Radioembolization pressure systems and methods for the detection of back-pressure within the radioembolization pressure systems

Abstract

Radioembolization pressure systems and methods include a strain gage pressure cuff and a compliant tubing, the strain gage pressure cuff configured to be disposed about a compliant tubing. The compliant tubing is configured for a radioembolization particulate delivery of particulate through the compliant tubing. The strain gage pressure cuff is configured to detect a pressure change amount within the compliant tubing. When the pressure change amount is above a change amount threshold, the pressure change amount is indicative of a back-pressure and the strain gage pressure cuff is configured to communicate a notification to the radioembolization pressure system based on the pressure change amount being above the change amount threshold.

Description

RADIOEMBOLIZATION PRESSURE SYSTEMS AND METHODS FOR THE DETECTION OF BACK-PRESSURE WITHIN THE RADIOEMBOLIZATION PRESSURE SYSTEMSTECHNICAL FIELD

[0001] The present disclosure generally relates to systems and methods for detecting a backpressure within components of medical devices for treating cancer, and more particularly to systems and methods using a strain gage pressure cuff for detecting a back-pressure within a radioembolization pressure system configured and operable to assist with delivery of radioactive compounds to a treatment area within a patient’s body in procedures such as transarterial radioembolization.BACKGROUND

[0002] Invasive and non-specific therapies, such as surgery, percutaneous ablation, radiation, and chemotherapy, may be employed in treating cancers. Transarterial radioembolization is a transcatheter intra-arterial procedure performed by interventional radiology and is commonly employed for the treatment of malignant tumors. During this medical procedure, a microcatheter, coupled to a delivery device, is navigated into a patient’s liver where particulate, such as radioembolizing microspheres loaded with a radioactive compound, such as yttrium-90 (90Y), are delivered through a compliant tubing in a distal direction away from the delivery device and toward the targeted tumors. The embolic microspheres embolize blood vessels that supply the tumors while also delivering radiation to kill tumor cells. Reflux may occur when the radioembolizing microspheres delivered through the compliant tubing in the distal direction away from the delivery device flow back towards the delivery device in the proximal direction, which may result in at least one of underdosing or non-target embolization.

[0003] Accordingly, a need exists for components of a medical device configured and operable to detect reflux in the compliant tubing during the radioembolization procedure.SUMMARY

[0004] In accordance with an embodiment of the disclosure, a radioembolization pressure system comprises a compliant tubing configured for a radioembolization particulate delivery of particulate through the compliant tubing. The radioembolization pressure system also includes a strain gage pressure cuff that is configured to be disposed about the compliant tubing to detect a pressure change amount within the compliant tubing. When the pressure change amount is above a change amount threshold, the pressure change amount is indicative of a back-pressure and the strain gage pressure cuff is configured to communicate a notification to the radioembolization pressure system based on the pressure change amount being above the change amount threshold.

[0005] In another embodiment, a radioembolization pressure system comprises a compliant tubing configured for a radioembolization particulate delivery of particulate through the compliant tubing. The system includes a strain gage pressure cuff configured to be disposed about the compliant tubing to detect a pressure change amount within the compliant tubing. The system includes a controller and a memory in communication with the controller. Machine readable instructions are stored in the memory. When executed by the controller, the machine readable instructions cause the radioembolization pressure system to perform at least the following: detect the pressure change amount within the compliant tubing when the strain gage pressure cuff is disposed about the compliant tubing and during the radioembolization particulate delivery of particulate through the compliant tubing, and when the pressure change amount is above a change amount threshold such that the pressure change amount is indicative of a back-pressure, communicate a notification via the strain gage pressure cuff to the radioembolization pressure system based on the pressure change amount being above the change amount threshold to indicate the back-pressure within the compliant tubing.

[0006] In yet another embodiment, a method for detecting a back-pressure within a radioembolization pressure system comprising delivering particulate through a compliant tubing of the radioembolization pressure system during a radioembolization particulate delivery, and measuring via a strain gage pressure cuff disposed about the compliant tubing a pressure change amount within the compliant tubing during the radioembolization particulate delivery. The method further comprises, when the pressure change amount is above a change amount threshold indicative of the back-pressure, communicating via the strain gage pressure cuff a notification tothe radioembolization pressure system based on the pressure change amount being above the change amount threshold.

[0007] These and additional features provided by the embodiments described herein will be more fully understood in view of the following detailed description, in conjunction with the drawings.BRIEF DESCRIPTION OF THE DRAWINGS

[0008] FIG. 1 is a perspective view of a delivery device including a console assembly and a vial sled, according to one or more embodiments shown and described herein;

[0009] FIG. 2 is a cross-sectional view of the vial sled of FIG. 1 according to one or more embodiments shown and described herein, the cross-section along line 2-2 of FIG. 1;

[0010] FIG. 3 is a perspective view of a vial assembly including an engagement head, according to one or more embodiments shown and described herein;

[0011] FIG. 4 is a partial cross-sectional view of the vial assembly of FIG. 3, the cross-section taken along line 4-4 of FIG. 3;

[0012] FIG. 5 is a perspective view of the vial sled of FIG. 1 with the vial assembly of FIG. 3 received therein, with a series of delivery lines coupled to the vial sled according to one or more embodiments shown and described herein;

[0013] FIG. 6 is a perspective view of a strain gage pressure cuff disposed about a compliant tubing, such as a delivery line of FIG. 5, according to one or more embodiments shown and described herein;

[0014] FIG. 7 schematically illustrates a radioembolization pressure system for implementing computer and software based methods to utilize the strain gage pressure cuff of FIG. 6 to detect back-pressure when delivering particulate via the delivery device FIG. 1, according to one or more embodiments shown and described herein; and

[0015] FIG. 8 is a flowchart of a process for using the strain gage pressure cuff of FIG. 6, and the radioembolization system of FIG. 7, for detecting back-pressure, according to one or more embodiments shown and described herein.

[0016] Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set out herein illustrate at least one embodiment of the disclosure,and such exemplifications are not to be construed as limiting the scope of the disclosure in any manner.DETAILED DESCRIPTION

[0017] Reference will now be made in detail to various embodiments of delivery devices for administering radioactive compounds to a patient, examples of which are illustrated in the accompanying drawings. Whenever possible, the same reference numerals will be used throughout the drawings to refer to the same or like parts. Directional terms as used herein — for example up, down, right, left, front, back, top, bottom, distal, and proximal — are made only with reference to the figures as drawn and are not intended to imply absolute orientation.

[0018] Ranges can be expressed herein as from “about” one particular value, and / or to “about” another particular value. When such a range is expressed, another embodiment includes from the one particular value and / or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent “about,” it will be understood that the particular value forms another embodiment. It will be further understood that the endpoints of each of the ranges are significant both in relation to the other endpoint, and independently of the other endpoint.

[0019] Unless otherwise expressly stated, it is in no way intended that any method set forth herein be construed as requiring that its steps be performed in a specific order, nor that with any apparatus specific orientations be required. Accordingly, where a method claim does not actually recite an order to be followed by its steps, or that any apparatus claim does not actually recite an order or orientation to individual components, or it is not otherwise specifically stated in the claims or description that the steps are to be limited to a specific order, or that a specific order or orientation to components of an apparatus is not recited, it is in no way intended that an order or orientation be inferred, in any respect. This holds for any possible non-express basis for interpretation, including: matters of logic with respect to arrangement of steps, operational flow, order of components, or orientation of components; plain meaning derived from grammatical organization or punctuation, and; the number or type of embodiments described in the specification.

[0020] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the disclosure belongs. The terminology used in the description herein is for describing particular embodimentsonly and is not intended to be limiting. As used in the specification and appended claims, the singular forms “a,” “an,” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise.

[0021] As used herein, the terms “horizontal,” “vertical,” “distal” and “proximal” are relative terms only, are indicative of a general relative orientation only, and do not necessarily indicate perpendicularity. These terms also may be used for convenience to refer to orientations used in the figures, which orientations are used as a matter of convention only and are not intended as characteristic of the devices shown. The present disclosure and the embodiments thereof to be described herein may be used in any desired orientation. Moreover, horizontal and vertical walls need generally only be intersecting walls, and need not be perpendicular. As used herein, the singular forms “a,” “an” and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to “a” component includes aspects having two or more such components, unless the context clearly indicates otherwise.

[0022] In embodiments described herein, a particulate material delivery assembly may include a radioembolization delivery device. A radioembolization delivery device comprises a medical device configured to deliver radioactive compounds to a treatment area within a patient’s body in procedures such as transarterial radioembolization. The radioactive compounds may be a mixed solution of saline and radioactive microspheres (i.e., a particulate) mixed in a vial of a vial assembly. The needle may include one or more ports as an outlet to inject fluid (i.e., saline), such as from a syringe or catheter line, into a vial including the radioactive microspheres to generate the mixed solution and as an inlet to deliver the mixed solution to the patient.

[0023] FIGS. 1-5 described below are directed to an embodiment of a delivery device 500 to deliver a particulate, and FIGS. 6-8 described in greater detail further below are directed to embodiments of one or more components of radioembolization pressure system 10 as described herein including the strain gage pressure cuff 600 disposed about compliant tubing of the delivery device 500 to indicate reflux when the delivery device 500 is delivering particulate through compliant tubing as described herein. The radioembolization pressure system 10 and strain gage pressure cuff 600 as described herein and in greater detail further below with respect to FIGS. 6- 8 provide for a detection of such reflux via detection of a pressure change amount within the compliant tubing used with the delivery device 500 when the pressure change amount is above a change amount threshold as measured by the strain gage pressure cuff 600 disposed aboutcompliant tubing. The strain gage pressure cuff 600 disposed about the compliant tubing may be a rigid material.

[0024] In some embodiments, as described in greater detail below, the delivery device 500 is a radioembolization delivery device, the particulate is a plurality of radioembolization beads, the fluid is a saline solution, and the resulting mixed fluid (e.g., the mixed fluid solution) is a radioembolization beads-saline solution. The needle 559 may be configured to deliver the radioembolization beads-saline solution as the mixed fluid solution through the delivery device 500, such as upon actuation of the vial engagement mechanism 520 in the positive pressure direction. In some embodiments, the fluid is a contrast-saline solution including a contrast agent, and the resulting mixed fluid (e.g., the mixed fluid solution) is a radioembolization beads-contrast- saline solution. The needle 559 may be configured to deliver the radioembolization beads- contrast-saline solution as the mixed fluid solution through the radioembolization delivery device. In some embodiments, the delivery device 500 is a chemoembolization delivery device, the particulate is a plurality of chemoembolization beads, and the mixed fluid solution is a beads- saline solution or a beads-contrast-saline solution.I. Mechanical Delivery Device with Removable Sled Assembly

[0025] FIGS. 1-5 show an embodiment of a delivery device 500 that is configured and operable to deliver a radioactive material (e.g., radioembolizing beads) while reducing radioactive emissions during use of the delivery device 500. The delivery device 500 may operate as described in International PCT App. No. PCT / 2019 / 033001, filed May 17, 2019, the entirety of which is incorporated herein.

[0026] Referring initially to FIG. 1, the delivery device 500 comprises a console assembly 510, which includes a console. The delivery device 500 may include a sled assembly 540 that is operable to transition between a coupled state and decoupled state relative to the console assembly 510. The console assembly 510 of the delivery device 500 comprises a base 512 defined by and extending between a proximal end 514 and a distal end 516. The proximal end 514 of the base 512 includes a handle (delivery handle) 528 movably coupled to the console assembly 510 and an interface display 530 positioned on the console assembly 510.

[0027] The proximal end 514 of the base 512 further includes an attachment device 538 that is configured to retain securely an external device to the base 512 of the console assembly 510. Theattachment device 538 is operable to facilitate an attachment of a complimentary device to the console assembly 510 for use with the delivery device 500 during a procedure.

[0028] Still referring to FIG. 1, the distal end 516 of the console assembly 510 defines a vial containment region 518 that is sized and shaped to receive a vial assembly 580 therein, as will be described in greater detail herein. The console assembly 510 further includes a vial engagement mechanism 520 extending from the base 512 adjacent to the distal end 516. In particular, the vial engagement mechanism 520 extends laterally outward from the base 512 of the console assembly 510 toward the distal end 516. The vial engagement mechanism 520 is positioned within the vial containment region 518 of the console assembly 510 and is movably coupled to the handle 528. In particular, the handle 528 of the console assembly 510 is operable to move, and in particular translate, the vial engagement mechanism 520 within the vial containment region 518 in response to an actuation of the handle 528.

[0029] The console assembly 510 includes a mechanical assembly disposed within the base 512 that is configured and operable to convert a manual motion of the handle 528 to a corresponding linear displacement of the vial engagement mechanism 520. In the present example, the mechanical assembly is coupled to the handle 528 and the vial engagement mechanism 520 such that selective actuation of the handle 528 at the proximal end 514 causes a simultaneous actuation of the vial engagement mechanism 520 at the distal end 516.

[0030] The sled cavity 532 is sized and shaped to receive the sled assembly 540 therein. As will be described in greater detail herein, the sled assembly 540 is configured to store and administer therapeutic particles (e.g., radioactive beads, microspheres, medium) therethrough. In particular, the sled assembly 540 is configured to partially receive a vial assembly 580 therein for administering the therapeutic particles from the delivery device 500 and to a patient during a procedure.

[0031] In embodiments, and referring to FIG. 2, a flow sensor of the delivery device 500 may be positioned in-line with the tubing set of the delivery device 500, and in particular the needle 559, the manifolds 555A, 555B, and / or one or more of the ports 556, and may be configured to measure an amount of fluid (e.g., suspension liquid after the therapeutic particles have effectively mixed with the fluid medium) that passes thereby. Referring back to FIG. 1, the vial engagement mechanism 520 comprises a pair of lever arms 522 extending outwardly from a neck 524 of the vial engagement mechanism 520, with the neck 524 extending laterally outward from the base512 of the console assembly 510. The neck 524 of the vial engagement mechanism 520 is disposed within a protective cover 525 such that only the pair of lever arms 522 of the vial engagement mechanism 520 extends through the protective cover 525. The protective cover 525 is operable to shield one or more internal components of the console assembly 510 from an exterior of the console assembly 510, and in particular from the vial containment region 518.

[0032] The pair of lever arms 522 is simultaneously movable with the neck 524 of the vial engagement mechanism 520 in response to an actuation of the handle 528 of the console assembly 510. Further, the pair of lever arms 522 are fixed relative to one another such that a spacing formed between the pair of lever arms 522 is relatively fixed. The pair of lever arms 522 of the vial engagement mechanism 520 is configured to engage securely the vial assembly 580 therebetween, and in particular within the spacing formed by the pair of lever arms 522. Accordingly, the vial engagement mechanism 520 is operable to attach securely the vial assembly 580 to the console assembly 510 at the vial containment region 518. Although the vial engagement mechanism 520 is shown and described herein as including a pair of lever arms 522, it should be understood that the vial engagement mechanism 520 may include various other structural configurations suitable for engaging the vial assembly 580. In a non-limiting example, the vial engagement mechanism 520 may include one or more magnets configured to engage with one or more corresponding magnets on the vial assembly.

[0033] Still referring to FIG. 1, the console assembly 510 further includes a safety shield 526 secured to the distal end 516 of the base 512 along the vial containment region 518. In particular, the safety shield 526 is a protective covering that is sized and shaped to enclose the vial containment region 518 of the console assembly 510 when secured thereon. The safety shield 526 is selectively attachable to the distal end 516 of the base 512 and is formed of a material that is configured to inhibit radioactive emissions from one or more radioactive doses stored within the vial containment region 518.

[0034] The distal end 516 of the console assembly 510 further includes a sled cavity 532 that is sized and shaped to receive the sled assembly 540 therein. The sled cavity 532 includes one or more or a pair of alignment features 534 extending therein, with the alignment features 534 sized and shaped to correspond with complimentary alignment features of the sled assembly 540 (e.g., alignment ribs 554) to thereby facilitate a coupling of the sled assembly 540 with the base 512 of the console assembly 510 within the sled cavity 532.

[0035] Still referring to FIG. 1, the sled assembly 540 is configured to partially receive a vial assembly 580 therein for administering therapeutic particles (e.g., radioactive fluid medium) from the delivery device 500 and to a patient. In particular, the sled assembly 540 comprises a distal end 542 and a proximal end 544 with a pair of sidewalls 546 extending therebetween. The distal end 542 of the sled assembly 540 includes a handle 552 extending proximally therefrom. The handle 552 is configured to facilitate movement of the sled assembly 540, and in particular, an insertion of the sled assembly 540 into the sled cavity 532 of the console assembly 510. The distal end 542 further includes one or more ports 556 for coupling one or more delivery lines (i.e., tubing) to the sled assembly 540. With the one or more delivery lines further be coupled to one or more external devices at an end of the line opposite of the ports 556, the ports 556 effectively serve to fluidly couple the sled assembly 540 to the one or more external devices via the delivery lines connected thereto. The pair of sidewalls 546 of the sled assembly 540 includes at least one alignment rib 554 extending laterally outward therefrom, where the alignment ribs 554 are sized and shaped to correspond with and mate to the pair of alignment features 534 of the console assembly 510. Accordingly, the pair of alignment ribs 554 are configured to facilitate an alignment and engagement of the sled assembly 540 with the console assembly 510 when the proximal end 544 is slidably received within the sled cavity 532 of the base 512.

[0036] The sled assembly 540 further includes a top surface 548 extending from the distal end 542 and the proximal end 544 and positioned between the pair of sidewalls 546. The top surface 548 of the sled assembly includes a recessed region 549 and a locking system 550. The recessed region 549 is sized and shaped to form a recess and / or cavity along the top surface 548, where the recessed region 549 is capable of receiving and / or collecting various materials therein, including, for example, leaks of various fluid media during use of the delivery device 500. The locking system 550 of the sled assembly 540 forms an opening along the top surface 548 that is sized and shaped to receive one or more devices therein, such as a priming assembly 560 and a vial assembly 580. In some embodiments, the sled assembly 540 comes preloaded with the priming assembly 560 disposed within the locking system 550. The priming assembly 560 includes a priming line 562 extending outwardly from the locking system 550 of the sled assembly 540. The priming assembly 560 connects the priming line 562 to needle 559 and manifolds 555A and 555B and serves to purge the delivery device 500, including the manifolds 555A and 555B, of air prior to utilizing the delivery device 500 in a procedure.

[0037] Referring now to FIG. 2, the locking system 550 includes an annular array of projections 551 extending outwardly therefrom, and in particular, extending laterally into the aperture formed by the locking system 550 along the top surface 548. The annular array of projections 551 are formed within an inner perimeter of the locking system 550 and extend along at least two sequentially-arranged rows. In embodiments, a single row may be used. The annular array of projections 551 included in the locking system 550 are configured to engage a corresponding locking feature 586 of the vial assembly 580 (See FIG. 3) to thereby securely fasten the vial assembly 580 to the sled assembly 540. It should be understood that the multiple rows of projections 551 of the locking system 550 serve to provide a double-locking system to ensure the sled assembly 540, and in particular a needle 559 of the sled assembly 540, is securely maintained through a septum 592 of the vial assembly 580 See FIG. 3) during use of the delivery device 500 in a procedure.

[0038] The sled assembly 540 further includes a vial chamber 558 that is sized and shaped to receive the priming assembly 560 and the vial assembly 580 therein, respectively. In other words, the vial chamber 558 is sized to individually receive both the priming assembly 560 and the vial assembly 580 separate from one another. The vial chamber 558 is encapsulated around a protective chamber or shield 557 disposed about the vial chamber 558. The protective shield 557 is formed of a material configured to inhibit radioactive emissions from extending outwardly from the vial chamber 558, such as, for example, a metal or plastic. Additionally, the sled assembly 540 includes a needle extending through the protective shield 557 and into the vial chamber 558 along a bottom end of the vial chamber 558. The needle 559 is fixedly secured relative to the vial chamber 558 such that any devices received through the aperture of the locking system 550 and into the vial chamber 558 are to encounter and interact with the needle 559 (e.g., the priming assembly 560, the vial assembly 580, and the like).

[0039] Still referring to FIG. 2, the needle 559 is coupled to a distal manifold 555A and a proximal manifold 555B disposed within the sled assembly 540, and in particular the manifold 555A, 555B is positioned beneath the vial chamber 558 and the protective shield 557. The proximal manifold 555B is fluidly coupled to the needle 559 and the distal manifold 555A is fluidly couplable to one or more delivery lines via the one or more ports 556 of the sled assembly 540. The proximal manifold 555B is in fluid communication with the distal manifold 555A through a one-way check valve 553 disposed therebetween.

[0040] Accordingly, the proximal manifold 555B is in fluid communication with the one or more ports 556 via the distal manifold 555A, however, the one or more ports 556 are not in fluid communication with the proximal manifold 555B due to a position of the one-way check valve 553 disposed between the manifolds 555A, 555B. Thus, the needle 559 is in fluid communication with the one or more delivery lines and / or devices coupled to the sled assembly 540 at the one or more ports 556 via the manifolds 555A, 555B secured therebetween. The one or more ports 556 of the sled assembly 540 may be coupled to a bag (e.g., saline bag), a syringe, a catheter, and / or the like via one or more delivery lines coupled thereto. In other embodiments, the needle 559 may be a cannula, catheter, or similar mechanism through which to inject and receive fluid and / or a solution as described herein.

[0041] Still referring to FIG. 2, the sled assembly 540 includes a removable battery pack 570 coupled to the sled assembly 540 along the proximal end 544. The removable battery pack 570 comprises a battery 572, electrical contacts 574, and a removable tab 576. The battery 572 of the delivery device 500 is isolated from one or more fluid paths and radiation sources due to a location of the battery 572 in the removable battery pack 570.

[0042] The electrical contacts 574 of the removable battery pack 570 extend outwardly from the removable battery pack 570 and are operable to contact against and interact with corresponding electrical contacts 511 of the console assembly 510 (See FIG. 1) when the sled assembly 540 is coupled to the base 512 at the sled cavity 532. Accordingly, the removable battery pack 570 is operable to provide electrical power to the delivery device 500, and in particular the console assembly 510, when the sled assembly 540 is coupled to the console assembly 510.

[0043] Additionally, as will be described in greater detail herein, in some embodiments the locking system 550 may include at least one planar wall relative to a remaining circular orientation of the locking system 550. In this instance, an aperture formed by the locking system 550 through the top surface 548 of the sled assembly 540 is irregularly-shaped, rather than circularly-shaped as shown and described above. In this instance, the vial assembly 580 includes a locking feature 586 that has a shape and size that corresponds to the locking system 550, and in particular the at least one planar wall such that the vial assembly 580 is received within the sled assembly 540 only when an orientation of the vial assembly 580 corresponds with an alignment of the locking feature 586 and the locking system 550. In other words, a corresponding planar wall 586A of the locking feature 586 See FIG. 3) must be aligned with the planar wall of the locking system 550 for thevial assembly 580 to be receivable within an aperture formed by the locking system 550 of the sled assembly 540.

[0044] Referring now to FIG. 3, the vial assembly 580 of the delivery device 500 is depicted. The vial assembly 580 comprises an engagement head 582, a plunger 584, a locking feature 586, and a vial body 589. In particular, the engagement head 582 of the vial assembly 580 is positioned at a terminal end of the plunger 584 opposite of the locking feature 586 and the vial body 589. The engagement head 582 includes a pair of arms 581 extending laterally outward relative to a longitudinal length of the plunger 584 extending downwardly therefrom. In the present example, the engagement head 582 is integrally formed with the plunger 584, however, it should be understood that in other embodiments the engagement head 582 and the plunger 584 may be separate features fastened thereto. In either instance, the engagement head 582 and the plunger 584 is movable relative to the locking feature 586 and the vial body 589 such that the engagement head 582 and the plunger 584 are slidably translatable through the locking feature 586 and the vial body 589. In particular, as will be described in greater detail herein, the plunger 584 may translate into and out of an internal chamber 588 of the vial body 589 in response to a linear translation of the vial engagement mechanism 520 when the engagement head 582 is secured to the pair of lever arms 522.

[0045] The plunger 584 includes a plurality of indicia and / or markings 583 positioned along a longitudinal length of the plunger 584. The plurality of markings 583 is indicative of a relative extension of the engagement head 582 and the plunger 584 from the locking feature 586 and the vial body 589. As briefly noted above, the engagement head 582 is configured to attach the vial assembly 580 to the vial engagement mechanism 520. In particular, the pair of arms 581 of the engagement head 582 are sized and shaped to couple with the pair of lever arms 522 of the vial engagement mechanism 520 when the vial assembly 580 is received within the sled assembly 540 and the sled assembly is inserted into the sled cavity 532 of the console assembly 510. As will be described in greater detail herein, the pair of lever arms 522 are received between the pair of arms 581 of the engagement head 582 and the plunger 584 in response to a predetermined translation force applied to the vial engagement mechanism 520. The engagement head 582 and the plunger 584 may be formed of various materials, including, but not limited to, a metal, plastic, and / or the like.

[0046] Still referring to FIG. 3, the vial assembly 580 further includes a safety tab 585 coupled to the plunger 584 relatively above the locking feature 586 and below the engagement head 582 such that the safety tab 585 is positioned along the longitudinal length of the plunger 584. The safety tab 585 may be formed of various materials, such as, for example, a plastic, and is preassembled onto the vial assembly 580 prior to a use of the delivery device 500. The safety tab 585 is removably-fastened to the plunger 584 and inhibits the plunger 584 from translating relative to the vial body 589. In particular, the safety tab 585 abuts against the locking feature 586 in response to an application of linear force onto the plunger 584 to translate the plunger 584 relatively downward into the vial body 589. In this instance, the safety tab 585 is configured to inhibit an inadvertent movement of the plunger 584, and in response, an inadvertent delivery of a fluid media stored within the internal chamber 588 of the vial body 589 (e.g., therapeutic particles, radioembolizing beads). As will be described in greater detail herein, the safety tab 585 is selectively disengaged from the plunger 584 in response to a coupling of the vial assembly 580 with the vial engagement mechanism 520, and in particular an engagement of the pair of lever arms 522 with the engagement head 582.

[0047] Referring back to FIG. 3, the locking feature 586 extends about a top end of the vial body 589. In the present example, the locking feature 586 of the vial assembly 580 comprises a bushing that defines a lateral edge 587 extending laterally outward along an outer perimeter of the locking feature 586. The lateral edge 587 of the locking feature 586 is sized and shaped to engage the annular array of projections 551 of the locking system 550 when the vial assembly 580 is received within the vial chamber 558 of the sled assembly 540. As will be described in greater detail herein, the locking feature 586, and in particular the lateral edge 587 of the locking feature 586, is configured to securely fasten the vial assembly 580 to the locking system 550 to inhibit removal of the vial body 589 from the vial chamber 558 of the sled assembly 540 during use of the delivery device 500 in a procedure. In some embodiments, as briefly described above, the locking feature 586 includes at least one planar wall 586A such that the locking feature 586 comprises an irregular-profile. The at least one planar wall 586A is configured to correspond to the planar wall 550A of the locking system 550 such that an alignment of the planar walls 550A, 586A is required for the vial assembly 580 to be received through an aperture formed by the locking system 550.

[0048] Still referring to FIG. 3, the vial body 589 extends downwardly relative from the locking feature 586 and has a longitudinal length that is sized to receive at least a portion of a longitudinal length of the plunger 584 therein. Accordingly, in some embodiments a longitudinal length of the plunger 584 exceed a longitudinal length of the vial body 589 such that a translation of the plunger 584 into the internal chamber 588 of the vial body 589 causes a fluid media stored therein to be transferred outward from the vial body 589. As will be described in greater detail herein, a translation of the plunger 584 through the internal chamber 588 of the vial body 589 provides for an administration of a fluid media stored within the vial body 589 outward from the vial assembly 580. The vial body 589 may be formed of various materials, including, for example, a thermoplastic polymer, copolyester, polycarbonate, a biocompatible plastic, polysulfone, ceramics, metals, and / or the like.

[0049] The vial body 589 is of the present example is formed of a material that is configured to inhibit radioactive emissions from a fluid media stored within the internal chamber 588 of the vial body 589. For example, the vial body 589 may be formed of a plastic, such as polycarbonate, and have a width. A density and material composition of the vial body 589 may collectively inhibit beta radiation emission from electron particles stored within the internal chamber 588. In the present example, a chemical composition of the plastic of the vial body 589, along with the 9 mm wall thickness, provides a plurality of atoms disposed within the vial body 589 that are capable of encountering the electron particles generating beta radiation and reducing an emission of said radiation from the vial assembly 580. Accordingly, the vial assembly 580 allows an operator to handle the radioactive material stored within the vial body 589 without being exposed to beta radiation. It should be understood that various other materials and / or wall sections may be incorporated in the vial body 589 of the vial assembly 580 in other embodiments without departing from the scope of the present disclosure.

[0050] Still referring to FIG. 3, the vial body 589 of the vial assembly 580 is sealed at a first terminal end 598 by the locking feature 586. The vial assembly 580 further includes a cap 590 positioned at an opposing, terminal end of the vial body 589 opposite of the locking feature 586, such that the cap 590 seals a second terminal end of the vial body 589 of the vial assembly 580. Additionally, the vial assembly 580 includes a septum 592 positioned adjacent to the cap 590 and in fluid communication with a terminal end of the vial body 589 opposite of the locking feature 586. The septum 592 forms a seal against a terminal end of the vial body 589 and the cap 590retains the septum 592 therein. The septum 592 may be formed of various materials, including, for example, an elastomer, silicon, bromobutyl elastomer, rubber, urethanes, and / or the like. The septum 592 is configured to provide an air-tight seal for the vial body 589 to thereby inhibit a release of a fluid media stored therein (e.g., radioembolizing beads). As will be described in greater detail herein, the septum 592 of the vial assembly 580 is configured to be punctured by the needle 559 of the sled assembly 540 when the vial assembly 580 is received within the vial chamber 558, thereby establishing fluid communication between the vial body 589 and the sled assembly 540. In other embodiments, the septum 592 may be omitted entirely for an alternative device, such as, for example, a valve system, needle injection port, and / or the like.

[0051] Referring to FIG. 4, the vial assembly 580 further includes a stopper 594 fixedly coupled to a terminal end of the plunger 584 opposite of the engagement head 582. In this instance, with the plunger 584 coupled to, and slidably translatable through, the internal chamber 588 of the vial body 589, the stopper 594 is effectively disposed within the vial body 589. Accordingly, it should be understood that the stopper 594 is sized and shaped in accordance with a size (e.g., a diameter) of the internal chamber 588 of the vial body 589. The stopper 594 is secured to the plunger 584 such that the stopper 594 is slidably translatable through the vial body 589 in response to a translation of the plunger 584 through the vial body 589. The stopper 594 is defined by two or more ribs 593 extending laterally outward and one or more troughs 595 defined between at least two ribs 593.

[0052] The stopper 594 is configured to form a liquid-seal against the internal chamber 588 of the vial body 589, and may be formed of a various polymers with a predetermined viscoelasticity. For example, in some embodiments the stopper 594 is formed of an elastomer, silicone, rubber, urethane, plastic, polyethylene, polypropylene, and / or the like. In this instance, the stopper 594 is operable to inhibit a fluid media stored within the vial body 589 from extending (i.e., leaking) past the stopper 594 and out of the vial body 589. In particular, the two or more ribs 593 of the stopper 594 abut against, and form a seal along, the internal chamber 588 of the vial body 589 to thereby inhibit a fluid media from passing beyond the ribs 593. The one or more troughs 595 formed between the two or more ribs 593 of the stopper 594 are configured to receive, and more specifically capture, any fluid media that may inadvertently extend (i.e., leak) beyond the ribs 593 of the stopper 594. Accordingly, the one or more troughs 595 serve as a safety mechanism of thevial assembly 580 to ensure a fluid media is maintained within the vial body 589 and not exposed beyond the vial assembly 580.

[0053] Still referring to FIG. 4, the two or more ribs 593 of the stopper 594 are additionally configured to push a fluid media stored within the vial body 589 in one or more directions therein (e.g., toward the cap 590) in response to a translation of the plunger 584. With the ribs 593 of the stopper 594 pressed against the internal chamber 588 of the vial body 589, translation of the plunger 584 provides for a translation of the ribs 593 against and along the internal chamber 588 of the vial body 589 such that any fluid media located in front (i.e., beneath) of the stopper 594 is effectively redirected within the vial body 589 in a direction of travel of the plunger 584 and the stopper 594. The vial assembly 580 further includes an annular washer 596 disposed within the vial body 589. In particular, the annular washer 596 is securely fixed to the plunger 584 adjacent to the stopper 594, which is secured to the plunger 584 at a terminal end opposite of the engagement head 582. Accordingly, the annular washer 596 is secured to the plunger 584 and disposed within the vial body 589 adjacent to the stopper 594. With the annular washer 596 secured to the plunger 584 adjacent to the stopper 594, the annular washer 596 is effectively disposed within the vial body 589.

[0054] Referring now to FIG. 5, in response to determining that the battery 572 contains or other power source provides a sufficient amount of power, one or more delivery lines are coupled to the sled assembly 540 via the one or more ports 556. In particular, a dose delivery line 10A is coupled to the sled assembly 540 at a delivery port 556A, a contrast line 10B is coupled to the sled assembly 540 at a contrast port 556B, and a flushing line 10C is coupled to the sled assembly 540 at a flushing port 556C. An opposing end of the dose delivery line 10A is initially coupled to a fluid reservoir, such as, for example, a collection bowl. As will be described in greater detail herein, the dose delivery line 10A may be subsequently coupled to an external device, such as a catheter, once the sled assembly 540 has been effectively primed by a fluid medium via the contrast line 10B. An opposing end of the flushing line 10C is coupled to an external device, such as, for example, a syringe. With both the dose delivery line 10A and the flushing line 10C coupled to the sled assembly 540, the sled assembly 540 is flushed with a fluid medium (e.g., saline) from the syringe coupled to the flushing line 10C. In this instance, the fluid medium is injected through the flushing line 10C, into the distal manifold 555A of the sled assembly 540, and out of the sledassembly 540 through the dose delivery line 10A. Accordingly, the fluid medium is ultimately received at the collection bowl and disposed thereat by the dose delivery line 10A.

[0055] With the distal manifold 555A of the sled assembly 540 separated from the proximal manifold 555B by the one-way valve 553 disposed therebetween, the fluid medium flushed through the distal manifold 555A from the syringe (via the flushing port 556C) is prevented from passing through the proximal manifold 555B and the needle 559 coupled thereto. Rather, the fluid medium injected from the syringe and through the flushing line 10C is received at the flushing port 556C, passed through the distal manifold 555A in fluid communication with the flushing port 556C, and redirected by the one-way valve 553 towards the dose delivery port 556 A that is coupled to the dose delivery line 10A. In this instance, the dose delivery line 10A receives and transfers the fluid medium to the collection bowl coupled thereto, such that the fluid medium is not directed beyond the one-way valve 553 and into the proximal manifold 555B that is in fluid communication with the needle 559.

[0056] The contrast line 10B is coupled to the sled assembly 540 at a contrast port 556B. An opposing end of the contrast line 10B is coupled to a fluid medium supply, such as, for example, a bag secured to the console assembly 510 via the attachment device 538. In the present example, the bag is a saline bag such that the fluid medium stored therein is saline. In this instance, with the sled assembly 540 including the priming assembly 560 positioned within the vial chamber 558 and the needle end 568 in fluid communication with the needle 559, a syringe is fluidly coupled to the priming line 562 of the priming assembly 560 and a plunger of the syringe is drawn back to pull saline through the contrast line 10B, the contrast port 556B, the sled assembly 540, the priming line 562 and into the syringe from the saline bag. The plunger of the syringe is thereafter pushed inwards to transfer the extracted saline back through the priming line 562, the central body 564, the elongated shaft 566, and the needle end of the priming assembly 560 such that the saline is received into the needle 559 of the sled assembly 540. Accordingly, the manifolds 555A, 555B of the sled assembly 540 are effectively primed with the saline from the syringe as the needle 559 that received the saline from the priming assembly 560 is in fluid communication with the manifolds 555A, 555B. With the manifolds 555A, 555B in further fluid communication with the dose delivery line 10A via the delivery port 556 A, the saline is effectively distributed to the collection bowl coupled thereto.

[0057] Referring now to FIG. 5, the sled assembly 540 is coupled to one or more external devices via the one or more ports 556. In particular, the sled assembly 540 is fluidly coupled to a catheter (e.g., microcatheter) via the dose delivery line 10A that is coupled to the delivery port 556A of the sled assembly 540. In this instance, the catheter is in fluid communication with the sled assembly 540 via the dose delivery line 10A. Further, the sled assembly 540 is fluidly coupled to a contrast source, such as, for example, a saline bag secured to the console assembly 510 via the attachment device 538 (See FIG. 1). The sled assembly 540 is in fluid communication with the saline bag via a contrast line 10B coupled to the contrast port 556B of the sled assembly 540. In this instance, the saline bag is in fluid communication with the sled assembly 540 via the contrast line 10B secured to the contrast port 556B.

[0058] The contrast port 556B is in fluid communication with the proximal manifold 555B while the delivery port 556A is in fluid communication with the distal manifold 555A. As will be described in greater detail herein, saline from the saline bag may be withdrawn through the needle 559 of the sled assembly 540 and into the vial body 589 of the vial assembly 580 as the contrast port 556B is coupled to the proximal manifold 555B, rather than the distal manifold 555A which is separated from the proximal manifold 555B by the one-way check valve 553 disposed therebetween.

[0059] Referring again to FIGS. 1 and 3, with the vial assembly 580 securely coupled to the sled assembly 540, the sled assembly 540 is coupled to the console assembly 510 by translating the distal end 542 of the sled assembly 540 toward and into the distal end 516 of the console assembly 510. In particular, the distal end 542 of the sled assembly 540 is directed into the sled cavity 532 of the console assembly 510 by aligning the alignment ribs 554 of the sled assembly 540 with the alignment features 534 of the console assembly 510. Once the proximal end 544 and the distal end 542 of the sled assembly 540 are fully seated within the sled cavity 532 of the console assembly 510, the electrical contacts 574 (FIG. 2) of the removable battery pack 570 interact with corresponding electrical contacts 511 (FIG. 1) of the console assembly 510. In this instance, power from the battery 572 is transmitted to the console assembly 510 via the electrical contacts 574, thereby activating the console assembly 510 of the delivery device 500. In this instance, the interface display 530 of the console assembly 510 is activated to display pertinent, real-time information relating to the delivery device 500 during a procedure.

[0060] Referring again to FIG. 5, as the vial engagement mechanism 520 and the plunger 584 are simultaneously translated within the vial containment region 518, a negative pressure is generated within the internal chamber 588 of the vial body 589 due to a retraction of the stopper 594. In this instance, with the saline bag coupled to the sled assembly 540 via the contrast line 10B and the contrast port 556B, saline from the saline bag is pulled into the internal chamber 588 of the vial body 589 through the proximal manifold 555B and the needle 559. Accordingly, with the vial body 589 being preloaded with a radioactive fluid media (e.g., radioembolizing microspheres), the saline is effectively mixed with the radioactive fluid media within the vial body 589 as the plunger 584 is retracted from the internal chamber 588 and the negative pressure is generated through the delivery device 500.

[0061] The sled assembly 540 further includes one-way check valves 553A in-line with the contrast line 10B and the flushing line 10C. In particular, the one-way check valves 553A are configured to permit fluid communication from the contrast port 556B and the flushing port 556C into the manifolds 555A, 555B, and further configured to prevent fluid communication from the manifolds 555A, 555B to the contrast port 556B and the flushing port 556C. Accordingly, it should be understood that the dose delivered from the vial body 589 to the manifold 555A, 555B is incapable of being directed into the contrast line 10B or the flushing line 10C due to the oneway check valves 553A positioned therein. Thus, the dose is directed to the dose delivery port 556A and received at the catheter fluidly coupled thereto by the dose delivery line 10A. In other words, the one-way check valves 553A prevent a backflow of fluid into the sled assembly 540 and / or the vial assembly 580 coupled thereto.II. Radioembolization Pressure System Embodiments

[0062] As briefly noted above, the radioembolization pressure system 10 described herein may include the strain gage pressure cuff 600 and a compliant tubing 602, embodiments of which are described in greater detail below with respect to FIGS. 6 and 7. The compliant tubing 602 may be a delivery line of a radioembolization delivery device, such as the dose delivery line 10A of the delivery device 500 as shown and described in FIGS. 1-5. The strain gage pressure cuff 600 is configured to measure strain on the complaint tubing 602. In response to an increase of pressure in the compliant tubing 602, the strain gage pressure cuff 600 may be configured to increaseelectrical resistance to measure strain. It will be appreciated that other types of strain gages may be used in other embodiments.

[0063] Referring to FIG. 6, the strain gage pressure cuff 600 is disposed about the compliant tubing 602 (such as dose delivery line 10A described above with respect to FIG. 5) that may be connected to a delivery port of a radioembolization delivery device (such as the delivery port 556A of the delivery device 500). The compliant tubing 602 may be configured for a radioembolization particulate delivery of particulate (e.g., a mixed solution of saline and radioactive microspheres as described herein) through the compliant tubing. The strain gage pressure cuff 600 disposed about the compliant tubing 602 may be configured to detect a pressure change amount within the compliant tubing 602. In embodiments, when the pressure change amount is above a change amount threshold, the pressure change amount is indicative of a backpressure in the compliant tubing 602 in a proximal direction when particulate is being delivery in a distal direction. Back-pressure may be indicative of reflux of the particulate within the compliant tubing 602 (and a compliant tubing lumen 604 of the complaint tubing 602) during the radioembolization particulate delivery as described herein. In embodiments, when the pressure change amount is above the change amount threshold, the pressure change amount is further indicative of reflux of the particulate within the compliant tubing 602 during the radioembolization particulate delivery. The strain gage pressure cuff 600 may be configured to communicate a notification to the radioembolization system 10 (FIG. 7) based on the pressure change amount being above the change amount threshold.

[0064] In embodiments, the pressure change amount may be a range between about 15 pounds per square inch (psi) to about 30 psi from an initial baseline pressure during the radioembolization particulate delivery (noting 1 psi is equivalent to 6.895 kilopascal (kPA) in an International System of Units (SI units) measurement, the range may be between about 103.421 kPA to about 206.843 kPA). The strain gage pressure cuff 600 may be configured to increase resistance in response to an increase of pressure in the compliant tubing 602. When a resistance increase measuring a resistance change amount from a baseline resistance is above a resistance change amount threshold, the resistance change amount may be indicative of the back-pressure. When the strain gage pressure cuff 600 increases resistance in response to the increase of pressure in the compliant tubing 602 from the baseline resistance to more than the resistance change amount threshold, the strain gage pressure cuff 600 may be configured to communicate the notification to theradioembolization pressure system 10 based on the resistance change amount being above the resistance change amount threshold. The resistance may be measured in kilo ohms.

[0065] Referring again to FIG. 6, the strain gage pressure cuff 600 may include a first portion 610 and a second portion 614. The first portion 610 may be configured to interlock with the second portion 614 and vice versa. The first portion 610 may be configured to interlock with the second portion 614 when the strain gage pressure cuff 600 is disposed about the compliant tubing 602, as shown in FIG. 6. As a non-limiting example, when the strain gage pressure cuff 600 is used in the radioembolization pressure system 10, the first portion 610 and the second portion 614 may separately be disposed about the compliant tubing 602 and then interlocked at an interlocking joint 618 so that the strain gage pressure cuff 600 is locked and disposed about the compliant tubing 602. In embodiments, the first portion 610 and the second portion 614 may also be unlocked at the interlocking joint 618 to remove the strain gage pressure cuff 600 from the compliant tubing 602, such as after completion of delivery of the particular by the delivery device 500 as described herein. When interlocked together, the first portion 610 and the second portion 614 form a strain gage pressure cuff lumen 640 that may be configured to be disposed and locked about an exterior surface of the compliant tubing 602. In embodiments, the strain gage pressure cuff 600 may include one or more portions configured to connect via a connection mechanism such as interlock, hinge, welding, or other similar mechanisms. The strain gage pressure cuff 600 may be a rigid material such as made of hard plastics or metals. The strain gage pressure cuff 600 disposed about the compliant tubing may be permanently affixed and disposable or removable and re-usable with various compliant tubing delivery lines based on corresponding size and shapes.

[0066] In embodiments, the first portion 610 may have a first portion proximal face 620, facing in a proximal direction 606, and a first portion distal face 622, facing in a distal direction 608. In embodiments, the second portion 614 may have a second portion proximal face 630, facing in the proximal direction 606 and a second portion distal face 632, facing in the distal direction 608. The first portion 610 may have a first portion arm 612 that distally extends from the first portion proximal face 620 that may be configured to interlock with a second portion arm 616 of the second portion 614 at the interlocking joint 618. The second portion arm 616 extends in the proximal direction 606 from the second portion distal face 632. In embodiments, a first portion distal lip 624 is adjacent to a first portion distal face 622. In embodiments, a second portion distal lip 634 is interposed between and is adjacent to each of the second portion distal face 632. It is noted thatin other embodiments the first portion 610 and the second portion 620 may take other suitable shapes which are configured to interlock to form the strain gage pressure cuff lumen 640.

[0067] Referring to FIG. 7, the radioembolization pressure system 10 may include a display (such as a display 706 of the console assembly 510 and / or the cuff display 722 of the strain gage pressure cuff 600) and be configured to display the notification based on the pressure change amount being above the change amount threshold on the display. The radio embolization pressure system 10 may further include a controller including the display. In embodiments, and as described in greater detail further below, the controller may be a processor 714 of a controller circuit 700 of the control assembly 510 of the delivery device 500 or may be a separate processor. The strain gage pressure cuff 600 may be configured to send the notification to the controller, and the controller is configured to display the notification on the display. The strain gage pressure cuff 600 may be configured to send the notification to the controller via a wired communication or a wireless communication. The notification communicated to the radioembolization pressure system may be an alert, an alarm, or combinations thereof. The alert may be a text communication and / or the alarm may be an audible alarm, a haptic alarm, a visual alarm, or combinations thereof.

[0068] In some embodiments, the radioembolization pressure system 10 and, more specifically, the console assembly 510 may include a graphical user interface (i.e., GUI) 702. The controller circuit 700 may be communicatively coupled to and thus in communication with the GUI 702 via a first internal bus structure 704 or any other suitable communicative coupling. The GUI 702 may be displayed on the console display 706, which may be a display screen or a touchscreen configured to accommodate user input. The controller circuit 700 may be communicatively coupled to and thus in communication with the strain gage pressure cuff 600 via a console assembly input / output (I / O) interface circuit 708, a second internal bus structure 710, and a first communication coupling 712, which may be wired or wireless. In embodiments, the controller circuit 700 may be communicatively coupled to and thus in communication with a console speaker 718 via a third internal bus structure 720. It will be appreciated that any other suitable communicative coupling may be provided in other embodiments.

[0069] The controller circuit 700 is an electrical circuit that has data processing capability and command generating capability. In embodiments, the controller circuit 700 has a processor 714 and a memory 716, which is an associated non-transitory electronic memory. The processor 714 may be in the form of a single microprocessor, or two or more parallel microprocessors. Thememory 716 may include multiple types of digital data memory, such as random access memory (RAM), non-volatile RAM (NVRAM), read only memory (ROM), and / or electrically erasable programmable read-only memory (EEPROM). The memory 716 may further include mass data storage in one or more of the electronic memory forms described above, or on a computer hard drive or optical disk. The controller circuit 700 may be assembled as one or more Application Specific Integrated Circuits (ASIC).

[0070] Still referring to FIG. 7, the strain gage pressure cuff 600 may include a cuff display 722, a cuff speaker 724, a haptic alarm 726, and one or more sensors 728 (such as pressure sensors), or any combination of the cuff display 722, the cuff speaker 724, the haptic alarm 726, and the one or more sensors 728. In embodiments, the strain gage pressure cuff 600 may include a memory and controller to operate autonomously of or in addition to use with the controller circuit 700.

[0071] In embodiments, the radioembolization pressure system 10 may include the compliant tubing 602 configured for a radioembolization particulate delivery of particulate through the compliant tubing 602, the strain gage pressure cuff 600 configured to be disposed about the compliant tubing 602 to detect a pressure change amount within the compliant tubing 602, the controller (e.g., the processor 714 of the controller circuit 700 or any other suitable controller on or remote to the strain gage pressure cuff 600), a memory in communication with the controller (e.g., the memory 716 in communication with the processor 714 of the controller circuit 700 or any other suitable memory on or remote to the strain gage pressure cuff 600), and machine readable instructions stored in the memory. As the strain gage pressure cuff 600 receives data from a sensor 728 regarding a pressure change amount within the compliant tubing 602, the strain gage pressure cuff 600 may communicate the pressure change amount to the processor 714 (or pressure measurements may be communicated to the processor 714 and the pressure change may be calculated by the processor 714). The memory 716 may store machine readable instructions that cause the radioembolization pressure system 10 to perform a control scheme (such as a process 800 of FIG. 8, described in greater detail below) when executed by the controller. In embodiments, the radioembolization pressure system 10 may be configured to detect the pressure change amount within the compliant tubing 602 when the strain gage pressure cuff 600 is disposed about the compliant tubing 602 and during the radioembolization particulate delivery of particulate through the compliant tubing 602. The radioembolization pressure system 10 mayfurther be configured to, when the pressure change amount is above a change amount threshold such that the pressure change amount is indicative of a back-pressure, communicate a notification via the strain gage pressure cuff 600 to the radioembolization pressure system 10 based on the pressure change amount being above the change amount threshold to indicate the back-pressure within the compliant tubing 602.

[0072] In embodiments, the change amount threshold is stored on the memory 716. If the pressure change amount is determined to be above the change amount threshold, then the pressure change amount is indicative of reflux of the particulate within the compliant tubing 602 during the radioembolization particulate delivery. If the pressure change amount is determined to be above the change amount threshold, the machine readable instructions may cause the radioembolization pressure system 10 (e.g., via the processor 714 as the controller) to deliver a notification to the cuff display 722, the cuff speaker 724, the haptic alarm 726, the GUI 702 (including the console display 706), the console speaker 718 and / or any other external device. The cuff display 722 and / or the console display 706 may be configured to display the notification. Each of the cuff speaker 724 and the console speaker 718 may be configured to audibly provide the notification. As described above, the notification may take the form of an alert, such as, but not limited to a text message. Alternatively or additionally, the notification may take the form of an alarm, such as an audible alarm, a visual alarm, a haptic alarm, or combinations thereof. The strain gage pressure cuff 600 may be configured to send the notification (e.g., to the controller circuit 700) via a wired communication or a wireless communication.

[0073] In some embodiments, the machine readable instructions when executed by the controller may cause the radioembolization pressure system 10 via the strain gage pressure cuff 600 and when executed by the controller to determine an initial baseline pressure during the radioembolization particulate delivery. By way of example and not as a limitation, the pressure change amount threshold, indicating back-pressure in the compliant tubing, may include a range between about 15 pounds per square inch (psi) to about 30 psi from the initial baseline pressure during the radioembolization particulate delivery.

[0074] FIG. 8 illustrates a process 800 as a control scheme that may be used with the radioembolization pressure system 10 and the strain gage pressure cuff 600 described herein with reference to FIGS. 6-7. The process 800 includes a method for detecting a back-pressure within the radioembolization pressure system 10. In embodiments in which the strain gage pressure cuff600 includes the first portion 610 and the second portion 614, the process 800 may include interlocking the first portion 610 and the second portion 614 together around the compliant tubing 602 to dispose and lock the strain gage pressure cuff 600 about and against the external surface of the compliant tubing 602.

[0075] In block 802, the particulate may be delivered through the compliant tubing 602 of the radioembolization pressure system 10 during a radioembolization particulate delivery as described herein, such as via the console assembly 510 of the delivery device 500 of FIGS. 1 and 5. With the strain gage pressure cuff 600 disposed about the compliant tubing 602, the particulate, such as the mixed solution of saline and radioactive microspheres described herein, may be delivered through the compliant tubing 602 of the radioembolization pressure system 10 during the radioembolization particulate delivery.

[0076] In block 804, a pressure change amount within the compliant tubing 602 during the radioembolization particulate delivery is measured via the strain gage pressure cuff 600, which is disposed about the compliant tubing 602. In block 806, when the pressure change amount is above a change amount threshold indicative of the back-pressure, the strain gage pressure cuff 600 communicates a notification to the radioembolization pressure system 10 based on the pressure change amount being above the change amount threshold. As described above, the notification may be delivered to one or more of the cuff display 722, the cuff speaker 724, the haptic alarm 726, the GUI 702, the console speaker 718, and one or more external devices.

[0077] During radioembolization, particulate is delivered in the distal direction 608 toward the patient through the compliant tubing 602. As noted above, reflux is the condition when the particulate starts to flow back toward the delivery device 500 in the proximal direction 606. Because the delivery device 500 may continue to deliver particulate in the distal direction 608 even while the particulate flows back toward the delivery device 500 in the proximal direction 606 during a state of reflux, the volume inside the compliant tubing 602 expands, causing a mechanical stress on a wall forming the compliant tubing 602. When the compliant tubing 602 expands as a result of the increased volume, the wall of the compliant tubing 602 presses outward and away from the longitudinal axis of the compliant tubing 602. Stated another way, reflux may cause an increase in pressure inside the compliant tubing 602 and be detected when a pressure change amount due to the increase is above a change amount threshold. The sensor 728 such as, for example, a piezoelectric pressure sensor or any other suitable pressure sensor, in the straingage pressure cuff 600 may be configured to sense slight expansions of the compliant tubing 602. The sensor 728 may measure voltage across a piezoelectric element when mechanical stress is applied to the wall of the compliant tubing 602, and the strain gage pressure cuff 600 may use the measured voltage to detect pressure changes in the compliant tubing 602. In an embodiment, a change in resistance (e.g., an increase) may be caused by a stretching of the strain gage pressure cuff 600 by the complaint tubing 602 (e.g., upon a pressure increase), which may further cause and be measured as a corresponding change in voltage. In another embodiment, a change in resistance (e.g., a decrease) may be caused by compression of the strain gage pressure cuff 600 by the complaint tubing 602, which may further cause and be measured as a corresponding change in voltage.

[0078] In some embodiments, the radioembolization pressure system 10 is part of an automated delivery system, having a feedback loop for controlling delivery of the particulate. In such embodiments, when reflux is detected by the radioembolization pressure system 10 via the strain gage pressure cuff 600, the automated delivery system may limit an associated delivery flow rate of the particulate in the distal direction 608.III. Aspects Listing

[0079] Aspect 1. A radioembolization pressure system comprises a compliant tubing and a strain gage pressure cuff. The compliant tubing is configured for a radioembolization particulate delivery of particulate through the compliant tubing. The strain gage pressure cuff is configured to be disposed about the compliant tubing to detect a pressure change amount within the compliant tubing. When the pressure change amount is above a change amount threshold, the pressure change amount is indicative of a back-pressure and the strain gage pressure cuff is configured to communicate a notification to the radioembolization pressure system based on the pressure change amount being above the change amount threshold.

[0080] Aspect 2. The radioembolization pressure system of Aspect 1, wherein the strain gage pressure cuff comprises a first portion and a second portion, the first portion configured to interlock with the second portion when the strain gage pressure cuff is disposed about the compliant tubing.

[0081] Aspect 3. The radioembolization pressure system of any of Aspect 1 to Aspect 2, wherein when the pressure change amount is above the change amount threshold, the pressurechange amount is further indicative of reflux of the particulate within the compliant tubing during the radioembolization particulate delivery.

[0082] Aspect 4. The radioembolization pressure system of any of Aspect 1 to Aspect 3, wherein the pressure change amount comprises a range between about 15 pounds per square inch (psi) to about 30 psi from an initial baseline pressure during the radioembolization particulate delivery.

[0083] Aspect 5. The radioembolization pressure system of any of Aspect 1 to Aspect 4, wherein the strain gage pressure cuff is configured to increase resistance in response to an increase of pressure in the compliant tubing, such that when a resistance increase measuring a resistance change amount from a baseline resistance is above a resistance change amount threshold, the resistance change amount is indicative of the back-pressure.

[0084] Aspect 6. The radioembolization pressure system of Aspect 5, wherein when the strain gage pressure cuff increases resistance in response to the increase of pressure in the compliant tubing from the baseline resistance to more than the resistance change amount threshold, the strain gage pressure cuff is configured to communicate the notification to the radioembolization pressure system based on the resistance change amount being above the resistance change amount threshold.

[0085] Aspect 7. The radioembolization pressure system of Aspect 5 or Aspect 6, wherein the resistance is measured in kilo ohms.

[0086] Aspect 8. The radioembolization pressure system of any of Aspect 1 to Aspect 7, wherein the strain gage pressure cuff further comprises a display and is configured to display the notification on the display.

[0087] Aspect 9. The radioembolization pressure system of any of Aspect 1 to Aspect 9, further comprising a controller including a display, wherein the strain gage pressure cuff is configured to send the notification to the controller, and the controller is configured to display the notification on the display.

[0088] Aspect 10. The radioembolization pressure system of Aspect 9, wherein the strain gage pressure cuff is configured to send the notification to the controller via a wired communication or a wireless communication.

[0089] Aspect 11. The radioembolization pressure system of any of Aspect 1 to Aspect 10, wherein the notification communicated to the radioembolization pressure system further comprises an alert, an alarm, or combinations thereof.

[0090] Aspect 12. The radioembolization pressure system of Aspect 11, wherein the alert comprises a text communication.

[0091] Aspect 13 The radioembolization pressure system of Aspect 11 or Aspect 12, wherein the alarm comprises an audible alarm, a haptic alarm, a visual alarm, or combinations thereof.

[0092] Aspect 14. A radioembolization pressure system comprising a compliant tubing, a strain gage pressure cuff, a controller, a memory, and machine readable instructions. The compliant tubing is configured for a radioembolization particulate delivery of particulate through the compliant tubing. The strain gage pressure cuff is configured to be disposed about the compliant tubing to detect a pressure change amount within the compliant tubing. The memory is in communication with the controller and the machine readable instructions are stored in the memory. The machine readable instructions cause the radioembolization pressure system to perform at least the following when executed by the controller: detect the pressure change amount within the compliant tubing when the strain gage pressure cuff is disposed about the compliant tubing and during the radioembolization particulate delivery of particulate through the compliant tubing, and when the pressure change amount is above a change amount threshold such that the pressure change amount is indicative of a back-pressure, communicate a notification via the strain gage pressure cuff to the radioembolization pressure system based on the pressure change amount being above the change amount threshold to indicate the back-pressure within the compliant tubing.

[0093] Aspect 15. The radioembolization pressure system of Aspect 14, wherein the strain gage pressure cuff comprises a first portion and a second portion, the first portion configured to interlock with the second portion when the strain gage pressure cuff is disposed about the compliant tubing.

[0094] Aspect 16. The radioembolization pressure system of Aspect 14 or Aspect 15, wherein the machine readable instructions further cause the radioembolization pressure system to perform at least the following when executed by the controller: determine an initial baseline pressure during the radioembolization particulate delivery, wherein the pressure change amount comprisesa range between about 15 pounds per square inch (psi) to about 30 psi from the initial baseline pressure.

[0095] Aspect 17. The radioembolization pressure system of any of Aspect 14 to Aspect 16, further comprising a display on the strain gage pressure cuff, the controller, or combinations thereof, the machine readable instructions further cause the radioembolization pressure system to perform at least the following when executed by the controller: display the notification on the display.

[0096] Aspect 18. The radioembolization pressure system of any of Aspect 14 to Aspect 17, wherein the strain gage pressure cuff is configured to send the notification to the controller via a wired communication or a wireless communication.

[0097] Aspect 19. A method for detecting a back-pressure within a radioembolization pressure system comprising delivering particulate through a compliant tubing of the radioembolization pressure system during a radioembolization particulate delivery and measuring via a strain gage pressure cuff disposed about the compliant tubing a pressure change amount within the compliant tubing during the radioembolization particulate delivery. The method further comprises, when the pressure change amount is above a change amount threshold indicative of the back-pressure, communicating via the strain gage pressure cuff a notification to the radioembolization pressure system based on the pressure change amount being above the change amount threshold.

[0098] Aspect 20. The method of Aspect 19, wherein the strain gage pressure cuff comprises a first portion and a second portion, the first portion configured to interlock with the second portion when the strain gage pressure cuff is disposed about the compliant tubing.

[0099] It is noted that the term “about” may be utilized herein to represent the inherent degree of uncertainty that may be attributed to any quantitative comparison, value, measurement, or other representation. This term is also utilized herein to represent the degree by which a quantitative representation may vary from a stated reference without resulting in a change in the basic function of the subject matter at issue.

[0100] While particular embodiments have been illustrated and described herein, it should be understood that various other changes and modifications may be made without departing from the spirit and scope of the claimed subject matter. Moreover, although various aspects of the claimed subject matter have been described herein, such aspects need not be utilized in combination. It istherefore intended that the appended claims cover all such changes and modifications that are within the scope of the claimed subject matter.

Claims

CLAIMS1. A radioembolization pressure system comprising: a compliant tubing configured for a radioembolization particulate delivery of particulate through the compliant tubing; and a strain gage pressure cuff configured to be disposed about the compliant tubing to detect a pressure change amount within the compliant tubing, wherein when the pressure change amount is above a change amount threshold, the pressure change amount is indicative of a backpressure and the strain gage pressure cuff is configured to communicate a notification to the radioembolization pressure system based on the pressure change amount being above the change amount threshold.

2. The radioembolization pressure system of claim 1, wherein the strain gage pressure cuff comprises a first portion and a second portion, the first portion configured to interlock with the second portion when the strain gage pressure cuff is disposed about the compliant tubing.

3. The radioembolization pressure system of claim 1, wherein when the pressure change amount is above the change amount threshold, the pressure change amount is further indicative of reflux of the particulate within the compliant tubing during the radioembolization particulate delivery.

4. The radioembolization pressure system of claim 1, wherein the pressure change amount comprises a range between about 15 pounds per square inch (psi) to about 30 psi from an initial baseline pressure during the radioembolization particulate delivery.

5. The radioembolization pressure system of claim 1, wherein the strain gage pressure cuff is configured to increase resistance in response to an increase of pressure in the compliant tubing, such that when a resistance increase measuring a resistance change amount from a baseline resistance is above a resistance change amount threshold, the resistance change amount is indicative of the back-pressure.

6. The radioembolization pressure system of claim 5, wherein when the strain gage pressure cuff increases resistance in response to the increase of pressure in the compliant tubing from the baseline resistance to more than the resistance change amount threshold, the strain gage pressure cuff is configured to communicate the notification to the radioembolization pressure system based on the resistance change amount being above the resistance change amount threshold.

7. The radioembolization pressure system of claim 5, wherein the resistance is measured in kilo ohms.

8. The radioembolization pressure system of claim 1, wherein the strain gage pressure cuff further comprises a display and is configured to display the notification on the display.

9. The radioembolization pressure system of claim 1, further comprising a controller including a display, wherein the strain gage pressure cuff is configured to send the notification to the controller, and the controller is configured to display the notification on the display.

10. The radioembolization pressure system of claim 9, wherein the strain gage pressure cuff is configured to send the notification to the controller via a wired communication or a wireless communication.

11. The radioembolization pressure system of claim 1, wherein the notification communicated to the radioembolization pressure system further comprises an alert, an alarm, or combinations thereof.

12. The radioembolization pressure system of claim 11, wherein the alert comprises a text communication.

13. The radioembolization pressure system of claim 11, wherein the alarm comprises an audible alarm, a haptic alarm, a visual alarm, or combinations thereof.

14. A radioembolization pressure system comprising: a compliant tubing configured for a radioembolization particulate delivery of particulate through the compliant tubing; a strain gage pressure cuff configured to be disposed about the compliant tubing to detect a pressure change amount within the compliant tubing; a controller; a memory in communication with the controller; machine readable instructions stored in the memory that cause the radioembolization pressure system to perform at least the following when executed by the controller: detect the pressure change amount within the compliant tubing when the strain gage pressure cuff is disposed about the compliant tubing and during the radioembolization particulate delivery of particulate through the compliant tubing, and when the pressure change amount is above a change amount threshold such that the pressure change amount is indicative of a back-pressure, communicate a notification via the strain gage pressure cuff to the radioembolization pressure system based on the pressure change amount being above the change amount threshold to indicate the backpressure within the compliant tubing.

15. A radioembolization pressure system of claim 14, wherein the strain gage pressure cuff comprises a first portion and a second portion, the first portion configured to interlock with the second portion when the strain gage pressure cuff is disposed about the compliant tubing.

16. The radioembolization pressure system of claim 14, the machine readable instructions further cause the radioembolization pressure system to perform at least the following when executed by the controller: determine an initial baseline pressure during the radioembolization particulate delivery, wherein the pressure change amount comprises a range between about 15 pounds per square inch (psi) to about 30 psi from the initial baseline pressure.

17. The radioembolization pressure system of claim 14, further comprising a display on the strain gage pressure cuff, the controller, or combinations thereof, the machine readableinstructions further cause the radioembolization pressure system to perform at least the following when executed by the controller: display the notification on the display.

18. The radioembolization pressure system of claim 14, wherein the strain gage pressure cuff is configured to send the notification to the controller via a wired communication or a wireless communication.

19. A method for detecting a back-pressure within a radioembolization pressure system comprising: delivering particulate through a compliant tubing of the radioembolization pressure system during a radioembolization particulate delivery; measuring via a strain gage pressure cuff disposed about the compliant tubing a pressure change amount within the compliant tubing during the radioembolization particulate delivery; and when the pressure change amount is above a change amount threshold indicative of the back-pressure, communicating via the strain gage pressure cuff a notification to the radioembolization pressure system based on the pressure change amount being above the change amount threshold.

20. The method of claim 19, wherein the strain gage pressure cuff comprises a first portion and a second portion, the first portion configured to interlock with the second portion when the strain gage pressure cuff is disposed about the compliant tubing.

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