and the prostate and / or to shield the rectum during treatment, thereby reducing rectal radiation dose and associated side effects.

[0046] In some aspects of this disclosure, the components of the injectable material are combined in a system formed according to various principles of this disclosure for injection into or near a target site. It should be understood that, unless otherwise stated, terms such as combination, mixing, and blending (including their other grammatical forms) are used interchangeably herein without limitation. Therefore, this document generally refers to combined systems without specifically requiring active combination / mixing.

[0047] Based on the various principles of this disclosure, injectable materials can be fillers, such as hydrophilic polymers, gels, hydrogels, etc. For example, injectable materials may include polymeric materials capable of forming hydrogels upon crosslinking. Optionally, the polymer forms a hydrogel in vivo. A hydrogel is a substance formed when a polymer (natural or synthetic) is crosslinked by covalent, ionic, or hydrogen bonds to form a three-dimensional structure that encapsulates water molecules to form a gel. Natural and synthetic hydrogel-forming polymers, polymer mixtures, and copolymers can be used as hydrogel precursors. In some aspects, the hydrogel may be formed from a composition of two or more components (e.g., a mixture of an accelerator fluid, a diluent, and polyethylene glycol (PEG)) and may include one or more polysaccharide compounds or salts thereof. For example, the composition may include cellulose compounds such as carboxymethyl cellulose (CMC) or salts thereof (e.g., sodium CMC), xanthan gum, alginate or salts thereof, such as calcium alginate beads, chitosan, and / or hyaluronic acid. In some instances, the composition may comprise a mixture of hyaluronic acid and CMC, and / or may be cross-linked with a suitable cross-linking compound, such as butylene glycol diglycidyl ether (BDDE). In some aspects, the polysaccharide may be a homopolysaccharide or a heteropolysaccharide.

[0048] In some aspects of this disclosure, two or more components of an injectable material are provided separately and combined by means of devices, systems, and methods according to various principles of this disclosure to form a composite material, which will be injected into or near a target site by means of devices, systems, and methods according to various principles of this disclosure. The injectable material can be delivered within a patient to cause tissue displacement relative to tissue to be treated by a treatment procedure or other means (e.g., not necessarily therapeutic). The composition to be injected into a patient can be a combination of two or more components combined by means of devices, systems, or methods according to various principles of this disclosure. For example, the means, systems, or methods of this disclosure can be used to combine a first component and a second component for injection into a patient. The first component can be a precursor, for example, a first component combined with a second component to form an injectable compound. The second component can be a promoter, activator, crosslinking inducer, catalyst, initiator, etc., which, when combined with a precursor, produces an injectable compound, for example, by altering the chemical composition or structure of the first component. These components can be combined before (e.g., before or during) delivery to the patient (e.g., during injection), so that the injectable material does not have time to form a structure that may be difficult to inject or otherwise deliver to the patient. Therefore, the combination of the first and second components allows the injectable compound to achieve its final desired properties / final form in situ.

[0049] In some embodiments, the injectable material is formed from a first component, a second component, and a third component. For example, for various reasons, it may be necessary to provide the first precursor component in solid form (e.g., to allow mixing during delivery and / or more stable storage and / or transport). The first component may be combined with the third component, and the resulting combined composition (which may be referred to as the precursor) may be combined with the second component once a healthcare professional is ready to deliver (e.g., inject) the injectable material to a patient. The second component may facilitate crosslinking interactions between the first and third components, for example, by initiating or accelerating the crosslinking interactions between the first and third components. Typically, one or more components of the injectable material are biocompatible polymers. In some aspects, one of the first or third components is a reactive polymer, such as a crosslinkable and / or hydrophilic polymer component (e.g., PEG), while the other is a diluent (e.g., primarily water), in which a solid or semi-solid form of one of the first and third components is dissolved or dispersed, and / or crosslinked (or at least crosslinkable, e.g., upon further binding with the second component) with one of the first components to form the precursor. The second component, which may be an accelerator, promoter, activator, catalyst, initiator, etc. (these terms are used interchangeably herein and are not intended to be limiting), can combine with and react with the precursor (formed from the first and third components) to form the desired injectable material. In one embodiment, under acidic pH conditions, the first component (specifically, trilysine containing multiple nucleophilic groups, specifically amino groups) in the form of a crosslinking agent is mixed with the third component (particularly PEG) in the form of a reactive polymer derivatized with reactive, optionally electrophilic groups (specifically, succinimide ester groups), wherein the succinimide ester groups and amino groups do not react significantly. When this mixture is mixed with the second component in the form of an accelerator (particularly an alkaline buffer solution), the resulting mixture becomes alkaline, at which point the amino group of the trilysine reacts with the succinimide ester group of the PEG to form a covalent bond, thereby crosslinking the PEG and forming a hydrogel.

[0050] It should be understood that references to “first,” “second,” or “third” do not imply a specific property of the material or an order of material combination. Therefore, according to the various principles of this disclosure, “first,” “second,” and “third” can be used to refer to any one of the three components forming the injectable material. A non-limiting example of such components that can be combined by means, systems, or methods according to the various principles of this disclosure includes: a first component (e.g., a reactive component, solute, etc.); a second component (e.g., a diluent that will combine with the reactive component to form a precursor); and a third component (e.g., an accelerator that can combine with the precursor to form the injectable material). The injectable material is a biocompatible material, such as a polymeric material, such as a filler, or such as a hydrogel.

[0051] In some instances, the composition may be or include a gel having the desired gel strength and / or viscosity, such as a biocompatible gel suitable for injection (e.g., via a needle), as discussed in further detail below. In one embodiment, one component is a biocompatible polymer component. More specifically, in one example of an embodiment, one component is a hydrophilic polymer, which may be natural or synthetic and may be anionic, cationic, zwitterionic, or neutrally charged. Non-limiting examples of hydrophilic polymers include natural hydrophilic polymers, including proteins such as collagen and polysaccharides such as gellan gum, xanthan gum, gum arabic, guar gum, locust bean gum, alginate, and carrageenan, as well as synthetic hydrophilic polymers such as polyethylene glycol (PEG), PEG methacrylate, PEG methyl methacrylate, polyvinyl alcohol, polyacrylates and polymethacrylates, polyacrylic acid and its salts, polymethacrylate and its salts, polymethyl methacrylate, carboxymethyl cellulose, hydroxyethyl cellulose, polyvinylpyrrolidone, and polyacrylamides such as N,N-methylenebisacrylamide or tris(hydroxymethyl)methylacrylamide. Hydrophilic polymers can be modified to provide functional groups that react with the functional groups of a suitable crosslinking agent, which can be a covalent or ionic crosslinking agent.

[0052] The concentration of the gelling agent in the composition formed according to various principles of this disclosure may be at least about 0.01% by weight relative to the total weight of the composition, and may be at most about 2.0% by weight relative to the total weight of the composition, including an increment of about 0.01% therebetween. For example, the concentration range of the gelling agent relative to the total weight of the composition may be about 0.02% to about 1.5%, about 0.05% to about 1.0%, about 0.05% to about 0.50%, 0.05% to about 0.15%, about 0.10% to about 0.20%, about 0.15% to about 0.25%, about 0.20% to about 0.30%, about 0.25% to about 0.35%, about 0.30% to about 0.40%, about 0.35% to about 0.45%, about 0.40% to about 0.5%, or about 0.1% to about 0.15% by weight. In at least one example, the total concentration of the gelling agent in the composition may be in the range of about 0.05% by weight to about 0.5% by weight relative to the total weight of the composition.

[0053] In some instances, compositions formed according to various principles of this disclosure are in 130s -1 The viscosity at the shear rate can be at least about 0.001 Pa·s and at most about 0.100 Pa·s. For example, at 130 s -1At the specified shear rate, the viscosity range of the composition can be from about 0.005 Pa·s to about 0.050 Pa·s, from about 0.010 Pa·s to 0.050 Pa·s, from about 0.01 Pa·s to 0.030 Pa·s, and from about 0.020 Pa·s. -1 From about 0.030 MPa·s or from about 0.020 Pa·s to about 0.040 Pa·s. Therefore, for example, the composition may be or comprise a gel with viscosities of about 0.005 Pa·s, about 0.006 Pa·s, 0.008 Pa·s, and about 0.010 Pa·s, and about 0.011 Pa·s. At 130 s -1 At shear rates of approximately 0.032 Pa·s, approximately 0.034 Pa·s, approximately 0.036 Pa·s, and approximately 0.038 Pa·s. In at least one example, the composition was effective at 130 s. -1 The viscosity at the shear rate can be greater than 0.0050 Pa·s, for example, at 130 s. -1 At the shear rate, the viscosity ranges from about 0.005 Pa·s to about 0.050 Pa·s. In at least one example, the composition exhibits a viscosity range of about 130 s. -1 The viscosity at the shear rate can be greater than 0.010 Pa·s, for example, at 130 s. -1 At the shear rate, the viscosity ranges from about 0.010 Pa·s to about 0.030 Pa·s.

[0054] Alternatively or additionally, compositions formed according to various principles of this disclosure may be in 768s -1 The viscosity at the shear rate can be at least about 0.001 Pa·s and at most about 0.050 Pa·s. For example, at 768 s... -1 At a shear rate of approximately 768 s, the viscosity of the composition can range from about 0.002 Pa·s to about 0.030 Pa·s, about 0.003 Pa·s to about 0.020 Pa·s, about 0.004 Pa·s to about 0.010 Pa·s, about 0.006 Pa·s to about 0.007 Pa·s, about 0.006 Pa·s to about 0.008 Pa·s, about 0.007 Pa·s to about 0.009 Pa·s, or about 0.008 Pa·s to about 0.01 Pa·s. Therefore, for example, the composition can be or contain a gel that, at a shear rate of approximately 768 s... -1 The viscosities at the shear rates were approximately 0.003 Pa·s, approximately 0.004 Pa·s, and approximately 0.005 Pa·s. In at least one example, the composition exhibited a viscosity of approximately 0.003 Pa·s, approximately 0.004 Pa·s, and approximately 0.005 Pa·s at 768 s. -1 The viscosity at the shear rate can be less than 0.010 Pa·s, for example, at 768 s. -1At the shear rate, the viscosity ranges from about 0.005 Pa·s to about 0.009 Pa·s. In at least one example, the composition exhibits a viscosity of about 768 s. -1 The viscosity range at the shear rate can be from about 0.004 Pa·s to about 0.010 Pa·s. Furthermore, for example, the composition exhibits a viscosity range of about 130 s. -1 The viscosity range at the shear rate can be from about 0.010 Pa·s to about 0.030 Pa·s, for example about 0.017 Pa·s, at 768 s. -1 The viscosity at the shear rate can be from about 0.004 Pa·s to about 0.010 MPa·s, for example, about 0.007 Pa·s.

[0055] The various components forming an injectable material can remain separate until the process of using the final composition for various reasons, such as maintaining the stability of the individual components. In some embodiments, a multi-chamber system includes separate chambers for combining components to form an injectable material delivered to a patient by an injection system. In some embodiments, a first component and a second component are respectively separately contained in the first and second chambers of a multi-chamber device. A third component may be contained in a separate device defining the third chamber of the multi-chamber system. To deliver the injectable material, the components of the first and third chambers are combined in the first chamber (e.g., to form a precursor), and then the components of the first and second chambers are injected together into the patient. The multi-chamber device may or may not mix the contents of the first chamber with the contents of the second chamber. Once the combined components are in the patient's body, the final form, structure, composition, properties, etc., of the injectable material are obtained.

[0056] This disclosure provides apparatus, systems, and methods for combining components to form an injectable material (or at least a precursor to an injectable material), as well as corresponding medical devices, systems, and methods of use for delivering said material to a treatment site in a patient. According to some aspects of this disclosure, as described above, a multi-chamber system may include multiple chambers for one or more components of the injectable material and combinations thereof. It should be understood that terms such as chamber, reservoir, container, vial, lumen, etc., are used interchangeably herein and are not intended to be limiting, referring to elements that contain, deliver, hold, transport, collect, etc., components (fluids, particles, liquids, solids, gases, etc.). Suitable chambers may include, for example, vials, syringes (e.g., syringe barrels compatible with manual or automated injection systems), and other fluid containers, such as those configured for use with a suitable injection system. Examples of materials suitable for the chambers of the apparatus or system of this disclosure include, but are not limited to, cyclic olefin polymers, polypropylene, polycarbonate, polyvinyl chloride, and glass. In some respects, one of these materials (e.g., specifically cyclic olefin copolymers) can be coated (such as a SiO2 coating), which is advantageous because the coating can provide a primary oxygen barrier, exhibiting a glassy layer, and / or can be applied using a vapor deposition process.

[0057] Combined devices or systems formed according to various principles of this disclosure, for combining two or more components to form an injectable material, can be detachably connected to one or more sub-injection systems configured to deliver the injectable material to a patient. According to some aspects of this disclosure, filler compositions that can be used with the various systems disclosed herein, such as compositions prepared by the different devices, systems, and methods disclosed herein, can have sufficient strength, such as gel strength, to withstand forces on the continuity of the composition's three-dimensional configuration (e.g., a gel network), thereby minimizing the effects of these forces. Simultaneously, compositions having sufficient strength to withstand the forces thereon can have a viscosity suitable for injection, for example, a viscosity that will not cause the composition to become stuck in a reservoir, delivery lumen, needle, or other structure contained in or through which the composition passes. According to some aspects of this disclosure, the composition can retain its three-dimensional structure until it is injected into a patient (e.g., through a needle), whereby the structure can then form fragments of the original continuous three-dimensional network. The diameter of these fragments may correspond to the diameter of the lumen into the patient (e.g., the lumen of the injection needle), such that the fragments are as large as possible within the body to retain as much of the composition's three-dimensional structure as possible. Injecting these larger particles or fragments is thought to increase the time the gel remains in the tissue.

[0058] In some examples, the injection system includes a needle. In some embodiments, the needle may be a hypodermic needle with a size ranging from 7 (outer diameter (OD) 4.57 mm, inner diameter (ID) 3.81 mm) to 33 (outer diameter 0.18 mm, inner diameter 0.08 mm), such as 16 (outer diameter 1.65 mm, inner diameter 1.19 mm), 18, 21 (outer diameter 0.82 mm, inner diameter 0.51 mm), 22 (outer diameter 0.72 mm, inner diameter 0.41 mm), 23 (outer diameter 0.64 mm, inner diameter 0.33 mm), or 24 (outer diameter 0.57 mm, inner diameter 0.31 mm). According to some aspects of this disclosure, the needle size may be selected based on the viscosity and / or components of the composition, and vice versa. According to some aspects of this disclosure, the needle size may be 23 or 25. In some cases, larger sizes such as 18, 20, 21, or 22 may be used to inject the compositions disclosed herein. Examples of materials that can be used to form the needle include, but are not limited to, metals and metal alloys such as stainless steel and nitinol, as well as polymers. The distal end of the needle may be pointed and may have a beveled shape. The proximal end of the needle may include a suitable fitting / adapter (e.g., a Luer adapter) for engagement with a syringe or other reservoir. In some examples, the needle may include an elongated tube or conduit between the needle tip and the proximal end fitting / adapter.

[0059] As described above, compositions used with the systems disclosed herein may have large particulate matter (relative to the lumen of the injection system) and / or high viscosity for use through a lumen sized to allow the material to be injected into a patient. The force required to pass the composition through the needle orifice (often referred to as the “peak load” force) may depend on the viscosity of the composition, the size of the needle (inner diameter, outer diameter, and / or length), and / or the material forming the needle. For example, a greater force may be applied to inject the composition through a 33-gauge needle compared to a 7-gauge needle. Other factors that may affect the force applied to inject the composition may include the size (inner diameter, outer diameter, and / or length) of the conduit that connects the mixing system to the needle. Suitable peak loads for injection with one or both hands can range from about 5 lb·f to about 25 lb·f, for example, from about 10 lb·f to about 20 lb·f, for example, about 15 lb·f. The load measured for a given gel concentration may vary depending on the needle and flow rate.

[0060] According to some aspects of this disclosure, a combination device or system may be included in a kit for introducing injectable materials into a patient, wherein the injectable materials may include any of a variety of suitable compositions. The kit or system may be configured to store one or more components of the composition until a healthcare professional is ready to mix the composition for delivery to a patient. For example, compositions, such as hydrogels, may be prepared to store precursors and any associated activators along with any diluents that may be required in the kit. An applicator may be used in conjunction with this. Kits formed according to various principles of this disclosure may be manufactured under medically acceptable conditions and contain components having sterility, purity, and pharmaceutically acceptable formulation. Solvents / solutions may be provided in the kit or separately. The kit may include one or more syringes and / or needles for mixing and / or delivering the injectable material, and / or other aspects of the procedure for using the injectable material. The kit or system may include the various components described herein. For example, one or more components of the kit may be used to pretreat the target site to which the injectable material is to be delivered. An example of pretreating includes water separation, such as with saline, to create space for injection of the injectable material at or near the target tissue site. Once the saline solution is injected into the treatment site, the assembly or system can be connected to a needle (e.g., an 18-gauge spinal needle), and then the injectable material can be delivered to the treatment site. For example, in the treatment of prostate cancer, a 5-10 mm layer of filler (e.g., a gel composition) can be injected along the posterior wall of the prostate between the prostate and the rectum. Once the filler is injected into the space between the rectum and the prostate, an ultrasound image can be obtained.

[0061] According to various principles of this disclosure, the combination and / or delivery system is configured to facilitate the combination of components of an injectable material. In some aspects, the injectable material is a combination of a first component, a second component, and a third component, as described above. According to various principles of this disclosure, the combination and / or delivery system includes an adapter configured to facilitate the combination of material in a first injectable material transfer device with a second injectable material delivery device. The first injectable material transfer device defines a chamber containing an injectable material component, and the second injectable material delivery device defines another chamber containing a separate component of the injectable material. The adapter is configured to fluidly connect the first injectable material transfer device and the second injectable material delivery device to combine their components. These components may be combined in one or both chambers of the first and second injectable material transfer devices. In some embodiments, the components are combined to form a precursor, and the combination and / or delivery system further includes another chamber containing an accelerator, catalyst, activator, crosslinking inducing agent, catalyst, initiator, etc. (these terms are used interchangeably herein and are not intended to limit their meaning; for convenience, they are generally referred to collectively as accelerators, and their scope is not intended to be limited). In some embodiments, the first injectable material transfer device has a cylinder and a plunger assembly defining a chamber therein, the plunger assembly being configured to move toward / into the cylinder cavity to eject material from the cylinder cavity and / or retract from the cylinder cavity to draw material into the cylinder cavity. In some embodiments, another injectable material transfer device is a vial, and the adapter is a vial adapter configured to facilitate fluid coupling between the vial and the first injectable material transfer device.

[0062] According to various principles of the present invention, multi-chamber assembly and / or transport systems formed according to various principles of the present invention have a fluid exchange system that provides various paths, channels, cavities, passages, reservoirs, etc., for fluid communication, exchange, transfer, etc., between various elements, chambers, components, parts, devices, systems, etc. of the multi-chamber assembly or transport system. It should be understood that, unless explicitly stated otherwise, references to communication, exchange, transfer, etc., herein are interchangeable and not intended to be limiting. Furthermore, unless otherwise stated, terms such as pathway, channel, cavity, passage, channel, reservoir, etc., are used interchangeably herein and are not intended to be limiting. Finally, it should be understood that, unless explicitly stated otherwise, references to elements, chambers, assemblies, parts, devices, systems, etc., herein are not intended to be limiting.

[0063] In some aspects, the combined and / or delivery system formed according to various principles of this disclosure includes a vial adapter that defines a portion of the fluid exchange system of the multi-chamber combined and / or delivery system. In some aspects, the vial adapter is configured to fluidly connect at least partially a chamber defined in a first injectable material transfer device to a separate chamber defined in a second injectable material delivery device. According to various principles of this disclosure, the vial adapter portion of the fluid exchange system includes a fluid exchange lumen and a vent lumen. The chamber defined in the first injectable material transfer device can be fluidly connected to a separate chamber defined in the second injectable material delivery device, allowing material to pass between them via the fluid exchange lumen (e.g., transfer, exchange, etc. between chambers). When material is withdrawn from the second injectable material transfer device back to the first injectable material delivery device, the vent lumen allows the second injectable material transfer device to be vented, thereby preventing the creation of a vacuum pressure within the second injectable material transfer device.

[0064] In some embodiments, the fluid exchange system includes a puncture element, such as a needle and a fluid exchange puncture device. The bottle cap includes a stop configured to retain material within a cavity defined by the vial. The stop may have a wall with a thinner portion to facilitate puncture by the puncture element. According to various principles of this disclosure, the puncture element is configured to puncture the stop to facilitate the passage of the fluid exchange puncture device (typically wider than the puncture element) through the stop. The puncture element may define a venting lumen of the fluid exchange system (as described above), and the fluid exchange puncture device may define a fluid exchange lumen of the fluid exchange system (as described above).

[0065] In some embodiments, the fluid exchange lumen and vent lumen of the venting system are defined in spaced-out structures. For example, in some embodiments, a bottle cap defines first and second nozzle ports, respectively defining the fluid exchange lumen and vent lumen of the fluid exchange system. The bottle cap nozzle ports can be fluidly coupled to the fluid exchange nozzles of a bottle adapter, which in turn fluidly couples the bottle to another injectable material transfer device.

[0066] In some aspects, the first injectable material transfer device has at least one nozzle that can be fluidly connected (typically relative to its placement) to a nozzle port defined by a vial adapter. In some aspects, at least the nozzle port (if not a nozzle) can be considered a component of a fluid exchange system. The nozzle and nozzle port facilitate fluid communication between the chamber defined in the first injectable material transfer device and the vial via the vial adapter, thereby facilitating material exchange via the vial adapter.

[0067] According to various principles of this disclosure, a vial adapter is configured to be fluidly coupled to the first and second chambers of a multi-chamber device. In some aspects, the vial adapter is configured to fluidly couple the first chamber of the multi-chamber device to a separate chamber defined in a separate injectable material transfer device, as described above. Alternatively or additionally, the vial adapter includes a purification system comprising a purification channel and a purification reservoir in fluid communication with the second chamber of the multi-chamber device. The purification system can be considered as part of a fluid exchange system of the vial adapter, such as the fluid exchange system described above. Excess / residual material (e.g., components of injectable material combined by a combination and / or delivery system) can be removed from the second chamber of the multi-chamber device into the purification reservoir. The amount of excess / residual material to be removed can be a defined / predetermined amount. For example, material can be removed from the second chamber based on the amount of material required to bind with the material in the first chamber. Alternatively or additionally, the purification system can allow purification of air / bubbles from the second chamber to eliminate air in the sealed chamber, thereby preventing air injection into the patient. In some embodiments, material is removed from the second chamber of the multi-chamber device when it is transferred from the first chamber to a third chamber, such as the third chamber defined by a separate injectable material transfer device, via a vial adapter. In some embodiments, the fluid exchange system includes a one-way valve seal configured to regulate / limit the fluid flow through the second nozzle port of the vial adapter and / or the second nozzle of the multi-chamber device. In some embodiments, the one-way valve seal is located within the vial adapter.

[0068] Various embodiments of combined and / or delivery apparatuses, systems, and methods will now be described with reference to the examples shown in the accompanying drawings. The references to “one embodiment,” “an embodiment,” “several embodiments,” “other embodiments,” etc., throughout this specification indicate that the embodiment may include one or more specific features, structures, concepts, and / or characteristics consistent with the principles of this disclosure. However, these references do not necessarily imply that all embodiments include the specific features, structures, concepts, and / or characteristics, nor do they necessarily imply that one embodiment includes all features, structures, and / or concepts. Some embodiments may include one or more such features, structures, concepts, and / or characteristics, as well as various combinations thereof. It should be understood that one or more features, structures, concepts, and / or characteristics described with reference to one embodiment may be combined with one or more features and / or structures, concepts, and / or characteristics of any other embodiment provided herein. That is, any features, structures, concepts, and / or characteristics described herein can be mixed and matched to create hybrid embodiments, and such hybrid embodiments are within the scope of this disclosure. Furthermore, the repeated use of terms such as “one embodiment,” “an embodiment,” “several embodiments,” “other embodiments,” etc., in the specification does not necessarily refer to the same embodiment; independent or alternative embodiments are not necessarily mutually exclusive. It should also be understood that the various features, structures, concepts, and / or characteristics of the disclosed embodiments are independent and separate from each other, and may be used or present individually, or in various combinations, to create alternative embodiments that are considered part of this disclosure. Therefore, this disclosure is not limited to the embodiments specifically described herein, as describing all possible combinations and sub-combinations of features, structures, concepts, and / or characteristics would be overly cumbersome, and the examples of embodiments disclosed herein are not intended to limit the broader aspects of this disclosure. It should be understood that the various dimensions provided herein are examples, and those skilled in the art can readily determine the appropriate range of standard deviations and acceptable variations covered by this disclosure and its related claims. The following description is merely illustrative examples of embodiments and is not intended to limit the broader aspects of this disclosure.

[0069] It should be understood that common features in the accompanying drawings are identified by common reference numerals, and for the sake of brevity and convenience, and without any intention of limitation, descriptions of common features are generally not repeated. For clarity, not all components with the same reference numeral are numbered. Furthermore, a group of similar elements can be represented by both numbers and letters, and often one or more elements or a group of elements can be referred to by numbers only (excluding the letters associated with each similar element). Finally, certain features in one embodiment may be used in different embodiments and are not necessarily labeled separately when appearing in different embodiments.

[0070] Now turn to the attached image. Figure 1Examples of embodiments of a combination and / or delivery system 100 formed according to various principles of this disclosure are shown. The combination and / or delivery system 100 can be used to transport components of an injectable material to a facility / location for delivering (e.g., by injection) an injectable substance into a patient. However, this disclosure is not intended to be limited to delivery by injection, or even to specifically injectable materials. The material combined and / or delivered by the combination and / or delivery system 100 of this disclosure can be any other type of material administered to a patient, such as materials other than those for injection. Therefore, it should be understood that the reference herein to combining and / or delivering injectable materials to a patient by injection is for convenience only and is not intended to be limiting. As mentioned above, an injectable material may include two or more components that remain separate prior to surgery. Once a medical professional is ready to inject the injectable material into a patient, the components of the injectable material are combined by the combination and / or delivery system 100 to form (e.g., through mutual reaction) a composite material having desired properties for delivery and / or deposition to the target site by the combination and / or delivery system 100.

[0071] The various components of the combined and / or conveying system 100 can be referenced. Figure 1 and Figure 2 The exploded view shown is for illustrative purposes. The combination and / or delivery system 100 can be considered as a multi-chamber combination and / or delivery system 100. An example embodiment of the multi-chamber combination and / or delivery system 100 shown includes a first injectable material transfer device 110 that defines at least one chamber for containing components of an injectable material to be delivered to a patient. Figure 1 and Figure 2 In the example of the illustrated embodiment, the first injectable material transfer device 110 has a barrel 120 and a plunger assembly 130. The barrel 120 defines a first chamber 102a and a second chamber 102b. The plunger assembly 130 includes a first plunger rod 130a slidable within the first barrel chamber 102a and a second plunger rod 130b slidable within the second barrel chamber 102b. The plunger assembly 130 extends proximally from the barrel 120 (towards the proximal end 111 of the first injectable material transfer device 110) and is movable relative to the barrel 120, for example, axially / longitudinally sliding (e.g., along the longitudinal axis LA), to remove (e.g., expel) and / or remove (e.g., inhale) material into the chambers within the barrel 120 as the respective plunger rods 130a, 130b move within the barrel 120.

[0072] Figure 1 and Figure 2 Examples of embodiments of the multi-chamber combination and / or delivery system 100 shown also include a separate chamber 102c. The separate chamber 102c is defined in a separate device 140, which is formed and provided separately from the first injectable material transfer device 110, as... Figure 1 and Figure 2 As shown. For convenience and without limitation, the individual device is referred to herein as vial 140, and the separate chamber 102c is referred to herein as third chamber 102c defined by vial body 142 (it may also be referred to herein as vial chamber 102c). According to various principles of the invention, the third chamber 102c of vial 140 will be fluidly connected to one of the chambers 102a, 102b of the first injectable material transfer device 110 to combine its contents, such as Figure 3 As shown.

[0073] In the illustrated embodiment, a first chamber 102a of the first injectable material delivery device 110 is configured to contain a first component 104a, a second chamber 102b of the first injectable material delivery device 110 is configured to contain a second component 104b, and a third chamber 102c of the first injectable material delivery device 110 is configured to contain a third component 104c. The first component 104a, the second component 104b, and the third component 104c will be combined to form an injectable material to be delivered to a patient. In some aspects, the first chamber 102a, the second chamber 102a, and the third chamber 102c are defined to be separate from each other and fluidly isolated. For example, when combined, the first component 104a can react with the second component 104b. In some embodiments, the first component 104a and the third component 104c are combined within the first chamber 102a and / or the third chamber 102c, as described in further detail below, to form a precursor 104d contained within the first chamber 102a. When the second component 104b binds to the precursor 104d, it may react (e.g., to accelerate the reaction between the first component 104a and the third component 104c). Therefore, it may be desirable to separate the second component 104b from the precursor 104d until ready for delivery to a patient. The fluid isolation of the chambers 102a, 102b of the first injectable material transfer device 110 prevents unintentional and / or premature binding of the contents of the first chamber 102a (the first component 104a, or the precursor 104d formed by combining the first component 104a and the third component 104c) to the contents of the second chamber 102b (the second component 104b). The components within the chambers 102a, 102b are combined and allowed to react with each other when (e.g., only when) a medical professional is ready to administer the injectable material (e.g., as a combined injectable material). Various devices, systems, and methods of this disclosure facilitate the easy and accurate combination of these components at the appropriate time, as described in further detail below.

[0074] According to various principles of this disclosure, the combined and / or delivery system 100 also includes a vial adapter 150 configured to facilitate fluid communication between the first chamber 102a and the third chamber 102c of the combined and / or delivery system 100. Figure 1 An example of an embodiment of the vial adapter 150 shown has a proximal end 151 defining a first nozzle orifice 152a and a second nozzle orifice 152b, the proximal end 151 being configured for fluid connection with a first injectable material transfer device 110, for example as... Figure 4 As shown, it illustrates the following: Figure 1 The IV-IV cross-section of the vial adapter wall 154 defines a fourth chamber 102d of the combined and / or delivery system 100, which opens to the distal end 153 of the vial adapter 150. The fourth chamber 102d is configured to facilitate the coupling of the first injectable material transfer device 110 with an additional injectable material delivery device. For example, the fourth chamber 102d may be configured as a vial receiving chamber configured to receive and hold vials 140 relative to the first injectable material delivery device 110, for example... Figure 3 The illustrated vial adapter 150 can also be configured to facilitate the holding and / or connection and / or alignment of the vial 140 relative to the first injectable material transfer device 110 to establish fluid communication between the first chamber 102a and the third chamber 102c, thereby exchanging material between them. For example, the vial adapter 150 can facilitate alignment and / or fluid sealing between the first injectable material transfer device 110, the vial adapter 150, and the vial 140, allowing material to be transferred between the vial 140 (when positioned within the vial adapter 150) and the first injectable material transfer device 110 without leakage and / or without significant manipulation of the components of the coupling and / or delivery system 100, for example, in a manner described in further detail below. More specifically, the vial adapter 250 facilitates fluid connection of the first chamber 202a of the multi-chamber device 210 formed according to various principles of the present disclosure with the individual chamber 202c and the combination of components 204a, 204c contained within the chambers 202a, 202c.

[0075] exist Figure 1 and Figure 2 In the example of the embodiment of the combined and / or delivery system 100 shown, the sleeve lock 160 facilitates a secure connection between the vial adapter 150 and the first injectable substance transfer device 110. For example, Figure 1 and Figure 2An example embodiment of the sleeve lock 160 shown is configured to stabilize the first injectable material transfer device 110 and the vial adapter 150 relative to each other, thereby maintaining fluid coupling between them without leakage. For example, the sleeve lock 160 may be generally cylindrical, such as in the shape of a ring or collar, and may alternatively be referred to as a lock ring, lock collar, adapter ring, adapter collar, etc., without intention to limit it. The length of the sleeve lock 160 along the longitudinal axis LA of the first injectable material transfer device 110 can be selected to maintain lateral movement (transverse to the longitudinal axis LA) of the vial adapter 150 relative to the first injectable material transfer device 110 when connected to the first injectable material transfer device 110. Figures 1 to 6 Further details of the sleeve lock 160 shown can be understood by referring to the co-pending provisional patent application _________, entitled “DEVICES, SYSTEMS, AND METHODS FOR COMBINING AND / OR DELIVERINGINJECTABLE MATERIALS”, filed on the date of this application [Attorney Document 2001.3126100], the entire contents and all purposes of which are incorporated herein by reference.

[0076] like Figure 1 As shown, the vial 140 is positioned within the fourth chamber 102d (e.g., Figure 3 (As shown) Before this, the protective cap 170 can be positioned within the fourth chamber 102d of the vial adapter 150. The protective cap 170 can be configured to protect or shield components of the fluid exchange device 180 disposed along the distal end 153 of the vial adapter 150. The protective cap 170 extends within the fourth chamber 102d defined by the vial adapter 150 toward the proximal end 181 of the fluid exchange device 180, as shown in the reference. Figure 4 Middle Figure 1 As can be understood from the cross-sectional view taken along line IV-IV, although the protective cap 170 may not necessarily completely cover the proximal end 181 of the fluid exchange device 180, the protective cap 170 may optionally include a shield portion 170s configured to extend at least around the distal end 183 of the fluid exchange device 180, which can also be seen in the reference to Figure 4 Understood. Alternatively, the protective cap 170 may protect the vial adapter 150 from unwanted substances or debris entering the fourth chamber 102d.

[0077] To prepare the first injectable material transfer device 110 for combining the first component 104a contained in the first chamber 102a with the third component 104c contained in the third chamber 102c (e.g., defined within the vial 140), the protective cap 170 is separated from the vial adapter 150 (e.g., removed from the fourth chamber 102d). Then, as... Figure 3 As shown, the vial 140 can be placed within the fourth chamber 102d (defined by the vial adapter 150). The first chamber 102a (defining the first injectable material transfer device 110) and the third chamber 102c (defined within the vial 140) can thus be fluidly connected via the vial adapter 150, as described in further detail below. Optionally, the protective cap 170 includes a gripping portion 172, such as a radially outwardly projecting flange and / or an axially extending protrusion / wing, configured to facilitate gripping and / or pulling the protective cap 170 to remove it from the vial receiving fourth chamber 102d of the multi-chamber assembly and / or delivery system 100 defined in the vial adapter 150.

[0078] Based on the various principles of this disclosure, such as Figure 1-6 The illustrated vial adapter 150 provides various fluid exchange paths, channels, cavities, channels, reservoirs, etc., facilitating fluid communication and / or fluid exchange between the first chamber 102a and at least the third chamber 102c (e.g., located within a fourth chamber 102d defined by the vial adapter 150) of a multi-chamber combination and / or delivery system 100 formed according to various principles of this disclosure. For example, as referenced... Figure 5 (showing along) Figure 3 (Cross-section diagram of the VV line) and Figure 7 As can be understood from the perspective view, the vial adapter 150 defines various cavities for fluid communication between the illustrated first chamber 102a and third chamber 102c, in order to allow further fluid exchange between them, as described in more detail below. Alternatively or alternatively, as referenced... Figure 6 (showing along) Figure 3 (Cross-section diagram of line VI-VI) and Figure 7 As understood from the perspective view, the vial adapter 150 defines a vent lumen for the third chamber 102c to reduce and / or eliminate potential vacuum pressure when material is removed from the third chamber 102d, as described in further detail below. Alternatively or alternatively, as referenced... Figure 5 (showing along) Figure 3 (Cross-section diagram of the VV line) and Figure 7As can be understood from the perspective view, the vial adapter 150 provides optional purification of the second chamber 102b, as described in further detail below. It should be noted that in the illustrated embodiment, the third chamber 102c is located within the fourth chamber 102d; therefore, the first chamber 102a can also be considered to be in substantially fluid communication with the fourth chamber 102c. Furthermore, it should be understood that the illustrated vial 140 can be replaced by other additional devices separate from the first injectable material transfer device 110, which can be received by the vial adapter 150 and define another chamber therein. Such additional chamber devices can be any configuration known to those skilled in the art (e.g., but not limited to...). Figure 3 , Figure 5 and Figure 6 The vial 140 shown in the illustration does not require a full and complete understanding by one of ordinary skill in the art. Therefore, the description of fluid communication between the first chamber 102a and another chamber (e.g., the third chamber 102c) can be applied to the fourth chamber 102d and / or additional chambers located or disposed within the fourth chamber 102c.

[0079] Back Figure 5 and Figure 7 An example of one embodiment of the vial adapter 150 is configured to connect with an example of a first injectable material transfer device 110 such that chambers 102a, 102d defined within the barrel 120 of the first injectable material transfer device 110 are in fluid communication with a fourth chamber 102d defined by the vial adapter 250. It should be understood that this fluid connection also allows the vial adapter 150 to fluidly communicate chambers 102a, 102b defined within the barrel 120 of the first injectable material transfer device 110 with additional chambers fluidly connected to the vial adapter 50. For example, when the vial 140 is located within the fourth chamber 102d, as... Figure 3 and Figure 5 As shown, the vial adapter 150 facilitates fluid coupling between the first chamber 102a and the third chamber 102c defined within the vial 140.

[0080] exist Figure 4 and Figure 5 In the example of the embodiment shown in cross-section, the fluid connection between the first injectable material transfer device 110 and the vial adapter 150 is through nozzles 122a, 122b of the barrel 120 of the first injectable material transfer device 110 (e.g., ...). Figure 2This is achieved through the nozzle ports 152a and 152b of the vial adapter 150 (as shown). More specifically, an example embodiment of the vial adapter 150 shown defines a first nozzle port 152a and a second nozzle port 152b at its proximal end 151, positioned and configured to be fluidly connected to a first cylindrical nozzle 122a and a second cylindrical nozzle 122b extending distally from the distal end 123 of the cylinder 120, respectively. Specifically, the vial adapter nozzle ports 152a and 152b may be configured to receive and be in fluid communication with the cylindrical nozzles 122a and 122b, and / or the cylindrical nozzles 122a and 122b may be configured to be in place relative to them, for example, by inserting (e.g., extending therein) the vial adapter nozzle ports 152a and 152b to be fluidly connected thereto. Therefore, the chambers 102a and 102b within the cylinder 120 can be in fluid communication with the fourth chamber 102d defined by the bottle adapter 150 and / or an additional chamber (e.g., the third chamber 102c within the bottle 140) located within the fourth chamber 102d and / or the additional chamber located within the fourth chamber 102c, as defined by the cylinder nozzles 122a and 122b and the nozzle ports 152a and 152b, respectively, through the inner cavities 125a and 125b defined by the cylinder nozzles 122a and 122b, the nozzle ports 152a and 152b, respectively, via the fluid passages defined by the nozzle ports 152a and 152b, and the fluid exchange inner cavities 155a and 155b defined in the bottle adapter 150 and the fluid exchange device 180. Seals 126a and 126b (e.g., O-rings) can be respectively disposed between the cylinder nozzles 122a and 122b and the bottle adapter nozzle ports 152a and 152b to seal against leakage, for example in a manner known to those skilled in the art.

[0081] Once the vial 140 is positioned within the fourth chamber 102d defined by the vial adapter 150, as Figure 3 As shown, the fluid exchange device 180 can provide fluid communication between the first chamber 102a (defined by the cylinder 120) and the third chamber 102c (defined within the vial 140), such as... Figure 5As shown. It should be understood that the fluid exchange device 180 can be considered as part of the overall fluid exchange system of the combined and / or delivery system 100, which can be considered to include elements / components of the first injectable material transfer device 110, the vial adapter 150, and even the vial 140, which are configured and engaged to facilitate fluid communication and exchange between the various chambers in the multi-chamber combined and / or delivery system 100. According to various principles of the invention, the fluid exchange device 180 is positioned and configured relative to the multi-chamber combined and / or delivery system 100 formed according to various principles of the invention to provide fluid communication between at least the first chamber 102a (through the first vial adapter nozzle port 152a and the first cylindrical nozzle 122a) and the fourth chamber 102d (defined within the vial adapter 150). Furthermore, according to various principles of this disclosure, the fluid exchange device 180 is positioned and configured relative to the multi-chamber combination and / or delivery system 100 to provide fluid communication between at least a first chamber 102a and a third chamber 102c, the third chamber 102c being defined within a vial 140 located within a fourth chamber 102d defined by the vial adapter 150.

[0082] More specifically, as referenced Figure 5 Understandably, the fluid exchange device 180 includes a base 182 from which a fluid exchange puncture device 184 extends. The fluid exchange puncture device 184 is configured to provide fluid communication with at least a first chamber 102a and a third chamber 102c of a multi-chamber assembly and / or delivery system 100 formed according to various principles of this disclosure. The fluid exchange puncture device 184 may be integrally formed with (e.g., as a single piece) or separately from the fluid exchange device base 182. Figure 5 As shown, the fluid exchange trocar 184 has a fluid exchange lumen 185 extending therethrough, with its distal end 185d extending through the fluid exchange trocar 184 to be positioned within a chamber 102c (as defined within the illustrated vial 140), and its proximal end 185p extending through the base 182 of the fluid exchange device 180. Figure 5As further shown, the proximal end 185p of the fluid exchange lumen 185 is in fluid communication with the first chamber 102a (defined within the first injectable material transfer device 110) of the multi-chamber assembly and / or delivery system 100 via a first vial adapter exchange chamber 155a defined in the vial adapter 150, as described above. Thus, the fluid exchange lumen 185 provides fluid communication between the third chamber 102c of the multi-chamber assembly and / or delivery system 100 and the first chamber 102a of the multi-chamber assembly and / or delivery system 100. Therefore, the first component 104a within the first chamber 102a can be transferred from the first chamber 102a to the third chamber 102c, and then engages with the third component 104c within the third chamber 102d. The first component 104a and the second component 104b (which can be considered as precursor 104d) can then be transferred from the third chamber 102c to the first chamber 102a (e.g., inhaled from the first chamber 102a) for delivery to the patient.

[0083] As described above, the vial adapter 150 can provide various fluid exchange paths, channels, cavities, passages, etc., to facilitate fluid communication and / or fluid transfer between the first chamber 102a and at least the third chamber 102c of the multi-chamber combination and / or delivery system 100. More specifically, Figures 1-7 The illustrated embodiment of the vial adapter 150 has a vial adapter base 190 that defines various fluid exchange paths, channels, cavities, reservoirs, etc., as shown in reference. Figure 7 The perspective view is as can be understood. The vial adapter base 190 may be integrally formed (e.g., as a single piece) with a portion defining the vial adapter 150 of the aforementioned fourth chamber 102d, or formed separately. See reference Figure 7 It is understood that the illustrated embodiment of the vial adapter base 190 has a fluid exchange channel 192 defined along the distal side 193 of the vial adapter base 190. Figure 5 As shown, the fluid exchange device base 182 mates with the medicine bottle adapter base 190 to form a base fluid exchange cavity 195 defined by the fluid exchange device base 182 and the fluid exchange channel 192. (Refer to...) Figure 5 and Figure 7 It is understood that the base fluid exchange cavity 195 is in fluid communication with the first vial adapter exchange cavity 155a and the first vial adapter nozzle port 152a (in / defined by the vial adapter base 190 on the proximal side 191).

[0084] It should be noted that the distal side 193 of the bottle adapter base 190 may also define a purification reservoir 104p together with the sidewall 194 of the bottle adapter base 190. The purification reservoir can be considered as a fifth chamber of the multi-chamber assembly and / or delivery system 100. The bottle adapter base 190 fluidly communicates the fifth chamber (defined in the distal side 193 of the bottle adapter base 190) with the second chamber 102b via the second bottle adapter exchange chamber 155b and the second bottle adapter nozzle port 152b (defined by the proximal side 191 of the bottle adapter base 190) and the second nozzle port 152a of the second cylindrical nozzle 122b. The purification reservoir 104p for purifying the second chamber 102a will be described in more detail below with reference to the fluid communication with the second chamber 102b provided by the bottle adapter 150.

[0085] The fluid exchange device base 182 described above can be sealed relative to the vial adapter base 190 to seal the base fluid exchange lumen 195, thereby ensuring leak-free passage of material between the first chamber 102a and the third chamber 102c of the multi-chamber assembly and / or delivery system 100. It should be understood that the fluid exchange device base 182 can be integrally formed with the fluid exchange puncture device 184, thus eliminating the need for sealing the fluid exchange puncture device 84 and the fluid exchange device base 182. Furthermore, it should be understood that the base fluid exchange lumen 195 and the first vial adapter exchange chamber 155a can be sealed relative to the first cylindrical nozzle chamber 125a via a first seal 126a. In some embodiments, the fluid exchange device base 182 has a cross-sectional shape that substantially corresponds to the cross-sectional shape of the vial adapter base 190 (e.g., as shown in the image). Figure 7 (as shown in the circular shape), and the fluid exchange device base 182 can be sealed relative to the vial adapter base 190 to seal / fluid isolate the various channels within the vial adapter base 190 from each other. However, if desired, such a seal can be achieved using other sealing elements known to those skilled in the art, in addition to matching the cross-sectional shape or as an alternative.

[0086] In some embodiments, the fluid exchange device base 182 includes a proximal extension 186 configured to extend into the second vial adapter exchange chamber 155b, as referenced. Figure 2 b、 Figure 4 and Figure 5 As can be understood. Alternatively, the fluid exchange device base 182 includes an alignment rib 186r that extends radially generally along the proximal surface of the fluid exchange device base 182 and is positioned, sized, shaped, configured, and / or sized proximally into a venting passage 198 in the vial adapter base 190 (and at least partially defines a base venting lumen 199, as discussed in further detail below), as referenced. Figure 6 and Figure 7 This is understandable. The proximal extension 186 and / or alignment ribs 186r of the fluid exchange device can help maintain the position of the fluid exchange device base 182 relative to the vial adapter base 190, for example, maintaining the alignment of their various features. For example, the proximal extension 186 and at least the second vial adapter exchange cavity 155b can have a non-circular cross-section (e.g., elliptical, square, rectangular, etc.) to suppress relative rotation between them. Figure 4 , Figure 5 , Figure 6 and Figure 7 In the example of the embodiment shown, the proximal extension 186 of the fluid exchange device and / or the alignment rib 186r can keep the proximal end 185p of the fluid exchange lumen 185 of the fluid exchange device 180 (which may be offset from the longitudinal axis LA of the multi-chamber assembly and / or delivery system 100) aligned with the fluid exchange channel 192 defined in the bottle adapter base 190 to maintain fluid communication between them.

[0087] In light of the foregoing, it should be understood that the base fluid exchange lumen 195 is fluidly isolated / sealed from at least the second vial adapter exchange lumen 155b, the second vial adapter nozzle port 152b, and the second cylindrical nozzle lumen 125b to prevent the second component 104b (located within the second chamber 102b and in fluid communication with the second cylindrical nozzle lumen 125a) from combining with any of the first component 104a (located within the first chamber 102a), the third component 104c (located within the third chamber 102c), or the precursor 104d (formed by combining the first component 104a and the third component 104c). Where appropriate, the precursor 104d may combine with the second component 104b contained in the second chamber 102b, as described above. However, such combination typically occurs after components 104a / 104d and 104b have been discharged from their respective chambers 102a, 102b. For example, the combination of components 104a / 104d and 104b can occur in another device (e.g., an injection system) and / or in a patient, for example in the manner described in a co-pending provisional patent application _________ entitled “DEVICES, SYSTEMS, ANDMETHODS FOR COMBINING AND / OR DELIVERING INJECTABLE MATERIALS”, filed herewith [Attorney Document 2001.3125100], the entire contents and all purposes of which are incorporated herein by reference.

[0088] In embodiments where the second component 104b remains separate from the first component 104a and / or the precursor 104d, in addition to the sealing of the various channels within the vial adapter 150 as described above, the valve seal 156 may also be located in the second vial adapter exchange chamber 155b. The valve seal 156 is positioned, sized, shaped, configured, and / or sized to prevent unnecessary flow of material via the second vial adapter nozzle port 152b and the second barrel nozzle inner cavity 125b relative to the second chamber 102b (within the first injectable material transfer device 110). Therefore, the valve seal 156 can ensure proper mixing of components within the multi-chamber combination and / or delivery system 100, and / or minimize (if not eliminate) mixing errors. Other aspects of the valve seal 156 are described in more detail below.

[0089] According to various principles of the invention, the fluid exchange device 180 associated with the vial adapter 150 formed according to various principles of the invention may further include a distal extension 188 extending distally from the fluid exchange trocar 184, such as... Figure 2 As shown. The distal extension 188 of the fluid exchange device can be mounted relative to the fluid exchange trocar 184 (e.g., on or inside the fluid exchange trocar). For example, in Figure 4 , Figure 5 and Figure 6 In the embodiment shown in the cross-sectional view, the fluid exchange trocar 184 includes a support cavity 187 configured to support the distal extension 188 of the fluid exchange device. However, other methods of mounting and / or coupling the fluid exchange trocar 184 and the distal extension 188 of the fluid exchange device, known to those skilled in the art, are also within the scope and spirit of this disclosure, and this disclosure is not limited in this respect. For example, it should be understood that the distal extension 188 of the fluid exchange device may be integrally formed with the fluid exchange trocar 184 (e.g., as a single piece), rather than formed as a separate component. Figure 4 and Figure 5 In the fluid exchange device 180 shown, the support cavity 187 and the fluid exchange cavity 185 are separate and spaced apart from each other. One or both of the support cavity 187 and the fluid exchange cavity 185 may extend generally axially (along the longitudinal axis LA) and / or be parallel to each other.

[0090] exist Figure 2 , Figure 4 and Figure 5In the example of the illustrated embodiment, the distal extension 188 of the fluid exchange device is configured as a piercing element, such as a needle. The distal extension 188 of the fluid exchange device may terminate at a sharp distal end 188t at the distal end 183 of the fluid exchange device 180, and is thus covered by a protective cap 170 before the vial 140 is positioned within the vial receiving fourth chamber 102d of the vial adapter 150, as referenced above. Figure 1 As stated, and as Figure 4 The cross-sectional view shows this in further detail. In some embodiments, the sharp distal tip 188t is configured to facilitate access of the fluid exchange trocar 184 into a third chamber 102c defined within a vial 140 fluidly connected to a vial adapter 150. For example, in some embodiments, the vial 140 has a cap 144 that closes the proximal end 141 of the vial body 142 (to accommodate a third component 104c within the defined third chamber 102c). See reference... Figure 5 Understandably, the cap 144 has a generally central opening region 144o that allows access to a stop or stop 146 located within the proximal end 141 of the opening in the vial body 142. The sharp distal tip 188t of the distal extension 188 of the fluid exchange device can be positioned, sized, shaped, configured, and / or sized to pierce the vial stop 146 to extend into the third chamber 102c defined within the vial 140. It should be understood that, unless otherwise specified, terms such as pierce, perforate, etc. (including their other grammatical forms) are used interchangeably herein without limitation. Once the stop 146 is pierced, a wider fluid exchange puncture device 184 (typically having a larger cross-sectional area than the distal extension 188 of the fluid exchange device extending distally from which it extends) can more easily extend through the stop 146 of the vial 140.

[0091] In some embodiments, the bottle stop 146 may be formed of a suitable material known to those skilled in the art, capable of sealing the third component 104c within a third chamber 102c defined within the bottle 140 (e.g., an elastic material). Optionally, the material of the stop 146 may also allow the sharp distal end 188t of the distal extension 188 of the fluid exchange device to pierce the stop 146 and extend into the third chamber 102c. In some embodiments, the stop 146 has a reduced wall thickness (e.g., a thinner wall portion, such as...). Figure 5 As shown), so that the sharp distal tip 188t can pierce the stop. It should be understood that the sharpened distal tip 188t can be positioned to be substantially aligned with the thinner wall portion of the stop 146 (e.g., aligned with the thinner wall portion along the substantially central region of the stop 146) so that the sharpened distal tip 188t can pierce the thin wall portion of the stop 146.

[0092] As described above, when material is extracted / absorbed from the third chamber 102c, it may be necessary to ventilate the third chamber 102d. Based on various principles of this disclosure, as described above, Figures 1-7 An example of one embodiment of the illustrated vial adapter 150 provides ventilation to the third chamber 102c when the contents of the third chamber 102c (e.g., a third component 104c delivered therein, or a precursor 104d formed therein if a first component 104a is injected into the third chamber 102c to bind with the delivered third component 104c) are withdrawn / inhaled. For example, as... Figure 6 As shown in the cross-sectional view, the vent cavity 189 of the fluid exchange device can be defined by the distal extension 188 of the fluid exchange device. An illustrated example of an embodiment of the vent cavity 189 has an outlet 189o that extends from the distal end 185d of the fluid exchange cavity 185 into the third chamber 102c (i.e., deeper into the third chamber 102c than the distal end of the fluid exchange cavity 185d, and closer to the distal end 143 of the vial 140), to ensure communication with an empty space within the vial 140 (e.g., when the vial 140 is inverted, as...). Figure 6 (As shown), instead of communicating with the third component 104c within the vial 40. The fluid exchange device vent cavity 189 extends proximally from its outlet 189o, located at the distal tip 188t of the distal extension 188 of the fluid exchange device, to its inlet 189i. The fluid exchange device vent cavity inlet 189i is in communication with atmospheric pressure via the bottom vent cavity 199. The base vent cavity 199 is in communication with atmospheric pressure via the vent cavity inlet 199i defined in the sidewall 194 of the vial adapter base 190, to equalize the pressure within the third chamber 102d when material is withdrawn / absorbed from the third chamber 102c.

[0093] In some aspects, the distal extension 188 of the fluid exchange device defines a ventilation lumen 189 of the fluid exchange device and a support cavity 187 in the fluid exchange trocar 184. For example, the ventilation lumen 189 of the fluid exchange device may extend together with the support cavity 187. (See also...) Figure 6 It is understood that the inlet 189i of the venting cavity of the fluid exchange device is in fluid communication with the support cavity 187, and the proximal end 187p of the support cavity 187 extends through the base 182 of the fluid exchange device 180 and is in fluid communication with the base venting cavity 199.

[0094] Reference Figure 6 and Figure 7It is understood that one of the various fluid exchange paths, channels, cavities, passages, reservoirs, etc., described in the illustrated embodiment of the vial adapter base 190 may include a venting passage 198, which cooperates with the fluid exchange device base 182 to define a base venting cavity 199. Through the sealing of the fluid exchange device base 182 relative to the vial adapter base 190, the base venting cavity 199 can be sealed / fluidly isolated, and fluidly communicated with other paths, channels, cavities, passages, reservoirs, etc., within the multi-chamber assembly and / or delivery system 100, as described above. Furthermore, the various alignment features described above with reference to the alignment of the fluid exchange device base 182 relative to the vial adapter base 190 can also align the proximal end 187p of the support cavity 187 with the venting passage 198 defined in the vial adapter base 190 to maintain fluid communication between them.

[0095] As described above, in some embodiments, it may be necessary to remove some material from the second chamber 102b. For example, it may be necessary to remove any remaining air (e.g., air bubbles) within the second chamber 102b so that air is not injected into the patient when the second component 104b is injected into the patient. According to various principles of this disclosure, an example fluid exchange system of embodiments of the multi-chamber combination and / or delivery system 100 defines a purification system. The purification system includes the aforementioned purification reservoir 104p defined in the proximal 193 of the vial adapter base 190. At least a portion of the second vial adapter exchange chamber 155b may extend through a sealing chamber 196 defined on the distal 193 of the vial adapter base 190 for positioning a valve seal 156 therein. Thus, the second vial adapter exchange chamber 155b (or at least a portion thereof) may be considered (and referred to herein alternately as) a valve chamber 155b. In some embodiments, the proximal extension 186 of the fluid exchange device extends proximally into the valve chamber 155b in such a manner that the valve seal 156 can move within the proximal extension 186 of the fluid exchange device and the second vial adapter exchange chamber 155b (e.g., axially along the longitudinal axis LA). Figure 5 As shown. Excess / residual material can be removed from the second chamber 102b, flow into the valve chamber 155b (through the second cylinder nozzle chamber 125b and the second vial adapter nozzle port 152b), and pass through the valve seal 156, through the removal channel 197 defined in the wall of the sealed chamber 196 (as shown). Figure 7 (as shown), and flows into the clearing reservoir 104p.

[0096] More specifically, for purifying the second chamber 102b, the second plunger rod 130b can extend distally into the second chamber 102a to eject excess / residual material and / or air through the second barrel nozzle chamber 125b and into the second vial adapter exchange chamber 155b (through the second vial adapter nozzle port 152b). In some respects, the second plunger rod 130b advances simultaneously with the first plunger rod 130a to eject material from the first chamber 102a into the third chamber 102c. The size, shape, configuration, and / or dimensions of the valve seal 156 allow the ejected material to be distally moved within the sealing chamber 196 (e.g., from the valve seal 56). Figure 4 The indicated sealing position is moved to Figure 5 The purified portion (as shown) flows through valve seal 154 and through a purified passage 197 defined in the wall of sealed chamber 196 into purified reservoir 104p. Therefore, any second component 104b discharged from second chamber 102b is collected within the multi-chamber combination and / or delivery system 100 and not discharged outside the system 100 (e.g., to healthcare professionals, patients, floors, etc.). In some embodiments, vent 182i is defined in the base 182 of the fluid exchange device (e.g., ...). Figure 2 (as shown), so as to ventilate the purification reservoir 104p in a manner known to those skilled in the art.

[0097] Valve seal 156 thereby regulates the flow rate of the second component 104b from the second chamber 102b into the purification reservoir 104p. In some embodiments, valve seal 156 may be a one-way valve whose positioning, size, shape, configuration, and / or dimensions allow material to be discharged from the second chamber 102b as needed / desired, while preventing undesired material from flowing into the second chamber 102a. For example, valve seal 156 may prevent material ejected from the first chamber 102a and / or sucked from the third chamber 102c from flowing into (e.g., being sucked into) the second chamber 102b. Alternative configurations of valve seal 156 are described in more detail below.

[0098] It should be understood that the various principles of this disclosure may be applied in alternative forms and configurations without departing from the scope and spirit of this disclosure. Figures 8-12 Alternative examples of embodiments of a multi-chamber assembly and / or delivery system 200 formed according to various principles of this disclosure are shown. Figures 1 to 7 The multi-chamber combination and / or delivery system 100 shown above is the same. Figures 8 to 12 The multi-chamber assembly or conveying system 200 shown has a fluid exchange system, which has various paths, channels, cavities, channels, reservoirs, etc., for fluid communication, exchange, and transfer between various components, chambers, parts, devices, and systems of the system 200. Furthermore, with... Figures 1 to 7 Similar to the multi-chamber combination and / or delivery system 100 shown above, Figures 8 to 12 The illustrated multi-chamber combination or delivery system 200 includes a vial adapter 250 configured to provide various features and functions related to establishing fluid communication with the fluid exchange system of the multi-chamber combination / delivery system 200. Similar to the vial adapter 150 described above, the features and functions provided by the vial adapter 250 include, but are not limited to, fluidly connecting two or more chambers of the multi-chamber combination and / or delivery system; allowing venting of the system (e.g., venting of at least one chamber of the multi-chamber system); facilitating the removal of material from at least one chamber of the multi-chamber system; etc.

[0099] It should be understood, with reference Figures 8-12 The described medicine bottle adapter 250 can be used with similar Figures 1-6 The first injectable material transfer device 210 of the first injectable material transfer device 110 shown is used together. Because the proximal portion of the first injectable material transfer device 210 is... Figures 1-6 The equivalent proximal portion of the first injectable substance transfer device 110 shown is substantially the same, therefore Figures 8-12 Only the distal end portion of the first injectable material transfer device 210, which is fluidly connected to the vial adapter 250, is shown in the image. For details regarding the proximal components, structure, features, etc., please refer to [link to relevant documentation]. Figure 1 and Figure 2 Furthermore, it should be understood that, although Figure 8 , Figure 9 , Figure 10 , Figure 12 The sleeve lock 260 of the multi-chamber assembly and / or conveying system 200 shown in Figure 13 and Figures 1-6 The sleeve lock 160 shown is different, but both sleeve locks 160 and 260 connect the first injectable material transfer device 110 to the vial adapter 150 or vial adapter 250. Therefore, please refer to the above regarding... Figures 1 to 7The differences between sleeve locks 160 and 260 can be further understood from the discussion of the sleeve lock 160 in the multi-chamber assembly and / or delivery system 100 shown, in conjunction with the accompanying drawings of this application and the aforementioned co-pending provisional patent application ________ [Attorney File No. 2001.3126100], and provisional patent application filed on the same day ________, entitled "DEVICES, SYSTEMS, AND METHODS FOR COMBINING AND / OR DELIVERING INJECTABLE MATERIALS", filed on the same day as this application [Attorney File No. 2001.3125100], the entire contents and all purposes of which are incorporated herein by reference.

[0100] Go to Figure 8 ,as well as Figure 9 The cross-sectional view shown along its IX-IX line illustrates an embodiment of the vial adapter 250 in fluid connection with a first injectable material transfer device 210, an example of a multi-chamber combination and / or delivery system 200. The vial adapter 250 includes nozzle ports 252a, 252b and fluid exchange cavities 255a, 255b, configured similarly to those described above. Figures 1-6 The illustrated embodiment of the vial adapter 150 and the first injectable material transfer device 110 is shown in an example manner in which the nozzles 222a, 222b of the first injectable material transfer device 210 are fluidly engaged. Typically, due to... Figures 8-12 The fluid connection between the first injectable material transfer device 210 and the proximal end 251 of the embodiment of the illustrated vial adapter 250 and... Figures 1-6 The fluid connections described above for the embodiment of the first injectable material transfer device 110 and the example of the vial adapter 150 are substantially the same. Therefore, referring to the vial adapter 150 and the first injectable material transfer device 110 described above, as... Figures 8-12 As shown, this is comparable to the vial adapter 250 and the first injectable substance transfer device 210.

[0101] although Figures 1-7 The proximal end 151 of the medicine bottle adapter 150 shown is with Figures 8-12 There is a similarity between the proximal ends 251 of the illustrated vial adapter 250, but the vial adapter 250 does not have a distal end 253 similar to the distal end 153 of the vial adapter 150. Nevertheless, with Figure 1-7 The embodiment of the medicine bottle adapter 150 shown is the same as that described above. Figures 8-12The illustrated vial adapter 250 provides various fluid exchange paths, channels, cavities, channels, reservoirs, etc., facilitating fluid communication and / or fluid transfer between at least a first chamber 202a and a third chamber 202c of a multi-chamber combination and / or delivery system 200 formed according to various principles of this disclosure. The third chamber 202c may be defined within a vial 240 located within the chamber defined by the vial adapter 250, which can be considered as a fourth chamber 202d of the multi-chamber combination and / or delivery system 200 (e.g., ...). Figures 10-12 (As shown). Therefore, in addition to the third chamber 202c, the first chamber 202a can also be considered to be in fluid communication with the fourth chamber 202d.

[0102] Similar to the multi-chamber assembly and / or delivery system 100 described above, an integrated fluid exchange system is defined relative to the first injectable material transfer device 210, the vial adapter 250, and the vial 240. For example... Figures 8-12 As shown, the entire fluid exchange system defines various internal cavities between the various chambers, components, devices, systems, etc., of the multi-chamber combination and / or transport system 200 for fluid communication, exchange, transfer, etc. Figures 1 to 7 The embodiment of the medicine bottle adapter 150 shown is the same as the one described above. Figures 8 to 12 The various elements, features, components, parts, etc., in the embodiments of the illustrated vial adapter 250 can be considered as part of the overall fluid exchange system forming the multi-compartment assembly and / or delivery system 200. However, instead of the fluid exchange device 180, the vial adapter 250 includes a fluid exchange nozzle 280, which can be considered as part of the overall fluid exchange system of the multi-compartment assembly and / or delivery system 200.

[0103] Once the vial 240 is fluidly connected relative to the distal end 253 of the vial adapter 250, as Figure 10 As shown, the fluid exchange nozzle 280 of the vial adapter 150 can establish fluid communication between the first chamber 202a within the first injectable material transfer device 210 and the third chamber 202c within the vial 240. More specifically, see reference... Figure 11 As understood, it shows along Figure 10 The cross-sectional view along line XI-XI shows examples of embodiments of the fluid exchange nozzle 280, including a fluid exchange nozzle 284 and a venting nozzle 288, which can be considered similar to, respectively, fluid exchange nozzle 284 and venting nozzle 288. Figures 4 to 6 The fluid exchange device 180 shown includes a fluid exchange puncture device 184 and a distal extension 188. (See reference...) Figure 11It can be further understood that the fluid exchange nozzle 284 defines a fluid exchange lumen 285 through which fluid can be exchanged between the first chamber 202a and the third chamber 202c. Furthermore, the vent nozzle 288 defines a vent lumen 289 that facilitates venting of the vial 240 when material is withdrawn / absorbed from the third chamber 202c, such as... Figure 12 As shown. With Figures 1-6 Like the protective cap 170, the fluid exchange system 180 can be provided with a protective cap 270 to cover the fluid exchange nozzle 280, such as Figure 8 As shown. (Refer to...) Figure 9 Understandably, the illustrated examples of embodiments of the protective cap 270 include cap ports 272a, 272b, which are configured to receive vial adapter nozzles 284, 288, for example, to protect vial adapter nozzles 284, 288 and / or seal cavities 285, 289 defined by vial adapter nozzles 285, 288, respectively.

[0104] Figures 8-12 The fluid exchange lumen 285 and vent lumen 289 of the fluid exchange nozzle 280 in the example embodiment of the medicine bottle adapter 250 shown have structures different from those of the fluid exchange nozzle 280. Figures 4-7 The corresponding structure of the fluid exchange device 180 of the illustrated medicine bottle adapter 150 is for fluid communication with the modified medicine bottle 240. Figure 13A and Figure 13B They are shown respectively Figures 8-12 The illustrated example is an embodiment of an improved vial 240 comprising a third chamber 202c of a multi-chamber combination and / or delivery system 200. (See also...) Figure 11 , Figure 12 and Figure 13B As shown, an example of one embodiment of the medicine bottle 240 includes a cap 244 having a generally central opening region 244o that allows access to a stop or stop 246 located within the opening end 241 of the medicine bottle body 242. While the example of the shown cap 244 may be similar to the cap 144 of the medicine bottle 140 described above, the stop 246 differs from the stop 146 of the medicine bottle 40 described above. Unlike the stop 146 of the medicine bottle 140 described above, the stop 246 of the modified medicine bottle 240 is not a punctureable stop, but instead defines two through-hole inlet ports 245, 247 that, when in fluid communication with the fluid exchange nozzle 280, respectively facilitate fluid transfer and discharge. Therefore, Figure 13A and Figure 13B The modified medicine bottle 240 and the modified medicine bottle stop 244b shown are, and Figure 12 The cross-sectional view in the middle can be regarded as Figures 10-12 It is part of the overall fluid exchange system of the multi-chamber combination and / or delivery system 200 shown.

[0105] Reference Figure 11 and Figure 13B The details of the fluid exchange facilitated by the port 245 of the improved stop 246 can be understood. Port 245 can be considered a fluid exchange port 245 configured to receive the fluid exchange nozzle 284 of the fluid exchange nozzle 280 of the vial adapter 250. (As...) Figure 11 As shown, a fluid exchange lumen 285 defined by a fluid exchange nozzle 284 is in fluid communication with a fluid exchange port 245 defined in a stop member 246, thereby enabling fluid communication between the first chamber 202a and the third chamber 202c. More specifically, the fluid exchange lumen 285 extends from its distal end 285d (extending from the distal end of the fluid exchange nozzle 284) through the vial adapter 250 to its proximal end 285p. The proximal end 285p of the fluid exchange lumen 285 is in fluid communication with the first nozzle port 252a of the vial adapter 250 and the first fluid exchange lumen 225a defined by the first nozzle 222a of the first injectable material transfer device 210 and in fluid communication with the first chamber 202a. Optionally, the stop member fluid exchange port 245 has a laterally extending distal end opening 245d in fluid communication with the third chamber 202c. Through this fluid exchange path, the first component 204a can be injected from the first chamber 202a into the third chamber 202c; the third component 204c can be drawn from the third chamber 202c into the first chamber 202a; and / or the precursor 204d (formed after combining the first component 204a injected into the third chamber 202c with the third component 204c in the third chamber 202a) can be drawn out from the third chamber 202c and enter the first chamber 202a.

[0106] As described above, if material is drawn in / extracted from the third chamber 202c, ventilation of the third chamber 202A may be required. The port 247 of the modified stop 246 of the modified vial 240 can be considered as the ventilation port 247. (Refer to...) Figure 12 and Figure 13B It is understood that the vent port 247 is in fluid communication with the distal extension 248 of the stop member, and the distal extension 248 of the stop member extends from the stop member 246 to the distal end into the third chamber 202c inside the medicine bottle 240. When the medicine bottle 240 is in... Figure 12When the bottle is inverted as shown, as the material is withdrawn from the vial 240, the vent port 247 is fluidly connected to the empty space within the vial 240 via the vent cavity 249 defined by the distal extension 248 of the stop member. It should be understood that the vent outlet 249o of the distal extension 248 of the stop member extends sufficiently beyond the laterally extending distal opening 245d of the fluid exchange port 245 of the stop member and toward the distal end 243 of the vial 240 (i.e., distally into the third chamber 202c, rather than extending through the distal end 245d opening of the fluid exchange port 245 of the stop member) to ensure communication with the void within the vial 240 (e.g., when the vial 240 is inverted, as...). Figure 9 (As shown), instead of communicating with the third component 204c within the vial 24. As the void increases (as material is drawn in / out from the third chamber 202c), the pressure therein is equalized via the vent inlet 257i defined in the sidewall 254 of the vial adapter 250. More specifically, the stop vent port 247 allows the distal end of the stop to extend into a vent lumen 249 (in fluid communication with the void within the third chamber 202c) and into a vent lumen 287 defined in the vent nozzle 288 of the fluid exchange nozzle 280 of the vial adapter 250. The nozzle vent lumen 287 is in fluid communication with the vent inlet 257i via a transverse vent lumen portion 287t defined in the vial adapter 250. Therefore, the voids within the vial 240 are discharged to the atmosphere through the inner cavities 249, 287, 287t and the venting inlet 257i, and the pressure within the third chamber 202A is equalized when material is drawn in / out of the third chamber 202c. If desired, an optional vent cap 270i (which itself is ventilable in a manner known to those skilled in the art) can be provided to cover the venting inlet 257i.

[0107] To limit undesirable fluid communication with the third chamber 202c defined within the modified bottle 240 before fluid connection with the vial adapter 250 of the multi-chamber assembly and / or delivery system 200, a protective cap 270' can be placed on the stop access ports 245, 247 to prevent accidental leakage or other undesirable liquid communication within the third chamber 202c of the modified vial 240, such as... Figure 13A As shown. Figure 13BAn example of one embodiment of the protective cap 270' shown has a stop extension 274' positioned, sized, shaped, configured, and / or sized to extend into and block the fluid exchange port 245, and / or a stop extension 278' positioned, sized, sized, configured, and / or sized to extend into and block the vent port 247. Alternatively, the protective cap 270' may include a gripping portion 272' configured to facilitate gripping and / or pulling the protective cap 270' to remove it from the vial 240. The gripping portion 272' may be in the form of a radially outwardly projecting flange and / or an axially extending protrusion / wing, as described above regarding the gripping portion 172 of the protective cap 170 of the multi-chamber assembly and / or delivery system 100 (as...). Figure 1 , Figure 2 and Figure 4 (As shown). In some embodiments, the protective cap 270 may be configured with extensions 274, 278 that are similar in size, shape, and shape to the vial adapter nozzles 284, 288, but do not extend through the inner cavity therethrough. In this embodiment, the extensions 274, 278 may be inserted into the ports 245, 247 of the vial 240 in place of the stop extensions 274', 278' of the protective cap 270'. Thus, before the multi-chamber assembly and / or delivery system 200 is ready for use (e.g., to assemble and / or deliver materials to a patient), the protective cap 270 may be positioned relative to the vial adapter 250 to cover the fluid exchange nozzle 280, and relative to the vial 240 to cover its ports 245, 247.

[0108] Based on various further principles of this disclosure, such as Figures 1-7 Examples of embodiments of the multi-chamber combination and / or delivery system 100 shown, Figures 8-12 The fluid exchange system in the illustrated embodiment of the multi-chamber combination and / or delivery system 200 defines a purification system. The purification system includes a purification reservoir 204p defined within a vial adapter 250, such as... Figure 9 , Figure 11 and Figure 12 As shown, excess / residual material and / or air (e.g., air) bubbles can be purified from the second chamber 202b into the purification reservoir. Figures 1-6Similar to the purification system described above in the multi-chamber combination and / or delivery system 100 shown, material from the second chamber 202b is ejected through a fluid exchange lumen 225b (e.g., as a result of advancement of the distal end of a plunger rod therein), which is defined by a second nozzle 222b of the first injectable material transfer device 210, and ejected through a second nozzle port 252b into a second fluid exchange lumen 255b defined in the vial adapter 250. In some aspects, material is ejected from the second chamber 202b simultaneously with material being ejected from the first chamber 202a into the third chamber 202c.

[0109] In some embodiments, such as Figure 11 As shown, valve seal 256 is located within a valve cavity 259 defined within vial adapter 250 (e.g., along its axial direction), and its size, shape, configuration, and / or dimensions prevent unwanted flow of material relative to the second chamber 202b (within the first injectable material transfer device 210). Similar to valve seal 156 described above, valve seal 256 is slidable within valve cavity 259 between a sealed position and a clean position, the sealed position sealing fluid communication relative to the second chamber 202b, and the clean position allowing fluid communication from the second chamber 202b to the clean reservoir 204p. After sufficient pressure is generated within the second chamber 202b (e.g., by advancing a plunger rod therein), valve seal 256 moves sufficiently distally within valve cavity 259 to the clean position. In the purification position, the second fluid exchange chamber 255b (which is in fluid communication with the second chamber 202b via the second fluid exchange chamber 225b defined in the second cylindrical nozzle 222b) is in fluid communication with the purification passage 259p extending from the valve chamber 259 to the purification reservoir 204p. (Refer to...) Figure 9 , Figure 11 and Figure 12 As can be understood from the cross-sectional view, in some embodiments, the nozzle ports 252a, 252b are not symmetrical with respect to the longitudinal axis LA of the multi-chamber assembly and / or delivery system 200, such as... Figure 9 and Figure 11 As shown. This positioning facilitates the formation of the purification reservoir 2040 within the vial adapter 250 by typically limiting the cross-sectional area of ​​the purification reservoir 204p to around the first nozzle port 252a rather than extending entirely around the second nozzle port 252b. Alternatively, this asymmetry also contributes to a linear structure for fluid flow from the chamber to the vial. (See reference...) Figure 9 , Figure 11 and Figure 12The cross-sectional view further illustrates that the illustrated embodiment of the vial adapter 250 includes a reservoir cap 290 defining the bottom / proximal wall of the purification reservoir 204p. Alternatively or additionally, the reservoir cap 290 surrounds the purification reservoir 204p to retain the purification material within the vial adapter 250, thereby preventing spillage (e.g., when the vial adapter 150 is separated from the first injectable material transfer device 210). In some embodiments, a purification reservoir vent 204i is defined in the vial adapter 250 to ventilate the purification reservoir 204p, thereby preventing pressure buildup that could otherwise occur when air is purged from the second chamber 202b into the purification reservoir 204.

[0110] As can be understood, similar to valve seal 156 described above, valve seal 256 can be a one-way valve. Furthermore, it should be understood that any one or both of valve seals 156 and 256 can have any of the various configurations suitable for the purification system described above. For example, refer to... Figure 4 and Figure 5 An example of an embodiment of the valve seal 156 shown, and Figure 14A and Figure 14B As illustrated in the embodiment of valve seal 356, it can be understood that the valve of the purification system formed according to various principles of this disclosure can have a main body portion 156a, 356a with a generally cylindrical cross-sectional shape (approximately constant outer diameter), and one or more sealing fins 156b, 356b extending circumferentially around the main body portion 156a, 356a and radially outward therefrom. Valves 156, 356 can be positioned in corresponding valve chambers to achieve a sealing position (e.g., ...). Figure 4 and Figure 14A (as shown) and purification locations (such as number 5 and Figure 14B The sealing fins 156b and 356b move between the valve chamber and the purification channel leading to the purification reservoir in the sealed position. In the purified position, the valve chamber is in fluid communication with the purification channel, so that the second chamber of the associated injectable material transfer device is in fluid communication with the purification reservoir of the associated vial adapter (through the valve chamber and the purification channel). It should be understood that the sealing fins 156b and 356b are positioned, sized, shaped, configured, and / or sized relative to the valve chamber and the purification channel to allow fluid to pass through them and / or between them. It is understood that the valve chamber does not need to have a constant diameter (e.g., by comparison). Figure 4 and Figure 5 The valve chamber 155b shown is... Figure 7 , Figure 9 , Figure 11 (The valve cavity 259 shown is understandable). Furthermore, the purification channel can have any of a variety of configurations, for example, by comparison. Figure 4 , Figure 5 , Figure 7 , Figure 9 , Figure 11 The examples shown are for illustrative purposes.

[0111] It is understood that various modifications can be made to the valve seal described above based on the various principles of this disclosure without departing from the scope and spirit of this disclosure. For example, valve seals formed according to the various principles of this disclosure do not require a valve body with a constant diameter (e.g., such as...). Figure 4 , Figure 5 , Figure 14A and Figure 14B (The illustrated embodiment). Conversely, valve seals formed according to various principles of this disclosure can have more than one diameter (e.g., stepped, conical, etc.). Figure 9 and Figure 11 In the embodiment shown, the valve seal 256 has a smaller diameter portion closer to the proximal end 251 of the vial adapter 250 and a larger diameter portion closer to the distal end 253 of the vial adapter 250. Figure 15A and Figure 15B Another example of an embodiment of a valve seal 456 having a stepped diameter is shown. Valve seals 256, 456 having stepped diameters can be advantageously used in valve cavities having stepped diameters. As the valve seals 256, 456 move distally from a narrower valve cavity portion to a wider valve cavity portion (e.g., from...),... Figure 9 Move the position in the middle to Figure 11 The position in the middle, or from Figure 15A The position in the middle is moved to Figure 15B (In the middle position), the narrower valve body portion is moved into the wider valve chamber portion to facilitate fluid flow through the purification channel that is in fluid communication with the wider valve chamber portion. (Refer to...) Figure 15A and Figure 15B As can be understood from the example of the valve seal 456 shown, the sealing fin 456b, similar to the sealing fins 156b and 356b described above, can extend circumferentially around the seal body 456a and radially outward therefrom to achieve a similar sealing effect as described above with reference to the sealing fins 156a and 356b.

[0112] Reference Figure 16A and Figure 16B It is understood that the valve seal 556 formed according to the various principles of this disclosure may be generally spherical, rather than having a generally cylindrical body (e.g., the generally cylindrical valve seal portions 156a, 256a, 356a, 456a described above). Similar to valve seals 156, 256, 356, 456, the spherical valve seal 556 may be positioned in a stepped valve cavity to achieve a sealing position relative to the narrower valve cavity portion (e.g., ...). Figure 16A(as shown) and the movement between the clean position within a wider valve cavity (with a diameter wider than that of valve seal 566) and the clean position within the wider valve cavity (as shown). Figure 16B As shown), to allow a narrower portion of the valve chamber (in fluid communication with a second chamber of the associated multi-chamber assembly and / or delivery system) to be in fluid communication with the purification passage leading to the purification reservoir.

[0113] It should be understood that, despite Figure 1 -- Figure 7 The embodiments of the multi-chamber combination and / or delivery system 100 shown are similar to Figure 8 -- Figure 13B While there are some differences between the embodiments of the multi-chamber combination or delivery system 200 shown, they establish similar fluid communication. For example, Figure 1 -- Figure 7 Various features of the medicine bottle adapter 150, the medicine bottle adapter base 190, and the fluid exchange device 180 are present in Figure 8 -- Figure 12 The medicine bottle adapter 250 exists in different configurations. For example, as referenced... Figure 11 and Figure 12 As can be understood from the illustration of the vial adapter 250 in fluid communication with the embodiment of vial 240, the distal end 253 of the vial adapter 250 defines a fourth chamber 202d of the multi-chamber assembly and / or delivery system 200, which is significantly shorter than Figures 1-6 The fourth chamber 102d of the multi-chamber combination or delivery system 100 shown. Specifically, the fourth chamber 202d of the vial adapter 250 is not designed to accommodate most (if not substantially all) of the length of the vial 140, as the fourth chamber 102d of the vial adapter 150 is, but is designed to receive the cap portion 242 of the vial 240, without most of the vial body 242. Therefore, Figure 1-6 In the illustrated embodiment, fluid engagement between the vial adapter 150 and the vial 140 typically occurs at the proximal end 151 of the vial adapter 150, while Figure 8-12 In the illustrated embodiment, fluid engagement between the vial adapter 250 and the vial 240 typically occurs at the distal end 253 of the vial adapter 250.

[0114] In view of the foregoing, it is understood that multi-chamber combination and / or delivery systems with vial adapters formed according to the various principles of this disclosure simplify the devices, systems, and methods for combining and / or delivering injectable materials to patients, and / or reduce (if not eliminate) human error that occurs when using complex existing systems.

[0115] Furthermore, in view of the foregoing, it should be understood that the various embodiments shown in the accompanying drawings have several individual and independent features, each of which individually possesses unique advantages that are desirable but not essential to the devices, systems, and methods of this disclosure. Therefore, not all of the various individual features described herein need to be present to achieve at least some of the desired features and / or benefits described herein. For example, only one of the various features described above may be present in a device or system formed according to the various principles of this disclosure. Alternatively, one or more features described with reference to one embodiment may be combined with one or more features of any other embodiment provided herein. That is, any features described herein can be mixed and matched to create hybrid designs, and such hybrid designs are within the scope of this disclosure.

[0116] Those skilled in the art should understand that this discussion is merely a description of illustrative examples of embodiments and is not intended to limit the broader aspects of this disclosure. All apparatuses and methods discussed herein are examples of apparatuses and / or methods implemented according to one or more principles of this disclosure. These examples are not the only ways to implement these principles, but are merely examples and are not intended to limit the broader aspects of this disclosure. Therefore, references to elements or structures or features in the drawings must be understood as references to embodiments of this disclosure and should not be construed as limiting this disclosure to the specific elements, structures, or features shown. Other examples of ways of implementing the disclosed principles will conceive of those skilled in the art upon reading this disclosure. Those skilled in the art should understand that variations can be applied to the disclosed apparatuses, systems, and / or methods and / or the sequence of steps of the methods described herein without departing from the concept, spirit, and scope of this disclosure. It should be understood that various features described with respect to one embodiment can generally be applied to another implementation, whether or not explicitly indicated. The various features described below can be used alone or in any combination thereof. Therefore, the invention is not limited to the embodiments specifically described herein, and all substitutions and modifications that are obvious to those skilled in the art are considered to be within the spirit, scope, and concept of this disclosure as defined by the appended claims. In addition to those discussed above, those skilled in the art will understand various other benefits of the aspects, features, components, and structures of the aforementioned devices, systems, and methods.

[0117] The foregoing discussion has broad applications and is provided for illustrative and descriptive purposes, and is not intended to limit the disclosure to one or more forms disclosed herein. It should be understood that various additions, modifications, and substitutions can be made to the embodiments disclosed herein without departing from the concept, spirit, and scope of this disclosure. In particular, those skilled in the art will appreciate that the principles of this disclosure can be embodied in other forms, structures, arrangements, proportions, and other elements, materials, and components without departing from its concept, spirit, scope, or characteristics. For example, to simplify this disclosure, various features of this disclosure are grouped into one or more aspects, embodiments, or configurations. However, it should be understood that various features of certain aspects, embodiments, or configurations of this disclosure can be combined in alternative aspects, implementations, or configurations. While this disclosure is presented according to embodiments, it should be understood that not all of the various individual features of this subject matter need to be present in order to achieve at least some of the desired features and / or benefits of this subject matter or these individual features. Those skilled in the art will understand that this disclosure can be used with numerous modifications or variations in structure, arrangement, proportions, materials, components, and other aspects used in the practice of this disclosure without departing from the principles, spirit, or scope thereof. These modifications or variations are particularly suited to specific environments and operational requirements. For example, an element shown as integrally formed may be composed of multiple parts, or an element shown as multiple parts may be integrally formed; the operation of an element may be reversed or otherwise varied; and the size or dimensions of an element may be varied. Similarly, although the operations or actions or procedures are described in a particular order, this should not be construed as requiring such a particular order, nor should it be interpreted as requiring the performance of all operations, actions, or procedures to achieve the desired result. Furthermore, other embodiments are also within the scope of the following claims. In some cases, the actions described in the claims may be performed in a different order and may still achieve the desired result. Therefore, the embodiments disclosed herein should be considered illustrative rather than restrictive in all respects, and the scope of the claimed subject matter is indicated by the appended claims, but is not limited to the specific embodiments or arrangements described above or herein. In view of the foregoing, various features of any embodiment may be used and may be claimed individually or in combination with features of that embodiment or any other embodiment. The appended claims indicate the scope of the subject matter and are not limited to the foregoing description.

[0118] The following will be understood in the foregoing description and the following claims. The phrases “at least one,” “one or more,” and “and / or” as used herein are open-ended expressions, functioning as both conjunctions and disjunctions in operation. The terms “a,” “an,” “the,” “first,” “second,” etc., do not exclude plurals. For example, the term “a” or “an” as used herein refers to one or more of that entity. Therefore, the terms “a” (or “an”), “one or more,” and “at least one” are used interchangeably herein. The term “or” as used in this specification and the appended claims generally includes “and / or” in its sense, unless the context expressly specifies otherwise. As used herein, unless the context expressly indicates otherwise, the conjunction “and” includes each structure, component, feature, etc. so connected, and unless the context expressly indicates otherwise, the conjunction “or” includes one or more structures, components, or features so connected individually and in any combination and number. All directional references (e.g., proximal end, distal end, upper, lower, upward, downward, left, right, lateral, longitudinal, front, rear, top, bottom, above, below, vertical, horizontal, radial, axial, clockwise, counterclockwise, etc.) are used solely for identification purposes to aid the reader's understanding of this disclosure and / or to distinguish areas of related elements, and do not limit the related elements, particularly regarding their location, orientation, or use in this disclosure. Connection references (e.g., appendage, coupling, connection, joining, linking, etc.) should be interpreted broadly unless otherwise stated and may include intermediate members between sets of elements and relative movement between elements. Therefore, connection references do not necessarily infer that two elements are directly connected and have a fixed relationship with each other. Identifying terms (e.g., primary, secondary, first, second, third, fourth, etc.) are not used to imply importance or priority, but rather to distinguish different features.

[0119] The following claims are incorporated herein by reference, each existing independently as a separate embodiment of this disclosure. In the claims, the terms “comprising,” “including,” “covering,” and “referring to” do not exclude the appearance of other elements, components, features, groups, regions, integrals, steps, operations, etc. Furthermore, although individual features may appear in different claims, these features may have combined advantages, and their appearance in different claims does not imply that such combinations are infeasible and / or unhelpful. Moreover, singular references do not exclude plural references. Reference numerals in the claims are provided as clarifying examples only and should not be construed as limiting the scope of the claims in any way.

Claims

1. A medicine bottle adapter, comprising: The proximal end is configured to be fluidly connected to a material transfer device that defines the first chamber of a multi-chamber system; The distal end is configured to be fluidly connected to an independent chamber of the multi-chamber system; and A fluid exchange system defined between the proximal end and the distal end of the vial adapter, and comprising: A fluid exchange lumen extends through the distal end of the vial adapter to provide fluid communication between a separate chamber fluidly connected to the distal end of the vial adapter and a first chamber fluidly connected to the proximal end of the vial adapter. as well as A ventilation lumen extending through the distal end of the vial adapter to ventilate a separate chamber fluidly connected to the distal end of the vial adapter, wherein the ventilation lumen is fluidly isolated from the fluid exchange lumen and fluidly communicates with a ventilation lumen inlet defined in the wall of the vial adapter.

2. The medicine bottle adapter according to claim 1, wherein: The proximal end of the vial adapter defines a first port configured to receive and fluidly communicate with a first nozzle of a material transfer device defining a first chamber of a multi-chamber system, thereby fluidly communicating the fluid exchange lumen with the first chamber of the multi-chamber system via the first port of the vial adapter and the first nozzle of the material transfer device. and The distal end of the vial adapter defines a vial receiving chamber configured to receive vials, thereby defining an independent chamber in a multi-chamber system.

3. The medicine bottle adapter according to any one of claims 1-2, wherein: The fluid exchange lumen and the vent lumen are defined within the base of the vial adapter; and The vial receiving chamber extends distally from the base of the vial adapter to define the vial receiving chamber, which is sized to receive the body of the vial, thereby defining the separate chamber.

4. The vial adapter according to any one of claims 1-3, further comprising a fluid exchange device, the fluid exchange device comprising: Base of fluid exchange device; A fluid exchange puncture device extends distally from the base of the fluid exchange apparatus and defines a fluid exchange lumen therethrough, the distal end of the fluid exchange lumen extending through the fluid exchange puncture device to be positioned within the vial receiving chamber, and the proximal end of the fluid exchange lumen extending through the base of the fluid exchange apparatus. as well as A distal extension extends from the base of the fluid exchange device toward a distal end and defines a ventilation lumen therethrough, the ventilation outlet being located distal to the distal end of the fluid exchange lumen in the fluid exchange puncture device.

5. The medicine bottle adapter according to any one of claims 3-4, wherein: The base of the medicine bottle adapter defines a fluid exchange channel that forms a base fluid exchange cavity with the base of the fluid exchange device and a venting channel that forms a base venting cavity with the base of the liquid exchange device. The base fluid exchange lumen is in fluid communication with the fluid exchange lumen and the first port defined in the proximal end of the vial adapter; and The base ventilation cavity is in fluid communication with the ventilation cavity and the ventilation cavity inlet.

6. The vial adapter according to any one of claims 4-5, wherein the distal extension of the fluid exchange device has a sharp distal end for piercing a stop of the vial defining an independent chamber to facilitate the fluid exchange puncture device passing through the vial stop and into the independent chamber, and the vent outlet of the distal extension of the fluid exchange device is defined in the distal end of the sharp distal end of the distal extension of the fluid exchange device.

7. The medicine bottle adapter according to any one of claims 2-6, wherein: The vial adapter further includes a fluid exchange nozzle and a vent nozzle, which extend distally from the distal end of the vial adapter and are configured to be fluidly connected to a fluid exchange port and a vent port, respectively, which are defined in a stop member of a vial received in the vial receiving chamber. The fluid exchange lumen extends through the fluid exchange nozzle to communicate with the independent chamber; and The venting lumen extends through the venting nozzle to be in fluid communication with the distal extension, which extends distally beyond the fluid exchange port in the vial stop within a separate chamber.

8. The medicine bottle adapter according to any one of claims 1-7, wherein: The proximal end of the vial adapter defines a second port, the second port being configured to receive and be in fluid communication with the second nozzle of the material transfer device; and The vial adapter also includes a purification reservoir in fluid communication with the second port, thereby allowing material from the second chamber defined in the material transfer device to be in fluid communication with the purification reservoir via the second nozzle and the second port.

9. The vial adapter of claim 8, wherein the purification reservoir is defined in the base of the vial adapter and is fluidly isolated from the fluid exchange lumen and the vent lumen.

10. The medicine bottle adapter according to claim 8, wherein: The vial adapter also includes a reservoir cap located near the proximal end of the vial adapter and enclosing the purification reservoir within the vial adapter; and The purification reservoir is fluidly isolated from the fluid exchange chamber and the venting chamber.

11. A multi-chamber combination and / or delivery system, comprising: A material transfer device, wherein a first chamber is defined; and A medicine bottle adapter that defines a medicine bottle receiving chamber; in: The vial adapter has a proximal end that defines a first nozzle port; The multi-chamber device has a first nozzle configured to be fluidly connected to the nozzle port of the first vial adapter; The vial adapter has a distal end that defines a fluid exchange lumen in fluid communication with the nozzle port of the first vial adapter and the nozzle of the first multi-chamber device; and The distal end of the vial adapter also defines a venting lumen that is fluidly isolated from the fluid exchange lumen, the venting lumen extending from a venting lumen inlet defined in the wall of the vial adapter to the distal end of the vial adapter.

12. The system of claim 11, further comprising a fluid exchange device, the fluid exchange device comprising: Base of fluid exchange device; A fluid exchange trocar extends distally from the base of the fluid exchange device and defines a fluid exchange lumen therethrough, the distal end of the fluid exchange lumen extending through the fluid exchange trocar to be positioned within the vial receiving chamber, and the proximal end of the fluid exchange lumen extending through the base of the fluid exchange device to be in fluid communication with the nozzle port of the first vial adapter; and A distal extension extends distally from the base of the fluid exchange device and defines the ventilation lumen therethrough, the ventilation outlet being located in the vial receiving chamber distal to the distal end of the fluid exchange lumen in the fluid exchange trocar.

13. The system according to claim 11, further comprising a vial body having an open end and a vial stop located within the open end of the vial body, wherein: The main body of the medicine bottle defines an independent chamber that can be positioned within the medicine bottle receiving chamber defined by the medicine bottle adapter; The medicine bottle stop defines a fluid exchange port and a vent port that extends therethrough, the fluid exchange port and the vent port being in fluid communication with the independent chamber defined within the medicine bottle body; The vial adapter further includes a fluid exchange nozzle and a vent nozzle. The fluid exchange nozzle extends distally from the distal end of the vial adapter and is configured to be fluidly connected to the independent chamber via the fluid exchange port of the vial stop. The vent nozzle extends outwardly from the distal end of the vial adapter and is configured to be fluidly connected to the independent chamber via the vent port of the vial stop. The bottle stop also includes a distal extension extending into the separate chamber, wherein when the bottle is inverted and material is removed from the bottle through the fluid exchange port of the bottle stop, the distal extension is located distal to the fluid exchange port of the bottle stop and within the empty space of the separate chamber.

14. The system according to claim 11, characterized in that: The proximal end of the vial adapter further defines a second nozzle port; The multi-chamber device further defines a second chamber therein; and The multi-chamber device has a second nozzle configured to be fluidly connected to the nozzle port of the second vial adapter, so that the second chamber is in fluid communication with the vial adapter.

15. The system of claim 14, wherein the vial adapter further defines a purification reservoir fluidly connected to the second nozzle port of the vial adapter, the nozzle of the second multi-chamber device, and the second chamber, and fluidly isolated from the fluid exchange lumen of the vial adapter, the first nozzle port of the vial adapter, the nozzle of the first multi-chamber device, and the first chamber.

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