Patent Application
20240358922
The present disclosure relates generally to the field of devices for delivering injectable materials and/or compositions to a patient, and associated systems and methods. More particularly, the present disclosure relates to devices for combining constituents of injectable materials and/compositions, and associated systems and methods.
Various forms of cancer and other medical conditions are treated by local application of radiation therapy. However, various risks may accompany radiation therapy. Since the conception of conformal radiotherapy, physicians have paid attention to the radiation dose delivered to the target and surrounding tissues. Investigators have been able to correlate side effects to the amount of tissue receiving a certain radiation dose. And yet, time, distance, and shielding affect the dose that is delivered. The less time an area is exposed to radiation, the less dose is delivered. The greater the distance from the radiation, the less dose is delivered. Filler materials may be injected into a treatment area to provide a shield to tissue surrounding the target of the radiation therapy. For instance, numerous men are diagnosed with prostate cancer each year. Traditionally, treatment options include interstitial implant therapy, surgery, and external beam radiotherapy. While the best treatment is still debatable, side effects of treating prostate cancer have become less toxic with implant therapy and radiotherapy. Various systems provide filler material to treatment sites to decrease the radiation dose to tissue surrounding radiation target sits (e.g., to shield the rectum during radiotherapy for prostate cancer). Such filler materials are often reactive, and therefore are generally combined/mixed immediately prior to or even during delivery to the patient.
Various systems are known for combining/mixing (e.g., in vitro) filler materials injected into radiation treatment areas. However, most such systems include numerous subcomponents, are complex to assemble, and are susceptible to filler mixing errors prior to delivery within a patient at a treatment site. Various challenges posed by such mixing systems may result in errors and mishaps which lead unnecessarily to increased procedure time and increased procedure costs. Solutions to these and other issues presented by combining and delivering injectable materials would be welcome in the art.
This Summary is provided to introduce, in simplified form, a selection of concepts described in further detail below in the Detailed Description. This Summary is not intended to necessarily identify key features or essential features of the claimed subject matter, nor is it intended as an aid in determining the scope of the claimed subject matter. One of skill in the art will understand that each of the various aspects and features of the present disclosure may advantageously be used separately in some instances, or in combination with other aspects and features of the disclosure in other instances, whether or not described in this Summary. No limitation as to the scope of the claimed subject matter is intended by either the inclusion or non-inclusion of elements, components, or the like in this Summary.
In accordance with certain embodiments of the present disclosure, devices, systems, and methods for combining and/or delivering injectable materials are disclosed.
In a first example, a system for producing a mixture to deliver to a treatment site may comprise a needle hub and a multi-reservoir system. The multi-reservoir system may comprise 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 defining a first lumen extending from the proximal end to the distal, the first barrel including a plurality of channels formed in an inner wall thereof and a second barrel defining a second lumen extending from the proximal end to the distal end, a first floating or movable gasket disposed within the first lumen of the barrel portion, the first floating gasket dividing the first lumen of the barrel portion into a first reservoir configured to contain a first constituent and a second reservoir configured to contain a second constituent, and a second floating gasket disposed within the second lumen of the barrel portion, the second floating gasket dividing the second lumen of the barrel portion into a third reservoir and a fourth reservoir configured to contain a third constituent. Actuating the plunger assembly relative to the barrel portion may cause the first constituent to be injected from the first reservoir, through the channels, and into the second reservoir to mix with the second constituent to form a precursor and further actuation of the plunger assembly may cause the precursor and the third constituent to be delivered from the second and fourth reservoirs, respectively, into the needle hub.
In another example, a system for producing a mixture to deliver to a treatment site may comprise a needle hub and a multi-reservoir system. The multi-reservoir system may comprise 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 defining a first lumen extending from the proximal end to the distal, the first barrel including at least one channel configured to communication between different positions along a length of an insider of the first barrel and a second barrel defining a second lumen extending from the proximal end to the distal end, a first floating or movable gasket disposed within the first lumen of the barrel portion, the first floating or movable gasket dividing the first lumen of the barrel portion into a first reservoir configured to contain a first constituent and a second reservoir configured to contain a second constituent, and a second floating gasket disposed within the second lumen of the barrel portion, the second floating gasket dividing the second lumen of the barrel portion into a third reservoir and a fourth reservoir configured to contain a third constituent. Actuating the plunger assembly relative to the barrel portion may cause the first constituent to be injected from the first reservoir, through the channels, and into the second reservoir to mix with the second constituent to form a precursor and further actuation of the plunger assembly may cause the precursor and the third constituent to be delivered from the second and fourth reservoirs, respectively, into the needle hub.
In another example, a system for producing a mixture to deliver to a treatment site may comprise a needle hub and a multi-reservoir system. The multi-reservoir system may comprise 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 defining a first lumen extending from the proximal end to the distal, the first barrel including a plurality of channels formed in an inner wall thereof and a second barrel defining a second lumen extending from the proximal end to the distal end, a first floating gasket disposed within the first lumen of the barrel portion, the first floating gasket dividing the first lumen of the barrel portion into a first reservoir configured to contain a first constituent and a second reservoir configured to contain a second constituent, and a second gasket disposed within the second lumen of the barrel portion, the second gasket bounding a third reservoir configured to contain a third constituent. Actuating the plunger assembly relative to the barrel portion may cause the first constituent to be injected from the first reservoir, through the channels, and into the second reservoir to mix with the second constituent to form a precursor and further actuation of the plunger assembly may cause the precursor and the third constituent to be delivered from the second and third reservoirs, respectively, into the needle hub.
Alternatively or additionally to any of the examples above, in another example, the at least one channel or the plurality of channels may extend less than an entire length of the first lumen.
Alternatively or additionally to any of the examples above, in another example, prior to actuating the plunger assembly a distal end of the first floating or movable gasket may be proximal to a proximal end of the at least one channel or the plurality of channels.
Alternatively or additionally to any of the examples above, in another example, actuating the plunger assembly relative to the barrel portion to cause the first constituent to be injected into the second reservoir may actuate the first floating gasket such that the first floating or movable gasket is adjacent to the at least one channel or the plurality of channels.
Alternatively or additionally to any of the examples above, in another example, the system may further comprise 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 limiting movement of the plunger assembly relative to the barrel portion to a first length configured to inject the first constituent into the second reservoir.
Alternatively or additionally to any of the examples above, in another example, the system may further comprise a second removable retainer positioned between the proximal end of the plunger assembly and the proximal end of the barrel portion and proximal to a distal end of the first retainer, the second removable retainer limiting 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.
Alternatively or additionally to any of the examples above, in another example, the system may further comprise a cap removably coupled with a distal end region of the barrel portion.
Alternatively or additionally to any of the examples above, in another example, the cap may include at least one cavity configured to receive fluid from the second, third and/or fourth reservoirs.
Alternatively or additionally to any of the examples above, in another example, the plunger assembly may be configured to be at least partially actuated with the cap coupled to the distal end region of the barrel portion.
Alternatively or additionally to any of the examples above, in another example, the system may further comprise a needle that is configured to be coupled to the needle hub.
Alternatively or additionally to any of the examples above, in another example, the needle hub may comprise a first lumen in fluid communication with the second reservoir of the barrel portion, a second lumen in fluid communication with the third or fourth reservoir of the barrel portion, a central lumen configured to be in fluid communication with a needle, and a mixing region connecting the first and second lumens with the central lumen.
Alternatively or additionally to any of the examples above, in another example, the needle hub may be removably coupled to a distal end region of the barrel portion of the multi-reservoir system.
In another example, a method for producing a mixture with a mixing system to deliver to a treatment site may comprise actuating a plunger assembly within a barrel portion a first length to move a first constituent from a first reservoir of the barrel portion to a second reservoir of the barrel portion to form a precursor, wherein the first constituent is a fluid constituent, actuating the plunger assembly within the barrel portion a second length to remove air and/or excess fluid from the barrel portion, coupling a needle hub having a mixing region to the distal end of the barrel portion, and actuating the plunger assembly to move the precursor and a second constituent disposed within a third reservoir of the barrel portion into the mixing region of the needle hub to form an injectable mixture, wherein the second constituent is a fluid constituent.
Alternatively or additionally to any of the examples above, in another example, the method may further comprise removing a first retainer from the plunger assembly prior to actuating the plunger assembly to remove air and/or excess fluid from the barrel portion.
Alternatively or additionally to any of the examples above, in another example, the method may further comprise a second retainer from the plunger assembly prior to actuating the plunger assembly move the precursor and the second constituent.
Alternatively or additionally to any of the examples above, in another example, the method may further comprise removing a cap from a distal end of the barrel portion prior to coupling the needle hub to the distal end of the barrel portion.
In another example, a kit for producing a mixture for delivery to a treatment site may comprise a multi-reservoir system, a needle hub, and a needle coupled to the needle hub. The multi-reservoir system may comprise 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 defining a first lumen extending from the proximal end to the distal, the first barrel including a plurality of channels formed in an inner wall thereof and a second barrel defining a second lumen extending from the proximal end to the distal end, a first floating gasket disposed within the first lumen of the barrel portion, the first floating gasket dividing the first lumen of the barrel portion into a first reservoir configured to contain a first constituent and a second reservoir configured to contain a second constituent, and a second gasket disposed within the second lumen of the barrel portion, the second gasket dividing the second lumen of the barrel portion into a third reservoir and a fourth reservoir configured to contain a third constituent.
In another example, a kit for producing a mixture for delivery to a treatment site may comprise a multi-reservoir system, a needle hub, and a needle coupled to the needle hub. The multi-reservoir system may comprise 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 defining a first lumen extending from the proximal end to the distal, the first barrel including a plurality of channels formed in an inner wall thereof and a second barrel defining a second lumen extending from the proximal end to the distal end, a first floating gasket disposed within the first lumen of the barrel portion, the first floating gasket dividing the first lumen of the barrel portion into a first reservoir configured to contain a first constituent and a second reservoir configured to contain a second constituent, and a second gasket disposed within the second lumen of the barrel portion, the second gasket bounding a third reservoir configured to contain a third constituent.
Alternatively or additionally to any of the examples above, in another example, the kit may further comprise 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 limiting movement of the plunger assembly relative to the barrel portion to a first length configured to inject the first constituent into the second reservoir.
Alternatively or additionally to any of the examples above, in another example, the kit may further comprise a second removable retainer positioned between the proximal end of the plunger assembly and the proximal end of the barrel portion and distal to a proximal end of the first retainer, the second removable retainer limiting movement of the plunger assembly relative to the barrel portion to a second length configured to purge air from the second and third or fourth reservoirs.
Alternatively or additionally to any of the examples above, in another example, the kit may further comprise a cap removably coupled with a distal end region of the barrel portion.
Alternatively or additionally to any of the examples above, in another example, the kit may further comprise a connector, the connector configured to couple the needle hub to a syringe.
These and other features and advantages of the present disclosure, will be readily apparent from the following detailed description, the scope of the claimed invention being set out in the appended claims. While the following disclosure is presented in terms of aspects or embodiments, it should be appreciated that individual aspects can be claimed separately or in combination with aspects and features of that embodiment or any other embodiment.
Non-limiting embodiments of the present disclosure are described by way of example with reference to the accompanying drawings, which are schematic and not intended to be drawn to scale. The accompanying drawings are provided for purposes of illustration only, and the dimensions, positions, order, and relative sizes reflected in the figures in the drawings may vary. For example, devices may be enlarged so that detail is discernable, but is intended to be scaled down in relation to facilitate injection into a patient. For purposes of clarity and simplicity, not every element is labeled in every figure, nor is every element of each embodiment shown where illustration is not necessary to allow those of ordinary skill in the art to understand the disclosure. Moreover, reference characters may indicate elements in some figures which are illustrated in other figures, and which, for the sake of brevity, are described only with reference to the other figures.
The detailed description will be better understood in conjunction with the accompanying drawings, wherein like reference characters represent like elements, as follows:
While the disclosure is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the disclosure.
The following detailed description should be read with reference to the drawings, which depict illustrative embodiments. It is to be understood that the disclosure is not limited to the particular embodiments described, as such may vary. All apparatuses and systems and methods discussed herein are examples of apparatuses and/or systems and/or methods implemented in accordance with 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 are merely examples. Thus, references to elements or structures or features in the drawings must be appreciated as references to examples of embodiments of the disclosure, and should not be understood as limiting the disclosure to the specific elements, structures, or features illustrated. Other examples of manners of implementing the disclosed principles will occur to a person of ordinary skill in the art upon reading this disclosure. In fact, it will be apparent to those skilled in the art that various modifications and variations can be made in the present disclosure without departing from the scope or spirit of the present subject matter. For instance, features illustrated or described as part of one embodiment can be used with another embodiment to yield a still further embodiment. Thus, it is intended that the present subject matter covers such modifications and variations as come within the scope of the appended claims and their equivalents.
It will be appreciated that the present disclosure is set forth in various levels of detail in this application. In certain instances, details that are not necessary for one of ordinary skill in the art to understand the disclosure, or that render other details difficult to perceive may have been omitted. The terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting beyond the scope of the appended claims. Unless defined otherwise, technical terms used herein are to be understood as commonly understood by one of ordinary skill in the art to which the disclosure belongs. All of the devices and/or methods disclosed and claimed herein can be made and executed without undue experimentation in light of the present disclosure.
As used herein, “proximal” refers to the direction or location closest to the user (medical professional or clinician or technician or operator or physician, etc., such terms being used interchangeably herein without intent to limit, and including automated controller systems or otherwise), etc., such as when using a device (e.g., introducing the device into a patient, or during implantation, positioning, or delivery), and/or closest to a delivery device, and “distal” refers to the direction or location furthest from the user, such as when using the device (e.g., introducing the device into a patient, or during implantation, positioning, or delivery), and/or closest to a delivery device. “Longitudinal” means extending along the longer or larger dimension of an element. A “longitudinal axis” extends along the longitudinal extent of an element, though is not necessarily straight and does not necessarily maintain a fixed configuration if the element flexes or bends, and “axial” generally refers to along the longitudinal axis. However, it will be appreciated that reference to axial or longitudinal movement with respect to the above-described systems or elements thereof need not be strictly limited to axial and/or longitudinal movements along a longitudinal axis or central axis of the referenced elements. “Central” means at least generally bisecting a center point and/or generally equidistant from a periphery or boundary, and a “central axis” means, with respect to an opening, a line that at least generally bisects a center point of the opening, extending longitudinally along the length of the opening when the opening comprises, for example, a tubular element, a channel, a cavity, or a bore. As used herein, a “lumen” or “channel” or “bore” or “passage” is not limited to a circular cross-section. As used herein, a “free end” of an element is a terminal end at which such element does not extend beyond. It will be appreciated that terms such as at or on or adjacent or along an end may be used interchangeably herein without intent to limit unless otherwise stated, and are intended to indicate a general relative spatial relation rather than a precisely limited location.
Various medical procedures involve delivery (e.g., injection) of injectable material(s) into the body before, during, or after the procedure. Preferably, the injectable material is biocompatible, and optionally biodegradable. The injectable material may serve a variety of purposes, including, without limitation, differentiating tissue (e.g., by creating a “bleb” or other raised or swelled region to distinguish an anatomical region), spacing anatomical structures from one another, otherwise affecting (e.g., shielding, coating, covering, modifying, etc.) an anatomical structure, etc. It will be appreciated that the term “tissue” is a broad term that encompasses a portion of or site within a body: for example, a group of cells, a group of cells and interstitial matter, an organ, a portion of an organ, an anatomical portion of a body, e.g., a rectum, ovary, prostate, nerve, cartilage, bone, brain, or portion thereof, etc. Moreover, reference may be made, herein, to a “target” in referring to an area of the patient's body at which a procedure is to be performed. However, it will be appreciated that such reference is to be broadly understood and is not intended to be limited to tissue or to particular procedures. Finally, reference may be made to target tissue, target location, target site, target tissue site, anatomical site, delivery site, deployment site, injection site, treatment site, etc., including combinations thereof and other grammatical forms thereof, interchangeably and without intent to limit.
Certain specific aspects of the present disclosure relate to placing an injectable material between target tissue to be treated and other tissues. For the sake of convenience, and without intent to limit, reference is made to an injectable material, such as a filler, including, without limitation, a gel composition. The injectable material may be delivered within the patient to displace the tissue relative to a tissue that is to be treated by a therapeutic procedure or otherwise (e.g., not necessarily therapeutic). Certain aspects of the present disclosure include displacing and/or shielding a tissue to protect the tissue against possible side effects of treatment of a target tissue, such as the effects of a treatment involving radiation or cryotherapy. In some aspects, the injectable material may displace anatomical tissue and/or may increase the distance between the target tissue and other tissues. For instance, if the target tissue is to be irradiated, the injectable material may space other tissues from the target tissue so that the other tissues are exposed to less radiation and/or are shielded from the radiation. In some aspects, the injectable material is injected as a filler in a space between tissues. A first tissue may then be treated by radiation, while the injectable material reduces passage of radiation therethrough into a second tissue. The first tissue may be irradiated while the second tissue, spaced by the injectable material, receives less radiation than it would have in the absence of the injectable material. An effective amount of an injectable material may be injected into a space between a first tissue to be treated and a second tissue which can be a critically sensitive organ. For instance, in the context of treatment of prostate cancer, an injectable material may be injected into the Denonvilliers' space (a region between the rectum and prostate) to create additional space between the rectum and prostate and/or to shield the rectum during treatment, thereby reducing rectal radiation dose and associated side effects.
In some aspects of the present disclosure, constituents of an injectable material are combined by a system formed in accordance with various principles of the present disclosure and injected into or near a target site. It will be appreciated that terms such as combine, mix, blend, etc., (including other grammatical forms thereof) may be used interchangeably herein without intent to limit unless otherwise indicated. Reference is accordingly made herein to a combining system generically, without intent to specifically require active combining/mixing.
In accordance with various principles of the present disclosure, the injectable material may be a filler such as a hydrophilic polymer, a gel, a hydrogel, etc. For instance, the injectable material can include polymeric materials which are capable of forming a hydrogel upon crosslinking. Optionally, the polymer forms a hydrogel within the body. A hydrogel is defined as a substance formed when a polymer (natural or synthetic) is crosslinked via covalent, ionic, or hydrogen bonds to create a three-dimensional structure which entraps water molecules to form a gel. Naturally occurring and synthetic hydrogel forming polymers, polymer mixtures and copolymers may be utilized as hydrogel precursors. In some aspects, the hydrogel can be formed by a composition formed by two or more constituents/components (e.g., mixing accelerant fluid, diluent, and polyethylene glycol (PEG) together), and may include one or more polysaccharide compounds or a salt thereof. For example, the composition may include a cellulose compound such as carboxymethyl cellulose (CMC) or salt thereof (e.g., CMC sodium), xanthan gum, alginate or a salt thereof (e.g., calcium alginate, such as Ca-alginate beads), chitosan, and/or hyaluronic acid. In some examples, the composition may comprise a mixture of hyaluronic acid and CMC, and/or may be crosslinked with a suitable crosslinking compound, such as butanediol diglycidyl ether (BDDE). In some aspects, the polysaccharide may be a homopolysaccharide or a heteropolysaccharide.
In some aspects of the present disclosure, two or more constituents of an injectable material are provided separately, and are combined by a device, system, and method in accordance with various principles of the present disclosure to form an injectable material to be injected into or near a target site by devices, systems, and methods in accordance with various principles of the present disclosure. The injectable material may be delivered within the patient to displace the tissue relative to a tissue that is to be treated by a therapeutic procedure or otherwise (e.g., not necessarily therapeutic). A composition to be injected into a patient may be a combination of two or more constituents combined by a device, system, or method formed in accordance with various principles of the present disclosure. In accordance with various principles of the present disclosure, a composition to be injected into a patient may be a combination of two or more constituents combined by a device, system, or method such as formed in accordance with various principles of the present disclosure. For instance, devices, systems, or methods of the present disclosure may be used to combine a first constituent and a second constituent for injection into a patient. The first constituent may be a precursor, e.g., a first constituent to be combined with an additional constituent to form the injectable compound. The second constituent may be an accelerator, an activating agent, a catalyst, an initiator, etc., which, upon combination with the precursor, produces the injectable compound, such as by altering the chemical composition or structure of the first constituent or precursor. The constituents may be combined prior (e.g., immediately prior) to delivery (e.g., injection) or as the constituents are being delivered to the patient so that the injectable material does not have time to form into a structure which may be difficult to inject or otherwise deliver to the patient. As such, the combination of the first constituent or precursor and the second constituent may be such that the injectable compound attains its desired properties and/or reaches its final form in situ.
In some embodiments, the injectable material is formed of a first constituent, a second constituent, and a third constituent. For instance, for various reasons it may be desirable to provide a first, precursor constituent in a solid form (e.g., to be more stable for storage and/or transport). The first constituent is combinable with the third constituent, and the thus-formed combined composition (which may be referenced as the precursor) is then combinable with the second constituent once the medical professional is ready to deliver (e.g., inject) the injectable material to the patient. The second constituent may facilitate a crosslinking interaction between the first and third constituents, for example, by initiating or accelerating the crosslinking interaction of the first and third constituents. Typically, one or more of the constituents of the injectable materials are biocompatible polymers. In some aspects, one of the first, second, or third constituents is a reactive polymer, such as a cross-linkable and/or hydrophilic polymer constituent (e.g., polyethylene glycol (PEG)), and one of the first, second, third constituent is a diluent (e.g., mostly water) in which a solid or semi-solid form of the reactive polymer is dissolved or dispersed, and/or with which the reactive polymer is cross-linked (or at least cross-linkable, such as upon further combination with the second constituent), to form a precursor. Another of the first, second, or third constituents may be an accelerator, an accelerant, an activating agent, a catalyst, an initiator, etc. (such terms being used interchangeably herein without intent to limit), combinable and reactive with the precursor to form the desired injectable material. In one example of an embodiment, a first constituent, in the form of a reactive polymer (specifically, PEG) that has been derivatized with reactive electrophilic groups (specifically, succinimide ester groups), is mixed with a third constituent, in the form of a cross-linking agent (specifically, trilysine, which contains multiple nucleophilic groups, specifically, amino groups), under acidic pH conditions where the succinimide ester groups and the amino groups do not react to any significant degree. When this mixture is combined with a second constituent, in the form of an accelerant (specifically, a basic buffer solution), the pH of the resulting mixture becomes basic, at which point the amino groups of the trilysine react with the succinimide ester groups of the PEG to form covalent bonds, thereby crosslinking the PEG and forming a hydrogel. It will be appreciated that reference to “first”, “second”, or “third” is not intended to connote a particular nature of the material or the order in which the material is combined. As such, “first”, “second”, and “third” may be used to reference any of three constituents forming an injectable material in accordance with various principles of the present disclosure. A non-limiting example of such constituents combinable by devices, systems, or methods in accordance with various principles of the present disclosure includes a reactive constituent, a diluent with which the reactive constituent is to be combined to form a precursor, and an accelerator combinable with the precursor to form an injectable material. The injectable material is a biocompatible material, such as a polymeric material, such as a filler, or such as a hydrogel.
In some examples, the composition may be or include a gel with a desired gel strength and/or viscosity, such as a biocompatible gel suitable for injection (e.g., through a needle), as discussed in further detail below. In one example of an embodiment, the first constituent is a biocompatible polymeric constituent. More particularly, in one example of an embodiment, the first constituent is a hydrophilic polymer, which may be natural or synthetic in origin, 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 carrageenans, and synthetic hydrophilic polymers such as polyethylene glycols (PEG), PEG-methacrylates, PEG-methylmethacrylates, polyvinyl alcohols, polyacrylates and polymethacrylates, polyacrylic acids and their salts, polymethacrylic acids and their salts, polymethylmethacrylates, carboxymethylcelluloses, hydroxyethylcelluloses, polyvinylpyrrolidones, polyacrylamides such as N,N-methylene-bis-acrylamides or tris (hydroxymethyl) methacrylamides. The hydrophilic polymer may be modified to provide functional groups that are reactive with functional groups of a suitable cross-linking agent, which may be a covalent or ionic cross-linking agent.
The concentrations of gelling agent(s) in a composition formed in accordance with various principles of the present disclosure maybe at least about 0.01% by weight with respect to the total weight of the composition, and at most about 2.0% by weight with respect to the total weight of the composition, including increments of about 0.01% therebetween. For instance, the concentration of gelling agent(s) may range from about 0.02% to about 1.5%, from about 0.05% to about 1.0%, from about 0.05% to about 0.50%, from 0.05% to about 0.15%, from about 0.10% to about 0.20%, from about 0.15% to about 0.25%, from about 0.20% to about 0.30%, from about 0.25% to about 0.35%, from about 0.30% to about 0.40%, from about 0.35% to about 0.45%, from about 0.40% to about 0.50%, from about 0.1% to about 0.5%, or from about 0.1% to about 0.15% by weight with respect to the total weight of the composition. In at least one example, the total concentration of the gelling agent(s) in the composition may range from about 0.05% to about 0.5% by weight with respect to the total weight of the composition.
In some examples, a composition formed in accordance with various principles of the present disclosure may have a viscosity of at least about 0.001 pascal-second (Pa·s), and at most about 0.100 Pa·s at a shear rate of 130 s−1. For instance, the composition may have a viscosity ranging from about 0.005 Pa·s to about 0.050 Pa·s, from about 0.010 Pa·s to about 0.050 Pa·s, from about 0.010 Pa·s to about 0.030 Pa·s, from about 0.010 Pa·s to about 0.020 Pa·s, from about 0.020 Pa·s to about 0.030 Pa·s, or from about 0.020 Pa·s to about 0.040 Pa·s at a shear rate of 130 s−1. Thus, for example, the composition may be or comprise a gel having a viscosity of about 0.005 Pa·s, about 0.006 Pa·s, 0.008 Pa·s, about 0.010 Pa·s, about 0.011 Pa·s, about 0.012 Pa·s, about 0.013 Pa·s, about 0.014 Pa·s, about 0.015 Pa·s, about 0.016 Pa·s, about 0.017 Pa·s, about 0.018 Pa·s, about 0.019 Pa·s, about 0.020 Pa·s, about 0.022 Pa·s, about 0.024 Pa·s, about 0.026 Pa·s, about 0.028 Pa·s, about 0.030 Pa·s, about 0.032 Pa·s, about 0.034 Pa·s, about 0.036 Pa·s, about 0.038 Pa·s, about 0.040 Pa·s, about 0.042 Pa·s, about 0.044 Pa·s, about 0.046 Pa·s, about 0.048 Pa·s, or about 0.050 Pa·s at a shear rate of 130 s−1. In at least one example, the composition may have a viscosity greater than 0.0050 Pa·s at a shear rate of 130 s−1, e.g., a viscosity ranging from about 0.005 Pa·s to about 0.050 Pa·s, at a shear rate of 130 s−1. In at least one example, the composition may have a viscosity greater than 0.010 Pa·s at a shear rate of 130 s−1, e.g., a viscosity ranging from about 0.010 Pa·s to about 0.030 Pa·s, at a shear rate of 130 s−1.
Alternatively or additionally, a composition formed in accordance with various principles of the present disclosure may have a viscosity of at least about 0.001 Pa·s, and at most about 0.050 Pa·s at a shear rate of 768 s−1. For instance, the composition may have a viscosity ranging 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 about 0.010 Pa·s, from about 0.004 Pa·s to about 0.006 Pa·s, from about 0.005 Pa·s to about 0.007 Pa·s, from about 0.006 Pa·s to about 0.008 Pa·s, from about 0.007 Pa·s to about 0.009 Pa·s, or from about 0.008 Pa·s to about 0.01 Pa·s at a shear rate of 768 s−1. Thus, for example, the composition may be or comprise a gel having a viscosity of about 0.003 Pa·s, about 0.004 Pa·s, about 0.005 Pa·s, about 0.006 Pa·s, about 0.007 Pa·s, about 0.008 Pa·s, about 0.009 Pa·s, or about 0.010 Pa·s at a shear rate of 768 s−1. In at least one example, the composition may have a viscosity less than 0.010 Pa·s at a shear rate of 768 s−1, e.g., a viscosity ranging from about 0.005 Pa·s to about 0.009 Pa·s at a shear rate of 768 s−1. In at least one example, the composition may have a viscosity ranging from about 0.004 Pa·s to about 0.010 Pa·s at a shear rate of 768 s−1. Further, for example, the composition may have a viscosity ranging from about 0.010 Pa·s to about 0.030 Pa·s, e.g., about 0.017 Pa·s at a shear rate of 130 s−1 and a viscosity ranging from about 0.004 Pa·s to about 0.010 Pa·s, e.g., about 0.007 Pa·s, at a shear rate of 768 s−1.
In some embodiments, a multi-reservoir system includes separate reservoirs for constituents to be combined to form the injectable material to be delivered to the patient by an injection system. In some embodiments, a first constituent and a second constituent are separately contained within a first reservoir and a second reservoir, respectively, of a multi-reservoir device. A third constituent may be contained in a separate reservoir defining a third reservoir of the multi-reservoir system. To deliver the injectable material, the constituents of the first and second reservoirs are combined within the second reservoir (e.g., to form a precursor) and then the constituents 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 reservoir with the contents of the third reservoir. For instance, the multi-reservoir device may deliver and inject the constituents of the injectable material to an injection system, with the injection system including a mixer component configured to mix the constituents from the second reservoir of the multi-reservoir device with the contents from the third reservoir of the multi-reservoir device as those contents are injected from the multi-reservoir device and the injection system into the patient. The already-combined first and second constituents are combined with the third constituent to form the desired form, structure, composition, properties, etc., of the injectable material to be delivered and deposited within the patient. The final form, structure, composition, properties, etc., of the injectable material may be attained once the combined constituents are within the patient.
The present disclosure provides devices, systems, and methods for combining constituents to form an injectable composition, and corresponding medical devices, systems, and methods for use thereof and/or delivery to a treatment site of a patient. According to some aspects of the present disclosure, such as described above, a multi-reservoir system may include a plurality of reservoirs for the one or more constituents of the injectable material and for combinations of such constituents. It will be appreciated that terms such as chamber, reservoir, container, vial, lumen, etc., may be used interchangeably herein without intent to limit, to refer to elements which contain, convey, hold, transport, collect, etc., a constituent (fluid, particulate, liquid, solid, gas, etc.) of an injectable material. Suitable chambers may include, for example, vials, syringes (e.g., a syringe barrel compatible with a manual or automatic injection system) and other fluid containers, such as configured for use with a suitable injection system. Examples of materials suitable for the reservoir of devices or systems of the present disclosure include, but are not limited to, cyclic olefin polymer, polypropylene, polycarbonate, polyvinyl chloride, and glass. In some aspects, one of these materials (e.g., cyclic olefin copolymer specifically) can have a coating applied to it (such as SiO2 coating), which is advantageous so the coating can provide a primary oxygen barrier, behave as a glass-like layer, and/or can be applied using a vapor deposition process.
A combining device or system formed in accordance with various principles of the present disclosure to combine two or more constituents to form an injectable material may include and/or be removably connected to one or more injection systems which are configured to deliver the injectable materials to a patient. According to some aspects of the present disclosure, the filler compositions which may be used with various systems disclosed herein, e.g., the compositions prepared by the various devices, systems, methods disclosed herein, may have sufficient strength, e.g., gel strength, to withstand the forces on the continuity of the three-dimensional configuration (e.g., gel network) of the composition, and thereby minimize the effects of such forces. In the meantime, compositions with 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 the reservoir(s), delivery lumen, needle, or other structure in which the composition is contained or through which it passes. According to some aspects of the present disclosure, the composition may maintain its three-dimensional structure until the composition is injected into a patient (e.g., through a needle), whereupon the structure may form fragments of the original continuous, three-dimensional network. Those fragments may have a diameter corresponding to the diameter of the lumen through which it passes into the patient (e.g., the lumen of an injection needle), such that the fragments are as large as possible in-vivo to retain as much of the three-dimensional structure of the composition as possible. Injection of these larger-sized particles or fragments is believed to increase the amount of time the gel remains within the tissue.
In some examples, the injection system includes a needle. In some embodiments, the needle may be a hypodermic needle, and may range from a size of 7-gauge (4.57 mm outer diameter (OD), 3.81 mm inner diameter (ID)) to 33-gauge (0.18 mm OD, 0.08 mm ID), e.g., a size of 16-gauge (1.65 mm OD, 1.19 mm ID), 18-gauge, 21-gauge (0.82 mm OD, 0.51 mm ID), 22-gauge (0.72 mm OD, 0.41 mm ID), 23-gauge (0.64 mm OD, 0.33 mm ID), or 24-gauge (0.57 mm OD, 0.31 mm ID). According to some aspects of the present disclosure, the size of the needle may be chosen based on the viscosity and/or constituents of the composition, or vice versa. According to some aspects of the present disclosure, the size of the needle may be 23-gauge or 25-gauge. In some cases, a larger size of 18-gauge, 20-gauge, 21-gauge, or 22-gauge may be used to inject the compositions disclosed herein. Examples of materials which may 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 tip of the needle may be sharpened, and may have a beveled shape. The proximal end of the needle may include a suitable fitting/adaptor (e.g., a Luer adapter) for engagement with a syringe or other reservoir. In some examples, the needle may include an elongated tube or catheter between the needle tip and the proximal fitting/adapter.
As noted above, compositions used with systems disclosed herein may have large particulate matter (relative to the injection system lumen) and/or a 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 a needle aperture (generally described as “peak load” force) may depend on the viscosity of the composition, the dimensions of the needle (inner diameter, outer diameter, and/or length), and/or the material(s) from which the needle is formed. For example, a greater amount of force may be applied to inject the composition through a 33-gauge needle in comparison to a 7-gauge needle. Additional factors that may affect the amount of force applied to inject the composition may include the dimensions of a catheter (inner diameter, outer diameter, and/or length) connecting the mixing system to the needle. Suitable peak loads for injection with one or two hands may range from about 5 pound-force (lb·f) to about 25 lb·f, such as from about 10 lb·f to about 20 lb·f, e.g., about 15 lb·f. The loads measured for a given gel concentration may vary for different needles and flow rates.
According to some aspects of the present disclosure, the size of the needle may be chosen based on the viscosity and/or constituents of the composition, or vice versa. According to some aspects of the present disclosure, the size of the needle may be 23-gauge or 25-gauge. In some cases, a larger size of 18-gauge, 20-gauge, 21-gauge, or 22-gauge may be used to inject the compositions disclosed herein.
According to some aspects of the present disclosure, a combining device or system can be included in a kit for introducing an injectable material into a patient, whereby the injectable material can include any of a variety of suitable compositions. Kits or systems may be configured to store one or more of the constituents of a composition until the medical professional is ready to mix the composition for delivery to a patient. For instance, compositions, such as hydrogels, may be prepared so that the precursor(s) and any related activating agent(s) are stored in the kit with diluents as may be needed. Applicators may be used in combination with the same. Kits formed in accordance with various principles of the present disclosure can be manufactured using medically acceptable conditions and contain constituents that have sterility, purity, and preparation that is pharmaceutically acceptable. Solvents/solutions may be provided in the kit or separately. The kit may include one or more syringes and/or needles for mixing and/or delivery of the injectable material, and/or for additional aspects of the procedure in which the injectable material is to be used. The kit or system may comprise various constituents as set forth herein. For instance, a target site into which an injectable material is to be delivered may be pre-treated using one or more constituents of the kit. One example of a pretreatment includes hydrodissection, such as with saline, to create space for injectable material to be injected at or in the vicinity of the target tissue site. Once saline has been injected to the treatment site, a combining device or system can be connected to a needle (e.g., an 18-gauge spinal needle) to then deliver the injectable material to the treatment site. For instance, in treating prostate cancer, a 5-10 mm layer of filler (e.g., gel composition) may be injected along the posterior wall of the prostate between the prostate and rectum. Once the filler has been injected into the space between the rectum and prostate, ultrasound images can be obtained.
In accordance with various principles of the present disclosure, a combining and/or delivery system is configured to facilitate combining of constituents of an injectable material. In some aspects, the injectable material is a combination of a first constituent, a second constituent, and a third constituent, such as described above. A combining and/or delivery system formed in accordance with various principles of the present disclosure facilitates combining/mixing of the various constituents of an injectable material. Additionally or alternatively, a combining and/or delivery system formed in accordance with various principles of the present disclosure facilitates delivery of the injectable material 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 particularly, various aspects of the present disclosure simplify assembly, alignment, mixing, dispensing, etc., of an injectable material which is combined or blended or mixed from separate constituents before delivery to a patient.
In some aspects, a combining and/or delivery system formed in accordance with various principles of the present disclosure includes three distinct lumens, chambers, or reservoirs for respective first, second, and third constituents of an injectable material to be delivered and injected into a patient. The present disclosure facilitates combination of the separately-provided first and third constituents before a procedure, as well as combination of the recently-combined first and third constituents with the second component for injection into the patient. In particular, an example of an embodiment of a mixing and/or delivery system disclosed herein includes a combining system configured to facilitate the combining of the first, second, and third constituents of an injectable material before delivery to a patient. As described above, it may be desirable to provide the first, second, and third constituents separate from one another for combination only once a procedure is to be performed utilizing the injectable material formed by combining the first, second, and third constituents.
Turning to the drawings,
The injection system 102 may include a needle 112 which can be any needle of this disclosure suitable for hydrodissection as well as delivering the injectable material (e.g., a gel composition) to the treatment site. A proximal end 114 of the needle 112 can be connected to a distal end 118 of a needle hub 116 (e.g., the needle 112 can be overmolded to connect to the needle hub 116). The proximal end 120 of the needle hub 116 may be attached to a distal end of a connector 122. In some embodiments, it is contemplated that the needle 112 may be replaced with a catheter tube or similar structure to reach a target location deeper in the body.
The multi-reservoir system 104 of the overall system 100 may generally include a plunger assembly 124, a barrel portion 126, a cap 128, a first retainer 130, and a second retainer 132. Briefly, a distal portion of the plunger assembly 124 may be slidably disposed within a proximal portion of the barrel portion 126. The plunger assembly 124 may be configured to actuate to dispense the third constituent 110 from a reservoir into another reservoir containing the first constituent to first mix two constituents 106, 110 to form a precursor and then to mix the precursor 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.
Referring additionally to
The first plunger 138a may include a seal 140a affixed to the distal end thereof. 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 monolithic structure. In other embodiments, the plunger assembly 124 may be formed as two or more distinct components that are subsequently coupled together or individually actuatable. In some cases, the actuation member 135 and the first and second plungers 138a, 138b may be formed as a single monolithic structure and the seal 140a may be provided as separate components. This is just one example. Other configurations may be used, as desired.
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 region to allow the 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 and second barrels 146a, 146b may extend side-by-side and may be interconnected by a connection portion 145 adjacent the proximal end thereof and laterally spaced adjacent the distal end thereof. The first barrel 146a may define a first lumen 148a and the second barrel 146b may define a second lumen 148b. The first and second lumens 148a, 148b may cach extend through the body portion 127 from a proximal opening 150a, 150b adjacent to the proximal end 142 to a distal opening 152a, 152b adjacent to the distal end 144 of the barrel portion 126. In some cases, the first and second lumens 148a, 148b may have a same cross-sectional shape and/or dimension along a length thereof. For example, the first and second lumens 148a, 148b may have a generally semi-circular or “D” shaped cross-sectional shape along a length thereof. However, this is not required. The first and second lumens 148a, 148b may take other cross-sectional shapes, as desired.
The proximal opening 150a, 150b may be selectively fluidly isolated from the distal opening 152a, 152b via a stopper or gasket 154a, 154b. In some embodiments, the stoppers 154a, 154b may be floating gaskets that are not fixedly coupled to any portion of the plunger assembly 124 or the barrel portion 126. The floating gaskets 154a, 154b may form a fluid-tight seal with an inner surface of the barrel portion 126. The first floating gasket 154a may be positioned within the first lumen 148a between the proximal opening 150a and the distal opening 152a thereof. The first floating gasket 154a may selectively fluidly isolate the proximal end region and the distal end region of the first lumen 148a to form a first reservoir 156a for containing a third constituent 110, or diluent and a second reservoir 156b for containing a first constituent 106, or PEG. For example, the seal 140a of the first plunger 138a and the first floating gasket 154a may bound the first reservoir 156a while the first floating gasket 154a and the distal opening 152a may bound the second reservoir 156b. Similarly, the second floating gasket 154b may selectively fluidly isolate the proximal end region and the distal end region of the second lumen 148b to form a cavity 156c and a third reservoir 156d for containing a second constituent 108, or accelerator. For example, the distal end of the second plunger 138b and the second floating gasket 154b may bound the cavity 156c while the second floating gasket 154b and the distal opening 152b may bound the third reservoir 156d. It is contemplated that the cavity 156c may not be sealed and may not include a constituent of the injectable material. As such, the distal end of the second plunger 138b may be free from a seal or stopper. However, if it is desired to store a constituent in the 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 with a plunger/gasket that is only actuated after a first actuated distance of the first plunger 138a. In other examples, the second plunger 138b may be provided with a seal or gasket configured to bound the third reservoir 156d.
It is contemplated that the first, second, and third reservoirs 156a, 156b, 156d may be selectively fluidly isolated from one another. Further, the third reservoir 156d may be fluidly isolated from the cavity 156c. In some cases, the body portion 127 may define a wall 157 between the first and second barrels 146a, 146b to fluidly isolate the lumens 148a, 148b thereof. In some embodiments, the cross-sectional dimension of the second and third reservoirs 156b, 156d may decrease from a proximal end thereof to the distal end 144 of the barrel portion 126. The cross-sectional dimension may decrease in an abrupt step-wise manner to form discrete transitions in the cross-sectional dimension or the cross-sectional dimension may gradually taper. In some embodiments, the barrel portion 126 may be formed as a single monolithic structure. In other embodiments, the barrel portion 126 may be formed as two or more distinct components that are subsequently coupled together.
The reservoirs 156a, 156b, 156d may be sized to hold a desired volume of respective constituents 106, 108, 110. In some examples, the volume of at least some of the reservoirs 156a, 156b, 156d may be increased or decreased as the constituents 106, 108, 110 are moved within the multi-reservoir system 104.
Referring additionally to
A cap 128 may be releasably coupled to the distal end 144 of the barrel portion 126. The cap 128 may be sized and shaped to be disposed over and fluidly seal the distal openings 152a, 152b of the barrel portion 126. While not explicitly shown, the cap 128 may include an elastomeric or deformable sealing material disposed on an interior surface thereof and configured to contact the distal end 144 of the barrel portion 126 to form a fluid tight seal between the cap 128 and the barrel portion 126. The cap 128 may form a snap fit with the distal end 144 of the barrel portion 126. For example, when the cap 128 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 apertures 176a, 176b of the cap 128. The one or more apertures 176a, 176b may be disposed below one or more buttons 171a, 171b of the cap 128 such that actuating (e.g., depressing) the one or more buttons 171a, 171b is configured to disengage the one or more tabs 173a, 173b of the barrel portion 126 from the one or more mating apertures 176a, 176b to allow the cap 128 to be uncoupled from the multi-reservoir system 104. However, other coupling mechanisms may be used, as desired, such as, but not limited to, friction fits, threaded engagements, rotational locks, etc. In some examples, the cap 128 may be replaced with valve or other flow control mechanism configured to selectively fluidly scal the distal openings 152a, 152b.
The cap 128 may include a first portion 158 and a second portion 160 with an O-ring 162 or other sealing member disposed therebetween. The second portion 160 may include one or more latches 168a, 168b configured to engage one or more mating ledges or protrusions 170a, 170b of the first portion 158. In some cases, the first portion 158 may include the one or more buttons 171a, 171b configured to releasably secure the cap 128 to the barrel portion 126 while the second portion 160 may include one or more chambers 164a, 164b configured to receive fluid from the second and third reservoirs 156b, 156d during an air purge, as will be described in more detail herein. The one or more chambers 164a, 164b may each include a floating seal 166a, 166b configured to selectively seal the distal openings 152a, 152b. For example, the floating seals 166a, 166b may be configured to move away from the distal openings 152a, 152b in response to pressure generated through actuation of the plunger assembly 124.
The first retainer 130 may be removably positioned proximal to the proximal end 142 of the barrel portion 126. In some cases, the first retainer 130 may form a snap fit, 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 (see also, for example,
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 (see also, for example,
Generally, the plunger assembly 124 and the barrel portion 126 may be assembled in a telescoping arrangement. For example, a portion of plunger assembly 124 may be disposed within a portion of the barrel portion 126. More particularly, the plunger assembly 124 may be assembled with the barrel portion 126 such that the first plunger 138a of the plunger assembly 124 and the first floating gasket 154a are slidably disposed within the first lumen 148a of the barrel portion 126 and the second plunger 138b of the plunger assembly 124 and the second floating gasket 154b are slidably disposed within the second lumen 148b of the barrel portion 126. The plunger assembly 124 is movable, such as axially and/or longitudinally slidable, with respect to the barrel portion 126 to move (e.g., eject) materials out of and/or to move (e.g., aspirate) materials into first, second, and/or third reservoirs 156a, 156b, 156d within the barrel portion 126.
The barrel portion 126 may be pre-loaded with the constituents required to form the injectable material. For example, a first constituent, such as, but not limited to, a first cross-linkable constituent 106 may be disposed within the second reservoir 156b of the barrel portion 126. In some examples, the first cross-linkable constituent 106 may be provided as a powder. A second constituent 108, such as, but not limited to, an accelerator, may be disposed within the third reservoir 156d of the barrel portion 126. In some examples, the second constituent 108 may be provided as a liquid. A third constituent 110, such as, but not limited to, a second cross-linkable constituent, may be disposed within the first reservoir 156a of the barrel portion 126. In some examples, the third constituent 110 may be provided as a liquid. The first floating gasket 154a may fluidly isolate the third constituent 110 from the first constituent 106 until mixing is desired. Further, the second constituent 108 may be fluidly isolated from each of the first and third constituents 106, 110 until mixing is desired.
A method for dispensing or injecting the injectable material, along with additional features of the combining and/or delivery system 100 will now be described with respect to
The second plunger 138b may be actuated or distally advanced within the second lumen 148b substantially simultaneously with the first plunger 138a. However, in the absence of a seal on the distal end of the second plunger 138b, the second floating gasket 154b may remain stationary as any air that is displaced by movement of the second plunger 138b exits the second lumen 148b via the proximal opening 150b thereof.
The cap 128 may inhibit or prevent fluid from exiting the distal openings 152a, 152b of the second and third reservoirs 156b, 156d as fluid is transferred from the first reservoir 156a to the second reservoir 156b of the barrel portion 126. The first and third constituents 106, 110 may now be in the second reservoir 156b of the barrel portion 126 and the second constituent 108 may remain in third reservoir 156d of the barrel portion 126.
Once the first constituent 106 has been injected from the first reservoir 156a into the second reservoir 156b, the multi-reservoir system 104 may be shaken, as shown in
After mixing, the first retainer 130 is removed from the plunger assembly 124 while the second retainer 132 remains in place, as shown in
Once the first retainer 130 has been removed, the plunger assembly 124 may again be actuated or distally advanced. For example, the plunger assembly 124 may be pushed or depressed axially towards the distal end 144 of the barrel portion 126 to remove air and/or to excess fluid from the second and/or third reservoirs 156b, 156d. This may be done with the cap 128 coupled to the distal end region of the barrel portion 126. As described above, the air and/or excess fluid may be trapped within cavities 164a, 164b in the cap 128. The plunger assembly 124 may be actuated or distally advanced until the second retainer 132 contacts the proximal end 142 of the barrel portion 126, as shown in
Next, the cap 128 may be removed as shown in
Next, the second retainer 132 is removed from the plunger assembly 124, as shown in
The multi-reservoir system 104 may be held in an upright manner (e.g., with the distal end 144 of the barrel portion 126 pointed upwards (or away from the ground) to prevent an excess of fluid from dripping and/or leaking from the second and third reservoirs 156b, 156d of the barrel portion 126. In some cases, some fluid may be dispensed from the second and third reservoirs 156b, 156d during air purging to ensure no air remains in the second and third reservoirs 156b, 156d.
The multi-reservoir system 104 may be maintained in an upright orientation as hydrodissection is performed. Hydrodissection may be optionally performed before injecting the injectable material into the body.
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 can be positioned on or adjacent to an outer surface of lower housing 200. In some cases, two buttons 202 may be positioned on opposing sides of the lower housing 200. The button(s) 202 can be configured so that an actuating squeeze or other movement by a user causes latches of an adaptor or connector 122 and/or the barrel portion 126 of the multi-reservoir system 104 to release from mating apertures in the needle hub 116. However, other coupling mechanisms between the needle hub 116 and the connector 122 or barrel portion 126 are contemplated as needed or required. For example, and without limitation, snap fit connectors, magnetic connectors, female-male connectors, hook and loop fasteners, and the like are contemplated.
The needle hub 116 may also include a transitional portion 204 through which the needle 112 can be inserted. The transitional portion 204 can include a diameter (or cross-sectional dimension) smaller than the lower housing 200. In some examples, the transitional portion 204 can be tapered and/or include a textured outer surface. A central tubular lumen 206 connected to a first lumen 208 and a second lumen 210 (sec, for example,
To perform the hydrodissection, the injection system 102 and a saline syringe 198 may be required, as shown in
Next, the multi-reservoir system 104 may be connected to the needle hub 116. To do so, the first and second lumens 208, 210 may be aligned with the distal openings 152a, 152b of the barrel portion 126, as shown in
Once the multi-reservoir system 104 has been assembled with the injection system 102, the plunger assembly 124 can be actuated or distally advanced to cause the precursor (e.g., resulting from the mixture of the first constituent 106 and the third constituent 110) disposed in the second reservoir 156b of the barrel portion 126 and the second constituent 108 (e.g., the accelerator, such as, but not limited to a basic buffer solution) disposed in the third reservoir 156d of the barrel portion 126 to be dispensed from the distal openings 152a, 152b. Referring additionally to
It will be apparent to those skilled in the art that various modifications and variations can be made to the disclosed device without departing from the scope of the disclosure. Other embodiments of the disclosure will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the invention being indicated by the following claims.
All apparatuses and methods discussed herein are examples of apparatuses and/or methods implemented in accordance with one or more principles of this disclosure. These examples are not the only way to implement these principles but are merely examples. Thus, references to clements or structures or features in the drawings must be appreciated as references to examples of embodiments of the disclosure, and should not be understood as limiting the disclosure to the specific elements, structures, or features illustrated. Other examples of manners of implementing the disclosed principles will occur to a person of ordinary skill in the art upon reading this disclosure.
In the foregoing description and the following claims, the following will be appreciated. The phrases “at least one”, “one or more”, and “and/or”, as used herein, are open-ended expressions that are both conjunctive and disjunctive in operation. The term “a” or “an” entity, as used herein, refers to one or more of that entity. As such, the terms “a” (or “an”), “one or more” and “at least one” can be used interchangeably herein. All directional references (e.g., proximal, distal, upper, lower, upward, downward, left, right, lateral, longitudinal, front, back, top, bottom, above, below, vertical, horizontal, radial, axial, clockwise, counterclockwise, and/or the like) are only used for identification purposes to aid the reader's understanding of the present disclosure, and/or serve to distinguish regions of the associated elements from one another, and do not limit the associated element, particularly as to the position, orientation, or use of this disclosure. Connection references (e.g., attached, coupled, connected, and joined) are to be construed broadly and may include intermediate members between a collection of elements and relative movement between elements unless otherwise indicated. As such, connection references do not necessarily infer that two elements are directly connected and in fixed relation to each other. Identification references (e.g., primary, secondary, first, second, third, fourth, etc.) are not intended to connote importance or priority, but are used to distinguish one feature from another.
The foregoing discussion has been presented for purposes of illustration and description and is not intended to limit the disclosure to the form or forms disclosed herein. It will be understood that various additions, modifications, and substitutions may be made to embodiments disclosed herein without departing from the concept, spirit, and scope of the present disclosure. In particular, it will be clear to those skilled in the art that principles of the present disclosure may be embodied in other forms, structures, arrangements, proportions, and with other elements, materials, and components, without departing from the concept, spirit, or scope, or characteristics thereof. For example, various features of the disclosure are grouped together in one or more aspects, embodiments, or configurations for the purpose of streamlining the disclosure. However, it should be understood that various features of the certain aspects, embodiments, or configurations of the disclosure may be combined in alternate aspects, embodiments, or configurations. One skilled in the art will appreciate that the disclosure may be used with many modifications of structure, arrangement, proportions, materials, components, and otherwise, used in the practice of the disclosure, which are particularly adapted to specific environments and operative requirements without departing from the principles of the present disclosure. For example, elements shown as integrally formed may be constructed of multiple parts or elements shown as multiple parts may be integrally formed, the operation of elements may be reversed or otherwise varied, the size or dimensions of the elements may be varied, and features and components of various embodiments may be selectively combined. The presently disclosed embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the claimed invention being indicated by the appended claims, and not limited to the foregoing description.
The following claims are hereby incorporated into this Detailed Description by this reference, with each claim standing on its own as a separate embodiment of the present disclosure. In the claims, the term “comprises/comprising” does not exclude the presence of other elements or steps. Furthermore, although individually listed, a plurality of means, elements or method steps may be implemented by, e.g., a single unit or processor. Additionally, although individual features may be included in different claims, these may possibly advantageously be combined, and the inclusion in different claims does not imply that a combination of features is not feasible and/or advantageous. In addition, singular references do not exclude a plurality. The terms “a”, “an”, “first”, “second”, etc., do not preclude a plurality. Reference signs in the claims are provided merely as a clarifying example and shall not be construed as limiting the scope of the claims in any way.
This application claims the benefit of U.S. Provisional Patent Application Ser. No. 63/462,152 filed on Apr. 26, 2023, the disclosure of which is incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| 63462152 | Apr 2023 | US |
