Microcatheter manifold adapters and related systems and methods

Abstract

An adapter (1000) for improving an existing delivery system (100) is provided to improve delivery of injectable therapeutic material through the delivery system. The conveying system is an existing conveying system which is formed separately and does not take into account the manufacture of adapters when formed. The delivery system includes a drug delivery assembly (110) and a catheter assembly (120) coupled together in fluid communication by a manifold (130). The injectable therapeutic material may be in the form of microspheres or beads that may be caught within void spaces of existing manifolds of the delivery system. The adapter (1000) reconfigures the interior of the manifold (130) to facilitate full flow of injectable therapeutic material without jamming or otherwise detaining within the manifold to ensure delivery into the patient.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Provisional Application No. 63 / 442,905, filed February 2, 2023, the entire disclosure of which is incorporated herein by reference for all purposes. Technical Field

[0003] This disclosure generally relates to the field of devices, systems, and methods for delivering therapeutic materials into a patient's body. More specifically, this disclosure relates to modifying existing injectable therapeutic material delivery devices, systems, and methods to improve the medical devices, systems, and methods through which injectable therapeutic materials are delivered. More specifically, this disclosure relates to modifying existing therapeutic material delivery devices, systems, and methods to efficiently deliver injectable therapeutic materials in the form of microspheres, microbeads, etc. Background Technology

[0004] Various devices, systems, and methods exist for delivering injectable therapeutic materials to a patient. Injectable therapeutic materials can be contained in vials. Any of a variety of drug delivery assemblies can be used to obtain the injectable material from the vial for delivery to the patient. Typically, a drug delivery assembly includes a flexible tubular element, one end of which is fluidly connected to the vial, and the other end of which has a fitting / connector for connecting a catheter or microcatheter into the patient to deliver the injectable therapeutic material. The catheter or microcatheter typically includes a manifold at one end, configured to connect to the drug delivery assembly. The other end of the microcatheter is typically configured to be inserted into the patient to deliver the injectable therapeutic material. The manifold typically has a fitting / connector configured to connect to the fitting / connector of the drug delivery assembly. For some injectable therapeutic materials, there are several challenges in enabling them to pass completely through the manifold and into the catheter or microcatheter. For example, some injectable therapeutic materials have properties that cause them to become stuck in the manifold. This problem becomes particularly serious when low doses of injectable therapeutic materials are administered, and when more than approximately 5% of the material fails to reach the patient via the manifold. Solutions to these and other challenges are welcome. Summary of the Invention

[0005] This summary aims to present, in a simplified form, some concepts further elaborated in the detailed description below. This summary is not intended to necessarily identify key or essential features of the claimed subject matter, nor is it intended to assist in determining the scope of the claimed subject matter. Those skilled in the art will understand that various aspects and features of this disclosure may be advantageously used separately in some cases and in combination with other aspects and features of this disclosure in others, whether or not such aspects and features are described in this summary. The inclusion or exclusion of certain elements, components, etc., in this summary is not intended to limit the scope of the claimed subject matter.

[0006] According to various principles of this disclosure, an adapter is configured to improve a separately manufactured delivery system through which injectable therapeutic materials are delivered to a patient. In some aspects, the adapter has an adapter body extending from a proximal end to a distal end, defining a lumen through the adapter body extending between the proximal and distal ends of the adapter body. In some aspects, the size, shape, construction, and / or dimensions of the adapter are designed to fit into a lumen defining a manifold through the delivery system to reduce the size of the manifold lumen, thereby facilitating the flow of injectable therapeutic materials from the proximal end of the manifold through the manifold lumen to the distal end of the manifold. In some aspects, the proximal end of the adapter is configured to mate with a convex fitting of a drug delivery assembly configured to deliver injectable therapeutic materials through the manifold; the distal end of the adapter is configured to be positioned within the manifold lumen upstream of the proximal end of a catheter within the manifold lumen.

[0007] In some embodiments, the adapter cavity includes a tapered segment. In some embodiments, the tapered segment is adjacent to the proximal end of the adapter body. In some embodiments, the adapter cavity has a constant-diameter segment extending from the tapered segment to the distal end of the adapter body. In some embodiments, a tubular element extends within the constant-diameter segment of the adapter cavity. In some embodiments, the adapter body is made of a flexible material, and the tubular element is made of a material that is more rigid than the adapter body material. In some embodiments, the adapter body is molded onto the rigid tubular element.

[0008] In some embodiments, the proximal end of the adapter is configured to mate with the end face of an accessory of a drug delivery component located upstream of the manifold of the delivery system, or is configured to accommodate a convex accessory of the drug delivery component therein.

[0009] In some embodiments, the proximal end of the adapter is configured to mate with the end face of a fitting of a piping assembly located upstream of the manifold of the delivery system, or is configured to receive a convex fitting of the piping assembly therein.

[0010] According to various principles of this disclosure, an adapter is configured to improve a manifold through which injectable therapeutic materials flow for delivery to a patient. In some aspects, the adapter has an adapter body extending from a proximal end to a distal end, and a cavity defining a passage through the adapter body extending between the proximal and distal ends of the adapter body. In some aspects, the size, shape, construction, and / or dimensions of the adapter are designed to be inserted into the cavity defining passage through the manifold to reduce the size of the manifold lumen, thereby facilitating the flow of injectable therapeutic materials from the proximal end of the manifold through the manifold lumen to the distal end of the manifold. In some aspects, the adapter is at least partially made of a flexible material to conform to the manifold lumen, thereby filling the space within the manifold lumen. In some aspects, the size, shape, construction, and / or dimensions of the adapter are designed, and the forming material is selected, such that the adapter body maintains the patency of the adapter lumen when positioned within the manifold.

[0011] In some embodiments, the adapter cavity includes a tapered segment. In some embodiments, the tapered segment is adjacent to the proximal end of the adapter body. In some embodiments, the adapter cavity has a constant-diameter segment extending from the tapered segment to the distal end of the adapter body. In some embodiments, a tubular element extends within the constant-diameter segment of the adapter cavity. In some embodiments, the adapter body is made of a flexible material, and the tubular element is made of a material that is more rigid than the adapter body material. In some embodiments, the adapter body is molded onto the rigid tubular element.

[0012] In some embodiments, the tubular element extends within the adapter body cavity. In some embodiments, the adapter body is made of a flexible material, and the tubular element is made of a more rigid material than the adapter body material. In some embodiments, the adapter body is molded onto the rigid tubular element.

[0013] In some embodiments, the adapter cavity has a constant-diameter section. In some embodiments, a tubular element extends through the constant-diameter section of the adapter cavity. In some embodiments, the adapter body is made of a flexible material, and the tubular element is made of a more rigid material than the adapter body material. In some embodiments, the adapter body is molded onto a rigid tubular element.

[0014] In some embodiments, the proximal end of the adapter is configured to mate with the end face of a fitting of a piping assembly located upstream of the manifold of the delivery system, or is configured to receive a convex fitting of the piping assembly therein.

[0015] According to various principles of this disclosure, a method for reconfiguring a system for delivering injectable therapeutic materials includes inserting a flexible adapter into the lumen of an existing manifold that is separately and independently formed from the adapter; and assembling the adapter within the manifold lumen to occupy space therein, thereby reducing the volume within the manifold lumen to facilitate the flow of injectable therapeutic materials through the manifold into the patient.

[0016] In some respects, the method also includes placing a tubular element within the adapter cavity to maintain its patency, thereby facilitating the flow of injectable therapeutic materials.

[0017] In some aspects, the method also includes mates the convex fitting of the piping assembly with the proximal end of the adapter. In some aspects, the method also includes inserting the convex fitting of the piping assembly into an adapter cavity within the manifold. In some aspects, the method also includes using the convex fitting of the piping assembly to push the adapter into the manifold.

[0018] These and other features and advantages of this disclosure will be readily understood in the detailed description below, and the scope of the claimed invention is defined in the appended claims. Although the following disclosure is presented in the form of aspects or embodiments, it should be understood that aspects may be claimed separately or in combination with aspects and features of that embodiment or any other embodiment. Attached Figure Description

[0019] Non-limiting embodiments of this disclosure are described by way of example with reference to the accompanying drawings, which are schematic and not drawn to scale. The drawings are provided for illustrative purposes only, and the dimensions, positions, order, and relative sizes reflected in the drawings may be varied. For example, devices may be enlarged to show details clearly, but are intended to be scaled down relative to, for example, when mounted within the working channel of a delivery catheter or endoscope. In the drawings, identical or nearly identical or equivalent elements are generally denoted by the same reference numerals, and repeated descriptions are omitted. For clarity and brevity, not every element is labeled in every drawing, and not every element of every embodiment is shown where illustrations are sufficient for those skilled in the art to understand this disclosure.

[0020] This disclosure will be better understood by reading the detailed description in conjunction with the accompanying drawings, wherein the same reference numerals denote the same elements, as follows:

[0021] Figure 1 A perspective view is shown of a conveying system with an adapter embodiment example formed according to various aspects of this disclosure.

[0022] Figure 2 Show Figure 1 The exploded perspective view of the conveying system and adapter shown.

[0023] Figure 3A A perspective view showing examples of adapter embodiments formed according to various principles of this disclosure.

[0024] Figure 3B Show along Figure 3A A sectional view of line IIIB-IIIB in the diagram.

[0025] Figure 4A A perspective view showing examples of adapter embodiments formed according to various principles of this disclosure.

[0026] Figure 4B Show along Figure 4A A cross-sectional view of the IVB-IVB line.

[0027] Figure 5A A perspective view showing examples of adapter embodiments formed according to various principles of this disclosure.

[0028] Figure 5B Show along Figure 5A A sectional view of the VB-VB line in the diagram. Detailed Implementation

[0029] This disclosure will be better understood by reading the following detailed description in conjunction with the accompanying drawings, which illustrate exemplary embodiments. It should be understood that this disclosure is not limited to the specific embodiments described, as these embodiments are subject to change. All apparatuses, systems, and methods discussed herein are examples of apparatuses and / or systems and / or methods implemented according to one or more principles of this disclosure. Each example embodiment is provided by way of explanation only and is not the only way to implement these principles, but merely an example. Therefore, elements or structures or features mentioned in the drawings should 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 shown. 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 this disclosure. For example, features shown or described as part of one embodiment may be used with another embodiment to produce yet another embodiment. Therefore, it is intended that this subject matter cover such modifications and variations falling within the scope of the appended claims and their equivalents.

[0030] It should be understood that this disclosure is set forth in varying degrees of detail throughout this application. In some cases, details that are unnecessary for those skilled in the art to understand this disclosure, or details that would make other details difficult to understand, have been omitted. The terminology used herein is for describing particular embodiments only and is not intended to limit the scope beyond the appended claims. Unless otherwise defined, the technical terms used herein should be understood to mean as commonly understood by those skilled in the art. With the guidance of this disclosure, all the apparatuses and / or methods disclosed and claimed herein can be made and performed without excessive experimentation.

[0031] As used herein, “proximal” refers to the direction or location closest to the user (medical professional, clinician, technician, operator, or physician, etc., these terms are used interchangeably herein and are not intended to be restrictive, including automatic control systems, etc.) and / or the direction or location 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 location furthest from the user, for example, when using the device (e.g., introducing the device into a patient, or during implantation, positioning, or delivery), and / or the location closest to the treatment site within the patient. “Longitudinal” refers to the direction extending along the longer or larger dimension of the element. “Longitudinal axis” extends along the longitudinal extent of the element, but is not necessarily a straight line, and does not necessarily maintain a fixed configuration if the element is bent or kinked; “axial” generally refers to the direction along the longitudinal axis. However, it should be understood that references to the axial or longitudinal movement of the aforementioned system or its elements are not necessarily strictly limited to axial and / or longitudinal movement along the longitudinal axis or central axis of the referenced element. “Center” means at least approximately bisecting the center point and / or approximately equidistant from the periphery or boundary; “central axis” with respect to an opening means a line that at least approximately bisects the center point of the opening, and when the opening includes, for example, a tubular element, channel, cavity, or hole, this line extends longitudinally along the length of the opening. As used herein, “cavity” or “channel” or “hole” or “passage” is not limited to a circular cross-section. As used herein, “free end” of an element means the end beyond which the element no longer extends. It should be understood that, unless otherwise stated, terms such as “at the end” or “on the end” or “near the end” or “along the end” are used interchangeably herein, and these terms are intended to indicate a general relative spatial relationship rather than a precisely defined location. Finally, reference to “at” a location or part is intended to include “at” and / or “near” that location or part (e.g., along that location or part, adjacent to that location or part, etc.).

[0032] This disclosure describes apparatus, systems, and methods for delivering injectable therapeutic materials into a patient. It should be understood that, for convenience, the terms "injectable therapeutic material" or "injectable" are used herein not to limit the scope, but rather to refer to therapeutic materials in injectable form, including but not limited to pharmaceuticals, diagnostic agents (including but not limited to imaging materials), therapeutic devices (including but not limited to particles, beads, spheres, etc.), and including solid particles carried by a fluid medium and / or fluids carried by a fluid medium. The injectable material can be a liquid, a solid (e.g., a dried solid, such as microspheres, typically suspended / carried in a fluid) or a combination thereof (e.g., microspheres in deionized water, microspheres containing a fluorescent contrast agent, etc.). The injectable material can be used for diagnostic, imaging, therapeutic, therapeutic, etc., without limitation, and this disclosure is not limited in this respect. Furthermore, the injectable material can be in various desired or specified forms, such as fluids (e.g., typical pharmaceutical forms), gels, or solids (e.g., solid particles, such as beads, microspheres, microspheres, or other particles, for example, known for therapeutic uses, typically suspended / carried in a fluid). In some cases, the injectable therapeutic material may be beads or microbeads or microspheres (these terms are used interchangeably in this document; for convenience, microspheres are usually referred to, and this is not intended to be limiting), and is typically suspended in a fluid medium.

[0033] The delivery device, system, and method include a drug delivery assembly (also referred to as a tubing assembly or conduit assembly, not intended to be limiting) that connects a container containing injectable therapeutic material to a catheter configured to deliver the injectable therapeutic material into a patient. The injectable therapeutic material container may be a vial, syringe, etc., and this disclosure is not limited in this respect. Typically, the catheter includes a manifold with a connector, and the drug delivery assembly includes a connector that can engage with the connector of the manifold. Furthermore, microcatheters (e.g., with an inner diameter of approximately 0.40-1.30 mm) are typically used to deliver microspheres into the patient. However, the term "microcatheter" as used herein is not necessarily limited to this, but should be understood to include catheters, nerve conduits, etc., and this disclosure is not limited by the size, dimensions, etc., of the catheter.

[0034] In some cases, the injectable therapeutic material may be a radiomedical injectable therapeutic material (e.g., a radiopharmaceutical, radiotherapy agent, radiodiagnostic agent, radioimaging agent, tracer, etc.), but this disclosure is not limited in this respect. For example, the injectable therapeutic material delivered using the apparatus, system, and method of this disclosure may be beads, microbeads, or microspheres, such as irradiated beads, microbeads, or microspheres. An example of a radiomedical injectable therapeutic material is TheraSphere. TM Y-90 glass microspheres (infused with yttrium, particularly Y-90 glass microspheres), marketed by Boston Scientific, are used in cancer treatment (radiotherapy). TheraSphere TMMicrospheres can be delivered to the tumor site within a patient via microcatheters and accumulate in the tumor's microvessels for precise local tumor ablation. Alternatively, another type of injectable radiomedical material can be provided for imaging and diagnostic purposes. More specifically, microspheres formed from suitable materials such as glass can be injected, labeled, or coated with radioactive materials, such as technetium, particularly Tc-99m. Tc-99m-labeled microspheres exhibit similar properties to TheraSphere. TM The microspheres have essentially the same diameter (average diameter approximately 25 μm) and essentially the same flow characteristics, therefore they can be used as TheraSpheres. TM Substitutes or alternatives for microspheres. Therefore, Tc-99m microspheres can be used in TheraSpheres with a significantly longer injection half-life. TM Microspheres (Y-90 has a half-life of 64 hours, while Tc-99m has a half-life of 6 hours) have previously been used for imaging and diagnostics. It should be understood that surface textures on components of devices and systems formed according to the various principles of this disclosure preferably have a structure smaller than the diameter of particles passing through them, to ensure that these particles do not "stick" to the components of the devices and systems.

[0035] Such as TheraSphere TM Microspheres, such as microspheres, emit high-intensity beta radiation at low doses, for example, as low as 1 GBQ per 15 ml of carrier (e.g., water), or even as low as 0.5 GBQ per 15 ml of carrier, for example, in vials containing up to 0.6 ml of pyrogen-free water, delivered via syringe along with 20 cc of saline. When microspheres are injected into microcatheters at low doses and flow rates, it is crucial to deliver the full dose to the patient. However, various aspects of current delivery systems and their components can interfere with the delivery of the full dose. For example, microspheres may condense within the system, such as along the hubs connecting the various components of the system. For example, vials containing injectable therapeutic materials are typically fluidly coupled to a drug delivery assembly, which is typically connected to a microcatheter via a manifold for delivery to the patient. Porous spaces may exist between the drug delivery assembly connector and the lumen of the microcatheter. More specifically, pore spaces may exist within the manifold that fluidly couples the drug delivery assembly and the microcatheter. As microspheres pass through the manifold of the microcatheter, they may adhere to the sidewalls of the manifold, resulting in not the full dose of microspheres reaching the lesion site. Repeated tapping to release microspheres can unnecessarily expose healthcare professionals to radiation due to the close proximity and lack of shielding between the active microspheres and the professionals. Furthermore, this tapping process is often uncontrolled and variable, which can stress healthcare professionals and produce inconsistent results, potentially affecting delivery efficiency and the residence time of microcatheters within the body.

[0036] Furthermore, up to 10 flushing cycles may be required to deliver the microspheres to the lesion site. For gliomas, reducing the number of flushing cycles is desirable. Reducing the number of flushing cycles required to remove the microspheres from the vial and delivery system (including the drug delivery components, manifold, and microcatheter) reduces patient risk in several ways. First, reducing the number of flushing cycles reduces the risk of injecting too much fluid too quickly, which can increase the risk of backflow near the catheter tip. Microsphere backflow may cause treatment to be delivered to unaffected areas, which is a potential risk to the patient. In addition, injecting too much fluid too quickly may lead to tissue volume saturation or edema. Second, reducing the number of flushing cycles will shorten procedure time and reduce the time the catheter remains in the body, thereby reducing potential patient risks. Finally, reducing the number of flushing cycles will improve the user experience of the system by reducing the physical exertion required, alleviating the user's psychological burden, and / or shortening the overall procedure time.

[0037] According to various principles of this disclosure, an adapter, separate and separately formed from an existing, pre-formed, and separately formed delivery system, is configured to dock with the delivery system to facilitate complete flow of injectable therapeutic material through the delivery system into the patient. As used herein, descriptions such as “existing,” “pre-formed,” “separately formed,” and “separately manufactured” are intended to refer to a manufactured device or system, such as a commercially available, off-the-shelf device or system, which is not formed with reference to a specific injectable therapeutic material (such as the microspheres described herein). Adapters such as those described herein are separately and independently formed according to various principles of this disclosure to modify various characteristics of the manufactured device or system. In this case, the “pre-formed” delivery system is a delivery system separately and independently formed from the adapter, and its formation is not necessarily for the purpose of targeting the already formed adapter. The adapter has a cavity in fluid communication with the delivery cavity of the drug delivery component and the cavity of the microcatheter of the delivery system through which the injectable therapeutic material is delivered into the patient. In some aspects, the adapter is configured to be positioned within a manifold connecting the drug delivery component and the catheter. The manifold is configured to dock with the drug delivery component and / or the catheter to seal the connection between them to ensure complete flow of the injectable therapeutic material. In some aspects, the adapter mates with a convex fitting of the drug delivery component to seal the fitting. In some aspects, the adapter has a tapered inner diameter to deliver injectable therapeutic material into the microcatheter. The external shape of the adapter can be configured to prevent injectable therapeutic material from filling the internal pore spaces of the manifold. The adapter can be configured to operate in both vertical and horizontal positions to ensure that the bead is delivered to the lesion site regardless of how the healthcare professional positions the delivery system during use. In some embodiments, a tubular insert (e.g., a tubular metal insert) is provided within at least a portion of the manifold to provide column strength to the distal end of the adapter lumen.

[0038] It should be understood that the adapters formed according to the various principles of this disclosure minimize the required flushing operations, thereby reducing the time the catheter remains in the body, shortening the overall operation time, and reducing the risks of inconsistent microsphere delivery, microsphere reflux, tissue volume saturation, edema, etc.

[0039] Furthermore, it should be understood that adapters formed according to the principles of this disclosure ensure that injectable therapeutic materials (e.g., beads) do not become stuck in one or more components of the delivery system without requiring the tapping of components. For example, placing an adapter formed according to the principles of this disclosure within the manifold of an existing delivery system can facilitate the flow of injectable therapeutic materials, eliminating the need for healthcare professionals administering the material to tap the manifold (e.g., with a separate instrument) when delivering the dose to the lesion site. Therefore, using adapters formed according to the principles of this disclosure reduces the risk of radiation exposure for healthcare professionals and patients, reduces catheter dwell time in the body, shortens overall procedure time, and reduces the risk of inconsistent microsphere delivery. Adapters formed according to the principles of this disclosure are adaptable to any manifold because the adapter is formed to conform to existing manifold specifications to accommodate the characteristics of injectable therapeutic materials flowing through it. Furthermore, adapters formed according to the principles of this disclosure are adaptable to any microcatheter, catheter, etc. Even if the external profile of the adapter depends on the catheter (if inserted into the same manifold lumen as the catheter), the inner diameter and profile of the adapter will ensure correct and complete delivery of the injectable therapeutic material.

[0040] Various embodiments of adapters and related methods for delivering injectable therapeutic materials for devices and systems will now be described with reference to the examples shown in the accompanying drawings. References to “one embodiment,” “embodiment,” “some embodiments,” “other embodiments,” etc., in this specification indicate that one or more specific features, structures, concepts, and / or characteristics according to the principles of this disclosure may be included in that embodiment. However, such references do not necessarily mean that all embodiments include that specific feature, structure, concept, and / or characteristic, nor do they mean that one embodiment includes all features, structures, concepts, and / or characteristics. Some embodiments may include one or more such features, structures, concepts, and / or characteristics in various combinations. It should be understood that one or more features, structures, concepts, and / or characteristics described with reference to one embodiment may be combined with one or more features, structures, concepts, and / or characteristics of any other embodiment provided herein. That is, any features, structures, concepts, and / or characteristics described herein can be mixed and matched to create hybrid embodiments, and such hybrid embodiments are within the scope of this disclosure. Furthermore, references to “one embodiment,” “embodiment,” “some embodiments,” “other embodiments,” etc., in different places in the specification do not necessarily refer to the same embodiment, nor do they mean that separate or alternative embodiments are necessarily mutually exclusive with other embodiments. It should also be understood that the various features, structures, concepts, and / or characteristics of the disclosed embodiments are independent and separate, and may be used or manifested individually or in various combinations thereof to create alternative embodiments, which are considered part of this disclosure. Therefore, this disclosure is not limited to the embodiments specifically described herein, as describing all possible combinations and sub-combinations of features, structures, concepts, and / or characteristics would be overly cumbersome, and the examples of embodiments disclosed herein are not intended to limit the broader aspects of this disclosure. It should be understood that the various dimensions provided herein are merely examples, and their standard deviations and acceptable ranges of variation can be readily determined by those skilled in the art, all of which are covered within the scope of this disclosure and the related claims. The following description is for illustrative examples only and is not intended to limit the broader aspects of this disclosure.

[0041] It should be understood that, for the sake of brevity and convenience, common features are identified by common reference elements and are not intended to be limiting; descriptions of common features are generally not repeated. For clarity, not all components with the same reference number are numbered. Furthermore, a group of similar elements may be represented by numbers and letters, and one or more such elements or groups of such elements may generally be referred to individually by numbers (excluding the letters associated with each similar element). It should be understood that, in the following description, similar elements or components in various illustrated embodiments of adapters formed according to the various principles of this disclosure are generally represented by the same reference numbers that are multiples of 100, and repeated descriptions are generally omitted for brevity. Furthermore, certain features in one embodiment may be used in different embodiments, and when they appear in different embodiments, they are not necessarily separately labeled.

[0042] Figure 1 and Figure 2 An injectable therapeutic material delivery system 100, formed according to various principles of this disclosure, is shown, comprising a drug delivery component 110 at a proximal end 101 and a microcatheter assembly 120 at a distal end 103. The proximal end of the drug delivery component 110 is coupled to a vial containing injectable therapeutic material. The proximal end of the drug delivery component 110, the vial, and the injectable therapeutic material may employ any configuration known to those skilled in the art, depending, for example, on the type of injectable therapeutic material to be delivered by the injectable therapeutic material delivery system 100; therefore, illustration of these elements is not necessary for those skilled in the art to fully understand them.

[0043] The illustrated embodiments of the drug delivery assembly 110 and microcatheter assembly 120 are connected via an illustrated embodiment of the manifold 130. More specifically, the distal end 113 of the drug delivery assembly 110 is connected to the proximal end 131 of the manifold 130, and the proximal end 121 of the microcatheter assembly 120 is connected to the distal end 133 of the manifold 130. This arrangement allows fluid communication between the lumen 115 defined within and through the tubular element 112 of the drug delivery assembly 110, and the lumen 125 defined within and through the manifold 130, and the lumen 125 defined within and through the microcatheter 122 of the microcatheter assembly 120. The distal end of the microcatheter 122 can be configured for insertion into a patient to deliver injectable therapeutic material into the patient in a manner known to those skilled in the art. Therefore, an illustration of the distal end of the microcatheter 122 is not necessary for those skilled in the art to fully understand the element.

[0044] like Figure 2As shown in more detail, the drug delivery assembly 110 includes a fitting 114 extending distally from its distal end 113. It should be understood that, unless otherwise stated, terms such as fitting, connector, coupling, adapter, etc., are used interchangeably herein and are not intended to be limiting. The drug delivery assembly fitting 114 is configured to engage with a corresponding fitting 132 extending proximally from the proximal end 131 of the manifold 130. In the illustrated embodiment example, a recess 114a of the drug delivery assembly fitting 114 is configured to fit onto the manifold fitting 132, and a protrusion 114b of the drug delivery assembly fitting 114 is configured to fit within the manifold fitting 132 to allow fluid communication between the drug delivery assembly cavity 115 and the manifold cavity 135. Optionally, the drug delivery assembly recess 114a and the manifold fitting 132 have an engaging configuration to hold these elements in place relative to each other. Figure 1 and Figure 2 In the illustrated embodiment example, the drug delivery component recess 114a and the manifold fitting 132 have corresponding threads 117, 137 that engage with each other. However, this disclosure is not limited in this respect and covers other engaging configurations known to those skilled in the art.

[0045] exist Figure 1 and Figure 2 In an example embodiment of the microcatheter assembly 120 shown, the microcatheter 122 of the microcatheter assembly 120 may be coupled to the manifold 130 via a strain relief member 124 extending along the proximal portion of the microcatheter 122. The strain relief member 124 may extend to a distal fitting 134 of the manifold extending distally from the distal end 133 of the manifold 130. The microcatheter 122 may extend proximally from the strain relief member 124 into the manifold lumen 135 for closer communication with a lumen 115 defined within the drug delivery assembly 110.

[0046] Optionally, the manifold 130 includes one or more extensions 138, such as wings, extending radially outward from the outer surface of the manifold 130 to facilitate gripping. The extensions 138 may extend sufficiently radially outward from the manifold 130 and sufficiently longitudinally along the manifold 130 to facilitate manipulation of the manifold 130, such as rotating the manifold 130 relative to at least the drug delivery assembly 110 to connect the manifold 130 and the drug delivery assembly 110 together.

[0047] This disclosure relates to apparatus, systems, and methods for modifying existing, pre-formed, separately formed, or separately manufactured injectable therapeutic material delivery systems (such as those described above) after their manufacture. More specifically, the apparatus, systems, and methods of this disclosure improve fluid flow within existing, separately formed injectable therapeutic material delivery systems, such as those described above. Therefore, the manufacture of adapter devices and systems formed according to the various principles of this disclosure is not limited by the manufacturing requirements of the injectable therapeutic material delivery system to which they are used. Consequently, adapter devices and systems formed according to the various principles of this disclosure offer greater flexibility in improving fluid flow within the manifold of existing injectable therapeutic material delivery systems to accommodate the requirements of specific injectable therapeutic materials. Therefore, the size, shape, construction, and / or spatial dimensions of the devices and / or systems formed according to the various principles of this disclosure can be selected to conform to the requirements of the injectable therapeutic material delivery system and the injectable therapeutic material to be delivered therethrough. For example, the size, shape, construction, and / or spatial dimensions of the device and / or system formed according to the various principles of this disclosure can be selected based on the properties, characteristics, and features of the injectable therapeutic material to be delivered by the injectable therapeutic material delivery system used in conjunction with the device and / or system of this disclosure. For example, the component materials of the device and system formed according to the various principles of this disclosure can be specifically selected to withstand radiation exposure from radioactive injectable therapeutic materials passing through them.

[0048] According to various principles of this disclosure, a separately formed adapter 1000 is configured to be inserted into a lumen 135 of a manifold 130, such as the injectable therapeutic material delivery system 100 described above. The adapter 1000 has an adapter body extending from a proximal end 1001 to a distal end 1003, configured to fit within the manifold lumen 135 to modify an existing or pre-formed manifold 130 to deliver injectable therapeutic materials with altered flow characteristics, different from those produced by flow through at least the formed manifold 130. For example, the adapter 1000 formed according to various principles of this disclosure can reduce the size of the manifold lumen 135 to facilitate the flow of microbeads or other injectable therapeutic materials (such as those described above), thereby improving the delivery of the injectable therapeutic material to the patient by reducing the diameter of the flow path from the drug delivery assembly 110 to the microcatheter assembly 120.

[0049] Figure 1 and Figure 2An example embodiment of an adapter 1000 formed according to various principles of the present disclosure is shown, extending within a manifold lumen 135. The proximal end 1001 of the illustrated example embodiment of the adapter 1000 is configured to receive a protrusion 114b of a drug delivery component fitting 114. For example, a distal portion of the protrusion 114b of the drug delivery component fitting 114 may extend into an adapter lumen 1005. The distal end 1003 of the adapter 1000 is further inserted into the manifold lumen 135 such that the body of the adapter 1000 occupies space within the manifold lumen 135 to reduce the size of the manifold lumen 135, thereby facilitating the flow of injectable therapeutic materials (such as microspheres) therethrough. It has been found that reducing the volume within the manifold lumen 135 can reduce the amount of injectable therapeutic material (such as microspheres) that is trapped or retained, or otherwise prevent microspheres from becoming trapped in the voids of the manifold lumen 135. The proximal end 121 of the microcatheter 122 is inserted into the distal end 133 of the manifold 130, close to the distal end 1003 of the adapter 1000. Optionally, the manifold 130 may have a step or shoulder to position the proximal end 121 of the microcatheter 122. The distal end 1003 of the adapter 1000 may be located upstream of the proximal end 121 of the microcatheter 122, or optionally abutted against the proximal end 121 of the microcatheter 122. It should be understood that other arrangements, for example, that may depend on one or more characteristics of the injectable therapeutic material delivery system 100 and / or the injectable therapeutic material, are also within the scope and spirit of this disclosure.

[0050] Since the adapter 1000, formed according to the various principles of this disclosure, is formed separately from the injectable therapeutic material delivery system 100, its material is not limited by the manufacturing processes associated with the injectable therapeutic material delivery system 100. However, preferably, the material selection of the adapter 1000 takes into account at least compatibility with the injectable therapeutic material delivery system 100: the material of the adapter 1000, formed according to the various principles of this disclosure, is moldable, such as a moldable resin. Alternatively or additionally, the material of the adapter 1000, formed according to the various principles of this disclosure, is flexible, conformable to and / or seals the components it mates with, while possessing sufficient column strength to prevent collapse under compression, thus not adversely affecting the flow of material therethrough. It is understood that the dimensions, shape, construction, and / or spatial dimension design of the walls of the body of the adapter 1000, and its material selection, should ensure sufficient strength and resistance to collapse to maintain the patency of the adapter cavity 1005 and not impair or obstruct the flow of injectable therapeutic materials such as microspheres. For example, the length of adapter 1000 can be determined based on the length of manifold 135 to ensure that adapter 1000 has sufficient space within manifold 135 and is not compressed within manifold 135 (which could impede flow through adapter 1000). Examples of materials that can be used include, but are not limited to, thermoplastic elastomers, such as polyether block amides (e.g., 25d or 35d block copolymers, composed of rigid polyamide blocks and flexible polyether blocks and manufactured by Arkema; ​​thermoplastic polyester elastomers (e.g., Block copolymers, consisting of hard (crystalline) segments of polybutylene terephthalate and soft (amorphous) segments based on polyether chemistry and manufactured by DuPont; thermoplastic polyurethanes (e.g., manufactured by Lubrizol Corporation). Aromatic polyethers and polyesters); thermoplastic vulcanized products (e.g., manufactured by Celanese). Dynamically vulcanized polymer alloys (composed of cured ethylene propylene diene monomer (EPDM)); DEHP-free PVC (polyvinyl chloride without di(2-ethylhexyl) phthalate), etc. Figure 3A , Figure 3B , Figure 4A , Figure 4B , Figure 5A and Figure 5B Various configurations of embodiments of adapters 1100, 1200, 1300 formed according to various principles of this disclosure are shown in more detail.

[0051] The cavity of the adapter formed according to the various principles of this disclosure can have more than one geometric configuration. For example, in Figure 3A and Figure 3B In the embodiment of the adapter 1100 shown, the cavity 1105 has a proximal tapered segment 1105a and a distal segment 1105b, the taper of which differs from that of the proximal tapered segment 1105a. For example, the taper of the distal segment 1105b may be smaller than that of the proximal tapered segment 1105a. Figure 3A and Figure 3B As shown, the distal segment 1105b may have a substantially constant inner diameter (i.e., substantially no taper).

[0052] Optionally, a tubular element may be inserted into at least a portion of the cavity of an adapter formed according to various principles of this disclosure. The tubular element may be configured to assist and / or guide the flow of injectable therapeutic material through the adapter, thereby entering the patient through the injectable therapeutic material delivery system 100. Such a tubular element may be disposed in an adapter cavity with a constant diameter or in an adapter cavity with a varying diameter. The tubular element may have a constant diameter or may taper, for example, depending on the characteristics of the injectable therapeutic material, the adapter cavity, the material of the tubular element, etc. For example, a tapered tubular element may be disposed in a segment of the adapter cavity with a substantially constant diameter to increase the taper into the cavity. The tubular element may be made of a material that is more rigid than the material forming the adapter. For example, a rigid tubular element may provide structural support to a flexible adapter (e.g., to resist collapse or at least partial collapse of the adapter cavity, as collapse may impair and / or impede the flow of injectable therapeutic material through a collapsed area), for example, to provide support to a segment of the adapter cavity whose diameter decreases relative to another segment of the adapter cavity. The rigid tubular element may be made of stainless steel or any other biocompatible metal or other biocompatible material. Optionally, the material of the adapter body is molded onto the tubular element. Optionally, the external configuration of the tubular element (e.g., with texture, corrugation, etc.) is designed to mechanically engage with the molded adapter material, thereby reducing and preferably eliminating relative movement between them.

[0053] Figure 4A and Figure 4B An example embodiment of an adapter 1200 formed according to various principles of the present disclosure is shown, wherein a rigid tubular element 1210 is provided in at least a portion of a cavity 1205 of the adapter 1200. The segment where the rigid tubular element 1210 is provided is the distal segment 1105b and has a substantially constant diameter. However, the rigid tubular element 1210 may alternatively or additionally be positioned in the proximal tapered segment 1205a and / or the tapered segment of the adapter cavity 1205. Optionally, anchoring flanges 1212 may be provided at one or both ends of the rigid tubular element 1210 to mount the rigid tubular element 1210 relative to the adapter 1200, thereby preventing it from falling out of the adapter 1200.

[0054] It should be understood that various other modifications can be made to adapters such as those described herein without departing from the general principles of this disclosure. The configuration of the adapter can be varied internally or externally, for example, determined based on various factors including the properties, characteristics, and features of the injectable therapeutic material, and / or the properties, characteristics, and features of the injectable therapeutic material delivery system and its components (e.g., the size, shape, construction, and / or spatial dimensions of the manifold, such as the interior of the manifold) used in conjunction with the adapter. Various characteristics of the adapter formed according to the various principles of this disclosure can be modified to ensure the desired flow of the injectable therapeutic material, for example, by reducing turbulence and generating high shear forces on the surface to minimize (if not eliminate) the space for agglomeration of the injectable therapeutic material (e.g., microspheres). In some cases, the taper and / or length of the cavity of the adapter formed according to the various principles of this disclosure can be modified. Figure 5A and Figure 5B In the embodiment example of the adapter 1300 shown, the proximal segment of the cavity 1305 of the adapter 1300 is defined.

[0055] The taper of 1305a is greater than Figure 3A and Figure 3B The taper of the proximal segment 1105a in the embodiment of the adapter 1100 shown is shorter than the length of the proximal segment 1105a. Figure 3A and Figure 3B The longer proximal tapered segment 1105a of the adapter 1100 allows the protrusion 114b of the drug delivery assembly fitting 114 to be inserted into the adapter cavity 1105, and / or can be compressed and sealed when the connection between the drug delivery assembly 110 and the manifold 130 is tightened. In contrast, Figure 5A and Figure 5B The shorter proximal tapered segment 1305a of the adapter 1300 can be configured to mate with the surface of the drug delivery assembly fitting 114. The adapters 1000, 1100, 1200, and 1300 formed according to various principles of the present disclosure can be pushed into the separately manufactured manifolds 130 by means of the protrusions 114b of the drug delivery assembly fitting 114.

[0056] It should be understood that all apparatuses, systems, and methods discussed herein are examples of apparatuses, systems, and / or methods implemented according to one or more principles of this disclosure. Various features described with respect to one embodiment may be applied to another embodiment, whether or not explicitly indicated. It should be understood that the examples described herein are not the only ways to implement these principles, but are merely examples and are not intended to limit the broader aspects of this disclosure. Therefore, elements or structures or features mentioned in the drawings should 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 shown. Therefore, the invention is not limited to the embodiments specifically described herein. Upon reading this disclosure, those skilled in the art will conceive of other examples of ways to implement the disclosed principles, as well as various other advantages of the aspects, features, components, and structures of the apparatuses and systems disclosed herein.

[0057] The foregoing discussion has broad applicability and is presented for illustrative and descriptive purposes only, and is not intended to limit this disclosure to the 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. Specifically, it will be apparent to those skilled in the art that the principles of this disclosure can be embodied in other forms, structures, arrangements, proportions, and other elements, materials, and components without departing from its concept, spirit, scope, or characteristics. For example, to simplify this disclosure, various features of this disclosure are combined in one or more aspects, embodiments, or configurations. However, it should be understood that various features of certain aspects, embodiments, or configurations of this disclosure can be combined in alternative aspects, embodiments, or configurations. Although this disclosure is presented in the form of embodiments, it should be understood that not all of the various separately present features of the subject matter need to be present to achieve at least some of the desired characteristics and / or advantages of the subject matter, or that these separately present features may exist separately. Those skilled in the art will understand that many modifications or changes can be made in practice to the structure, arrangement, proportions, materials, components, etc., which are particularly suitable for specific environments and operational requirements without departing from the principles, spirit, or scope of this disclosure. For example, an element shown as a single unit 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 altered; and the size or dimensions of the element may be changed. Similarly, although operations or actions or procedures are described in a particular order, this should not be construed as requiring them to be performed in this particular order, or requiring all operations or actions or procedures to achieve the desired result. Furthermore, other embodiments are also within the scope of the following claims. In some cases, the actions listed in the claims may be performed in a different order, still achieving the desired result. Therefore, the embodiments disclosed herein should be considered illustrative rather than restrictive in all respects, and the scope of the claimed subject matter is indicated by the appended claims, not by the foregoing description or the specific embodiments or arrangements shown herein. In view of the foregoing, various features of any embodiment may be used separately or in combination with features of that embodiment or any other embodiment, and the scope of the claimed subject matter is indicated by the appended claims, not by the foregoing description.

[0058] In the foregoing description and the following claims, the following should be understood: As used herein, the phrases “at least one,” “one or more,” and “and / or” are open-ended expressions that are both connective and disjoint in operation. The terms “a,” “an,” “the,” “first,” “second,” etc., do not exclude plural forms. For example, as used herein, the term “a” or “an” refers to one or more of that entity. Therefore, the terms “a” (or “an”), “one or more,” and “at least one” are used interchangeably herein. In this specification and the appended claims, the term “or” is generally used in the sense of including “and / or” unless the context clearly indicates otherwise. As used herein, the conjunction “and” includes each structure, component, feature, etc. so connected unless the context clearly indicates otherwise; the conjunction “or” includes one or the other of such structures, components, features, etc., separately and in any combination and number, unless the context clearly indicates otherwise. All directional references (e.g., proximal, distal, up, down, upward, downward, left, right, lateral, longitudinal, front, back, top, bottom, above, below, vertical, horizontal, radial, axial, clockwise, counterclockwise, etc.) are used solely for identification purposes to aid the reader's understanding of this disclosure and / or to distinguish areas of related elements, and not to limit the related elements, particularly regarding the location, orientation, or purpose of this disclosure. Connection references (e.g., attachment, joint, connection, engagement, and bonding) should be interpreted broadly and may include intermediate components between sets of elements and relative movement between elements, unless otherwise stated. Therefore, a connection reference does not necessarily mean that two elements are directly connected and fixed to each other. Identification references (e.g., primary, secondary, first, second, third, fourth, etc.) are not intended to indicate importance or priority, but are used to distinguish one feature from another.

[0059] The following claims are hereby incorporated by reference into this detailed description, each claim being a separate embodiment of this disclosure. In the claims, the terms "comprising" or "including" do not exclude the presence of other elements, components, features, groups, regions, integers, steps, operations, etc. Furthermore, 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 combinations of features are unfeasible and / or disadvantageous. Moreover, singular references do not exclude plural forms. Reference marks in the claims are provided only as clarifying examples and should not be construed in any way as limiting the scope of the claims.

Claims

1. An adapter configured to improve a separately manufactured delivery system through which injectable therapeutic material is delivered to a patient, the adapter comprising an adapter body extending from a proximal end to a distal end, wherein: A cavity is defined through the adapter body, the cavity extending between the proximal and distal ends of the adapter body; The size, shape, construction, and / or dimensions of the adapter are designed to fit within the lumen of a manifold that defines the delivery system, thereby reducing the size of the manifold lumen and facilitating the flow of the injectable therapeutic material from the proximal end of the manifold through the manifold lumen to the distal end of the manifold. The proximal end of the adapter is configured to mate with a convex fitting of a drug delivery assembly configured to deliver injectable therapeutic material through the manifold; and The distal end of the adapter is configured to be positioned within the manifold lumen upstream of the proximal end of the catheter within the manifold lumen.

2. The adapter according to claim 1, wherein the adapter cavity includes a tapered segment.

3. The adapter of claim 2, wherein the tapered segment is adjacent to the proximal end of the adapter body.

4. The adapter according to claim 2 or 3, wherein the adapter cavity has a constant diameter section extending from the tapered segment to the distal end of the adapter body.

5. The adapter according to any one of claims 1-4, further comprising a tubular element extending within the constant diameter segment of the adapter cavity.

6. The adapter of claim 5, wherein the adapter body is made of a flexible material and the tubular element is made of a more rigid material than the material of the adapter body.

7. The adapter of claim 6, wherein the adapter body is molded on a rigid tubular element.

8. The adapter according to any one of claims 1-7, wherein the proximal end of the adapter is configured to mate with an end face of a fitting of the drug delivery component, or to accommodate a convex fitting of the drug delivery component therein. The drug delivery component is located upstream of the manifold of the delivery system.

9. An adapter configured as an improved manifold through which injectable therapeutic material is delivered to a patient, the adapter comprising an adapter body extending from a proximal end to a distal end, wherein: A cavity is defined through the adapter body, the cavity extending between the proximal and distal ends of the adapter body; The size, shape, construction, and / or dimensions of the adapter are designed for insertion into a lumen defined by the manifold to reduce the size of the manifold lumen, thereby facilitating the flow of the injectable therapeutic material from the proximal end of the manifold through the manifold lumen to the distal end of the manifold. The adapter is at least partially made of a flexible material to conform to the manifold lumen, thereby filling the space within the manifold lumen; and The size, shape, construction, and / or dimensions of the adapter are designed and the forming materials are selected such that the adapter body maintains the patency of the adapter cavity when positioned within the manifold.

10. The adapter of claim 9, wherein the adapter cavity includes a tapered segment.

11. The adapter of claim 10, wherein the tapered segment is adjacent to the proximal end of the adapter body.

12. The adapter according to claim 10 or 11, wherein the adapter cavity has a constant diameter section extending from the tapered segment to the distal end of the adapter body.

13. The adapter according to any one of claims 9-12, further comprising a tubular element extending within a constant diameter segment of the adapter cavity, wherein the adapter body is made of a flexible material and the tubular element is made of a material that is more rigid than the material of the adapter body.

14. A method for reconfiguring an injectable therapeutic material delivery system, the method comprising: The flexible adapter is inserted into the lumen of an existing manifold that is separate from and independently formed from the adapter; as well as The adapter is fitted into the manifold lumen to occupy the space therein, thereby reducing the volume within the manifold lumen to facilitate the flow of the injectable therapeutic material through the manifold into the patient.

15. The method of claim 14, further comprising providing a tubular element within the cavity of the adapter to maintain the patency of the cavity of the adapter, thereby facilitating the flow of the injectable therapeutic material.

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