Fluid transfer cartridge

Abstract

The utility model relates to a technical scheme of a treatment system with a generator and a fluid transfer box. A fluid transfer cartridge is provided that includes a cartridge housing defining a cartridge cavity, a syringe barrel, and a syringe piston. The cartridge case includes one or more stabilizing prongs. And the injector barrel is arranged in the box cavity. And the injector piston is arranged in the injector barrel. The syringe piston includes a stopper and a shaft extending longitudinally from the stopper to a shaft end. The shaft includes a plurality of piston notches, each of the plurality of piston notches receiving at least one of the one or more stabilizing prongs. Other embodiments are also described and claimed.

Description

[0001] This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 501,364, filed on May 10, 2023, entitled "Therapeutic System with Generator and Fluid Transfer Box," and U.S. Non-Provisional Patent Application No. 18 / 614,170, filed on March 22, 2024, entitled "Tissue Therapy System with Contrast Agent Injector," which are incorporated herein by reference in their entireties to provide continuity of disclosure. Technical Field

[0002] The present application generally relates to medical devices, systems, and methods for delivering energy and fluid to devices for targeting an anatomical location in a subject. More specifically, the present application relates to a fluid transfer cassette for delivering cooling fluid to a catheter-based intraluminal device. Background Art

[0003] High blood pressure (also known as hypertension) typically affects adults. If left untreated, hypertension may cause kidney disease, arrhythmias, and heart failure. In recent years, the treatment of hypertension has focused on inactivating the renal nerves surrounding the renal arteries through interventional methods. Autonomic nerves tend to follow blood vessels to the organs they innervate. Intraluminal devices (such as catheters) can reach specific structures in the lumen close to where the catheter travels, such as the renal nerves. Therefore, catheter-based systems can deliver energy from within the lumen to inactivate the renal nerves in the vessel wall.

[0004] An ultrasonic transducer can be mounted at the distal end of the catheter, and the unfocused ultrasonic energy can heat tissue adjacent to the body cavity within which the catheter (and transducer) is disposed. Such unfocused ultrasonic energy can, for example, ablate target nerves surrounding the body cavity without damaging non-target tissue (such as the lining of the body cavity or unexpected organs outside the body cavity). The unfocused ultrasonic energy system can also include an airbag mounted at the distal end of the catheter around the ultrasonic transducer. During the delivery of ultrasonic energy, a cooling fluid can be circulated through the airbag to cool the body cavity. This type of design can produce one or more ablation zones sufficient to achieve long-term nerve inactivation at different locations around the circumference of the blood vessel. Summary of the Invention

[0005] The present disclosure is defined in the independent claims. Further embodiments of the present disclosure are defined in the dependent claims.

[0006] A fluid transfer cassette is provided herein. The fluid transfer cassette includes a cassette housing defining a cassette cavity. The cassette housing includes one or more stabilizing prongs. The fluid transfer cassette includes a syringe barrel disposed within the cassette cavity. The fluid transfer cassette includes a syringe piston disposed within the syringe barrel. The syringe piston includes a stopper and a shaft extending longitudinally from the stopper to a shaft end. The shaft includes a plurality of piston recesses, each of the piston recesses receiving at least one of the one or more stabilizing prongs.

[0007] A fluid transfer cassette is provided herein. The fluid transfer cassette includes a cassette housing defining a cassette cavity. The cassette housing includes a plurality of stabilizing prongs separated by gaps. The fluid transfer cassette includes a syringe barrel disposed within the cassette cavity. The fluid transfer cassette includes a syringe piston disposed within the syringe barrel. The syringe piston includes a stopper and a shaft extending longitudinally from the stopper through the gap to a shaft end.

[0008] A fluid transfer cassette is provided. The fluid transfer cassette includes a cassette housing defining a cassette cavity between a front housing portion and a rear housing portion. The rear housing portion includes sidewalls extending longitudinally from a rear base to a rear surface. Several latch retainers extend through the sidewalls. Several latch guides are formed along the edges between the sidewalls and the rear surface.

[0009] A fluid transfer cassette is provided herein. The fluid transfer cassette includes a cassette housing defining a cassette cavity between a front housing portion and a rear housing portion. The rear housing portion includes a sidewall extending longitudinally from a rear base plate to a rear surface. A plurality of latch holes extend through the sidewall. The fluid transfer cassette includes a housing plate contained within the cassette cavity between the front housing portion and the rear housing portion. The housing plate includes a plurality of transverse projections extending into the plurality of latch holes to define a plurality of latch retainers between the plurality of transverse projections and the rear surface.

[0010] A fluid transfer cartridge is provided herein. The fluid transfer cartridge includes a cartridge housing defining a cartridge cavity between a front housing portion and a rear housing portion. The rear housing portion includes a marking recess located in a rear surface. The marking recess has a depth of 0.01 to 0.02 inches.

[0011] A fluid transfer cassette is provided herein. The fluid transfer cassette includes a cassette housing defining a cassette cavity between a front housing portion and a rear housing portion. The rear housing portion includes a sidewall extending longitudinally from a rear base plate to a rear surface. A plurality of latch holes extend through the sidewall. The fluid transfer cassette includes a housing plate contained within the cassette cavity between the front housing portion and the rear housing portion. The housing plate includes a plurality of transverse projections extending into the plurality of latch holes to define a plurality of latch retainers between the plurality of transverse projections and the rear surface.

[0012] A fluid transfer cassette is provided herein. The fluid transfer cassette includes a cassette housing defining a cassette cavity between a front and a rear face. The cassette housing includes a handle extending from the front face across the opening. The handle includes a removable front panel.

[0013] A fluid transfer cassette is provided herein. The fluid transfer cassette includes a cassette housing defining a cassette cavity between a front face and a rear face. The front face includes a tab extending into a conduit port defined by an edge. The fluid transfer cassette includes a conduit routing plate that engages the front face along the edge. The tab is positioned within a conduit slot in the conduit routing plate.

[0014] The above summary does not constitute an exhaustive list of all aspects of the present disclosure. It is contemplated that the present disclosure includes all systems and methods that can be practiced by combining the various aspects summarized above and disclosed in the following detailed description and specifically pointed out in the claims filed with this application. Such combinations have particular advantages not specifically listed in the above summary. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] The novel features of the invention are set forth with particularity in the appended claims.A better understanding of the features and advantages of the invention may be obtained by reference to the following detailed description taken in conjunction with the accompanying drawings which illustrate illustrative embodiments in which the principles of the invention are utilized.

[0016] Figure 1 is a perspective view of a catheter of a treatment system according to an embodiment.

[0017] Figure 2 is a front perspective view of a generator and fluid transfer cassette of a therapy system according to an embodiment.

[0018] Figure 3 is a rear perspective view of a generator and fluid transfer cassette of a therapy system according to an embodiment.

[0019] Figure 4 is a perspective view of a cassette-receiving portion of a generator and a fluid transfer cassette of a therapy system according to an embodiment.

[0020] Figure 5 is an exploded view of a cartridge housing of a fluid transfer cartridge according to an embodiment.

[0021] Figure 6 is a cross-sectional view of a light-end syringe of a fluid transfer cartridge according to an embodiment.

[0022] Figure 7 is a front perspective view of a fluid transfer cartridge according to an embodiment.

[0023] Figure 8 is a rear perspective view of a fluid transfer cartridge according to an embodiment.

[0024] Figure 9 is a front view of a tubing routing port of a fluid transfer cartridge according to an embodiment.

[0025] Figure 10is a front view of a tubing routing plate installed in a tubing routing opening of a fluid transfer cassette, according to an embodiment.

[0026] Figure 11 is a cross-sectional view of a fluid transfer cassette installed in a cassette receptacle of a generator of a therapy system, according to an embodiment.

[0027] Figure 12 is a rear perspective view of a fluid transfer cartridge according to an embodiment.

[0028] Figure 13 is a front perspective view of a cartridge receiving portion of a generator according to an embodiment.

[0029] Figure 14 is an exploded view of a cartridge housing of a fluid transfer cartridge according to an embodiment.

[0030] Figures 15A to 15B is a perspective view of a cartridge manifold according to an embodiment.

[0031] Figure 16 is an exploded view of a cartridge manifold according to an embodiment.

[0032] Figure 17 is a front view of a fluid transfer plate of a cartridge manifold according to an embodiment.

[0033] Figure 18 is a rear view of a fluid transfer plate of a cartridge manifold, according to an embodiment.

[0034] Figure 19 is a perspective view of a piston of a cartridge manifold according to an embodiment.

[0035] Figure 20 is a perspective view of a piston of a cartridge manifold according to an embodiment.

[0036] Figure 21 is a cross-sectional view (along the line) of a piston of a cartridge manifold in an open position according to an embodiment. Figure 18 AA).

[0037] Figure 22 is a cross-sectional view of a piston of a cartridge manifold in a closed position according to an embodiment (along the Figure 18 AA).

[0038] Figure 23 is a side view of a generator for an ultrasound-based therapy system according to an embodiment.

[0039] Figure 24 is a cross-sectional view (along the Figure 23 BB intercepted).

[0040] Figure 25is a perspective view of a non-invasive sensor according to an embodiment.

[0041] Figure 26 is a perspective view of a non-invasive sensor according to an embodiment.

[0042] Figure 27 is a front view of an interior portion of a fluid transfer cartridge according to an embodiment.

[0043] Figure 28 is a cross-sectional view of an interior portion of a fluid transfer cassette having a pneumatically actuated syringe, according to an embodiment.

[0044] Figure 29 is a cross-sectional view of an interior portion of a fluid transfer cartridge having a non-contact position sensor according to an embodiment.

[0045] Figure 30 is a perspective view of an ultrasound-based treatment system according to an embodiment.

[0046] Figure 31 is a cross-sectional view of a drive mechanism of a fluid transfer cartridge according to an embodiment.

[0047] Figure 32 is a block diagram of a controller of a treatment system according to an embodiment.

[0048] Figure 33 is a perspective view of a shaft end with an optical tab according to an embodiment.

[0049] Figure 34 is a rear view of a cartridge housing of a fluid transfer cartridge according to an embodiment.

[0050] Figure 35 is a rear perspective view of a cartridge housing of a fluid transfer cartridge according to an embodiment.

[0051] Figure 36 is a perspective view of a syringe piston of a fluid transfer cassette according to an embodiment.

[0052] Figure 37 is a cross-sectional view of a syringe piston according to an embodiment.

[0053] Figure 38 is a cross-sectional view of a fluid transfer cartridge according to an embodiment.

[0054] Figure 39 is a side view of a fluid transfer cartridge according to an embodiment.

[0055] Figure 40 is a perspective view of a latch guide according to an embodiment.

[0056] Figure 41 is a perspective view of a latch guide according to an embodiment.

[0057] Figure 42 is a perspective exploded view of a fluid transfer cartridge according to an embodiment.

[0058] Figure 43 is a perspective view of a housing plate of a fluid transfer cartridge according to an embodiment.

[0059] Figure 44 is a perspective view of a cartridge housing of a fluid transfer cartridge according to an embodiment.

[0060] Figure 45 is a side view of a latch retainer according to an embodiment.

[0061] Figure 46 is a perspective view of a cartridge case according to an embodiment.

[0062] Figure 47 is a rear view of the handle of the cartridge case according to the embodiment.

[0063] Figure 48 is a perspective exploded view of a fluid transfer cartridge according to an embodiment.

[0064] Figure 49 is an end view of a handle of a fluid transfer cartridge according to an embodiment.

[0065] Figure 50 is a front perspective view of a pipe routing plate according to an embodiment.

[0066] Figure 51 is a rear perspective view of a pipe routing plate according to an embodiment.

[0067] Figure 52 is a cross-sectional perspective view of a pipe routing plate according to an embodiment.

[0068] Figure 53 is a perspective view of a piston of a cartridge manifold according to an embodiment.

[0069] Figure 54 is a cross-sectional view of a piston of a cartridge manifold according to an embodiment.

[0070] Figure 55 is a cross-sectional view (along the line) of a piston of a cartridge manifold in an open position according to an embodiment. Figure 18 AA). DETAILED DESCRIPTION

[0071] Provided herein are systems and methods for using the same for treating tissue using unfocused ultrasonic energy. In certain embodiments, acoustic-based tissue therapy transducers, devices, systems, and portions thereof are provided. The system may be catheter-based. The system may be intraluminal (e.g., intravascular) delivery so that the transducer is placed within a target anatomical region of a subject, e.g., within a suitable body cavity such as a blood vessel. Once correctly positioned within the target anatomical region, the transducer may be activated to radially outwardly deliver unfocused ultrasonic energy so as to appropriately heat and thereby treat tissue within the target anatomical region. The transducer or piezoelectric material may be activated at a frequency, duration, and energy level suitable for treating ablation targets (e.g., target tissue). In a non-limiting example, the unfocused ultrasonic energy generated by the transducer or piezoelectric material or the radiofrequency (RF) energy transmitted by the electrode may be targeted to selected neural tissue of the subject and such tissue may be heated in such a manner so as to perform neuromodulation (e.g., complete or partial ablation, necrosis, or stimulation) on the neural tissue.

[0072] Neuromodulation of the renal nerves can be used to treat a variety of conditions, such as hypertension, chronic kidney disease, atrial fibrillation, the autonomic nervous system for treating various medical conditions, arrhythmias, heart failure, end-stage renal disease, myocardial infarction, anxiety, contrast-induced nephropathy, diabetes, metabolic disorders, and insulin resistance. However, it should be understood that the balloon catheter can be appropriately used to treat other nerves and conditions, such as the sympathetic nerves of the hepatic plexus within the hepatic artery that are responsible for blood sugar levels that are important for treating diabetes, or any suitable tissue (e.g., cardiac tissue that triggers abnormal heart rhythms), and is not limited to treatment (e.g., neuromodulation) of renal nerve tissue. In another example, a tissue treatment catheter is used to ablate the sympathetic nerves of the renal and hepatic arteries to treat diabetes or other metabolic disorders. In certain embodiments, the tissue treatment catheter is used to treat autoimmune and / or inflammatory conditions, such as rheumatoid arthritis, sepsis, Crohn's disease, ulcerative colitis, and / or gastrointestinal dysmotility, by neuromodulating sympathetic nerves within one or more of the splenic artery, celiac trunk, superior mesenteric artery, or inferior mesenteric artery. In certain embodiments, the tissue treatment catheter is used to ablate nerve fibers in the celiac ganglion and / or renal arteries to treat hypertension. In certain embodiments, the transducer is used to treat pain, such as pain associated with pancreatic cancer, for example, by neuromodulating the nerves that innervate the pancreas. Ultrasonic energy or radiofrequency energy can also be used to ablate the nerves of both the pulmonary veins and the renal arteries to treat atrial fibrillation. In yet other examples, ultrasonic energy or radiofrequency energy can be used additionally or alternatively to ablate the nerves that innervate the carotid body to treat hypertension and / or chronic kidney disease.

[0073] Existing hypertension treatment systems include a generator that generates energy (e.g., RF or ultrasonic energy) and delivers it to a catheter-based intraluminal device. The treatment system may also include components that engage the generator to facilitate treatment. For example, a cassette may be mounted on the generator to deliver an inflation or cooling fluid to a balloon mounted at one end of the catheter. The generator and / or cassette may be large and bulky, especially when combined. In addition, the mechanical and electrical connections between the generator and cassette may be unreliable due to imperfect installation, tolerance stacking, or movement between components during operation. When a cassette is used to deliver fluid, it may not be possible to accurately monitor fluid transfer visually or automatically due to a lack of lighting in the process room and / or an unstable sensor connection between the generator and cassette. The system can also integrate longer lengths of internal tubing, thereby increasing the overall form factor of the device. Therefore, a treatment system for delivering energy and fluid to a catheter-based intraluminal device would benefit from a more compact, mechanically stable, electrically stable, and ergonomic design.

[0074] As described below, embodiments may include a treatment system having a generator and a fluid transfer cartridge and methods of using the treatment system. The treatment system may be an ultrasound-based tissue treatment system for delivering unfocused ultrasound energy radially outward to treat tissue within a target anatomical region (e.g., renal nerves within a renal artery). Alternatively, the tissue treatment system may be used in other applications, such as for treating sympathetic nerves of the hepatic plexus within a hepatic artery. Thus, when the system is referred to as a renal denervation system or for use in treatment (e.g., neuromodulation), it is not limited to renal nerve tissue.

[0075] In various embodiments, description is made with reference to the accompanying drawings. However, certain embodiments may be implemented without one or more of these specific details, or may be implemented in combination with other known methods and configurations. In the description below, a large number of specific details (such as specific configurations, dimensions and processes) are set forth in order to provide a thorough understanding of the embodiments. In other cases, well-known processes and manufacturing techniques are not shown in detail to avoid unnecessary confusion of the present invention. References throughout this specification to "one embodiment", "an embodiment" or the like are intended to be included in at least one embodiment in conjunction with the described specific features, structures, configurations or characteristics. Therefore, the phrases "one embodiment", "an embodiment" or similar phrases appearing at different locations throughout this specification do not necessarily all refer to the same embodiment. In addition, specific features, structures or characteristics may be combined in any suitable manner in one or more embodiments.

[0076] Relative terms used throughout the description may indicate relative positions or directions. For example, "above" may indicate a first direction relative to a component. Similarly, "below" may indicate a second direction relative to a component, opposite to the first direction. However, such terms are provided to establish a relative frame of reference and are not intended to limit the use or orientation of treatment system components (e.g., fluid transfer cartridges or generators) to the specific configurations described in the various embodiments below.

[0077] In one aspect, a treatment system for performing a medical procedure (e.g., renal ablation catheterization) is provided. The treatment system includes a fluid transfer cassette for delivering fluid to a catheter and a generator for delivering energy to the catheter. The fluid transfer cassette and the generator combine to form a control unit for the treatment system. The control unit is compact. More specifically, the fluid transfer cassette fits within the generator's cassette container, creating a clean and compact profile for the control unit. Additionally, the fluid transfer cassette includes a syringe component that can be completely contained within the cassette housing, reducing the overall form factor of the control unit. The control unit is mechanically stable. The fluid transfer cassette can be secured to the generator via a fastening mechanism that evenly distributes the retaining force around the cassette housing and includes a quick-release mechanism for rapid and reliable engagement and disengagement of the components. The control unit is electrically stable. The electrical connection between the fluid transfer cassette and the generator can be via spring-loaded electrical contact pins (commonly referred to as spring pins). The spring-loaded pins maintain pressure at the electrical contact points between the components, providing a resilient connection that resists relative movement that may occur during operation. Additionally, sensors for detecting movement of system components (such as the syringe piston of a fluid transfer cartridge) can include position sensors (such as magnetic switches or optical sensors), which are more stable and less prone to misalignment than, for example, mechanical switches. The control unit is user-friendly. The control unit can include one or more processors and various sensors that operate to determine the system readiness state (e.g., whether various electrical or component connections have been made) and provide feedback to the user. For example, the system can detect whether the fluid transfer cartridge is installed in the cartridge container of the generator and activate a light within the fluid transfer cartridge to illuminate the syringe, thereby providing feedback to the user regarding this state. Thus, a treatment system having a compact, mechanically stable, electrically stable, and ergonomic design is provided.

[0078] Reference Figure 1, shows a perspective view of a catheter-based intraluminal device of a treatment system according to an embodiment. The catheter-based intraluminal device of the treatment system 100 may include a catheter 101 having an elongated catheter body extending from a catheter proximal end 1350 to a catheter distal end 104. An expandable member 106 (such as a balloon 112) may be mounted on the catheter 101 at the catheter distal end 104. One or more energy transducers 108 (such as an ultrasound transducer 210) may be positioned within the expandable member 106. The expandable member 106 may be adapted to expand within a target anatomical structure (e.g., a renal artery), and the energy transducer 108 may be adapted to deliver ablative energy (e.g., ultrasound energy) to the target anatomical structure during a medical procedure (e.g., renal denervation).

[0079] The catheter 101 can include one or more lumens, such as a fluid lumen for delivering inflation / cooling fluid to the expandable member 106; a cable channel containing an electrical cable for delivering energy to the transducer 108; a guidewire lumen for exchanging guidewires, and the like. The lumen(s) can be connected to corresponding connectors at the proximal end 1350 of the catheter. For example, the fluid lumen can be connected to one or more catheter fluid ports 1352 that receive inflation / cooling fluid from a fluid transfer box of the treatment system 100, as described below. Similarly, a cable can be connected to an external connector 1352 that receives energy from a generator of the treatment system 100, as described below.

[0080] Reference Figure 2 , shows a front perspective view of a generator and fluid transfer cartridge of a treatment system according to an embodiment. Treatment system 100 includes a control unit connected to catheter 101 to regulate the inflation of balloon 106 using an inflation / cooling fluid and manage the delivery of ultrasonic energy to transducer 108. In one embodiment, the control unit includes a generator 202 for generating ultrasonic energy and a fluid transfer cartridge 204 for transferring cooling fluid to and from balloon 106 via one or more fluid conduits 206. For example, fluid conduit 206A can transfer cooling fluid between a fluid reservoir (e.g., an intravascular fluid bag) and fluid transfer cartridge 204. Similarly, fluid conduit 206B can transfer cooling fluid between fluid transfer cartridge 204 and catheter 101. The control unit includes several other components (some of which are described below) to facilitate the energy and fluid transfer functions. Such components may include a display 208 to present process information to a user. Additionally, the control unit may include one or more processors (not shown) configured to execute instructions stored in a memory device (not shown) to cause treatment system 100 to perform various operations of a medical procedure, as described below.

[0081] Reference Figure 3, shows a rear perspective view of a generator and fluid transfer cartridge of a treatment system according to an embodiment. The generator 202 of the treatment system 100 can have a cartridge container 302 shaped and sized to receive the fluid transfer cartridge 204. More specifically, the generator 202 can include a generator housing 304 having a cartridge container 302 configured to receive the fluid transfer cartridge 204. The generator housing 304 can include an outer wall having a certain shape (e.g., a box-shaped envelope), and the cartridge container 302 can be a recessed area extending into the shape. The fluid transfer cartridge 204 can include a cartridge shell 306 that can fill the cartridge container 302 of the generator 202. More specifically, the cartridge shell 306 can include an outer wall having a shape that smoothly merges with the generator housing wall to complete the envelope of the generator 202. For example, the fluid transfer cartridge 204 and the generator 202 can be combined to form a box-shaped envelope. In this case, the exterior, outward-facing surfaces of the fluid transfer box 204 and the generator 202 can be parallel and coplanar at the seam where the components meet, so that the form factor of the combined components transitions smoothly (e.g., without steps) at the transition between the generator wall and the fluid transfer box wall.

[0082] In one embodiment, the fluid transfer cartridge 204 includes a handle 307 that a user can grasp when installing or removing the cartridge from the generator 202. The handle 307 can include a curved, ergonomic shape for easy gripping. Thus, the user can carry the fluid transfer cartridge 204 by the handle 307 and insert the fluid transfer cartridge 204 into the cartridge receptacle 302 to engage a compact form factor assembly having outer walls that extend continuously above the generator housing 304 and the cartridge housing 306.

[0083] In combination with the generator 202, the fluid transfer box 204 can be used to drive fluid into the catheter 101 using one or more syringes. More specifically, the fluid transfer box 204 can include one or more syringes that pump fluid to and from the balloon 106. As described below, each syringe can include a corresponding syringe piston disposed within a corresponding syringe barrel. Moving the syringe piston relative to the syringe barrel can draw cooling fluid into the syringe or expel cooling fluid from the syringe. Fluid can be transferred to or from the fluid transfer box 204 via a fluid conduit 206, which can be connected to the catheter 101, a fluid reservoir, or another fluid container external to the fluid transfer box 204.

[0084] Reference Figure 4 , shows a perspective view of a cartridge receiving portion of a generator and a fluid transfer cartridge of a treatment system according to an embodiment. The cartridge housing 306 of the fluid transfer cartridge 204 can define a cartridge cavity 402 in which one or more syringes are disposed. More specifically, the cartridge housing 306 can define a front face 404 of the cartridge housing 306 and a rear face 407 of the cartridge housing 306 ( Figure 8) between the cartridge housing 306. The space between the front and back faces 404, 407 of the cartridge housing 306 can contain a syringe. Thus, the syringe (including the syringe shaft) can be stored inside the cartridge housing 306 rather than being exposed externally from the housing. Thus, the overall form factor of the fluid transfer cartridge 204 can be compacted. The cartridge cavity 402 can further be defined between the top and bottom faces of the cartridge housing 306.

[0085] One or more syringes of the fluid transfer cartridge 204 can be disposed within the cartridge cavity 402 parallel to the handle 307. For example, the handle 307 can extend from the front 404 of the cartridge housing 306 to above an opening leading to the cartridge cavity 402. The opening can be a window 406 or an inlet that exposes the interior volume of the cartridge cavity 402 for viewing from the surrounding environment. More specifically, the front 404 can include an opening that visibly exposes the cartridge cavity 402 for viewing by a user. The handle 307 can extend vertically from an upper end 416 of the opening to a lower end 418 of the opening. Thus, the handle 307 can bend outward from the front 404 to above the opening and vertically downward above the opening to terminate at the front 404 below the opening. Similarly, a syringe can extend vertically through the cartridge cavity 402 so that the syringe barrel is visibly exposed through the opening.

[0086] In one embodiment, the fluid transfer cartridge 204 includes a first syringe barrel 408 positioned within the cartridge cavity 402 and visibly exposed through an opening on a first side 410 of the handle 307. Similarly, the fluid transfer cartridge 204 may include a second syringe barrel 412 positioned within the cartridge cavity 402 and visibly exposed through an opening on a second side 414 of the handle 307. Similar to the handle 307, the syringes may, for example, extend vertically within the cartridge cavity 402. More specifically, the first syringe barrel 408 and the second syringe barrel 412 may have respective syringe axes 420 that extend vertically within the cartridge cavity 402, for example. The syringe axis 420 may be the central axis of the syringe barrel. For example, the syringe barrels may be cylindrical and may extend vertically along the syringe axis 1650. Thus, the handle 307 may be easily grasped from the front of the fluid transfer cartridge 204, while the syringes may remain exposed for viewing through the opening in the front face 404. Thus, the fluid transfer cartridge 204 is easy to handle, easy to view, and has a compact form factor for engagement with the generator 202.

[0087] Reference Figure 5 , shows an exploded view of a cartridge housing of a fluid transfer cartridge according to an embodiment. The cartridge housing 306 provides an outer envelope for the fluid transfer cartridge 204 and can have a variety of geometric shapes.

[0088] The fluid transfer cartridge 204 may include several parts that snap fit or are otherwise fastened together. The cartridge housing 306 may include a handle front panel 1750 and a rear panel 504. The handle front panel 1750 may include a handle 307, a front face 404 of the housing, and a top face 506 of the housing. Similarly, the rear panel 504 may include a rear face 407 of the housing, several side walls 508 extending laterally outward from the cartridge cavity 402, and a bottom face 510 of the housing. When combined, the handle front panel 1750 and the rear panel 504 may define a cartridge cavity 402 that is centrally located between the walls and faces. As described above, the cartridge cavity 402 may still be visibly exposed through the opening 406 in the handle front panel 1750.

[0089] The front 404 may include a front periphery 511. The front periphery 511 may be the outer edge of the front 404. The front periphery 511 may have a curved and straight edge that combine to form the outline of the front 404. Similarly, the back 407 may include a back periphery 512. The back periphery 512 may have a curved and straight edge that combine to form the outline of the back 407. In one embodiment, the front periphery 511 and the back periphery 512 have the same outline. More specifically, the outline of the front periphery 511 may conform to the outline of the back periphery 512 so that when the front periphery 511 is joined to the back periphery 512, these peripheries are effectively sealed or in contact with each other. When the peripheries are in contact, the box cavity 402 may be enclosed in the box shell 306. The enclosed box cavity 402 is defined between the front 404 and the back 407.

[0090] When snap-fit ​​or otherwise assembled together, the handle front plate 1750 and the rear plate 504 can comprise one or more components in the box cavity 402 to provide a fluid transfer function. For example, the fluid transfer box 204 can include a syringe holder 513 to hold the syringe in the box cavity 402. The syringe holder 513 can stabilize the syringe during fluid delivery, as described below. The fluid transfer box 204 can also include a manifold, pipe fittings, electronic equipment, etc. (not shown) that are conducive to fluid moving from the syringe to the fluid conduit 206 and the catheter 101. The internal components of the fluid transfer box 204 can be confined in the interior space of the box housing 306 and can interact with each other and interact with the generator 202 mechanically and / or electrically to perform the fluid transfer function of delivering inflation / cooling fluid to the catheter fluid port 1352 of the catheter 101.

[0091] In one embodiment, a syringe holder 513 mounted within the cartridge cavity 402 restricts movement of the syringe. The syringe may include a plunger that is driven axially within the syringe barrel 408 during operation. The plunger can rotate about the syringe axis 1650 and, therefore, can apply a certain rotational load to the syringe. The syringe holder 513 can resist rotation of the barrel that might otherwise be caused by the plunger. The syringe holder 513 may include one or more retaining features. The retaining features may be ribs, protrusions, or other features formed in the syringe holder 513. When the barrel is assembled, the retaining features may remain fixed relative to the front 404 and back 407 of the fluid transfer cartridge 204. Additionally, when assembled, a portion of the syringe barrel 408 (e.g., a tab extending laterally outward from the cylindrical syringe barrel 408) may engage the retaining features. For example, the syringe barrel 408 may include a finger-shaped tab that fits into a corresponding recess in the syringe holder 513. The finger-shaped tab may be positioned within a recess between several ridges, such that the syringe holder 513 mechanically interferes with the movement of the tab. Thus, the stop feature engages the interference feature of the syringe barrel 408 such that rotation of the syringe barrel 408 relative to the cartridge housing 306 is limited.

[0092] Reference Figure 6 , shows a cross-sectional view of an end-lit syringe of a fluid transfer cartridge according to an embodiment. The fluid transfer cartridge 204 may include one or more light sources 602 within the cartridge cavity 402. For example, the light sources 602 may be light emitting diodes. As shown, two light sources 602 may be symmetrically located on each side of the syringe axis 1650. Alternatively, three or more light sources 602 may be symmetrically arranged about the syringe axis 1650. More specifically, when viewed from above, the angle between the light sources 602 may be 360° divided by the number of light sources 602 (e.g., the angle between each of the three light sources 602 when viewed along the syringe axis 1650 is 120°).

[0093] The light source 1850 can illuminate one or more syringes so that a user can see the syringe barrel 408 and / or the cooling fluid 603 within the syringe. More specifically, the light source 1850 can be located within the cartridge cavity 402 and can be directed through the syringe barrel 408 to illuminate the contents of the syringe barrel 408 and / or the walls of the syringe barrel 408. When the light source 1850 is activated, the user can observe the syringe and cooling fluid operation by looking through the opening / window 406 in the fluid transfer cartridge 204. It will be appreciated that the light source 1850 allows for easier monitoring of fluid transfer and troubleshooting of cooling fluid problems, particularly when viewed in a darkened process room.

[0094] In one embodiment, light source 1850 is guided through syringe barrel 408. For example, the syringe can be end-illuminated by light source 1850. Each of one or more light sources 602 can guide light 606 into corresponding light guide 605. Light guide 605 can include a cylindrical transparent column that acts as a light pipe to transmit light 606 from light source 1850 to the far (upper) end of the syringe. More specifically, light source 1850 can be guided through end face 1852 of syringe barrel 408. End face 1852 can be a section of the barrel that is inclined or tapered from the generally cylindrical side wall of syringe barrel 408 toward syringe axis 1650. Therefore, the axis oriented perpendicular to the outer surface of end face 1852 can form a certain angle with syringe axis 1650 that is less than the angle formed between syringe axis 1650 and the axis perpendicular to the barrel side wall.

[0095] The syringe can be side-illuminated by light source 1850. For example, rather than shining longitudinally into the syringe, light source 1850 can be oriented in a transverse or radial direction relative to syringe axis 1650. Thus, light 606 can illuminate syringe barrel 408 and its contents from the end, side, or back of cartridge cavity 402.

[0096] In certain embodiments, the light source 1850 may be directed through the syringe barrel 408 to aid in assembly.

[0097] Light 606 can be emitted in the direction of syringe axis 1650. Therefore, a portion of light 606 can be transmitted to syringe barrel 408 and the fluid contained therein by end face 1852. In addition, a portion of light 606 can be transmitted to the wall of syringe barrel 408. Light 606 can propagate along the wall to produce a light pipe effect. Therefore, the end-illuminated syringe barrel 408 can provide good contrast for the fluid and mechanical parts (such as stopper 608) of the syringe. Therefore, light source 1850 makes it easier to observe the movement of the syringe during medical operation and otherwise visualizes the function of the syringe.

[0098] Light source 1850 can have significant ergonomic features. In one embodiment, light source 1850 emits blue light. More specifically, the wavelength of light 606 emitted by light source 1850 can be in the visible blue range. In a darkened process chamber, the blue light can have a cooling and calming effect. Furthermore, the blue light can have an intensity that is not distracting to the user, yet sufficient to illuminate the cooling fluid 603 for accurate monitoring.

[0099] In addition to illuminating syringe components, light source 1850 may also have the significant feature of providing prompts and visual feedback to the user. The control unit includes one or more processors configured to activate light source 1850 based on input from one or more sensors. In one embodiment, when syringe barrel 408 is filled with a first volume of fluid, light source 1850 emits light 606 of a first color. A flow sensor or other fluid sensor may be used to detect the first volume of fluid. One or more processors may receive a volume signal from the sensor indicating that the first volume of fluid is contained within syringe barrel 408. In response to this volume signal, one or more processors may cause light source 1850 to emit light of a first color (e.g., orange). The control unit may be configured so that when syringe barrel 408 is filled with a second volume of fluid, light source 1850 emits light of a second color (e.g., blue). For example, in response to detecting the second volume of fluid, one or more processors may cause light source 1850 to emit light of a second color (e.g., blue). Thus, the user can easily identify whether the syringe is partially filled (based on the presence of orange light) or fully filled (based on the presence of blue light). Of course, the light color can indicate different fill levels or fluid amounts in syringe barrel 408, and this embodiment is not limiting. Similarly, intensity or another light characteristic (other than color) may be changed based on fill level, and thus the example of color change is not limiting.

[0100] Reference Figure 7 , shows a front perspective view of a fluid transfer cartridge according to an embodiment. As described above, each syringe of the fluid transfer cartridge 204 can include a syringe piston 702 disposed within a syringe barrel 408. The left syringe barrel is shown as opaque, and the right syringe barrel is shown as transparent to expose the stopper 608 within the syringe cavity. The opacity of the syringe barrel can vary.

[0101] The syringe piston 702 may include a stopper 608, which may be a rubber stopper that, if not otherwise resisted by the syringe holder 513, can apply friction and cause the syringe barrel 408 to rotate. The syringe piston 702 may also include an axis 704 extending from the stopper 608 in the syringe barrel 408 to an axis end 706 outside the syringe barrel 408. As described below, the axis end 706 may include an element for triggering a position sensor. For example, the element may include a magnet for triggering a magnetic sensor, or an optical feature (e.g., a tongue, a fork, a flag, etc.) for triggering an optical sensor. Regardless of the position of the stopper 608 in the syringe barrel 408, the axis end 706 may be located outside the syringe barrel 408. However, the axis end 706 may have several positions, and at least one position may be located inside the cartridge chamber 402. For example, the bottom surface of the axis end 706 may be flush with the bottom surface 510 of the cartridge housing 306.

[0102] In one embodiment, when the stopper 608 is in the starting position within the syringe barrel 408, the shaft end 706 is disposed within the cartridge cavity 402. Alternatively, when the stopper 608 is in the starting position, the shaft end 706 may be flush with the bottom surface 510 of the cartridge housing 306. In either case, when the stopper 608 is in the starting position, the shaft end 706 may not be outside the envelope defined by the cartridge housing 306. The starting position may be the highest position of the stopper 608, or the position closest to the end face 1852 of the syringe. In the starting position, the shaft end 706 may be close to the syringe barrel 408 but located outside of the syringe barrel. More specifically, the shaft end 706 may have a vertical position located between the proximal end of the syringe barrel 408 and the bottom surface 510 of the fluid transfer cartridge 204. In the starting position, the syringe components are completely contained within the cartridge cavity 402. Thus, the fluid transfer cartridge 204 can have a compact form factor defined by the outer surface of the cartridge housing 306, without requiring additional clearance for the syringe or syringe components.

[0103] The fluid transfer box 204 can be transported when the syringe piston 702 is in the starting position. More specifically, before filling the syringe with the cooling fluid 603 (during transportation or when the fluid transfer box 204 is initially installed on the generator 202), the stopper 608 can be in the starting position. Therefore, compared with transporting a fluid transfer box 204 with a syringe shaft 704 exposed from the box housing 306, the packaging size can be minimized to reduce packaging requirements. In addition, the fluid transfer box 204 can take up less space in the process chamber because the syringe and syringe components are not exposed outwardly from the box. In other words, the shaft 704 can be fully moved into the box cavity 402 to fully accommodate the syringe in the fluid transfer box 204 and can reduce the overall form factor of the fluid transfer box 204. The reduction of the form factor makes the box more compact for transportation and / or use.

[0104] In contrast to the starting position, when the stopper 608 is in the end position in the syringe barrel 408, the shaft end 706 can be disposed outside of the cartridge cavity 402. The end position can be the lowest position, or the position within the syringe barrel that is furthest from the end face 1852 of the syringe. In the end position, the shaft end 706 can be outside of the syringe barrel 408 and the cartridge cavity 402. More specifically, the shaft end 706 can be exposed below the bottom surface 510 of the fluid transfer cartridge 204, as shown in FIG. Figure 7 shown.

[0105] Reference Figure 8, shows a rear perspective view of a fluid transfer cassette according to an embodiment. The fluid transfer cassette 204 includes a drive mechanism to advance the syringe plunger 702 relative to the syringe barrel 408. In one embodiment, the shaft 704 of the syringe plunger 702 includes external threads 802 extending along the outer surface of the shaft 704 between the stopper 608 and the shaft end 706. The fluid transfer cassette 204 may also include a gear 804 mounted on the cassette housing 306. The gear 804 may include internal threads that engage the external threads 802 of the syringe shaft 704. Thus, when the gear 804 rotates (e.g., when driven by a motor of the generator 202), the internal threads of the gear 804 can drive the external threads 802 of the shaft 704 in an axial direction. Thus, the shaft 704 can be driven upward toward a starting position and / or downward toward an end position. When the shaft 704 is driven downward, the stopper 608 can move away from the end face 1852 of the syringe barrel 408 to draw fluid into the syringe. Conversely, when the shaft 704 is driven upward, the stopper 608 may move toward the end face 1852 to expel fluid from the syringe barrel 408 .

[0106] When the gear 804 drives the syringe piston 702 in the direction of the syringe axis 1650, a rotational friction load can be applied to the syringe shaft 704 through the gear. Similar to the stabilizing effect of the syringe holder 513 on the syringe barrel 408, the fluid transfer box 204 may also include features that stabilize the syringe piston 702. In one embodiment, the shaft 704 of the syringe piston 702 includes a piston recess 806 extending longitudinally between the stopper 608 and the shaft end 706. The longitudinal piston recess 806 can receive a fork tip (not shown) extending from the box housing 306 and / or the syringe holder 513. For example, the tip can be built into the chassis of the box to fix the tip relative to the box housing. When the gear 804 rotates relative to the shaft 704, it can apply a friction load to the external thread 802 of the shaft 704. To ensure that the shaft 704 does not rotate relative to the gear 804, the fork tip can slide within the piston recess 806 and interfere with the recess wall to resist and limit the rotation of the shaft 704 relative to the gear 804. Thus, rotational movement is converted into translational movement along the syringe axis 1650. More specifically, the tip can limit rotation of the syringe piston 702 and limit movement of the stopper 608 to axial direction at minimal rotation.

[0107] Reference Figure 9, shows a front view of a tubing routing port of a fluid transfer cassette according to an embodiment. As described above, the components of the fluid transfer cassette 204 can be fastened in various ways (including snap-fit ​​connections). In one embodiment, the cassette housing can include a tubing routing area through which the fluid conduit 206 can be routed. More specifically, the cassette housing 306 can include a cassette routing opening 902 in the front 404. The cassette routing opening 902 can improve the manufacturability of the fluid transfer cassette 204 by providing a cutout through which the fluid conduit 206, which can have a considerable length, can be embedded and / or routed through the fluid transfer cassette 204. The cassette routing opening 902 can be a cutout formed in the front 404 along the lower edge of the cassette. More specifically, the opening can have a lower edge extending along the corner of the cassette between the front 404 and the bottom surface 510 of the fluid transfer cassette 204.

[0108] Reference Figure 10 , shows a front view of a tubing routing plate installed in a tubing routing opening of a fluid transfer cassette, according to an embodiment. The cassette housing 306 may include a tubing routing plate 1002 that engages the front face 404 along an edge 1004. The edge 1004 may be the perimeter of the tubing routing opening. In one embodiment, the tubing routing plate 1002 and the portion of the front face 404 that extends along the tubing routing opening may include corresponding notches 1006 at the edge 1004. For example, the notch 1006 in the front face 404 may be a semicircular notch 1006, and the notch 1006 in the tubing routing plate 1002 may also be a semicircular notch 1006. The tubing routing plate 1002 may snap fit into (or otherwise be secured to) the tubing routing opening to block the opening and form an aperture through which the fluid tubing 206 may be routed. For example, partial cutouts in the housing may combine to form a tubing port for the fluid tubing 206. In the case of semicircular recesses 1006, the recesses can combine to form a circular tubing routing port 1008 in the front face 404 of the assembled fluid transfer cassette 204. Before the tubing routing plate 1002 is snapped into the opening, a predetermined length of fluid tubing 206 can be exposed outside the cassette. When the tubing routing plate 1002 is snapped into the opening, the plate's edges 1004 and the cassette housing 306 can clamp around the fluid tubing 206 to hold the fluid tubing 206 in place. The ability to easily determine the length of tubing that is inserted through the opening into the cavity and the length of tubing that extends outside the opening (which lengths are separated by the plate snapping into the opening to clamp the tubing in place) can provide efficient routing and the ability to quickly and efficiently route tubing during manufacturing.

[0109] Reference Figure 11, shows a cross-sectional view of a fluid transfer cartridge installed in a cartridge container of a treatment system generator according to an embodiment. In the cross-section, the interaction between the fluid transfer cartridge 204 and the generator 202 can be identified. For example, it can be seen that when the fluid transfer cartridge 204 is received within the cartridge container 302, the rear plate 504 of the fluid transfer cartridge 204 is juxtaposed and in contact with the generator 202. The separation between the fluid transfer cartridge 204 and the generator 202 is Figure 11 1650. The fluid transfer cartridge 204 is shown by dashed lines in FIG. 166. When received, the fluid transfer cartridge 204 can be actuated to drive the syringe shaft 704 from the starting position 1102 to the end position 1104. More specifically, a generator gear 1106 (or gear train) driven by a motor 1108 of the generator 202 can engage and drive the gear 804 of the fluid transfer cartridge 204 to simultaneously move the syringe piston 702 along the syringe axis 1650. For example, the motor 1108 can be operably coupled to the shaft 704 and actuated by one or more processors of the control unit to cause the internal threads 1109 of the gear 804 to move the external threads 802 of the shaft 704 (and the syringe piston 702) during fluid transfer through the syringe.

[0110] When the stopper 608 is in the end position 1104, the shaft end 706 is located outside the cartridge cavity 402. In one embodiment, the generator housing 304 includes a well 1110 located below the cartridge container 302. The well 1110 may have outer walls surrounding a space within which the shaft end 706 is located when the stopper 608 is in the end position 1104. Thus, the well 1110 can receive the syringe piston 702 of the fluid transfer cartridge 204 during fluid transfer by the syringe. When the syringe piston 702 is contained within the well 1110, the shaft 704 is protected from damage. More specifically, the well 1110 can shield the shaft 704 from contact with external surfaces that could damage syringe components. Similarly, the well 1110 shields the shaft 704 from the user, thereby reducing pinch points that could otherwise injure the user. Finally, by containing the shaft 704 within the generator 202, rather than extending outward from the control unit, the overall form factor of the control unit can be compacted.

[0111] The dimensions of the well 1110 can be designed to accommodate several functions. First, the size of the space within the well 1110 can allow a user to easily clean the well 1110, for example, by wiping the inner surface of the well 1110. Additionally, the height of the well 1110 can be greater than the stroke length of the syringe to ensure that the shaft end 706 does not directly contact the inner surface of the well 1110 when the stopper 608 reaches the end position 1104. Additionally, the depth of the well 1110 can allow the fluid transfer cartridge 204 to be removed from the generator 202 without having to reposition the stopper 608. More specifically, when removing the cartridge with the shaft 704 fully extended, the cartridge can be tilted forward and there can be sufficient space within the well 1110 to allow the shaft 704 to be tilted and removed upward from the well cavity.

[0112] As described above, the syringe can be operated to move the stopper 608 within the syringe barrel 408 between the starting position 1102 and the end position 1104. The stopper 608 can be placed at the starting position 1102, for example, during transport to a process chamber. The starting position 1102 can also be a position to purge air bubbles from the syringe barrel 408 after the stopper 608 has cycled between the starting position 1102 and the end position 1104 one or more times. More specifically, a stroke of the syringe can include the starting position 1102 of the syringe piston 702 removing air bubbles from the syringe. Similarly, when the stopper 608 is in the end position 1104, the cooling fluid 603 can be drawn into the syringe barrel 408 to fill the syringe. When the stopper 608 is moved to the end position 1104 after purging the syringe barrel 408, the cooling fluid 603 within the syringe can be free of air bubbles. The method of purging the syringe will be described in further detail below, however it should be understood that at this stage movement of the syringe piston 702 is achieved by a motor 1108 which may be controlled by one or more processors of the control unit.

[0113] The movement of the syringe piston 702 can be controlled by one or more processors by controlling the motor 1108. For example, the motor 1108 can be a stepper motor 1108, and the processor can drive the stepper motor 1108 through a predetermined angular rotation that, when taking into account the gear ratio between the generator gear 1106 (or gear train) and the gear 804 of the cartridge, can result in a predetermined axial movement of the shaft 704. In addition, the control unit can incorporate a sensor to detect the position of the syringe piston 702 (e.g., the shaft end 706). By sensing the shaft position, the one or more processors can determine the position of the stopper 608 within the syringe barrel 408 and, therefore, the amount of fluid contained within the syringe.

[0114] The sensor for detecting the shaft position can be magnetic, optical, mechanical, etc. In one embodiment, the sensor includes one or more position switches 1120. For example, the treatment system 100 may include a position switch 1120, such as an optical switch (e.g., an optical sensor), configured to detect when the stopper 608 is in the starting position 1102. An optical sensor can provide better resolution than a magnetic switch. On the other hand, a magnetic sensor may require less maintenance than an optical sensor. Therefore, the position switch 1120 can be selected based on design requirements.

[0115] Optionally, a second position switch 1120 (not shown) can be configured to detect when the stopper 608 is in the end position 1104. The position switch 1120 can be mounted within or along a wall of the generator well 1110. For example, the position switch 1120 can be mounted along the rear wall of the well 1110. When more than one switch is incorporated, the switches can be aligned in series along a vertical axis extending parallel to and adjacent to the syringe axis 1650.

[0116] In one embodiment, the shaft end 706 includes an element that can trigger the position switch 1120. For example, the element can include an optical tab to trigger an optical sensor. Figure 33 The optical tab is further described and may be mounted at shaft end 706. As the syringe piston travels vertically along syringe axis 1650, the optical tab may travel along the vertical axis and pass by the optical switch. The optical switch of generator 202 may interact with the optical tab mounted on syringe piston 702. For example, the optical tab may be disposed at shaft end 706 on shaft 704. When the optical tab approaches the optical switch (e.g., is adjacent to the optical switch), the optical tab may block the optical switch. For example, the optical sensor may include a light-emitting diode to emit a light signal, and the tab may block or reflect the optical sensor's light signal. Thus, when the state of the optical switch changes, it indicates the proximity between the optical tab and the optical switch. This proximity between the optical tab and the optical switch may be detected by one or more processors of the control unit and used to determine the travel of one or more syringes of the fluid transfer cartridge 204. More specifically, one or more processors can monitor the state of the optical switch to identify the position of the syringe piston 702 relative to the syringe barrel 408, and more specifically, the position of the shaft 704 and / or whether the stopper 608 is at the starting position 1102, the end position 1104, or at an intermediate position between the start and end of the stroke.

[0117] In one embodiment, the shaft end 706 includes an element that can trigger a position switch 1120. For example, the element can include a magnet that can be mounted at the shaft end 706 and can move along the vertical axis and past the switch when the syringe piston 702 moves vertically along the syringe axis 1650. The magnetic switch of the generator 202 can interact with the magnet mounted on the syringe piston 702. For example, the magnet can be positioned at the shaft end 706 on the shaft 704. When the magnet approaches the magnetic switch (e.g., is adjacent to the magnetic switch), the magnet moves the contacts of the magnetic switch. Therefore, when the state of the magnetic switch changes, it indicates the proximity between the magnet and the magnetic switch. This proximity between the magnet and the magnetic switch can be detected by one or more processors of the control unit and used to determine the travel of one or more syringes of the fluid transfer cartridge 204. More specifically, the one or more processors can monitor the state of the magnetic switch to identify the position of the syringe piston 702 relative to the syringe barrel 408, and more specifically, whether the stopper 608 is in the starting position 1102, the end position 1104, or an intermediate position between the start and end of the travel.

[0118] Position switch 1120 can act as a limit switch to provide information to the control unit that can be used to prepare the syringe for fluid delivery. Given that magnetic switches do not require precise alignment between the magnet and the magnetic switch, magnetic switches can provide more reliable limit switches than, for example, mechanically activated switches. Thus, one or more processors of the control unit can use the switch signal from the magnetic switch to control pre-circulation of the syringe.

[0119] During the pre-cycle, the control unit cycles the syringe using the limit switches to detect whether the syringe is properly filled with cooling fluid 603, whether the fluid lines 206 of the fluid transfer cartridge 204 and the manifold are filled with cooling fluid 603, and to ensure that air bubbles are removed from the fluid lines 206, the manifold, and the syringe. The control unit purges the syringe during the pre-cycle to achieve these goals.

[0120] The fluid transfer cartridge 204 can be installed on the generator 202 with the stopper 608 in the starting position 1102. When in the starting position 1102, the shaft end 706 can be located within the cartridge cavity 402 and, therefore, above and outside the well 1110. In the starting position 1102, the syringe is empty. To begin pre-circulation, one or more processors of the control unit can drive the motor 1108 to actuate the syringe piston 702 in a downward direction. Moving the stopper 608 creates a vacuum within the syringe barrel 408 and draws the cooling fluid 603 into the syringe. Thus, the initial stage of pre-circulation fills the syringe with cooling fluid 603.

[0121] When the syringe is filled with fluid, the shaft end 706 moves into the well 1110 outside the cartridge cavity 402. One or more processors can determine the fill level or fill amount of the syringe. For example, when the stopper 608 is in the end position 1104 in the syringe barrel 408, the shaft end 706 can be positioned near the lowest position switch 1120 of the generator 202. The proximity of the shaft end to the position switch can trigger (e.g., close (or open)) the contacts of the switch to generate a switch signal that is sent to the one or more processors. The processor can determine that the syringe is filled with a predetermined amount of cooling fluid 603 based on the switch signal. For example, the predetermined amount of cooling fluid 603 can be the volume of the syringe barrel 408.

[0122] While the predetermined amount of cooling fluid 603 can correspond to a determination that the stopper 608 is in the end position 1104, the one or more processors can be configured to determine other fill levels. For example, one or more intermediate position switches 1120 can be positioned between the highest position switch corresponding to the starting position 1102 and the lowest position switch corresponding to the end position 1104. The placement of the position switches can be selected to correspond to known fluid volumes within the syringe. For example, the position switches can be positioned at positions corresponding to 10 mL increments of the syringe fill level.

[0123] When the syringe is filled, pre-circulation can continue. One or more processors can drive the motor 1108 to move the syringe piston 702 upward to expel the cooling fluid 603 from the syringe. The cooling fluid 603 is expelled into the fluid path of the cassette. For example, the cooling fluid 603 can flow from the syringe into the fluid conduit 206 connecting the fluid transfer cassette 204 to the catheter 101. In one embodiment, the syringe is completely emptied of the cooling fluid 603. The one or more processors can determine that one or more syringes are empty based on a switch signal generated by a position switch. The switch signal can indicate that the stopper 608 is in the starting position 1102 and, therefore, the syringe is empty.

[0124] Driving the cooling fluid 603 out of the syringe can remove air bubbles from one or more of the syringes or fluid paths of the fluid transfer cartridge 204. More specifically, air drawn into the syringe when the stopper 608 is initially moved from the starting position 1102 to the end position 1104 can be expelled from the fluid network when the stopper 608 is subsequently driven back to the starting position 1102. Purging air from the fluid network can prime the system to ensure that the fluid network is filled with an incompressible fluid (e.g., sterile water) and is relatively stable.

[0125] In a pre-cycle operation, after purging air from the syringe, the syringe can be filled with cooling fluid 603. One or more processors can drive motor 1108 to move stopper 608 from starting position 1102 to end position 1104. As a result, cooling fluid 603 can be drawn into syringe barrel 408. After the purging operation, the fluid drawn into syringe barrel 408 can be largely or completely free of air bubbles. In one embodiment, the purging operation can be repeated one or more times until the cooling fluid 603 in the syringe is completely free of air bubbles.

[0126] It should be understood that the magnetic switch provides one type of limit switch, and other types of limit switches can be incorporated into the treatment system 100. In one embodiment, the limit switch is an optical switch, such as an optical proximity sensor. Thus, the shaft end 706 can be configured to emit or reflect light to a light sensor of the treatment system 100, such as a light sensor located within the generator 202.

[0127] The optical limit switch can include a light source mounted on the shaft end 706. The light source can shine radially outward from the axis 1650, for example, toward the back wall of the well 1110 of the generator 202. The back wall can include one or more light sensors to receive the light emitted from the shaft end 706. Alternatively, the back wall can include a proximity light sensor that emits light toward the shaft end 706 and receives reflected light returned from the shaft end 706. Thus, the light sensor can detect when the shaft end 706 is in proximity to the light sensor based on the detected light and send a corresponding switch signal to one or more processors of the treatment system 100. The processor can use the switch signal to detect and control the shaft position, as described above. Thus, a magnetic switch is a non-limiting example of a limit switch that can be integrated into the treatment system 100, and optical or mechanical switches can also be used to detect the shaft position.

[0128] Reference Figure 12 , shows a rear perspective view of a fluid transfer cartridge according to an embodiment. When the cartridge is mounted on the generator 202, the rear face 407 of the fluid transfer cartridge 204 can be juxtaposed with the surface of the generator 202 that defines the cartridge receptacle 302. The rear face 407 can include a protrusion 1202 that protrudes outward from the surrounding base surface. In one embodiment, the protrusion 1202 has a protrusion perimeter 1204 that extends around the portion of the rear face 407 that rests on the protrusion 1202. The protrusion perimeter 1204 can extend laterally inward from the outer perimeter of the rear face 407. More specifically, a rear face boundary 1206 can define edges that separate the rear face 407 from the top, side, and bottom surfaces of the cartridge. Thus, the rear face 407 can have a portion that covers the base surface laterally outward from the portion that covers the protrusion 1202. The rear portions can be offset from each other, for example, at different locations in the rearward direction. Thus, when viewed from the side, the rear surface has a stepped profile.

[0129] In one embodiment, the fluid transfer cartridge 204 includes one or more electrical contact pads 1208 or pins for connecting to corresponding circuitry within the generator 202. More specifically, the electrical contact pads 1208 or pins can be connected to a circuit board. For example, the circuit board can be a pressure sensor board containing a sensor and / or processor configured to detect and / or determine pressure along the fluid path of the control unit. The electrical contact pads 1208 or pins can include spring-loaded electrical contact pins exposed through the rear face 407 of the cartridge near the upper end of the protrusion 1202. The electrical contact pads 1208 can include conductive contact pads exposed through the rear face 407 near the upper end of the protrusion 1202 and positioned to contact spring-loaded electrical contact pins extending from the generator 202. In this context, the upper end can refer to the side of the protrusion perimeter 1204 farthest from the base plate. The electrical contact pads or pins and their placement in the upper region of the cartridge can provide several advantages. First, in the case of the contact pins, the spring-loaded structure allows the pins to deflect when in contact with the generator 202. 2. Thus, in the event of misalignment or movement between components during operation, the pins can engage the generator 202. This benefit is similarly achieved when the contact pads of the fluid transfer cartridge 204 engage the contact pins of the generator 202. Thus, the deflectable pins allow for a better connection between the generator 202 and the cartridge during operation. Secondly, placing the pads or pins along the top of the cartridge can reduce the likelihood of an electrical short in the event of a leak in the tubing. More specifically, the pads or pins can be placed vertically above the fluid path inside the cartridge housing 306 so that any leaks from the fluid path will fall down to the floor without contacting (and potentially shorting) the electrical connections.

[0130] Reference Figure 13 , shows a front perspective view of a cartridge receiving portion of a generator according to an embodiment. The protrusion 1202 of the fluid transfer cartridge 204 can engage a corresponding feature in the generator 202. In one embodiment, the cartridge receptacle 302 includes a rear recess 1302 to receive the protrusion 1202. The rear recess 1302 can have a recess perimeter 1304 extending around the recessed surface of the generator 202. The recess perimeter 1304 of the rear recess 1302 can have a contour that matches the contour of the protrusion perimeter 1204. For example, the protrusion 1202 can be a rectangular protrusion and the rear recess 1302 can be a rectangular recess. Thus, the protrusion 1202 can engage and fill the rear recess 1302, such that the lateral sidewalls of the protrusion 1202 are juxtaposed and aligned with the lateral sidewalls of the rear recess 1302. Similarly, the rear surface of the fluid transfer cartridge 204 can be juxtaposed and aligned with the front surface of the generator housing 304. The conforming surfaces of the components may stabilize the fluid transfer cartridge 204 relative to the generator 202 and minimize movement between the components during operation.

[0131] The contact pads or pins of the fluid transfer cartridge 204 can extend toward or face a slot located in an upper region of the rear recess 1302. The slot can expose one or more electrical contacts that the contacts of the fluid transfer cartridge 204 can engage when the cartridge is mounted on the generator 202. Thus, an electrical connection can be established between the cartridge and the generator 202 to transmit signals (including switch signals, light activation signals, etc.).

[0132] To further stabilize the control unit components and secure the fluid transfer cartridge 204 to the generator 202, the treatment system 100 may include a fastening mechanism 1310 to latch the fluid transfer cartridge 204 within the cartridge container 302. The fastening mechanism 1310 may include corresponding snaps 1312 and recesses disposed on the fluid transfer cartridge 204 and the generator 202. Referring again to FIG. Figure 12 , the male portion 1202 can include a plurality of recesses 1210 distributed around a male perimeter 1204 of the male portion 1202. For example, the male portion 1202 can have a rectangular profile, and four or more recesses 1210 can be located within a lateral sidewall of the male portion 1202 around the male perimeter 1204. In one embodiment, each of the four recesses 1210 can be located near a respective corner of the rectangular profile. Distributing the recesses 1210 around the male perimeter 1204 can distribute the holding load applied by the generator 202 to the fluid transfer cartridge 204 and, therefore, can optimally stabilize the cartridge relative to the generator housing 304.

[0133] Refer again Figure 13 , the fastening mechanism 1310 can include a plurality of latches 1312 distributed around the recess perimeter 1304. For example, the rear recess 1302 can have a rectangular profile, and four latches can be positioned along the lateral sidewalls of the rear recess 1302 around the recess perimeter 1304. In one embodiment, the four latches are located at positions corresponding to the positions of the recesses 1210 in the male portion 1202. More specifically, the latches 1312 can be configured to engage the recesses 1210 of the male portion 1202 to secure the fluid transfer cartridge 204 to the generator 202.

[0134] In one embodiment, each catch 1312 is a spring-loaded catch 1312 operably coupled to a release button 1314 of the securing mechanism 1310. The release button 1314 can move between a latched position and an unlatched position. For example, when the release button is fully extended (unsqueezed), the release button 1314 can be in the latched position. Squeezing the release button 1314 can move the button from the latched position to the unlatched position. The release button 1314 can be operably coupled to the catch 1312 such that moving the release button 1314 from the latched position causes the catch 1312 to move out of the cartridge container 302. More specifically, movement of the release button 1314 can cause the catch 1312 to move from an extended position within the cartridge's recess 1210 to a recessed position outside the male recess 1210. When the catch 1312 engages the male recess 1210, the cartridge is secured to the generator 202. Conversely, when the catch 1312 is retracted from the male recess 1210, the cartridge can be released from the generator 202. Thus, the fastening mechanism 1310 provides a quick release mechanism for installing and removing the fluid transfer cartridge 204 from the generator 202.

[0135] In addition to providing a quick release mechanism, the fastening mechanism 1310 also promotes a firm and stable mechanical connection between the box 204 and the generator 202. The distributed latches around the protrusion 1202 and the rear recess 1302 ensure that the mechanical load of the box during operation can be evenly distributed, and therefore, the latch can share the load and minimize the deflection at any given position around the box. Although the fastening mechanism 1310 can have four or more friction points that make the buckle 1312 engage the recess 1210, the release button 1314 that actuates the spring-loaded latch can be used to make the box smoothly disengage. In one embodiment, the buckle 1312 is driven by a linkage system, a plate with a cam mechanism, or another intermediate structure between the release button 1314 and the buckle 1312. This type of mechanism can operate smoothly and in a manner that provides a beneficial degree of tactile feedback to the user. Therefore, the fastening mechanism 1310 can advantageously fix the box to the generator 202 in a user-friendly manner.

[0136] The securing mechanism 1310 may include one or more catches 1312 operably coupled to a release button 1314 such that moving the release button 1314 from a latched position to an unlatched position causes the one or more catches 1312 to move out of the cartridge container 302. The catches 1312 need not be directly loaded by a spring, but rather may be biased relative to the release button 1314. More specifically, the release button 1314 may be movable from a latched position to an unlatched position, and the release button 1314 may be operably coupled to one or more springs to bias the release button 1314 toward the latched position. Thus, the one or more springs may bias the catches 1312 into the cartridge container 302.

[0137] In one embodiment, the one or more springs biasing the release button 1314 are a single spring. More specifically, the release button 1314 can be driven into the latched position by a single spring. In contrast, the one or more catches 1312 can include a plurality of catches 1312 interconnected by a linkage. More specifically, the linkage can interconnect the catches 1312 such that movement of the release button 1314 serves as an input to cause movement of the linkage, which in turn drives the catches 1312 into and out of the cartridge container 302. When the release button 1314 is moved from the latched position to the unlatched position, the one or more catches 1312 can be moved out of the cartridge container 302.

[0138] The therapeutic system 100 may include one or more processors configured to execute instructions stored in a non-transitory computer-readable medium to cause the therapeutic system 100 to perform various methods (such as the pre-cycle described above). The methods may include providing visual feedback to the user to indicate that an electrical connection has been made between components of the therapeutic system 100 or between the therapeutic system and an external component. Several such methods are described below.

[0139] In one embodiment, after the fluid transfer cartridge 204 is installed on the generator 202, the treatment system 100 can illuminate the syringe. In operation, one or more processors are configured to determine whether the fluid transfer cartridge 204 is received in the cartridge container 302. Cartridge installation can be detected by various sensors. For example, when the cartridge is received in the cartridge container 302, one or more electrical contact pads 1208 can engage corresponding electrical contacts of the generator 202. The electrical contacts can cause an input signal to be sent to the one or more processors. In response to detecting the input signal, and therefore in response to determining that the fluid transfer cartridge 204 is received in the cartridge container 302, the one or more processors can activate the light source 1850 of the fluid transfer cartridge 204. The light source 1850 can be directed toward the syringe, as described above. Thus, when the syringe becomes illuminated, visual feedback can be provided to the user to confirm that the components of the treatment system 100 are engaged and ready for operation.

[0140] In one embodiment, the treatment system 100 includes one or more indicator lights 452 to indicate that the generator 202 has established a connection with one or more external components. Figure 4 The generator 202 may include one or more electrical connectors 450 configured to connect to external connectors of corresponding external components. For example, the electrical connector 1652 of the generator 202 may be an electrical receptacle for receiving the external connector 1352 of the catheter 101. Additional electrical connectors 450 may include plugs for receiving external connectors of other components (e.g., a remote control). The external connector may be a plug that engages a receptacle of an external connector, or vice versa.

[0141] The generator 202 may include an indicator light 452 located near the electrical connector 1652. For example, the indicator light 452 may be a single light emitting diode (LED) adjacent to the electrical outlet, or several LEDs positioned around the outlet. In one embodiment, the indicator light 452 includes an indicator light ring 454 extending around the electrical connector 1652. More specifically, as Figure 4 As shown, the indicator light ring 454 can include an annular light shield circumferentially surrounding the electrical connector 1652. One or more LEDs can be mounted behind the light shield so that when illuminated, the light shield appears to be a solid light ring. The light ring can allow the light to be viewed from any direction without being blocked by, for example, cables or conduit 101.

[0142] The indicator light 452 can have an illumination state or mode that provides visual feedback to the user. For example, one or more processors of the treatment system 100 can be configured to determine whether the electrical connector 1652 is electrically connected to the external connector 1352. For example, when the external connector 1352 is inserted into the electrical connector 1652, a signal can be sent to the one or more processors, indicating and allowing the processor to determine that a connection has been established. In operation, in response to determining that the electrical connector 1652 is connected to the external connector 1352, the illumination mode of the indicator light 452 can change. In one embodiment, the indicator light 452 changes from an unactivated, unilluminated state to an activated, illuminated state. Thus, the user can see that the indicator light 452 has illuminated to confirm that the external component is electrically connected to the generator 202.

[0143] The change in lighting mode from an unlit state to an illuminated state is provided as a non-limiting example. Alternatively, the lighting mode can be changed from a first lighting mode in which the indicator light 452 is illuminated (e.g., blinking) to a second lighting mode in which the indicator light 452 is illuminated continuously (e.g., the illumination is considered continuous). In another alternative, the lighting mode can be changed from a first lighting mode in which the indicator light 452 emits a first color of light (e.g., red) to a second lighting mode in which the indicator light 452 emits a second color of light (e.g., blue). In any case, the change in lighting mode provides visual feedback to the user that the external component is electrically connected to the generator 202 and is therefore ready for use.

[0144] Reference Figure 14 , shows an exploded view of a cartridge housing of a fluid transfer cartridge according to an embodiment. As described above, the cartridge housing 306 of the fluid transfer cartridge 204 can include a handle front panel 1750 and a rear panel 504. When combined, the handle front panel 1750 and the rear panel 504 can define a cartridge cavity 402 centrally located between the respective walls and faces.

[0145] When snapped or otherwise assembled together, the handle front plate 1750 and the rear plate 504 can contain one or more components within the cartridge cavity 402 to provide fluid transfer functionality. For example, the fluid transfer cartridge 204 can include a syringe holder 513 to hold the syringe barrels 408, 412 within the cartridge cavity 402. The syringe holder 513 can stabilize the syringe during fluid transfer. The fluid transfer cartridge 204 can also include a conduit 1406 to facilitate movement of fluid from the syringe to the catheter 101.

[0146] In whole fluid transfer box 204, using pipeline to transfer fluid may need long pipeline line and many glue joints to realize the fluid path and interconnection required for fluid transfer.For example, the exclusive use of pipeline may need more than five feet of pipeline and 40 glue joints to create fluid network.Yet this type of fluid network may take up sizable volume, may cause leakage and / or flow inconsistency at the glue joints, and may be difficult to assemble during manufacture.In one embodiment, box manifold 1402 can be used to replace most of pipeline length and joint, thereby provides more compact, reliable and be easier to manufacture fluid network.Because the size and weight of fluid network reduce, the corresponding size and weight of fluid transfer box 204 also can reduce, thereby allows once more boxes to be sterilized and more boxes per unit volume are transported.

[0147] The cassette manifold 1402 can replace some (but not all) of the fluid conduits within the fluid transfer cassette 204. For example, a syringe barrel 408 can have a syringe cavity 1404 connected to the fluid passages of the cassette manifold 1402 by one or more conduits 1406. Other conduits 1406 (e.g., between the cassette manifold 1402 and a second syringe barrel 412, a balloon catheter 101, a fluid reservoir, etc.) can also be routed through the cassette cavity 402. Such conduits 1406 are not provided in the cassette manifold 1402. Figure 14 are shown in to avoid cluttering the diagram.

[0148] Reference Figure 15A , shows a perspective view of a cassette manifold according to an embodiment. The cassette manifold 1402 may include several plates assembled to one another. In one embodiment, the cassette manifold 1402 includes a front plate 1502 assembled to a rear plate 1504. The front plate 1502 and the rear plate 1504 may be secured to one another. For example, the front plate 1502 may be snap-fit ​​(e.g., secured by a snap closure) to the rear plate 1504. As described below, the front plate 1502 and the rear plate 1504 may secure an intermediate plate having channels and ports to move cooling fluid throughout the cassette manifold 1402 and exchange cooling fluid with external components (e.g., the balloon catheter 101 and the fluid reservoir). Making the front plate 1502 transparent allows for easy manipulation of the cooling fluid during operation. Figure 15A An intermediate plate was observed in the

[0149] Reference Figure 15B, shows a perspective view of a cartridge manifold according to an embodiment. Alternatively, front plate 1502 and tail plate 1504 may be fastened to each other by screws or otherwise secured thereto. More specifically, a number of manifold fasteners 1508 may extend through through-holes in tail plate 1504 and screw into threaded holes formed in front plate 1502. Fasteners 1508 may hold the plates together to sandwich the intermediate plate, as described below.

[0150] Reference Figure 16 , shows an exploded view of a cartridge manifold according to an embodiment. The cartridge manifold 1402 in the cartridge cavity 402 may include a fluid transfer plate 1602 sandwiched between a front plate 1502 and a rear plate 1504. The fluid transfer plate 1602 may include channels on its front and rear surfaces connected by various ports in the plate. More specifically, one or more front fluid channels 1604 in the front plate surface 1606 may carry cooling fluid to one or more outlet ports 1608 via channels on the rear surface for transfer to external components.

[0151] In one embodiment, the outlet ports 1608 of the front plate 1502 are connected to external components. More particularly, the outlet ports 1608 can include fittings (e.g., barb fittings) that are connected to the fluid conduits 1406, and these conduits can extend to connect to external components (such as syringes, fluid reservoirs, balloon catheters 101, or pressure sensors). Thus, the front plate outlet ports 1608 can serve as a fluid interface for external components. Through the outlet ports 1608, fluid can be transferred into and out of the box manifold 1402. In one embodiment, the front plate 1502 includes four outlet ports 1608 along the upper edge and five outlet ports 1608 along the lower edge, but the number and position of these outlet ports 1608 can vary depending on the layout of the external components and the fluid transfer box 204.

[0152] The movement of fluid through the channels and ports of the cartridge manifold 1402 can be controlled by one or more pistons 1610. Each piston 1610 can be associated with or include a spring 1612. More specifically, the piston 1610 can be spring-loaded to bias the piston 1610 to a given position. For example, as described below, the spring 1612 can bias the piston 1610 to an open position, and a solenoid can actuate the piston 1610 to move the piston 1610 to a closed position. Specifically, the piston 1610 can move between positions that seal or unseal the fluid ports in the fluid transfer plate 1602 to start or stop the flow of the cooling fluid 603 through the fluid channels.

[0153] Reference Figure 17, shows a front view of a fluid transfer plate of a cartridge manifold according to an embodiment. The front plate surface 1606 of the fluid transfer plate 1602 may include several front fluid channels 1604. In one embodiment, the front fluid channels 1604 belong to corresponding fluid circuits. More specifically, some channels and ports may belong to the upper fluid circuit 1702, and other channels and ports may belong to the lower fluid circuit 1704. Each fluid circuit may include a corresponding front fluid channel 1604 and one or more outlets. As described below, the fluid channels and outlets may be interconnected with the outlet ports 1608 of the front plate 1502 to transfer fluid to or from an external component. In addition, the fluid transfer plate 1602 may include one or more fluid ports 1706. Each fluid port 1706 may extend from a front fluid channel 1604 in the front plate surface 1606 to a rear fluid channel ( Figure 18 Thus, cooling fluid 603 may move from channels in front of fluid transfer plate 1602 to channels behind fluid transfer plate 1602 through fluid ports 1706 .

[0154] In one embodiment, the fluid channels of the fluid transfer plate 1602 can be surrounded by corresponding channel seals 1710. The channel seals 1710 can be gaskets placed along the outer perimeter of the fluid channels, such as O-rings or bands of elastomeric material having a circular, rectangular, cross-shaped, or other cross-sectional profile. The seals can be fitted into grooves, injection molded into the plates, or otherwise attached to the fluid transfer plate 1602. When the fluid transfer cassette 204 is assembled, the channel seals 1710 can be sandwiched between the fluid transfer plate 1602 and the adjacent front plate 1502 or rear plate 1504. The sandwich seals can form an airtight seal around the fluid channels to isolate the cooling fluid 603 within the channels.

[0155] The lower fluid circuit 1704 can be associated with the syringe barrel 408 for delivering fluid to the balloon catheter 101. More specifically, the cooling fluid 603 can be transferred from an external fluid reservoir (e.g., a fluid-filled bag) to the syringe barrel 408 through the lower fluid circuit 1704. The outlets in the front plate surface 1606 that connect to the corresponding outlet ports 1608 of the front plate 1502 can be labeled for ease of reference. For example, the lower fluid circuit 1704 can have an L1 outlet 1712, an L2 outlet 1714, an L3 outlet 1716, an L4 outlet 1718, and an L5 outlet 1720. Each of the L1-L5 outlets 1720 can be connected to a fitting on the front plate 1502, which in turn is connected to the tubing 1406. More specifically, the L1-L5 outlets can be in fluid communication with the outlet ports 1608 along the lower edge of the front plate 1502. These tubes 1406 may be connected to external components, such as a fluid reservoir, a syringe barrel 408, an inlet line of a balloon catheter 101, and / or one or more pressure sensors.

[0156] The upper fluid circuit 1702 can be associated with the second syringe barrel 412 for withdrawing fluid from the balloon catheter 101. More specifically, the cooling fluid 603 can be transferred from the balloon catheter 101 through the upper fluid circuit 1702 to transfer the fluid to an external fluid reservoir. The outlets in the front plate surface 1606 that are interconnected to the corresponding outlet ports 1608 of the front plate 1502 can be labeled for ease of reference. For example, the upper fluid circuit 1702 can have a U1 outlet 1722, a U2 outlet 1724, a U3 outlet 1726, and a U4 outlet 1728. Each of the U1-U4 outlets can be connected to a fitting on the front plate 1502, which in turn is connected to the conduits 1406. More specifically, the U1-U4 outlets can be in fluid communication with the outlet ports 1608 along the upper edge of the front plate 1502. These conduits 1406 can be connected to external components, such as the outlet line of the balloon catheter 101, the second syringe barrel 412, a fluid reservoir, and / or one or more pressure sensors.

[0157] As will be apparent, some of the outlets are in fluid communication with each other via fluid channels. For example, the U3 outlet 1726 and the U4 outlet 1728 are in fluid communication with each other via the front fluid channel 1604 of the upper fluid circuit 1702. Similarly, the L2 outlet 1714 and the L3 outlet 1716 are in fluid communication with each other via the front fluid channel 1604 of the lower fluid circuit 1704. As described below, outlets isolated on the front side of the fluid transfer plate 1602 (e.g., the U1, U2, L1, L4, and L5 outlets 1720) can also be in fluid communication with other outlets via fluid channels on the rear side of the fluid transfer plate 1602. More specifically, each outlet and / or channel can include a corresponding fluid port 1706 extending through the fluid transfer plate 1602 for connection to corresponding channel(s) on the rear side of the fluid transfer plate.

[0158] Reference Figure 18 , shows a rear view of a fluid transfer plate of a cartridge manifold according to an embodiment. The cartridge manifold 1402 includes a rear plate surface 1802 having one or more rear fluid channels 1804. Similar to the front fluid channels 1604, the rear fluid channels 1804 can be surrounded by channel seals 1710 to separate the fluid within the fluid channels. For example, the tail plate 1504 can be juxtaposed with the rear plate surface 1802 such that the channel seals 1710 are sandwiched between the rear plate surface 1802 and the tail plate 1504. By extending around the rear fluid channels 1804, the channel seals can thereby define a fluid path for transferring the cooling fluid 603.

[0159] Rear fluid channels 1804 belong to corresponding fluid circuits. More specifically, some channels and ports may belong to upper fluid circuit 1702, and other channels and ports may belong to lower fluid circuit 1704. Fluid channels and outlets on rear plate surface 1802 may be interconnected with fluid channels and outlets on front plate surface 1606 via fluid ports 1706. More specifically, each fluid port 1706 may extend through fluid transfer plate 1602 to interconnect front fluid channels 1604 and ports to rear fluid channels 1804 and ports. Similarly, considering that the fluid channels and ports of fluid transfer plate 1602 are connected to fittings on front plate 1502, which are in turn connected to syringe barrel 408 via tubing 1406, then front fluid channels 1604, rear fluid channels 1804, and fluid ports 1706 are in fluid communication with syringe cavity 1404. Thus, cooling fluid 603 can move between syringe cavity 1404 and channels in fluid transfer plate 1602. Similarly, cooling fluid 603 can move between other external components and channels in fluid transfer plate 1602 .

[0160] exist Figure 18 The outlets in the rear panel surface 1802 are marked to show the Figure 17 1606 . Thus, it is apparent that the labeled outlets extend from the front plate surface 1606 through the plate to the rear plate surface 1802 . More specifically, in the upper fluid circuit 1702 , the U1 outlet 1722 and the U2 outlet 1724 are through-holes extending through the plate. Similarly, in the lower fluid circuit 1704 , the L1 outlet 1712 , the L4 outlet 1718 , and the L5 outlet 1720 are through-holes extending through the plate. Thus, outlets that are separated from one another on the front plate surface 1606 can be interconnected via the rear plate surface 1802 . For example, the U1 outlet 1722 and the U2 outlet 1724 are physically separated on the front plate surface 1606 , however, these outlets are interconnected via the rear fluid channel 1804 on the rear plate surface 1802 . Similarly, the L1 outlet 1712 and the L5 outlet 1720 are physically separated on the front plate surface 1606 , however, these outlets are interconnected by a rear fluid channel 1804 on the rear plate surface 1802 .

[0161] While fluid channels can interconnect separate outlets on one side of a plate with outlets on the other side, fluid ports 1706 can be used to reversibly interconnect fluid channels on one side of a plate with fluid channels on the other side. In one embodiment, each fluid port 1706 can be located within a corresponding valve seat on rear plate surface 1802. For ease of reference in the valve actuation logic described below, the valve seats are labeled. Upper fluid circuit 1702 may include a V1 valve seat 1730. V1 valve seat 1730 can receive a corresponding piston 1610 to open and close fluid port 1706, which, at this position, interconnects front fluid channel 1604 of upper fluid circuit 1702 with rear fluid channel 1804 of upper fluid circuit 1702. Thus, a fluid port 1706 corresponding to V1 valve seat 1730 can enable or disable fluid transfer between front fluid channel 1604 and rear fluid channel 1804 of upper fluid circuit 1702. Thus, the fluid port 1706 corresponding to the V1 valve seat 1730 may separate or interconnect the U1 and U2 outlets 1724 with the U3 and U4 outlets 1728 .

[0162] In one embodiment, lower fluid circuit 1704 includes several valve seats. V2 valve seat 1732 can receive a corresponding piston 1610 to open and close fluid port 1706, which interconnects front fluid channel 1604 of lower fluid circuit 1704 with first rear fluid channel 1804 of lower fluid circuit 1704. First rear fluid channel 1804 can interconnect L1 outlet 1712 to L5 outlet 1720. Thus, fluid port 1706 corresponding to V1 valve seat 1730 can allow or prevent fluid transfer between front fluid channel 1604 and first rear fluid channel 1804 of lower fluid circuit 1704. Thus, fluid port 1706 corresponding to V2 valve seat 1732 can isolate or interconnect L2 and L3 outlets 1716 with L1 and L5 outlets 1720.

[0163] In one embodiment, the V3 valve seat 1734 can receive a corresponding piston 1610 to open and close a fluid port 1706 that interconnects the front fluid channel 1604 of the lower fluid circuit 1704 with the second rear fluid channel 1804 of the lower fluid circuit 1704. The second rear fluid channel 1804 can interconnect the fluid port 1706 at the V3 valve seat 1734 to the L4 outlet 1718. Thus, the fluid port 1706 corresponding to the V3 valve seat 1734 can allow or stop fluid transfer between the front fluid channel 1604 and the second rear fluid channel 1804 of the lower fluid circuit 1704. Thus, the fluid port 1706 corresponding to the V3 valve seat 1734 can isolate or interconnect the L2 and L3 outlets 1716 with the L4 outlet 1718. It should also be understood by examining the fluid network shown that actuating the piston 1610 to simultaneously open the fluid ports 1706 at the V2 valve seat 1732 and the V3 valve seat 1734 will thereby cause all outlets of the lower fluid circuit 1704 to be fluidically connected to each other through the front fluid channel 1604, the first rear fluid channel 1804 and the second rear fluid channel 1804.

[0164] As described above, the fluid network formed by the various channels and ports of the fluid transfer plate 1602 can be used to interconnect various components outside the box manifold 1402. An embodiment of the external component connection will now be described. Starting from the upper fluid circuit 1702, the U1 outlet 1722 can be connected to the second syringe barrel 412. Therefore, transferring fluid through the U1 outlet 1722 can transfer fluid to the second syringe barrel 412 or transfer fluid from the second syringe barrel. The U2 outlet 1724 can be connected to a fluid reservoir. Therefore, transferring fluid through the U2 outlet 1724 can transfer fluid to the fluid reservoir or transfer fluid from the fluid reservoir. The U3 outlet 1726 can be connected to a pressure sensor. Therefore, the U3 outlet 1726 can allow sensing of the fluid pressure in the front fluid channel 1604 (or the rear fluid channel 1804 of the upper fluid circuit 1702 when the corresponding valve is open). The U4 outlet 1728 can be connected to the outlet line of the balloon catheter 101. Thus, transferring fluid through the U4 outlet 1728 can transfer fluid to or from the outlet line of the balloon catheter 101 .

[0165] For the lower fluid circuit 1704, the L1 outlet 1712 can be connected to the inlet line of the balloon catheter 101. Therefore, transferring fluid through the L1 outlet 1712 can transfer fluid to or from the inlet line of the balloon catheter 101. The L2 outlet 1714 can be connected to the syringe barrel 408. Therefore, transferring fluid through the L2 outlet 1714 can transfer fluid to or from the syringe barrel 408. The L3 outlet 1716 can be connected to a pressure sensor. Therefore, the L3 outlet 1716 can allow sensing of the fluid pressure in the front fluid channel 1604 (or one or both rear fluid channels 1804 of the lower fluid circuit 1704 when the corresponding valves are open). The L4 outlet 1718 can be connected to a fluid reservoir. Therefore, transferring fluid through the L4 outlet 1718 can transfer fluid to or from the fluid reservoir. The L5 outlet 1720 can be connected to a pressure sensor. Accordingly, L5 outlet 1720 may allow sensing of fluid pressure in first rear fluid passage 1804 of lower fluid circuit 1704 (or one or both of front fluid passage 1604 or second rear fluid passage 1804 of lower fluid circuit 1704 when corresponding valves are open).

[0166] Having described the fluid network and, in one embodiment, the external components connected to the fluid network, a method for circulating cooling fluid 603 from a fluid reservoir to the balloon catheter 101 and back to the fluid reservoir can now be described. In a first operation, the fluid port 1706 at the V2 valve seat 1732 can be closed and the fluid port 1706 at the V3 valve seat 1734 can be opened. This closing / opening action can be generated by actuating the piston 1610, as described below. Alternatively, other valve designs can be integrated with the fluid transfer plate 1602 to open and close the corresponding fluid ports 1706.

[0167] At a first operation, with the V3 valve open, the L2, L3, and L4 outlets can be in fluid communication with each other, and the L1 and L5 outlets can be isolated from the other outlets in the lower fluid circuit 1704. As a result, the syringe piston 702 of the syringe barrel 408 can be retracted to draw fluid from the fluid reservoir into the syringe chamber 1404. More specifically, the cooling fluid 603 can enter the L4 outlet 1718 from the fluid reservoir, pass through the fluid port 1706 at the V3 valve seat 1734, enter the front fluid channel 1604, and exit the L2 outlet 1714 into the tubing 1406 connected to the syringe barrel 408. At this stage, a pressure sensor connected to the L3 outlet 1716 can sense, for example, the pressure of the transferred cooling fluid 603 in the syringe chamber 1404.

[0168] At the second operation, the V3 valve is closed and the V2 valve is opened. At this stage, the L1, L2, L3, and L5 outlets can be in fluid communication with each other, and the L4 outlet 1718 can be isolated from the other outlets in the lower fluid circuit 1704. Therefore, the syringe piston 702 of the syringe barrel 408 can be advanced to push the fluid from the syringe cavity 1404 into the inlet line of the balloon catheter 101. More specifically, the cooling fluid 603 can enter the L2 outlet 1714 from the syringe cavity 1404, pass through the fluid port 1706 at the V2 valve seat 1732, and exit the L1 outlet 1712 to enter the inlet line of the balloon catheter 101. At this stage, the pressure sensor connected to the L5 outlet 1720 can sense the pressure of the cooling fluid 603 transferred in the balloon catheter 101, for example.

[0169] At the third operation, with the opening of the V1 valve, the U1, U2, U3 and U4 outlets can be fluidically connected to each other. Therefore, the syringe piston 702 of the second syringe barrel 412 can be retracted to aspirate the fluid from the outlet line of the balloon catheter 101 into the syringe chamber 1404. More specifically, the cooling fluid 603 can enter the U4 outlet 1728 from the outlet line of the balloon catheter 101, pass through the fluid port 1706 at the front fluid channel 1604 and the V1 valve seat 1730, enter the rear fluid channel 1804, and leave the U1 outlet 1722 to enter the pipe 1406 connected to the second syringe barrel 412. The pipe 1406 connecting the U2 outlet 1724 to the fluid reservoir can have a one-way check valve to prevent backflow, and therefore no suction is applied to the fluid reservoir at the U2 outlet 1724. At this stage, the pressure sensor connected to the U3 outlet 1726 can sense the pressure of the cooling fluid 603 transferred in the syringe chamber 1404, for example.

[0170] At the fourth operation, the V1 valve is closed. At this stage, the U1 and U2 outlets 1724 can be in fluid communication with each other, and the U3 and U4 outlets 1728 can be isolated from the other outlets in the upper fluid circuit 1702. Therefore, the syringe piston 702 of the second syringe barrel 412 can be advanced to push the fluid from the syringe chamber 1404 into the fluid reservoir. More specifically, the cooling fluid 603 can enter the U1 outlet 1722 from the syringe chamber 1404, pass through the rear fluid channel 1804 of the upper fluid circuit 1702, and leave the U2 outlet 1724 through the conduit 1406 (and the check valve) to fill the fluid reservoir.

[0171] The above operations can be performed in series and / or in parallel to circulate the cooling fluid 603 through the balloon catheter 101. For example, adding fluid to the balloon in a second operation can be performed simultaneously with removing fluid from the balloon in a third operation to balance the positive and negative pressures in the balloon so that the balloon diameter remains constant while maintaining the temperature of the cooling fluid 603 within the balloon. Control of the operations can be provided based in part on pressure data fed back to one or more processors by a pressure sensor connected to the cassette manifold 1402.

[0172] Reference Figure 19 , shows a perspective view of the piston of the cartridge manifold according to an embodiment. The valve for opening and closing the fluid port 1706 may include a piston 1610. More specifically, the piston 1610 can interact with the fluid transfer plate 1602 to seal and unseal the fluid port 1706. In one embodiment, the piston 1610 includes an end seal 1902. As described below, the piston 1610 can be placed in an open position, wherein the end seal 1902 unseals (does not block) the corresponding fluid port 1706 to allow the cooling fluid 603 to pass through the fluid port 1706. The piston 1610 can be moved from the open position to a closed position, wherein the end seal 1902 seals (blocks) the corresponding fluid port 1706 to prevent the cooling fluid 603 from passing through the fluid port 1706. Therefore, the piston 1610 acts as a valve to control the fluid flowing therethrough by covering or exposing the fluid port 1706.

[0173] In one embodiment, end seal 1902 has a rounded distal surface. The distal surface can be flat. The seal can include a resilient, cylindrical plug embedded in the body of piston 1610. One side of the plug extends distally from the body to seal against an opposing surface. For example, end seal 1902 can be pressed against rear plate surface 1802 of fluid transfer plate 1602. More specifically, one side of end seal 1902 can seal against rear plate surface 1802 at a corresponding valve seat surrounding a corresponding fluid port 1706 to close the valve. Therefore, end seal 1902 can be sized to be larger than fluid port 1706. For example, the diameter of the face of end seal 1902 can be larger than (e.g., twice) the diameter of fluid port 1706.

[0174] As described above, piston 1610 can be spring-loaded. Piston 1610 can include a spring groove 1904. Spring groove 1904 can include an annular groove sized and shaped to receive the proximal end of spring 1612. Spring 1612 can be a helical compression spring 1612. The distal end of spring 1612 can similarly engage a corresponding spring groove 1904 at the valve seat. Spring groove 1904 can stabilize spring 1612 and allow spring 1612 to act on back plate surface 1802 and piston 1610. Thus, spring 1612 can bias piston 1610 outward to maintain piston 1610 in a normally open position, wherein end seal 1902 is deflected from back plate surface 1802 to allow fluid to flow through fluid port 1706.

[0175] Piston 1610 may include side seals 1906 to seal against one of the manifold plates. For example, side seals 1906 may seal against tail plate 1504. Thus, piston 1610 may include end seals 1902 for pressing against rear plate surface 1802 of fluid transfer plate 1602 and side seals 1906 for sealing against tail plate 1504. In one embodiment, side seals 1906 may include O-rings that fit within grooves in the body of piston 1610. Thus, end seals 1902 may have an annular distal surface. The O-rings may extend laterally beyond the cylindrical wall of the body, so that when the piston body is inserted into the receiving hole of tail plate 1504, side seals 1906 may press against and seal against tail plate 1504. Side seals 1906 may maintain a seal while sliding against tail plate 1504, allowing piston 1610 to move axially within tail plate 1504. Thus, the piston 1610 may be advanced to block the corresponding fluid port 1706 or retracted to open the corresponding fluid port 1706 .

[0176] Reference Figure 20 , shows a perspective view of a piston of a cartridge manifold according to an embodiment. End seal 1902 may include an O-ring. The O-ring may be disposed within a groove in one end of piston 1610. For example, the groove may be machined and the O-ring may be press-fitted into the groove. Alternatively, to more securely retain the O-ring, the body of piston 1610 may be injection molded around the O-ring. Thus, end seal 1902 may be tightly secured within the body of piston 1610. In either case, end seal 1902 may extend distally from the body of piston 1610 so that the seal may press against rear plate surface 1802 when piston 1610 is moved to the closed position. The outer diameter of annular end seal 1902 may be sized to be larger than fluid port 1706. For example, the outer diameter of O-ring end seal 1902 may be larger than (e.g., twice) the diameter of fluid port 1706.

[0177] Reference Figure 21, showing a cross-sectional view (along the Figure 18 (The piston 1610 may be a free-floating piston 1610 having side seals 1906 to radially seal against the transom 1504, as described above. Additionally, the end seal 1902 may face the fluid port 1706 in the fluid transfer plate 1602. However, in the open position, the spring 1612 may maintain the end seal 1902 spaced apart from the fluid port 1706. Furthermore, the fluid pressure within the fluid channel in front of the end face 1852 may press against the end face 1852, biasing the piston 1610 to the open position. Thus, the cooling fluid 603 may flow through the front fluid channel 1604 and the fluid port 1706 and into the rear fluid channel 1804.

[0178] Reference Figure 22 , showing a cross-sectional view (along the sectional view) of a piston of a cartridge manifold in a closed position according to an embodiment Figure 18 AA). Solenoid 2202 can be actuated (force vectors are shown, but solenoid 2202 is omitted) to push piston 1610 forward. The force of solenoid 2202 can overcome spring 1612 and fluid pressure acting in the opposite direction on piston 1610 to move piston 1610 to the closed position. In the closed position, end seal 1902 blocks the path of fluid flow through fluid port 1706. More specifically, cooling fluid 603 is prevented from flowing through fluid port 1706 to or from front fluid channel 1604.

[0179] Notably, the solenoid 2202 can close the valve using a force of less than 10 lbf (e.g., 5 lbf or less). This closing force is advantageous relative to alternative valve designs, such as pinch valves that squeeze the tubing of the tube 1406. Thus, the cartridge manifold 1402 can also be designed to withstand lower compressive forces, thereby allowing for the use of less material in the design and achieving a more compact form factor.

[0180] The valve can be switched from Figure 22 The closed position can be reversibly moved to Figure 21 Open position: De-energize the solenoid 2202. When the solenoid 2202 is no longer energized, the compression spring 1612 can act on the piston 1610 to return the piston 1610 to the open position.

[0181] like Figures 21 to 22 As shown, in the open position ( Figure 21 ) and closed position ( Figure 22) In both positions of the piston 1610, the rear piston surface 2102 of the piston 1610 can be located behind the back surface 2104 of the tail plate 1504. By maintaining the rear piston surface 2102 beyond the back surface 2104 in both piston 1610 positions, contact between the solenoid 2202 and the piston 1610 is facilitated. More specifically, the likelihood of the solenoid 2202 losing contact with the rear piston surface 2102 is reduced because the rear piston surface 2102 does not enter the hole in the tail plate 1504 below the back surface 2104 in the shape of a recess 1210.

[0182] The above is aimed at Figures 19 to 22 The piston embodiments described are provided by way of example only and not limitation. Other piston embodiments may be incorporated into the cartridge manifold to control the flow of fluid through the fluid ports. For example, as described below with respect to Figures 53 to 55 As described, the piston embodiments may include a diaphragm seal to mechanically constrain and seal the piston relative to the fluid transfer plate. More particularly, the piston may be sealed to the surrounding structure by a flexible flange-like seal that allows the piston to move axially relative to the fluid transfer plate to open and close the fluid ports.

[0183] Non-invasive pressure / flow sensors

[0184] As described above, the pressure sensor used to monitor balloon inflation can be integrated directly into the disposable portion of the system (e.g., the fluid transfer cartridge 204). However, the pressure sensor is invasive, meaning it comes into direct contact with the inflation fluid. Due to this direct contact, the pressure sensor must be discarded after each procedure. However, pressure sensors are expensive, and thus the current practice of using invasive pressure sensing increases the cost of each procedure.

[0185] Reference Figure 23 , shows a side view of a generator for an ultrasound-based therapy system according to an embodiment. Pressure and / or flow sensors can be integrated into the generator 202 rather than incorporated into the fluid transfer cartridge 204. Additionally, the pressure and / or flow sensors located in the generator can be non-invasive, meaning they do not directly contact the inflation fluid used to inflate the balloon. Non-invasive sensors can be used in multiple procedures, thus reducing the cost of disposable parts by removing expensive sensors from the cartridge design.

[0186] In one embodiment, the pressure fitting 2302 is mounted on the generator housing 304. As described above, the generator housing 304 has a cartridge receptacle 302 configured to receive the fluid transfer cartridge 204. Thus, when the fluid transfer cartridge 204 is loaded into the cartridge receptacle 302 of the generator 202, the pressure fitting 2302 can be positioned behind the cartridge. The pressure fitting 2302 can be configured to connect to one or more conduits 1406 of the fluid transfer cartridge 204. For example, when the fluid transfer cartridge 204 is loaded into the generator 202, a fitting connected to a conduit 1406 in the fluid transfer cartridge 204 can engage the pressure fitting 2302 of the generator 202. In one embodiment, the pressure fitting 2302 can be connected to the cartridge manifold 1402 via the conduit 1406, for example, to an outlet of the manifold. Thus, the pressure fitting 2302 can be used to transmit pressure from the cartridge manifold 1402 to the generator 202.

[0187] Reference Figure 24 , showing a cross-sectional view (along the Figure 23 AA). In one aspect, the generator 202 incorporates a non-invasive pressure sensor 2402 to monitor and measure the fluid transferred (e.g., delivered to the airbag) by the fluid transfer cartridge 204. In one embodiment, the generator 202 includes a pressure sensor 2402 within the generator housing 304. The pressure sensor 2402, integrated within the generator 202, is separate from the fluid transfer cartridge 204. The pressure sensor 2402 can be configured to sense the pressure at the pressure fitting 2302. Thus, the pressure sensor 2402 can be used to measure the pressure of the fluid delivered to the airbag via the fluid transfer cartridge 204. Nevertheless, the pressure sensor 2402 can remain within the generator 202 (and be reused) when the cartridge is removed and discarded.

[0188] A pressure sensor 2402 located in the generator (which can replace the pressure sensor located in the cartridge described above) can sense the inflation fluid in a non-invasive manner. For example, the pressure fitting 2302 can have a diaphragm that contacts the cooling fluid 603 but isolates it from the generator cavity. Thus, the pressure sensor 2402 can be connected to a fluid line in the cartridge (e.g., a tee) to a fluid line in the generator 202, while the pressure and / or flow sensor in the generator 202 can be isolated from the fluid in the cartridge. Thus, the cooling fluid 603 supplied to the balloon can be sensed without being contacted by the pressure sensor 2402. The sensor in the generator 202 can effectively monitor the fluid supplied to the balloon without being contaminated. Thus, the pressure sensor 2402 is non-invasive and reusable, thereby reducing the cost of disposable components of the treatment system 100.

[0189] In one embodiment, the diaphragm of the pressure fitting 2302 acts on a fluid (such as air) in a line between the pressure fitting 2302 and the pressure sensor 2402. For example, a chamber (e.g., air chamber 2404) can be inserted between the pressure fitting 2302 (and thus the fluid line in the cartridge) and the fluid line in the generator 202. The chamber can have a chamber inlet 2406 connected to the pressure fitting 2302 and a chamber outlet 2408 connected to the pressure sensor 2402. When the diaphragm is acted upon by the fluid in the cartridge, the air in the chamber can be compressed, and thus, the air pressure can change as the bladder inflation pressure changes. These changes can be sensed by the pressure sensor 2402.

[0190] As further described below, several types of non-invasive sensors are contemplated. In alternative embodiments, the chamber is a fluid chamber that can be filled with a liquid rather than air. More specifically, the chamber and / or tubing between the diaphragm of pressure fitting 2302 and pressure sensor 2402 can be filled with an incompressible fluid. This incompressible fluid can be acted upon by the diaphragm to transfer pressure from fluid transfer cartridge 204 to generator 202 for non-invasive sensing.

[0191] Reference Figure 25 , shows a perspective view of a non-invasive sensor according to an embodiment. Pressure sensor 2402 can alternatively be a flow sensor. The non-invasive pressure and / or flow sensor in generator 202 can be an ultrasonic sensor. This type of sensor can use an ultrasonic signal directed into a fluid line in generator 202 to detect the Doppler shift of the reflected signal. The processor of generator 202 can receive the sensed signal and determine the fluid flow rate in the fluid line based on the Doppler shift. The sensor is non-invasive because the ultrasonic sensor does not contact the fluid supplied to the airbag and transmits information through a plastic tube.

[0192] Reference Figure 26 , shows a perspective view of a non-invasive sensor according to an embodiment. The non-invasive fluid sensor may include a rotatable element mounted in a housing having an inlet and an outlet. The inlet and outlet may be connected to a fluid line within the generator 202, which in turn is in fluid communication with a fluid line within the cartridge. As fluid flows through the housing, the blades of the rotatable element are driven. An optical sensor mounted outside the housing may detect the speed of the blades through the housing wall. The sensed signal may be provided to a processor of the generator 202 to determine the pressure and / or flow rate of the fluid within the fluid line based on the movement of the blades.

[0193] It should be understood that other non-invasive sensor types can be used. For example, motor 1108 can drive the plunger of the cartridge to deliver and withdraw fluid from the balloon. The force required to drive motor 1108 or the torque output of motor 1108 can be sensed. The sensed motor parameters (input or output parameters) can be used by the processor of generator 202 to determine the pressure and / or flow rate of the fluid delivered to the balloon without the sensor actually contacting the fluid.

[0194] In one embodiment, a force sensor can detect the force applied to the sensor by a fluid line. For example, the fluid line can include a compliant tube portion that can be positioned against the force sensor. As the pressure within the compliant tube increases or decreases, the force applied to the sensor will increase or decrease because the tube wall will expand or contract. The sensed force can be provided to a generator processor to determine the pressure or flow rate of the fluid within the fluid line based on the force. The force sensor does not directly contact the fluid and is therefore a non-invasive sensor that can be used in a variety of processes.

[0195] Using non-invasive sensors in the generator 202 to monitor fluid delivered to / from the balloon, rather than using invasive sensors in the fluid transfer cassette 204, can allow for: reducing the cost of manufacturing the cassette, enabling the fluid monitoring sensors to be used in multiple processes, and thereby reducing the cost of each process.

[0196] Pneumatic syringe drivers

[0197] As mentioned above, the fluid drive system can be mechanically driven. More specifically, the drive system can include a stepper motor and a transmission with several gears and screws. However, mechanical system components can increase the cost and space requirements of the system. In addition, the drive system can be complex.

[0198] The mechanically driven fluid drive system can be replaced by a pneumatically driven fluid drive system. More specifically, the screw drive can be replaced by a pneumatic pressure line. While the screw drive moves the shaft of the syringe by advancing the gear mechanism of the screw, the pneumatic pressure line can use positive and negative pressure to advance / retract the stopper 608.

[0199] Refer again Figure 24 The system may incorporate a pneumatic drive system 2410 to advance and / or retract the stopper 608 of the syringe that supplies the inflation fluid to the balloon. The generator 202 may include a pneumatic accessory 2304 ( Figure 23 ), the pneumatic accessory is connected to the pneumatic drive system 2410. More specifically, the pneumatic accessory 2304 can be mounted on the generator housing 304.

[0200] The pneumatic fitting 2304 can be connected to a pneumatic drive system 2410. The pneumatic drive system 2410 can be located in the generator housing 304. The pneumatic drive system 2410 can be configured to apply one or more of positive pressure or negative pressure to the pneumatic fitting 2304. For example, the pneumatic drive system 2410 can include a pneumatic pump and / or a vacuum pump that increases or decreases the pressure at the pneumatic fitting 2304.

[0201] Reference Figure 27 , shows a front view of the interior portion of a fluid transfer cartridge according to an embodiment. A pneumatic drive system 2410 can be connected to a pressure line 2702 connected to a syringe. For example, pressure line 2702 can be a section of tubing extending from pneumatic fitting 2304 to a syringe connector attached to the base of syringe barrel 408. By applying positive and negative pressure to pressure line 2702, the syringe's stopper 608 can be driven back and forth within syringe barrel 408. More specifically, positive pressure delivered to pressure line 2702 via pneumatic fitting 2304 can drive stopper 608 upward to advance cooling fluid 603 into the distal fluid line, while negative pressure applied to pressure line 2702 via pneumatic fitting 2304 can drive stopper 608 downward to withdraw inflation fluid from the fluid line. Thus, inflation fluid can be delivered to and withdrawn from the balloon during a procedure.

[0202] Reference Figure 28 , shows a cross-sectional view of an interior portion of a fluid transfer cartridge having a pneumatically driven syringe, according to an embodiment. The syringe may include a corresponding stopper 608. Stopper 608 may be disposed between distal syringe chamber 2802 and proximal syringe chamber 2804 within syringe barrel 408. Proximal syringe chamber 2804 is in fluid communication with pneumatic fitting 2304, and distal syringe chamber 2802 is in fluid communication with a fluid network at the distal end of the syringe. As described above, the fluid network may include a fluid reservoir. Thus, distal syringe chamber 2802 may be in fluid communication with the fluid reservoir, for example, via cartridge manifold 1402. When pneumatic fitting 2304 applies positive pressure to proximal syringe chamber 2804, stopper 608 advances to expel cooling fluid 603 from distal syringe chamber 2802. When pneumatic fitting 2304 draws a vacuum from proximal syringe chamber 2804, stopper 608 retracts to draw cooling fluid 603 into syringe barrel 408.

[0203] The use of a pneumatic drive system 2410 simplifies fluid drive design. A pneumatic system requires fewer disposable components because it uses a simple pressure line 2702 instead of gears and screws. Thus, the complexity and cost of the system can be reduced.

[0204] In one embodiment, the syringe can be completely removed from the box and relocated near the fluid reservoir. Alternatively, the syringe can be provided as part of an assembly including a syringe and a fluid reservoir, which can then be connected to the generator 202. In either case, the box can be completely eliminated because the fluid transfer function can be performed directly by the generator 202. In this case, the generator 202 can have inlet / outlet fluid lines that transfer fluid from the fluid reservoir directly to the airbag without having to transfer through the box. The generator 202 can include a pressure line 2702 connected to the syringe, and the syringe can directly receive / output fluid to the reservoir. The generator 202 can include a pinch valve connected to the syringe, and the syringe can directly receive / output fluid to the reservoir. Therefore, converting from a mechanical drive mode to a pneumatic drive mode can substantially reduce the complexity and cost of the treatment system 100.

[0205] Contactless syringe position sensing

[0206] As described above, the positioning of the syringe piston 702 can be sensed by a switch. More specifically, a mechanical switch and / or a magnetic switch can be used to detect the position of the piston end. One or more processors of the generator 202 can use position feedback to detect and / or determine when the syringe is empty or full. Mechanical switches can be prone to failure. In addition, such switches need to be precisely placed in the generator 202 to provide accurate data. Magnetic switches tend to provide lower position resolution. Therefore, the precision of such switches is required. Therefore, the treatment system 100 can benefit from a rugged, durable, and accurate position sensing component. The system can also benefit from information about the position of the syringe piston 702 throughout the entire process, rather than just at the empty or full position.

[0207] Reference Figure 29 , shows a cross-sectional view of an interior portion of a fluid transfer cartridge having a non-contact position sensor according to an embodiment. The generator 202 may include a non-contact position sensor 2904 mounted in the generator housing 304. The non-contact position sensor 2904 may be configured to detect the position of the syringe piston 702. More specifically, the non-contact position sensor 2904 may be positioned and oriented such that a line of sight 2906 of the sensor is directed toward the portion of the syringe where the syringe is connected to the stopper 608. For example, the sensor may direct radiation (e.g., light) toward the piston and sense reflected radiation that indicates the position of the piston end 2902.

[0208] In one embodiment, the non-contact position sensor 2904 includes a time-of-flight sensor 2908. The time-of-flight sensor 2908 can be oriented parallel to the central axis of the syringe and / or syringe piston 702. For example, the time-of-flight sensor 2908 can be mounted on the bottom wall of the generator housing 304 that faces upward toward the syringe. Thus, the sensor can be positioned in the longitudinal direction, which is the direction of shaft movement.

[0209] The time-of-flight sensor 2908 can emit radiation toward the piston end 2902, and a certain amount of the radiation can be reflected by the piston 1610 back to the time-of-flight sensor 2908. The reflected signal can be processed by one or more processors of the generator 202 to determine the distance between the time-of-flight sensor 2908 and the piston end 2902. More specifically, the time it takes for the radiation to travel to the piston end 2902 and bounce back to the sensor can be measured and used to determine the distance. Based on the known geometric relationship between the piston end 2902 of the syringe and the stopper 608, information about the volume of the cooling fluid 603 in the syringe can be determined.

[0210] In one embodiment, the non-contact position sensor 2904 includes a proximity sensor 2910. The proximity sensor 2910 can be oriented parallel to the direction of shaft movement, as described above. However, in one embodiment, the proximity sensor 2910 has a line of sight 2906 that is orthogonal to the direction of shaft movement. For example, the non-contact position sensor 2904 can be mounted on a sidewall of the generator housing 304 and can be directed radially through a cavity that receives the syringe piston 702 during syringe operation.

[0211] The proximity sensor 2910 can provide a "yes-no" indication of whether the piston end 2902 has reached a predetermined position along the direction of movement. When the piston end 2902 moves downwardly within the cavity to that position, the proximity sensor 2910 will detect the presence of the piston end 2902. More specifically, as the piston end 2902 passes through the line of sight 2906, the intensity of the reflected radiation sensed by the proximity sensor 2910 will change. Thus, the proximity sensor 2910 can detect the position of the piston end 2902. Several proximity sensors 2910 can be placed along the sidewall to detect different positions of the piston end 2902 corresponding to the fluid level of the syringe. For example, several proximity sensors 2910 can sense the piston position corresponding to the syringe being full, half full, and empty of cooling fluid.

[0212] The syringe position data generated by the non-contact position sensor 2904 can be used to determine the volume of fluid delivered to the balloon catheter 101. This data can be continuous, for example, throughout the entire syringe stroke, and therefore can provide an indication of the position of the syringe at each position along the stroke. In addition, the non-contact position sensor 2904 can be stably mounted on the generator housing 304, and its position can be calibrated so that the position data can be accurate. Time-of-flight, proximity, and other types of non-contact position sensors 2904 are relatively inexpensive, and therefore can be implemented at low cost.

[0213] It should be understood that alternative sensors and sensor arrangements can be used. For example, the non-contact position sensor 2904 can include an acoustic sensor rather than an optical sensor. The acoustic sensor transmits and receives acoustic signals to determine the presence of and distance from a surface (e.g., piston end 2902).

[0214] The location of the sensor can also be moved to any location within the generator 202. For example, a structure other than the generator housing 304 can provide a mounting location for the non-contact position sensor 2904. In one embodiment, the non-contact position sensor 2904 can be mounted on a structure other than the generator 202. For example, the sensor can be placed on the syringe shaft 704. In this case, the time-of-flight sensor 2908 can be mounted on the shaft end 706. The sensor can be directed toward the direction of shaft movement to sense movement of the shaft 704 based on a change in distance between the sensor and an adjacent surface (e.g., the generator housing 304).

[0215] The position of the sensor can also be moved to any position in the box. For example, a structure other than the box housing can provide a mounting location for the non-contact position sensor 2904. In one embodiment, the non-contact position sensor 2904 can be mounted on a structure other than the box. For example, the sensor can be placed on the syringe shaft 704. In this case, a time-of-flight sensor 2908 can be mounted on the shaft end 706. The sensor can be guided toward the direction of shaft movement to sense the movement of the shaft 704 based on the distance change between the sensor and the adjacent surface (e.g., box housing).

[0216] Fluid reservoir testing

[0217] The treatment system 100 includes a fluid reservoir containing a cooling fluid 603 that circulates through the balloon catheter 101. The fluid reservoir can be a container that holds the cooling fluid 603. For example, the container can be a bag containing the cooling fluid 603. The cooling fluid 603 can be selected based on the procedure and / or device being used. For example, some balloon catheters 101 may work best with sterile water, while other configurations may work with saline. Therefore, the presence and type of the fluid reservoir (e.g., its volume and contents) are important for proper system performance. In one embodiment, the treatment system 100 is capable of detecting the presence and / or type of fluid reservoir being used during a procedure.

[0218] Reference Figure 30 , shows a perspective view of an ultrasound-based treatment system according to an embodiment. The treatment system 100 can include a fluid reservoir holder 3004 to hold a fluid reservoir 3002. The fluid reservoir holder 3004 can have an attachment 3006 (e.g., a hook) to hold the reservoir. For example, the fluid reservoir 3002 can be a sterile water-filled bag with a loop that can be placed on the attachment 3006 to suspend the bag from the fluid reservoir holder 3004.

[0219] In one embodiment, the system includes a sensor for sensing the presence and / or characteristics of the fluid reservoir 3002. The characteristic may be the weight of the fluid reservoir 3002. For example, a weight sensor 3008 may be coupled to the accessory 3006 to generate weight data based on the weight of the fluid reservoir 3002. The weight sensor 3008 may be mounted within or on the generator housing 304. Alternatively, the weight sensor 3008 may be integrated with the fluid reservoir holder 3004. For example, the weight sensor 3008 may include a strain gauge having an end connected to the accessory 3006 and an end connected to a crossbar or column of the bag suspension structure 3004. Thus, the strain gauge may be located at any location subject to tension, compression, or bending moment due to the weight of the fluid reservoir. Thus, the weight sensor 3008 may detect and / or measure the physical strain generated by such a load to generate data corresponding to the weight of the fluid reservoir 3002.

[0220] The generated data may be used by one or more processors to determine information about the fluid reservoir 3002. More specifically, the one or more processors may receive weight data from the weight sensor 3008 and determine information corresponding to the fluid reservoir 3002 based on the weight data.

[0221] In one embodiment, one or more processors determine whether the fluid reservoir 3002 is present. Presence detection can be used to verify that the fluid reservoir 3002 is available at the appropriate time during the procedure (or to determine whether it has been removed). The fluid reservoir 3002 may be necessary for one or more procedural operations (e.g., priming and inflation of the balloon catheter 101). When the fluid reservoir 3002 is not present (e.g., when the fluid bag is not suspended from the bag holder), these procedural operations may fail, which may undesirably prolong the procedure.

[0222] The one or more processors can determine the presence of the fluid reservoir 3002 based on weight data that is above a predetermined weight threshold or within a predetermined weight range. The one or more processors can generate a presence signal based on the weight. The presence signal can serve as a gate for a logical sequence in the process. For example, the presence signal can allow the user interface to proceed to a subsequent operation in the preparation process, or generate an error message prompting the user to load or replace the fluid reservoir 3002.

[0223] In addition to acting as a logic gate, weight data can also be used as an interlock for other system components. For example, when the fluid reservoir 3002 is not present, the syringe drive system can be disabled to prevent operation when no cooling fluid 603 is available to fill the syringe barrel 408. Presence is only one of the characteristics that can drive the above decision. Other characteristics that can be sensed include fluid reservoir type (including cooling fluid type) and / or leak detection.

[0224] In one embodiment, one or more processors determine whether the fluid reservoir is a predetermined fluid reservoir. The weight of the fluid reservoir 3002 can be known based on the volume and density of the cooling fluid 603 stored in the reservoir. For example, a specific volume of saline may have a different weight than the same volume of sterile water. In addition, the fluid reservoir can be made of different materials (such as vinyl or silicone), which can also affect the predetermined weight of the fluid reservoir 3002. The treatment system 100 can be calibrated or programmed with a specific fluid reservoir of known weight. Therefore, one or more processors can use weight data to determine whether a specific fluid reservoir with a specified cooling fluid volume and / or type is installed on the fluid reservoir holder 3004.

[0225] Some balloon catheters 101 can be optimally operated using sterile water as the cooling fluid 603 for the transducer 108. For example, using saline instead of sterile water in such transducers may cause the transducer to malfunction. Therefore, one or more processors can determine whether the fluid reservoir 3002 contains sterile water or saline based on the weight of the bag. When one or more processors determine that the fluid reservoir 3002 contains sterile water, the process can be allowed to continue. Alternatively, if the bag contains saline, one or more processors can generate an error signal and / or stop the operation of other system components to prevent damage to the transducer 108. For example, if a specific weight is not detected, the system can prompt the user to verify whether sterile water (or glucose, etc.) is being used. Therefore, the weight sensor 3008 can be used to detect whether the correct fluid is being used based on a bag with a specific and unique weight.

[0226] In one embodiment, the one or more processors determine whether a leak exists in the fluid reservoir 3002. The weight data can be used to detect changes in the bag weight during the procedure. More specifically, the one or more processors can detect changes in the weight of the fluid reservoir 3002 during the procedure, which can indicate a loss of fluid due to a leak. In response to leak detection, the system can generate an error message and / or prompt the user to verify that the fluid reservoir 3002 is not leaking or to take another corrective action.

[0227] Reference Figure 31 , shows a cross-sectional view of the driving mechanism of the fluid transfer box according to the embodiment. Figure 8 As depicted, the drive mechanism includes a shaft 704 of a syringe piston 702 having external threads 802, and a gear 804 having internal threads 1109 that engage with the external threads 802. In one embodiment, the external threads 802 and internal threads 1109 are configured to prevent binding between the threads. For example, when using a standard thread design where there is insufficient clearance between the crest and root of the mating threads, binding between the threads may occur. More specifically, binding is more likely to occur when the working depths of the external threads 802 and internal threads 1109 are equal. In one embodiment, the external threads 802 and internal threads 1109 have different working depths. For example, the external threads 802 may have an external working depth 3102, and the internal threads 1109 may have an internal working depth 3104. The external working depth 3102 may be greater than the internal working depth 3104. For example, the external working depth 3102 may be at least 25%, for example, 50%, greater than the internal working depth 3104. The varying working depths allow the threads to securely engage without binding as the shaft 704 is driven by the gear 804 .

[0228] Reference Figure 32, shows a block diagram of a controller of a treatment system according to an embodiment. This block diagram represents an exemplary embodiment of the controller described above. The controller 3200 is shown as including one or more processors 3202, a memory 3204, a user interface 3206, and an ultrasonic excitation source 3208, but may include additional and / or alternative components. Although not specifically shown, the processor 3202 can be located on a control board or more typically a printed circuit board (PCB) along with additional circuitry of the controller 3200. The processor 3202 can communicate with the memory 3204, which can include a non-transitory computer-readable medium storing instructions. The processor 3202 can execute instructions to cause the treatment system 100 to perform the methods described herein. The user interface 3206 interacts with the processor 3202 to transmit electrical signals at a selected actuation frequency to the ultrasonic transducer 108 via a connecting cable and wires extending through the wiring of the catheter shaft 704. These wires electrically couple the controller 3200 to the transducer 108 so that the controller 3200 can send electrical signals to the transducer 108 and receive electrical signals from the transducer 108. The processor 3202 can control the ultrasonic excitation source 3208 to control the amplitude and timing of the electrical signals, thereby controlling the power level and duration of the ultrasonic signals emitted by the transducer 108. More generally, the controller 3200 can control one or more ultrasonic treatment parameters used to perform ultrasonic treatment. In some embodiments, the excitation source can also detect the electrical signals generated by the transducer 108 and transmit such signals to the processor 3202 and / or control board circuitry. Although the ultrasonic excitation source 3208 is Figure 32 Although shown as part of the controller 3200, the ultrasonic excitation source 3208 can also be located outside the controller 3200 while still being controlled by the controller 3200, and more specifically, by the processor 3202 of the controller 3200.

[0229] The user interface 3206 may include a touch screen and / or buttons, switches, etc. to allow an operator (user) to enter patient data, select treatment parameters, view records stored on a storage / retrieval unit (not shown), and / or otherwise communicate with the processor 3202. The user interface 3206 may include a voice-activated mechanism for entering patient data or may be capable of communicating with an additional device such that the controller 3200 is controlled via a separate user interface 3206 (e.g., a wired or wireless remote control). In some embodiments, the user interface 3206 is configured to receive operator-defined inputs, which may include, for example, the duration of energy delivery, one or more other temporal aspects of energy delivery pulses (e.g., frequency, duty cycle, etc.), power, body lumen length, operating mode, verification of patient parameters (e.g., height and weight), and / or arterial diameter, or a combination thereof. Exemplary operating modes may include, but are not limited to, system startup and setup, catheter preparation, balloon inflation, balloon apposition verification, pre-cooling, sonication, post-cooling, balloon deflation, and catheter removal. In certain embodiments, user interface 3206 provides a graphical user interface (GUI) that instructs the user on how to properly operate treatment system 100. User interface 3206 may also be used to display treatment data for review and / or download and to allow software updates and / or the like.

[0230] The controller 3200 can also control a cooling fluid supply subsystem 3210, which can include the fluid transfer cartridge 204 and fluid reservoir 3002 described above, but can include alternative types of fluid pumps and / or the like. The cooling fluid supply subsystem 3210 is fluidically coupled to the catheter shaft and, in turn, to one or more fluid lumens (e.g., 110) of the balloon. The cooling fluid supply subsystem 3210 can be configured to circulate cooling liquid through the catheter 101 to the transducer 108 in the balloon. The cooling fluid supply subsystem 3210 can include components for providing a quantity of cooling fluid 603 to the interior of the balloon at a controlled temperature, desirably at or below body temperature, such as a fluid reservoir 3002 for containing the cooling fluid 603, a pump (e.g., a syringe), a refrigeration coil (not shown), or the like. The processor 3202 interfaces with the cooling fluid supply subsystem 3210 to control the flow of cooling fluid 603 into and out of the balloon. For example, the processor 3202 can control a motor control device connected to a drive motor 1108 that is associated with a pump to control the speed at which the pump (e.g., a syringe) is operated. This type of motor control device can be used, for example, when the pump is a positive displacement pump (e.g., a peristaltic pump). Alternatively or additionally, the control circuit can include a structure connected in the fluid circuit to change the resistance of the circuit to fluid flow, such as a controllable valve (not shown). The processor 3202 can monitor the pressure measurements obtained by the pressure sensors (e.g., P1, P2, and P3) to monitor and control the cooling fluid 603 passing through the catheter 101 and the airbag. The pressure sensor can also be used to determine whether there is a blockage and / or leak in the catheter 101. When the airbag is in an inflated state, the pressure sensor can be used to maintain a desired pressure in the airbag, for example, maintaining a pressure between 10psi and 30psi, but not limited to this. As described in more detail below, the processor 3202 can use sensor measurements from the pressure sensor 2402 and / or one or more of the other sensors to determine the time that the balloon is in apposition with the body cavity and to estimate the inner diameter of the body cavity in order to select an appropriate dose of ultrasonic energy to be delivered to treat tissue surrounding the body cavity.

[0231] The controller 3200 can control the operation of the generator 202 and fluid transfer box 204 components to drive the inflation of the airbag before or during the intervention procedure. For example, the controller 3200 can control the priming process. The priming process can fill one or more of the syringes, fluid manifolds, fluid tubing lines, and airbags of the treatment system 100 with fluid and remove air bubbles from the system. More specifically, the priming process can purge air from the fluid system and prepare the treatment system 100 for delivery to the patient. As described below, the priming process can include draining fluid from the return syringe before filling the injection syringe to avoid introducing air into the injection syringe. As described above, the controller 3200 can also control the inflation process by vertically driving the syringe piston 702 to move the stopper 608 within the syringe and thereby draw fluid into the syringe or drain fluid from the syringe.

[0232] The position of the stopper 608 within the syringe can be determined by the controller 3200 based on a number of sensor inputs. The controller 3200 can receive feedback from the motor 1108 that drives the syringe piston 702 to determine the stopper position. For example, the motor 1108 can provide data corresponding to the number of rotations of the gear 804, and the controller 3200 can determine the distance the stopper 608 has moved within the syringe based on the number of rotations and the known pitch information. In addition, as described above, a magnetic or optical sensor can detect the position of the shaft end 706, such as the starting position 1102. When the shaft end 706 is at the starting position 1102, the stopper 608 can be located at a known position within the syringe.

[0233] Although the motor 1108 feedback and the home position sensor can provide accurate determination of the home position 1102, system slippage of the gear teeth or motor 1108 can result in some inaccuracy as to whether the stopper 608 is exactly at the same home position 1102 after each inflation / deflation cycle. More specifically, as the plunger is driven up and down within the syringe over several cycles, the shaft end 706 can be driven to a different home position 1102 based on the rotation of the motor 1108, without triggering the home sensor. When this occurs, the system may generate an error. However, when the trigger is incorrect, only a slightly different amount of fluid may remain in the syringe compared to when the stopper 608 was in the original home position 1102, which can be troublesome and require the user to re-home the system, even when there is no actual impact on the system's performance.

[0234] To avoid this type of trouble, a homing process can be used that dynamically adjusts the starting position when changes in the starting position will not negatively impact system operation and generates errors when such changes could negatively impact system operation.

[0235] In operation, the fluid transfer cartridge 204 is loaded into the generator 202. When operation begins, the shaft end 706 of the fluid transfer cartridge 204 will be detected or not detected by the homing sensor. If the shaft end 706 is not detected, the controller 3200 can determine that the syringe must be homed before continuing with fluid priming and / or balloon inflation / deflation. If the shaft end 706 is detected, it can be determined that the syringe has been homed.

[0236] In the first case, when the shaft end 706 is not initially detected, the controller 3200 can drive the motor 1108 to raise the syringe piston 702 until the shaft end 706 is detected by the position sensor. This is the initial starting position. The controller 3200 can set the encoder volume to zero at the initial starting position. More specifically, the controller 3200 can determine the position value of the motor 1108 encoder, and this position value can be set as the initial starting position (corresponding to the starting position of the shaft end 706).

[0237] The switch includes positions of always on, always off, and intermittent (between always on and always off). In one embodiment, upon reaching the initial starting position, the shaft end 706 can be in either the always on position or the intermittent position. If the initial starting position is the always on position, then lowering and then raising the shaft end 706 to the initial starting position should trigger the home position sensor. If the initial starting position is the intermittent position, then lowering and then raising the shaft end 706 to the initial starting position may or may not trigger the home position sensor.

[0238] It should be understood that by monitoring the shaft end position and the motor encoder, the position of the shaft end 706 and the remaining fluid volume can be compared. For example, at any position, the motor encoder information can be used to determine the stopper position, and therefore the amount of cooling fluid 603 remaining in the syringe. In one embodiment, when the starting position sensor is triggered, the controller 3200 can determine the remaining fluid volume in the syringe. When the remaining fluid volume is less than a predetermined volume (e.g., 3 to 5 mL), if the position sensor detects the shaft end 706 (even if the motor encoder is not in the same position as the initial starting position), the controller 3200 can set the motor position to a new starting position. Alternatively, if the remaining volume is greater than the predetermined volume (e.g., greater than 5 mL), the controller 3200 can generate an error to require the user to troubleshoot the system and reset it. In either case, the motor encoder can be used to determine the cooling fluid volume in the syringe at all times during startup and / or inflation / deflation.

[0239] In the second scenario, when the shaft end 706 is initially detected, the controller 3200 may drive the motor 1108 to lower the syringe piston 702 to draw a predetermined volume of cooling fluid 603 (e.g., 3 to 5 mL) into the syringe. The home position sensor may be monitored during the lowering process. If the home position sensor turns off during the lowering movement, the motor encoder position may be set by the controller 3200 to a new home position. The controller 3200 may continue to control the system to perform the startup and / or inflation / deflation process. Alternatively, if the home position sensor remains on after the syringe is lowered to draw the predetermined volume of cooling fluid 603 into the syringe, the controller 3200 may generate an error requesting the user to troubleshoot the system and return to the home position. More specifically, if the sensor remains on after the syringe is lowered, it may indicate that the sensor has malfunctioned, and the user may be notified accordingly. In either case, the motor encoder may be driven to perform the startup and / or inflation / deflation process.

[0240] Reference Figure 33 , shows a perspective view of a shaft end with an optical tab according to an embodiment. As described above, the shaft end 706 may include a feature for triggering a position sensor. For example, this feature may be an optical tab 3302, also referred to as an optical feature. Optical tab 3302 may include a tab, a prong, a flag, etc. to trigger an optical sensor. In one embodiment, optical tab 3302 extends radially outward from axis 3304. Axis 3304 may be the longitudinal axis of shaft 704. The radial extension may protrude outward so that when the shaft end 706 is adjacent to the optical sensor, light emitted by the optical sensor in a direction transverse to axis 3304 may be reflected from optical tab 3302. Thus, optical tab 3302 may block the optical sensor, triggering it and indicating to controller 3200 that the shaft 704 and plug 608 are in a specific position.

[0241] Reference Figure 34 , shows a rear view of a cartridge housing of a fluid transfer cartridge according to an embodiment. The cartridge housing 306 of the fluid transfer cartridge 204 includes a cartridge cavity 402 defined in a front housing portion ( Figure 39 ) and the rear shell portion 3402 having the rear face 407. In one embodiment, the rear shell portion 3402 includes a marking recess 3404 ( Figure 35 ), the marking recess is located in the rear face 407. The marking recess 3404 can be a cavity extending longitudinally forward to the rear face 407.

[0242] Reference Figure 35 , shows a rear perspective view of a cartridge housing of a fluid transfer cartridge according to an embodiment. The marking recess 3404 can be an indentation or void extending into the rear face 407 at a depth 3502.

[0243] The size of the marking recess 3404 can correspond to the size of the marking (not shown) received within the marking recess 3404. For example, the marking recess 3404 can have a profile including a height of approximately 1.3 inches and a width of approximately 1.5 inches. The dimensions can be slightly larger than the corresponding height and width of the marking. Similarly, the depth 3502 of the marking recess 3404 can correspond to the thickness of the marking received within the marking recess 3404.

[0244] A label can be mounted in label recess 3404. The label can include product information and can have a predetermined thickness. For example, the label thickness can be the thickness of the substrate on which the product information is printed. The substrate thickness can be, for example, 0.003 to 0.009 inches. In one embodiment, the depth 3502 of label recess 3404 allows space for the label. More specifically, label recess 3404 can be sized so that the label thickness is less than the depth 3502 of label recess 3404. By way of example, label recess 3404 can have a depth 3502 of 0.010 to 0.020 inches, for example, 0.015 inches. This depth 3502 can be greater than the thickness of the substrate, and therefore, when the label is mounted in label recess 3404, it will not interfere with or contact the generator 306 into which the cartridge housing is loaded. Therefore, the generator's latch can align with a corresponding recess in cartridge housing 306, as described below. Thus, the latch can engage cartridge housing 306 and lock it to the generator.

[0245] Reference Figure 36 , shows a perspective view of a syringe piston of a fluid transfer cartridge according to an embodiment. As described above, the syringe piston 702 can be disposed within the syringe barrel 408. Similarly, the syringe barrel 408 can be disposed within the cartridge cavity 402 defined by the cartridge housing 306. The syringe piston 702 includes a stopper 608 and a shaft 704. The shaft 704 extends longitudinally from the stopper 608 to a shaft end 706. In addition, the shaft 704 includes external threads 802, which, as described above, can engage the internal threads 1109 ( Figure 38 ). Gear 804 can be mounted on the box shell 306 ( Figure 34 ).

[0246] Piston recess 806 (as described above for Figure 8 Description)Hidden in Figure 36 In one embodiment, the shaft 704 includes another piston recess 806. More particularly, the piston recess 806 ( Figure 36 shown) can be used with Figure 8 The notches shown are diametrically opposite.

[0247] Reference Figure 37, shows a cross-sectional view of a syringe piston according to an embodiment. Diametrically opposed notches 806 of the shaft 704 are visible in the cross-sectional end view. More specifically, in the figure, a first piston notch 806 is shown at the six o'clock position and a second piston notch 806 is shown at the twelve o'clock position. Such notches 806 can be on opposite sides of the circular profile of the shaft 704. The cross-section was taken near the shaft end 706.

[0248] Reference Figure 38 , shows a cross-sectional view of a fluid transfer cartridge according to an embodiment. The cross-section is taken across notch 806. Each piston notch 806 can extend into the shaft 704 to a corresponding notch base 3801. The notch 806 of the shaft 704 can provide an anti-rotation feature to limit or prevent rotation of the shaft 704 relative to the cartridge housing 306. More specifically, the notch 806 can constrain rotation of the shaft 704 relative to a gear 804 that moves when driven by the generator. Rotation of the shaft 704 relative to the cartridge housing 306 can be constrained by one or more stabilizing prongs 3802 that engage with the notch 806 of the shaft 704. More specifically, the cartridge housing 306 can include several stabilizing prongs 3802 that are inserted into the notches 806 of the shaft 704. In one embodiment, the stabilizing prongs 3802 are separated by gaps 3804. The shaft 704 can extend longitudinally through the gaps 3804 to the shaft end 706. More specifically, shaft 704 can fit within gap 3804 such that stabilizing prongs 3802 are positioned within recesses in shaft 704. When positioned within recesses 806, stabilizing prongs 3802 can engage the walls surrounding the recess. Thus, shaft 704 can move vertically within gap 3804 such that stabilizing prongs 3802 can move vertically within recesses 806; however, stabilizing prongs 3802 and shaft 704 can remain rotationally fixed relative to each other.

[0249] The gap may be a space that fills the distance between the prongs 3802. The prongs 3802 may be diametrically opposed, such as Figure 38However, in one embodiment, several prongs are not diametrically opposed. For example, the cartridge housing 306 may include two or more prongs 3802 arranged about the central shaft axis, but not diametrically opposed. There may be three prongs 3802 distributed around the central shaft axis, such that the prongs are 120° apart from each other. Four prongs 3802 may be 90° apart from each other. Furthermore, the distribution of prongs 3802 may not be symmetrical. For example, two prongs may be 60° apart, and a third prong may be 150° apart from the other two prongs. In any case, a line drawn transverse to the axial direction between adjacent prongs may extend through the distance between the prongs. The space filling this distance may be defined as a gap 3804. Thus, gap 3804 may not extend through the central shaft axis, but may still extend between prongs 3802.

[0250] As described above, a groove along the longitudinal axis of the screw can provide anti-rotation. Adding a second groove (e.g., second piston recess 806) on the side of the shaft 704 opposite to the first groove can improve resistance to rotational movement. More specifically, several (e.g., two) stabilizing prongs 3802 (rather than a single stabilizing prong 3802) can resist rotation of the shaft 704. In addition, the reaction force applied to the shaft 704 by the stabilizing prongs 3802 can be distributed over more surface area, which can reduce the possibility of binding between the shaft 704 and the cartridge housing 306. Therefore, the rotational stability and longitudinal movement of the shaft 704 within the chassis of the cartridge housing 306 can be improved.

[0251] When the stabilizing prongs 3802 become wedged between the teeth of the external thread 802, binding between the shaft 704 and the cartridge housing 306 may occur. To prevent this binding, the stabilizing prongs 3802 may have a longitudinal width that is greater than the pitch 3806 of the external thread 802. More specifically, the thickness of the stabilizing prongs 3802 within the recess, measured in the longitudinal direction along the shaft length, may be greater than the longitudinal distance between adjacent teeth of the external thread 802. In one embodiment, the longitudinal width of the stabilizing prongs 3802 is at least 1.5 times the pitch 3806 of the external thread 802. For example, the longitudinal width may be twice the pitch 3806. Thus, the stabilizing prongs 3802 may be wide enough to consistently contact at least two teeth of the external thread 802 and may be too large to fit between adjacent teeth of the external thread 802. Consequently, the stabilizing prongs 3802 may not bind between the teeth.

[0252] Reference Figure 39, shows a side view of a fluid transfer cartridge according to an embodiment. The cartridge housing 306 can define a cartridge cavity 402 between a front housing portion 3902 and a rear housing portion 3402. In one embodiment, the rear housing portion 3402 includes a sidewall 3904 extending longitudinally from a rear base 3906 to a rear face 407. The rear housing portion 3402 can be inserted into a corresponding cavity of a generator to engage one or more latches of the generator. Accordingly, the fluid transfer cartridge 204 can include several latch retainers 3908 to receive the generator latches. The latch retainers 3908 can extend through the sidewall 3904. For example, the latch retainers 3908 can include a cavity into which the generator latch can be inserted to engage the sidewall 3904 and prevent the fluid transfer cartridge 204 from being removed from the generator.

[0253] Misalignment between the latch retainer 3908 and the generator latch may result in ineffective latching between the fluid transfer cartridge 204 and the generator. More specifically, it has been discovered that alignment between the latch retainer 3908 and the generator latch is critical to the effective function of the fluid transfer cartridge. When the generator latch is not properly aligned with the latch retainer 3908 and / or is not properly guided into the latch retainer, the latch may not engage within the generator and the fluid transfer cartridge 204 may not be secured within the generator. Therefore, in one embodiment, the fluid transfer cartridge 204 includes several latch guides 3910 to widen the area for engagement with the generator latch and allow for angled contact between the sets of latches.

[0254] The latch guide 3910 allows the fluid transfer cartridge 204 to engage the generator latch at a wider range of entry angles. For example, the latch guide 3910 can be formed as a radiused or beveled feature along the rear edge 3912 between the sidewall 3904 and the rear face 407. The rear edge 3912 can be a sharp corner, or a radiused or broken corner. In any case, the latch guide 3910 can have a larger radius than the rear edge 3912.

[0255] Reference Figure 40 , shows a perspective view of latch guides according to an embodiment. Each latch guide 3910 can include a bevel 4002 on a rear edge 3912. The bevel 4002 can be a chamfered bevel that provides a smooth transition between the rear face 407 and the sidewall 3904. Each latch guide 3910 can be longitudinally aligned with a corresponding one of the latch retainers 3908. Thus, the latch guides 3910 can provide guidance for the generator latch to pass over the rear housing portion 3402 and into the corresponding latch retainer 3908. Thus, the latch guides 3910 can increase the engagement range of the latch mechanism to improve the performance of the fluid transfer cartridge 204.

[0256] In addition to guiding the generator latch longitudinally across the surface of the rear housing portion 3402 and into the latch retainer 3908, the latch guide 3910 can also be positioned to guide the generator latch vertically into the latch retainer 3908. For example, the length 4004 of the ramp 4002 of the latch guide 3910 can be greater than the width 4006 of the corresponding latch retainer 3908. When the generator latch is slightly above or below the latch retainer 3908, the latch can still engage the latch guide 3910 and slide into place within the latch guide 3908. Thus, making the latch guide 3910 wider than the latch retainer 3908 can facilitate secure engagement between the generator latch and the latch retainer 3908.

[0257] Reference Figure 41 , shows a perspective view of a latch guide according to an embodiment. Each latch retainer 3908 can include a blind hole extending transversely into the sidewall 3904. More specifically, the guide retainer can have a depth defined by the thickness of a retainer wall 4102 extending around the latch retainer cavity. The thickness of the retainer wall 4102 and the depth of the retainer are sufficient to receive a generator latch. When the generator latch is engaged within the retainer, the generator latch can interfere with the retainer wall 4102 and thereby prevent removal of the fluid transfer cartridge 204 from the generator.

[0258] Reference Figure 42 , shows a perspective exploded view of a fluid transfer cartridge according to an embodiment. The fluid transfer cartridge 204 may include a housing plate 4202 contained within a cartridge cavity 402. As described above, the cartridge cavity 402 may be defined between the front shell portion 3902 and the rear shell portion 3402 of the cartridge housing 306. The housing plate 4202 may be contained within the cartridge cavity 402 between the front shell portion 3902 and the rear shell portion 3402. More specifically, the housing plate 4202 may be inserted into the interior cavity of the rear shell portion 3402 and optionally attached thereto. Thus, the rear shell portion 3402 is not a one-piece design, but rather may include a housing having sidewalls 3904 and a rear face 407, with the housing plate 4202 positioned within the housing in front of the rear face 407.

[0259] The rear housing portion 3402 can be implemented as a multi-piece design. More specifically, the housing plate 4202 and the outer shell of the rear housing portion 3402 can be molded. Thus, the unit part cost and manufacturability of the fluid transfer cartridge 204 can be improved. In addition, several pieces of the rear housing portion 3402 can interact to form a latch retainer 3908. The pieces can fit together so that the latch retainer 3908 is confined between the two pieces. The pieces can interlock to define the latch retainer 3908, and the interlocking structure can provide a stable structure. More specifically, the interlocking parts can fit tightly together to provide a stable system that securely engages the generator latch.

[0260] Reference Figure 43 , shows a perspective view of a housing plate of a fluid transfer cartridge according to an embodiment. Housing plate 4202 may include a plurality of transverse protrusions 4302 extending from plate surface 4304. Plate surface 4304 may be the surface on which transverse protrusions 4302 are located. Transverse protrusions 4302 may be, for example, rectangular protrusions extending outward from plate surface 4304.

[0261] Reference Figure 44 , shows a perspective view of a cartridge housing for a fluid transfer cartridge according to an embodiment. The cartridge housing 306, for example, the rear housing portion 3402, may include a plurality of latch holes 4402. The latch holes 4402 may extend through the sidewall 3904 of the rear housing portion 3402. The latch holes 4402 may be through-holes extending from the outwardly facing surface of the sidewall 3904 into the interior of the cartridge housing 306 including the housing plate 4202.

[0262] Reference Figure 45 , shows a side view of a latch retainer according to an embodiment. When the housing plate 4202 is inserted into the cassette housing 306, the transverse protrusions 4302 of the housing plate 4202 can be inserted into the corresponding latch holes 4402 to form the latch retainer 3908. More specifically, the transverse protrusions 4302 can fill a portion of the latch holes 4402, and the remaining recesses (unfilled portions) can be the latch retainer 3908. The latch retainer 3908 can be defined between retainer walls 4102, which face each other longitudinally across the latch retainer recess. A portion of the retainer wall 4102 can be located on the transverse protrusions 4302, and a portion of the retainer wall 4102 can be located on the side wall 3904. Thus, the latch retainer 3908 can be defined between the transverse protrusions 4302 and the side wall 3904 or the rear face 407. Thus, when the generator latch engages the latch retainer 3908, the latch can be located between the rear face 407 and the lateral protrusion 4302.

[0263] Reference Figure 46 , shows a perspective view of a cartridge housing according to an embodiment. The cartridge housing 306 of the fluid transfer cartridge 204 can include a handle 307, as described above. The handle 307 can extend from the front 404 of the cartridge housing 306 to above the opening (e.g., window 406). The handle 307 allows an operator to grasp and physically control the fluid transfer cartridge 204. For example, an operator can grasp the handle 307 to engage the fluid transfer cartridge 204 into and remove the cartridge from the generator.

[0264] The housing 306 of the fluid transfer cartridge 204 can be injection molded. Injection molding requires a mold gate, which can leave gate marks, such as dimples and / or protrusions. Furthermore, the part can be ribbed to facilitate the molding process. Such protrusions and ribs can interfere with the operator's grip. Furthermore, such surface features can snag on the operator's gloves. Therefore, improvements to the handle interface may be necessary.

[0265] In one embodiment, the handle 307 is formed such that the front surface 4806 of the handle 307 is completely smooth. More particularly, the front surface 4806 can be flat and smooth without mold gate marks. The smooth front surface 4806 is shown in FIG. Figure 46 and can create a seamless aesthetic.

[0266] Reference Figure 47 , shows a rear view of a handle of a cartridge case according to an embodiment. Similar to the front surface 4806 of the handle 307, the handle 307 may include a rear surface 4702. Similar to the front surface 4806, the rear surface 4702 may be completely smooth. For example, the rear surface 4702 may be free of mold gate marks, such as protrusions or hooks.

[0267] Reference Figure 48 , shows a perspective exploded view of a fluid transfer cartridge according to an embodiment. The smooth outer surface of the handle 307 can be achieved using a multi-part design. More specifically, the handle 307 can include a removable front plate 4802 that is attached to the rear handle portion 4804. The removable front plate 4802 can be mounted on the rear handle portion 4804 and can have a completely smooth front surface 4806. More specifically, the front surface 4806 can be free of protrusions, indentations, or other features caused by mold gates. Similarly, as described above, the rear handle portion 4804 can have a completely smooth rear surface 4702.

[0268] Removing the removable front plate 4802 from the rear handle portion 4804 can expose the front surface 4808 of the rear handle portion 4804. The front surface 4808 can have ribs that are an artifact of the molding process used to form the front shell portion 3902. The ribs intersect at a center 4810 of the front surface 4808. In one embodiment, the front surface 4808 has a molding gate 4812. The molding gate 4812 can be located at the center 4810 of the front surface 4808. When the removable front plate 4802 is installed on the rear handle portion 4804, the plate can cover the molding gate 4812. However, when removed, the molding gate 4812 can be exposed. Therefore, when attached to the rear handle portion 4804, the removable front plate 4802 can contain the molding between the smooth front surface 4806 and the smooth rear surface 4702 of the handle 307.

[0269] Reference Figure 49 , shows an end view of a handle of a fluid transfer cartridge according to an embodiment. The end view shows the profile of the front surface 4806. In profile, the front surface 4806 is continuous and smooth. For example, the profile can be flat or curved. More specifically, the front surface 4806 does not have any sharp edges or protrusions that could snag on gloves. The removable front plate 4802 can include a plurality of clamping portions 4902 extending rearward from the front surface 4806. The clamping portions 4902 can be curved inward toward the midplane of the removable front plate 4802. Thus, the clamping portions 4902 can wrap around the rear handle portion 4804 and snap onto it to secure the removable front plate 4802 to the cartridge housing 306.

[0270] Reference Figure 50 , shows a front perspective view of a tubing routing plate according to an embodiment. The fluid transfer cassette 204 can include a tubing routing plate 1002. The tubing routing plate 1002 can be used to cover tubing ports in the front face 404 of the cassette housing 306. The tubing routing plate 1002 can be shaped to securely engage one or more features of the cassette housing 306. For example, the tubing routing plate 1002 can include a tubing slot 5004 formed between a front lip 5006 and a rear lip 5008. As described below, the tubing slot 5004 can receive a feature of the cassette housing 306 to secure the tubing routing plate 1002 and lock it in place relative to the cassette housing 306.

[0271] In one embodiment, the pipe routing plate 1002 is formed from a material having high strength, high stiffness, high heat resistance, and high impact resistance. These properties can be maintained even at low temperatures. By way of example, the pipe routing plate 1002 can be formed from a polycarbonate / acrylonitrile butadiene styrene (PC-ABS) material. This material can maintain dimensional stability over time. As a result, the pipe routing plate 1002 can be strong and durable.

[0272] Reference Figure 51 , shows a rear perspective view of a pipe routing plate according to an embodiment. The pipe routing plate 1002 can include one or more notches 1006, as described above. The notches 1006 can be grooves that mate with protrusions on the cassette housing 306 to form ports through which the fluid conduits 206 can be routed. The pipe routing plate 1002 can include additional features that mate with corresponding features of the cassette housing 306. For example, a rear lip 5102 can extend rearwardly from the body of the pipe routing plate 1002. The rear lip 5102 can engage a corresponding portion of the cassette housing 306 to secure the pipe routing plate 1002 to the cassette housing 306. For example, the rear lip 5102 can be inserted into a corresponding slot in the rear housing portion 3402 or rest on a corresponding lip on the rear housing portion.

[0273] Reference Figure 52, shows a cross-sectional perspective view of a conduit routing plate mounted on a cassette housing according to an embodiment. The cross-sectional view illustrates the interlocking features of the cassette housing 306 and the conduit routing plate 1002. More particularly, the front face 404 of the cassette housing 306 can include tabs 5202 extending into conduit ports. The conduit ports can be windows defined in the front surface of the front face 404, for example, defined by edges 5204. Note that in Figure 52 In the embodiment of the present invention, the duct ports are filled by the duct routing plate 1002, but will become through-holes in the front face 404 when the duct routing plate 1002 is removed. Nevertheless, when the duct routing plate 1002 is engaged with the front face 404, the tabs 5202 can be positioned in the duct slots 5004 of the duct routing plate 1002. The duct routing plate 1002 can engage the front face 404 along the edges 5204 that define the duct ports. The duct routing plate 1002 can be snapped into place, which can improve manufacturability. When the duct routing plate 1002 is so engaged, raised features of the front case, such as the tabs 5202, can lock the duct routing plate 1002 in place.

[0274] The interlocking cassette housing 306 and the tube routing plate 1002 can define a tube routing port 1008. More specifically, the recess 1006 in the front face 404 of the cassette housing 306 and the recess 1006 in the tube routing plate 1002 (all of which can be along the edge 5204) can combine to form the tube routing port 1008. The tube routing port 1008 provides a port through which the fluid tube 206 can be routed.

[0275] Reference Figure 53 , showing a perspective view of a piston of a cartridge manifold according to an embodiment. Figure 54 A cross-sectional view of a piston of a cartridge manifold according to an embodiment is shown. Figures 53 to 54 .

[0276] The valve for opening and closing the fluid ports 1706 may include a piston 1610. More specifically, the piston 1610 may interact with the fluid transfer plate 1602 to seal and unseal the fluid ports 1706. As described above, the piston 1610 may include an end seal 1902. The piston 1610 may be placed in an open position, in which the end seal 1902 unseals (unblocks) the corresponding fluid port 1706 to allow the cooling fluid 603 to pass through the fluid port 1706. The piston 1610 may be moved from the open position to a closed position, in which the end seal 1902 seals (blocks) the corresponding fluid port 1706 to prevent the cooling fluid 603 from passing through the fluid port 1706. Thus, the piston 1610 acts as a valve by covering or uncovering the fluid port 1706 to control the fluid flowing therethrough.

[0277] As described above, the piston 1610 can be spring loaded. The piston 1610 can include a spring groove 1904. The spring groove 1904 can include an annular groove sized and shaped to receive the proximal end of the spring 1612 ( Figure 55 ). Spring 1612 can be a coil compression spring 1612. Optionally, the distal end of spring 1612 can similarly engage a corresponding spring recess in the valve seat. Spring recess 1904 can stabilize spring 1612 and allow spring 1612 to act on back plate surface 1802 and piston 1610. Thus, spring 1612 can bias piston 1610 outward to maintain piston 1610 in a normally open position, wherein end seal 1902 is deflected from back plate surface 1802 to allow fluid to flow through fluid port 1706.

[0278] The piston 1610 may include a diaphragm seal 1906 to form a seal between the piston 1610 and one or more of the manifold plates. The diaphragm seal 1906 may have an annular disc structure including an inner periphery 6504 and an outer periphery 6506. In one embodiment, the diaphragm seal 1906 includes an inner lip 6508 ( Figure 54 ) and an outer lip 6510 having an outer periphery 6506. The lip can have a substantially circular cross-sectional profile, similar to an O-ring, such as the O-ring of the channel seal 1710. Thus, the lips 6508, 6510 can be positioned against respective surfaces to form a seal. For example, the inner lip 6508 can fit within a side recess of the piston 1610 to seal against the surface of the side recess. Similarly, the outer lip 6510 can seal against a surface of the fluid transfer plate 1602. For example, the outer lip 6510 can contact and be clamped between adjacent plates (e.g., the front plate 1502 and the tail plate 1504) to form a seal against the fluid transfer plate 1602 ( Figure 55 ).

[0279] The diaphragm seal 6502 may include a sealing flange 6512 extending radially between the lips. The sealing flange 6512 may include a thin annular membrane. More specifically, the sealing flange 6512 may be disc-shaped and have a thickness that is less than the cross-sectional dimensions of the inner lip 6508 or the outer lip 6510. The sealing flange 6512 may extend radially between the lips 6508, 6510 to constrain the lips relative to each other. More specifically, the lips may be located at the outer edges of the flanges and may move relative to each other when the flanges flex. The diaphragm seal 1906 may be formed from an elastomeric material, such as silicone. Thus, the lips and flanges form part of a flexible seal that can seal the piston 1610 and the fluid transfer plate 1602 and provide for relative movement therebetween.

[0280] Reference Figure 55, showing a cross-sectional view (along the Figure 18 (The piston 1610 may be a free-floating piston having a diaphragm seal 6502 to radially seal against the side surfaces of the piston and the tail plate 1504, as described above. Additionally, the end seal 1902 may face the fluid port 1706 in the fluid transfer plate 1602. In the open position, a spring 1612 may maintain the end seal 1902 spaced apart from the fluid port 1706. Furthermore, the fluid pressure within the fluid channel in front of the end face 1852 may press against the end face 1852, biasing the piston 1610 into the open position. Consequently, the cooling fluid 603 may flow through the front fluid channel 1604 and the fluid port 1706 and into the rear fluid channel 1804.

[0281] As described above, the solenoid 2202 can be actuated to push the piston 1610 forward. The solenoid 2202 force can overcome the spring 1612 and the fluid pressure acting on the piston 1610 in the opposite direction to move the piston 1610 to the closed position (not shown, but similar to the Figure 22 In the closed position, the end seal 1902 blocks the path of fluid flow through the fluid port 1706. More specifically, the cooling fluid 603 is blocked from flowing into or out of the front fluid channel 1604 through the fluid port 1706.

[0282] It should be appreciated that during actuation between the open and closed positions, the seal formed by the sealing flange 6512 is maintained without the lip sliding on the exterior surface. More specifically, rather than the side seal 1906 sliding against the adjacent surface, the lip can remain engaged within the corresponding groove and the flange can flex to allow relative movement of the adjacent surfaces. This action (i.e., flexing rather than sliding) can be advantageous because the diaphragm seal 6502 can maintain the placement and function of the seal controlling the axial movement of the piston relative to the fluid transfer plate, while also eliminating the need for lubrication of the sliding seal and / or the attendant friction that can cause seal failure.

[0283] The foregoing describes embodiments of a therapeutic system. More specifically, embodiments of the therapeutic system are described, either explicitly or implicitly. The following paragraphs summarize some of the described embodiments. More particularly, embodiments are described in the examples listed below.

[0284] Example 1. A fluid transfer cartridge comprising: a cartridge housing defining a cartridge cavity, wherein the cartridge housing includes one or more stabilizing prongs; a syringe barrel disposed within the cartridge cavity; and a syringe piston disposed within the syringe barrel, wherein the syringe piston includes a stopper and a shaft extending longitudinally from the stopper to an axial end, and wherein the shaft includes a plurality of piston recesses, each of the plurality of piston recesses receiving at least one of the one or more stabilizing prongs.

[0285] Example 2. The fluid transfer cartridge of example 1, wherein two of the stabilizing prongs face each other, and the shaft extends through a gap separating the two stabilizing prongs.

[0286] Example 3. The fluid transfer cartridge of example 2, wherein the shaft includes external threads, and further comprising a gear mounted on the cartridge housing, wherein the gear includes internal threads that engage the external threads.

[0287] Example 4. The fluid transfer cartridge of example 3, wherein the one or more stabilizing prongs have a longitudinal width that is greater than a pitch of the external threads.

[0288] Example 5. The fluid transfer cartridge of example 4, wherein the longitudinal width of the one or more stabilizing prongs is at least 1.5 times the pitch of the external threads.

[0289] Example 6. A fluid transfer cartridge comprising: a cartridge housing defining a cartridge cavity, wherein the cartridge housing comprises a plurality of stabilizing prongs separated by gaps; a syringe barrel disposed within the cartridge cavity; and a syringe piston disposed within the syringe barrel, wherein the syringe piston comprises a stopper and a shaft extending longitudinally from the stopper through the gap to an axial end.

[0290] Example 7. The fluid transfer cartridge of example 6, wherein the plurality of stabilizing prongs are located in a plurality of piston recesses of the shaft.

[0291] Example 8. The fluid transfer cartridge of example 7, wherein the shaft comprises external threads, and further comprising a gear mounted on the cartridge housing, wherein the gear comprises internal threads that engage the external threads.

[0292] Example 9. The fluid transfer cartridge of example 8, wherein the plurality of stabilizing prongs have a longitudinal width greater than a pitch of the external threads.

[0293] Example 10. The fluid transfer cartridge of example 9, wherein the longitudinal width of the plurality of stabilizing prongs is at least 1.5 times the pitch of the external threads.

[0294] Example 11. A fluid transfer cartridge comprising: a cartridge housing defining a cartridge cavity between a front housing portion and a rear housing portion, wherein the rear housing portion includes a sidewall extending longitudinally from a rear base plate to a rear face, wherein a plurality of latch retainers extend through the sidewall, and wherein a plurality of latch guides are formed along an edge between the sidewall and the rear face.

[0295] Example 12. The fluid transfer cartridge of example 11, wherein each latch guide of the plurality of latch guides is longitudinally aligned with a corresponding one of the plurality of latch retainers.

[0296] Example 13. The fluid transfer cartridge of example 11, wherein each of the plurality of latch guides comprises a bevel on the edge.

[0297] Example 14. The fluid transfer cartridge of example 13, wherein the length of the ramp is greater than the width of a corresponding one of the plurality of latch retainers.

[0298] Example 15. A fluid transfer cartridge comprising: a cartridge housing defining a cartridge cavity between a front housing portion and a rear housing portion, wherein the rear housing portion includes a marking recess in a rear face, and wherein the marking recess has a depth of 0.01 to 0.02 inches.

[0299] Example 16. The fluid transfer cartridge of example 15, wherein the depth is 0.015 inches.

[0300] Example 17. The fluid transfer cartridge of example 15, further comprising a marking mounted in the marking recess, wherein the marking has a thickness less than the depth of the marking recess.

[0301] Example 18. A fluid transfer box, comprising: a box shell, the box shell defining a box cavity between a front shell portion and a rear shell portion, wherein the rear shell portion includes a side wall extending longitudinally from a rear base plate to a rear surface, and wherein a plurality of latch holes extend through the side wall; and a shell plate, the shell plate being contained within the box cavity between the front shell portion and the rear shell portion, wherein the shell plate includes a plurality of lateral protrusions extending into the plurality of latch holes to define a plurality of latch retainers between the plurality of lateral protrusions and the rear surface.

[0302] Example 19. A fluid transfer cartridge comprising: a cartridge housing defining a cartridge cavity between a front face and a rear face, wherein the cartridge housing includes a handle extending from the front face across an opening, wherein the handle includes a removable front plate.

[0303] Example 20. The fluid transfer cassette of example 19, wherein the handle comprises the removable front plate mounted on a rear handle portion, and wherein a front surface of the removable front plate is substantially smooth.

[0304] Example 21. The fluid transfer cartridge of example 20, wherein the rear surface of the rear handle portion is completely smooth.

[0305] Example 22. The fluid transfer cartridge of example 21, wherein a front surface of the rear handle portion has a molding gate, and wherein the removable front plate covers the molding gate.

[0306] Example 23. The fluid transfer cartridge of example 22, wherein the molding gate is located at a middle portion of the front surface.

[0307] Example 24. A fluid transfer cassette comprising: a cassette housing defining a cassette cavity between a front face and a rear face, wherein the front face includes a tab extending into a tubing port defined by an edge; and a tubing routing plate engaging the front face along the edge, wherein the tab is positioned in a tubing slot of the tubing routing plate.

[0308] Example 25. The fluid transfer cassette of example 24, wherein the front face and the tubing routing plate include corresponding notches at the edge, and wherein the corresponding notches combine to form a tubing routing port through which fluid tubing is routed.

[0309] In the foregoing specification, the present disclosure has been described with reference to specific exemplary embodiments thereof. It will be apparent that various modifications may be made thereto without departing from the broader spirit and scope of the present disclosure as set forth in the following claims. The specification and drawings are, therefore, to be regarded in an illustrative rather than a restrictive sense.

Claims

1. A fluid transfer box, characterized in that The fluid transfer box includes: a cartridge housing defining a cartridge cavity, wherein the cartridge housing includes one or more stabilizing prongs; a syringe barrel disposed within the cartridge cavity; and A syringe piston is disposed within the syringe barrel, wherein the syringe piston includes a stopper and a shaft extending longitudinally from the stopper to an axial end, and wherein the shaft includes a plurality of piston recesses, each of the plurality of piston recesses receiving at least one of the one or more stabilizing prongs.

2. The fluid transfer cassette of claim 1 , wherein two of the stabilizing prongs face each other, and the shaft extends through a gap separating the two stabilizing prongs.

3. The fluid transfer cartridge of claim 2, wherein the shaft includes external threads, and further comprising a gear mounted on the cartridge housing, wherein the gear includes internal threads that engage the external threads.

4. The fluid transfer cartridge of claim 3, wherein the one or more stabilizing prongs have a longitudinal width greater than a pitch of the external threads.

5. The fluid transfer cartridge of claim 4, wherein the longitudinal width of the one or more stabilizing prongs is at least 1.5 times the pitch of the external threads.

6. A fluid transfer box, characterized in that The fluid transfer box includes: a cartridge housing defining a cartridge cavity, wherein the cartridge housing includes a plurality of stabilizing prongs separated by gaps; a syringe barrel disposed within the cartridge cavity; and A syringe piston is disposed within the syringe barrel, wherein the syringe piston includes a stopper and a shaft extending longitudinally from the stopper through the gap to an axial end.

7. The fluid transfer cartridge of claim 6, wherein the plurality of stabilizing prongs are located in a plurality of piston recesses in the shaft.

8. The fluid transfer cartridge of claim 7, wherein the shaft includes external threads, and further comprising a gear mounted on the cartridge housing, wherein the gear includes internal threads that engage the external threads.

9. The fluid transfer cartridge of claim 8, wherein the plurality of stabilizing prongs have a longitudinal width greater than a pitch of the external threads.

10. The fluid transfer cassette of claim 9, wherein the longitudinal width of the plurality of stabilizing prongs is at least 1.5 times the pitch of the external threads.

11. A fluid transfer box, characterized in that The fluid transfer box includes: a case shell defining a case cavity between a front shell portion and a rear shell portion, wherein the rear shell portion includes a side wall extending longitudinally from a rear base plate to a rear face, wherein a plurality of latch retainers extend through the side wall, and wherein a plurality of latch guides are formed along an edge between the side wall and the rear face; a syringe barrel disposed within the cartridge cavity; and A syringe piston is disposed within the syringe barrel, wherein the syringe piston includes a stopper and a shaft extending longitudinally from the stopper to an axial end.

12. The fluid transfer cassette of claim 11, wherein each of the plurality of latch guides is longitudinally aligned with a corresponding one of the plurality of latch retainers.

13. The fluid transfer cassette of claim 11, wherein each of the plurality of latch guides comprises a bevel on the edge.

14. The fluid transfer cassette of claim 13, wherein a length of the ramp is greater than a width of a corresponding one of the plurality of latch retainers.

15. A fluid transfer box, characterized in that The fluid transfer box includes: a cartridge housing defining a cartridge cavity between a front housing portion and a rear housing portion, wherein the rear housing portion includes a marking recess in a rear face, and wherein the marking recess has a depth of 0.01 to 0.02 inches; a syringe barrel disposed within the cartridge cavity; and A syringe piston is disposed within the syringe barrel, wherein the syringe piston includes a stopper and a shaft extending longitudinally from the stopper to an axial end.

16. The fluid transfer cassette of claim 15, wherein the depth is 0.015 inches.

17. The fluid transfer box according to claim 15, characterized in that The fluid transfer cartridge further includes a marking mounted in the marking recess, wherein the marking has a thickness less than the depth of the marking recess.

18. A fluid transfer box, characterized in that The fluid transfer box includes: a box housing defining a box cavity between a front housing portion and a rear housing portion, wherein the rear housing portion includes side walls extending longitudinally from a rear base plate to a rear face, and wherein a plurality of latch holes extend through the side walls; and a shell plate contained within the box cavity between the front shell portion and the rear shell portion, wherein the shell plate includes a plurality of transverse projections extending into the plurality of latch apertures to define a plurality of latch retainers between the plurality of transverse projections and the rear face; a syringe barrel disposed within the cartridge cavity; and A syringe piston is disposed within the syringe barrel, wherein the syringe piston includes a stopper and a shaft extending longitudinally from the stopper to an axial end.

19. A fluid transfer box, characterized in that The fluid transfer box includes: a case shell defining a case cavity between a front face and a rear face, wherein the case shell includes a handle extending from the front face across the opening, wherein the handle includes a removable front panel; a syringe barrel disposed within the cartridge cavity; and A syringe piston is disposed within the syringe barrel, wherein the syringe piston includes a stopper and a shaft extending longitudinally from the stopper to an axial end.

20. The fluid transfer cassette of claim 19, wherein the handle includes the removable front plate mounted on a rear handle portion, and wherein a front surface of the removable front plate is substantially smooth.

21. The fluid transfer cassette of claim 20, wherein the rear surface of the rear handle portion is completely smooth.

22. The fluid transfer cartridge of claim 21, wherein a front surface of the rear handle portion has a molding gate, and wherein the removable front plate covers the molding gate.

23. The fluid transfer cartridge of claim 22, wherein the molding gate is located at a center portion of the front surface.

24. A fluid transfer box, characterized in that The fluid transfer box includes: a cassette housing defining a cassette cavity between a front face and a rear face, wherein the front face includes a tab extending into a conduit port defined by the rim; and a duct routing plate engaging the front face along the edge, wherein the tab is located in a duct slot of the duct routing plate; a syringe barrel disposed within the cartridge cavity; and A syringe piston is disposed within the syringe barrel, wherein the syringe piston includes a stopper and a shaft extending longitudinally from the stopper to an axial end.

25. The fluid transfer cassette of claim 24, wherein the front face and the tubing routing plate include corresponding notches at the edges, and wherein the corresponding notches combine to form a tubing routing port through which fluid tubing is routed.

Images