Therapeutic system with generator and fluid transfer cassette

Abstract

A treatment system (100) includes a generator (202) and a fluid transfer cassette (204). The fluid transfer cassette (204) includes a cassette housing (306) defining a cassette cavity (402) between a front face (404) and a rear face (404). The front face (402) includes an opening (406), and the cassette cavity (402) is visibly exposed through the opening (406). The fluid transfer cassette (204) includes a syringe barrel (408) disposed within the cassette cavity (402) and a handle (307) extending from the front face (404) above the opening (406). The syringe barrel (408) can be visibly exposed on a side (410) of the handle (307).

Description

Technical Field

[0001] This application generally relates to medical systems for delivering energy and fluid to a device, and more specifically, to a treatment system having a generator for delivering energy and a fluid transfer cartridge for delivering cooling fluid to a catheter-based intraluminal device. Background Technology

[0002] High blood pressure (also known as hypertension) typically affects adults. If left untreated, hypertension can lead to kidney disease, arrhythmias, and heart failure. In recent years, treatment for 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 within the lumen of the vessel, 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.

[0003] One method of renal nerve deactivation uses radiofrequency (RF) energy. RF energy is delivered to a catheter with multiple electrodes placed against the intima of the renal artery to generate an electric field in the vessel wall and surrounding tissue. This electric field causes the resistance (ohms) to heat the tissue, thereby ablating the tissue and the renal nerves passing through it. To treat all the renal nerves around the renal artery, the RF electrodes are repositioned several times inside and around the renal artery.

[0004] Another method of renal nerve devitalization is the use of high-intensity focused ultrasound (HIFU). HIFU relies on delivering vibrational energy to the catheter to cause frictional heating and destruction of the tissue. The tissue temperature is then sufficiently raised to cause ablation or remodeling of the tissue containing the renal nerve. However, intravascular HIFU can at most create a thin focused ring in the vessel and surrounding tissue. If applied to renal denervation, it is difficult to align this thin ring with the renal nerve because the renal nerve is located at different radial distances along the length of the renal artery. Another problem is that the thin focused ring results in a smaller longitudinal treatment area relative to the vessel axis.

[0005] Many problems associated with RF and HIFU systems can be addressed with systems featuring ultrasound transducers that emit one or more therapeutic doses of unfocused ultrasound energy. The ultrasound transducer can be mounted distal to a catheter, and the unfocused ultrasound energy can heat tissue adjacent to the body cavity where the catheter (and transducer) is internally located. Such unfocused ultrasound energy can, for example, ablate target nerves around the body cavity without damaging non-target tissues (e.g., the lining of the body cavity or unintended organs outside the body cavity). Unfocused ultrasound energy systems may also include a balloon mounted distal to the ultrasound transducer around the catheter. Cooling fluid can circulate through the balloon during ultrasound energy delivery to cool the body cavity. This design allows for the creation of one or more ablation zones at different locations around the circumference of the vessel, sufficient to achieve long-term nerve deactivation. Summary of the Invention

[0006] This invention is defined in the independent claims. Further embodiments of the invention are defined in the dependent claims.

[0007] This document provides a therapeutic system having a generator and a fluid transfer cartridge for delivering energy and / or fluid to a catheter-based intraluminal device. In one embodiment, the fluid transfer cartridge includes a housing defining a cavity. The cavity may be an internal volume between a front and a rear end and may contain components of the fluid transfer cartridge. For example, a syringe barrel may be disposed within the cavity. The housing may have an opening in the front. A handle may extend from the front over the opening. The syringe barrel may be visible through, for example, an opening on a first side of the handle. Thus, the user can easily grasp and carry the fluid transfer cartridge.

[0008] The foregoing summary does not constitute an exhaustive list of all aspects of the invention. It is conceivable that the invention can be practiced through all suitable combinations of the aspects outlined above and those disclosed in the detailed embodiments described below and specifically pointed out in the claims. Such combinations possess specific advantages not specifically listed in the foregoing summary. Attached Figure Description

[0009] The novel features of the present invention are specifically set forth in the appended claims. The features and advantages of the invention can be better understood by referring to the following detailed description of illustrative embodiments utilizing the principles of the invention, and in conjunction with the accompanying drawings.

[0010] Figure 1 This is a perspective view of the catheter of the treatment system according to an embodiment.

[0011] Figure 2 This is a front perspective view of the generator and fluid transfer box of the treatment system according to an embodiment.

[0012] Figure 3This is a rear perspective view of the generator and fluid transfer box of the treatment system according to an embodiment.

[0013] Figure 4 This is a perspective view of the generator receiving portion and the fluid transfer box of the treatment system according to an embodiment.

[0014] Figure 5 This is an exploded view of the casing of the fluid transfer box according to an embodiment.

[0015] Figure 6 This is a cross-sectional view of an end-illuminated syringe of a fluid transfer cartridge according to an embodiment.

[0016] Figure 7 This is a front perspective view of the fluid transfer box according to an embodiment.

[0017] Figure 8 This is a rear perspective view of the fluid transfer box according to an embodiment.

[0018] Figure 9 This is a perspective view of the piping routing ports of the fluid transfer box according to an embodiment.

[0019] Figure 10 This is a perspective view of a pipe routing plate installed in a pipe routing opening of a fluid transfer box according to an embodiment.

[0020] Figure 11 This is a cross-sectional view of a fluid transfer box installed in the container of a generator in a treatment system according to an embodiment.

[0021] Figure 12 This is a rear perspective view of the fluid transfer box according to an embodiment.

[0022] Figure 13 This is a front perspective view of the housing receiving portion of the generator according to an embodiment.

[0023] Figure 14 This is an exploded view of the casing of the fluid transfer box according to an embodiment.

[0024] Figures 15A to 15B This is a perspective view of the box manifold according to an embodiment.

[0025] Figure 16 This is an exploded view of the manifold according to an embodiment.

[0026] Figure 17 This is a front view of the fluid transfer plate of the manifold according to an embodiment.

[0027] Figure 18 This is a rear view of the fluid transfer plate of the manifold according to an embodiment.

[0028] Figure 19This is a perspective view of the piston of the manifold according to an embodiment.

[0029] Figure 20 This is a perspective view of the piston of the manifold according to an embodiment.

[0030] Figure 21 This is a cross-sectional view (along the axis) of the piston of the manifold in the open position according to an embodiment. Figure 18 (Line AA is cut off).

[0031] Figure 22 This is a cross-sectional view (along the) of the piston of the manifold in the closed position according to an embodiment. Figure 18 (Line AA is cut off).

[0032] Figure 23 This is a side view of a generator for an ultrasound-based therapeutic system according to an embodiment.

[0033] Figure 24 This is a cross-sectional view (alongside) of a generator for an ultrasound-based therapeutic system according to an embodiment. Figure 23 (Line AA is cut off).

[0034] Figure 25 This is a perspective view of a non-invasive sensor according to an embodiment.

[0035] Figure 26 This is a perspective view of a non-invasive sensor according to an embodiment.

[0036] Figure 27 This is a front view of the internal portion of the fluid transfer box according to an embodiment.

[0037] Figure 28 This is a cross-sectional view of the internal portion of a fluid transfer cartridge having a pneumatically driven syringe according to an embodiment.

[0038] Figure 29 This is a cross-sectional view of the internal portion of a fluid transfer box with a non-contact position sensor according to an embodiment.

[0039] Figure 30 This is a perspective view of an ultrasound-based treatment system according to an embodiment.

[0040] Figure 31 This is a cross-sectional view of the drive mechanism of the fluid transfer box according to an embodiment.

[0041] Figure 32 This is a block diagram of the controller of the treatment system according to an embodiment.

[0042] Figure 33 This is a perspective view of the shaft end with an optical tab according to an embodiment. Detailed Implementation

[0043] The embodiments describe a treatment system having a generator and a fluid transfer cartridge, and a method of using the treatment system. The treatment system can be an ultrasound-based tissue treatment system for radially outward delivery of unfocused ultrasound energy to treat tissue within a target anatomical region (e.g., renal nerves within the renal artery). Alternatively, the tissue treatment system can be used in other applications, such as for treating the sympathetic nerves of the hepatic plexus within the hepatic artery. Therefore, referring to the system as a renal denervation system or for treatment (e.g., neuromodulation) is not limited to renal nerve tissue.

[0044] In various embodiments, reference is made to the accompanying drawings. However, some embodiments may be implemented without one or more of these specific details, or may be implemented in combination with other known methods and configurations. Numerous specific details (e.g., specific configurations, dimensions, and processes) are set forth in the following description to provide a thorough understanding of the embodiments. In other instances, well-known processes and manufacturing techniques have not been shown in detail so as not to unnecessarily obscure the invention. Throughout this specification, references to “an embodiment,” “a particular embodiment,” or similar phrases mean that a particular feature, structure, configuration, or characteristic described is included in at least one embodiment. Therefore, the phrases “an embodiment,” “a particular embodiment,” or similar phrases appearing throughout different places in this specification do not necessarily refer to the same embodiment. Furthermore, specific features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.

[0045] Relative terms used throughout the description may indicate relative position or direction. For example, “above” may indicate a first direction relative to the component. Similarly, “below” may indicate a second direction relative to the 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 therapeutic system components (e.g., fluid transfer cartridges or generators) to the specific configurations described in the various embodiments below.

[0046] Existing hypertension treatment systems include generators that generate energy (e.g., RF or ultrasound energy) and deliver it to catheter-based endoluminal devices. Treatment systems may also include components that engage with the generator to facilitate treatment. For example, a cartridge may be mounted on the generator to deliver inflatable or cooling fluid to a balloon mounted at one end of the catheter. Generators and / or cartridges can be large and bulky, especially when combined. Furthermore, the mechanical and electrical connections between the generator and cartridge can be unreliable due to improper installation, tolerance overlap, or movement between components during operation. When using cartridges to deliver fluid, fluid transfer may not be accurately monitored visually or automatically due to lack of lighting in the process chamber and / or unstable sensor connections between the generator and cartridge. The system may also integrate long lengths of internal tubing, increasing the overall form factor of the device. Therefore, treatment systems for delivering energy and fluid to catheter-based endoluminal devices would benefit from more compact, mechanically stable, electrically stable, and ergonomic designs.

[0047] In one aspect, a treatment system is provided for performing medical procedures, such as renal ablation catheter insertion. The treatment system includes a fluid transfer cartridge for delivering fluid to a catheter and a generator for delivering energy to the catheter. The fluid transfer cartridge and generator are combined to form a control unit of the treatment system. The control unit is compact. More specifically, the fluid transfer cartridge is fitted within the housing of the generator to form a clean and compact profile of the control unit. Additionally, the fluid transfer cartridge has a syringe component that can be completely contained within the housing to reduce the overall shape factor of the control unit. The control unit is mechanically stable. The fluid transfer cartridge can be fastened to the generator via a fastening mechanism that evenly distributes the retention force around the housing and has a quick-release mechanism to allow for rapid and reliable engagement and disengagement of the components. The control unit is electrically stable. The electrical connection between the fluid transfer cartridge and the generator can be made via a spring-loaded electrical contact pin (commonly referred to as a spring pin). The spring-loaded pin maintains pressure at the electrical contact point between the components, making the connection resilient to resist relative movement that may occur during operation. Additionally, sensors used to detect movement of system components (e.g., the syringe piston of the fluid transfer cartridge) may include position sensors (e.g., 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. It may include one or more processors and various sensors that operate to determine the system's readiness status (e.g., whether various electrical or component connections have been completed) and provide feedback to the user. For example, the system may detect whether the fluid transfer cartridge is installed in the generator's container and activate light within the fluid transfer cartridge to illuminate the syringe, thereby providing feedback to the user regarding this status. Thus, a compact, mechanically stable, electrically stable, and ergonomically designed therapeutic system is provided.

[0048] Reference Figure 1 The image shows a perspective view of a catheter-based endoluminal device of a treatment system according to an embodiment. The catheter-based endoluminal device of the treatment system 100 may include a catheter 101 having an elongated catheter body extending from a proximal end 102 to a distal end 104. An expandable member 106 (e.g., a balloon) may be mounted on the distal end 104 of the catheter 101. One or more energy transducers 108 (e.g., ultrasound transducers) 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 ablation energy (e.g., ultrasound energy) to the target anatomical structure during a medical procedure (e.g., renal denervation).

[0049] The catheter 101 may include one or more lumens, such as: a fluid lumen for delivering inflation / cooling fluid to the expandable member 106; a cable channel including a cable for delivering energy to the transducer 108; a guidewire lumen for exchanging guidewires, etc. The lumen may be connected to a corresponding connector at the proximal end 102 of the catheter. For example, the fluid lumen may be connected to one or more fluid ports 110 that receive inflation / cooling fluid from the fluid transfer cartridge of the treatment system 100, as described below. Similarly, the cable may be connected to an external connector 112 that receives energy from the generator of the treatment system 100, as described below.

[0050] Reference Figure 2 The image shows a front perspective view of the generator and fluid transfer cartridge of a treatment system according to an embodiment. The treatment system 100 includes a control unit connected to a catheter 101 to regulate the inflation of a balloon 106 using inflation / cooling fluid and to control the delivery of ultrasonic energy to a 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 the 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 the fluid transfer cartridge 204. Similarly, fluid conduit 206B can transfer cooling fluid between the fluid transfer cartridge 204 and the catheter 101. The control unit includes several other components (some of which are described below) to facilitate energy and fluid transfer functions. Such components may include a display 208 to present process information to the 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 the treatment system 100 to perform various operations, as described below.

[0051] Reference Figure 3The image shows a rear perspective view of a generator and a fluid transfer cartridge of a treatment system according to an embodiment. The generator 202 of the treatment system 100 may have a container 302 shaped and sized to receive the fluid transfer cartridge 204. More specifically, the generator 202 may include a generator housing 304 having a container 302 configured to receive the fluid transfer cartridge 204. The generator housing 304 may include an outer wall having a shape (e.g., a box-like enclosure), and the container 302 may be a recessed area extending into this shape. The fluid transfer cartridge 204 may include a housing 306 that can fill the container 302 of the generator 202. More specifically, the housing 306 may include an outer wall having a shape that smoothly merges with the generator housing wall to complete the enclosure of the generator 202. For example, the fluid transfer cartridge 204 and the generator 202 may be combined to form a box-like enclosure. In this configuration, the external, outward-facing surfaces of the fluid transfer box 204 and the generator 202 can be parallel and coplanar at the joints where the components intersect, allowing the shape factor of the combined components to transition smoothly (e.g., steplessly) at the transition between the generator wall and the fluid transfer box wall.

[0052] In one embodiment, the fluid transfer cartridge 204 includes a handle 307 that a user can grip when installing or removing the cartridge from the generator 202. The handle 307 may include a curved, ergonomic shape for easy gripping. Thus, a user can carry the fluid transfer cartridge 204 via the handle 307 and insert the fluid transfer cartridge 204 into the cartridge container 302 to engage components having a compact shape factor with an outer wall that extends continuously over the generator housing 304 and the cartridge housing 306.

[0053] In combination with generator 202, fluid transfer cartridge 204 can be used to drive fluid into conduit 101 using one or more syringes. More specifically, fluid transfer cartridge 204 may include one or more syringes for pumping fluid into and from balloon 106. As described below, each syringe may include a corresponding syringe piston disposed within a corresponding syringe barrel. Moving the syringe piston relative to the syringe barrel may draw cooling fluid into or expel cooling fluid from the syringe. Fluid may be transferred to or from fluid transfer cartridge 204 via fluid conduit 206, which may be connected to conduit 101, a fluid reservoir, or another fluid container outside fluid transfer cartridge 204.

[0054] Reference Figure 4 The image shows a perspective view of the cartridge receiving portion of the generator and the fluid transfer cartridge of a treatment system according to an embodiment. The cartridge housing 306 of the fluid transfer cartridge 204 may define a cavity 402 within which one or more syringes are disposed. More specifically, the cartridge housing 306 may define a front end 404 and a rear end 407 of the cartridge housing 306. Figure 8The cavity 402 between the front and rear surfaces 404 and 407 of the housing 306 can contain the syringe. Therefore, the syringe (including the syringe shaft) can be stored inside the housing 306, rather than exposed to the outside. This allows for the compaction of the overall shape factor of the fluid transfer box 204. The cavity 402 can be further defined between the top and bottom surfaces of the housing 306.

[0055] One or more syringes of the fluid transfer cartridge 204 may be disposed parallel to the handle 307 within the cartridge cavity 402. For example, the handle 307 may extend from the front end 404 of the cartridge housing 306 above an opening leading to the cartridge cavity 402. This opening may be a window 406 or entrance that exposes the internal volume of the cartridge cavity 402 for observation of the surrounding environment. More specifically, the front end 404 may include an opening that visibly exposes the cartridge cavity 402 for observation by a user. The handle 307 may extend vertically from the upper end 416 of the opening to the lower end 418 of the opening. Thus, the handle 307 may bend outward from the front end 404 above the opening and vertically downward above the opening to terminate below the opening at the front end 404. Similarly, the syringe may extend vertically through the cartridge cavity 402 such that the syringe barrel is visibly exposed through the opening.

[0056] In one embodiment, the fluid transfer cartridge 204 includes a first syringe barrel 408 located within a cavity 402 and visible 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 located within a cavity 402 and visible through an opening on a second side 414 of the handle 307. Similar to the handle 307, the syringe may extend vertically within the cavity 402, for example. More specifically, the first syringe barrel 408 and the second syringe barrel 412 may have respective syringe axes 420 extending vertically within the cavity 402, for example. The syringe axis 420 may be the central axis of the syringe barrel. For example, the syringe barrel may be cylindrical and may extend vertically along the syringe axis 420. Thus, the handle 307 can be easily grasped from the front of the fluid transfer cartridge 204; however, the syringe can remain exposed for observation through the opening in the front 404. Therefore, the fluid transfer cartridge 204 is easy to handle, easy to observe, and has a compact shape factor for engagement with the generator 202.

[0057] Reference Figure 5 An exploded view of the housing of a fluid transfer cartridge according to an embodiment is shown. The housing 306 provides an outer cover for the fluid transfer cartridge 204 and can have various geometries.

[0058] The fluid transfer cartridge 204 may include several parts that snap together or otherwise fasten together. The housing 306 may include a handle front panel 502 and a rear panel 504. The handle front panel 502 may include a handle 307, a front surface 404 of the housing, and a top surface 506 of the housing. Similarly, the rear panel 504 may include a rear surface 407 of the housing, several side walls 508 extending laterally outward from the housing cavity 402, and a bottom surface 510 of the housing. When assembled, the handle front panel 502 and the rear panel 504 may define a housing cavity 402 centrally located between the respective walls and surfaces. As described above, the housing cavity 402 remains visible through an opening 406 in the handle front panel 502.

[0059] The front end 404 may include a front periphery 511. The front periphery 511 may be the outer edge of the front end 404. The front periphery 511 may have curved and straight edges that combine to form the contour of the front end 404. Similarly, the rear end 407 may include a rear periphery 512. The rear periphery 512 may have curved and straight edges that combine to form the contour of the rear end 407. In one embodiment, the front periphery 511 and the rear periphery 512 have the same contour. More specifically, the contour of the front periphery 511 may conform to the contour of the rear periphery 512 such that when the front periphery 511 engages with the rear periphery 512, these peripheries effectively seal or contact each other. When the peripheries contact, the cavity 402 can be closed within the housing 306. The closed cavity 402 is defined between the front end 404 and the rear end 407.

[0060] When snapped together or otherwise assembled, the handle front plate 502 and rear plate 504 may contain one or more components within the cavity 402 to provide fluid transfer functionality. For example, the fluid transfer box 204 may include a syringe holder 513 to retain the syringe within the cavity 402. The syringe holder 513 may stabilize the syringe during fluid delivery, as described below. The fluid transfer box 204 may also include manifolds, fittings, electronics, etc. (not shown) that facilitate fluid movement from the syringe to the fluid conduit 206 and conduit 101. The internal components of the fluid transfer box 204 may be confined within the internal space of the housing 306 and may interact mechanically and / or electrically with each other and with the generator 202 to perform the fluid transfer function of delivering aerated / cooling fluid to the fluid port 110 of the conduit 101.

[0061] In one embodiment, a syringe retainer 513 mounted within the cavity 402 restricts syringe movement. The syringe may have a plunger that is axially driven within the syringe barrel 408 during operation. The plunger can rotate about the syringe axis 420 and thus can apply a rotational load to the syringe. The syringe retainer 513 resists rotation of the barrel that may additionally be caused by the plunger. The syringe retainer 513 may include one or more stop features. The stop features may be ribs, protrusions, or other features formed in the syringe retainer 513. When the barrel is assembled, the stop features may be held fixed relative to the front 404 and rear 407 of the fluid transfer cartridge 204. Additionally, when assembled, a portion of the syringe barrel 408 (e.g., a tongue extending laterally outward from the cylindrical syringe barrel 408) may engage the stop features. For example, the syringe barrel 408 may have finger-shaped tongues that fit into corresponding recesses in the syringe retainer 513. The finger-shaped tongues may be positioned within recesses between a plurality of ridges such that the syringe retainer 513 mechanically interferes with movement of the tongues. Therefore, the stop feature engages with the interference feature of the syringe barrel 408, thereby restricting the rotation of the syringe barrel 408 relative to the housing 306.

[0062] Reference Figure 6 The figure shows a cross-sectional view of an end-illuminated syringe with a fluid transfer cartridge according to an embodiment. The fluid transfer cartridge 204 may include one or more light sources 602 within a cartridge cavity 402. For example, the light source 602 may be a light-emitting diode (LED). As shown, two light sources 602 may be symmetrically located on each side of the syringe axis 420. Alternatively, three or more light sources 602 may be symmetrically arranged around the syringe axis 420. 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 three light sources 602 is 120° when viewed along the syringe axis 420).

[0063] Light source 602 can illuminate one or more syringes, allowing the user to see the syringe barrel 408 and / or the cooling fluid 603 within the syringe. More specifically, light source 602 can be located within the 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 light source 602 is activated, the user can observe the operation of the syringe and cooling fluid through the opening / window 406 in the fluid transfer box 204. It should be understood that, especially when observing in a dark process room, light source 602 allows for easier monitoring of fluid transfer and troubleshooting of cooling fluid problems.

[0064] In one embodiment, a light source 602 is guided through a syringe barrel 408. For example, the syringe may be end-illuminated by the light source 602. Each of one or more light sources 602 may guide light 606 into a corresponding light guide 605. The light guide 605 may include a cylindrical transparent column that acts as a light guide to transmit light 606 from the light source 602 to the distal (upper) end of the syringe. More specifically, the light source 602 may be guided through an end face 604 of the syringe barrel 408. The end face 604 may be a section of the barrel that slopes or tapers from the generally cylindrical sidewall of the syringe barrel 408 toward the syringe axis 420. Thus, an axis oriented perpendicular to the outer surface of the end face 604 may form an angle with the syringe axis 420 that is smaller than the angle formed between the syringe axis 420 and an axis perpendicular to the barrel sidewall.

[0065] The syringe can be illuminated from the side by the light source 602. For example, the light source 602 can be oriented laterally or radially relative to the syringe axis 420, rather than longitudinally illuminating the syringe. Therefore, light 606 can illuminate the syringe barrel 408 and its contents from the end, side, or rear of the cavity 402.

[0066] In some embodiments, the light source 602 may be guided through the syringe barrel 408 to aid in assembly.

[0067] Light 606 can be emitted along the syringe axis 420. Therefore, a portion of the light 606 can be transmitted through the end face 604 to the syringe barrel 408 and the fluid contained therein. Additionally, a portion of the light 606 can be transmitted to the wall of the syringe barrel 408. The light 606 can propagate along the wall to produce a light guide effect. Therefore, the end-illuminated syringe barrel 408 can provide good contrast for the fluid and mechanical components of the syringe (e.g., the stopper 608). Thus, the light source 602 makes it easier to observe syringe movement during medical procedures and otherwise visualizes syringe function.

[0068] The light source 602 may have ergonomically designed features. In one embodiment, the light source 602 emits blue light. More specifically, the wavelength of the light 606 emitted by the light source 602 may be in the visible blue range. In a dark process chamber, the blue light can produce a cooling and calming effect. Additionally, the blue light may have an intensity that is not distracting to the user, but sufficient to illuminate the cooling fluid 603 for precise monitoring.

[0069] In addition to illuminating the syringe components, the light source 602 may also have prominent features that provide cues and visual feedback to the user. The control unit includes one or more processors configured to activate the light source 602 based on input from one or more sensors. In one embodiment, the light source 602 emits light 606 of a first color when the syringe barrel 408 is filled with a first volume of fluid. A flow sensor or other fluid sensor can be used to detect the first volume of fluid. One or more processors can receive a volume signal from the sensor indicating that the first volume of fluid is contained within the syringe barrel 408. In response to this volume signal, one or more processors can cause the light source 602 to emit light of the first color (e.g., orange). The control unit can be configured such that the light source 602 emits light 606 of a second color when the syringe barrel 408 is filled with a second volume of fluid. For example, in response to detecting a second volume of fluid, one or more processors can cause the light source 602 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 volumes in the syringe barrel 408, and this embodiment is not limiting. Similarly, intensity or another optical property (besides color) can be changed based on the fill level, and therefore embodiments that change color are not limiting.

[0070] Reference Figure 7 The image shows a front perspective view of a fluid transfer cartridge according to an embodiment. As described above, each syringe in the fluid transfer cartridge 204 may 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 a stopper 608 within the syringe cavity. The opacity of the syringe barrels may vary.

[0071] The syringe piston 702 may include a stopper 608, which may be a rubber stopper, capable of applying friction and rotating the syringe barrel 408 unless otherwise resisted by the syringe holder 513. The syringe piston 702 may also include a shaft 704 extending from the stopper 608 within the syringe barrel 408 to a shaft end 706 outside the syringe barrel 408. As described below, the shaft end 706 may include elements 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 tab, fork tip, flag, etc.) for triggering an optical sensor. Regardless of the position of the stopper 608 within the syringe barrel 408, the shaft end 706 may be located outside the syringe barrel 408. However, the shaft end 706 may have several positions, and at least one position may be located inside the cavity 402. For example, the bottom surface of the shaft end 706 may be flush with the bottom surface 510 of the housing 306.

[0072] In one embodiment, when the stopper 608 is in the initial position within the syringe barrel 408, the shaft end 706 is disposed within the cavity 402. Alternatively, when the stopper 608 is in the initial position, the shaft end 706 may be flush with the bottom surface 510 of the housing 306. In either case, when the stopper 608 is in the initial position, the shaft end 706 may not be outside the envelope defined by the housing 306. The initial position may be the highest position of the stopper 608, or the position closest to the end face 604 of the syringe. In the initial position, the shaft end 706 may be close to the syringe barrel 408, but located outside 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 initial position, the syringe components are completely contained within the cavity 402. Therefore, the fluid transfer cartridge 204 may have a compact shape factor defined by the outer surface of the housing 306, and no additional clearance is required for the syringe or syringe components.

[0073] The fluid transfer cartridge 204 can be transported with the syringe piston 702 in the initial position. More specifically, the stopper 608 can be in the initial position before the syringe is filled with cooling fluid 603 (during transport or when the fluid transfer cartridge 204 is initially mounted on the generator 202). Therefore, the packaging size can be minimized to reduce packaging requirements compared to transporting the fluid transfer cartridge 204 with the syringe shaft 704 exposed from the cartridge housing 306. Additionally, the fluid transfer cartridge 204 can occupy less space within the process chamber because the syringe and syringe components are not exposed outwards from the cartridge. That is, the ability of the shaft 704 to move fully into the cartridge cavity 402 to fully accommodate the syringe within the fluid transfer cartridge 204 reduces the overall form factor of the fluid transfer cartridge 204. This reduction in form factor makes the cartridge more compact for transport and / or use.

[0074] Conversely, when the stopper 608 is in the end position within the syringe barrel 408, the shaft end 706 may be positioned outside the cavity 402. The end position can be the lowest position or the position within the syringe barrel furthest from the syringe end face 604. In the end position, the shaft end 706 may be outside both the syringe barrel 408 and the cavity 402. More specifically, the shaft end 706 may be exposed below the bottom surface 510 of the fluid transfer cartridge 204, such as... Figure 7 As shown.

[0075] Reference Figure 8The image shows a rear perspective view of a fluid transfer cartridge according to an embodiment. The fluid transfer cartridge 204 includes a drive mechanism to advance a syringe piston 702 relative to a syringe barrel 408. In one embodiment, the shaft 704 of the syringe piston 702 includes an external thread 802 extending along the outer surface of the shaft 704 between a stopper 608 and a shaft end 706. The fluid transfer cartridge 204 may also include a gear 804 mounted on a housing 306. The gear 804 may include an internal thread engaging the external thread 802 of the syringe shaft 704. Thus, when the gear 804 rotates (e.g., when driven by a motor of generator 202), the internal thread of the gear 804 can drive the external thread 802 of the shaft 704 in an axial direction. Therefore, 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 604 of the syringe barrel 408 to draw fluid into the syringe. Conversely, when the shaft 704 is driven upward, the plug 608 can move toward the end face 604 to discharge fluid from the syringe barrel 408.

[0076] When gear 804 drives syringe piston 702 along syringe axis 420, rotational frictional load can be applied to syringe shaft 704 through gear 804. Similar to the stabilizing effect of syringe holder 513 on syringe barrel 408, fluid transfer cartridge 204 may also include features that stabilize syringe piston 702. In one embodiment, shaft 704 of syringe piston 702 includes a recess 806 extending longitudinally between plug 608 and shaft end 706. Longitudinal recess 806 may receive a tip (not shown) extending from cartridge housing 306 and / or syringe holder 513. For example, the tip may be built into the chassis of the cartridge to fix the tip relative to the cartridge housing. When gear 804 rotates relative to shaft 704, it can apply a frictional load to external thread 802 of shaft 704. To ensure that shaft 704 does not rotate relative to gear 804, the tip may slide within recess 806 and contact the recess wall to resist and limit rotation of shaft 704 relative to gear 804. Thus, rotational movement is converted into translational movement along syringe axis 420. More specifically, the tip can restrict the rotation of the syringe piston 702 and limit the movement of the stopper 608 to the axial direction at minimum rotation.

[0077] Reference Figure 9The diagram shows a perspective view of the piping routing port of a fluid transfer cartridge according to an embodiment. As described above, the components of the fluid transfer cartridge 204 can be fastened in various ways, including snap-fit ​​connections. In one embodiment, the cartridge housing may include a piping routing area through which the fluid piping 206 can be routed. More specifically, the cartridge housing 306 may include a cartridge routing opening 902 in the front 404. The cartridge routing opening 902 can improve the manufacturability of the fluid transfer cartridge 204 by providing a cutout through which a fluid piping 206 of considerable length can be inserted and / or routed through the fluid transfer cartridge 204. The cartridge routing opening 902 may be a cutout formed in the front 404 along the lower edge of the cartridge. More specifically, the opening may have a lower edge extending along a corner of the cartridge between the front 404 and the bottom surface 510 of the fluid transfer cartridge 204.

[0078] Reference Figure 10 The image shows a perspective view of a pipe routing plate installed in a pipe routing opening of a fluid transfer cassette according to an embodiment. The cassette housing 306 may include a pipe routing plate 1002 engaging a front end 404 along an edge 1004. The edge 1004 may be the periphery of the pipe routing opening. In one embodiment, the portions of the pipe routing plate 1002 and the front end 404 extending along the pipe routing opening may include corresponding recesses 1006 at the edge 1004. For example, the recess 1006 in the front end 404 may be a semi-circular recess 1006, and the recess 1006 in the pipe routing plate 1002 may also be a semi-circular recess 1006. The pipe routing plate 1002 may snap-fit ​​into (or otherwise secure to) the pipe routing opening to block the opening and form an aperture through which the fluid conduit 206 can be routed. For example, partial cutouts in the housing may be combined to form a pipe port for the fluid conduit 206. In the case of the semi-circular notch 1006, the notch can be combined to form a circular pipe routing port 1008 in the front 404 of the assembled fluid transfer box 204. A predetermined length of fluid pipe 206 can be exposed on the outside of the box before the pipe routing plate 1002 is snapped into the opening. When the pipe routing plate 1002 is snapped into the opening, the edge 1004 of the plate and the box housing 306 can clamp around the fluid pipe 206 to hold it in place. The ability to easily determine the length of pipe inserted through the opening into the cavity and the length of pipe extending outside the opening (these lengths are separated by the plate that snaps into the opening to clamp the pipe in place) provides efficient routing and the ability to route the pipe quickly and efficiently during manufacturing.

[0079] Reference Figure 11A cross-sectional view of a fluid transfer cartridge installed in a cartridge container of a generator according to an embodiment is shown. 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 abuts against the generator 202. The separation between the fluid transfer cartridge 204 and the generator 202 is shown in… Figure 11 The figure is shown in dashed lines. 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 generator 202 can mesh with and drive a gear 804 of fluid transfer cartridge 204 to simultaneously move the syringe piston 702 along syringe axis 420. For example, motor 1108 can be operatively coupled to shaft 704 and actuated by one or more processors of a control unit to move the external thread 802 (and syringe piston 702) of shaft 704 via the internal thread 1109 of gear 804 during fluid transfer via syringe.

[0080] 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 302. The well 1110 may have an outer wall surrounding the 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 delivery 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 may cover the shaft 704 so that the shaft does not come into contact with outer surfaces that could damage syringe components. Similarly, the well 1110 isolates the shaft 704 from the user, thereby reducing pinch points that could further injure the user. Finally, by containing the shaft 704 within the generator 202, rather than having the shaft 704 extend outward from the control unit, the overall shape factor of the control unit can be compacted.

[0081] The dimensions of well 1110 can be designed to accommodate several functions. First, the internal space of well 1110 allows the user to easily clean it, for example, by wiping its inner surface. Additionally, the height of 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 well 1110 when the stopper 608 reaches the end position 1104. Furthermore, the depth of well 1110 allows the fluid transfer cartridge 204 to be removed from the generator 202 without requiring the stopper 608 to return to its original position. More specifically, when the cartridge is removed with the shaft 704 fully extended, the cartridge can tilt forward, and there is sufficient space within well 1110 to allow the shaft 704 to tilt and be removed upwards from the well cavity.

[0082] As described above, the syringe can be operated to move the stopper 608 within the syringe barrel 408 between a starting position 1102 and an ending position 1104. The stopper 608 may, for example, be placed at the starting position 1102 during transport to the process chamber. The starting position 1102 can also be the position where air bubbles are removed from the syringe barrel 408 after the stopper 608 has been circulated between the starting position 1102 and the ending position 1104 one or more times. More specifically, the stroke of the syringe may include the starting position 1102 of the syringe piston 702 removing air bubbles from the syringe. Similarly, when the stopper 608 is in the ending position 1104, cooling fluid 603 may be drawn into the syringe barrel 408 to fill the syringe. When the stopper 608 is moved to the ending position 1104 after rinsing the syringe barrel 408, the cooling fluid 603 within the syringe may be free of air bubbles. The method for cleaning the syringe will be described in further detail below; however, it should be understood that at this stage, the movement of the syringe piston 702 is achieved by a motor 1108 that can be controlled by one or more processors of the control unit.

[0083] The movement of the syringe piston 702 can be controlled by one or more processors via a control motor 1108. For example, the motor 1108 can be a stepper motor 1108, and the processor can drive the stepper motor 1108 by rotating it at a predetermined angle. This predetermined angle rotation, taking into account the transmission ratio between the generator gear 1106 (or gear train) and the gear 804 of the cartridge, can cause a predetermined axial movement of the shaft 704. Additionally, the control unit can incorporate sensors to detect the position of the syringe piston 702 (e.g., shaft end 706). By sensing the shaft position, one or more processors can determine the position of the stopper 608 within the syringe barrel 408, and thus determine the amount of fluid contained within the syringe.

[0084] The sensor used to detect the axis 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 position switches 1120 configured to detect the syringe piston 702 when the stopper 608 is in the initial position 1102, such as optical switches (e.g., optical sensors). Optical sensors can provide better resolution than magnetic switches. On the other hand, magnetic sensors may require less maintenance than optical sensors. Therefore, the position switch 1120 can be selected according to design needs.

[0085] Optionally, a second position switch 1120 (not shown) may be configured to detect the syringe piston 702 when the stopper 608 is in the end position 1104. The position switch 1120 may be mounted within or along the wall of the generator well 1110. For example, the position switch 1120 may be mounted along the rear wall of the well 1110. When more than one switch is incorporated, these switches may be aligned in series along a vertical axis parallel to and adjacent to the syringe axis 420.

[0086] In one embodiment, shaft end 706 includes an element that can trigger position switch 1120. For example, the element may include an optical tab to trigger an optical sensor. See below. Figure 33 Further describing the optical tab, it can be mounted at the shaft end 706. As the syringe piston travels vertically along the syringe axis 420, the optical tab can travel along the vertical axis and pass the optical switch. The optical switch of generator 202 can interact with the optical tab mounted on syringe piston 702. For example, the optical tab can be located at the shaft end 706 on shaft 704. When the optical tab approaches (e.g., is adjacent to) the optical switch, the optical tab can block the optical switch. For example, the optical sensor can have a light-emitting diode to emit a light signal, and the tab can block or reflect the light signal from the optical sensor. Therefore, 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 can be detected by one or more processors of the control unit and used to determine the stroke of one or more syringes of 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, whether the position of the shaft 704 and / or the plug 608 is at the starting position 1102, the ending position 1104, or an intermediate position between the start and end of the stroke.

[0087] In one embodiment, shaft end 706 includes an element that can trigger position switch 1120. For example, this element may include a magnet that can be mounted at shaft end 706 and can travel along the vertical axis and past the switch as the syringe piston 702 travels vertically along syringe axis 420. The magnetic switch of generator 202 can interact with the magnet mounted on syringe piston 702. For example, the magnet may be located at shaft end 706 on 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. Thus, 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 stroke of one or more syringes of fluid transfer cartridge 204. More specifically, one or more processors can monitor the state of the magnetic switch to identify the position of syringe piston 702 relative to syringe barrel 408, and more specifically, whether stopper 608 is located at starting position 1102, ending position 1104, or an intermediate position between the start and end of the stroke.

[0088] Position switch 1120 can act as a limit switch to provide the control unit with information 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 switch itself, they can provide a more reliable limit switch than, for example, mechanically activated switches. Therefore, one or more processors in the control unit can use the switching signal from the magnetic switch to control the pre-cycle of the syringe.

[0089] During pre-cycle, the control unit uses limit switches to cycle the syringe to detect whether the syringe is properly filled with cooling fluid 603, whether the fluid lines 206 and manifold of the fluid transfer box 204 are filled with cooling fluid 603, and to ensure that air bubbles are removed from the fluid lines 206, manifold, and syringe. The control unit cleans the syringe during pre-cycle to achieve these objectives.

[0090] The fluid transfer cartridge 204 can be mounted on the generator 202 when the stopper 608 is in the initial position 1102. When in the initial position 1102, the shaft end 706 can be located within the cartridge cavity 402 and thus above and outside the well 1110. In the initial 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 cooling fluid 603 into the syringe. Thus, the initial phase of pre-circulation fills the syringe with cooling fluid 603.

[0091] When the syringe is filled with fluid, the shaft end 706 moves into the well 1110 outside the chamber 402. One or more processors can determine the filling level or volume of the syringe. For example, when the stopper 608 is at the end position 1104 in the syringe barrel 408, the shaft end 706 may 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 switch contacts to generate a switching signal sent to one or more processors. The processors can determine, based on the switching signal, that the syringe is filled with a predetermined amount of cooling fluid 603. For example, the predetermined amount of cooling fluid 603 may be the volume of the syringe barrel 408.

[0092] While the predetermined amount of cooling fluid 603 may correspond to the stopper 608 being in the end position 1104, one or more processors can be configured to determine other fill levels. For example, one or more intermediate position switches 1120 may 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 a known fluid volume within the syringe. For example, the position switches may be positioned at positions corresponding to 10 mL increments of syringe fill level.

[0093] When the syringe is filled, pre-circulation can continue. One or more processors can drive motor 1108 to move syringe piston 702 upward to discharge cooling fluid 603 from the syringe. Cooling fluid 603 is discharged into the fluid path of the cartridge. For example, cooling fluid 603 can flow from the syringe into fluid conduit 206 connecting fluid transfer cartridge 204 and conduit 101. In one embodiment, the syringe is completely emptied of cooling fluid 603. One or more processors can determine that one or more syringes are empty based on a switching signal generated by a position switch. The switching signal can indicate that stopper 608 is in the initial position 1102, and therefore the syringe is empty.

[0094] Expelling the cooling fluid 603 from the syringe can remove air bubbles from one or more of the syringe or fluid path in the fluid transfer cartridge 204. More specifically, air drawn into the syringe when the stopper 608 initially moves from the starting position 1102 to the ending position 1104 can be expelled from the fluid network as the stopper 608 is subsequently driven back to the starting position 1102. Purges the air from the fluid network to ensure the system is filled with an incompressible fluid (e.g., sterile water) and is relatively stable.

[0095] In the pre-circulation operation, after air is purged from the syringe, the syringe may be filled with cooling fluid 603. One or more processors may drive motor 1108 to move stopper 608 from starting position 1102 to ending position 1104. Thus, cooling fluid 603 may be drawn into syringe barrel 408. After the purging operation, the fluid drawn into syringe barrel 408 may be mostly or completely free of air bubbles. In one embodiment, the purging operation may be repeated once or more until the cooling fluid 603 in the syringe is completely free of air bubbles.

[0096] 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 2910. Thus, the shaft end 706 can be configured as a light sensor that emits or reflects light to the treatment system 100, such as a light sensor located within the generator 202.

[0097] The optical limit switch may include a light source mounted on the shaft end 706. The light source can illuminate radially outward from axis 420, for example, toward the rear wall of well 1110 of generator 202. The rear wall may include one or more photosensors to receive light emitted from the shaft end 706. Alternatively, the rear wall may include a proximity photosensor that emits light toward the shaft end 706 and receives reflected light returning from the shaft end 706. Thus, the photosensor can detect when the shaft end 706 approaches the photosensor based on the detected light and send a corresponding switching signal to one or more processors of the treatment system 100. The processor can use the switching signal to detect and control the shaft position, as described above. Therefore, a magnetic switch is a non-limiting embodiment of a limit switch that can be integrated into the treatment system 100, and optical or mechanical switches can also be used to detect shaft position.

[0098] Reference Figure 12 The image shows a rear perspective view of a fluid transfer cartridge according to an embodiment. When the cartridge is mounted on generator 202, the rear end 407 of the fluid transfer cartridge 204 can be juxtaposed with the surface defining the cartridge container 302 in generator 202. The rear end 407 may include a protrusion 1202 projecting outward from a surrounding base surface. In one embodiment, the protrusion 1202 has a protruding periphery 1204 extending around a portion of the rear end 407 on the protrusion 1202. The protruding periphery 1204 may extend laterally inward from the outer periphery of the rear end 407. More specifically, the rear periphery 1206 may define an edge separating the rear end 407 from the top, side, and bottom surfaces of the cartridge. Thus, the rear end 407 may have a portion extending laterally outward from the portion covering the protrusion 1202 covering the base surface. The rear portions may, for example, be offset from each other at different locations in a rearward direction. Thus, when viewed from the side, the rear surface has a stepped profile.

[0099] In one embodiment, the fluid transfer cartridge 204 includes one or more electrical contact pads 1208 or pins for connection to corresponding circuitry of the generator 202. More specifically, the electrical contact pads 1208 or pins may be connected to a circuit board. For example, the circuit board may be a pressure sensor board of a sensor and / or processor configured to detect and / or determine pressure along a fluid path of the control unit. The electrical contact pads 1208 or pins may include spring-loaded electrical contact pins exposed near the upper end of the protrusion 1202 through the rear 407 of the cartridge. The electrical contact pads 1208 may include conductive contact pads exposed near the rear 407 of the upper end of the protrusion 1202 and positioned to contact spring-loaded electrical contact pins extending from the generator 202. In this case, the upper end may refer to the side of the protrusion perimeter 1204 furthest 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 contact pins, the spring-loaded structure allows the pin to deflect upon contact with the generator 202. Therefore, in the event of misalignment or movement between components during operation, the pin can engage with the generator 202. A similar benefit is achieved when the contact pad of the fluid transfer box 204 engages with the contact pin of the generator 202. Thus, the deflectable pin allows for a better connection between the generator 202 and the box during operation. Secondly, placing the pad or pin along the top of the box reduces the likelihood of an electrical short circuit in the event of a pipe leak. More specifically, the pad or pin can be placed vertically above the fluid path inside the housing 306, so that any leak from the fluid path will fall down to the base plate without contacting (and potentially short-circuiting) the electrical connections.

[0100] Reference Figure 13 The image shows a front perspective view of the cartridge receiving portion of a generator according to an embodiment. A protrusion 1202 of the fluid transfer cartridge 204 can engage a corresponding feature in the generator 202. In one embodiment, the cartridge container 302 includes a rear recess 1302 to receive the protrusion 1202. The rear recess 1302 may have a recessed periphery 1304 extending around a recessed surface of the generator 202. The recessed periphery 1304 of the rear recess 1302 may have a profile that matches the profile of the protrusion periphery 1204. For example, the protrusion 1202 may be a rectangular projection and the rear recess 1302 may 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 fitted with the lateral sidewalls of the rear recess 1302. Similarly, the rear surface of the fluid transfer cartridge 204 can be juxtaposed and fitted with the front surface of the generator housing 304. The mating surfaces of the components can stabilize the fluid transfer box 204 relative to the generator 202 and minimize movement between the components during operation.

[0101] The contact pads or pins of the fluid transfer cartridge 204 may extend toward or toward a slot located in the upper region of the rear recess 1302. The slot may expose one or more electrical contacts that 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 switching signals, photoactivation signals, etc.).

[0102] 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 latches 1312 and recesses 1210 disposed on the fluid transfer cartridge 204 and the generator 202. (See again...) Figure 12 The protrusion 1202 may include a plurality of recesses 1210 distributed around a protrusion periphery 1204 of the protrusion 1202. For example, the protrusion 1202 may have a rectangular profile, and four or more recesses 1210 may be located within the lateral sidewalls of the protrusion 1202 around the protrusion periphery 1204. In one embodiment, each of the four recesses 1210 may be located near a corresponding corner of the rectangular profile. Distributing the recesses 1210 around the protrusion periphery 1204 can distribute the holding load applied to the fluid transfer cartridge 204 by the generator 202, and thus can optimally stabilize the cartridge relative to the generator housing 304.

[0103] Refer again Figure 13 The fastening mechanism 1310 may include a plurality of latches 1312 distributed around the periphery 1304 of the recess. For example, the rear recess 1302 may have a rectangular profile, and four latches may be positioned along the lateral sidewalls of the rear recess 1302 around the periphery 1304 of the recess. In one embodiment, four latches are located at positions corresponding to the positions of the recesses 1210 in the protrusion 1202. More specifically, the latches 1312 may be configured to engage the recesses 1210 of the protrusion 1202 to secure the fluid transfer cartridge 204 to the generator 202.

[0104] In one embodiment, each latch 1312 is a spring-loaded latch 1312 operatively coupled to a release button 1314 of the fastening mechanism 1310. The release button 1314 is movable between a latched position and an unlocked position. For example, the release button 1314 may be in the latched position when the release button is fully extended (not pressed). Pressing the release button 1314 moves the button from the latched position to the unlocked position. The release button 1314 is operatively coupled to the latch 1312 such that moving the release button 1314 from the latched position to the unlocked position causes the latch 1312 to be disengaged from the cassette container 302. More specifically, movement of the release button 1314 causes the latch 1312 to move from an extended position within a recess 1210 of the cassette to a recessed position outside the protruding recess 1210. When the latch 1312 engages with the protruding recess 1210, the cassette is secured to the generator 202. Conversely, the cartridge can be released from the generator 202 when the latch 1312 retracts from the protrusion / recess 1210. Thus, the fastening mechanism 1310 provides a quick-release mechanism for installing and removing the fluid transfer cartridge 204 from the generator 202.

[0105] In addition to providing a quick-release mechanism, the fastening mechanism 1310 also facilitates a secure and stable mechanical connection between the cartridge 204 and the generator 202. The distributed latches around the protrusion 1202 and the rear recess 1302 ensure that the mechanical load on the cartridge is evenly distributed during operation, and therefore, the latches can distribute the load and minimize deflection at any given location around the cartridge. Although the fastening mechanism 1310 may have four or more friction points that engage the latch 1312 with the recess 1210, the cartridge can be smoothly disengaged using a release button 1314 that actuates the spring-loaded latch. In one embodiment, the latch 1312 is driven by a linkage system, a plate with a cam mechanism, or another intermediate structure between the release button 1314 and the latch 1312. Such mechanisms can operate smoothly and in a manner that provides a beneficial level of tactile feedback to the user. Therefore, the fastening mechanism 1310 can advantageously secure the cartridge to the generator 202 in a user-friendly manner.

[0106] The fastening mechanism 1310 may include one or more latches 1312 operably coupled to the release button 1314, such that moving the release button 1314 from the latched position to the unlocked position causes one or more latches 1312 to disengage from the cassette container 302. The latches 1312 do not need to be directly loaded by a spring, but can be biased relative to the release button 1314. More specifically, the release button 1314 can be moved from the latched position to the unlocked position, and the release button 1314 can be operably coupled to one or more springs to bias the release button 1314 toward the latched position. Thus, one or more springs can bias the latches 1312 into the cassette container 302.

[0107] In one embodiment, one or more springs of the biased release button 1314 are a single spring. More specifically, the release button 1314 may be actuated to the latched position by a single spring. In contrast, one or more latches 1312 may comprise a plurality of latches 1312 interconnected by a linkage. More specifically, the linkage may interconnect the latches 1312 such that movement of the release button 1314 serves as input to cause movement of the linkage, which in turn drives the latches 1312 into and out of the cassette container 302. When the release button 1314 moves from the latched position to the unlocked position, one or more latches 1312 may be displaced from the cassette container 302.

[0108] The treatment system 100 may include one or more processors configured to execute instructions stored in a non-transitory computer-readable medium to cause the treatment system 100 to perform various methods (e.g., the pre-loop described above). This method may include providing visual feedback to a user to indicate that electrical connections have been formed between components of the treatment system 100 or between the treatment system and external components. Several such methods are described below.

[0109] In one embodiment, after the fluid transfer cartridge 204 is mounted 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 within the cartridge container 302. Cartridge mounting 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 transmit an input signal to 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 within the cartridge container 302, one or more processors can activate the light source 602 of the fluid transfer cartridge 204. The light source 602 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.

[0110] 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. (See again...) 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 450 of the generator 202 may be an electrical receptacle for receiving an external connector 112 of the conduit 101. Additional electrical connectors 450 may include plugs for receiving other components (e.g., remote control devices). The external connector may be a plug that engages with a receptacle of an external connector, or vice versa.

[0111] Generator 202 may include indicator light 452 located near electrical connector 450. For example, indicator light 452 may be a single light-emitting diode (LED) adjacent to the electrical socket, or a plurality of LEDs positioned around the socket. In one embodiment, indicator light 452 includes an indicator light ring 454 extending around electrical connector 450. More specifically, as... Figure 4 As shown, the indicator light ring 454 may include an annular light shield circumferentially surrounding the electrical connector 450. One or more LEDs may be mounted behind the light shield, so that when illuminated, the light shield appears as a solid light ring. The light ring allows the light to be viewed from any direction without being obstructed by, for example, cables or conduits 101.

[0112] Indicator light 452 may have an illumination state or pattern that provides visual feedback to the user. For example, one or more processors of the treatment system 100 may be configured to determine whether electrical connector 450 is electrically connected to external connector 112. For instance, when external connector 112 is inserted into electrical connector 450, a signal may be sent to one or more processors indicating and allowing the processors to determine that a connection has been established. In operation, the illumination pattern of indicator light 452 may change in response to determining that electrical connector 450 is connected to external connector 112. In one embodiment, indicator light 452 changes from an inactive, off-light state to an active, illuminated state. Thus, the user can see that indicator light 452 has lit up to confirm that the external component is electrically connected to generator 202.

[0113] A change in lighting mode from an off state to an illuminated state is provided as a non-limiting example. Alternatively, the change in lighting mode can be from a first lighting mode in which indicator light 452 emits light (e.g., flashes) to a second lighting mode in which indicator light 452 emits light continuously (e.g., the lighting is considered continuous). In another alternative, the change in lighting mode can be from a first lighting mode in which indicator light 452 emits light of a first color (e.g., red) to a second lighting mode in which indicator light 452 emits light of a second color (e.g., blue). In any case, the change in lighting mode provides the user with visual feedback that external components are electrically connected to generator 202 and are therefore ready for use.

[0114] Reference Figure 14 An exploded view of the housing of a fluid transfer cartridge according to an embodiment is shown. As described above, the housing 306 of the fluid transfer cartridge 204 may include a handle front plate 502 and a rear plate 504. When assembled, the handle front plate 502 and the rear plate 504 may define a cavity 402 centrally located between the respective walls and surfaces.

[0115] When snapped together or otherwise assembled, the handle front plate 502 and rear plate 504 may contain one or more components within the cavity 402 to provide fluid transfer functionality. For example, the fluid transfer cassette 204 may include a syringe retainer 513 to hold syringe barrels 408, 412 within the cavity 402. The syringe retainer 513 may stabilize the syringe during fluid delivery. The fluid transfer cassette 204 may also include a conduit 1406 to facilitate fluid movement from the syringe to the tubing 101.

[0116] Using piping to transfer fluid throughout the fluid transfer box 204 can require long piping lines and numerous glue joints to achieve the fluid paths and interconnections needed for fluid transfer. For example, exclusive use of piping may require more than five feet of pipe and forty glue joints to create a fluid network. However, such fluid networks can take up a considerable volume, potentially leading to leaks and / or inconsistent flow at glue joints, and may be difficult to assemble during manufacturing. In one embodiment, the box manifold 1402 can be used to replace most of the piping length and joints, providing a more compact, reliable, and easier-to-manufacture fluid network. Due to the reduced size and weight of the fluid network, the corresponding size and weight of the fluid transfer box 204 can also be reduced, allowing more boxes to be sterilized at once and more boxes to be transported per unit volume.

[0117] The manifold 1402 can replace some (but not all) of the fluid conduits within the fluid transfer cartridge 204. For example, the syringe barrel 408 may have a syringe cavity 1404 with a fluid passage connected to the manifold 1402 via one or more conduits 1406. Other conduits 1406 (e.g., between the manifold 1402 and the second syringe barrel 412, the balloon catheter 101, the fluid reservoir, etc.) may also be routed through the cavity 402. Such conduits 1406 are not... Figure 14 This is shown in the diagram to avoid confusing the illustration.

[0118] Reference Figure 15A The diagram shows a perspective view of a cassette manifold according to an embodiment. The cassette manifold 1402 may include a plurality of plates assembled to each other. In one embodiment, the cassette manifold 1402 includes a front plate 1502 assembled to a tail plate 1504. The front plate 1502 and the tail plate 1504 may be secured to each other. For example, the front plate 1502 may snap-fit ​​(e.g., secured by snap-closure) to the tail plate 1504. As described below, the front plate 1502 and the tail plate 1504 may secure an intermediate plate having channels and ports to allow cooling fluid to move through the cassette manifold 1402 and exchange cooling fluid with external components (e.g., airbag conduit 101 and fluid reservoir). The front plate 1502 is made transparent to allow... Figure 15A The middle plate was observed in the middle.

[0119] Reference Figure 15BThe diagram shows a perspective view of the manifold according to an embodiment. Alternatively, the front plate 1502 and the rear plate 1504 may be fastened to each other by screws or otherwise. More specifically, a plurality of manifold fasteners 1508 may extend through through holes in the rear plate 1504 and screw into threaded holes formed in the front plate 1502. The fasteners 1508 may hold these plates together to clamp the intermediate plate in the middle, as described below.

[0120] Reference Figure 16 An exploded view of a casing manifold according to an embodiment is shown. The casing manifold 1402 in casing 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 connected through various ports on its front and rear surfaces. More specifically, one or more front fluid channels 1604 in the front plate surface 1606 may deliver cooling fluid via channels on the rear surface to one or more outlet ports 1608 for transfer to external components.

[0121] In one embodiment, the outlet port 1608 of the front panel 1502 is connected to an external component. More specifically, the outlet port 1608 may include fittings (e.g., barbed fittings) connected to fluid conduits 1406, and these conduits may extend to connect to external components (e.g., syringes, fluid reservoirs, balloon catheters 101, or pressure sensors). Thus, the front panel outlet port 1608 can serve as a fluid interface to the external component. Fluid can be transferred in and out of the manifold 1402 through the outlet port 1608. In one embodiment, the front panel 1502 includes four outlet ports 1608 along the upper edge 1004 and five outlet ports 1608 along the lower edge 1004, but the number and location of these outlet ports 1608 may vary depending on the arrangement of the external component and the fluid transfer cartridge 204.

[0122] The movement of fluid through the channels and ports of the manifold 1402 can be controlled by one or more pistons 1610. Each piston 1610 may be associated with or include a spring 1612. More specifically, the piston 1610 may be spring-loaded to bias the piston 1610 to a given position. For example, as described below, the spring 1612 may bias the piston 1610 to an open position, and a solenoid may actuate the piston 1610 to move it to a closed position. Specifically, the piston 1610 may move between positions that seal or unseal the fluid ports in the fluid transfer plate 1602 to initiate or stop the flow of cooling fluid 603 through the fluid channels.

[0123] Reference Figure 17The diagram shows a front view of a fluid transfer plate of a manifold according to an embodiment. The front plate surface 1606 of the fluid transfer plate 1602 may include a plurality of front fluid channels 1604. In one embodiment, the front fluid channels 1604 belong to a corresponding fluid loop. More specifically, some channels and ports may belong to an upper fluid loop 1702, and other channels and ports may belong to a lower fluid loop 1704. Each fluid loop may include a corresponding front fluid channel 1604 and one or more outlets. As described below, the fluid channels and outlets may interconnect with outlet ports 1608 of the front plate 1502 to transfer fluid to or from external components. Additionally, the fluid transfer plate 1602 may include one or more fluid ports 1706. Each fluid port 1706 extends via the fluid transfer plate 1602 from the front fluid channel 1604 in the front plate surface 1606 to a rear fluid channel in the rear plate surface. Figure 18 Therefore, cooling fluid 603 can move from the channel in front of fluid transfer plate 1602 to the channel behind fluid transfer plate 1602 through fluid port 1706.

[0124] In one embodiment, the fluid passages of the fluid transfer plate 1602 may be surrounded by corresponding passage seals 1710. The passage seals 1710 may be gaskets, such as O-rings or strips of elastomeric material having circular, rectangular, cross-shaped, or other cross-sectional profiles, placed along the outer periphery of the fluid passages. The seals may be fitted into recesses, injection-molded into the plate, or otherwise attached to the fluid transfer plate 1602. When the fluid transfer cartridge 204 is assembled, the passage seals 1710 may be sandwiched between the fluid transfer plate 1602 and the adjacent front plate 1502 or tail plate 1504. A sandwich seal may form an air seal around the fluid passages to isolate the cooling fluid 603 within the passages.

[0125] The lower fluid circuit 1704 may be associated with a syringe barrel 408 for delivering fluid to the balloon conduit 101. More specifically, cooling fluid 603 can be transferred from an external fluid reservoir (e.g., a fluid filling bag) to the syringe barrel 408 via the lower fluid circuit 1704. The outlets in the front panel surface 1606 that connect to the front panel 1502 may be labeled for reference. For example, the lower fluid circuit 1704 may have L1 outlet 1712, L2 outlet 1714, L3 outlet 1716, L4 outlet 1718, and L5 outlet 1720. Each of the L1-L5 outlets 1720 may be connected to a fitting on the front panel 1502, which in turn connects to conduit 1406. More specifically, the L1-L5 outlets may be in fluid communication with outlet ports 1608 along the lower edge 1004 of the front panel 1502. These conduits 1406 can be connected to external components, such as a fluid reservoir, syringe barrel 408, inlet line of balloon catheter 101, and / or one or more pressure sensors.

[0126] The upper fluid circuit 1702 may be associated with a second syringe barrel 412 for drawing fluid from the balloon conduit 101. More specifically, cooling fluid 603 may be transferred from the balloon conduit 101 via the upper fluid circuit 1702 to transfer fluid to an external fluid reservoir. Outlets in the front panel surface 1606 interconnecting to corresponding outlet ports 1608 of the front panel 1502 may be labeled for reference. For example, the upper fluid circuit 1702 may have outlets U1 1722, U2 1724, U3 1726, and U4 1728. Each of outlets U1-U4 may be connected to a fitting on the front panel 1502, which in turn connects to conduit 1406. More specifically, outlets U1-U4 may be in fluid communication with outlet ports 1608 along the upper edge 1004 of the front panel 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.

[0127] It is evident that some outlets are fluidly connected to each other via fluid channels. For example, outlets U3 1726 and U4 1728 are fluidly connected to each other via a front fluid channel 1604 of the upper fluid circuit 1702. Similarly, outlets L2 1714 and L3 1716 are fluidly connected to each other via a 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., outlets U1, U2, L1, L4, and L5 1720) may also be fluidly connected to other outlets via fluid channels on the rear side of the fluid transfer plate 1602. More specifically, each outlet and / or channel may include a corresponding fluid port 1706 extending through the fluid transfer plate 1602 to connect to a corresponding channel on the rear side of the fluid transfer plate 1602.

[0128] Reference Figure 18 The diagram shows a rear view of the fluid transfer plate of a cassette manifold according to an embodiment. The cassette manifold 1402 includes a rear plate surface 1802 having one or more rear fluid passages 1804. Similar to the front fluid passage 1604, the rear fluid passage 1804 may be surrounded by a channel seal 1710 to separate fluid within the fluid passage. For example, a tail plate 1504 may be juxtaposed with the rear plate surface 1802 such that the channel seal 1710 is sandwiched between the rear plate surface 1802 and the tail plate 1504. By extending around the rear fluid passage 1804, the channel seal can thus define a fluid path for transferring the cooling fluid 603.

[0129] The rear fluid channel 1804 belongs to a corresponding fluid circuit. More specifically, some channels and ports may belong to the upper fluid circuit 1702, and others may belong to the lower fluid circuit 1704. Fluid channels and outlets on the rear plate surface 1802 can interconnect with fluid channels and outlets on the front plate surface 1606 via fluid ports 1706. More specifically, each fluid port 1706 may extend through the fluid transfer plate 1602 to interconnect the front fluid channel 1604 and port to the rear fluid channel 1804 and port. Similarly, considering that the fluid channels and ports of the fluid transfer plate 1602 are connected to fittings on the front plate 1502, which in turn are connected to the syringe barrel 408 via conduit 1406, the front fluid channel 1604, the rear fluid channel 1804, and the fluid port 1706 are in fluid communication with the syringe cavity 1404. Therefore, cooling fluid 603 can move between the channels in the syringe cavity 1404 and the fluid transfer plate 1602. Similarly, cooling fluid 603 can move between other external components and channels in the fluid transfer plate 1602.

[0130] exist Figure 18 The outlet in the rear plate surface 1802 is marked to indicate its relationship with the center. Figure 17 The correspondence of the outlets in the front panel surface 1606 is shown. Therefore, it is evident that the marked outlets extend from the front panel surface 1606 through the plate to the rear panel surface 1802. More specifically, in the upper fluid circuit 1702, outlets U1 1722 and U2 1724 are through-holes extending through the plate. Similarly, in the lower fluid circuit 1704, outlets L1 1712, L4 1718, and L5 1720 are through-holes extending through the plate. Thus, the outlets separated from each other on the front panel surface 1606 can be interconnected through the rear panel surface 1802. For example, outlets U1 1722 and U2 1724 are physically separated on the front panel surface 1606; however, these outlets are interconnected through the rear fluid channel 1804 on the rear panel surface 1802. Similarly, L1 outlet 1712 and L5 outlet 1720 are physically separated on the front panel surface 1606; however, these outlets are interconnected via a rear fluid channel 1804 on the rear panel surface 1802.

[0131] Although fluid channels can interconnect outlets separated from each other on one side of the plate on the other side, fluid ports 1706 can be used to reversibly interconnect fluid channels on one side of the plate with fluid channels on the other side of the plate. In one embodiment, each fluid port 1706 may be located within a corresponding valve seat on the rear plate surface 1802. The valve seats are labeled for easy reference in the valve actuation logic described below. The upper fluid circuit 1702 may include a V1 valve seat 1730. The V1 valve seat 1730 may receive a corresponding piston 1610 to open and close the fluid port 1706, which interconnects the front fluid channel 1604 of the upper fluid circuit 1702 with the rear fluid channel 1804 of the upper fluid circuit 1702 in that position. Thus, the fluid port 1706 corresponding to the V1 valve seat 1730 may allow or stop fluid transfer between the front fluid channel 1604 and the rear fluid channel 1804 of the upper fluid circuit 1702. Therefore, the fluid port 1706 corresponding to the V1 valve seat 1730 can separate or interconnect the U1 and U2 outlets 1724 with the U3 and U4 outlets 1728.

[0132] In one embodiment, the lower fluid circuit 1704 includes a plurality of valve seats. A V2 valve seat 1732 may receive a corresponding piston 1610 to open and close a fluid port 1706 that interconnects a front fluid passage 1604 of the lower fluid circuit 1704 with a first rear fluid passage 1804 of the lower fluid circuit 1704. The first rear fluid passage 1804 interconnects an L1 outlet 1712 to an L5 outlet 1720. Therefore, the fluid port 1706 corresponding to the V1 valve seat 1730 may allow or stop fluid transfer between the front fluid passage 1604 and the first rear fluid passage 1804 of the lower fluid circuit 1704. Thus, the fluid port 1706 corresponding to the V2 valve seat 1732 may isolate or interconnect L2 and L3 outlets 1716 with L1 and L5 outlets 1720.

[0133] In one embodiment, the V3 valve seat 1734 may receive a corresponding piston 1610 to open and close a fluid port 1706 that interconnects a front fluid passage 1604 of the lower fluid circuit 1704 with a second rear fluid passage 1804 of the lower fluid circuit 1704. The second rear fluid passage 1804 may interconnect the fluid port 1706 at the V3 valve seat 1734 to the L4 outlet 1718. Therefore, the fluid port 1706 corresponding to the V3 valve seat 1734 may allow or stop fluid transfer between the front fluid passage 1604 and the second rear fluid passage 1804 of the lower fluid circuit 1704. Thus, the fluid port 1706 corresponding to the V3 valve seat 1734 may isolate or interconnect the L2 and L3 outlets 1716 with the L4 outlet 1718. It should also be understood that by examining the fluid network shown, actuating piston 1610 to simultaneously open fluid ports 1706 at valve seats 1732 and 1734 will thus make all outlets of the lower fluid circuit 1704 fluidly connected to each other through the front fluid passage 1604, the first rear fluid passage 1804, and the second rear fluid passage 1804.

[0134] As described above, the fluid network formed by the various channels and ports of the fluid transfer plate 1602 can be used for various components outside the interconnecting manifold 1402. An embodiment of the external component connection is now described. Starting from the upper fluid circuit 1702, outlet U1 1722 can be connected to the second syringe barrel 412. Therefore, fluid can be transferred to or from the second syringe barrel 412 by transferring fluid through outlet U1 1722. Outlet U2 1724 can be connected to a fluid reservoir. Therefore, fluid can be transferred to or from the fluid reservoir by transferring fluid through outlet U2 1724. Outlet U3 1726 can be connected to a pressure sensor. Therefore, outlet U3 1726 can allow sensing of the fluid pressure in the front fluid passage 1604 (or the rear fluid passage 1804 of the upper fluid circuit 1702 when the corresponding valve is open). Outlet U4 1728 can be connected to the outlet line of the balloon conduit 101. Therefore, fluid can be transferred to or from the outlet line of the balloon catheter 101 via the U4 outlet 1728.

[0135] For the lower fluid circuit 1704, outlet L1 1712 can be connected to the inlet line of the balloon conduit 101. Therefore, fluid can be transferred to or from the inlet line of the balloon conduit 101 via outlet L1 1712. Outlet L2 1714 can be connected to the syringe barrel 408. Therefore, fluid can be transferred to or from the syringe barrel via outlet L2 1714. Outlet L3 1716 can be connected to a pressure sensor. Therefore, outlet L3 1716 allows sensing of fluid pressure in the front fluid passage 1604 (or one or both rear fluid passages 1804 of the lower fluid circuit 1704 when the corresponding valve is open). Outlet L4 1718 can be connected to a fluid reservoir. Therefore, fluid can be transferred to or from the fluid reservoir via outlet L4 1718. Outlet L5 1720 can be connected to a pressure sensor. Accordingly, L5 outlet 1720 may allow sensing of fluid pressure in the first downstream fluid passage 1804 of the downstream fluid circuit 1704 (or one or both of the upstream fluid passage 1604 or the second downstream fluid passage 1804 of the downstream fluid circuit 1704 when the corresponding valve is open).

[0136] 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 the fluid reservoir to the airbag conduit 101 and then back to the fluid reservoir can now be described. In a first operation, fluid port 1706 at valve seat 1732 can be closed and fluid port 1706 at valve seat 1734 can be opened. This closing / opening action can be generated by actuating piston 1610, as described below. Alternatively, other valve designs can be integrated with fluid transfer plate 1602 to open and close the respective fluid ports 1706.

[0137] At the first operation point, with the opening of valve V3, outlets L2, L3, and L4 can be fluidly connected to each other, and outlets L1 and L5 can be isolated from other outlets in the lower fluid circuit 1704. Therefore, the syringe piston 702 of syringe barrel 408 can retract to draw fluid from the fluid reservoir into syringe chamber 1404. More specifically, cooling fluid 603 can enter from the fluid reservoir into outlet L4 1718, through the fluid port 1706 at valve seat V3 1734, into the front fluid passage 1604, and exit from outlet L2 1714 into conduit 1406 connected to syringe barrel 408. During this stage, a pressure sensor connected to outlet L3 1716 can sense, for example, the pressure of the cooling fluid 603 transferred in syringe chamber 1404.

[0138] At the second operation point, valve V3 is closed and valve V2 is opened. During this stage, outlets L1, L2, L3, and L5 are fluidly connected to each other, and outlet L4 1718 is isolated from the other outlets in the lower fluid circuit 1704. Therefore, the syringe piston 702 of syringe barrel 408 can be advanced to expel fluid from syringe chamber 1404 into the inlet line of balloon conduit 101. More specifically, cooling fluid 603 can enter from syringe chamber 1404 into outlet L2 1714, through fluid port 1706 at valve seat V2 1732, and exit from outlet L1 1712 into the inlet line of balloon conduit 101. During this stage, a pressure sensor connected to outlet L5 1720 can sense, for example, the pressure of the cooling fluid 603 transferred in balloon conduit 101.

[0139] At the third operation point, with the opening of valve V1, outlets U1, U2, U3, and U4 can be fluidly connected to each other. Therefore, the syringe piston 702 of the second syringe barrel 412 can retract to draw fluid from the outlet line of the balloon conduit 101 into the syringe chamber 1404. More specifically, cooling fluid 603 can enter from the outlet line of the balloon conduit 101 into outlet U4 1728, through the front fluid passage 1604 and the fluid port 1706 at valve seat V1 1730, into the rear fluid passage 1804, and exit from outlet U1 1722 into conduit 1406 connected to the second syringe barrel 412. Conduit 1406 connecting outlet U2 1724 to the fluid reservoir may have a one-way check valve to prevent backflow, and therefore no suction is applied to the fluid reservoir at outlet U2 1724. At this stage, a pressure sensor connected to outlet U3 1726 can sense, for example, the pressure of the cooling fluid 603 transferred in syringe chamber 1404.

[0140] At the fourth operation point, valve V1 is closed. At this stage, outlets U1 and U2 1724 are in fluid communication with each other, and outlets U3 and U4 1728 are isolated from other outlets in the upper fluid circuit 1702. Therefore, the syringe piston 702 of the second syringe barrel 412 can be advanced to expel fluid from the syringe chamber 1404 into the fluid reservoir. More specifically, cooling fluid 603 can enter outlet U1 1722 from syringe chamber 1404, pass through the rear fluid passage 1804 of the upper fluid circuit 1702, and exit outlet U2 1724 through conduit 1406 (and a check valve) to fill the fluid reservoir.

[0141] The above operations can be performed in series and / or in parallel to circulate the cooling fluid 603 through the airbag conduit 101. For example, adding fluid to the airbag in a second operation can be performed simultaneously with removing fluid from the airbag in a third operation to balance the positive and negative pressures in the airbag, keeping the airbag diameter constant while maintaining the temperature of the cooling fluid 603 within the airbag. Control of the operation can be provided in part based on pressure data fed back to one or more processors by a pressure sensor connected to the box manifold 1402.

[0142] Reference Figure 19 The diagram shows a perspective view of a piston in a manifold according to an embodiment. A valve for opening and closing fluid port 1706 may include a piston 1610. More specifically, piston 1610 may interact with fluid transfer plate 1602 to seal and unseal fluid port 1706. In one embodiment, piston 1610 includes an end seal 1902. As described below, piston 1610 may be positioned in an open position, wherein end seal 1902 unseals (does not block) the corresponding fluid port 1706 to allow cooling fluid 603 to pass through fluid port 1706. Piston 1610 may be moved from the open position to a closed position, wherein end seal 1902 seals (blocks) the corresponding fluid port 1706 to prevent cooling fluid 603 from passing through fluid port 1706. Thus, piston 1610 functions as a valve to control the flow of fluid through fluid port 1706 by covering or exposing fluid port 1706.

[0143] In one embodiment, end seal 1902 has a circular distal surface. The distal surface may be flat. The seal may include a resilient, cylindrical plug embedded in the body of piston 1610. One side of the plug may extend distally from the body to seal opposing surfaces. For example, end seal 1902 may press against the rear plate surface 1802 of fluid transfer plate 1602. More specifically, one side of end seal 1902 may seal the rear plate surface 1802 around a corresponding valve seat of a corresponding fluid port 1706 to close the valve. Therefore, end seal 1902 may be dimensioned to be larger than fluid port 1706. For example, the diameter of the face of end seal 1902 may be larger than (e.g., twice) the diameter of fluid port 1706.

[0144] As described above, piston 1610 may be spring-loaded. Piston 1610 may include a spring recess 1904. Spring recess 1904 may include an annular recess sized and shaped to receive the proximal end of spring 1612. Spring 1612 may be a helical compression spring 1612. The distal end of spring 1612 may similarly engage with a corresponding spring recess 1904 at the valve seat. Spring recess 1904 may stabilize spring 1612 and allow spring 1612 to act on rear plate surface 1802 and piston 1610. Thus, spring 1612 may outwardly bias piston 1610 to hold piston 1610 in a normally open position, with its central seal 1902 offset from rear plate surface 1802 to allow fluid flow through fluid port 1706.

[0145] Piston 1610 may include a side seal 1906 to seal one of the manifold plates. For example, side seal 1906 may seal tail plate 1504. Therefore, piston 1610 may include an end seal 1902 for pressing against the rear plate surface 1802 of fluid transfer plate 1602 and a side seal 1906 for sealing tail plate 1504. In one embodiment, side seal 1906 may include an O-ring fitted within a recess in the piston body. Therefore, end seal 1902 may have an annular distal surface. The O-ring 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 seal 1906 may press against and seal to tail plate 1504. Side seal 1906 may maintain a seal while sliding against tail plate 1504, and therefore, piston 1610 may move axially within tail plate 1504. Therefore, the piston 1610 can be pushed forward to block the corresponding fluid port 1706 or retracted to open the corresponding fluid port 1706.

[0146] Reference Figure 20 The diagram shows a perspective view of the piston of a manifold according to an embodiment. The end seal 1902 may include an O-ring. The O-ring may be disposed within a groove in one end of the piston 1610. For example, the groove may be machined and the O-ring may be pressed into the groove. Alternatively, to more securely retain the O-ring, the piston 1610 body may be injection molded around the O-ring. Thus, the end seal 1902 may be tightly secured within the piston 1610 body. In either case, the end seal 1902 may extend distally from the piston 1610 body such that the seal may press against the rear plate surface 1802 when the piston 1610 moves to the closed position. The outer diameter of the annular end seal 1902 may be designed to be larger than the fluid port 1706. For example, the outer diameter of the O-ring end seal 1902 may be larger than (e.g., twice) the diameter of the fluid port 1706.

[0147] Reference Figure 21 A cross-sectional view (along the axis) of the piston of the cassette manifold in the open position according to an embodiment is shown. Figure 18 (Line AA is cut off). The piston 1610 can be a free-floating piston 1610 with a side seal 1906 to radially seal the tail plate 1504, as described above. Additionally, the end seal 1902 can face the fluid port 1706 in the fluid transfer plate 1602. However, in the open position, the spring 1612 can keep the end seal 1902 spaced apart from the fluid port 1706. Furthermore, the fluid pressure in the fluid passage in front of the end face 604 can press against the end face 604, biasing the piston 1610 to the open position. Therefore, cooling fluid 603 can flow through the front fluid passage 1604 and the fluid port 1706 and enter the rear fluid passage 1804.

[0148] Reference Figure 22 A cross-sectional view (along the cylinder piston in the closed position according to an embodiment) is shown. Figure 18 (Line AA is cut off). The solenoid 2202 (force vector shown, but solenoid 2202 omitted) can be actuated to push the piston 1610 forward. The force of the solenoid 2202 can overcome the spring 1612 and the fluid pressure acting on the piston 1610 in the opposite direction, causing the piston 1610 to move to the closed position. In the closed position, the end seal 1902 obstructs the path of fluid flow through the fluid port 1706. More specifically, it prevents the cooling fluid 603 from flowing through the fluid port 1706 to or out of the front fluid passage 1604.

[0149] It is worth noting that solenoid 2202 can be closed with a force of less than 10 lbf (e.g., 5 lbf or less). This closing force is more advantageous compared to alternative valve designs (e.g., pinch valves in the squeeze pipe 1406). Consequently, manifold 1402 can also be designed to withstand lower compressive forces, allowing for the use of less material and a more compact form factor in the design.

[0150] The valve can be reversibly switched from its original position by de-energizing solenoid 2202. Figure 22 The closing position is moved to Figure 21 The open position. 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.

[0151] like Figure 21-22 As shown, in the open position ( Figure 21 ) and closing position ( Figure 22In this configuration, the rear surface 2102 of the piston 1610 can be located behind the back surface 2104 of the tail plate 1504. Maintaining the rear surface 2102 extending beyond the back surface 2104 in both piston 1610 positions facilitates contact between the solenoid 2202 and the piston 1610. More specifically, the likelihood of the solenoid 2202 losing contact with the rear surface 2102 is reduced because the rear surface 2102 will not recess 1210 into the hole in the tail plate 1504 below the back surface 2104.

[0152] Non-invasive pressure / flow sensor

[0153] As described above, the pressure sensor used to monitor airbag inflation can be directly integrated into a disposable part of the system (e.g., 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 process. However, pressure sensors are expensive, thus the current practice of using invasive pressure sensing increases the cost per process.

[0154] Reference Figure 23 The image shows a side view of a generator for an ultrasound-based therapeutic 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 processes, thus reducing the cost of disposable components by removing expensive sensors from the cartridge design.

[0155] In one embodiment, pressure fitting 2302 is mounted on generator housing 304. As described above, generator housing 304 has a housing 302 configured to receive fluid transfer cartridge 204. Therefore, when fluid transfer cartridge 204 is loaded into housing 302 of generator 202, pressure fitting 2302 can be located at the rear of the cartridge. Pressure fitting 2302 can be configured to connect to one or more conduits 1406 of fluid transfer cartridge 204. For example, when fluid transfer cartridge 204 is loaded into generator 202, fittings in fluid transfer cartridge 204 connected to conduits 1406 can engage pressure fitting 2302 of generator 202. In one embodiment, pressure fitting 2302 can be connected to housing manifold 1402 via conduit 1406, for example, to the outlet of the manifold. Therefore, pressure fitting 2302 can be used to transmit pressure from housing manifold 1402 to generator 202.

[0156] Reference Figure 24 A cross-sectional view (alongside) of a generator for an ultrasound-based therapeutic system according to an embodiment is shown. Figure 23(Line AA cut). In one aspect, generator 202 incorporates a non-invasive pressure sensor 2402 to monitor and measure fluid transferred (e.g., delivered to an airbag) through fluid transfer cartridge 204. In one embodiment, generator 202 includes pressure sensor 2402 within generator housing 304. Pressure sensor 2402 integrated within generator 202 is spaced apart from fluid transfer cartridge 204. Pressure sensor 2402 can be configured to sense pressure at pressure fitting 2302. Thus, pressure sensor 2402 can be used to measure the pressure of fluid delivered to airbag through fluid transfer cartridge 204. Nevertheless, when the cartridge is removed and discarded, pressure sensor 2402 can remain within generator 202 (and be reused).

[0157] The pressure sensor 2402 located in the generator (which can replace the pressure sensor located in the housing described above) can sense the inflation fluid in a non-invasive manner. For example, the pressure fitting 2302 may have a diaphragm that contacts the cooling fluid 603 but isolates the cooling fluid 603 from the generator cavity. Therefore, the pressure sensor 2402 can be connected to the fluid line in the housing via a fluid connection (e.g., a tee to), however, the pressure and / or flow sensors in the generator 202 can be isolated from the fluid in the housing. Thus, the cooling fluid 603 supplied to the balloon can be sensed without contact with the pressure sensor 2402. The sensor in the generator 202 can effectively monitor the fluid supplied to the balloon without contamination. Therefore, the pressure sensor 2402 is non-invasive and reusable, and thus reduces the cost of disposable components of the treatment system 100.

[0158] In one embodiment, the diaphragm of pressure fitting 2302 acts on fluid (e.g., air) in a conduit located between pressure fitting 2302 and pressure sensor 2402. For example, a chamber (e.g., air chamber 2404) may be inserted between the fluid conduit in pressure fitting 2302 (and therefore the fluid conduit in the cartridge) and the fluid conduit in generator 202. The chamber may have a chamber inlet 2406 connected to pressure fitting 2302 and a chamber outlet 2408 connected to pressure sensor 2402. When the diaphragm is acted upon by fluid in the cartridge, the air in the chamber can be compressed, and therefore the air pressure can change with variations in the airbag inflation pressure. These variations can be sensed by pressure sensor 2402.

[0159] As further described below, several types of non-invasive sensors are considered. In alternative embodiments, the chamber is a fluid chamber that may be filled with liquid rather than air. More specifically, the chamber and / or tubing between the diaphragm of pressure fitting 2302 and pressure sensor 2402 may 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.

[0160] Reference Figure 25 A perspective view of a non-invasive sensor according to an embodiment is shown. 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 ultrasonic signals guided into a fluid line in generator 202 to detect the Doppler shift of the reflected signal. A processor in generator 202 can receive the sensed signal and determine the fluid flow rate within 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.

[0161] Reference Figure 26 The diagram illustrates 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 a generator 202, which is in fluid communication with a fluid line within the housing. As fluid flows through the housing, blades of the rotatable element are actuated. An optical sensor mounted on the outside of the housing can detect the speed of the blades through the housing wall. The sensed signal may be provided to a processor in generator 202 to determine the pressure and / or flow rate of the fluid within the fluid line based on the blade movement.

[0162] 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 recycle fluid from the airbag. 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 airbag without actually requiring the sensor to contact the fluid.

[0163] In one embodiment, a force sensor can detect forces applied to the sensor by a fluid line. For example, the fluid line may include a compliant tube section 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 as the tube wall expands or contracts. 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 that force. The force sensor does not directly contact the fluid and is therefore a non-invasive sensor that can be used in multiple processes.

[0164] Using a non-invasive sensor in generator 202 to monitor the fluid being delivered to / from the airbag, instead of using an invasive sensor in fluid transfer box 204, allows for: reduced manufacturing costs of the box, enabling the fluid monitoring sensor to be used in multiple processes, and thus reducing the cost of each process.

[0165] pneumatic injector driver

[0166] As mentioned above, fluid drive systems can be mechanically driven. More specifically, the drive system may include a stepper motor and a transmission mechanism with several gears and screws. However, mechanical system components may increase the system's cost and space requirements. Furthermore, the drive system can be quite complex.

[0167] Mechanically driven fluid drive systems can be replaced by pneumatically driven fluid drive systems. More specifically, screw actuators can be replaced by pneumatic pressure lines. Although screw actuators move the syringe shaft by a gear mechanism that pushes the screw, pneumatic pressure lines can use positive and negative pressure to advance / retract the stopper 608.

[0168] Refer again Figure 24 The system can integrate a pneumatic drive system 2410 to advance and / or retract the plug 608 of the syringe that supplies inflation gas to the airbag. The generator 202 may include a pneumatic fitting 2304 connected to the pneumatic drive system 2410. Figure 23 More specifically, pneumatic fitting 2304 can be mounted on generator housing 304.

[0169] Pneumatic fitting 2304 can be connected to pneumatic drive system 2410. Pneumatic drive system 2410 can be located within generator housing 304. Pneumatic drive system 2410 can be configured to apply one or more of positive or negative pressure to pneumatic fitting 2304. For example, pneumatic drive system 2410 may include a pneumatic pump and / or vacuum pump to increase or decrease the pressure at pneumatic fitting 2304.

[0170] Reference Figure 27The diagram shows a front view of the internal portion of the fluid transfer cartridge according to an embodiment. A pneumatic drive system 2410 can be connected to a pressure line 2702 connected to the syringe. For example, the pressure line 2702 can be a section of tubing extending from the pneumatic fitting 2304 to a syringe connector attached to the base of the syringe barrel 408. By applying positive and negative pressure to the pressure line 2702, the syringe stopper 608 can be driven back and forth within the syringe barrel 408. More specifically, positive pressure delivered to the pressure line 2702 via the pneumatic fitting 2304 can drive the stopper 608 upward to advance cooling fluid 603 into the distal fluid line, and negative pressure applied to the pressure line 2702 via the pneumatic fitting 2304 can drive the stopper 608 downward to retrieve inflation fluid from the fluid line. Thus, inflation fluid can be delivered to and retrieved from the airbag during the process.

[0171] Reference Figure 28 A cross-sectional view of the internal portion of a fluid transfer cartridge with a pneumatically driven syringe according to an embodiment is shown. The syringe may include a corresponding stopper 608. The stopper 608 may be disposed between a distal syringe chamber 2802 and a proximal syringe chamber 2804 within a syringe barrel 408. The proximal syringe chamber 2804 is in fluid communication with a pneumatic fitting 2304, and the 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, the distal syringe chamber 2802 may be in fluid communication with the fluid reservoir, for example, via a cartridge manifold 1402. When the pneumatic fitting 2304 delivers positive pressure to the proximal syringe chamber 2804, the stopper 608 advances forward to discharge cooling fluid 603 from the distal syringe chamber 2802. When the pneumatic fitting 2304 evacuates the proximal syringe chamber 2804, the stopper 608 retracts to draw cooling fluid 603 into the syringe barrel 408.

[0172] The use of the pneumatic drive system 2410 simplifies the design of fluid actuators. The pneumatic system requires fewer disposable parts because it uses simple pressure lines 2702 instead of gears and screws. Therefore, system complexity and cost can be reduced.

[0173] In one embodiment, the syringe can be completely removed from the cartridge and repositioned near the fluid reservoir. Alternatively, the syringe can be provided as part of an assembly comprising the syringe and the fluid reservoir, which can then be connected to the generator 202. In either case, the cartridge can be completely eliminated because the fluid transfer function can be performed directly by the generator 202. In this case, the generator 202 may have inlet / outlet fluid lines that transfer fluid directly from the fluid reservoir to the balloon without passing through the cartridge. The generator 202 may include a pressure line 2702 connected to the syringe, and the syringe may directly receive / output fluid to the reservoir. The generator 202 may include a clamp valve connected to the syringe, and the syringe may directly receive / output fluid to the reservoir. Therefore, the shift from a mechanically driven mode to a pneumatically driven mode can substantially reduce the complexity and cost of the treatment system 100.

[0174] Non-contact syringe position sensing

[0175] As described above, the positioning of the syringe piston 702 can be sensed via a switch. More specifically, mechanical and / or magnetic switches can be used to detect the position of the piston end. One or more processors in the generator 202 can use position feedback to detect and / or determine the time when the syringe is emptied or filled. Mechanical switches can be prone to failure. Additionally, such switches need to be precisely positioned within the generator 202 to provide accurate data. Magnetic switches tend to offer lower position resolution. Therefore, the accuracy of such switches is required. Thus, the treatment system 100 can benefit from robust, durable, and accurate position sensing components. The system can also benefit from information about the position of the syringe piston 702 throughout the entire process, not just at the emptied or filled position.

[0176] Reference Figure 29 A cross-sectional view of the internal portion of a fluid transfer cartridge with a non-contact position sensor according to an embodiment is shown. Generator 202 may include a non-contact position sensor 2904 mounted in generator housing 304. The non-contact position sensor 2904 may be configured to detect the position of syringe piston 702 1610. More specifically, the non-contact position sensor 2904 may be positioned and oriented such that the sensor's line of sight 2906 is directed towards the syringe portion 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 indicating the position of piston end 2902.

[0177] 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 facing upwards toward the syringe. Therefore, the sensor can be positioned in the longitudinal direction, which is the direction of axial movement.

[0178] The time-of-flight sensor 2908 can emit radiation toward the piston end 2902, and a certain amount of radiation can be reflected back to the time-of-flight sensor 2908 by the piston 1610. 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 and the stopper 608 of the syringe, information about the volume of cooling fluid 603 in the syringe can be determined.

[0179] In one embodiment, the non-contact position sensor 2904 includes a proximity sensor 2910. The proximity sensor 2910 may be oriented parallel to the axial movement direction, as described above. However, in one embodiment, the proximity sensor 2910 has a line of sight 2906 orthogonal to the axial movement direction. For example, the non-contact position sensor 2904 may be mounted on a sidewall of the generator housing 304 and may be radially guided through a cavity that receives the syringe piston 702 during syringe operation.

[0180] 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. The proximity sensor 2910 detects the presence of the piston end 2902 as it moves downwards into that position within the cavity. More specifically, the intensity of reflected radiation sensed by the proximity sensor 2910 changes as the piston end 2902 passes through the line of sight 2906. Therefore, 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 different fluid levels in the syringe. For example, several proximity sensors 2910 can sense piston positions corresponding to syringes filled, half-filled, and emptied of cooling fluid.

[0181] 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 conduit 101. This data can, for example, be continuous throughout the entire syringe stroke, and thus can provide an indication of the syringe's position at each location along the stroke. Furthermore, the non-contact position sensor 2904 can be stably mounted on the generator housing 304, and its position can be calibrated, thereby ensuring accurate position data. Time-of-flight, proximity, and other types of non-contact position sensors 2904 are relatively inexpensive and can therefore be implemented at low cost.

[0182] It should be understood that alternative sensors and sensor arrangements can be used. For example, the non-contact position sensor 2904 may include an acoustic sensor instead of a light sensor. The acoustic sensor emits and receives acoustic signals to determine the presence of a surface (e.g., piston end 2902) and the distance to the surface.

[0183] The sensor can also be moved to any location within generator 202. For example, a structure other than 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 generator 202. For example, the sensor can be placed on syringe shaft 704. In this case, time-of-flight sensor 2908 can be mounted on shaft end 706. The sensor can be guided toward the direction of shaft movement to sense movement of shaft 704 based on changes in distance between the sensor and adjacent surfaces (e.g., generator housing 304).

[0184] The sensor can also be moved to any location within the housing. For example, a structure other than the 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 housing. 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 guided in the direction of shaft movement to sense the movement of the shaft 704 based on changes in distance between the sensor and adjacent surfaces (e.g., the housing).

[0185] Fluid storage device detection

[0186] The treatment system 100 includes a fluid reservoir containing cooling fluid 603 circulating through the balloon catheter 101. The fluid reservoir can be a container holding 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 process and / or apparatus being used. For example, some balloon catheters 101 may optimally operate using sterile water, while others may operate using saline. Therefore, the presence and type of fluid reservoir (e.g., its volume and contents) are important for appropriate system performance. In one embodiment, the treatment system 100 is capable of detecting the presence and / or type of fluid reservoir being used during the process.

[0187] Reference Figure 30 The image shows a perspective view of an ultrasound-based therapeutic system according to an embodiment. The therapeutic system 100 may include a fluid reservoir holder 3004 to hold a fluid reservoir 3002. The fluid reservoir holder 3004 may have an attachment 3006 (e.g., a hook) to hold the reservoir. For example, the fluid reservoir 3002 may be a sterile water-filled bag with a ring that can be placed on the attachment 3006 to suspend the bag from the fluid reservoir holder 3004.

[0188] In one embodiment, the system includes sensors for sensing the presence and / or characteristics of a fluid reservoir 3002. This characteristic may be the weight of the fluid reservoir 3002. For example, a weight sensor 3008 may be coupled to an 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 anywhere subjected to tensile, compressive, or bending moments due to the weight of the fluid reservoir. Therefore, the weight sensor 3008 can detect and / or measure the physical strain generated by such a load to generate data corresponding to the weight of the fluid reservoir 3002.

[0189] The generated data can be used by one or more processors to determine information about the fluid reservoir 3002. More specifically, one or more processors can receive weight data from the weight sensor 3008 and determine information corresponding to the fluid reservoir 3002 based on the weight data.

[0190] In one embodiment, one or more processors determine the presence of the fluid reservoir 3002. Presence detection can be used to verify that the fluid reservoir 3002 is available at the appropriate time during the process (or to determine if it has been removed). The fluid reservoir 3002 may be necessary for one or more process operations, such as the preparation and inflation of the balloon catheter 101. When the fluid reservoir 3002 is absent (e.g., when the fluid bag is not suspended from the bag holder), these process operations may fail, which could undesirably prolong the process.

[0191] One or more processors may determine the presence of fluid reservoir 3002 based on weight data that is above a predetermined weight threshold or within a predetermined weight range. One or more processors may generate a presence signal based on the weight. The presence signal can be used as a gate for a logical sequence in the process. For example, the presence signal may allow the user interface to proceed to subsequent operations in the preparation process, or generate an error message to prompt the user to load or replace fluid reservoir 3002.

[0192] Besides serving as a logic gate, weight data can also be used for interlocking other system components. For example, when fluid reservoir 3002 is absent, the syringe drive system can be deactivated to prevent operation when no cooling fluid 603 is available to fill syringe barrel 408. Presence is just one of the features that can drive the above decisions. Other features that can be sensed include fluid reservoir type (including cooling fluid type) and / or leak detection.

[0193] In one embodiment, one or more processors determine whether a fluid reservoir is a predetermined fluid reservoir. The weight of fluid reservoir 3002 may 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. Additionally, the fluid reservoir may be made of different materials (e.g., vinyl or silicone), which can also affect the predetermined weight of fluid reservoir 3002. Treatment system 100 can be calibrated or programmed using a specific fluid reservoir of known weight. Thus, 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 mounted on fluid reservoir holder 3004.

[0194] Some balloon catheters 101 can be optimally operated using sterile water as the cooling fluid 603 for transducers 108. For example, using saline instead of sterile water in such transducers may cause transducer malfunction. Therefore, one or more processors may 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 may 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 may prompt the user to verify whether sterile water (or glucose, etc.) is being used. Thus, 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.

[0195] In one embodiment, one or more processors determine whether a leak exists in the fluid reservoir 3002. Weight data can be used to detect changes in the bag's weight during the process. More specifically, one or more processors can detect weight changes in the fluid reservoir 3002 during the process, which can indicate fluid loss 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.

[0196] Reference Figure 31 A cross-sectional view of the drive mechanism of the fluid transfer cartridge according to an embodiment is shown. As described above regarding... Figure 8 The drive mechanism includes a shaft 704 of a syringe piston 702 having an external thread 802, and a gear 804 having an internal thread 1109 that engages with the external thread 802. In one embodiment, the external thread 802 and the internal thread 1109 are configured to prevent thread-to-thread adhesion. For example, when using a standard thread design where there is insufficient clearance between the tip and root of the engaging thread, thread-to-thread adhesion can occur. More specifically, adhesion occurs more frequently when the working depths of the external thread 802 and the internal thread 1109 are equal. In one embodiment, the external thread 802 and the internal thread 1109 have different working depths. For example, the external thread 802 may have an outer working depth 3102, and the internal thread 1109 may have an inner working depth 3104. The outer working depth 3102 may be greater than the inner working depth 3104. For example, the outer working depth 3102 may be at least 25%, such as 50%, greater than the inner working depth 3104. Different working depths allow the threads to engage securely without sticking as the shaft 704 is driven by the gear 804.

[0197] Reference Figure 32A block diagram of a controller for a treatment system according to an embodiment is shown. This block diagram represents an exemplary implementation 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 ultrasound excitation source 3208, but may include additional and / or alternative components. Although not specifically shown, the processor 3202 may be located on a control board or more generally a printed circuit board (PCB) along with additional circuitry of the controller 3200. The processor 3202 may communicate with the memory 3204, which may 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 via a connecting cable and wires extending through wiring through the conduit shaft 704 to the ultrasound transducer 108. These wires electrically couple the controller 3200 to the transducer 108, allowing the controller 3200 to send and receive electrical signals to and from the transducer 108. The processor 3202 can control the ultrasonic excitation source 3208 to control the amplitude and duration 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 therapy parameters for performing 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 The ultrasonic excitation source 3208 is shown as part of the controller 3200, but it may also be located outside the controller 3200 and still be controlled by the controller 3200, and more specifically, by the processor 3202 of the controller 3200.

[0198] User interface 3206 may include a touchscreen and / or buttons, switches, etc., to allow an operator (user) to input patient data, select treatment parameters, view records stored on a storage / retrieval unit (not shown), and / or otherwise communicate with processor 3202. User interface 3206 may include a voice activation mechanism for inputting patient data or may be able to communicate with additional devices to control controller 3200 (e.g., wired or wireless remote control) via user interface 3206 alone. In some embodiments, user interface 3206 is configured to receive input set by the operator, which may include, for example, the duration of energy delivery, one or more other time aspects of the energy delivery pulse (e.g., frequency, duty cycle, etc.), power, body cavity length, operating mode, verification of patient parameters (e.g., height and weight) and / or arterial diameter, or combinations thereof. Exemplary operating modes may include (but are not limited to): system startup and setup, catheter preparation, balloon inflation, balloon juxtaposition verification, pre-cooling, ultrasound treatment, post-cooling, balloon deflation, and catheter removal, but are not limited thereto. In some embodiments, the user interface 3206 provides a graphical user interface (GUI) to guide the user on how to properly operate the treatment system 100. The user interface 3206 may also be used to display treatment data for viewing and / or downloading and to allow software updates and / or similar purposes.

[0199] The controller 3200 may also control the cooling fluid supply subsystem 3210, which may include the fluid transfer cartridge 204 and fluid reservoir 3002 described above, but may include alternative types of fluid pumps and / or the like. The cooling fluid supply subsystem 3210 is fluidly coupled to one or more fluid lumens (e.g., 110) within the conduit shaft and subsequently to the airbag. The cooling fluid supply subsystem 3210 may be configured to circulate cooling fluid through conduit 101 to the transducer 108 within the airbag. The cooling fluid supply subsystem 3210 may include elements for supplying a quantity of cooling fluid 603 to the internal space of the airbag at a controlled temperature, desired to be at or below body temperature, such as the fluid reservoir 3002 for containing the cooling fluid 603, a pump (e.g., a syringe), a cooling coil (not shown), or the like. The processor 3202 interfaces with the cooling fluid supply subsystem 3210 to control the inflow and outflow of cooling fluid 603 from the airbag. For example, processor 3202 can control a motor control device connected to drive motor 1108, which is associated with a pump to control the speed of operating the pump (e.g., a syringe). Such a 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 loop may include a structure connected in the fluid loop to change the loop's resistance to fluid flow, such as a controllable valve (not shown). Processor 3202 can monitor pressure measurements obtained by pressure sensors (e.g., P1, P2, and P3) to monitor and control the cooling fluid 603 through conduit 101 and the air bladder. The pressure sensors can also be used to determine if there is a blockage and / or leakage in conduit 101. When the air bladder is inflated, the pressure sensors can be used to maintain a desired pressure in the air bladder, for example, maintaining a pressure between 10 psi and 30 psi, but are not limited thereto. As described in more detail below, the processor 3202 may use sensor measurements from one or more of the pressure sensor 2402 and other sensors to determine the time the airbag is juxtaposed with the body cavity and to estimate the inner diameter of the body cavity in order to select an appropriate dose of ultrasound energy to be delivered to treat the tissues surrounding the body cavity.

[0200] The controller 3200 can control the operation of the generator 202 and fluid transfer cartridge 204 components to drive the inflation of the balloon before or during an intervention procedure. For example, the controller 3200 can control the initiation process. The initiation process can use one or more of the syringe, fluid manifold, fluid lines, and balloon of the treatment system 100 to fill it with fluid and remove air bubbles from the system. More specifically, the initiation process can purge air from the fluid system and prepare the treatment system 100 for delivery to the patient. As described below, the initiation process may include draining fluid from the return syringe before filling the injection syringe to avoid introducing air into the injection syringe. As mentioned 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 thus draw fluid into or expel fluid from the syringe.

[0201] The position of the stopper 608 within the syringe can be determined by the controller 3200 based on several 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 known pitch information. Additionally, as described above, a magnetic or optical sensor can detect the position of the shaft end 706, such as the initial position 1102. When the shaft end 706 is at the initial position 1102, the stopper 608 may be located at a known position within the syringe.

[0202] Although the feedback from the motor 1108 and the starting position sensor can provide a precise determination of the starting position 1102, system slippage of the gear teeth or the motor 1108 can lead to some inaccuracy regarding whether the stopper 608 is accurately located at the same starting position 1102 after each inflation / deflation cycle. More specifically, as the piston is driven up and down within the syringe through several cycles, the shaft end 706 can be driven to a different starting position 1102 without triggering the return sensor, based on the rotation of the motor 1108. When this occurs, the system may err. However, when an erroneous trigger occurs, only a slightly different amount of fluid may remain in the syringe compared to when the stopper 608 is in its original starting position 1102, which can cause problems requiring the user to reposition the system, even if it does not actually affect system performance.

[0203] To avoid such problems, a reset procedure can be used. When changes to the starting position do not negatively affect system operation, the procedure will dynamically adjust the starting position and generate an error when such changes may negatively affect system operation.

[0204] During operation, the fluid transfer cartridge 204 is loaded into the generator 202. When operation begins, the spool end 706 of the fluid transfer cartridge 204 will be detected or not detected by the homing sensor. If the spool end 706 is not detected, the controller 3200 can determine that the syringe must be homed before continuing fluid initiation and / or balloon inflation / deflation. If the spool end 706 is detected, it can be determined that the syringe has been homed.

[0205] In the first scenario, when the shaft end 706 is initially not detected, the controller 3200 can drive the motor 1108 to lift 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 encoder on the motor 1108, and this position value can be set as the initial starting position (corresponding to the starting position of the shaft end 706).

[0206] The switch includes always-on, always-off, and intermittent (between always-on and always-off) positions. In one embodiment, the shaft end 706 may be in either the always-on or intermittent position upon reaching the initial starting position. If the initial starting position is in the always-on position, lowering and raising the shaft end 706 to the initial starting position should trigger the starting position sensor. If the initial starting position is in the intermittent position, lowering and raising the shaft end 706 to the initial starting position may or may not trigger the starting position sensor.

[0207] It should be understood that the position of the shaft end 706 and the remaining fluid volume can be compared by monitoring the shaft end position and the motor encoder. For example, at any position, the motor 1108 encoder information can be used to determine the stopper position and thus the amount of cooling fluid 603 retained in the syringe. In one embodiment, the controller 3200 can determine the remaining fluid volume in the syringe when the starting position sensor is triggered. When the remaining fluid volume is less than a predetermined volume (e.g., 3 to 5 mL), the controller 3200 can set the motor position to the new starting position 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). 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 and reset the system. In either case, the motor encoder can be used to determine the cooling fluid volume in the syringe in all states during startup and / or inflation / deflation.

[0208] In the second scenario, upon initial detection of shaft end 706, controller 3200 may drive motor 1108 to lower syringe piston 702 to draw a predetermined volume of cooling fluid 603 (e.g., 3 to 5 mL) into the syringe. The starting position sensor may be monitored during the lowering process. If the starting position sensor is off during the lowering movement, the motor encoder position may be set to the new starting position by controller 3200. Controller 3200 may continue to control the system to perform the start-up and / or inflation / deflation process. Alternatively, if the starting position sensor remains on after the syringe has been lowered to draw a predetermined volume of cooling fluid 603 into the syringe, controller 3200 may generate an error to request the user to troubleshoot the system and reset it. More specifically, the sensor remaining on after syringe lowering may indicate a sensor malfunction and the user may be notified accordingly. In either case, the motor encoder may be driven to perform the start-up and / or inflation / deflation process.

[0209] Reference Figure 33 The diagram shows a perspective view of a shaft end 706 with an optical tab according to an embodiment. As described above, the shaft end 706 may include features for triggering a position sensor. For example, this feature may be an optical tab 3302, also referred to as an optical feature. The optical tab 3302 may include a tab, a fork tip, a flag, etc., to trigger the optical sensor. In one embodiment, the optical tab 3302 extends radially outward from an axis 3304. The axis 3304 may be the longitudinal axis of the shaft 704. The radial extension may project outward such that when the shaft end 706 is adjacent to the optical sensor, light emitted by the optical sensor in a direction transverse to the axis 3304 may be reflected from the optical tab 3302. Therefore, the optical tab 3302 may block the optical sensor to trigger the sensor and indicate to the controller 3200 that the shaft 704 and the plug 608 are in a specific position.

[0210] The preceding text describes embodiments of the treatment system. More specifically, embodiments of the treatment system are described explicitly or implicitly. The following paragraphs summarize some of the described embodiments.

[0211] In one embodiment, the fluid transfer cartridge includes a housing defining a cavity between a front and a rear. The front includes an opening. The fluid transfer cartridge includes a handle extending from the front of the housing over the opening. The fluid transfer cartridge includes a syringe barrel disposed within the cavity and visible through an opening on a first side of the handle.

[0212] In one embodiment, the fluid transfer cartridge includes a second syringe barrel disposed within the cartridge cavity and visible to the naked eye through an opening on a second side of the handle.

[0213] In one embodiment, the handle extends vertically from the upper end of the opening to the lower end of the opening.

[0214] In one embodiment, the syringe barrel has a syringe axis extending vertically within the cavity.

[0215] In one embodiment, the fluid transfer cartridge includes a light source located within the cartridge cavity. The light source is guided through the syringe barrel.

[0216] In one embodiment, the light source is guided through the end face of the syringe barrel.

[0217] In one embodiment, the light source emits blue light.

[0218] In one embodiment, when the syringe barrel is filled with a first volume of fluid, the light source emits light of a first color. When the syringe barrel is filled with a second volume of fluid, the light source emits light of a second color.

[0219] In one embodiment, the fluid transfer cartridge includes a syringe retainer mounted within the cartridge cavity. The syringe retainer holds the syringe barrel such that rotation of the syringe barrel relative to the cartridge housing is restricted.

[0220] In one embodiment, the cavity is defined between a front, a rear, a top, and a bottom surface, and further includes a syringe piston disposed within a syringe barrel. The syringe piston includes a plug and a shaft extending from the plug to a shaft end. When the plug is in the initial position within the syringe barrel, the shaft end is flush with the bottom surface. When the plug is in the final position within the syringe barrel, the shaft end is located at the bottom surface.

[0221] In one embodiment, the shaft includes an external thread and further includes a gear mounted on a housing. The gear includes an internal thread that engages with the external thread.

[0222] In one embodiment, the external thread and the internal thread have different working depths.

[0223] In one embodiment, the shaft includes a notch extending longitudinally between the plug and the shaft end.

[0224] In one embodiment, the syringe piston includes an optical tab at the end of a shaft.

[0225] In one embodiment, a protrusion is included at the rear. The fluid transfer cartridge includes one or more electrical contact pads exposed at the rear near the upper end of the protrusion.

[0226] In one embodiment, the protrusion includes four or more recesses distributed around the periphery of the protrusion.

[0227] In one embodiment, the housing includes a conduit routing plate that engages with the front edge. The conduit routing plate and the front edge include corresponding notches. These corresponding notches combine to form a conduit routing port through which fluid conduits are routed.

[0228] In one embodiment, the treatment system includes a fluid transfer cartridge comprising a housing defining a cavity between a front and a rear. The front includes an opening, a handle extending from the front of the housing over the opening, and a syringe barrel disposed within the cavity and visible through an opening on a first side of the handle. The treatment system includes a generator having a generator housing comprising a cartridge container configured to receive the fluid transfer cartridge.

[0229] In one embodiment, the cavity is defined between a front, a rear, a top, and a bottom surface, and further includes a syringe piston disposed within a syringe barrel. The syringe piston includes a plug and a shaft extending from the plug to a shaft end. When the plug is in the initial position within the syringe barrel, the shaft end is flush with the bottom surface. When the plug is in the final position within the syringe barrel, the shaft end is located at the bottom surface.

[0230] In one embodiment, the generator includes an optical switch. The shaft includes an optical tab to block the optical switch, thereby indicating the position of the shaft.

[0231] In one embodiment, the generator includes one or more processors configured to determine the stroke of one or more syringes based on the position of an axis.

[0232] In one embodiment, the stroke of one or more syringes includes the initial position of the syringe piston, in which the syringe piston removes air bubbles from one or more syringes.

[0233] In one embodiment, the generator includes a motor operatively coupled to a shaft. One or more processors are configured to actuate the motor to move the syringe piston during syringe preparation for fluid transfer.

[0234] In one embodiment, one or more processors are configured to drive a motor to fill a syringe with cooling fluid. One or more processors are configured to determine that the syringe is filled with a predetermined amount of cooling fluid. One or more processors are configured to drive a motor to empty the cooling fluid from the syringe. One or more processors are configured to determine that the syringe is empty.

[0235] In one embodiment, the fluid transfer cartridge includes a front portion having a front periphery and a handle extending over an opening. The fluid transfer cartridge includes a rear portion having a rear periphery. When the front periphery engages with the rear periphery, a cavity is defined between the front and rear portions such that the cavity is visible through an opening on a first side of the handle.

[0236] In one embodiment, the handle extends vertically from the upper end of the opening to the lower end of the opening.

[0237] In one embodiment, the fluid transfer cartridge housing includes a light source located within the cartridge cavity. The light source emits blue light.

[0238] In one embodiment, a protrusion is included at the rear. The generator includes one or more electrical contact pads exposed at the rear near the upper end of the protrusion.

[0239] In one embodiment, the protrusion includes four or more recesses distributed around the periphery of the protrusion.

[0240] In one embodiment, the housing includes a conduit routing plate that engages with the front edge. The conduit routing plate and the front edge include corresponding recesses located at the edges, which combine to form conduit routing ports through which fluid conduits are routed.

[0241] In one embodiment, the fluid transfer cartridge includes a housing having a cavity between a front and a rear section. The fluid transfer cartridge includes a syringe barrel disposed within the cavity and having a syringe chamber. The fluid transfer cartridge includes a manifold located within the cavity. The manifold includes a fluid transfer plate having a front fluid channel in a front plate surface, a rear fluid channel in a rear plate surface, and a fluid port extending from the front fluid channel to the rear fluid channel through the fluid transfer plate. The front fluid channel, the rear fluid channel, and the fluid port are in fluid communication with the syringe chamber.

[0242] In one embodiment, the manifold includes a piston with an end seal. The piston is movable from an open position (where the end seal unseals the fluid port to allow cooling fluid to flow through the fluid port) to a closed position (where the end seal seals the fluid port to prevent cooling fluid from flowing through the fluid port).

[0243] In one embodiment, the end seal has a circular distal surface.

[0244] In one embodiment, the end seal includes an O-ring.

[0245] In one embodiment, the cassette manifold includes a tail plate juxtaposed with the rear plate surface of the fluid transfer plate. The cassette manifold includes a channel seal extending around the rear fluid passage. The channel seal is sandwiched between the rear plate surface and the tail plate.

[0246] In one embodiment, in the closed and open positions, the rear surface of the piston is located behind the rear surface of the tail plate.

[0247] In one embodiment, the end seal presses against the rear plate surface of the fluid transfer plate, and the side seal seals the tail plate.

[0248] In one embodiment, the piston is spring-loaded to move the piston from the open position to the closed position.

[0249] In one embodiment, the piston includes an annular groove to receive a spring for spring loading of the piston.

[0250] In one embodiment, the fluid transfer plate is sandwiched between the front plate and the rear plate. The front plate snaps into the rear plate.

[0251] In one embodiment, the treatment system includes a fluid transfer cartridge comprising a housing having a cavity between a front and a rear end, a syringe barrel disposed within the cavity and having a syringe chamber, and a cartridge manifold within the cavity. The cartridge manifold includes a fluid transfer plate having a front fluid channel in a front plate surface, a rear fluid channel in a rear plate surface, and a fluid port extending from the front fluid channel to the rear fluid channel through the fluid transfer plate. The front fluid channel, the rear fluid channel, and the fluid port are in fluid communication with the syringe chamber, and the generator has a generator housing including a cartridge container configured to receive the fluid transfer cartridge.

[0252] In one embodiment, the manifold includes a piston with an end seal. The piston is movable from an open position (where the end seal unseals the fluid port to allow cooling fluid to flow through the fluid port) to a closed position (where the end seal seals the fluid port to prevent cooling fluid from flowing through the fluid port).

[0253] In one embodiment, the end seal has a circular distal surface.

[0254] In one embodiment, the end seal includes an O-ring.

[0255] In one embodiment, the cassette manifold includes a tail plate juxtaposed with the rear plate surface of the fluid transfer plate. The cassette manifold includes a channel seal extending around the rear fluid passage. The channel seal is sandwiched between the rear plate surface and the tail plate.

[0256] In one embodiment, in the closed and open positions, the rear surface of the piston is located behind the rear surface of the tail plate.

[0257] In one embodiment, the end seal presses against the rear plate surface of the fluid transfer plate, and the side seal seals the tail plate.

[0258] In one embodiment, the piston is spring-loaded to move the piston from the open position to the closed position.

[0259] In one embodiment, the piston includes an annular groove to receive a spring for spring loading of the piston.

[0260] In one embodiment, the fluid transfer plate is sandwiched between the front plate and the rear plate. The front plate snaps into the rear plate.

[0261] In one embodiment, the cassette manifold includes a fluid transfer plate having a front fluid channel in a front plate surface, a rear fluid channel in a rear plate surface, and a fluid port extending from the front fluid channel to the rear fluid channel via the fluid transfer plate. The cassette manifold includes a piston with an end seal. The piston is movable from an open position (where the end seal releases the fluid port to allow cooling fluid to flow through the fluid port) to a closed position (where the end seal seals the fluid port to prevent cooling fluid from flowing through the fluid port).

[0262] In one embodiment, the end seal has a circular distal surface.

[0263] In one embodiment, the end seal includes an O-ring.

[0264] In one embodiment, the cassette manifold includes a tail plate juxtaposed with the rear plate surface of the fluid transfer plate. The cassette manifold includes a channel seal extending around the rear fluid passage. The channel seal is sandwiched between the rear plate surface and the tail plate.

[0265] In one embodiment, in the closed and open positions, the rear surface of the piston is located behind the rear surface of the tail plate.

[0266] In one embodiment, the end seal presses against the rear plate surface of the fluid transfer plate, and the side seal seals the tail plate.

[0267] In one embodiment, the piston is spring-loaded to move the piston from the open position to the closed position.

[0268] In one embodiment, the piston includes an annular groove to receive a spring for spring loading of the piston.

[0269] In one embodiment, the fluid transfer plate is sandwiched between the front plate and the rear plate. The front plate snaps into the rear plate.

[0270] In one embodiment, a fluid transfer cartridge for an ultrasound-based therapeutic system includes a housing defining a cavity between a front and a rear. The front includes an opening. The fluid transfer cartridge includes a handle extending from the front of the housing over the opening. The fluid transfer cartridge includes a syringe barrel disposed within the cavity and visible through an opening on a first side of the handle.

[0271] In one embodiment, the fluid transfer cartridge includes a second syringe barrel disposed within the cartridge cavity and visible to the naked eye through an opening on a second side of the handle.

[0272] In one embodiment, the handle extends vertically from the upper end of the opening to the lower end of the opening.

[0273] In one embodiment, the syringe barrel has a syringe axis extending vertically within the cavity.

[0274] In one embodiment, a fluid transfer cartridge for an ultrasound-based therapeutic system includes a housing defining a cavity between a front and a rear. The front includes a window. The fluid transfer cartridge includes a handle extending from the front of the housing above the window. The fluid transfer cartridge includes a syringe barrel disposed within the cavity and visible through an opening on a first side of the handle.

[0275] In one embodiment, the fluid transfer cartridge includes a second syringe barrel disposed within the cartridge cavity and visible through a window on a second side of the handle.

[0276] In one embodiment, the handle extends vertically from the top of the window to the bottom of the window.

[0277] In one embodiment, the syringe barrel has a syringe axis extending vertically within the cavity.

[0278] In one embodiment, a fluid transfer cartridge for an ultrasound-based therapeutic system includes a housing defining a cavity between a front and a rear end. The fluid transfer cartridge includes a syringe barrel visibly exposed within the cavity. The fluid transfer cartridge includes a light source located within the cavity. The light source is directed through an end face of the syringe barrel.

[0279] In one embodiment, the light source emits blue light.

[0280] In one embodiment, when the syringe barrel is filled with a first volume of fluid, the light source emits light of a first color. When the syringe barrel is filled with a second volume of fluid, the light source emits light of a second color.

[0281] In one embodiment, a fluid transfer cartridge for an ultrasound-based therapeutic system includes a housing defining a cavity between a front and a rear end. The fluid transfer cartridge includes a syringe barrel visibly exposed within the cavity. The fluid transfer cartridge includes a light source located within the cavity. The light source is guided through the syringe barrel.

[0282] In one embodiment, the light source emits blue light.

[0283] In one embodiment, when the syringe barrel is filled with a first volume of fluid, the light source emits light of a first color. When the syringe barrel is filled with a second volume of fluid, the light source emits light of a second color.

[0284] In one embodiment, a fluid transfer cassette for an ultrasound-based therapeutic system includes a housing defining a cavity between a front and a rear end. The fluid transfer cassette includes a syringe barrel visibly exposed within the cavity. The fluid transfer cassette includes a syringe retainer mounted within the cavity. The syringe retainer holds the syringe barrel such that rotation of the syringe barrel relative to the housing is restricted.

[0285] In one embodiment, the fluid transfer cartridge includes a housing defining a cavity between a front and a rear end. The fluid transfer cartridge includes one or more syringes disposed within the cavity. Each of the one or more syringes includes a syringe piston disposed within a syringe barrel. The syringe piston includes a stopper and a shaft extending from the stopper to a shaft end. When the stopper is in an initial position within the syringe barrel, the shaft end is disposed within the cavity. When the stopper is in an end position within the syringe barrel, the shaft end is disposed outside the cavity.

[0286] In one embodiment, the shaft includes an external thread. The fluid transfer cartridge includes a gear mounted on the cartridge housing. The gear includes an internal thread that engages with the external thread.

[0287] In one embodiment, the shaft includes a notch extending longitudinally between the plug and the shaft end.

[0288] In one embodiment, the fluid transfer cartridge includes a housing defining a cavity between a front and a rear end. The fluid transfer cartridge includes one or more syringes disposed within the cavity. Each of the one or more syringes includes a syringe piston disposed within a syringe barrel. The syringe piston includes a stopper and a shaft extending from the stopper to a shaft end. The syringe piston includes a magnet disposed at the shaft end.

[0289] In one embodiment, the contacts of the magnetic switch in the magnet-moving therapy system indicate the proximity between the magnet and the magnetic switch.

[0290] In one embodiment, the treatment system includes one or more processors configured to determine the stroke of one or more syringes based on the proximity between a magnet and a magnetic switch.

[0291] In one embodiment, the stroke of one or more syringes includes the initial position of the syringe piston, in which the syringe piston removes air bubbles from one or more syringes.

[0292] In one embodiment, one or more processors are configured to actuate a motor operably coupled to a shaft to move a syringe piston during one or more syringes being prepared for fluid transfer.

[0293] In one embodiment, one or more processors are configured to: drive a motor to fill one or more syringes with cooling fluid; determine that the one or more syringes are filled with a predetermined amount of cooling fluid; drive a motor to empty the cooling fluid from the one or more syringes; and determine that the one or more syringes are empty.

[0294] In one embodiment, the method includes filling a plurality of syringes of a fluid transfer cartridge with cooling fluid. Each of the syringes includes a syringe piston disposed within a syringe barrel. The syringe piston includes a stopper and a shaft extending from the stopper to a shaft end. When the stopper is in an initial position within the syringe barrel, the shaft end is disposed within a cavity of the fluid transfer cartridge. When the stopper is in an end position within the syringe barrel, the shaft end is disposed outside the cavity. The method includes one or more processors determining the time for filling the plurality of syringes with a predetermined amount of cooling fluid based on the stopper being in the end position. The method includes filling a fluid path of the cartridge with cooling fluid. The method includes removing air bubbles from the fluid path and the plurality of syringes.

[0295] In one embodiment, determining whether a plurality of syringes are filled with a predetermined amount of cooling fluid includes detecting whether the stopper is in the end position.

[0296] In one embodiment, removing air bubbles from the fluid path and the plurality of syringes includes: filling the plurality of syringes with cooling fluid; determining that the plurality of syringes are filled with cooling fluid based on the stopper being in the end position; emptying the cooling fluid from the plurality of syringes; determining that the plurality of syringes are empty based on the stopper being in the beginning position; and filling the plurality of syringes with cooling fluid.

[0297] In one embodiment, the fluid transfer cartridge includes a housing defining a cavity between a front and a rear end. The fluid transfer cartridge includes one or more syringes disposed within the cavity. Each of the one or more syringes includes a syringe piston disposed within a syringe barrel. The syringe piston includes a stopper and a shaft extending from the stopper to a shaft end. The shaft end is configured to emit or reflect light.

[0298] In one embodiment, the shaft end emits or reflects light toward the photosensor of the treatment system to indicate the proximity between the shaft end and the photosensor.

[0299] In one embodiment, the treatment system includes one or more processors configured to determine the stroke of one or more syringes based on the proximity between the shaft end and the optical sensor.

[0300] In one embodiment, the stroke of one or more syringes includes the initial position of the syringe piston, in which the syringe piston removes air bubbles from one or more syringes.

[0301] In one embodiment, one or more processors are configured to actuate a motor operably coupled to a shaft to move a syringe piston during one or more syringes being prepared for fluid transfer.

[0302] In one embodiment, one or more processors are configured to: drive a motor to fill one or more syringes with cooling fluid; determine that the one or more syringes are filled with a predetermined amount of cooling fluid; drive a motor to empty the cooling fluid from the one or more syringes; and determine that the one or more syringes are empty.

[0303] In one embodiment, the method includes filling a plurality of syringes of a fluid transfer cartridge with cooling fluid. Each of the syringes includes a syringe piston disposed within a syringe barrel. The syringe piston includes a stopper and a shaft extending from the stopper to a shaft end. When the stopper is in an initial position within the syringe barrel, the shaft end is disposed within a cavity of the fluid transfer cartridge. When the stopper is in an end position within the syringe barrel, the shaft end is disposed outside the cavity. The method includes one or more processors determining the time for filling the plurality of syringes with a predetermined amount of cooling fluid based on the stopper being in the end position. The method includes filling a fluid path of the cartridge with cooling fluid. The method includes removing air bubbles from the fluid path and the plurality of syringes.

[0304] In one embodiment, determining whether a plurality of syringes are filled with a predetermined amount of cooling fluid includes detecting whether the stopper is in the end position.

[0305] In one embodiment, removing air bubbles from the fluid path and the plurality of syringes includes: filling the plurality of syringes with cooling fluid; determining that the plurality of syringes are filled with cooling fluid based on the stopper being in the end position; emptying the cooling fluid from the plurality of syringes; determining that the plurality of syringes are empty based on the stopper being in the beginning position; and filling the plurality of syringes with cooling fluid.

[0306] In one embodiment, the fluid transfer cartridge includes a housing defining a cavity between a front and a rear section. The rear section includes a protrusion. The fluid transfer cartridge includes one or more spring-loaded electrical contact pins exposed at the rear section near the upper end of the protrusion.

[0307] In one embodiment, the protrusion includes four or more recesses distributed around the periphery of the protrusion.

[0308] In one embodiment, the housing includes a conduit routing plate that engages with the front edge. The conduit routing plate and the front edge include corresponding notches. These corresponding notches combine to form a conduit routing port through which fluid conduits are routed.

[0309] In one embodiment, a generator for an ultrasound-based therapeutic system includes a generator housing configured to receive a cartridge container. The generator includes a fastening mechanism comprising a release button movable between a latched position and an unlatched position. The generator includes a plurality of spring-loaded latches operably coupled to the release button, such that moving the release button from the latched position to the unlatched position causes the plurality of spring-loaded latches to disengage from the cartridge container.

[0310] In one embodiment, the cartridge container includes a rear recess to receive a protrusion of a fluid transfer cartridge. The rear recess has a recess perimeter. A plurality of spring-loaded latches include four or more spring-loaded latches distributed around the perimeter of the recess.

[0311] In one embodiment, a generator for an ultrasound-based therapeutic system includes a generator housing configured to receive a cartridge container. The generator includes a fastening mechanism comprising a release button movable between a latched position and an unlatched position. The generator includes one or more latches operatively coupled to the release button, such that moving the release button from the latched position to the unlatched position causes one or more latches to disengage from the cartridge container.

[0312] In one embodiment, the generator includes one or more springs operably coupled to a release button to bias the release button toward a latch position.

[0313] In one embodiment, one or more springs comprise a single spring. One or more latches comprise a plurality of latches. A release button is operatively coupled to a link interconnecting the plurality of latches with the single spring to bias the plurality of latches into the container.

[0314] In one embodiment, the cartridge container includes a rear recess to receive a protrusion of a fluid transfer cartridge. The rear recess has a recess perimeter. One or more latches include four or more spring-loaded latches distributed around the perimeter of the recess.

[0315] In one embodiment, a generator for an ultrasound-based therapeutic system includes a generator housing configured to receive a fluid transfer cartridge. The generator includes a well located below the cartridge for receiving an syringe piston of the fluid transfer cartridge.

[0316] In one embodiment, the generator includes one or more magnetic switches mounted inside the well to detect a magnet disposed on the syringe piston of the fluid transfer cartridge.

[0317] In one embodiment, the ultrasound-based therapeutic system includes a generator having a cartridge container. The ultrasound-based therapeutic system includes a fluid transfer cartridge. The ultrasound-based therapeutic system includes one or more processors configured to determine whether the fluid transfer cartridge is received within the cartridge container, and to activate a light source of the fluid transfer cartridge in response to determining that the fluid transfer cartridge is received within the cartridge container. The light source is directed toward an syringe containing the fluid transfer cartridge.

[0318] In one embodiment, the generator includes an electrical connector and an indicator light. One or more processors are configured to determine whether the electrical connector is electrically connected to an external connector and, in response to determining that the electrical connector is connected to the external connector, change the illumination pattern of the indicator light.

[0319] In one embodiment, the lighting mode is changed from a first lighting mode in which the indicator light illuminates intermittently to a second lighting mode in which the indicator light illuminates continuously.

[0320] In one embodiment, the change in lighting mode is from a first lighting mode in which the indicator light emits light of a first color to a second lighting mode in which the indicator light emits light of a second color.

[0321] In one embodiment, the indicator light includes an indicator light ring extending around the electrical connector.

[0322] In one embodiment, a fluid transfer cartridge for an ultrasound-based therapeutic system includes a housing defining a cavity between a front and a rear. The front includes an opening. The fluid transfer cartridge includes a handle extending from the front of the housing over the opening. The fluid transfer cartridge includes a syringe barrel disposed within the cavity and visible through an opening on a first side of the handle.

[0323] In one embodiment, the fluid transfer cartridge includes a second syringe barrel disposed within the cartridge cavity and visible to the naked eye through an opening on a second side of the handle.

[0324] In one embodiment, the handle extends vertically from the upper end of the opening to the lower end of the opening.

[0325] In one embodiment, the syringe barrel has a syringe axis extending vertically within the cavity.

[0326] In one embodiment, a fluid transfer cartridge for an ultrasound-based therapeutic system includes a housing defining a cavity between a front and a rear. The front includes a window. The fluid transfer cartridge includes a handle extending from the front of the housing above the window. The fluid transfer cartridge includes a syringe barrel disposed within the cavity and visible through an opening on a first side of the handle.

[0327] In one embodiment, the fluid transfer cartridge includes a second syringe barrel disposed within the cartridge cavity and visible through a window on a second side of the handle.

[0328] In one embodiment, the handle extends vertically from the top of the window to the bottom of the window.

[0329] In one embodiment, the syringe barrel has a syringe axis extending vertically within the cavity.

[0330] In one embodiment, a fluid transfer cartridge for an ultrasound-based therapeutic system includes a housing defining a cavity between a front and a rear end. The fluid transfer cartridge includes a syringe barrel visibly exposed within the cavity. The fluid transfer cartridge includes a light source located within the cavity. The light source is directed through an end face of the syringe barrel.

[0331] In one embodiment, the light source emits blue light.

[0332] In one embodiment, when the syringe barrel is filled with a first volume of fluid, the light source emits light of a first color. When the syringe barrel is filled with a second volume of fluid, the light source emits light of a second color.

[0333] In one embodiment, a fluid transfer cartridge for an ultrasound-based therapeutic system includes a housing defining a cavity between a front and a rear end. The fluid transfer cartridge includes a syringe barrel visibly exposed within the cavity. The fluid transfer cartridge includes a light source located within the cavity. The light source is guided through the syringe barrel.

[0334] In one embodiment, the light source emits blue light.

[0335] In one embodiment, when the syringe barrel is filled with a first volume of fluid, the light source emits light of a first color. When the syringe barrel is filled with a second volume of fluid, the light source emits light of a second color.

[0336] In one embodiment, a fluid transfer cassette for an ultrasound-based therapeutic system includes a housing defining a cavity between a front and a rear end. The fluid transfer cassette includes a syringe barrel visibly exposed within the cavity. The fluid transfer cassette includes a syringe retainer mounted within the cavity. The syringe retainer holds the syringe barrel such that rotation of the syringe barrel relative to the housing is restricted.

[0337] In one embodiment, the fluid transfer cartridge includes a housing defining a cavity between a front and a rear end. The fluid transfer cartridge includes one or more syringes disposed within the cavity. Each of the one or more syringes includes a syringe piston disposed within a syringe barrel. The syringe piston includes a stopper and a shaft extending from the stopper to a shaft end. When the stopper is in an initial position within the syringe barrel, the shaft end is disposed within the cavity. When the stopper is in an end position within the syringe barrel, the shaft end is disposed outside the cavity.

[0338] In one embodiment, the shaft includes an external thread. The fluid transfer cartridge includes a gear mounted on the cartridge housing. The gear includes an internal thread that engages with the external thread.

[0339] In one embodiment, the shaft includes a notch extending longitudinally between the plug and the shaft end.

[0340] In one embodiment, the fluid transfer cartridge includes a housing defining a cavity between a front and a rear end. The fluid transfer cartridge includes one or more syringes disposed within the cavity. Each of the one or more syringes includes a syringe piston disposed within a syringe barrel. The syringe piston includes a stopper and a shaft extending from the stopper to a shaft end. The syringe piston includes a magnet disposed at the shaft end.

[0341] In one embodiment, the contacts of the magnetic switch in the magnet-moving therapy system indicate the proximity between the magnet and the magnetic switch.

[0342] In one embodiment, the treatment system includes one or more processors configured to determine the stroke of one or more syringes based on the proximity between a magnet and a magnetic switch.

[0343] In one embodiment, the stroke of one or more syringes includes the initial position of the syringe piston, in which the syringe piston removes air bubbles from one or more syringes.

[0344] In one embodiment, one or more processors are configured to actuate a motor operably coupled to a shaft to move a syringe piston during one or more syringes being prepared for fluid transfer.

[0345] In one embodiment, one or more processors are configured to: drive a motor to fill one or more syringes with cooling fluid; determine that the one or more syringes are filled with a predetermined amount of cooling fluid; drive a motor to empty the cooling fluid from the one or more syringes; and determine that the one or more syringes are empty.

[0346] In one embodiment, the method includes filling a plurality of syringes of a fluid transfer cartridge with cooling fluid. Each of the syringes includes a syringe piston disposed within a syringe barrel. The syringe piston includes a stopper and a shaft extending from the stopper to a shaft end. When the stopper is in an initial position within the syringe barrel, the shaft end is disposed within a cavity of the fluid transfer cartridge. When the stopper is in an end position within the syringe barrel, the shaft end is disposed outside the cavity. The method includes one or more processors determining the time for filling the plurality of syringes with a predetermined amount of cooling fluid based on the stopper being in the end position. The method includes filling a fluid path of the cartridge with cooling fluid. The method includes removing air bubbles from the fluid path and the plurality of syringes.

[0347] In one embodiment, determining whether a plurality of syringes are filled with a predetermined amount of cooling fluid includes detecting whether the stopper is in the end position.

[0348] In one embodiment, removing air bubbles from the fluid path and the plurality of syringes includes: filling the plurality of syringes with cooling fluid; determining that the plurality of syringes are filled with cooling fluid based on the stopper being in the end position; emptying the cooling fluid from the plurality of syringes; determining that the plurality of syringes are empty based on the stopper being in the beginning position; and filling the plurality of syringes with cooling fluid.

[0349] In one embodiment, the fluid transfer cartridge includes a housing defining a cavity between a front and a rear end; and one or more syringes disposed within the cavity. Each of the one or more syringes includes a syringe piston disposed within a syringe barrel. The syringe piston includes a stopper and a shaft extending from the stopper to a shaft end. The shaft end is configured to emit or reflect light.

[0350] In one embodiment, the shaft end emits or reflects light toward the photosensor of the treatment system to indicate the proximity between the shaft end and the photosensor.

[0351] In one embodiment, the treatment system includes one or more processors configured to determine the stroke of one or more syringes based on the proximity between the shaft end and the optical sensor.

[0352] In one embodiment, the stroke of one or more syringes includes the initial position of the syringe piston, in which the syringe piston removes air bubbles from one or more syringes.

[0353] In one embodiment, one or more processors are configured to actuate a motor operably coupled to a shaft to move a syringe piston during one or more syringes being prepared for fluid transfer.

[0354] In one embodiment, one or more processors are configured to: drive a motor to fill one or more syringes with cooling fluid; determine that the one or more syringes are filled with a predetermined amount of cooling fluid; drive a motor to empty the cooling fluid from the one or more syringes; and determine that the one or more syringes are empty.

[0355] In one embodiment, the method includes filling a plurality of syringes of a fluid transfer cartridge with cooling fluid. Each of the syringes includes a syringe piston disposed within a syringe barrel. The syringe piston includes a stopper and a shaft extending from the stopper to a shaft end. When the stopper is in an initial position within the syringe barrel, the shaft end is disposed within a cavity of the fluid transfer cartridge. When the stopper is in an end position within the syringe barrel, the shaft end is disposed outside the cavity. The method includes one or more processors determining the time for filling the plurality of syringes with a predetermined amount of cooling fluid based on the stopper being in the end position. The method includes filling a fluid path of the cartridge with cooling fluid. The method includes removing air bubbles from the fluid path and the plurality of syringes.

[0356] In one embodiment, determining whether a plurality of syringes are filled with a predetermined amount of cooling fluid includes detecting whether the stopper is in the end position.

[0357] In one embodiment, removing air bubbles from the fluid path and the plurality of syringes includes: filling the plurality of syringes with cooling fluid; determining that the plurality of syringes are filled with cooling fluid based on the stopper being in the end position; emptying the cooling fluid from the plurality of syringes; determining that the plurality of syringes are empty based on the stopper being in the beginning position; and filling the plurality of syringes with cooling fluid.

[0358] In one embodiment, the fluid transfer cartridge includes a housing defining a cavity between a front and a rear section. The rear section includes a protrusion. The fluid transfer cartridge includes one or more spring-loaded electrical contact pins exposed at the rear section near the upper end of the protrusion.

[0359] In one embodiment, the protrusion includes four or more recesses distributed around the periphery of the protrusion.

[0360] In one embodiment, the housing includes a conduit routing plate that engages with the front edge. The conduit routing plate and the front edge include corresponding recesses located at the edges, which combine to form conduit routing ports through which fluid conduits are routed.

[0361] In one embodiment, a generator for an ultrasound-based therapeutic system includes a generator housing configured to receive a cartridge container. The generator includes a fastening mechanism comprising a release button movable between a latched position and an unlatched position; and a plurality of spring-loaded latches operably coupled to the release button, such that moving the release button from the latched position to the unlatched position causes the plurality of spring-loaded latches to disengage from the cartridge container.

[0362] In one embodiment, the cartridge container includes a rear recess to receive a protrusion of a fluid transfer cartridge. The rear recess has a recess perimeter. A plurality of spring-loaded latches include four or more spring-loaded latches distributed around the perimeter of the recess.

[0363] In one embodiment, a generator for an ultrasound-based therapeutic system includes a generator housing configured to receive a cartridge container of a fluid transfer cartridge. The generator includes a fastening mechanism comprising a release button movable between a latched position and an unlatched position; and one or more latches operatively coupled to the release button such that moving the release button from the latched position to the unlatched position causes one or more latches to disengage from the cartridge container.

[0364] In one embodiment, the generator includes one or more springs operably coupled to a release button to bias the release button toward a latch position.

[0365] In one embodiment, one or more springs comprise a single spring. One or more latches comprise a plurality of latches. A release button is operatively coupled to a link interconnecting the plurality of latches with the single spring to bias the plurality of latches into the container.

[0366] In one embodiment, the cartridge container includes a rear recess to receive a protrusion of a fluid transfer cartridge. The rear recess has a recess perimeter. One or more latches include four or more spring-loaded latches distributed around the perimeter of the recess.

[0367] In one embodiment, a generator for an ultrasound-based therapeutic system includes a generator housing configured to receive a fluid transfer cartridge. The generator includes a well located below the cartridge for receiving an syringe piston of the fluid transfer cartridge.

[0368] In one embodiment, the generator includes one or more magnetic switches mounted inside the well to detect a magnet disposed on the syringe piston of the fluid transfer cartridge.

[0369] In one embodiment, the ultrasound-based therapeutic system includes a generator having a cartridge container. The ultrasound-based therapeutic system includes a fluid transfer cartridge. The ultrasound-based therapeutic system includes one or more processors configured to determine whether the fluid transfer cartridge is received within the cartridge container, and to activate a light source of the fluid transfer cartridge in response to determining that the fluid transfer cartridge is received within the cartridge container. The light source is directed toward an syringe containing the fluid transfer cartridge.

[0370] In one embodiment, the generator includes an electrical connector and an indicator light. One or more processors are configured to determine whether the electrical connector is electrically connected to an external connector and, in response to determining that the electrical connector is connected to the external connector, change the illumination pattern of the indicator light.

[0371] In one embodiment, the lighting mode is changed from a first lighting mode in which the indicator light illuminates intermittently to a second lighting mode in which the indicator light illuminates continuously.

[0372] In one embodiment, the change in lighting mode is from a first lighting mode in which the indicator light emits light of a first color to a second lighting mode in which the indicator light emits light of a second color.

[0373] In one embodiment, the indicator light includes an indicator light ring extending around the electrical connector.

[0374] In one embodiment, a fluid transfer cassette for an ultrasound-based therapeutic system includes a housing having a cavity between a front and a rear section. The fluid transfer cassette includes a syringe barrel disposed within the cavity and having a syringe chamber. The fluid transfer cassette includes a manifold located within the cavity. The manifold includes a fluid transfer plate having a front fluid channel in a front plate surface, a rear fluid channel in a rear plate surface, and a fluid port extending from the front fluid channel to the rear fluid channel through the fluid transfer plate. The front fluid channel, the rear fluid channel, and the fluid port are in fluid communication with the syringe chamber.

[0375] In one embodiment, the manifold includes a piston with an end seal. The piston is movable from an open position (where the end seal unseals the fluid port to allow cooling fluid to flow through the fluid port) to a closed position (where the end seal seals the fluid port to prevent cooling fluid from flowing through the fluid port).

[0376] In one embodiment, the cassette manifold includes a tail plate juxtaposed with the rear plate surface of the fluid transfer plate. The cassette manifold includes a channel seal extending around the rear fluid passage. The channel seal is sandwiched between the rear plate surface and the tail plate.

[0377] In one embodiment, the end seal presses against the rear plate surface of the fluid transfer plate, and the side seal seals the tail plate.

[0378] In one embodiment, the piston is spring-loaded to move the piston from the open position to the closed position.

[0379] In one embodiment, a generator for an ultrasound-based therapeutic system includes a generator housing configured to receive a fluid transfer cartridge. The generator includes a pressure fitting mounted on the generator housing. The pressure fitting is configured to connect to a conduit of the fluid transfer cartridge. The generator includes a pressure sensor located within the generator housing. The pressure sensor is configured to sense pressure at the pressure fitting.

[0380] In one embodiment, the generator includes a chamber having a chamber inlet connected to a pressure fitting and a chamber outlet connected to a pressure sensor.

[0381] In one embodiment, the ultrasound-based therapeutic system includes a generator comprising a generator housing. The ultrasound-based therapeutic system includes a pneumatic fitting mounted on the generator housing. The ultrasound-based therapeutic system includes a pneumatic drive system located within the generator housing. The pneumatic drive system is connected to the pneumatic fitting. The pneumatic drive system is configured to apply one or more of a positive or negative pressure to the pneumatic fitting.

[0382] In one embodiment, the ultrasound-based therapeutic system includes one or more syringes. Each of the one or more syringes includes a plug disposed within a syringe barrel between a distal syringe chamber and a proximal syringe chamber. The proximal syringe chamber is in fluid communication with a pneumatic fitting. The distal syringe chamber is in fluid communication with a fluid reservoir.

[0383] In one embodiment, a generator for an ultrasound-based therapeutic system includes a generator housing configured to receive a cartridge container of a fluid transfer cartridge. The generator includes a non-contact position sensor mounted within the generator housing. The non-contact position sensor is configured to detect the position of the syringe piston of the fluid transfer cartridge.

[0384] In one embodiment, the non-contact position sensor includes one or more time-of-flight sensors.

[0385] In one embodiment, the non-contact position sensor includes one or more proximity sensors.

[0386] In one embodiment, the ultrasound-based therapeutic system includes a fluid reservoir holder having an attachment for holding a fluid reservoir. The ultrasound-based therapeutic system includes a weight sensor coupled to the attachment to generate weight data based on the weight of the fluid reservoir. The ultrasound-based therapeutic system includes one or more processors configured to receive the weight data from the weight sensor and determine, based on the weight data, whether the fluid reservoir is a predetermined fluid reservoir.

[0387] In one embodiment, one or more processors are further configured to detect leaks in a fluid reservoir based on weight data.

[0388] In the foregoing description, the invention has been described with reference to specific exemplary embodiments. It is obvious that various modifications can be made to the invention without departing from the scope of the invention as set forth in the appended claims. Therefore, the description and drawings should be considered illustrative rather than restrictive.

Claims

1. A fluid transfer cartridge (204), comprising: A housing (306) defining a cavity (402) between a front (404) and a rear (407), wherein the front (404) includes an opening (406); A handle (307) extending from the front (404) of the housing (306) to above the opening (406); and The syringe barrel (408) is disposed within the cavity (402) and is visible through the opening (406) on the first side (410) of the handle (307).

2. The fluid transfer cartridge according to claim 1, further comprising a second syringe barrel (412) disposed within the cartridge cavity (402) and visiblely exposed through the opening (406) on the second side (414) of the handle (307).

3. The fluid transfer box according to claim 1 or 2, wherein the handle (307) extends vertically from the upper end (416) of the opening (406) to the lower end (418) of the opening (406).

4. The fluid transfer box according to claim 1 or 2, wherein the syringe barrel (408) has a syringe axis (420) extending vertically within the box cavity (402).

5. The fluid transfer cartridge according to claim 1, further comprising a light source (602) located within the cartridge cavity (402), wherein the light source (602) is guided through the syringe barrel (408).

6. The fluid transfer cartridge according to claim 5, wherein the light source (602) is guided through the end face (604) of the syringe barrel (408).

7. The fluid transfer cartridge according to claim 5 or 6, wherein the light source (602) emits blue light.

8. The fluid transfer cartridge according to claim 5 or 6, wherein when the syringe barrel (408) is filled with a first volume of fluid, the light source (602) emits light of a first color, and wherein when the syringe barrel (408) is filled with a second volume of fluid, the light source (602) emits light of a second color.

9. The fluid transfer cartridge according to any one of claims 1, 2, 5, and 6, further comprising a syringe holder (513) mounted within the cartridge cavity (402), wherein the syringe holder (513) holds the syringe barrel (408) such that rotation of the syringe barrel (408) relative to the cartridge housing (306) is restricted.

10. The fluid transfer cartridge according to any one of claims 1, 2, 5, and 6, wherein the cartridge cavity (402) is defined between the front (404), the rear (407), the top (506), and the bottom (510), and further includes a syringe piston (702) disposed within the syringe barrel (408), wherein the syringe piston (702) includes a plug (608) and a shaft (704) extending from the plug (608) to a shaft end (706), wherein when the plug (608) is in a starting position in the syringe barrel (408), the shaft end (706) is flush with the bottom (510), and wherein when the plug (608) is in a finishing position in the syringe barrel (408), the shaft end (706) is lower than the bottom (510).

11. The fluid transfer box according to claim 10, wherein the shaft (704) includes an external thread (802), and further includes a gear (804) mounted on the housing (306), wherein the gear (804) includes an internal thread that engages with the external thread (802).

12. The fluid transfer box according to claim 11, wherein the external thread (802) and the internal thread have different working depths.

13. The fluid transfer cartridge of claim 10, wherein the shaft (704) includes a recess (806) extending longitudinally between the plug (608) and the shaft end (706).

14. The fluid transfer cartridge according to claim 10, wherein the syringe piston (702) includes an optical tab (3302) disposed on the shaft (704) at the shaft end (706).

15. The fluid transfer cartridge according to any one of claims 1, 2, 5, 6, 11, 12, 13, wherein the rear end (407) includes a protrusion (1202) and further includes one or more electrical contact pads (1208) exposed through the rear end (407) near the upper end of the protrusion (1202).

16. The fluid transfer cartridge of claim 15, wherein the protrusion (1202) comprises four recesses (1210) distributed around the periphery (1204) of the protrusion (1202).

17. The fluid transfer cartridge of claim 15, wherein the protrusion (1202) includes four or more recesses (1210) distributed around the periphery (1204) of the protrusion (1202).

18. The fluid transfer box according to any one of claims 1, 2, 5, 6, 11, 12, 13, wherein the box housing (306) includes a pipe routing plate (1002) engaging the front end (404) along an edge (1004), and wherein the pipe routing plate (1002) and the front end (404) include corresponding recesses (1006) at the edge (1004), the corresponding recesses (1006) combining to form a pipe routing port (1008) through which the fluid pipe (206) is routed.

19. A treatment system (100) comprising: The fluid transfer cartridge (204) according to any one of claims 1, 2, 5, 6, 11, 12, 13; and A generator (202) having a generator housing (304) including a cartridge container (302) configured to receive the fluid transfer cartridge (204).

20. The treatment system of claim 19, wherein the fluid transfer cartridge (204) is the fluid transfer cartridge (204) of claim 10 and the generator (202) includes an optical switch, and wherein the shaft (704) includes an optical tab (3302) to block the optical switch thereby indicating the position of the shaft (704).

21. The treatment system of claim 20, wherein the generator (202) includes one or more processors configured to determine the stroke of one or more syringes based on the position of the axis (704).

22. The treatment system of claim 21, wherein the stroke of the one or more syringes includes an initial position of the syringe piston (702) in which the syringe piston (702) removes air bubbles from the one or more syringes.

23. The treatment system of claim 21, wherein the generator (202) includes a motor (1108) operatively coupled to the shaft (704), and wherein the one or more processors are configured to actuate the motor (1108) to move the syringe piston (702) during the preparation of the syringe for fluid transfer.

24. The treatment system of claim 23, wherein the one or more processors are configured to drive the motor (1108) to fill the syringe with cooling fluid; The syringe is determined to be filled with a predetermined amount of cooling fluid; the motor (1108) is driven to drain the cooling fluid from the syringe; and the syringe is determined to be empty.

25. A fluid transfer housing (306), comprising: A front (404) having a front periphery (511) and a handle (307) extending above an opening (406); as well as A rear (407) having a rear periphery (512), wherein when the front periphery (511) engages with the rear periphery (512), a cavity (402) is defined between the front (404) and the rear (407) such that the cavity (402) is visiblely exposed through the opening (406) on a first side of the handle (307).

26. The fluid transfer housing according to claim 25, wherein the handle (307) extends vertically from the upper end (416) of the opening (406) to the lower end (418) of the opening (406).

27. The fluid transfer housing according to claim 25 or 26, further comprising a light source (602) located within the housing cavity (402), wherein the light source (602) emits blue light.

28. The fluid transfer housing according to claim 25 or 26, wherein the rear end (407) includes a protrusion (1202) and further includes one or more electrical contact pads (1208) exposed through the rear end (407) near the upper end of the protrusion (1202).

29. The fluid transfer housing according to claim 28, wherein the protrusion (1202) includes four recesses (1210) distributed around the periphery (1204) of the protrusion (1202).

30. The fluid transfer housing according to claim 28, wherein the protrusion (1202) includes four or more recesses (1210) distributed around the periphery (1204) of the protrusion (1202).

31. The fluid transfer housing according to claim 25 or 26, wherein the housing (306) includes a conduit routing plate (1002) engaging the front end (404) along an edge (1004), and wherein the conduit routing plate (1002) and the front end (404) include corresponding recesses (1006) at the edge (1004), the corresponding recesses (1006) combining to form a conduit routing port (1008) through which the fluid conduit (206) is routed.

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