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

Abstract

A mixing system for producing a mixture for delivery to a treatment site. An exemplary system may include a needle hub and a multi-reservoir system including a plunger assembly and a barrel portion. The barrel portion may include a first lumen, a second lumen, and a plurality of channels formed in a wall of the first lumen. The first movable pad may divide the first lumen into a first reservoir configured to contain a first component and a second reservoir configured to contain a second component. The second pad may define a third reservoir configured to contain a third component. Actuating the plunger assembly relative to the barrel portion may first cause the diluent to be injected into the second reservoir to form a precursor, and then cause the precursor and the second component to be delivered to the needle hub.

Description

[0001] Cross-references to related applications

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 462,152, filed April 26, 2023, the disclosure of which is incorporated herein by reference. Technical Field

[0003] This disclosure generally relates to the field of devices, and associated systems and methods for delivering injectable materials and / or compositions to a patient. More specifically, this disclosure relates to devices, and associated systems and methods for combining components of injectable materials and / or compositions. Background Technology

[0004] Various forms of cancer and other diseases are treated with locally applied radiation therapy. However, radiation therapy can come with a variety of risks. Since the concept of conformal radiation therapy was introduced, physicians have been concerned about the radiation dose delivered to the target tissue and surrounding tissues. Researchers have been able to correlate side effects with the amount of tissue receiving a specific radiation dose. However, time, distance, and shielding affect the delivered dose. The shorter the time an area is exposed to radiation, the less dose is delivered. The greater the distance from radiation, the less dose is delivered. Filler materials can be injected into the treatment area to provide shielding to the tissues surrounding the target of radiation therapy. For example, a large number of men are diagnosed with prostate cancer each year. Traditionally, treatment options include interstitial implantation therapy, surgery, and external beam radiation therapy. Although the optimal treatment method remains controversial, the side effects of treating prostate cancer with implantation therapy and radiation therapy have become less toxic. Various systems deliver filler materials to the treatment site to reduce the radiation dose to the tissues surrounding the target site (e.g., shielding the rectum during radiation therapy for prostate cancer). These filler materials are often reactive and therefore are often combined / mixed just before or even during delivery to the patient.

[0005] Various systems are known for combining / mixing (e.g., in vitro) filler materials injected into radiotherapy areas. However, most such systems comprise numerous sub-components, are complex to assemble, and are prone to filler mixing errors before delivery to the treatment site within 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. Solutions to these and other problems arising from the combination and delivery of injectable materials are desirable in the art. Summary of the Invention

[0006] This overview is provided to introduce, in a simplified form, some concepts that are further described in detail below. This overview 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 each of the aspects and features of this disclosure may be advantageously used alone in some cases, or in combination with other aspects and features of this disclosure in others, whether or not described in the synopsis. The inclusion or exclusion of elements, components, etc., in the synopsis is not intended to limit the scope of the claimed subject matter.

[0007] According to certain embodiments of this disclosure, apparatus, systems, and methods for combining and / or delivering injectable materials are disclosed.

[0008] In a first example, a system for generating a mixture for delivery to a treatment site may include a needle hub and a multi-reservoir system. The multi-reservoir system may include: a plunger assembly comprising a first plunger and a second plunger; a barrel portion including a housing extending from a proximal end to a distal end, the housing including a first barrel and a second barrel, the first barrel defining a first lumen extending from the proximal end to the distal end, the first barrel including a plurality of channels formed in its inner wall, the second barrel defining a second lumen extending from the proximal end to the distal end; a first floating or movable liner disposed within the first lumen of the barrel portion, the first floating liner dividing the first lumen of the barrel portion into a first reservoir configured to receive a first component and a second reservoir configured to receive a second component; and a second floating liner disposed within the second lumen of the barrel portion, the second floating liner dividing the second lumen of the barrel portion into a fourth reservoir and a third reservoir configured to receive a third component. The actuation of the plunger assembly relative to the barrel portion can cause the first component to be injected from the first reservoir, injected through the channel, and injected into the second reservoir to mix with the second component to form a precursor, and further actuation of the plunger assembly can cause the precursor and the third component to be delivered from the second reservoir and the fourth reservoir to the needle hub, respectively.

[0009] In another example, a system for generating a mixture for delivery to a treatment site may include a needle hub and a multi-reservoir system. The multi-reservoir system may include: a plunger assembly including a first plunger and a second plunger; a barrel portion including a housing extending from a proximal end to a distal end, the housing including a first barrel and a second barrel, the first barrel defining a first lumen extending from the proximal end to the distal end, the first barrel including at least one channel configured to communicate between different locations along a length of the interior of the first barrel, the second barrel defining a second lumen extending from the proximal end to the distal end; a first floating or movable liner disposed within the first lumen of the barrel portion, the first floating or movable liner dividing the first lumen of the barrel portion into a first reservoir configured to receive a first component and a second reservoir configured to receive a second component; and a second floating liner disposed within the second lumen of the barrel portion, the second floating liner dividing the second lumen of the barrel portion into a fourth reservoir and a third reservoir configured to receive a third component. The actuation of the plunger assembly relative to the barrel portion can cause the first component to be injected from the first reservoir, injected through the channel, and injected into the second reservoir to mix with the second component to form a precursor, and further actuation of the plunger assembly can cause the precursor and the third component to be delivered from the second reservoir and the fourth reservoir to the needle hub, respectively.

[0010] In another example, a system for generating a mixture for delivery to a treatment site may include a needle hub and a multi-reservoir system. The multi-reservoir system may include: a plunger assembly comprising a first plunger and a second plunger; a barrel portion including a housing extending from a proximal end to a distal end, the housing including a first barrel and a second barrel, the first barrel defining a first lumen extending from the proximal end to the distal end, the first barrel including a plurality of channels formed in its inner wall, the second barrel defining a second lumen extending from the proximal end to the distal end; a first floating liner disposed within the first lumen of the barrel portion, the first floating liner dividing the first lumen of the barrel portion into a first reservoir configured to receive a first component and a second reservoir configured to receive a second component; and a second liner disposed within the second lumen of the barrel portion, the second liner defining a third reservoir configured to receive a third component. The actuation of the plunger assembly relative to the barrel portion can cause the first component to be injected from the first reservoir, injected through the channel, and injected into the second reservoir to mix with the second component to form a precursor, and further actuation of the plunger assembly can cause the precursor and the third component to be delivered from the second reservoir and the third reservoir, respectively, into the needle hub.

[0011] As an alternative to or supplement to any of the above examples, in another example, at least one or more channels may extend to be less than the entire length of the first lumen.

[0012] As an alternative to or supplement to any of the above examples, in another example, prior to the actuation plunger assembly, the distal end of the first floating or movable liner may be located proximal to the proximal end of at least one or more channels.

[0013] As an alternative or supplement to any of the above examples, in another example, actuating the plunger assembly relative to the barrel portion to inject the first component into the second reservoir can actuate the first floating liner, such that the first floating or movable liner is adjacent to at least one or more channels.

[0014] As an alternative or supplement to any of the above examples, in another example, the system may further include a first removable retainer positioned between a proximal end of the plunger assembly and a proximal end of the barrel portion, the first removable retainer restricting movement of the plunger assembly relative to the barrel portion to a first length configured to inject a first component into a second reservoir.

[0015] As an alternative or supplement to any of the above examples, in another example, the system may further include a second removable retainer positioned between the proximal end of the plunger assembly and the proximal end of the barrel portion and proximal to the distal end of the first retainer, the second removable retainer restricting movement of the plunger assembly relative to the barrel portion to a second length configured to purge any air that may be present from the second and third or fourth reservoirs.

[0016] As an alternative to or supplement to any of the above examples, in another example, the system may further include a cap that is removably coupled to the distal end region of the cylindrical portion.

[0017] As an alternative to or supplement to any of the above examples, in another example, the cap may include at least one cavity configured to receive fluid from a second, third, and / or fourth reservoir.

[0018] As an alternative to or supplement to any of the above examples, in another example, the plunger assembly may be configured to be at least partially actuated, wherein the cap is coupled to the distal end region of the barrel portion.

[0019] As an alternative to or supplement to any of the above examples, in another example, the system may further include a needle configured to be coupled to a needle hub.

[0020] As an alternative or supplement to any of the above examples, in another example, the needle hub may include a first lumen in fluid communication with a second reservoir of the barrel portion, a second lumen in fluid communication with a third or fourth reservoir of the barrel portion, a central lumen configured to be in fluid communication with the needle, and a mixing region connecting the first lumen and the second lumen to the central lumen.

[0021] As an alternative to or supplement to any of the above examples, in another example, the needle hub may be removably coupled to the distal end region of the cylinder portion of the multi-reservoir system.

[0022] In another embodiment, a method of generating a mixture using a mixing system for delivery to a treatment site may include: actuating a plunger assembly within a barrel portion by a first length to move a first component from a first reservoir in the barrel portion to a second reservoir in the barrel portion to form a precursor, wherein the first component is a fluid component; actuating the plunger assembly within the barrel portion by a second length to remove air and / or excess fluid from the barrel portion; coupling a needle hub having a mixing region to a distal end of the barrel portion; and actuating the plunger assembly to move the precursor and a second component disposed in a third reservoir in the barrel portion to a mixing region of the needle hub to form an injectable mixture, wherein the second component is a fluid component.

[0023] As an alternative to or supplement to any of the above examples, in another example, the method may further include removing a first retainer from the plunger assembly before actuating the plunger assembly to remove air and / or excess fluid from the cylinder portion.

[0024] As an alternative to or supplement to any of the above examples, in another example, the method may further include removing the second retainer from the plunger assembly before actuating the plunger assembly to move the precursor and the second component.

[0025] As an alternative to or supplement to any of the above examples, in another example, the method may further include removing the cap from the distal end of the barrel portion before attaching the needle hub to the distal end of the barrel portion.

[0026] In another example, a kit for producing a mixture for delivery to a treatment site may include a multi-reservoir system, a needle hub, and a needle coupled to the needle hub. The multi-reservoir system may include: a plunger assembly including a first plunger and a second plunger; a barrel portion including a housing extending from a proximal end to a distal end, the housing including a first barrel and a second barrel, the first barrel defining a first lumen extending from the proximal end to the distal end, the first barrel including a plurality of channels formed in its inner wall, the second barrel defining a second lumen extending from the proximal end to the distal end; a first floating liner disposed within the first lumen of the barrel portion, the first floating liner dividing the first lumen of the barrel portion into a first reservoir configured to receive a first component and a second reservoir configured to receive a second component; and a second liner disposed within the second lumen of the barrel portion, the second liner dividing the second lumen of the barrel portion into a fourth reservoir and a third reservoir configured to receive a third component.

[0027] In another example, a kit for producing a mixture for delivery to a treatment site may include a multi-reservoir system, a needle hub, and a needle coupled to the needle hub. The multi-reservoir system may include: a plunger assembly comprising a first plunger and a second plunger; a barrel portion including a housing extending from a proximal end to a distal end, the housing including a first barrel and a second barrel, the first barrel defining a first lumen extending from the proximal end to the distal end, the first barrel including a plurality of channels formed in its inner wall, the second barrel defining a second lumen extending from the proximal end to the distal end; a first floating liner disposed within the first lumen of the barrel portion, the first floating liner dividing the first lumen of the barrel portion into a first reservoir configured to receive a first component and a second reservoir configured to receive a second component; and a second liner disposed within the second lumen of the barrel portion, the second liner defining a third reservoir configured to receive a third component.

[0028] As an alternative to or supplement to any of the above examples, in another example, the kit may further include a first removable retainer positioned between the proximal end of the plunger assembly and the proximal end of the barrel portion, the first removable retainer restricting movement of the plunger assembly relative to the barrel portion to a first length configured to inject a first component into a second reservoir.

[0029] As an alternative or supplement to any of the above examples, in another example, the kit may further include a second removable retainer positioned between the proximal end of the plunger assembly and the proximal end of the barrel portion and distal to the proximal end of the first retainer, the second removable retainer restricting movement of the plunger assembly relative to the barrel portion to a second length configured to purge air from a second reservoir and a third or fourth reservoir.

[0030] As an alternative to or supplement to any of the above examples, in another example, the kit may further include a cap that is removably coupled to the distal end region of the cylindrical portion.

[0031] As an alternative to or supplement to any of the above examples, in another example, the kit may further include a connector configured to attach the needle hub to the syringe.

[0032] These and other features and advantages of this disclosure will become clear from the following detailed description, and the scope of the claimed invention is set forth in the appended claims. Although the following disclosure is presented by way of aspect or embodiment, it should be understood that aspects may be claimed individually or in combination with aspects and features of that embodiment or any other embodiment. Attached Figure Description

[0033] Non-limiting embodiments of the present disclosure have been 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 provided for illustrative purposes only, and the dimensions, positions, orders, and relative sizes reflected in the figures may vary. For example, the device may be enlarged to make details discernible, but is intended to be scaled down relative to ease of injection into a patient. For clarity and simplicity, not every element is labeled in every figure, nor is every element of every embodiment shown; in this case, the illustrations are unnecessary 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 simplicity, these figures are described with reference only to the other figures.

[0034] The detailed description will be better understood in conjunction with the accompanying drawings, in which the same reference numerals denote the same elements, as follows:

[0035] Figure 1 An exploded perspective view of an exemplary mixing system for mixing injectable materials is depicted;

[0036] Figure 2A Depicting in Figure 1 A cross-sectional view of the multi-memory system taken at line 2A-2A;

[0037] Figure 2B Depicting in Figure 1 A cross-sectional view of the multi-memory system taken at line 2B-2B;

[0038] Figure 3 Depicting in Figure 1 A cross-sectional view of the multi-memory system taken at line 3-3;

[0039] Figure 4 A side view of a multi-storage system is depicted, in which the plunger assembly is axially displaced;

[0040] Figure 5 A side view of an exemplary multi-storage system being shaken is depicted;

[0041] Figure 6 A perspective view of an exemplary multi-store system is depicted, in which the first holder is removed;

[0042] Figure 7 A side view of an exemplary multi-storage system is depicted, in which air / excess fluid is purged;

[0043] Figure 8 A side view of an exemplary multi-store system is depicted, in which the cap has been removed;

[0044] Figure 9 A perspective view of an exemplary multi-store system is depicted, in which the second holder is removed;

[0045] Figure 10A An exploded perspective view of an exemplary injection system and a saline injector is depicted;

[0046] Figure 10B A perspective view depicting an assembled exemplary injection system and saline syringe is shown;

[0047] Figure 10C A perspective view depicting an unassembled exemplary injection system and a saline syringe is shown;

[0048] Figure 11 A perspective view of the unassembled injection system and the multi-reservoir system is depicted;

[0049] Figure 12 A side view of the assembled injection system and multi-reservoir system is depicted;

[0050] Figure 13 Depicting in Figure 12 A cross-sectional view of the assembled injection system and multi-reservoir system taken at line 13-13;

[0051] Figure 14A side view depicts the assembled injection system and multi-reservoir system in a dispensing configuration; and

[0052] Figure 15 Depicting in Figure 14 A cross-sectional view of the assembled injection system and multi-reservoir system in its assigned configuration, taken at line 15-15.

[0053] While this disclosure is adaptable to various modifications and alternatives, its details have been illustrated by way of example in the accompanying drawings and will be described in detail. However, it should be understood that it is not intended to limit the invention to the specific embodiments described. Rather, the invention is intended to cover all modifications, equivalents, and alternatives falling within the spirit and scope of this disclosure. Detailed Implementation

[0054] 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 such embodiments can vary. All devices, systems, and methods discussed herein are examples of devices 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 examples of embodiments of this disclosure and should not be construed as limiting this disclosure to the specific elements, structures, or features illustrated. Other examples of ways of implementing the disclosed principles will conceive of those skilled in the art upon reading this disclosure. Indeed, it will be apparent to those skilled in the art 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 one embodiment may be used with another embodiment to produce yet another embodiment. Therefore, this subject matter is intended to cover such modifications and variations falling within the scope of the appended claims and their equivalents.

[0055] It should be understood that this disclosure is set forth in various levels of detail throughout this application. In some cases, details that are unnecessary for those skilled in the art to understand this disclosure or that make other details imperceptible may have been omitted. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limited beyond the scope of the appended claims. Unless otherwise defined, the technical terms used herein should be understood as those commonly understood by those skilled in the art to which this disclosure pertains. All apparatuses and / or methods disclosed and claimed herein according to this disclosure can be made and performed without excessive experimentation.

[0056] As used herein, “proximal” refers to the direction or position closest to the user (medical professional, clinician, technician, operator, or physician, etc., such terms are used interchangeably herein without limitation and include automated control systems or others) and / or closest to the delivery device, for example, when using the device (e.g., introducing the device into a patient, or during implantation, positioning, or delivery). “Distal” refers to the direction or position furthest from the user and / or closest to the delivery device, for example, when using the device (e.g., introducing the device into a patient, or during implantation, positioning, or delivery). “Longitudinal” means extending along the longer or larger dimension of the element. “Longitudinal axis” extends along the longitudinal extent of the element but is not necessarily straight and does not necessarily maintain a fixed configuration if the element flexes or bends. “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 approximately bisects the center point and / or is approximately equidistant from the periphery or boundary, while "central axis" refers to a line that, relative to the opening, at least approximately 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 borehole. As used herein, "cavity," "channel," "borehole," or "access" is not limited to a circular cross-section. As used herein, the "free end" of an element is the terminal end beyond which such an element does not extend. It should be understood that, unless otherwise stated, terms such as at an end, on an end, adjacent to an end, or along an end may be used interchangeably herein without limitation and are intended to indicate general relative spatial relationships rather than precisely limited locations.

[0057] Various medical procedures involve the delivery (e.g., injection) of injectable materials into the body before, during, or after the procedure. 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 forming “blisters” or other raised or swollen areas), separating anatomical structures from one another, otherwise influencing (e.g., masking, coating, covering, modifying, etc.) anatomical structures, and so on. It should be understood that the term “tissue” is a broad term that includes 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, reference may be made herein to “target,” which refers to an area in the patient’s body for which a procedure is to be performed. However, it should be understood that such references should be understood broadly and are not intended to be limited to tissues or specific procedures. Finally, references may be made 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 not intended to be restrictive.

[0058] Certain specific aspects of this disclosure relate to placing injectable materials between target tissue and other tissues. For convenience and without limitation, an injectable material, such as a filler, including but not limited to gel compositions, is mentioned. The injectable material can be delivered within a patient to displace tissue relative to tissue to be treated by a treatment procedure or otherwise (e.g., not necessarily therapeutically). Certain aspects of this disclosure include displacing and / or shielding tissue to protect it 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 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, thus exposing the other tissues to less radiation and / or shielding them from radiation. In some aspects, the injectable material is injected as a filler into the space between tissues. The first tissue can then be treated by radiation, while the injectable material reduces radiation penetration through the first tissue into the second tissue. The first tissue can be irradiated, while the second tissue, separated by the injectable material, receives less radiation than it would in the absence of the injectable material. An effective amount of injectable material can be injected into the space between the first tissue to be treated and a second tissue that may be an extremely sensitive organ. For example, in the case of treating prostate cancer, the injectable material can be injected into the space in Denonvilliers (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 the rectal radiation dose and associated side effects.

[0059] 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 and injected into or near the target site. It should be understood that, unless otherwise indicated, terms such as combination, mixing, blending, etc. (including their other grammatical forms) may be used interchangeably herein without limitation. Therefore, the combination system is generally referred to herein without specifically requiring active combination / mixing.

[0060] 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 defined as a substance formed when a polymer (natural or synthetic) is crosslinked via covalent, ionic, or hydrogen bonds to form a three-dimensional structure that traps water molecules to form a gel. Polymers, polymer mixtures, and copolymers that form naturally occurring and synthetic hydrogels can be used as hydrogel precursors. In some aspects, hydrogels may be formed from compositions 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, alginates or salts thereof (e.g., calcium alginate, 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.

[0061] 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 an injectable material to 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 into a patient to cause displacement of said tissue relative to tissue to be treated by a treatment procedure or otherwise (e.g., not necessarily therapeutically). 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 formed according to various principles of this disclosure. According to various principles of this disclosure, the composition to be injected into a patient can be a combination of two or more components, such as those combined by means of devices, systems, or methods formed 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 to be combined with additional components to form an injectable compound. The second component can be a promoter, activator, catalyst, initiator, etc., which, when combined with a precursor, generates an injectable compound, for example, by altering the chemical composition or structure of the first component or precursor. The components can be combined prior to delivery (e.g., injection) (e.g., immediately before delivery) or while the component is being delivered to the patient, so that the injectable material does not have time to form a structure that might be difficult to inject or otherwise deliver to the patient. Therefore, the combination of the first component or precursor with the second component allows the injectable compound to acquire its desired properties and / or reach its final form in situ.

[0062] In some embodiments, the injectable material is formed from a first component, a second component, and a third component. For example, it may be desirable to provide the first precursor component in solid form (e.g., for greater stability for storage and / or transport) for various reasons. The first component may be combined with the third component, and once a healthcare professional is ready to deliver (e.g., inject) the injectable material to a patient, the resulting combination (which may be referred to as the precursor) may be combined with the second component. The second component may facilitate the crosslinking interaction between the first and third components, for example, by initiating or accelerating the crosslinking interaction between the first and third components. Typically, one or more of the components of the injectable material are biocompatible polymers. In some aspects, one of the first, second, or third components is a reactive polymer, such as a crosslinkable and / or hydrophilic polymer component (e.g., polyethylene glycol (PEG)), and one of the first, second, or third components is a diluent (e.g., primarily water), in which the reactive polymer in solid or semi-solid form is dissolved or dispersed, and / or the reactive polymer is crosslinked (or at least crosslinkable, such as when further combined with the second component) to form the precursor. The other of the first, second, or third component can be a promoter, accelerator, activator, catalyst, initiator, etc. (such terms are used interchangeably herein and are not intended to be limiting), which can be combined with and react with the precursor to form the desired injectable material. In one example of the embodiment, under acidic pH conditions, the first component, in the form of a reactive polymer (specifically, PEG) derived from a reactive electrophilic group (specifically, succinimidyl ester group), is mixed with the third component in the form of a crosslinking agent (specifically, trilysine, which contains multiple nucleophilic groups, specifically, amino groups), wherein the succinimidyl ester group and the amino group do not react to any significant degree. When this mixture is combined with the second component in the form of an accelerator (specifically, an alkaline buffer solution), the resulting mixture becomes alkaline, at which point the amino group of the trilysine reacts with the succinimidyl ester group of the PEG to form a covalent bond, thereby crosslinking the PEG and forming a hydrogel. It should be understood that references to "first," "second," or "third" are not intended to imply a particular property of the material or the order of the material combination. Therefore, "first," "second," and "third" can be used to refer to any one of the three components that form the injectable material according to the various principles of this disclosure. Non-limiting examples of such components that can be combined by means, systems, or methods according to the various principles of this disclosure include reactive components, diluents with which the reactive components will be combined to form precursors, and promoters that can be combined with precursors to form the injectable material. Injectable materials are biocompatible materials, such as polymeric materials, fillers, or hydrogels.

[0063] In some examples, 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 example of the embodiments, the first component is a biocompatible polymer component. More specifically, in one example of the embodiments, the first 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; and synthetic hydrophilic polymers such as polyethylene glycol (PEG), PEG methacrylates, PEG methyl methacrylate, polyvinyl alcohol, polyacrylates and polymethacrylates, polyacrylic acid and its salts, polymethacrylic acid and its salts, polymethyl methacrylate, carboxymethyl cellulose, hydroxyethyl cellulose, polyvinylpyrrolidone, and polyacrylamide, 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 suitable crosslinking agents, which can be covalent or ionic crosslinking agents.

[0064] The concentration of the gelling agent in the composition formed according to the 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 of the gelling agent by weight relative to the total weight of the composition may be in the range of about 0.02% to about 1.5%, about 0.05% to about 1.0%, about 0.05% to about 0.50%, about 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%. In at least one example, the total concentration of the gelling agent in the composition may be in the range of about 0.05% to about 0.5% by weight, relative to the total weight of the composition.

[0065] In some examples, compositions formed according to various principles of this disclosure are in 130 s -1 At shear rates of 130 s, it can have a viscosity of at least about 0.001 Pa·s and at most about 0.100 Pa·s. For example, at 130 s -1At a certain shear rate, the viscosity of the composition can range 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 0.010 Pa·s to 0.030 Pa·s, from about 0.020 Pa·s to about 0.030 MPa·s, or from about 0.020 Pa·s to about 0.040 Pa·s. Therefore, for example, the composition can be or is contained in a shear rate of 130 s⁻¹. -1 The viscosities at the shear rates were approximately 0.005 Pa·s, approximately 0.006 Pa·s, 0.008 Pa·s, approximately 0.010 Pa·s, approximately 0.011 Pa·s, approximately 0.012 Pa·s, approximately 0.013 Pa·s, approximately 0.014 Pa·s, approximately 0.015 Pa·s, approximately 0.016 Pa·s, approximately 0.017 Pa·s, approximately 0.018 Pa·s, approximately 0.019 Pa·s, approximately 0.020 Pa·s, approximately 0.022 Pa·s, approximately 0.024 Pa·s, approximately 0.026 Pa·s, approximately 0.028 Pa·s, approximately 0.030 Pa·s, approximately 0.032 Pa·s, approximately 0.034 Pa·s, approximately 0.036 Pa·s, approximately 0.038 Pa·s, and approximately 0.040 Pa·s. Gels of approximately 0.042 Pa·s, approximately 0.044 Pa·s, approximately 0.046 Pa·s, approximately 0.048 Pa·s, and approximately 0.050 Pa·s. In at least one example, the composition was in the form of gels at 130 s. -1 It can have a viscosity greater than 0.0050 Pa·s at a shear rate, 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 130 s⁻¹. -1 It can have a viscosity greater than 0.010 Pa·s at a shear rate, 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.

[0066] Alternatively or additionally, compositions formed according to various principles of this disclosure are in 768 s -1 At a shear rate of 768 s, it can have a viscosity of at least about 0.001 Pa·s and at most about 0.050 Pa·s. For example, at 768 s -1At a certain shear rate, the viscosity of the composition can range from about 0.002 Pa·s to about 0.030 Pa·s, from about 0.003 Pa·s to about 0.020 Pa·s, from about 0.004 Pa·s to 0.010 Pa·s, from about 0.004 Pa·s to 0.006 Pa·s, from about 0.005 Pa·s to 0.007 Pa·s, from about 0.006 Pa·s to about 0.008 MPa·s, from about 0.007 Pa·s to about 0.009 MPa·s, or from about 0.008 Pa·s to about 0.01 Pa·s. Therefore, for example, the composition can be or is contained in a 768 s... -1 The composition exhibits a gel viscosity of approximately 0.003 Pa·s, approximately 0.004 Pa·s, 0.005 Pa·s, approximately 0.006 Pa·s, approximately 0.007 Pa·s, approximately 0.008 Pa·s, approximately 0.009 Pa·s, or approximately 0.010 Pa·s at a given shear rate. In at least one example, the composition exhibits a viscosity of approximately 0.003 Pa·s, approximately 0.004 Pa·s, approximately ... -1 It can have a viscosity of less than 0.010 Pa·s at a shear rate, for example, at 768 s. -1 At 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 range of 768 s⁻¹. -1 The composition can have a viscosity ranging from about 0.004 Pa·s to about 0.010 Pa·s at certain shear rates. Furthermore, for example, the composition exhibits a viscosity at 130 s⁻¹. -1 At a shear rate, it can have a viscosity ranging from about 0.010 Pa·s to about 0.030 Pa·s, for example about 0.017 Pa·s, and at 768 s... -1 It can have a viscosity ranging from about 0.004 Pa·s to about 0.010 MPa·s, for example, about 0.007 Pa·s, at a certain shear rate.

[0067] In some embodiments, the multi-reservoir system includes separate reservoirs for components to be combined to form an injectable material to be delivered to a patient via an injection system. In some embodiments, a first component and a second component are respectively housed separately in a first reservoir and a second reservoir of the multi-reservoir device. A third component may be housed in a separate reservoir defining a third reservoir of the multi-reservoir system. To deliver the injectable material, the components of the first and second reservoirs are combined within the second reservoir (e.g., to form a precursor), and then the components of the second and third reservoirs are injected together into the patient. The multi-reservoir device may or may not mix the contents of the second and third reservoirs. For example, the multi-reservoir device may deliver and inject components of the injectable material into an injection system, wherein the injection system includes a mixer component configured to mix the contents of the second reservoir from the multi-reservoir device and the contents of the third reservoir from the multi-reservoir device as they are injected into the patient from the multi-reservoir device and the injection system. The first, second, and third components, which have already been combined, are combined to form the desired form, structure, composition, properties, etc., of an injectable material to be delivered and deposited in the patient's body. Once the combined components are in the patient's body, the final form, structure, composition, properties, etc., of the injectable material are obtained.

[0068] This disclosure provides apparatus, systems, and methods for combining components to form injectable compositions, and corresponding medical devices, systems, and methods for their use and / or delivery to a patient's treatment site. According to some aspects of this disclosure, such as those described above, a multi-reservoir system may include multiple reservoirs for one or more components of an injectable material and combinations of such components. 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 for containing, delivering, holding, transporting, collecting, etc., components (fluids, particles, liquids, solids, gases, etc.) of an injectable material. 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 suitable injection systems. Examples of materials suitable for reservoirs used in the systems or apparatus 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 have a coating applied thereto (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.

[0069] Combination devices or systems for combining two or more components to form an injectable material, formed according to various principles of this disclosure, may include and / or be removably connected to one or more injection systems configured to deliver the injectable material to a patient. According to some aspects of this disclosure, filler compositions (e.g., compositions prepared by various devices, systems, and methods disclosed herein) that can be used with the various systems disclosed herein may have sufficient strength (e.g., gel strength) to withstand forces on the continuity of the composition's three-dimensional configuration (e.g., gel network), thereby minimizing the effects of such forces. Simultaneously, compositions having sufficient strength to withstand forces thereon may have a viscosity suitable for injection, e.g., a viscosity that does not cause the composition to become stuck in a reservoir, delivery lumen, needle, or other structure in which the composition is contained or through which it passes. According to some aspects of this disclosure, the composition may retain its three-dimensional structure until the composition is injected into a patient (e.g., via a needle), after which the structure may form fragments of the original continuous three-dimensional network. These fragments can have a diameter corresponding to the diameter of the lumen they pass through in the patient's body (e.g., the lumen of an injection needle), such that the fragments are as large as possible in the body to preserve as much of the composition's three-dimensional structure as possible. It is believed that injecting these larger particles or fragments increases the amount of time the gel remains in the tissue.

[0070] In some examples, the injection system includes a needle. In some embodiments, the needle may be a hypodermic needle and may range in size from 7 (outer diameter (OD) 4.57 mm, inner diameter (ID) 3.81 mm) to 33 (OD 0.18 mm, ID 0.08 mm), such as 16 (OD 1.65 mm, ID 1.19 mm), 18, 21 (OD 0.82 mm, ID 0.51 mm), 22 (OD 0.72 mm, ID 0.41 mm), 23 (OD 0.64 mm, ID 0.33 mm), or 24 (OD 0.57 mm, ID 0.31 mm). According to some aspects of this disclosure, the needle size may be selected based on the viscosity and / or composition 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) and 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 located between the needle tip and the proximal fitting / adapter.

[0071] 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 passage through a lumen sized to inject the material into the patient. The amount of force required to move the composition through the needle orifice (often described 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 amount of force can be applied to inject the composition through a 33-gauge needle compared to a 7-gauge needle. Other factors that may affect the amount of force applied to inject the composition may include the size of the conduit (inner diameter, outer diameter, and / or length) that connects the mixing system to the needle. Suitable peak loads for injections using one or both hands can range from about 5 lb-f to about 25 lb-f, such as 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.

[0072] According to some aspects of this disclosure, the needle size can be selected based on the viscosity and / or composition of the composition, and vice versa. According to some aspects of this disclosure, the needle size can be 23 or 25. In some cases, larger sizes such as 18, 20, 21, or 22 can be used to inject the compositions disclosed herein.

[0073] According to some aspects of this disclosure, a combination device or system can be included in a kit for introducing injectable material into a patient, whereby the injectable material can include any of a variety of suitable compositions. The kit or system can be configured to store one or more components of the composition until a healthcare professional is ready to mix the composition for delivery to the patient. For example, the composition (such as a hydrogel) can be prepared such that the precursor and any associated activator are stored in the kit along with any diluents that may be required. An applicator can be used in conjunction with it. Kits formed according to various principles of this disclosure can be manufactured using medically acceptable conditions and contain components having sterility, purity, and pharmaceutically acceptable formulation. Solvents / solutions can be provided in the kit or separately. The kit can include one or more syringes and / or needles for mixing and / or delivering the injectable material, and / or additional aspects of the procedure for using the injectable material. The kit or system can include various components as set forth herein. For example, the target site to which the injectable material is to be delivered can be pretreated using one or more components of the kit. An example of pretreatment 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 has been 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 has been injected into the space between the rectum and the prostate, an ultrasound image can be obtained.

[0074] According to various principles of this disclosure, combination and / or delivery systems are configured to facilitate the combination of components of injectable materials. In some aspects, the injectable material is a combination of a first component, a second component, and a third component, as described above. Combination and / or delivery systems formed according to various principles of this disclosure facilitate the combination / mixing of various components of the injectable material. Additionally or alternatively, combination and / or delivery systems formed according to various principles of this disclosure facilitate the delivery of injectable materials to an injection system configured to deliver (e.g., inject) and / or deposit the injectable material into a patient (e.g., to a target site within the patient). More specifically, various aspects of this disclosure simplify the assembly, alignment, mixing, dispensing, etc., of injectable materials composed of or blended or mixed from individual components prior to delivery to a patient.

[0075] In some aspects, the combination and / or delivery system formed according to various principles of this disclosure includes three distinct lumens, chambers, or reservoirs for a first, second, and third component of an injectable material to be delivered and injected into a patient. This disclosure facilitates the combination of separately provided first and third components prior to a procedure, as well as the combination of the most recently combined first and third components with a second component for injection into a patient. Specifically, examples of embodiments of the mixing and / or delivery systems disclosed herein include combination systems configured to facilitate the combination of the first, second, and third components of the injectable material prior to delivery to a patient. As mentioned above, it may be desirable to provide the first, second, and third components separately so that they can be combined only when performing surgery using the injectable material formed by combining the first, second, and third components.

[0076] Turn to the attached diagram. Figure 1 An exploded perspective view of an exemplary combination and / or delivery system 100 for mixing injectable materials according to certain aspects of this disclosure is depicted. In some embodiments, the combination and / or delivery system 100 may be provided as a kit, which may include, but is not limited to, a needle assembly or injection system 102 releasably attached to a multi-reservoir system 104, a first component 106 disposed within a chamber or lumen of the multi-reservoir system 104, a second component 108 disposed within another chamber or lumen of the multi-reservoir system 104, and a third component 110 disposed within yet another chamber or lumen of the multi-reservoir system 104. The multi-reservoir system 104 may be used to transport components 106, 108, 110 of the injectable material to sites and / or locations within a patient to which the injectable material will be delivered. For convenience and without limitation, reference may be made to delivery by injection into a patient (e.g., delivery of the injectable material to a patient by injection into the patient), although this disclosure is not intended to be so limiting. As described above, the first component 106, the second component 108, and the third component 110 can be mixed or combined during treatment to form an injectable material.

[0077] The injection system 102 may include a needle 112, which may be any needle of the present disclosure suitable for water separation and delivery of injectable materials (e.g., gel compositions) to a treatment site. A proximal end 114 of the needle 112 may be connected to a distal end 118 of a needle hub 116 (e.g., the needle 112 may be overmolded to connect to the needle hub 116). A proximal end 120 of the needle hub 116 may be attached to a distal end of a connector 122. In some embodiments, it is envisioned that the needle 112 may be replaced with a catheter, tube, or similar structure to reach deeper target locations within the body.

[0078] The multi-reservoir system 104 of the entire system 100 typically includes a plunger assembly 124, a barrel portion 126, a cap 128, a first retainer 130, and a second retainer 132. In short, the distal portion of the plunger assembly 124 may be slidably disposed within the proximal portion of the barrel portion 126. The plunger assembly 124 may be configured to actuate to dispense a third component 110 from one reservoir into another reservoir containing the first component, to first mix the two components 106, 110 to form a precursor, which is then mixed with an accelerator 108 to form an injectable composition. In some cases, at least some of the mixing may occur within the multi-reservoir system 104, and some of the mixing may occur within the injection system 102, as will be described in more detail herein.

[0079] For further reference Figure 2A (The figure depicts in) Figure 1 (Cross-sectional view of the multi-memory system 104 taken at line 2A-2A) and Figure 2B (The figure depicts in) Figure 1(A cross-sectional view of the multi-reservoir system 104 taken at line 2B-2B) The plunger assembly 124 may extend from a generally planar proximal end 134 to a distal end 136. The proximal end 134 may define a flange or actuating member 135 for depressing or actuating the plunger assembly 124. In some cases, the surface of the actuating member 135 may include textures, such as, but not limited to, raised ridges, etc., to improve the gripability of the proximal end 134. A first plunger 138a and a second plunger 138b may extend distally from the actuating member 135 to the distal end 136. The first plunger 138a and the second plunger 138b may be laterally spaced from each other to define a gap 137 therebetween. In some cases, the plungers 138a, 138b may change shape from their proximal end to their distal end. For example, the plungers 138a, 138b may have a first cross-sectional shape adjacent to their proximal end and a different second cross-sectional shape adjacent to their distal end. In some cases, the first cross-sectional shape may be a plus sign (e.g., +), while the second cross-sectional shape may be approximately semi-circular. These are merely examples. Other cross-sectional shapes may be used as desired. It is conceivable that the cross-sectional shape of the distal ends of plungers 138a, 138b may depend at least in part on the cross-sectional shape of the lumens 148a, 148b of the barrel portion 126. For example, the cross-sectional shape of the distal ends of plungers 138a, 138b may be selected to substantially conform to the inner surfaces of the lumens 148a, 148b of the barrel portion 126 in order to provide a fluid tight seal between them. Although the first plunger 138a and the second plunger 138b are shown as coupled to and extending from the actuating member 135, in some examples, the first plunger 138a and the second plunger 138b may be coupled to separate actuating members to allow the first plunger 138a and the second plunger 138b to be actuated independently of each other.

[0080] The first plunger 138a may include a seal 140a fixed to its distal end. The seal 140a may be configured to provide a fluid tight seal between the first plunger 138a and the barrel portion 126. In some embodiments, the plunger assembly 124 may be formed as a single, integral structure. In other embodiments, the plunger assembly 124 may be formed as two or more distinct components that are subsequently coupled together or actuated independently. In some cases, the actuating member 135, as well as the first plunger 138a and the second plunger 138b, may be formed as a single, integral structure, and the seal 140a may be provided as a separate component. This is merely an example. Other configurations may be used as desired.

[0081] The barrel portion 126 may include a body portion 127 extending from a proximal end 142 to a distal end 144. In some examples, the proximal end 142 may include a flange 141 configured to provide a gripping area to allow a user to actuate or advance the plunger assembly 124 relative to the barrel portion 126. The body portion 127 may include a first barrel 146a and a second barrel 146b. The first barrel 146a and the second barrel 146b may extend side-by-side and may be interconnected by a connecting portion 145 adjacent to their proximal ends and laterally spaced near their distal ends. The first barrel 146a may define a first lumen 148a, and the second barrel 146b may define a second lumen 148b. The first lumen 148a and the second lumen 148b may each extend from the proximal openings 150a, 150b adjacent to the proximal end 142 through the body portion 127 to the distal openings 152a, 152b adjacent to the distal end 144 of the cylinder portion 126. In some cases, the first lumen 148a and the second lumen 148b may have the same cross-sectional shape and / or dimensions along their length. For example, the first lumen 148a and the second lumen 148b may have a generally semi-circular or "D"-shaped cross-sectional shape along their length. However, this is not required. The first lumen 148a and the second lumen 148b may take other cross-sectional shapes as desired.

[0082] Proximal openings 150a, 150b can be selectively fluid isolated from distal openings 152a, 152b via plugs or gaskets 154a, 154b. In some embodiments, plugs 154a, 154b can be floating gaskets that are not fixedly connected to any part of the plunger assembly 124 or the barrel portion 126. Floating gaskets 154a, 154b can form a fluid-tight seal with the inner surface of the barrel portion 126. A first floating gasket 154a can be positioned within a first lumen 148a, between the proximal opening 150a and the distal opening 152a of the first lumen. The first floating gasket 154a can selectively fluid isolate the proximal and distal end regions of the first lumen 148a to form a first reservoir 156a for containing a third component 110 or a diluent and a second reservoir 156b for containing a first component 106 or PEG. For example, the seal 140a of the first plunger 138a and the first floating gasket 154a may define a first reservoir 156a, while the first floating gasket 154a and the distal opening 152a may define a second reservoir 156b. Similarly, the second floating gasket 154b may selectively fluidly isolate the proximal and distal end regions of the second lumen 148b to form a cavity 156c and a third reservoir 156d for containing the second component 108 or the promoter. For example, the distal end of the second plunger 138b and the second floating gasket 154b may define the cavity 156c, while the second floating gasket 154b and the distal opening 152b may define the third reservoir 156d. It is conceivable that the cavity 156c may not be sealed and may not contain components of injectable material. Therefore, the distal end of the second plunger 138b may not have a seal or plug. However, if it is desired to store components in cavity 156c, the second plunger 138b may include a seal similar to seal 140a. In some examples, the second floating gasket 154b may be omitted and replaced by a plunger / gasket actuated only after a first drive distance of the first plunger 138a. In other examples, the second plunger 138b may be provided with a seal or gasket configured to define the third reservoir 156d.

[0083] It is conceivable that the first reservoir 156a, the second reservoir 156b, and the third reservoir 156d can be selectively fluid isolated from each other. Furthermore, the third reservoir 156d can be fluidly isolated from the cavity 156c. In some cases, the body portion 127 may define a wall 157 between the first cylinder 146a and the second cylinder 146b to fluidly isolate the cavities 148a, 148b of the first and second cylinders. In some embodiments, the cross-sectional dimensions of the second reservoir 156b and the third reservoir 156d may decrease from the proximal end of the cylinder portion 126 to the distal end 144 of the cylinder portion. The cross-sectional dimensions may decrease abruptly in a stepped manner to form a discrete transition in the cross-sectional dimensions, or the cross-sectional dimensions may gradually taper. In some embodiments, the cylinder portion 126 may be formed as a single integral structure. In other embodiments, the cylinder portion 126 may be formed as two or more distinct components that are subsequently joined together.

[0084] Storage units 156a, 156b, and 156d can be sized to accommodate the desired volumes of the respective components 106, 108, and 110. In some examples, the volume of at least some of storage units 156a, 156b, and 156d can increase or decrease as components 106, 108, and 110 move within the multi-storage system 104.

[0085] For further reference Figure 3 (It describes in) Figure 1(A cross-sectional view of the multi-reservoir system 104 taken at line 3-3). The first cylinder 146a may include a plurality of channels 184a-e formed in its inner wall. Although the first cylinder 146a is shown as including five channels 184a-e, it is contemplated that the first cylinder 146a may include fewer or more channels as desired. It is further contemplated that the size and / or shape of the channels 184a-e may vary to achieve a desired flow path. Each channel 184a-e may extend from the proximal end 186 to the distal end 188. The channels 184a-e may extend less than the entire length of the first lumen 148a. In some examples, the channels 184a-e may have a length longer than the length of the first floating liner 154a. In some embodiments, prior to actuating the plunger assembly 124, the proximal end 186 of the channels 184a-e may be positioned distal to the first floating liner 154a, such that the first floating liner 154a can form a fluid-tight seal with the internal surface of the first cylinder 146a (e.g., with the wall of the first lumen 148a). When the plunger assembly 124 is actuated or advanced distally, the first floating liner 154a may also be actuated or advanced distally due to the force of the fluid in the first reservoir 156a on the distal end of the first floating liner 154a. When the first floating liner 154a is axially aligned with the channels 184a-e, the seal between the wall of the first cylinder 146a and the first floating liner 154a may be broken, and a flow path may be formed between the first reservoir 156a and the second reservoir 156b via the plurality of channels 184a-e. This allows the third component 110 to be selectively dispensed from the first storage 156a to the second storage 156b to mix the first component 106 and the third component 110.

[0086] Cap 128 can be releasably coupled to the distal end 144 of the cylindrical portion 126. Cap 128 can be sized and shaped to be disposed on the distal openings 152a, 152b of the cylindrical portion 126 and to fluid-tighten the distal openings of the cylindrical portion. Although not explicitly shown, cap 128 may include an elastomeric or deformable sealing material disposed on an inner surface of the cap and configured to contact the distal end 144 of the cylindrical portion 126 to form a fluid-tight seal between cap 128 and the cylindrical portion 126. Cap 128 can form a snap-fit ​​engagement with the distal end 144 of the cylindrical portion 126. For example, when cap 128 is assembled with the distal end region of the cylindrical portion 126, one or more tabs 173a, 173b of the cylindrical portion 126 can be received within one or more mating holes 176a, 176b of cap 128. One or more holes 176a, 176b may be located below one or more buttons 171a, 171b on the cap 128, such that actuation (e.g., pressing down) of one or more buttons 171a, 171b is configured to disengage one or more tabs 173a, 173b of the barrel portion 126 from one or more mating holes 176a, 176b, allowing the cap 128 to disengage from the multi-reservoir system 104. However, other coupling mechanisms may be used as desired, such as, but not limited to, friction fit, threaded engagement, rotational locking, etc. In some examples, the cap 128 may be replaced by a valve or other flow control mechanism configured to selectively fluid-tighten the distal openings 152a, 152b.

[0087] The cap 128 may include a first portion 158 and a second portion 160, with an O-ring 162 or other sealing member disposed between the first and second portions. The second portion 160 may include one or more latches 168a, 168b configured to engage one or more mating bosses or protrusions 170a, 170b of the first portion 158. In some cases, the first portion 158 may include one or more buttons 171a, 171b configured to releasably secure the cap 128 to the cylinder portion 126, while the second portion 160 may include one or more chambers 164a, 164b configured to receive fluid from a second reservoir 156b and a third reservoir 156d during air purging, as will be described in more detail herein. One or more chambers 164a, 164b may each include floating seals 166a, 166b configured to selectively seal distal openings 152a, 152b. For example, floating seals 166a, 166b may be configured to move away from distal openings 152a, 152b in response to pressure generated by actuation of plunger assembly 124.

[0088] The first retainer 130 can be removably positioned proximal to the proximal end 142 of the barrel portion 126. In some cases, the first retainer 130 can form a snap-fit ​​engagement or other coupling mechanism with the plunger assembly 124. For example, the first retainer 130 may include a first pair of laterally spaced arms 172a, 172b extending from the interconnection region 176 (see also, for example...). Figure 6 The first pair of laterally spaced arms 172a, 172b may be axially spaced from the second pair of laterally spaced arms 174a, 174b. A cavity 178 may be defined by the arms 172a, 172b, 174a, 174b and an interconnecting region 176. The first pair of laterally spaced arms 172a, 172b may be configured to be positioned on opposite sides of the plunger assembly 124 and received within recesses or slots 180a, 180b formed in each of the first plunger 138a and the second plunger 138b. Similarly, a second pair of laterally spaced arms 174a, 174b can be configured to be positioned on opposite sides of the plunger assembly 124 and received within recesses or slots 180c, 180d formed in each of the first plunger 138a and the second plunger 138b. In other embodiments, the first retainer 130 can form a frictional engagement with the plunger assembly 124. When the first retainer 130 is positioned between the plunger assembly 124 and the barrel portion 126, distal actuation of the plunger assembly 124 and / or proximal actuation of the barrel portion 126 may be limited.

[0089] The second retainer 132 may be removably positioned, at least partially, within the cavity 178 of the first retainer 130. In some cases, the second retainer 132 may form a snap-fit ​​or other coupling mechanism with the plunger assembly 124. For example, the second retainer 132 may include a pair of laterally spaced arms 182a, 182b extending from the interconnection region 181 (see also, for example...). Figure 9 The laterally spaced arms 182a, 182b can be axially positioned between the first pair of laterally spaced arms 172a, 172b and the second pair of laterally spaced arms 174a, 174b of the first retainer 130. The laterally spaced arms 182a, 182b can be configured to be positioned on opposite sides of the plunger assembly 124 and received within recesses or slots 183a, 183b formed in each of the first plunger 138a and the second plunger 138b. In other embodiments, the second retainer 132 can form a frictional engagement with the plunger assembly 124. When the second retainer 132 is located between the plunger assembly 124 and the barrel portion 126, distal actuation of the plunger assembly 124 and / or proximal actuation of the barrel portion 126 may be limited.

[0090] Typically, the plunger assembly 124 and the barrel portion 126 can be assembled in a telescopic arrangement. For example, a portion of the plunger assembly 124 can be disposed within a portion of the barrel portion 126. More specifically, the plunger assembly 124 can be assembled with the barrel portion 126 such that a first plunger 138a and a first floating gasket 154a of the plunger assembly 124 are slidably disposed within a first cavity 148a of the barrel portion 126, and a second plunger 138b and a second floating gasket 154b of the plunger assembly 124 are slidably disposed within a second cavity 148b of the barrel portion 126. The plunger assembly 124 is movable relative to the barrel portion 126 (e.g., axially and / or longitudinally sliding) to move (eject) material from the first reservoir 156a, the second reservoir 156b and / or the third reservoir 156d within the barrel portion 126 and / or move (e.g., draw) material into the first reservoir, the second reservoir and / or the third reservoir within the barrel portion.

[0091] The barrel portion 126 may be pre-loaded with components required to form the injectable material. For example, a first component (such as, but not limited to, a first crosslinkable component) 106 may be disposed within a second reservoir 156b of the barrel portion 126. In some examples, the first crosslinkable component 106 may be provided as a powder. A second component 108, such as, but not limited to, an accelerator, may be disposed within a third reservoir 156d of the barrel portion 126. In some examples, the second component 108 may be provided as a liquid. A third component 110, such as, but not limited to, the second crosslinkable component, may be disposed within a first reservoir 156a of the barrel portion 126. In some examples, the third component 110 may be provided as a liquid. A first floating liner 154a may fluidly isolate the third component 110 from the first component 106 until desired mixing. Furthermore, the second component 108 may fluidly isolate each of the first component 106 and the third component 110 until desired mixing.

[0092] Now refer to Figures 4-15 Methods for dispensing or injecting injectable materials and additional features of the assembly and / or delivery system 100 are described. While some steps are shown in sequence between each figure, in other embodiments, fewer steps are conceivable, and the order in which the steps are performed may differ from the illustrated order. First, the plunger assembly 124 may be actuated or advanced distally, as indicated by arrow 190. For example, the plunger assembly 124 may be axially pushed or pressed against the distal end 144 of the barrel portion 126. Figure 4A side view of the multi-reservoir system 104 is depicted, in which a plunger assembly 124 is axially displaced. The plunger assembly 124 can be actuated or advanced distally until the first pair of laterally spaced arms 172a, 172b of the first retainer 130 contacts the proximal end 142 of the barrel portion 126. When the plunger assembly 124 is actuated or advanced distally, the first plunger 138a and the seal 140a exert force on a third component 110 stored in the first reservoir 156a. The third component 110 then exerts a distal force on the first floating liner 154a to actuate or advance the first floating liner 154a distally. The first floating liner 154a can be actuated or advanced distally until it is adjacent to a plurality of channels 184a-e. In some examples, the first floating liner 154a can be actuated or advanced distally until the distal end of the first floating liner 154a is proximal to the distal end 188 of the channels 184a-e, and the proximal end of the first floating liner 154a is distal to the proximal end 186 of the channels 184a-e, to allow fluid to enter the channels at the proximal end 186 of the channels 184a-e and to exit the channels at the distal end 188 of the channels 184a-e. When the plunger assembly 124 is further actuated, once the first floating liner 154a is positioned to break the seal between the first floating liner 154a and the wall of the first cylinder 146a, the third component 110 can flow through the channels 184a-e and into the second reservoir 156b. When the third component 110 flows through channels 184a-e, the third component 110 no longer exerts a force on the first floating liner 154a sufficient to cause further axial displacement of the first floating liner 154a. In some embodiments, the first plunger 138a may contact the proximal end of the first floating liner 154a and actuate or distally advance the first floating liner 154a at least partially beyond the distal ends 188 of the plurality of channels 184a-e to again form a seal between the first floating liner 154a and the wall of the first cylinder 146a.

[0093] The second plunger 138b can be actuated or advanced distally within the second lumen 148b substantially simultaneously with the first plunger 138a. However, in the absence of a seal at the distal end of the second plunger 138b, the second floating gasket 154b can remain stationary because any air expelled by the movement of the second plunger 138b exits the second lumen 148b through the proximal opening 150b.

[0094] When fluid is delivered from the first reservoir 156a to the second reservoir 156b of the cylindrical portion 126, the cap 128 can inhibit or prevent fluid from leaving the distal openings 152a, 152b of the second reservoir 156b and the third reservoir 156d. The first component 106 and the third component 110 can now be located in the second reservoir 156b of the cylindrical portion 126, while the second component 108 can be retained in the third reservoir 156d of the cylindrical portion 126.

[0095] Once the first component 106 has been injected from the first reservoir 156a into the second reservoir 156b, the multi-reservoir system 104 can be shaken, as follows: Figure 5 (The figure depicts a side view of an exemplary multi-reservoir system 104 being shaken, as shown, to mix first component 106 and third component 110 to form precursor 106 / 110.) As used herein, the term “fluid” is broadly defined when referring to components 106, 108, 110 of system 100 and may include liquids, gels, oils, and / or particulate matter (e.g., fine particles, microspheres, or powders), or any combination of liquids, gels, oils, and / or particulate matter (e.g., fine particles, microspheres, or powders). In some examples, third component 110 may be a diluent fluid solution, and first component 106 may include a crosslinkable polymer, such as PEG having multiple succinimide ends, or any other reagent that may be mixed with diluent 110 to form a precursor. The diluent may include a low molecular weight compound containing multiple nucleophilic groups dissolved in a low pH (4.0) aqueous solution, such as trilysine containing multiple amino groups, although other diluent fluid solutions are also contemplated within the scope of this disclosure. Once mixed together, the precursor solution 106 / 110 can be formed in the second reservoir 156b.

[0096] After mixing, the first retainer 130 is removed from the plunger assembly 124, while the second retainer 132 remains in place, as... Figure 6 As shown in the figure, this is a perspective view of an exemplary multi-reservoir system 104, in which the first retainer 130 is removed. The first retainer 130 can be laterally displaced, as indicated by arrow 192, to disengage the first retainer 130 from the plunger assembly 124. However, other movements or actions can be used to disengage the first retainer 130 from the plunger assembly 124.

[0097] Once the first retainer 130 is removed, the plunger assembly 124 can be actuated or advanced distally. For example, the plunger assembly 124 can be axially pushed or pressed toward the distal end 144 of the cylinder portion 126 to remove air and / or excess fluid from the second reservoir 156b and / or the third reservoir 156d. This can be accomplished by attaching a cap 128 to the distal end region of the cylinder portion 126. As described above, air and / or excess fluid can be trapped within cavities 164a, 164b in the cap 128. The plunger assembly 124 can be actuated or advanced distally until the second retainer 132 contacts the proximal end 142 of the cylinder portion 126, such as... Figure 7 As shown in the figure, the diagram depicts a side view of an exemplary multi-storage system 104, in which air / excess fluid is purged.

[0098] Next, cap 128 can be removed, as follows: Figure 8 As shown in the figure, this depicts a side view of an exemplary multi-reservoir system 104, with cap 128 removed. In some examples, cap 128 may be axially displaced, as indicated by arrow 194. However, this is not necessary. In some examples, cap 128 may be removed by other movements and / or forces. In some examples, one or more buttons 171a, 171b may be pressed to release latches 173a, 173b on the cylinder portion, allowing cap 128 to be removed from cylinder portion 126.

[0099] Next, the second retainer 132 is removed from the plunger assembly 124, as follows: Figure 9 As shown in the figure, this is a perspective view of an exemplary multi-reservoir system 104, in which the second retainer 132 is removed. The second retainer 132 can be laterally displaced, as indicated by arrow 196, to disengage the second retainer 132 from the plunger assembly 124. However, other movements or actions can be used to disengage the second retainer 132 from the plunger assembly 124.

[0100] The multi-reservoir system 104 can be held upright (e.g., with the distal end 144 of the cylinder portion 126 pointing upwards (or away from the ground)) to prevent excessive fluid from dripping and / or leaking from the second reservoir 156b and the third reservoir 156d of the cylinder portion 126. In some cases, during air purging, some fluid may be distributed from the second reservoir 156b and the third reservoir 156d to ensure that no air remains in the second reservoir 156b and the third reservoir 156d.

[0101] When water separation is performed, the multi-reservoir system 104 can remain in an upright orientation. Water separation can optionally be performed before injectable materials are injected into the body. Figures 10A-10CIllustrative methods for assembling and disassembling a syringe 198 (such as, but not limited to, a saline syringe, for use in water separation) and an injection system 102 are described. Typically, the injection system 102 can be connected to the saline syringe 198. The needle 112 can then be positioned at the treatment site, and saline is injected to perform water separation. In some examples, the saline syringe 198 may be provided separately from the assembly and / or delivery system 100, although this is not required. Once water separation is complete, the saline syringe 198 can be detached from the injection system 102, with the needle 112 remaining in place and pre-filled at the treatment site (e.g., the distal end of the needle 112 remains in the body). However, this is not required. In some cases, the needle 112 can be removed from the body after water separation.

[0102] The needle hub 116 may include a lower housing 200 configured to be gripped and squeezed by a user. One or more externally positioned buttons 202 may be positioned on or adjacent to the outer surface of the lower housing 200. In some cases, two buttons 202 may be positioned on opposite sides of the lower housing 200. The buttons 202 may be configured such that actuation squeeze or other movement by the user causes the latch of the cylinder portion 126 of the adapter or connector 122 and / or the multi-reservoir system 104 to release from a mating hole in the needle hub 116. However, other coupling mechanisms between the needle hub 116 and the connector 122 or cylinder portion 126 may also be conceived as needed or required. For example, but not limited to, snap-fit ​​connectors, magnetic connectors, female-male connectors, hook and loop fasteners, etc., may be conceived.

[0103] The needle hub 116 may also include a transition portion 204 through which the needle 112 is inserted. The transition portion 204 may include a diameter (or cross-sectional dimension) smaller than that of the lower housing 200. In some examples, the transition portion 204 may taper and / or include a textured outer surface. When the needle 112 is connected to the needle hub 116, it connects to the first lumen 208 and the second lumen 210 (see, for example...). Figure 12 and Figure 15The central tubular lumen 206 of the needle hub 116 can pass through the needle hub 116 and be in fluid communication with the needle 112. The first lumen 208 and the second lumen 210 can be configured to be in fluid communication with one or more lumens of the connector 122 when connected to the connector 122, and to be in fluid communication with the distal openings 152a, 152b of the barrel portion 126 of the multi-reservoir system 104 when connected to the multi-reservoir system 104. The connector 122 can be an adapter, manifold, etc., configured to fluidly connect a single outlet of the saline injector 198 to the first lumen 208 and the second lumen 210 of the needle hub 116. For example, the connector 122 can have a single fluid inlet for connection to the outlet of the saline injector 198 and two or more fluid outlets for connection to the first lumen 208 and the second lumen 210 of the needle hub 116. The connector 122 may include more than one fluid inlet or fewer than two or more fluid outlets as needed or desired. The first lumen 208 and the second lumen 210 of the needle hub 116 may intersect or merge at the mixing region 212. The mixing region 212 may include a static mixer configured to mix fluids from the first lumen 208 and the second lumen 210.

[0104] To perform water separation, an injection system 102 and a saline syringe 198 may be required, such as Figure 10A As shown, the figure depicts an exploded perspective view of an exemplary injection system 102 and a saline injector 198. While the injector 198 is described as a saline injector, it is contemplated that it may include other fluids. To connect the injection system 102 to the saline injector 198, the proximal end of the connector 122, having a single fluid opening, can be aligned with the outlet of the saline injector 198. The connector 122 can then be connected to the outlet of the saline injector 198, as... Figure 10BAs shown, the figure depicts a perspective view of an assembled exemplary injection system 102 and saline injector 198. In some cases, the proximal end of connector 122 and the outlet of saline injector 198 may have mating Luer fittings. However, other connection mechanisms may be used as desired, such as, but not limited to, friction fits, snap-fits, threaded engagements, etc. Water separation can then be performed. Once water separation is complete, saline injector 198 can be disengaged from injection system 102, leaving needle 112 at the treatment site. It is further conceivable that connector 122 can also be disengaged from injection system 102. In some cases, connector 122 and saline injector 198 can be disengaged from injection system 102 substantially simultaneously. For example, actuation of button 202 can cause one or more latches 214 of connector 122 to release from mating recesses of needle hub 116. In some cases, latches 214 may be provided on each opposite side of connector 122, although this is not necessary. When button 202 of needle hub 116 is actuated, the proximal retraction of saline injector 198 releases connector 122 and saline injector 198 from needle hub 116, as... Figure 10C As shown in the figure, this depicts a perspective view of an unassembled exemplary injection system 102 and a saline injector 198. Connector 122 may remain connected to the saline injector 198, or may subsequently disengage from the saline injector 198, if desired. While connector 122 and saline injector 198 have been described as disengaging substantially simultaneously, in some cases, saline injector 198 may first disengage from connector 122, and then connector 122 may disengage from needle hub 116.

[0105] Next, the multi-storage system 104 can be connected to the needle hub 116. For this purpose, the first cavity 208 and the second cavity 210 can be aligned with the distal openings 152a, 152b of the barrel portion 126, as follows: Figure 11 As shown in the figure, this is a perspective view of the unassembled injection system 102 and multi-reservoir system 104. When assembled, the lower housing 200 of the needle hub 116 can slide on the outer surface of the distal end region of the barrel portion 126, as... Figure 12 As shown, this figure depicts a side view of the assembled injection system 102 and multi-reservoir system 104. For example, the needle hub 116 can be positioned in an area with a reduced cross-sectional size. See also... Figure 13 (The figure depicts in) Figure 12(A partial cross-sectional view of the assembled injection system 102 and multi-reservoir system 104 taken at line 13-13). When the needle hub 116 is assembled with the distal end region of the barrel portion 126, one or more tabs 173a, 173b of the barrel portion 126 may be received within one or more mating holes 201 of the needle hub 116. One or more holes 201 may be located below one or more buttons 202 such that actuation (e.g., pressing down) of one or more buttons 202 is configured to disengage one or more tabs 173a, 173b of the barrel portion 126 from one or more mating holes 201, allowing the injection system 102 to disengage from the multi-reservoir system 104.

[0106] Once the multi-reservoir system 104 has been assembled with the injection system 102, the plunger assembly 124 can be actuated or advanced distally, causing a precursor (e.g., produced by a mixture of first component 106 and third component 110) disposed in the second reservoir 156b of the barrel portion 126 and a second component 108 (e.g., a promoter, such as, but not limited to, an alkaline buffer solution) disposed in the third reservoir 156d of the barrel portion 126 to be dispensed from the distal openings 152a, 152b. See also... Figure 14 and Figure 15 (These depict side views and cross-sectional views of the assembled injection system 102 and multi-reservoir system 104 in a dispensing configuration, respectively.) The first lumen 208 and the second lumen 210 of the needle hub 116 are in fluid communication with the second reservoir 156b and the third reservoir 156d, as well as the distal openings 152a, 152b. When the plunger assembly 124 is actuated, advanced distally, or depressed, fluid can exit the second reservoir 156b and the third reservoir 156d of the barrel portion 126 and enter the first lumen 208 and the second lumen 210 of the needle hub 116. The first lumen 208 and the second lumen 210 of the needle hub 116 may be connected to a mixing region 212. The mixing region 212 may be configured to mix or combine the precursor 106 / 110 and the second component 108 before the components leave the needle 112. For example, mixing region 212 can mix or combine precursor 106 / 110 and second component 108 to form an injectable composition before the resulting mixture enters the central lumen 206 of needle hub 116 (which in turn is in fluid communication with the lumen of needle 112). The injectable composition can continue to flow out through needle 112 and eventually reach the treatment site. The injectable composition formed by the combination of precursor 106 / 110 and second component 108 can achieve its final desired properties and / or reach its final form in situ or at the target site.

[0107] It will be apparent to those skilled in the art that various modifications and variations can be made to the disclosed apparatus without departing from the scope of this disclosure. Other embodiments of this disclosure will be apparent to those skilled in the art in light of the specification and practice of the invention disclosed herein. The specification and examples are intended to be considered exemplary only, and the true scope and spirit of the invention are indicated by the appended claims.

[0108] All devices and methods discussed herein are examples of devices and / or methods implemented according to one or more principles of this disclosure. These examples are not the only ways to implement these far-reaching ideas, but are merely examples. Therefore, references to elements or structures or features in the drawings must be understood as references to examples of embodiments of this disclosure and should not be construed as limiting this disclosure to the specific elements, structures, or features illustrated. Other examples of ways of implementing the disclosed principles will occur to those skilled in the art upon reading this disclosure.

[0109] The following will be understood in the foregoing description and appended claims. As used herein, the phrases “at least one,” “one or more,” and “and / or” are open-ended expressions that are both conjunction and disjunction in operation. As used herein, the term “a (a or an)” refers to one or more of the entities. Thus, the terms “a (a or an),” “one or more,” and “at least one” are used interchangeably herein. All directional references (e.g., proximal, distal, upper, lower, upward, downward, left, right, lateral, longitudinal, front, rear, top, bottom, above, below, vertical, horizontal, radial, axial, clockwise, counterclockwise, and / or similar) are used only for identification purposes to aid the reader in understanding this disclosure, and / or to distinguish areas of associated elements from one another, and do not limit the associated elements, particularly regarding the location, orientation, or use of this disclosure. Unless otherwise indicated, connection references (e.g., attachment, link, connection, and coupling) should be interpreted broadly and may include intermediate members between sets of elements and relative movement between elements. Therefore, a connection reference does not necessarily imply that two elements are directly connected and have a fixed relationship with each other. Identification references (e.g., primary, secondary, first, second, third, fourth, etc.) are not intended to signify importance or priority, but rather to distinguish one feature from another.

[0110] The foregoing discussion is for illustrative and descriptive purposes and is not intended to limit this disclosure to the 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 may be embodied in other forms, structures, arrangements, proportions, and with other elements, materials, and components without departing from the concept, spirit, scope, or characteristics of this disclosure. For example, various features of this disclosure may be combined in one or more aspects, embodiments, or configurations for the purpose of simplifying this disclosure. However, it should be understood that various features of certain aspects, embodiments, or configurations of this disclosure may be combined in alternative aspects, embodiments, or configurations. Those skilled in the art will understand that this disclosure can be used with numerous modifications to the structures, arrangements, proportions, materials, components, etc., used in the practice of this disclosure, particularly suited to specific environments and operational requirements, without departing from the principles of this disclosure. 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 the element may be reversed or otherwise varied; the size or dimensions of the element may vary; and features and components of various embodiments may be selectively combined. Therefore, the embodiments disclosed herein are to be considered illustrative rather than restrictive in all respects, and the scope of the claimed invention is indicated by the appended claims and is not limited to the foregoing description.

[0111] The appended claims are hereby incorporated by reference into this specific embodiment, each claim being an independent embodiment of this disclosure. In the claims, the term "comprising / including" does not exclude the presence of other elements or steps. Furthermore, although listed separately, multiple devices, elements, or method steps may be implemented by, for example, a single unit or processor. Additionally, although individual features may be included in different claims, these features may be advantageously combined, and inclusion in different claims does not imply that such combination of features is impractical and / or disadvantageous. Furthermore, singular references do not exclude plurals. Terms such as "an (a, an)," "first," "second," etc., do not exclude plurals. Reference numerals in the claims are provided merely as illustrative examples and should not be construed as limiting the scope of the claims in any way.

Claims

1. A system for generating a mixture for delivery to a treatment site, the system comprising: Needle hub; as well as A multi-memory system, the multi-memory system comprising: A plunger assembly, comprising a first plunger and a second plunger; A cylindrical portion comprising a housing extending from a proximal end to a distal end, the housing comprising a first cylindrical body and a second cylindrical body, the first cylindrical body defining a first lumen extending from the proximal end to the distal end, the first cylindrical body including at least one channel configured to communicate between different locations along a length of the interior of the first cylindrical body, the second cylindrical body defining a second lumen extending from the proximal end to the distal end. A first movable liner is disposed within a first cavity of the cylindrical portion, the first movable liner dividing the first cavity of the cylindrical portion into a first reservoir configured to receive a first component and a second reservoir configured to receive a second component; and A second liner is disposed within a second cavity of the cylindrical portion, the second liner defining a third reservoir configured to receive a third component; Specifically, actuation of the plunger assembly relative to the barrel portion causes the first component to be injected from the first reservoir through the at least one channel and into the second reservoir to mix with the second component to form a precursor, and further actuation of the plunger assembly causes the precursor and the third component to be delivered from the second reservoir and the third reservoir, respectively, into the needle hub.

2. The system according to claim 1, wherein, The at least one channel extends to a length smaller than the entire length of the first lumen.

3. The system according to any one of claims 1-2, wherein, Before actuating the plunger assembly, the distal end of the first movable liner is located proximal to the proximal end of the at least one channel.

4. The system according to any one of claims 1-2, wherein, Actuating the plunger assembly relative to the barrel portion to inject the first component into the second reservoir actuates the first movable liner, such that the first movable liner is adjacent to the at least one channel.

5. The system of any one of claims 1-4, further comprising a first removable retainer positioned between a proximal end of the plunger assembly and a proximal end of the barrel portion, the first removable retainer restricting movement of the plunger assembly relative to the barrel portion to a first length configured to inject the first component into the second reservoir.

6. The system according to claim 5, wherein, The device further includes a second removable retainer positioned between the proximal end of the plunger assembly and the proximal end of the barrel portion and proximal to the distal end of the first retainer. The second removable retainer restricts movement of the plunger assembly relative to the barrel portion to a second length configured to purge any air that may be present from the second and third reservoirs.

7. The system according to any one of claims 1-6, further comprising a cap, the cap being removably coupled to the distal end region of the cylindrical portion.

8. The system according to claim 7, wherein, The cap includes at least one cavity configured to receive fluid from the second reservoir and / or the third reservoir.

9. The system according to any one of claims 7-8, wherein, The plunger assembly is configured to be at least partially actuated, wherein the cap is coupled to the distal end region of the barrel portion.

10. The system according to any one of claims 1-9, further comprising a needle configured to be coupled to the needle hub.

11. The system according to any one of claims 1-10, wherein, The needle hub includes a first cavity in fluid communication with a second reservoir of the cylindrical portion, a second cavity in fluid communication with a third reservoir of the cylindrical portion, a central cavity configured to be in fluid communication with the needle, and a mixing region connecting the first cavity and the second cavity to the central cavity.

12. The system according to any one of claims 1-11, wherein, The needle hub is removably coupled to the distal end region of the cylinder portion of the multi-storage system.

13. A method for generating a mixture using a mixing system for delivery to a treatment site, the method comprising: The plunger assembly is actuated by a first length within the barrel portion to move a first component from a first reservoir in the barrel portion to a second reservoir in the barrel portion to form a precursor, wherein the first component is a fluid component; The plunger assembly is actuated a second length within the cylinder portion to remove air and / or excess fluid from the cylinder portion; The needle hub with the mixing region is connected to the distal end of the cylindrical portion; and The plunger assembly is actuated to move the precursor and a second component disposed in a third reservoir in the barrel portion into the mixing region of the needle hub to form an injectable mixture, wherein the second component is a fluid component.

14. The method of claim 13, further comprising removing a first retainer from the plunger assembly prior to actuating the plunger assembly to remove air and / or excess fluid from the cylinder portion.

15. The method of claim 14, further comprising removing a second retainer from the plunger assembly prior to actuating the plunger assembly to move the precursor and the second component.

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