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WO2025010068A1 - Systèmes d'administration, ensembles aiguilles et procédés d'administration de composants - Google Patents

Systèmes d'administration, ensembles aiguilles et procédés d'administration de composants Download PDF

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Publication number
WO2025010068A1
WO2025010068A1 PCT/US2023/027002 US2023027002W WO2025010068A1 WO 2025010068 A1 WO2025010068 A1 WO 2025010068A1 US 2023027002 W US2023027002 W US 2023027002W WO 2025010068 A1 WO2025010068 A1 WO 2025010068A1
Authority
WO
WIPO (PCT)
Prior art keywords
component
channel
needle assembly
rings
lumen
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2023/027002
Other languages
English (en)
Inventor
Nick MOWREY
Heather STORM
Luke WINTERSTEIN
Jordan ADDISON
Dylan BEYHL
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Bard Peripheral Vascular Inc
Original Assignee
Bard Peripheral Vascular Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Bard Peripheral Vascular Inc filed Critical Bard Peripheral Vascular Inc
Priority to PCT/US2023/027002 priority Critical patent/WO2025010068A1/fr
Publication of WO2025010068A1 publication Critical patent/WO2025010068A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/329—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles characterised by features of the needle shaft
    • A61M5/3291—Shafts with additional lateral openings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3294—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles comprising means for injection of two or more media, e.g. by mixing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3295—Multiple needle devices, e.g. a plurality of needles arranged coaxially or in parallel
    • A61M5/3297—Needles arranged coaxially
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M2005/3201—Coaxially assembled needle cannulas placed on top of another, e.g. needles having different diameters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/19—Syringes having more than one chamber, e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly

Definitions

  • the present disclosure relates to needle assemblies, and, more particularly, to coaxial needle assemblies for delivering components.
  • An object of the present disclosure is to provide a needle assembly for delivering hydrogel spacers to a target site undergoing radiation treatment.
  • a needle assembly in one aspect, includes an elongate cannula including an outer lumen defining a first channel and having a plurality of outer lumen ports, the plurality of outer lumen ports being arranged in a plurality of outer rings about the outer lumen in a circumferential direction, and each of the plurality of outer rings being spaced from one another in a longitudinal direction.
  • the needle assembly further includes an inner cannula disposed within the outer lumen, the inner cannula including an inner lumen defining a second channel and having a plurality of inner lumen ports, with the plurality of inner lumen ports being arranged in a plurality of inner rings about the inner lumen in the circumferential direction, and each of the plurality of inner rings being spaced from one another in the longitudinal direction.
  • the plurality of outer rings and the plurality of inner rings are aligned in the longitudinal direction.
  • a delivery system in another aspect, includes a dual chamber applicator comprising a first component chamber containing a first component and a second component chamber containing a second component.
  • the delivery system further includes a needle assembly coupled to the dual chamber applicator, the needle assembly including an elongate cannula including an outer lumen defining a first channel and having a plurality of outer lumen ports, the plurality of outer lumen ports being arranged in a plurality of outer rings about the outer lumen in a circumferential direction, and each of the plurality of outer rings being spaced from one another in a longitudinal direction.
  • the needle assembly further includes an inner cannula disposed within the outer lumen, the inner cannula including an inner lumen defining a second channel and having a plurality of inner lumen ports, with the plurality of inner lumen ports being arranged in a plurality of inner rings about the inner lumen in the circumferential direction, and each of the plurality of inner rings being spaced from one another in the longitudinal direction.
  • the first component chamber is fluidly coupled to the first channel and the second component chamber is fluidly coupled to the second channel, such that the first component chamber provides the first component to the first channel and the second component chamber provides the second component to the second channel.
  • a method of operating a delivery system includes coupling a dual chamber applicator to a needle assembly such that a first component chamber containing a first component of the dual chamber applicator is fluidly coupled to a first channel defined by an outer lumen of the needle assembly and a second component chamber containing a second component of the dual chamber applicator is fluidly coupled to a second channel defined by an inner lumen of the needle assembly, wherein the outer lumen of the needle assembly includes a plurality of outer lumen ports arranged in a plurality of outer rings and the inner lumen of the needle assembly includes a plurality of inner lumen ports arranged in a plurality of inner rings, deploying the first component to the first channel and the second component to the second channel, and deploying a resultant mixture of the first component and the second component to a target site via the plurality of outer lumen ports.
  • the first component and the second component mix at a distal end of the needle assembly.
  • FIG. 1 depicts a side view of a delivery system including a dual chamber applicator, an auxiliary applicator, and a needle assembly having an elongate stylet, according to one or more embodiments shown and described herein;
  • FIG. 2A depicts a partial perspective view of the needle assembly of FIG. 1, according to one or more embodiments shown and described herein;
  • FIG. 2B depicts a partial side view of the needle assembly of FIG. 1, according to one or more embodiments shown and described herein;
  • FIG. 3 depicts an illustrative flow diagram of a method of using a delivery system, according to one or more embodiments shown and described herein
  • the delivery system may include a dual chamber applicator and a needle assembly, with the dual chamber applicator being fluidly coupled to the needle assembly.
  • the dual chamber applicator may include a first component chamber and a second component chamber, with the first component chamber being fluidly coupled to a first channel of the needle assembly and the second component chamber being fluidly coupled to a second channel of the needle assembly.
  • the dual chamber applicator may be engaged to deploy a first component to the first channel (e.g., via the first component chamber) and a second component to the second channel (e.g., via the second component chamber).
  • the needle assembly may further include a plurality inner lumen ports positioned circumferentially about the second channel and a plurality of outer lumen ports positioned about the first channel, with the plurality of inner points fluidly coupling the first channel to the second channel and the plurality of outer lumen ports fluidly coupling the first channel to a target site. Accordingly, as the second component flows through the second channel, the second component may pass through the plurality of inner points such that the second component enters the first channel and mixes with the first component. In these embodiments, the mixture of the first component and the second component may be deployed to the target site.
  • the plurality of inner lumen ports may be arranged in a plurality of inner rings, while the plurality of outer lumen ports may be arranged in a plurality of outer rings, such that each of the plurality of inner lumen ports is aligned with at least one of the plurality of outer lumen ports in a longitudinal direction.
  • the stacked port arrangement allows for more even distribution of a component (e.g., fluid) across the target site, which may effectively reduce the risk of clogging or blockages forming within the needle assembly as compared to other commonly use port configuration (e.g., spiral, linear, etc.).
  • a component e.g., fluid
  • FIG. 1 depicts an illustrative delivery system 100 according to various embodiments.
  • the delivery system 100 in accordance with an aspect of the present invention, may be for use in a spacer delivery procedure whereby a multi-component spacer (e.g., a hydrogel) is delivered to a site that has been prepped via a hydro-dissection procedure.
  • the delivery system 100 generally includes a dual chamber applicator 200, an auxiliary applicator 300, and/or a needle assembly 400.
  • the various components for the delivery system 100 are couplable together for the purposes of delivering a dual component mixture (e.g., a dual component hydrogel) and an additional material (e.g., saline or other hydro-dissection solution, or the like), as indicated by the dashed lines in FIG. 1 and described herein.
  • a dual component mixture e.g., a dual component hydrogel
  • an additional material e.g., saline or other hydro-dissection solution, or the like
  • the dual chamber applicator 200 generally includes a body 210 having a proximal end 212 and a distal end 214 spaced a distance apart from the proximal end 212.
  • the body 210 also defines a pair of syringes 220.
  • the dual chamber applicator 200 is configured to separately carry each of a first component, such as a first precursor material of a multi-component hydrogel, and a second component, such as a second precursor material of the multi-component hydrogel.
  • first component include, but are not limited to, albumin, polyethylenimine (PEI), an amine containing polyethylene glycol (PEG) or protein, or the like.
  • second component examples include, but are not limited to, an N- hydroxysuccinimide (NHS) ester component such as PEG-(SS)2, PEG-(SS)4, PEG-(SS)8, PEG- (SG)4, PEG-(SG)8, and/or the like.
  • NHS N- hydroxysuccinimide
  • the first component and the second component are combined and mixed within the needle assembly 400, as will be described in greater detail herein.
  • the pair of syringes 220 includes an actuator 223, a first component chamber 222A, and a second component chamber 222B.
  • the first component chamber 222A may be, for example, a cylindrical tube that is configured to carry the first precursor material of the hydrogel spacer.
  • the first component chamber 222A has a first output port 223A (e g., a first component port).
  • the second component chamber 222B also may be, for example, a cylindrical tube that is configured to carry the second precursor material of the hydrogel spacer.
  • the second component chamber 222B has a second output port 223B (e.g., a second component port).
  • the first component chamber 222A and the second component chamber 222B are arranged in a substantially longitudinally parallel arrangement.
  • the actuator 223 includes a first piston 224A, a second piston 224B, and a handle 225.
  • the handle 225 is in the form of a link member that perpendicularly extends between, and is connected to, each of the first piston 224A and the second piston 224B to facilitate simultaneous movement of the first piston 224A and the second piston 224B with the depression or retraction of the handle 225.
  • the first piston 224A is in the form of a plunger that is positioned in the first component chamber 222A proximal to the first sealant component.
  • the second piston 224B is in the form of a plunger that is positioned in the second component chamber 222B proximal to the second sealant component.
  • the first output port 223 A of the first component chamber 222A and the second output port 223B of the second component chamber 222B may be arranged within the distal end 214 of the body 210 of the dual chamber applicator 200.
  • the first output port 223 A and the second output port 223B are generally component outputs, such as fluid outputs, that are aligned with outer lumen ports of other components, as will be described herein, such that the first component and the second component can be dispensed from and/or received within the respective component chamber 222A, 222B.
  • the first output port 223A may be concentrically aligned with the first component chamber 222A and the second output port 223B may be concentrically aligned with the second component chamber 222B.
  • the first output port 223 A may be located radially inward of a central area of the second component chamber 222B such that the first output port 223A and the second output port 223B are as close as possible to a central axis Cl of the body 210 of the dual chamber applicator to facilitate alignment with the other components of the delivery system 100 described herein.
  • the body 210 of the dual chamber applicator may further include a connection mechanism 229 for connecting the dual chamber applicator 200 to the needle assembly 400.
  • the body 210 of the dual chamber applicator 200 may include a quarter turn connector or other connector integrated with the distal end 214 of the dual chamber applicator 200.
  • various components of the connection mechanism 229 are integrated with the body 210 such that the connection mechanism 229 and the body 210 are a single monolithic piece.
  • connection mechanism 229 may be separate pieces that are permanently or semi-permanently j oined with the body 210 of the dual chamber applicator 200 (e.g., permanently or semi-permanently joined with the dual chamber applicator 200).
  • connection mechanism 229 may be generally located at the distal end 214 of the body 210 of the dual chamber applicator 200 such that various components of the connection mechanism 229 are positioned adjacent the first output port 223 A and the second output port 223B.
  • the connection mechanism 229 may be generally shaped and sized to releasably interlock with a corresponding connection mechanism 429 of the needle assembly 400, as will be described in additional detail herein.
  • the auxiliary applicator 300 generally includes a body 310 having a proximal end 312 and a distal end 314 spaced a distance apart from the proximal end 312.
  • the body 310 further defines a syringe 320, which may be used to carry a material, such as a hydro-dissection solution (e.g., saline or another hydro-dissection solution), an anesthetic solution, and/or the like.
  • a hydro-dissection solution e.g., saline or another hydro-dissection solution
  • anesthetic solution e.g., anesthetic solution
  • the saline chamber 322 may be, for example, a cylindrical tube that is configured to carry the hydro-dissection solution, the anesthetic solution, and/or the like.
  • the saline chamber 322 may include an output port 322A.
  • the actuator 323 further includes a piston 324 and a handle 325.
  • the handle 325 may be connected to the piston 324 at a proximal end thereof to facilitate movement of the piston 324 with the depression and/or retraction of the handle 325.
  • the piston 324 may take the form of a plunger that is positioned in the saline chamber 322 proximal to the hydro-dissection solution, the anesthetic solution, and/or the like.
  • the output port 322A of the saline chamber 322 may be arranged within the distal end 314 of the body 310 of the auxiliary applicator 300.
  • the output port 322A may be a component output, such as a fluid output, that is fluidly coupled to an auxiliary port of a hub of the needle assembly 400, as will be described in additional detail herein.
  • the needle assembly 400 is depicted (FIG. 1 depicts the needle assembly 400 in full, and FIGS. 2A-2B depict a distal portion of the needle assembly 400).
  • the needle assembly 400 generally includes a hub 430 and an elongate stylet 432 (e.g., an elongate hollow stylet) that extends distally (e g., in the - x- direction as depicted in the coordinate axis of FIG. 1) from the hub 430.
  • the elongate stylet 432 has a proximal end 434 and a distal end 436. As depicted most clearly in FIG.
  • the hub 430 is fixedly attached (e g., through overmolding, adhesive and/or pressed fit) to the proximal end 434 of the elongate stylet 432.
  • the hub 430 further includes a plurality ofinput ports (e.g., a first input port 430A, a second input port 430B, and/or the auxiliary input port 430C) of the needle assembly 400.
  • the hub 430 may be configured for removable connection to the dual chamber applicator 200 via the corresponding connection mechanism 229 such that, when connected, the first input port 430A of the needle assembly 400 is aligned and sealed with the first output port 223A of the dual chamber applicator 200 and the second input port 430B of the needle assembly 400 is aligned and sealed with the second output port 223B of the dual chamber applicator 200, as described in greater detail herein.
  • the hub 430 may include the auxiliary input port 430C for fluidly coupling the needle assembly 400 to the auxiliary applicator 300 (e.g., via tubing or the like coupled between the output port 322A of the saline chamber 322 of the syringe 320 and the auxiliary input port 430C of the hub 430).
  • the elongate stylet 432 further includes an elongate cannula 440 that extends from the proximal end 434 to the distal end 436 of the elongate stylet 432.
  • the elongate stylet 432 may be a hollow stylet, such that the elongate cannula 440 includes an outer lumen 438 positioned concentrically within the elongate stylet 432 and extending from the proximal end 434 to the distal end 436 of the elongate stylet 432.
  • the outer lumen 438 may define a first channel 442 that may be configured for receiving the first component (e.g. via the first input port 430A of the hub 430 coupled to the first output port 223A of the dual chamber applicator 200), as will be described in additional detail herein.
  • the distal end 436 of the elongate stylet 432 may include a closed distal end having a distal port 436A that allows for components, such as fluid, to be dispensed from the elongate cannula 440.
  • the distal end 436 of the elongate cannula 440 may be, for example, a blunt tip that avoids and/or reduces the chance of puncture of structures positioned at a target site.
  • the distal end 436 of the elongate cannula 440 may include a needle tip that may be used to pierce tissue positioned at the target site.
  • the elongate stylet 432 may further include an inner cannula 450 that is positioned coaxially within the outer lumen 438 of the elongate stylet 432 (and in turn, within the first channel 442 defined by the outer lumen 438).
  • the inner cannula 450 may include a proximal end 452 and a distal end 454, and may be positioned within the outer lumen 438 such that the distal end 454 of the inner cannula 450 is positioned proximally (e.g., in the + x-direction as depicted in the coordinate axes of FIGS.
  • the inner cannula 450 may further define an inner lumen 458 which is positioned concentrically within the inner cannula 450 and extends from the proximal end 452 to the distal end 454 of the inner cannula 450.
  • the inner lumen 458 may further define a second channel 462 that may be configured for receiving the second component (e.g., via the second input port 430B of the hub 430 coupled to the second output port 223B of the dual chamber applicator 200), as will be described in additional detail herein.
  • the elongate cannula 440 and the inner cannula 450 may each include a plurality of ports that extend through the outer lumen 438 and the inner lumen 458, respectively.
  • the inner cannula 450 may include a plurality of inner lumen ports 464 and the elongate cannula 440 may include a plurality of outer lumen ports 448.
  • the plurality of inner lumen ports 464 may fluidly couple the inner lumen 458 to the outer lumen 438, such that components that pass through the second channel defined by the inner lumen 458 may flow out of the plurality of inner lumen ports 464 and mix with the components that flows through the first channel defined by the outer lumen 438.
  • the plurality of outer lumen ports 448 may expose the elongate stylet 432 to an external environment (e.g., a target site), such that components that pass through both the first channel defined by the outer lumen 438 and components that pass through the second channel defined by the inner lumen 458 may be deposited at the target site.
  • an external environment e.g., a target site
  • the plurality of inner lumen ports 464 may be arranged in a plurality of inner rings 465 that extend about the inner cannula 450 in a circumferential direction C.
  • each of the plurality of inner rings 465 may be spaced along a portion of the distal end 454 of the inner cannula 450 in a longitudinal direction (e.g., in the +/- x-direction as depicted in the coordinate axes of FIGS. 2A-2B).
  • the plurality of inner rings 465 may be evenly spaced along the portion of the distal end 454 of the inner cannula 450.
  • the plurality of inner rings 465 may be variably spaced in the longitudinal direction (e.g., having different lengths of space in the longitudinal direction between each adjacent inner ring of the plurality of inner rings 465) along the portion of the distal end of the inner cannula 450.
  • the plurality of outer lumen ports 448 may similarly be arranged in a plurality of outer rings 449 that extend about the elongate cannula 440 in the circumferential direction.
  • each of the plurality of outer rings 449 may be spaced along a portion of the distal end 436 of the elongate stylet 432 in the longitudinal direction (e.g., in the +/- x-direction as depicted in the coordinate axes of FIGS. 2A-2B).
  • the plurality of outer rings 449 may be evenly spaced along the portion of the distal end 436 of the elongate stylet 432.
  • the plurality of outer rings 449 may be variably spaced in the longitudinal direction (e.g., having different lengths of space in the longitudinal direction between each adjacent outer ring of the plurality of outer rings 449) along the portion of the distal end of the elongate stylet 432.
  • the plurality of outer rings 449 and the plurality of inner rings 465 are depicted as extending around the distal portion of the elongate cannula 440 and the inner cannula 450, respectively, in the circumferential direction. Furthermore, although the plurality of outer rings 449 and the plurality of inner rings 465 are depicted as including three outer lumen ports 448 and three inner lumen ports 464, respectively, it should be appreciated that the plurality of outer rings 449 and the plurality of inner rings 465 may include any number of ports without departing from the scope of the present disclosure. Accordingly, it should also be appreciated that the plurality of outer rings 449 and the plurality of inner rings 465 may include a different number of ports. For example, the plurality of outer rings 449 may include three outer lumen ports 448 while the plurality of inner rings 465 may include four inner lumen ports 464.
  • each of the plurality of outer rings 449 and each of the plurality of inner rings 465 may include a different number of ports.
  • the plurality of outer rings 449 may include a first outer ring, a second outer ring, and a third outer ring, with the first outer ring including two ports, the second outer ring including three ports, and the third outer ring including four ports.
  • the plurality of outer rings 449 and the plurality of inner rings 465 may include any combination of rings and/or ports without departing from the scope of the present disclosure.
  • the plurality of inner rings 465 and the plurality of outer rings 449 may be positioned along the distal ends of the inner cannula 450 and the elongate stylet 432, respectively, such that each of the plurality of inner rings 465 is aligned with at least one of the plurality of outer rings 449, and vice versa.
  • the arrangement of the plurality of inner rings 465 and the plurality of outer rings 449 may be referred to as a “stacked” arrangement.
  • the plurality of inner rings 465 and the plurality of outer rings 449 may be staggered along the distal end of the inner cannula 450 and the elongate cannula 440, respectively.
  • the inner cannula 450 may include four inner rings 465, such as a first inner ring 465a, a second inner ring 465b, a third inner ring 465c, and a fourth inner ring 465d.
  • the elongate cannula 440 may include four outer rings 449, including a first outer ring 449a, a second outer ring 449b, a third outer ring 449c, and a fourth outer ring 449d.
  • the first inner ring 465a may be positioned proximally to the first outer ring 449a (e.g., in the + x-direction as depicted in the coordinate axis of FIG. 2B), the second inner ring 465b may be positioned between the first outer ring 449a and the second outer ring 449b, the third inner ring 465c may be positioned between the second outer ring 449b and the third outer ring 449c, the fourth inner ring 465d may be positioned between the third outer ring 449c and the fourth outer ring 449d and the fourth outer ring 449d may be positioned distally (e.g., in the - x-direction as depicted in the coordinate axis of FIG. 2B), such that each ring of the plurality of outer rings 449 is positioned adjacent an inner ring 465 of the plurality of inner rings 465.
  • the elongate stylet 432 may be configured to facilitate fluid communication with the plurality of output ports 223 A, 223B of the dual chamber applicator 200 so as to receive the first and second components from the dual chamber applicator 200 and direct the two components to the distal end 436 of the elongate stylet for mixing and delivery to the target site.
  • the elongate stylet 432 of the needle assembly 400 is configured to facilitate fluid communication with the output port 322A of the auxiliary applicator 300 so as to receive the contents of the auxiliary applicator 300 and direct the contents to the distal end 436 of the elongate stylet 432 for delivery to the target site.
  • the syringe 320 of the auxiliary applicator 300 may be depressed to deploy the contents of the saline chamber 322 into the elongate stylet 432, such that the contents of the saline chamber 322 are received by the outer lumen 438 and/or the inner lumen 458 of the elongate stylet and flow through the first channel 442 and/or second channel 462 towards the distal end 436 of the elongate stylet 432.
  • the contents of the chamber reach the distal end 436 of the elongate stylet 432, the contents may be deployed via the plurality of outer lumen ports 448 and/or inner lumen ports 464 to the target site.
  • the contents of the auxiliary applicator 300 may be a fluid, such as saline, that may serve a variety of purposes in preparing the target site for receiving the first and second components from the dual chamber applicator 200.
  • the auxiliary applicator 300 may supply saline to the elongate stylet 432 to flush the needle assembly 400 and remove any debris present in the elongate stylet 432 in order to avoid clogging.
  • the auxiliary applicator 300 may provide saline, or any other similar fluid, to the elongate stylet 432 in order to create a space within the target site where the first and second components of the dual chamber applicator 200 may be deployed.
  • tissue at the target site may be expanded, which may allow for the needle assembly 400 to more easily access the target site while reducing the risk of injury to surrounding tissue.
  • supplying a fluid to the target site via the auxiliary applicator 300 may further help flush out and debris and/or fluid from the target site, which may improve visualization of the target site and minimize the risk of infection.
  • the dual chamber applicator 200 may be similarly utilized to supply the first and second components to the elongate stylet 432 of the needle assembly, as has been described herein.
  • the dual chamber applicator 200 may be coupled to the needle assembly 400 such that the first output port 223A is fluidly coupled to the first channel 442 of the elongate stylet 432, while the second output port 223B is coupled to the second channel 462 of the elongate stylet 432.
  • the first component chamber 222A may deploy the first component into the first channel 442, while the second component chamber 222B may deploy the second component into the second channel 462. Accordingly, it should be appreciated that the first channel 442 and the second channel 462 maintain a separation of the first component and the second component until the components reach the distal end 436 of the elongate stylet 432, thereby avoiding a situation where the components prematurely mix.
  • the first component and the second component may traverse the first channel and the second channel, respectively, until the first component and second channel reach the distal end 436 of the elongate stylet 432.
  • the second component may escape the second channel 462 via the inner lumen ports 464 of the inner lumen 458, such that the second component enters the first channel 442 and mixes with the first component.
  • the mixture of components may continue to traverse the distal end 436 of the elongate stylet 432 until the mixture of components is deployed to the target site via the outer lumen ports 448 of the outer lumen 438.
  • the outer lumen ports 448 may be arranged in a plurality of inner rings 465 and a plurality of outer rings 449.
  • at least a first inner ring of the plurality of inner rings may be arranged in a plurality of inner rings 465 and a plurality of outer rings 449.
  • first component 465 may be positioned proximally (e.g., in the + x-direction as depicted in the coordinate axes of FIGS. 2A-2B) to at least a first outer ring of the plurality of outer rings 449.
  • the first inner ring of the plurality of inner rings 465 By positioning at least the first inner ring of the plurality of inner rings 465 proximally to at least the first outer ring of the plurality of outer rings 449, it may be possible to ensure that neither the first component or the second component escape the elongate stylet without mixing, as the second component flowing through the second channel 462 may escape from at least the first inner ring of the plurality of inner rings 465 and mix with the first component prior to the first component being deployed from at least the first outer ring of the plurality of outer rings 449.
  • arranging the outer lumen ports 448 and the inner lumen ports 464 in a plurality of outer rings 449 and a plurality of inner rings 465, respectively, that are in the stacked arrangement may provide a number of advantages over other configurations (e.g., linear, spiral, etc.).
  • arranging the plurality of outer rings 449 and the plurality of inner rings 465 it may be possible to increase the number of ports provided on the distal end 436 of the elongate stylet 432 without increasing the diameter of the elongate stylet 432.
  • the disclosed stacked configuration may allow for increased opportunities to provide precise component delivery to the target site.
  • arranging the plurality of inner rings 465 and the plurality of outer rings 449 as described herein may further act to reduce the risk that the needle assembly 400 becomes clogged during a procedure.
  • the proposed configuration allows for more even distribution of components, such as fluid, across the target site (e.g., compared to traditional port configurations including spiral, linear, etc.) which may effectively reduce the risk of clogging or blockages forming within the needle assembly 400.
  • the stacked arrangement of the plurality of inner rings 465 and the plurality of outer rings 449 may also allow for increased control and precision in the delivery of components to the target site. For example, by providing ports around the circumference of each of the elongate cannula 440 and the inner cannula 450, it may be possible to evenly distribute components, such as fluid, from each side of the needle assembly 400 simultaneously or substantially simultaneously and at even intervals along the length of the needle assembly 400. This may be particularly advantageous during procedures which involve precise placement of components within the target site.
  • the arrangement of the plurality of inner rings 465 and the plurality of outer rings 449 described herein may also provide improved visibility of the needle assembly 400 during placement. For example, the inner rings and outer rings may be more easy to identify during placement of the delivery system 100, which may allow for more accurate placement of the needle assembly 400 within the target site.
  • the needle assembly 400 may be used in conjunction with the introducer cannula 560 (also sometimes referred to in the art as a coaxial introducer needle) to allow elongate stylet 432 to be removed from the introducer cannula 560, while maintaining access to the target site with the elongate stylet 432. That is, a portion of the delivery system 100 may be removed from the introducer cannula 560 and replaced with a variety of other instruments, such as a biopsy device or another stylet.
  • the introducer cannula 560 also sometimes referred to in the art as a coaxial introducer needle
  • the introducer cannula 560 has a coaxial hub 562, a coaxial cannula 564, a cannula lumen 566 and a distal annular rim 568.
  • the cannula lumen 566 for example, is configured (e g., having a cylindrical shape) to receive the elongate stylet 432 of the needle assembly 400.
  • the elongate stylet 432 of the needle assembly 400 When the elongate stylet 432 of the needle assembly 400 is fully inserted into the cannula lumen 566 of the introducer cannula 560 (e.g., distal movement of the elongate stylet 432 is stopped by contact of the hub 430 of the needle assembly 400 with the coaxial hub 562 of the introducer cannula 560, the plurality ports of the elongate stylet 432 are located distal to the distal annular rim 568 of the introducer cannula 560. That is, the distal end 436 of the elongate stylet 432 extends beyond the distal annular rim 568 such that the introducer cannula 560 does not block the plurality of ports.
  • the method may begin at block 610, which may involve coupling a dual chamber applicator to a needle assembly.
  • the dual chamber applicator may include a first component chamber and a second component chamber, and the dual chamber applicator may be coupled to the needle assembly such that the first component chamber is fluidly coupled to a first channel of the needle assembly and the second component chamber is fluidly coupled to a second channel of the needle assembly.
  • the dual chamber applicator may be depressed to supply a first component to the first channel and a second component to the second channel, as depicted at blocks 620 and 630.
  • the first component may be contained within the first component chamber, while the second component may be contained within the second component chamber.
  • the dual chamber applicator may further include a piston, or other similar mechanism, that may be depressed to deploy the first component from the first component chamber and the second component from the second component chamber, respectively.
  • the piston may be coupled to both the first component chamber and the second component chamber, such that the first component and the second component are deployed simultaneously into the first channel and the second channel, respectively, as is depicted in FIG. 3
  • the first component and the second component may traverse the needle assembly to reach a distal portion of the needle assembly.
  • the method may move to block 640, which may involve mixing the first component with the second component within the needle assembly.
  • the second component may flow out of a plurality of ports positioned within a distal end of the second channel, such that the second component may pass into the first channel and mix with the first component.
  • the method may move to block 640, which may involve deploying the first component and the second component mixture to the target site.
  • the delivery system may include a dual chamber applicator and a needle assembly, with the dual chamber applicator being fluidly coupled to the needle assembly.
  • the dual chamber applicator may include a first component chamber and a second component chamber, with the first component chamber being fluidly coupled to a first channel of the needle assembly and the second component chamber being fluidly coupled to a second channel of the needle assembly.
  • the dual chamber applicator may be engaged to deploy a first component to the first channel (e.g., via the first component chamber) and a second component to the second channel (e.g., via the second component chamber).
  • the needle assembly may further include a plurality inner lumen ports positioned circumferentially about the second channel and a plurality of outer lumen ports positioned about the first channel, with the plurality of inner points fluidly coupling the first channel to the second channel and the plurality of outer lumen ports fluidly coupling the first channel to a target site. Accordingly, as the second component flows through the second channel, the second component may pass through the plurality of inner points such that the second component enters the first channel and mixes with the first component. In these embodiments, the mixture of the first component and the second component may be deployed to the target site.
  • the plurality of inner lumen ports may be arranged in a plurality of inner rings, while the plurality of outer lumen ports may be arranged in a plurality of outer rings, such that each of the plurality of inner lumen ports is adjacent at least one of the plurality of outer lumen ports in a longitudinal direction.
  • a needle assembly comprising: an elongate cannula including an outer lumen defining a first channel and having a plurality of outer lumen ports, the plurality of outer lumen ports being arranged in a plurality of outer rings about the outer lumen in a circumferential direction, and each of the plurality of outer rings being spaced from one another in a longitudinal direction; and an inner cannula disposed within the outer lumen, the inner cannula including an inner lumen defining a second channel and having a plurality of inner lumen ports, the plurality of inner lumen ports being arranged in a plurality of inner rings about the inner lumen in the circumferential direction, and each of the plurality of inner rings being spaced from one another in the longitudinal direction, wherein the plurality of outer rings and the plurality of inner rings are aligned in the longitudinal direction.
  • Clause 4 The needle assembly of any of clauses 1-3, wherein the second component enters the first channel via the plurality of inner lumen ports, and a distal end of the elongate cannula receives the second component and the first component and causes the first component and the second component to mix.
  • Clause 5 The needle assembly of any of clauses 1-4, wherein a resultant mixture of the first component and the second component is deployed to a target site via the plurality of outer lumen ports.
  • Clause 6 The needle assembly of any of clauses 1-5, wherein at least one of the plurality of inner rings is positioned proximally to each of the plurality of outer rings.
  • Clause 7 The needle assembly of any of clauses 1-6, wherein the elongate cannula further includes a distal end having a distal port.
  • Clause 8 The needle assembly of any of clauses 1-7, wherein the plurality of inner lumen ports fluidly couple the second channel to the first channel.
  • a delivery system comprising: a dual chamber applicator comprising: a first component chamber containing a first component and a second component chamber containing a second component; a needle assembly coupled to the dual chamber applicator, the needle assembly comprising: an elongate cannula including an outer lumen defining a first channel and having a plurality of outer lumen ports, the plurality of outer lumen ports being arranged in a plurality of outer rings about the outer lumen in a circumferential direction, and each of the plurality of outer rings being spaced from one another in a longitudinal direction; and an inner cannula disposed within the outer lumen, the inner cannula including an inner lumen defining a second channel and having a plurality of inner lumen ports, the plurality of inner lumen ports being arranged in a plurality of inner rings about the inner lumen in the circumferential direction, each of the plurality of inner rings being spaced from one another in the longitudinal direction, and each of the plurality of inner rings
  • Clause 12 The delivery system of clauses 10 or 11, wherein the first component and the second component are hydrogels.
  • Clause 13 The delivery system of any of clauses 10-12, wherein the second component enters the first channel via the plurality of inner lumen ports, and a distal end of the elongate cannula receives the second component and the first component and causes the first component and the second component to mix.
  • Clause 14 The delivery system of any of clauses 10-13, wherein a resultant mixture of the first component and the second component is deployed to a target site via the plurality of outer lumen ports.
  • Clause 15 The delivery system of any of clauses 10-14, wherein the elongate cannula further includes a distal end having a distal port.
  • Clause 16 The delivery system of any of clauses 10-15, wherein the plurality of inner lumen ports fluidly coupled the second channel to the first channel.
  • Clause 17 The delivery system of any of clauses 10-16, wherein the plurality of outer lumen ports provide an exterior opening into the first channel.
  • Clause 18 The delivery system of any of clauses 10-17, further comprising an auxiliary applicator coupled to the needle assembly.
  • Clause 20 The delivery system of any of clauses 10-19, wherein the saline chamber of the auxiliary applicator is fluidly coupled to the first channel and/or the second channel.
  • a method of operating a delivery system comprising: coupling a dual chamber applicator to a needle assembly such that a first component chamber containing a first component of the dual chamber applicator is fluidly coupled to a first channel defined by an outer lumen of the needle assembly and a second component chamber containing a second component of the dual chamber applicator is fluidly coupled to a second channel defined by an inner lumen of the needle assembly, wherein the outer lumen of the needle assembly includes a plurality of outer lumen ports arranged in a plurality of outer rings and the inner lumen of the needle assembly includes a plurality of inner lumen ports arranged in a plurality of inner rings; deploying the first component to the first channel and the second component to the second channel; and deploying a resultant mixture of the first component and the second component to a target site via the plurality of outer lumen ports; wherein the first component and the second component mix at a distal end of the needle assembly.
  • Clause 22 The method of clause 21, wherein the resultant mixture of the first component and the second component is a hydrogel.
  • Clause 23 The method of clause 22 or 23, further comprising coupling an auxiliary applicator having a saline chamber to the needle assembly such that the saline chamber is fluidly coupled to the first channel and/or the second channel.
  • Clause 24 The method of any of clauses 21-23, further comprising deploying saline from the auxiliary applicator to the first channel and/or the second channel of the needle assembly.

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  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

Ensemble aiguille comprenant une canule allongée comprenant une lumière externe définissant un premier canal et ayant une pluralité d'orifices de lumière externe, la pluralité d'orifices de lumière externe étant agencés en une pluralité d'anneaux externes autour de la lumière externe dans une direction circonférentielle et chacune de la pluralité d'anneaux externes étant espacée l'une de l'autre dans une direction longitudinale. L'ensemble aiguille comprend en outre une canule interne agencée à l'intérieur de la lumière externe et comprenant une lumière interne définissant un second canal et ayant une pluralité d'orifices de lumière interne, la pluralité d'orifices de lumière interne étant agencés en une pluralité d'anneaux internes autour de la lumière interne dans la direction circonférentielle et chaque anneau de la pluralité d'anneaux internes étant espacé l'un de l'autre dans la direction longitudinale. La pluralité d'anneaux externes et la pluralité d'anneaux internes sont alignés dans la direction longitudinale.
PCT/US2023/027002 2023-07-06 2023-07-06 Systèmes d'administration, ensembles aiguilles et procédés d'administration de composants Pending WO2025010068A1 (fr)

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PCT/US2023/027002 WO2025010068A1 (fr) 2023-07-06 2023-07-06 Systèmes d'administration, ensembles aiguilles et procédés d'administration de composants

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999022683A1 (fr) * 1997-10-30 1999-05-14 Windsor Ting Systeme d'administration de medicament a l'interieur d'un organe (ias)
US20110077644A1 (en) * 2009-09-30 2011-03-31 Boston Scientific Scimed, Inc. Medical probe with translatable co-access cannula
US20230028989A1 (en) * 2019-12-03 2023-01-26 Scripps Health Cell injection printing with a coaxial needle

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999022683A1 (fr) * 1997-10-30 1999-05-14 Windsor Ting Systeme d'administration de medicament a l'interieur d'un organe (ias)
US20110077644A1 (en) * 2009-09-30 2011-03-31 Boston Scientific Scimed, Inc. Medical probe with translatable co-access cannula
US20230028989A1 (en) * 2019-12-03 2023-01-26 Scripps Health Cell injection printing with a coaxial needle

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