Treatment system having a generator and fluid transfer cartridge - Patents.com

Abstract

The treatment system 100 includes a generator 202 and a fluid transfer cartridge 204. The fluid transfer cartridge 204 includes a cartridge shell 306 that defines a cartridge cavity 402 between a front face 402 and a rear face 404. The front face 402 includes an opening 406 through which the cartridge cavity 402 is visibly exposed. The fluid transfer cartridge 204 includes a syringe barrel 408 disposed within the cartridge cavity 402 and a handle 307 that extends from the front face 404 across the opening 406. The syringe barrel 408 can be visibly exposed on a side 410 of the handle 307.

Description

[Technical field]

[0001] The present application relates generally to medical systems used to deliver energy and fluids to devices, and more particularly to a treatment system having a generator for delivering energy to a catheter-based intraluminal device and a fluid transfer cartridge for delivering cooling fluid to the catheter-based intraluminal device. [Background technology]

[0002] High blood pressure, also known as hypertension, commonly affects adults. Left untreated, high blood pressure can result in kidney disease, arrhythmias, and heart failure. In recent years, the treatment of hypertension has focused on interventional approaches to inactivate the renal nerves around the renal arteries. Autonomic nerves tend to subordinate blood vessels to the organs they innervate. Intraluminal devices such as catheters can reach certain structures, such as renal nerves, that are in close proximity to the lumen through which the catheter travels. Thus, catheter-based systems can deliver energy from within the lumen to inactivate renal nerves within the vessel wall.

[0003] One approach to renal nerve deactivation uses radio frequency (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 within the vessel wall and surrounding tissue. The electric field results in resistive (ohmic) heating of the tissue to ablate the tissue and the renal nerve passing through it. The RF electrodes are repositioned multiple times around the inside of the renal artery to treat all the renal nerves surrounding the renal artery.

[0004] Another approach to renal nerve deactivation uses high-intensity focused ultrasound (HIFU). HIFU relies on the delivery of vibrational energy to a catheter to cause frictional heating and destruction of tissue. The temperature of the tissue is then raised sufficiently to cause ablation or remodeling of the tissue containing the renal nerve. However, the use of HIFU in blood vessels can result in the formation of a thin focal ring in the vessel and surrounding tissue at most. When applied to renal denervation, it is difficult to align this thin ring with the renal nerve because the renal nerve is at a different radial distance along the length of the renal artery. Also problematic is that the thin focal ring results in a longitudinal shortening of the treatment zone relative to the axis of the vessel.

[0005] Many of the problems associated with RF and HIFU systems are solved by a system having an ultrasound transducer that emits one or more therapeutic doses of unfocused ultrasound energy. The ultrasound transducer may be mounted at the distal end of a catheter, and the unfocused ultrasound energy may heat tissue adjacent to the body lumen in which the catheter (and transducer) is placed. Such unfocused ultrasound energy may ablate targeted nerves around the body lumen without damaging non-targeted tissue, such as the lining of the body lumen or unintended organs outside the body lumen. Unfocused ultrasound energy systems may also include a balloon mounted at the distal end of the catheter around the ultrasound transducer. Cooling fluid may be circulated through the balloon to cool the body lumen during ultrasound energy delivery. Such a design enables the creation of one or more ablation zones sufficient to achieve long-term nerve inactivation at different locations around the periphery of the blood vessel. Summary of the Invention

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

[0007] Provided herein is a treatment system having a generator and a fluid transfer cartridge for delivering energy and / or fluid to a catheter-type intraluminal device. In one embodiment, the fluid transfer cartridge includes a cartridge shell defining a cartridge cavity. The cartridge cavity can be an internal volume between a front face and a rear face and can contain the components of the fluid transfer cartridge. For example, a syringe barrel can be disposed within the cartridge cavity. The cartridge shell can have an opening in the front face. A handle can extend from the front face across the opening. The syringe barrel can be visibly exposed through the opening, for example, on a first side of the handle. Thus, a user can easily grasp and carry the fluid transfer cartridge.

[0008] The above summary does not include a comprehensive list of all aspects of the invention. It is contemplated that the invention may be practiced from all appropriate combinations of the various aspects summarized above, as well as those discussed in the following detailed description and particularly pointed out in the claims. Such combinations have certain advantages not specifically recited in the above summary.

[0009] The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention can be obtained by reference to the following detailed description which sets forth illustrative embodiments in which the principles of the invention are utilized and the accompanying drawings of which: [Brief description of the drawings]

[0010] [Figure 1] FIG. 1 is a perspective view of a catheter of a treatment system, according to one embodiment. [Diagram 2] FIG. 1 illustrates a front perspective view of a generator and fluid transfer cartridge of a treatment system, according to one embodiment. [Diagram 3] FIG. 1 illustrates a rear perspective view of a generator and fluid transfer cartridge of a treatment system, according to one embodiment. [Figure 4] FIG. 1 is a perspective view of a cartridge receiving portion of a generator of a treatment system and a fluid transfer cartridge according to one embodiment. [Diagram 5] FIG. 1 is a close-up view of a cartridge shell of a fluid transfer cartridge according to one embodiment. [Figure 6] FIG. 2 is a cross-sectional view of an end lit syringe of a fluid transfer cartridge, according to one embodiment. [Figure 7] FIG. 1 illustrates a front perspective view of a fluid transfer cartridge according to one embodiment. [Figure 8] FIG. 1 illustrates a rear perspective view of a fluid transfer cartridge according to one embodiment. [Figure 9] FIG. 13 is a perspective view of a conduit routing port of a fluid transfer cartridge according to one embodiment. [Figure 10] FIG. 2 is a perspective view of a conduit routing plate mounted within a conduit routing opening of a fluid transfer cartridge, according to one embodiment. [Figure 11] FIG. 13 is a cross-sectional view of a fluid transfer cartridge mounted in a cartridge receptacle of a generator of a treatment system according to one embodiment. [Figure 12] FIG. 1 illustrates a rear perspective view of a fluid transfer cartridge according to one embodiment. [Figure 13] FIG. 2 is a front perspective view of a cartridge receiving portion of a generator according to one embodiment. [Figure 14] FIG. 1 is a close-up view of a cartridge shell of a fluid transfer cartridge according to one embodiment. [Figure 15A] FIG. 1 is a perspective view of a cartridge manifold according to one embodiment. [Figure 15B] FIG. 1 is a perspective view of a cartridge manifold according to one embodiment. [Figure 16] FIG. 1 is an expanded view of a cartridge manifold, according to one embodiment. [Figure 17]FIG. 1 is a front view of a fluid transfer plate of a cartridge manifold according to one embodiment. [Figure 18] FIG. 13 is a rear view of a fluid transfer plate of a cartridge manifold according to one embodiment. [Figure 19] FIG. 13 is a perspective view of a piston of a cartridge manifold according to one embodiment. [Figure 20] FIG. 13 is a perspective view of a piston of a cartridge manifold according to one embodiment. [Figure 21] FIG. 19 is a cross-sectional view taken along line AA of FIG. 18 of a piston of a cartridge manifold in an open position according to one embodiment. [Figure 22] FIG. 19 is a cross-sectional view taken along line AA of FIG. 18 of a piston of a cartridge manifold in a closed position according to one embodiment. [Figure 23] FIG. 2 is a side view of a generator of an ultrasound-based treatment system, according to one embodiment. [Figure 24] 24 is a cross-sectional view taken along line AA of FIG. 23 of a generator for an ultrasound-based treatment system according to one embodiment. [Diagram 25] FIG. 1 is a perspective view of a non-invasive sensor according to one embodiment. [Figure 26] FIG. 1 is a perspective view of a non-invasive sensor according to one embodiment. [Figure 27] FIG. 2 is a front view of an internal portion of a fluid transfer cartridge according to one embodiment. [Figure 28] FIG. 13 is a cross-sectional view of an internal portion of a fluid transfer cartridge having a pneumatically actuated syringe, according to one embodiment. [Figure 29] 1 is a cross-sectional view of an internal portion of a fluid transfer cartridge having a non-contact position sensor according to one embodiment. [Diagram 30] FIG. 1 is a perspective view of an ultrasound-based treatment system according to one embodiment. [Diagram 31] FIG. 13 is a cross-sectional view of a drive mechanism for a fluid transfer cartridge according to one embodiment. [Diagram 32] FIG. 2 is a block diagram of a controller of a treatment system, according to one embodiment. [Diagram 33] FIG. 13 is a perspective view of a shaft end with an optical tab according to one embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0011] 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 may be an ultrasound-based tissue treatment system used to deliver unfocused ultrasound energy radially outward to treat tissue in a target anatomical region, such as the renal nerves in the renal artery. Alternatively, the tissue treatment system may be used in other applications, such as treating the sympathetic nerves of the hepatic plexus in the hepatic artery. Thus, reference to the system as being a renal denervation system or as being used in treating, for example, neuromodulating renal nerve tissue, is not limiting.

[0012] Various embodiments are described with reference to the drawings. However, certain embodiments may be implemented without one or more of these specific details or in combination with other known methods and configurations. In the following description, numerous specific details, such as specific configurations, dimensions, and processes, are set forth to provide a thorough understanding of the embodiments. In other instances, known processes and manufacturing techniques are not described in particular detail so as not to unnecessarily obscure the description. References throughout this specification to "one embodiment" or "an embodiment" or the like mean that a particular feature, structure, configuration, or characteristic described is included in at least one embodiment. Thus, the appearance of phrases such as "one embodiment" or "an embodiment" in various places throughout this specification does not necessarily refer to the same embodiment. Furthermore, particular features, structures, configurations, or characteristics may be combined in any suitable manner in one or more embodiments.

[0013] Use of relative terms throughout the description may represent relative locations and orientations. For example, "above" may indicate a first direction relative to a component. Similarly, "below" may indicate a second direction relative to the component that is opposite the first direction. Such terms are provided to establish a relative frame of reference, but are not intended to limit the use or orientation of a treatment system component, such as a fluid delivery cartridge or generator, to the specific configurations described in various embodiments below.

[0014] Existing hypertension treatment systems include a generator for generating and delivering energy, e.g., RF or ultrasound energy, to a catheter-based intraluminal device. The treatment system may also include components that interact with the generator to facilitate treatment. For example, a cartridge may be mounted on the generator to deliver inflation or cooling fluids to a balloon mounted on the end of the catheter. The generator and / or cartridge may be large and bulky, especially in combination. Furthermore, the mechanical and electrical connections between the generator and cartridge may not be reliable due to imperfect mounting, tolerance stacking, or movement that occurs between the components during operation. In the case of cartridges that deliver fluids, the fluid transfer may not be accurately monitored, either visually or automatically, due to lack of lighting in the procedure room and / or unstable sensor connections between the generator and cartridge. The system may also integrate long lengths of internal tubing that increase the overall form factor of the device. Thus, treatment systems used to deliver energy and fluids to catheter-based intraluminal devices benefit from a more compact, mechanically stable, electrically stable, and ergonomic design.

[0015] In one aspect, a treatment system for performing a medical procedure, e.g., a nephrectomy catheter therapy, is provided. The treatment system includes a fluid transfer cartridge for delivering fluid to the catheter and a generator for delivering energy to the catheter. The fluid transfer cartridge and the generator are combined to form a control unit of the treatment system. The control unit is compact. More specifically, the fluid transfer cartridge fits within a cartridge receptacle of the generator to form a clean and compact profile of the control unit. Furthermore, the fluid transfer cartridge has a syringe component that can be fully contained within the cartridge housing to reduce the overall form factor of the control unit. The control unit is mechanically stable. The fluid transfer cartridge can be secured to the generator by a locking mechanism, which has a quick release mechanism to distribute the retention force evenly around the cartridge housing and make engagement and disengagement of the components fast and reliable. The control unit is electrically stable. The electrical connection between the fluid transfer cartridge and the generator can be via spring-loaded electrical contact pins, commonly referred to as pogo pins. The spring-loaded pins can maintain pressure at the points of electrical contact between the components, so that the connections are resilient against relative movement that may occur during operation. Additionally, sensors used to detect movement of system components, such as the syringe piston of the fluid transfer cartridge, can include position sensors, such as, for example, magnetic switches or optical sensors, which are more stable and less susceptible to misalignment than mechanical switches. The control unit is user friendly. The control unit can include one or more processors and various sensors that operate to determine a readiness state of the system, for example, to determine whether various electrical or component connections have been made, and provide feedback to the user.As one illustrative example, the system can detect whether a fluid delivery cartridge is loaded into the generator's cartridge receptacle and can activate a light within the fluid delivery cartridge to illuminate the syringe and provide feedback to the user regarding its status. Thus, a treatment system is provided that is compact, mechanically stable, electrically stable, and has an ergonomic design.

[0016] Referring to FIG. 1, a perspective view of a catheter-based intraluminal device of a treatment system is shown, according to one embodiment. The catheter-based intraluminal device of the treatment system 100 can include a catheter 101 having an elongated catheter body extending from a proximal catheter end 102 to a distal catheter end 104. An expandable member 106, such as a balloon, can be mounted on the catheter 101 at the distal catheter end 104. One or more energy transducers 108, such as ultrasound transducers, can be positioned within the expandable member 106. The expandable member 106 can be adapted to expand within a target anatomical structure, e.g., a renal artery, and the energy transducer 108 can be adapted to deliver ablation energy, e.g., ultrasound energy, to the target anatomical structure during a medical procedure, e.g., a renal denervation procedure.

[0017] The catheter 101 may include one or more lumens, such as a fluid lumen for delivering inflation / cooling fluid to the expandable member 106, an electrical cable passageway containing an electrical cable for delivering energy to the transducer 108, a guidewire lumen for exchanging guidewires, etc. The lumens may be connected to corresponding connectors at the proximal catheter end 102. For example, as described below, the fluid lumen may connect to one or more fluid ports 110 that receive inflation / cooling fluid from a fluid transfer cartridge of the treatment system 100. Similarly, as described below, the electrical cable may connect to an external connector 112 that receives energy from a generator of the treatment system 100.

[0018] Referring to FIG. 2, a front perspective view of a generator and fluid transfer cartridge of a treatment system is shown, according to one embodiment. The treatment system 100 includes a control unit that connects to the catheter 101 to regulate the inflation of the balloon 106 with an inflation / cooling fluid and to manage the delivery of ultrasonic energy to the 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 through one or more fluid conduits 206. For example, the fluid conduit 206A can transfer cooling fluid between a fluid reservoir, e.g., an intravascular fluid bag, and the fluid transfer cartridge 204. Similarly, the 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, for facilitating the energy and fluid transfer functions. Such components can include a display 208 for presenting procedural information to a user. Further, 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 of a medical procedure, such as those described below.

[0019] Referring to FIG. 3, a rear perspective view of a generator and a fluid transfer cartridge of a treatment system is shown, according to one embodiment. The generator 202 of the treatment system 100 can have a cartridge receptacle 302 shaped and sized to receive the fluid transfer cartridge 204. More specifically, the generator 202 can include a generator housing 304 having a cartridge receptacle 302 configured to receive the fluid transfer cartridge 204. The generator housing 304 can include an outer wall having a shape, for example, a box-like envelope, and the cartridge receptacle 302 can be a recessed area extending within the shape. The fluid transfer cartridge 204 can include a cartridge shell 306, which can accommodate the cartridge receptacle 302 of the generator 202. More specifically, the cartridge shell 306 can include an outer wall having a shape that smoothly integrates with the generator housing walls to complete the envelope of the generator 202. For example, the fluid transfer cartridge 204 and the generator 202 can be combined to form a box-like envelope. In such a case, the exterior, outwardly facing surfaces of the fluid transfer cartridge 204 and the generator 202 can be parallel and coplanar at the seams where the components meet such that the form factors of the combined components transition smoothly, e.g., without a step, at the transition between the generator walls and the fluid transfer cartridge walls.

[0020] In one embodiment, the fluid transfer cartridge 204 includes a handle 307 that a user can hold when loading or unloading the cartridge from the generator 202. The handle 307 can include a curved, ergonomic shape that is easily gripped. Thus, a user can carry the fluid transfer cartridge 204 by the handle 307 and insert the fluid transfer cartridge 204 into the cartridge receptacle 302 to engage components in a compact form factor having an outer wall that extends continuously across the generator housing 304 and the cartridge shell 306.

[0021] In combination with the generator 202, the fluid transfer cartridge 204 can be used to drive fluid into the catheter 101 using one or more syringes. More specifically, the fluid transfer cartridge 204 can include one or more syringes that pump fluid to and from the balloon 106. As described below, each syringe can include a respective syringe piston disposed within a respective syringe barrel. Movement of the syringe piston relative to the syringe barrel can draw cooling fluid into the syringe or expel cooling fluid out of the syringe. Fluid can be transferred to and from the fluid transfer cartridge 204 through a fluid conduit 206 that can be connected to the catheter 101, a fluid reservoir, or another fluid container outside the fluid transfer cartridge 204.

[0022] Referring to FIG. 4, a perspective view of a cartridge receiving portion of a generator of a treatment system and a fluid transfer cartridge is shown, according to one embodiment. The cartridge shell 306 of the fluid transfer cartridge 204 can define a cartridge cavity 402 in which one or more syringes are disposed. More specifically, the cartridge shell 306 can define the cartridge cavity 402 between a front surface 404 of the cartridge shell 306 and a rear surface 407 of the cartridge shell 306 (FIG. 8). The space between the front surface 404 and the rear surface 407 of the cartridge shell 306 can contain the syringe. Thus, the syringe (including the syringe shaft of the syringe) can be embedded inside the cartridge shell 306, rather than being exposed outwardly from the shell. Thus, the overall form factor of the fluid transfer cartridge 204 can be compact. The cartridge cavity 402 can further be defined between a top surface and a bottom surface of the cartridge shell 306.

[0023] The one or more syringes of the fluid transfer cartridge 204 can be disposed within the cartridge cavity 402 parallel to the handle 307. For example, the handle 307 can extend from the front face 404 of the cartridge shell 306 across an opening that opens into the cartridge cavity 402. The opening can be a window 406 or a portal that exposes the interior volume of the cartridge cavity 402 for viewing from the surrounding environment. More specifically, the front face 404 can include an opening that visibly exposes the cartridge cavity 402 for viewing by a user. The handle 307 can extend vertically from a top end 416 of the opening to a bottom end 418 of the opening. Thus, the handle 307 can curve outward from the front face 404 above the opening and can curve vertically downward across the opening to terminate at the front face 404 below the opening. Similarly, the syringe can extend vertically through the cartridge cavity 402 such that the syringe barrel is visibly exposed through the opening.

[0024] In one embodiment, the fluid transfer cartridge 204 includes a first syringe barrel 408 that is disposed within the cartridge cavity 402 and visibly exposed through an opening on a first side 410 of the handle 307. Similarly, the fluid transfer cartridge 204 can include a second syringe barrel 412 that is disposed within the cartridge cavity 402 and visibly exposed through an opening on a second side 414 of the handle 307. The syringe, such as the handle 307, can extend vertically, for example, within the cartridge cavity 402. More specifically, the first syringe barrel 408 and the second syringe barrel 412 can have respective syringe axes 420 that extend vertically, for example, within the cartridge cavity 402. The syringe axis 420 can be a 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 may be easily grasped from the front of the fluid delivery cartridge 204, while the syringe remains exposed for viewing through an opening in the front face 404. Thus, the fluid delivery cartridge 204 is easy to manipulate, easy to view, and has a compact form factor to mate with the generator 202.

[0025] 5, a close-up view of the cartridge shell of a fluid transfer cartridge is shown, according to one embodiment. The cartridge shell 306 provides the outer envelope of the fluid transfer cartridge 204 and can have a variety of geometries.

[0026] The fluid transfer cartridge 204 may include several parts that are snap-fit ​​or otherwise secured together. The cartridge shell 306 may include a handle front plate 502 and a back plate 504. The handle front plate 502 may include a handle 307, a front surface 4047 of the shell, and a top surface 506 of the shell. Similarly, the back plate 504 may include a rear surface 407 of the shell, several side walls 508 laterally outward from the cartridge cavity 402, and a bottom surface 510 of the shell. When combined, the handle front plate 502 and the back plate 504 may define a cartridge cavity 402 that is centered between the various walls and surfaces. As described above, the cartridge cavity 402 may nevertheless be visibly exposed through an opening 406 in the handle front plate 502.

[0027] The front face 404 can include a front face perimeter 511. The front face perimeter 511 can be an outer edge of the front face 404. The front face perimeter 511 can have curved and straight edges that combine to form the contour of the front face 404. Similarly, the rear face 407 can include a rear face perimeter 512. The rear face perimeter 512 can have curved and straight edges that combine to form the contour of the rear face 407. In one embodiment, the front face perimeter 511 has the same contour as the rear face perimeter 512. More specifically, the contour of the front face perimeter 511 can conform to the contour of the rear face perimeter 512, such that when the front face perimeter 511 engages the rear face perimeter 512, the perimeters effectively seal or contact each other. When the perimeters contact, the cartridge cavity 402 can be enclosed within the cartridge shell 306. An enclosed cartridge cavity 402 is defined between a front face 404 and a rear face 407 .

[0028] When snapped or otherwise fitted together, the handle front plate 502 and back plate 504 can contain one or more components to provide fluid transfer functionality within the cartridge cavity 402. For example, the fluid transfer cartridge 204 can include a syringe holder 513 for holding a syringe within the cartridge cavity 402. The syringe holder 513 can stabilize the syringe during fluid delivery, as described below. The fluid transfer cartridge 204 can also include manifolds, tubing, electronics, etc. (not shown) that facilitate movement of fluid from the syringe to the fluid conduit 206 and catheter 101. The internal components of the fluid transfer cartridge 204 can be constrained within the interior space of the cartridge shell 306 and can mechanically and / or electrically interact with each other and the generator 202 to perform the fluid transfer function of delivering expansion / cooling fluid to the fluid port 110 of the catheter 101.

[0029] In one embodiment, a syringe holder 513 mounted within the cartridge cavity 402 limits the movement of the syringe. The syringe may have a plunger that is driven axially within the syringe barrel 408 during operation. The plunger may rotate about the syringe axis 420, thus imparting some rotational load to the syringe. The syringe holder 513 may resist rotation of the barrel that may otherwise be caused by the plunger. The syringe holder 513 may include one or more stop features. The stop features may be ribs, protrusions, or other features formed within the syringe holder 513. The stop features may remain fixed relative to the front face 404 and rear face 407 of the fluid transfer cartridge 204 when the cartridge is assembled. Additionally, when assembled, portions of the syringe barrel 408, such as tabs extending laterally outwardly from the cylindrical syringe barrel 408, may engage the stop features. For example, the syringe barrel 408 can have a finger tab that fits into a corresponding recess in the syringe holder 513. The finger tab can be enclosed within the recess between several ridges such that the syringe holder 513 mechanically interacts with the movement of the tab. Thus, a stop feature engages an interference feature in the syringe barrel 408 such that rotation of the syringe barrel 408 relative to the cartridge shell 306 is limited.

[0030] Referring to FIG. 6, a cross-sectional view of an end-illuminated syringe of a fluid transfer cartridge is shown, according to one embodiment. The fluid transfer cartridge 204 can include one or more light sources 602 within the cartridge cavity 402. For example, the light sources 602 can be light-emitting diodes. As illustrated, two light sources 602 can be symmetrically located on each side of the syringe axis 420. Alternatively, three or more light sources 602 can be symmetrically positioned around the syringe axis 420. More specifically, when viewed from above, the angle between the light sources 602 can be 360° divided by the number of light sources 602 (e.g., 120° between each of the three light sources 602 when viewed along the syringe axis 420).

[0031] The light source 602 can illuminate one or more of the syringes so that the syringe barrel 408 and / or the cooling fluid 603 within the syringe can be viewed by a user. More specifically, the light source 602 can be within the cartridge cavity 402 and can be directed through the syringe barrel 408 to illuminate the contents of the syringe barrel 408 and / or the walls of the syringe barrel 408. When the light source 602 is activated, the user can look through the opening / window 406 within the fluid transfer cartridge 204 to view the syringe and cooling fluid operation. It will be appreciated that the light source 602 allows for easier monitoring of the fluid transfer and troubleshooting cooling fluid problems, especially when viewed within a darkened procedure room.

[0032] In one embodiment, the light source 602 is directed through the syringe barrel 408. For example, the syringe can be end-illuminated by the light source 602. Each of the one or more light sources 602 can direct light 606 into a respective light guide 605. The light guide 605 can include a cylindrical transparent column that acts as a light pipe to transport the light 606 from the light source 602 to the distal (superior) end of the syringe. More specifically, the light source 602 can be directed through an end face 604 of the syringe barrel 408. The end face 604 can be a section of the barrel that is angled or tapered from a substantially 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 can form an angle with the syringe axis 420 that is less than the angle formed between the syringe axis 420 and an axis perpendicular to the barrel sidewall.

[0033] The syringe may be side-lit by a light source 602. For example, rather than shining longitudinally into the syringe, the light source 602 may be oriented laterally or radially relative to the syringe axis 420. Thus, the light 606 may illuminate the syringe barrel 408 and its contents from the end, side, or rear of the cartridge cavity 402.

[0034] In certain embodiments, the light source 602 may be directed through the syringe barrel 408 to aid in assembly.

[0035] The light 606 can be emitted in the direction of the syringe axis 420. Thus, a portion of the light 606 can be transmitted through the end face 604 into the syringe barrel 408 and the fluid contained therein. Furthermore, a portion of the light 606 can be transmitted into the wall of the syringe barrel 408. The light 606 can propagate along the wall, creating a light pipe effect. Thus, the end-illuminated syringe barrel 408 can provide good contrast to the fluid and mechanical components of the syringe, such as the stopper 608. The light source 602 thus facilitates viewing the syringe movement during a medical procedure, as well as visualizing the function of the syringe.

[0036] The light source 602 may have ergonomic visibility characteristics. 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 procedure room, the blue light may have a cooling and calming effect. Furthermore, the blue light may have a brightness that does not distract the user, yet still adequately illuminates the cooling fluid 603 for accurate monitoring.

[0037] In addition to illuminating the syringe components, the light source 602 may have a visible characteristic that provides 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 a first color of light 606 when the syringe barrel 408 is filled with a first volume of fluid. The first volume of fluid can be detected using a flow sensor or other fluid sensor. The one or more processors may receive a volumetric signal from the sensor indicating that the first volume of fluid is contained within the syringe barrel 408. In response to the volumetric signal, the one or more processors may cause the light source 602 to emit a first color of light 606, e.g., orange. The control unit may be configured to cause the light source 602 to emit a second color of light 606 when the syringe barrel 408 is filled with a second volume of fluid. For example, in response to detecting a second volume of fluid, the one or more processors may cause the light source 602 to emit a second color of light, e.g., blue. Thus, a user may easily recognize whether the syringe is partially filled based on the presence of orange light and whether the syringe is fully filled based on the presence of blue light. Of course, the color of the light may indicate different levels of fill or amounts of fluid within the syringe barrel 408, and this example is not limiting. Similarly, intensity characteristics or another light characteristic (other than color) may change based on the fill level, and thus examples of changing colors are not limiting.

[0038] 7, a front perspective view of a fluid transfer cartridge is shown, according to one embodiment. As described above, each syringe of the fluid transfer cartridge 204 can include a syringe piston 702 disposed within a syringe barrel 408. The left syringe barrel is illustrated as being opaque and the right syringe barrel is illustrated as being transparent to expose the stopper 608 within the syringe cavity. The opacity of the syringe barrels can be variable.

[0039] The syringe piston 702 can include a stopper 608, which can be a rubber stopper capable of providing friction and allowing the syringe barrel 408 to rotate if not otherwise resisted by the syringe holder 513. The syringe piston 702 can also include a shaft 704 that extends 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 can include an element for triggering a position sensor. For example, the element can include a magnet for triggering a magnetic sensor or an optical feature, such as a tab, prong, flag, etc., for triggering an optical sensor. Regardless of the location of the stopper 608 within the syringe barrel 408, the shaft end 706 can be outside the syringe barrel 408. However, the shaft end 706 can have several positions, at least one of which can be inside the cartridge cavity 402. For example, the bottom surface of the shaft end 706 can be flush with the bottom surface 510 of the cartridge shell 306 .

[0040] In one embodiment, when the stopper 608 is in the home position of the syringe barrel 408, the shaft end 706 is disposed within the cartridge cavity 402. Alternatively, when the stopper 608 is in the home position, the shaft end 706 may be flush with the bottom surface 510 of the cartridge shell 306. In either case, when the stopper 608 is in the home position, the shaft end 706 may not be outside of the envelope defined by the cartridge shell 306. The home position may be the topmost position of the stopper 608, or the position closest to the syringe end surface 604. In the home position, the shaft end 706 may be close to, but outside of, the syringe barrel 408. More specifically, the shaft end 706 may have a vertical position between the proximal end of the syringe barrel 408 and the bottom surface 510 of the fluid transfer cartridge 204. In the home position, the syringe component is entirely contained within the cartridge cavity 402. Thus, the fluid transfer cartridge 204 can have a compact form factor defined by the exterior surface of the cartridge shell 306 without additional clearance required by a syringe or syringe components.

[0041] The fluid transfer cartridge 204 can be delivered with the syringe piston 702 in the home position. More specifically, prior to filling the syringe with the cooling fluid 603 (either during delivery of the fluid transfer cartridge 204 or upon initial loading of the fluid transfer cartridge 204 into the generator 202), the stopper 608 can be in the home position. Thus, compared to delivering the fluid transfer cartridge 204 with the syringe shaft 704 exposed from the cartridge shell 306, the package size can be minimized to reduce packaging requirements. Furthermore, because the syringe and syringe components are not exposed outwardly from the cartridge, the fluid transfer cartridge 204 can take up less space in the procedure room. That is, the ability to move the shaft 704 entirely into the cartridge cavity 402 to contain the syringe entirely within the fluid transfer cartridge 204 can reduce the overall form factor of the fluid transfer cartridge 204. The reduced form factor makes the cartridge more compact for delivery and / or use.

[0042] In contrast to the home position, when the stopper 608 is in an end position within the syringe barrel 408, the shaft end 706 may be disposed outside of the cartridge cavity 402. The end position may be the lowest position, or the position furthest from the syringe end face 604 within the syringe barrel. In the end position, the shaft end 706 may be outside of the syringe barrel 408 and the cartridge cavity 402. More specifically, the shaft end 706 may be exposed below the bottom surface 510 of the fluid transfer cartridge 204, as shown in FIG.

[0043] Referring to FIG. 8, a rear perspective view of a fluid transfer cartridge is shown, according to one embodiment. The fluid transfer cartridge 204 includes a drive mechanism for advancing a syringe piston 702 relative to a syringe barrel 408. In one embodiment, a shaft 704 of the syringe piston 702 includes an external thread 802 extending along an exterior surface of the shaft 704 between a stopper 608 and a shaft end 706. The fluid transfer cartridge 204 can also include a gear 804 mounted on the cartridge shell 306. The gear 804 can include an internal thread that engages with the external thread 802 of the syringe shaft 704. Thus, as the gear 804 rotates, for example when driven by a motor of the generator 202, the internal thread of the gear 804 can axially drive the external thread 802 of the shaft 704. Thus, the shaft 704 can be driven upwards toward a home position and / or downwards toward an end position. As 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. In contrast, as the shaft 704 is driven upward, the stopper 608 can move toward the end face 604 to expel fluid from the syringe barrel 408.

[0044] As the gear 804 drives the syringe piston 702 in the direction of the syringe axis 420, a rotational frictional load can be applied by the gear 804 to the syringe shaft 704. Similar to the stabilizing effect that the syringe holder 513 has on the syringe barrel 408, the fluid transfer cartridge 204 can also include features to stabilize the syringe piston 702. In one embodiment, the shaft 704 of the syringe piston 702 includes a notch 806 extending longitudinally between the stopper 608 and the shaft end 706. The longitudinal notch 806 can receive a prong (not shown) extending from the cartridge shell 306 and / or the syringe holder 513. For example, the prong can be constructed into the chassis of the cartridge to secure the prong relative to the cartridge housing. As the gear 804 rotates relative to the shaft 704, it can apply a frictional load to the external threads 802 of the shaft 704. To ensure that the shaft 704 does not rotate relative to the gear 804, the prongs can slide within the notches 806 and can interfere with the notch walls to resist and limit the rotation of the shaft 704 relative to the gear 804, thereby converting rotational movement into translational movement along the syringe axis 420. More specifically, the prongs can limit the rotation of the syringe piston 702 with a minimum of rotation and can axially constrain the movement of the stopper 608.

[0045] Referring to FIG. 9, a perspective view of a conduit routing port of a fluid transfer cartridge is shown, according to one embodiment. As discussed above, the components of the fluid transfer cartridge 204 can be secured in a variety of manners, including snap-fit ​​connections. In one embodiment, the cartridge enclosure can include a conduit routing area through which the fluid conduits 206 can be routed. More specifically, the cartridge shell 306 can include a cartridge routing opening 902 in the front surface 404. The cartridge routing opening 902 can improve the manufacturability of the fluid transfer cartridge 204 by providing a cutout through which the fluid conduits 206, which can have a substantial length, can remain within and / or be routed through the fluid transfer cartridge 204. The cartridge routing opening 902 can be a cutout formed in the front surface 404 along a bottom edge of the cartridge. More specifically, the opening can have a bottom edge that extends along a corner of the cartridge between the front surface 404 and the bottom surface 510 of the fluid transfer cartridge 204.

[0046] 10, a perspective view of a conduit routing plate mounted within a conduit routing opening of a fluid transfer cartridge is shown, according to one embodiment. The cartridge shell 306 can include a conduit routing plate 1002 that engages the front surface 404 along an edge 1004. The edge 1004 can be the perimeter of the conduit routing opening. In one embodiment, the conduit routing plate 1002 and the portion of the front surface 404 that extends along the conduit routing opening can include respective notches 1006 at the edge 1004. For example, the notch 1006 in the front surface 404 can be a semicircular notch 1006 and the notch 1006 in the conduit routing plate 1002 can also be a semicircular notch 1006. The conduit routing plate 1002 can be snap-fit ​​(or otherwise secured) into the conduit routing opening to fill the opening and form an aperture through which the fluid conduit 206 can be routed. For example, partial cutouts in the enclosure can combine to form a conduit port for the fluid conduit 206. In the case of semicircular notches 1006, the notches can combine to form a circular conduit routing port 1008 in the front face 404 of the assembled fluid transfer cartridge 204. Prior to snapping the conduit routing plate 1002 into the aperture, a predetermined length of the fluid conduit 206 can remain exposed on the outside of the cartridge. When the conduit routing plate 1002 is snapped into the aperture, the edge 1004 of the plate and the cartridge shell 306 can snap around the fluid conduit 206 to hold the fluid conduit 206 in place. The ability to easily determine the length of the conduit to insert into the cavity through the aperture and the length of the conduit that extends outside of the aperture (the lengths are separated by a plate that is snap-fitted into the aperture to hold the conduit in place) can provide efficient routing during manufacturing and the ability to quickly and effectively route the conduit.

[0047] 11, a cross-sectional view of a fluid transfer cartridge mounted in a cartridge receptacle of a generator of a treatment system is shown, according to one embodiment. In the cross-section, the interaction between the fluid transfer cartridge 204 and the generator 202 can be appreciated. For example, when the fluid transfer cartridge 204 is received in the cartridge receptacle 302, the back plate 504 of the fluid transfer cartridge 204 appears to juxtapose and conform to the generator 202. The separation between the fluid transfer cartridge 204 and the generator 202 is represented by a dotted line in FIG. 11. When received, the fluid transfer cartridge 204 can be actuated to drive the syringe shaft 704 from a home position 1102 to an end position 1104. More specifically, a generator gear 1106 (or gear train), driven by a motor 1108 of the generator 202, can mesh with and drive a gear 804 of the fluid transfer cartridge 204 to simultaneously move a syringe piston 702 along the syringe axis 420. For example, the motor 1108 can be operatively coupled to the shaft 704 and actuated by one or more processors of the control unit to move the outer threads 802 of the shaft 704 (and thus the syringe piston 702) against the inner threads 1109 of the gear 804 during fluid transfer with the syringe.

[0048] When the stopper 608 is in the end position 1104, the shaft end 706 is outside the cartridge cavity 402. In one embodiment, the generator housing 304 includes a well 1110 below the cartridge receptacle 302. The well 1110 can have an exterior wall around the space in which the shaft end 706 resides when the stopper 608 is in the end position 1104. Thus, the well 1110 can receive the syringe piston 702 of the fluid transfer cartridge 204 during fluid transfer with the syringe. When the syringe piston 702 is contained within the well 1110, the shaft 704 can be protected from damage. More specifically, the well 1110 can encase the shaft 704 so that it does not come into contact with exterior surfaces that may strain the syringe components. Similarly, the well 1110 can shield the shaft 704 from the user, thereby reducing pinch points that could otherwise injure the user. Finally, by constraining the shaft 704 within the generator 202 rather than extending the shaft 704 outwardly from the control unit, the overall form factor of the control unit may be smaller.

[0049] The well 1110 may be dimensioned to accommodate several functions. First, the size of the space in the well 1110 may allow the user to easily clean the well 1110, for example, by wiping the interior surface of the well 1110. Furthermore, the height of the well 1110 may be greater than the length of the syringe throw to ensure that the shaft end 706 does not directly contact the interior surface of the well 1110 when the stopper 608 reaches the end position 1104. Additionally, the depth of the well 1110 may allow the fluid transfer cartridge 204 to be removed from the generator 202 without the stopper 608 having to home. More specifically, when removing the cartridge with the shaft 704 fully extended, the cartridge may be tilted forward and there may be sufficient space within the well 1110 to allow the shaft 704 to be tilted upward and removed from the well cavity.

[0050] As described above, the syringe can be operated to move the stopper 608 between a home position 1102 and an end position 1104 within the syringe barrel 408. The stopper 608 can be located at the home position 1102, for example, during delivery to a procedure room. The home position 1102 can also be a position where the syringe barrel 408 purges air bubbles after the stopper 608 has cycled between the home position 1102 and the end position 1104 one or more times. More specifically, the syringe run can include a home position 1102 of the syringe piston 702 where the syringe piston 702 removes bubbles from the syringe. Similarly, when the stopper 608 is at the end position 1104, the cooling fluid 603 can be drawn into the syringe barrel 408 to fill the syringe. When the stopper 608 moves to the end position 1104 after purging the syringe barrel 408, the cooling fluid 603 in the syringe may be free of bubbles. The method of purging the syringe is described in further detail below, but it will be appreciated that at this stage the movement of the syringe piston 702 is affected by a motor 1108, which may be controlled by one or more processors of a control unit.

[0051] Movement of the syringe piston 702 can be controlled by one or more processors through control of the motor 1108. For example, the motor 1108 can be a stepper motor 1108, and the processor can drive the stepper motor 1108 through a predetermined axial rotation that results in a predetermined axial movement of the shaft 704 when considering the gearing ratio between the generator gear 1106 (or gear train) and the cartridge gear 804. Additionally, the control unit can incorporate a sensor for detecting the position of the syringe piston 702, e.g., the shaft end 706. By sensing the shaft position, the one or more processors can determine the position of the stopper 608 within the syringe barrel 408, and thus the amount of fluid contained within the syringe.

[0052] The sensor used to detect the shaft position can be magnetic, optical, mechanical, etc. In one embodiment, the sensor includes one or more position switches 1120. For example, the treatment system 100 can include a position switch 1120, e.g., an optical switch, such as an optical sensor configured to detect the syringe piston 702 when the stopper 608 is in the home position 1102. An optical sensor may provide better resolution than a magnetic switch. On the other hand, a magnetic sensor may require less maintenance than an optical sensor. Thus, the position switch 1120 can be selected based on design needs.

[0053] 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 in or along a wall of the generator well 1110. For example, the position switch 1120 can be mounted along a rear wall of the well 1110. When more than one switch is incorporated, the switches can be aligned in series along a vertical axis that runs parallel to and adjacent to the syringe axis 420.

[0054] In one embodiment, the shaft end 706 includes an element that can trigger the position switch 1120. For example, the element can include an optical tab for triggering an optical sensor. The optical tab can be further described with respect to FIG. 33 and can be mounted at the shaft end 706. The optical tab can travel along a vertical axis and can pass the optical switch as the syringe piston travels vertically along the syringe axis 420. The optical switch of the generator 202 can interact with the optical tab mounted on the syringe piston 702. For example, the optical tab can be disposed on the shaft 704 at the shaft end 706. When the optical tab is in close proximity to the optical switch, e.g., adjacent to the optical switch, the optical tab can interrupt the optical switch. For example, the optical sensor can have a light emitting diode for emitting an optical signal, and the tab can obstruct or reflect the optical signal of the optical sensor. Thus, when the optical switch changes state, it indicates the proximity between the optical tab and the optical switch. Such proximity between the optical tab and the optical switch can be detected and used by one or more processors of the control unit to determine the travel of one or more syringes of the fluid transfer cartridge 204. More specifically, the one or more processors can monitor the state of the optical switch to identify where the syringe piston 702 is located relative to the syringe barrel 408, more specifically the position of the shaft 704, and / or to identify whether the stopper 608 is at the home position 1102, the end position 1104, or an intermediate position between the start and end of the travel.

[0055] In one embodiment, the shaft end 706 includes an element capable of triggering the position switch 1120. For example, the element can include a magnet, which can be mounted on the shaft end 706 and can travel along a vertical axis as the syringe piston 702 travels vertically along the syringe axis 420, passing the switch. A magnetic switch of the generator 202 can interact with the magnet mounted on the syringe piston 702. For example, the magnet can be disposed on the shaft 704 at the shaft end 706. When the magnet approaches the magnetic switch, e.g., when 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. Such proximity between the magnet and the magnetic switch can be detected and used by one or more processors of the control unit to determine the travel of one or more syringes of the fluid transfer cartridge 204. More specifically, the one or more processors can monitor the state of the magnetic switch to identify where the syringe piston 702 is located relative to the syringe barrel 408, and more specifically, whether the stopper 608 is in the home position 1102, the end position 1104, or is located in an intermediate position between the start and end of a run.

[0056] The position switch 1120 may act as a limit switch to provide information to the control unit that may be used to prime the syringe for fluid delivery. A magnetic switch may provide a more reliable limit switch than, for example, a mechanically activated switch, given that the magnetic switch does not require precise alignment between the magnet and the magnetic switch. Thus, one or more processors of the control unit may use the switching signal from the magnetic switch to control the preparation cycle of the syringe.

[0057] During the warm-up cycle, the control unit detects whether the syringe is properly filled with cooling fluid 603, whether the fluid conduits 206 and manifold of the fluid transfer cartridge 204 are filled with cooling fluid 603, and cycles the syringe using limit switches to ensure that air bubbles are removed from the fluid conduits 206, manifold, and syringe. The control unit purges the syringe during the warm-up cycle to achieve these goals.

[0058] The fluid transfer cartridge 204 can be mounted on the generator 202 by the stopper 608 in the home position 1102. When in the home position 1102, the shaft end 706 can be within the cartridge cavity 402 and thus above and outside the well 1110. In the home position 1102, the syringe is empty. To begin the warm-up cycle, the processor or processors of the control unit can drive the motor 1108 in a downward direction to actuate the syringe piston 702. The movement of the stopper 608 creates a vacuum within the syringe barrel 408, drawing the cooling fluid 603 into the syringe. Thus, the initial stage of the warm-up cycle fills the syringe with the cooling fluid 603.

[0059] As the syringe fills with fluid, the shaft end 706 moves outside the cartridge cavity 402 and into the well 1110. The one or more processors can determine the level or amount of fill of the syringe. For example, when the stopper 608 is at the end position 1104 within the syringe barrel 408, the shaft end 706 can be positioned adjacent to a lowest position switch 1120 of the generator 202. The proximity of the shaft end to the position switch can trigger, for example, the closing (or opening) of a contact of the switch to generate a switching signal that is sent to the one or more processors. The processor can determine that the syringe is filled with a predetermined amount of cooling fluid 603 based on the switching signal. For example, the predetermined amount of cooling fluid 603 can be the volume of the syringe barrel 408.

[0060] The predetermined amount of cooling fluid 603 may correspond to determining that the stopper 608 is in the end position 1104, and the one or more processors may be configured to determine other fill levels. For example, one or more intermediate position switches 1120 may be located between a top position switch corresponding to the home position 1102 and a bottom position switch corresponding to the end position 1104. The placement of the position switches may be selected to correspond to known volumes of fluid in the syringe. For example, the position switches may be located in positions corresponding to 10 mL increments of the syringe fill level.

[0061] When the syringes are filled, a preparation cycle can proceed. The one or more processors can drive the motor 1108 to move the syringe piston 702 upwardly and expel the cooling fluid 603 from the syringe. The cooling fluid 603 is expelled into a fluid path of the cartridge. For example, the cooling fluid 603 can flow from the syringe into a fluid conduit 206 that connects the fluid transfer cartridge 204 to the catheter 101. In one embodiment, the syringes are totally emptied of the cooling fluid 603. The one or more processors can determine that the one or more syringes are empty based on a switching signal generated by a position switch. The switching signal can indicate that the stopper 608 is in the home position 1102 and thus the syringes are empty.

[0062] Forcing the cooling fluid 603 out of the syringe can remove bubbles from one or more of the syringes or fluid paths of the fluid transfer cartridge 204. More specifically, air drawn into the syringe when the stopper 608 initially moves from the home position 1102 to the end position 1104 can be expelled from the fluid network when the stopper 608 is then driven back towards the home position 1102. Purging the air from the fluid network can prime the system to ensure that the fluid network is filled with an incompressible fluid, e.g., sterile water, and that the fluid network is stable.

[0063] In a warm-up cycle of operations, after purging the air from the syringe, the syringe may be filled with cooling fluid 603. The one or more processors may drive the motor 1108 to move the stopper 608 from the home position 1102 to the end position 1104. Thus, the cooling fluid 603 may be drawn into the syringe barrel 408. After the purging operation, the fluid drawn into the syringe barrel 408 may be largely or entirely free of bubbles. In one embodiment, the purging operation may be repeated one or more times until the cooling fluid 603 in the syringe is entirely free of bubbles.

[0064] It will be appreciated that a magnetic switch provides one type of limit switch, and that other types of limit switches may be incorporated into treatment system 100. In one embodiment, the limit switch is an optical switch, such as an optical proximity sensor 2910. Thus, shaft end 706 may be configured to emit or reflect light to an optical sensor in treatment system 100, such as an optical sensor located within generator 202.

[0065] The optical limit switch may include a light source mounted on the shaft end 706. The light source may shine radially outward from the shaft axis 420, for example, toward a rear wall of the well 1110 of the generator 202. The rear wall may include one or more light sensors for receiving light emitted from the shaft end 706. Alternatively, the rear wall may include a proximity light sensor that emits light toward the shaft end 706 and receives reflected light back from the shaft end 706. The light sensor may thus detect when the shaft end 706 is in proximity to the light sensor based on the detected light, and may send a corresponding switching signal to one or more processors of the treatment system 100. The processor may use the switching signal to detect and control the shaft position, as described above. Thus, a magnetic switch is a non-limiting example of a limit switch that may be integrated into the treatment system 100, and optical or mechanical switches may also be used to detect the shaft position.

[0066] 12, a rear perspective view of a fluid transfer cartridge is shown, according to one embodiment. A rear surface 407 of the fluid transfer cartridge 204 may juxtapose with a surface of the generator 202 that defines the cartridge receptacle 302 when the cartridge is mounted on the generator 202. The rear surface 407 may include a ridge 1202 that projects outwardly from a surrounding base surface. In one embodiment, the ridge 1202 has a ridge perimeter 1204 that extends around a portion of the rear surface 407 above the ridge 1202. The ridge perimeter 1204 may be inwardly directed along a side of the outer perimeter of the rear surface 407. More specifically, the rear surface perimeter 1206 may define an edge that separates the rear surface 407 from the top, sides, and bottom surfaces of the cartridge. Thus, the rear surface 407 may have a portion that covers the base surface that faces outwardly along a side of the portion that covers the ridge 1202. The rear surface portions may be offset from one another, for example at different positions in a rearward direction, such that the rear surface has a stepped profile when viewed from the side.

[0067] In one embodiment, the fluid transfer cartridge 204 includes one or more electrical contact pads 1208 or pins for connecting to corresponding circuitry of the generator 202. More specifically, the electrical contact pads 1208 or pins can be connected to an electrical circuit board. For example, the electrical circuit board can be a pressure sensor board having 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 can include spring-loaded electrical contact pins exposed through the rear face 407 of the cartridge near the top end of the ridge 1202. The electrical contact pads 1208 can include conductive contact pads exposed through the rear face 407 near the top end of the ridge 1202 and positioned to contact spring-loaded electrical contact pins extending from the generator 202. In this case, the top end can refer to the side of the ridge perimeter 1204 furthest from the floor. The electrical contact pads or pins and their location in the upper region of the cartridge can provide several advantages. First, in the case of a contact pin, the spring-suspended structure allows the pin to deflect when placed in contact with the generator 202. Thus, the pin can conform to the generator 202 in the event of misalignment or movement between the components during operation. Such benefits are similarly realized when the contact pads of the fluid transfer cartridge 204 engage the contact pins of the generator 202. Thus, the deflectable pins allow for better connection between the generator 202 and the cartridge during operation. Second, the placement of the pads or pins along the top of the cartridge can reduce the likelihood of electrical shorting in the event of a conduit leak. More specifically, the pads or pins can be placed vertically above the fluid path that is inside the cartridge shell 306, so that any leaks from the fluid path will drop downward to the floor without contacting (and potentially shorting) the electrical connection.

[0068] 13, a front perspective view of a cartridge receiving portion of a generator is shown, according to one embodiment. The ridge 1202 of the fluid transfer cartridge 204 can engage a corresponding feature in the generator 202. In one embodiment, the cartridge receptacle 302 includes a rear recess 1302 for receiving the ridge 1202. The rear recess 1302 can have a recess perimeter 1304 that extends around a surface of the recessed generator 202. The recess perimeter 1304 of the rear recess 1302 can have a contour that matches the contour of the ridge perimeter 1204. For example, the ridge 1202 can be a rectangular protrusion and the rear recess 1302 can be a rectangular recess. Thus, the ridge 1202 may engage and fill the rear recess 1302 such that the lateral sidewall of the ridge 1202 juxtaposes and complies with the lateral sidewall of the rear recess 1302. Similarly, the rear surface of the fluid transfer cartridge 204 juxtaposes and complies with the front surface of the generator housing 304. The compliant surfaces of the components may stabilize the fluid transfer cartridge 204 relative to the generator 202 and may minimize movement between the components during operation.

[0069] The contact pads or pins of the fluid transfer cartridge 204 may extend towards or face a slot located in an upper region of the rear recess 1302. The slot may expose one or more electrical contacts with which the contacts of the fluid transfer cartridge 204 may engage when the cartridge is mounted onto the generator 202. Thus, electrical connections may be made between the cartridge and the generator 202 to communicate signals including switching signals, photoactivation signals, etc.

[0070] To further stabilize the control unit components and secure the fluid transfer cartridge 204 to the generator 202, the treatment system 100 can include a locking mechanism 1310 for latching the fluid transfer cartridge 204 within the cartridge receptacle 302. The locking mechanism 1310 can include corresponding catches 1312 and recesses 121 arranged on the fluid transfer cartridge 204 and the generator 202. Referring again to FIG. 12, the ridge 1202 can include several recesses 1210 distributed around the ridge perimeter 1204 of the ridge 1202. As an example, the ridge 1202 can have a rectangular outline and four or more recesses 1210 can be located within a sidewall along a side of the ridge 1202 around the ridge perimeter 1204. In one embodiment, each of the four recesses 1210 can be located adjacent a respective corner of the rectangular outline. Distributing the recesses 1210 around the raised perimeter 1204 may distribute the retention load applied by the generator 202 to the fluid transfer cartridge 204 and thus optimally stabilize the cartridge relative to the generator housing 304.

[0071] 13, the securing mechanism 1310 can include several catches 1312 distributed around the recess perimeter 1304. As an example, the rear recess 1302 can have a rectangular profile and four latches can be located along the sidewalls along the sides of the rear recess 1302 around the recess perimeter 1304. In one embodiment, there are four latches at positions corresponding to the positions of the recess 1210 in the ridge 1202. More specifically, the catches 1312 can be configured to engage the recess 1210 of the ridge 1202 to secure the fluid transfer cartridge 204 to the generator 202.

[0072] In one embodiment, each catch 1312 is a spring-loaded catch 1312 operably coupled to a release button 1314 of the securing mechanism 1310. The release button 1314 may be movable between a latched position and an unlatched position. For example, the release button 1314 may be in a latched position when it is fully extended (unstressed). Depressing the release button 1314 may move the button from the latched position to the unlatched position. The release button 1314 may be operably coupled to the catch such that moving the release button 1314 from the latched position to the unlatched position moves the catch 1312 out of the cartridge receptacle 302. More specifically, movement of the release button 1314 may move the catch 1312 from an extended position within the cartridge recess 1210 to a recessed position outside the raised recess 1210. When the catch 1312 is engaged with the raised recess 1210, the cartridge is secured to the generator 202. In contrast, when the catch 1312 is retracted from the raised recess 1210, the cartridge may be released from the generator 202. The securing mechanism 1310 thus provides a quick release mechanism for attaching and removing the fluid transfer cartridge 204 to and from the generator 202.

[0073] In addition to providing a quick release mechanism, the securing mechanism 1310 promotes a secure and stable mechanical connection between the cartridge 204 and the generator 202. The distributed latches around the ridge 1202 and rear recess 1302 ensure that the mechanical load of the cartridge during operation is evenly distributed, thus allowing the latches to share the load and minimize deflection at any given location around the cartridge. Although the securing mechanism 1310 can have four or more friction points where the catch 1312 engages the recess 1210, the cartridge can be smoothly released using a release button 1314 that activates a spring-loaded latch. In one embodiment, the catch 1312 is driven by a linkage system, a plate with a cam mechanism, or another intermediate structure between the release button 1314 and the catch 1312. Such a mechanism can operate smoothly and in a manner that provides a preferred degree of tactile feedback to the user. Thus, the securing mechanism 1310 can advantageously secure the cartridge to the generator 202 in a user-friendly manner.

[0074] The securing mechanism 1310 may include one or more catches 1312 operably coupled to a release button 1314 such that moving the release button 1314 from a latched position to an unlatched position moves the one or more catches 1312 out of the cartridge receptacle 302. The catches 1312 need not be directly spring suspended, but rather may be biased with respect to the release button 1314. More specifically, the release button 1314 may be movable from a latched position to an unlatched position, and the release button 1314 may be operably coupled to one or more springs to bias the release button 1314 towards the latched position. Thus, the one or more springs may bias the catches 1312 into the cartridge receptacle 302.

[0075] In one embodiment, the one or more springs biasing the release button 1314 are a single spring. More specifically, the release button 1314 can be driven to the latched position by a single spring. In contrast, the one or more catches 1312 can include several catches 1312 interconnected by a linkage. More specifically, the linkage can interconnect the catches 1312 such that movement of the release button 1314 acts as an input to cause movement of the linkage, which then drives the catches 1312 into and out of the cartridge receptacle 302. When the release button 1314 moves from a latched position to an unlatched position, the one or more catches 1312 can move out of the cartridge receptacle 302.

[0076] The treatment system 100 may include one or more processors configured to execute instructions stored on a non-transitory computer readable medium to cause the treatment system 100 to perform various methods, such as the preparation cycle described above. The methods may include methods that provide visual feedback to a user that an electrical connection has been made between components of the treatment system 100 or between the treatment system and an external component. Several such methods are described below.

[0077] In one embodiment, the treatment system 100 can illuminate the syringe upon loading the fluid transfer cartridge 204 onto the generator 202. During operation, the one or more processors are configured to determine whether the fluid transfer cartridge 204 can be received within the cartridge receptacle 302. Detection of the loading cartridge can be performed by various sensors. For example, when the cartridge is received within the cartridge receptacle 302, one or more of the electrical contact pads 1208 can engage corresponding electrical contacts of the generator 202. The electrical contacts can cause the one or more processors to transmit an input signal. In response to detecting the input signal, and thus in response to determining that the fluid transfer cartridge 204 can be received within the cartridge receptacle 302, the 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 at the end, the user is provided with visual feedback confirming that the components of the treatment system 100 are engaged and ready for operation.

[0078] In one embodiment, the treatment system 100 includes one or more indicator lights 452 to indicate that a connection between the generator 202 and one or more external components has been made. Referring again to FIG. 4, the generator 202 may include one or more electrical connectors 450 configured to connect to an external connector of a corresponding external component. For example, the electrical connector 450 of the generator 202 may be an electrical socket for receiving the external connector 112 of the catheter 101. The additional electrical connector 450 may include a plug for receiving an external connector of another component, such as a remote control device. The external connector may be a plug that engages with a socket of the external connector or vice versa.

[0079] The generator 202 can include an indicator light 452 located near the electrical connector 450. For example, the indicator light 452 can be a single light-emitting diode (LED) adjacent to the electrical socket, or several LEDs positioned around the socket. In one embodiment, the indicator light 452 includes an indicator light ring 454 that extends around the electrical connector 450. More specifically, as shown in FIG. 4, the indicator light ring 454 can include an annular bezel that circumferentially surrounds the electrical connector 450. One or more LEDs can be mounted behind the bezel such that the bezel appears as a solid light ring upon illumination. The light ring can allow the light to be viewed from any direction without the view being blocked by, for example, a cable or catheter 101.

[0080] The indicator light 452 can have an illumination state or illumination mode that provides visual feedback to the user. For example, the one or more processors of the treatment system 100 can be configured to determine whether the electrical connector 450 is electrically connected to the external connector 112. As an example, when the external connector 112 is plugged into the electrical connector 450, a signal can be sent to the one or more processors indicating that a connection has been made and enabling the processor to determine that a connection has been made. In operation, in response to determining that the electrical connector 450 is connected to the external connector 112, an illumination mode of the indicator light 452 can change. In one embodiment, the indicator light 452 changes from an inactive, unilluminated state to an active, illuminated state. Thus, a user can see that the indicator light 452 has become illuminated to confirm that the external component is electrically connected to the generator 202.

[0081] A change in lighting mode from an unlit state to an illuminated state is provided as a non-limiting example. Alternatively, the change in lighting mode may be from a first lighting mode in which the indicator light 452 emits light, e.g., flashes, to a second lighting mode in which the indicator light 452 emits light continuously, e.g., the light is viewed as solid. In another alternative, the change in lighting mode may be from a first lighting mode in which the indicator light 452 emits a first color of light, e.g., red, to a second lighting mode in which the indicator light 452 emits a second color of light, e.g., blue. In either case, the change in lighting mode provides visual feedback to the user that an external component has been connected to the generator 202 and is therefore ready for use.

[0082] 14, a close-up view of a cartridge shell of a fluid transfer cartridge is shown, according to one embodiment. As described above, the cartridge shell 306 of the fluid transfer cartridge 204 can include a handle front plate 502 and a back plate 504. When combined, the handle front plate 502 and the back plate 504 can define a cartridge cavity 402 that is centrally located between various walls and surfaces.

[0083] When snapped or otherwise fitted together, the handle front plate 502 and back plate 504 can include one or more components for providing fluid transfer functionality within the cartridge cavity 402. For example, the fluid transfer cartridge 204 can include a syringe holder 513 for holding the syringe barrels 408, 412 within the cartridge cavity 402. The syringe holder 513 can stabilize the syringe during fluid delivery. The fluid transfer cartridge 204 can also include tubing 1406 for facilitating transfer of fluid from the syringe to the catheter 101.

[0084] The use of tubing to transfer fluid throughout the fluid transfer cartridge 204 may require conduit lines and many bonded joints to achieve the fluid pathways and interconnections necessary for fluid transfer. For example, the exclusive use of tubing may require more than 5 feet of tubing and more than 40 bonded joints to create a fluid network. However, such a fluid network may occupy a significant volume, lead to leakage and / or flow inconsistencies at the bonded joints, and may be challenging to assemble during manufacturing. In one embodiment, the cartridge manifold 1402 may be used to replace most of the tubing lengths and joints, thereby providing a more compact, reliable, and easy to manufacture fluid network. Due to the reduced size and weight of the fluid network, the corresponding size and weight of the fluid transfer cartridge 204 may also be reduced, allowing more cartridges to be sterilized at one time and allowing more cartridges to be pumped per unit volume.

[0085] The cartridge manifold 1402 may replace some, but not all, of the fluid tubing in the fluid transfer cartridge 204. As an example, the syringe barrel 408 may have a syringe cavity 1404 connected to the fluid channels of the cartridge manifold 1402 by one or more conduits 1406. Other conduits 1406, for example between the cartridge manifold 1402 and the second syringe barrel 412, the balloon catheter 101, fluid reservoirs, etc., may also be routed through the cartridge cavity 402. Such conduits 1406 are not shown in FIG. 14 to avoid cluttering the illustration.

[0086] Referring to FIG. 15A, a perspective view of a cartridge manifold is shown, according to one embodiment. The cartridge manifold 1402 can include several plates assembled together. In one embodiment, the cartridge manifold 1402 includes a bow plate 1502 assembled to a stern plate 1504. The bow plate 1502 and the stern plate 1504 can be secured together. For example, the bow plate 1502 can be snap-fit ​​to the stern plate 1504, e.g., secured by a snap closure. As described below, the bow plate 1502 and the stern plate 1504 can secure a middle plate, which has channels and ports for moving cooling fluid throughout the cartridge manifold 1402 and exchanging cooling fluid with external components, such as the balloon catheter 101 and fluid reservoirs. The bow plate 1502 is made transparent to allow the middle plate to be viewed in FIG. 15A.

[0087] 15B, a perspective view of a cartridge manifold is shown, according to one embodiment. Alternatively, the bow plate 1502 and the stern plate 1504 may be secured or otherwise fastened to one another by screws. More specifically, several manifold fasteners 1508 may extend through through holes in the stern plate 1504 and thread into threaded holes formed in the bow plate 1502. The fasteners 1508 may hold the plates together to sandwich a middle plate, as described below.

[0088] 16, a close-up view of a cartridge manifold is shown, according to one embodiment. The cartridge manifold 1402 in the cartridge cavity 402 can include a fluid transfer plate 1602 sandwiched between a bow plate 1502 and an aft plate 1504. The fluid transfer plate 1602 can include channels on the front and rear surfaces connected through various ports in the plates. More specifically, one or more front fluid channels 1604 in the front plate surface 1606 can convey cooling fluid through channels on the rear surface to one or more outlet ports 1608 for transfer to an external component.

[0089] In one embodiment, the outlet ports 1608 of the bow plate 1502 connect to external components. More specifically, the outlet ports 1608 can include fittings, e.g., barb fittings, that connect to the fluid conduits 1406, which can extend to connect to external components such as syringes, fluid reservoirs, balloon catheters 101, or pressure sensors. Thus, the bow plate outlet ports 1608 can function as a fluid interface to external components. Through the outlet ports 1608, fluid can be transferred into and out of the cartridge manifold 1402. In one embodiment, the bow plate 1502 includes four outlet ports 1608 along the top edge 1004 and five outlet ports 1608 along the bottom edge 1004, although the number and location of the outlet ports 1608 can be variable depending on the external components and the layout of the fluid transfer cartridge 204.

[0090] The movement of fluid through the channels and ports of the cartridge manifold 1402 can be controlled by one or more pistons 1610. Each piston 1610 can be associated with or include a spring 1612. More specifically, the pistons 1610 can be spring suspended to bias the pistons 1610 to a given position. For example, as described below, the springs 1612 can bias the pistons 1610 to an open position and a solenoid can actuate the pistons 1610 to move the pistons 1610 to a closed position. In particular, the pistons 1610 can be moved between positions that seal or unseal fluid ports in the fluid transfer plate 1602 to start or stop the flow of cooling fluid 603 through the fluid channels.

[0091] 17, a front view of a fluid transfer plate of a cartridge manifold is shown, according to one embodiment. A front plate surface 1606 of the fluid transfer plate 1602 can include several front fluid channels 1604. In one embodiment, the front fluid channels 1604 belong to respective fluid circuits. More specifically, some channels and ports can belong to an upper fluid circuit 1702 and other channels and ports can belong to a lower fluid circuit 1704. Each of the fluid circuits can include a respective front fluid channel 1604 and one or more outlets. The fluid channels and outlets can be interconnected with outlet ports 1608 of the bow plate 1502 to transfer fluid to and from external components, as described below. Additionally, the fluid transfer plate 1602 can include one or more fluid ports 1706. Each fluid port 1706 can extend through the fluid transfer plate 1602 from a front fluid channel 1604 in the front plate surface 1606 to a rear fluid channel ( FIG. 18 ) in the rear plate surface. Thus, the cooling fluid 603 can travel through the fluid ports 1706 from a channel in front of the fluid transfer plate 1602 to a channel behind the fluid transfer plate 1602.

[0092] In one embodiment, the fluid channels of the fluid transfer plate 1602 may be surrounded by respective channel seals 1710. The channel seals 1710 may be gaskets, e.g., O-rings, or stripes of elastic material having a circular, rectangular, cross-shaped, or cross-sectional profile, placed along the outer perimeter of the fluid channels. The seals may be fitted into grooves, overmolded into the plate, or otherwise attached to the fluid transfer plate 1602. When the fluid transfer cartridge 204 is assembled, the channel seals 1710 may be sandwiched between the fluid transfer plate 1602 and the adjacent bow plate 1502 or stern plate 1504. The sandwiched seals may form a hermetic seal around the fluid channels to isolate the cooling fluid 603 within the channels.

[0093] The lower fluid circuit 1704 may be associated with a syringe barrel 408 used to deliver fluid to the balloon catheter 101. More specifically, the cooling fluid 603 may be transferred from an external fluid reservoir, e.g., a fluid filled bag, to the syringe barrel 408 through the lower fluid circuit 1704. The outlets of the front plate surface 1606 that connect to respective outlet ports 1608 of the bow plate 1502 may be labeled for ease of reference. For example, the lower fluid circuit 1704 may have an L1 outlet 1712, an L2 outlet 1714, an L3 outlet 1716, an L4 outlet 1718, and an L5 outlet 1720. Each of the L1-L5 outlets 1720 may connect to a fitting on the bow plate 1502, which in turn connects to the conduit 1406. More specifically, the L1-L5 outlets may be in fluid communication with the outlet ports 1608 along the lower edge 1004 of the bow plate 1502. These conduits 1406 may connect to external components such as a fluid reservoir, a syringe barrel 408, an inlet line of the balloon catheter 101, and / or one or more pressure sensors.

[0094] The upper fluid circuit 1702 may be associated with a second syringe barrel 412 used to draw fluid from the balloon catheter 101. More specifically, the cooling fluid 603 may be transferred from the balloon catheter 101 through the upper fluid circuit 1702 to transfer the fluid to an external fluid reservoir. The outlets of the front plate surface 1606 that interconnect with respective outlet ports 1608 of the bow plate 1502 may be labeled for ease of reference. For example, the upper fluid circuit 1702 may have a U1 outlet 1722, a U2 outlet 1724, a U3 outlet 1726, and a U4 outlet 1728. Each of the U1-U4 outlets may connect to a fitting on the bow plate 1502, which in turn connects to the conduit 1406. More specifically, the U1-U4 outlets may be in fluid communication with the outlet ports 1608 along the upper edge 1004 of the bow plate 1502. These conduits 1406 may connect 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.

[0095] It is apparent that some of the outlets are in fluid communication with each other through fluid channels. For example, U3 outlet 1726 and U4 outlet 1728 are in fluid communication with each other through the front fluid channel 1604 of the upper fluid circuit 1702. Similarly, L2 outlet 1714 and L3 outlet 1716 are in fluid communication with each other through the front fluid channel 1604 of the lower fluid circuit 1704. As described below, the outlets isolated on the front side of the fluid transfer plate 1602, e.g., U1, U2, L1, L4, and L5 outlets 1720, may also be in fluid communication with other outlets through fluid channels on the rear side of the fluid transfer plate 1602. More specifically, each outlet and / or channel may include a respective 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.

[0096] 18, a rear view of a fluid transfer plate of a cartridge manifold is shown, according to one embodiment. The cartridge manifold 1402 includes a rear plate surface 1802 having one or more rear fluid channels 1804. Like the front fluid channels 1604, the rear fluid channels 1804 can be surrounded by a channel seal 1710 to isolate the fluid within the fluid channels. For example, the aft plate 1504 can be juxtaposed with the aft plate surface 1802, such that the channel seal 1710 is sandwiched between the aft plate surface 1802 and the aft plate 1504. By extending around the rear fluid channels 1804, the channel seal can define a fluid passage for transferring the cooling fluid 603 accordingly.

[0097] The rear fluid channels 1804 belong to the respective fluid circuits. More specifically, some channels and ports may belong to the upper fluid circuit 1702 and other channels and ports may belong to the lower fluid circuit 1704. The fluid channels and outlets on the rear plate surface 1802 may be interconnected with the fluid channels and outlets on the front plate surface 1606 through the fluid ports 1706. More specifically, each fluid port 1706 may extend through the fluid transfer plate 1602 to interconnect the front fluid channels 1604 and ports with the rear fluid channels 1804 and ports. Similarly, the front fluid channels 1604, the rear fluid channels 1804, and the fluid ports 1706 are in fluid communication with the syringe cavity 1404, assuming that the fluid channels and ports of the fluid transfer plate 1602 are connected to fittings on the bow plate 1502, which are then connected to the syringe barrel 408 through the conduit 1406. Thus, cooling fluid 603 can move between the syringe cavities 1404 and channels in the fluid transfer plate 1602. Similarly, cooling fluid 603 can move between other external components and channels in the fluid transfer plate 1602.

[0098] The outlets in the rear plate surface 1802 are labeled in FIG. 18 to show a correspondence with the outlets in the front plate surface 1606 of FIG. 17. Thus, it is apparent that the labeled outlets extend through the plate from the front plate surface 1606 to the rear plate surface 1802. More specifically, in the upper fluid circuit 1702, the U1 outlet 1722 and the U2 outlet 1724 are through-holes extending through the plate. Similarly, in the lower fluid circuit 1704, the L1 outlet 1712, the L4 outlet 1718, and the L5 outlet 1720 are through-holes extending through the plate. Thus, the outlets isolated from one another on the front plate surface 1606 may be interconnected through the rear plate surface 1802. For example, the U1 outlet 1722 and the U2 outlet 1724 are physically isolated on the front plate surface 1606, but the outlets are interconnected through the rear fluid channel 1804 on the rear plate surface 1802. Similarly, the L1 outlet 1712 and the L5 outlet 1720 are physically isolated on the front plate surface 1606, but the outlets are interconnected through a rear fluid channel 1804 on the rear plate surface 1802.

[0099] The fluid channels can interconnect outlets on one side of the plate and the plates are isolated from each other on the other side of the plate, while the fluid ports 1706 can be used to reversibly interconnect the fluid channels on one side of the plate with the fluid channels on the other side of the plate. In one embodiment, each fluid port 1706 can be located in a corresponding valve seat on the rear plate surface 1802. The valve seats are labeled for ease of reference in the valve actuation logic described below. The upper fluid circuit 1702 can include a V1 valve seat 1730. The V1 valve seat 1730 can receive a corresponding piston 1610 to open and close the fluid port 1706 that in its position interconnects the front fluid channel 1604 of the upper fluid circuit 1702 with the rear fluid channel 1804 of the upper fluid circuit 1702. Thus, the fluid port 1706 corresponding to the V1 valve seat 1730 can allow or prevent fluid communication between the front fluid channel 1604 and the rear fluid channel 1804 of the upper fluid circuit 1702. Thus, the fluid port 1706 corresponding to the V1 valve seat 1730 can isolate the U1 and U2 outlets 1724 from the U3 and U4 outlets 1728 or interconnect the U3 and U4 outlets 1728.

[0100] In one embodiment, the lower fluid circuit 1704 includes several valve seats. The V2 valve seat 1732 can receive a corresponding piston 1610 to open and close a fluid port 1706 that interconnects the front fluid channel 1604 of the lower fluid circuit 1704 with a first rear fluid channel 1804 of the lower fluid circuit 1704. The first rear fluid channel 1804 can interconnect the L1 outlet 1712 with the L5 outlet 1720. Thus, the fluid port 1706 corresponding to the V1 valve seat 1730 can enable or stop fluid communication between the front fluid channel 1604 and the first rear fluid channel 1804 of the lower fluid circuit 1704. Thus, the fluid port 1706 corresponding to the V2 valve seat 1732 can isolate the L2 and L3 outlets 1716 from the L1 and L5 outlets 1720 or interconnect them with the L1 and L5 outlets 1720.

[0101] In one embodiment, the V3 valve seat 1734 can receive a corresponding piston 1610 to open and close a fluid port 1706 that interconnects the front fluid channel 1604 of the lower fluid circuit 1704 with a second rear fluid channel 1804 of the lower fluid circuit 1704. The second rear fluid channel 1804 can interconnect the fluid port 1706 to the L4 outlet 1718 at the V3 valve seat 1734. Thus, the fluid port 1706 corresponding to the V3 valve seat 1734 can enable or prevent fluid communication between the front fluid channel 1604 and the second rear fluid channel 1804 of the lower fluid circuit 1704. Thus, the fluid port 1706 corresponding to the V3 valve seat 1734 can isolate the L2 and L3 outlets 1716 from the L4 outlet 1718 or interconnect them with the L4 outlet 1718. It will also be appreciated by inspection of the illustrated fluid network that actuating piston 1610 to simultaneously open fluid ports 1706 at V2 valve seat 1732 and V3 valve seat 1734 thereby places all of the outlets of lower fluid circuit 1704 in fluid communication with each other through front fluid channel 1604, first rear fluid channel 1804, and second rear fluid channel 1804.

[0102] As described above, the fluid network formed by the various channels and ports of the fluid transfer plate 1602 can be used to interconnect various components outside the cartridge manifold 1402. Examples of external component connections are now described. Starting from the upper fluid circuit 1702, the U1 outlet 1722 can be connected to the second syringe barrel 412. Thus, transmitting fluid through the U1 outlet 1722 can transmit fluid to or from the second syringe barrel 412. The U2 outlet 1724 can be connected to a fluid reservoir. Thus, transmitting fluid through the U2 outlet 1724 can transmit fluid to or from the fluid reservoir. The U3 outlet 1726 can be connected to a pressure sensor. Thus, the U3 outlet 1726 can allow the fluid pressure in the front fluid channel 1604 (or the rear fluid channel 1804 of the upper fluid circuit 1702 when the corresponding valve is opened) to be sensed. The U4 outlet 1728 can be connected to an outlet line of the balloon catheter 101. Thus, transmitting fluid through the U4 outlet 1728 can transmit fluid to or from the outlet line of the balloon catheter 101.

[0103] With respect to the lower fluid circuit 1704, the L1 outlet 1712 can be connected to an inlet line of the balloon catheter 101. Thus, transmitting fluid through the L1 outlet 1712 can transmit fluid to or from an inlet line of the balloon catheter 101. The L2 outlet 1714 can be connected to a syringe barrel 408. Thus, transmitting fluid through the L2 outlet 1714 can transmit fluid to or from the syringe barrel 408. The L3 outlet 1716 can be connected to a pressure sensor. Thus, the L3 outlet 1716 can enable the fluid pressure in the front fluid channel 1604 (or one or both of the rear fluid channels 1804 of the lower fluid circuit 1704 when the corresponding valve is opened) to be sensed. The L4 outlet 1718 can be connected to a fluid reservoir. Thus, transmitting fluid through the L4 outlet 1718 can transmit fluid to or from the fluid reservoir. The L5 outlet 1720 can be connected to a pressure sensor. Thus, the L5 outlet 1720 can enable the fluid pressure in the first rear fluid channel 1804 of the lower fluid circuit 1704 (or one or both of the front fluid channel 1604 or the second rear fluid channel 1804 of the lower fluid circuit 1704 when a corresponding valve is opened) to be sensed.

[0104] Having described the fluid network and, in one embodiment, external components connected to the fluid network, it is now possible to describe a method for circulating the cooling fluid 603 from a fluid reservoir to the balloon catheter 101 and then back to the fluid reservoir. In a first action, the fluid port 1706 in the V2 valve seat 1732 may be closed and the fluid port 1706 in the V3 valve seat 1734 may be opened. This closing / opening action may be caused by the actuation of the piston 1610, as described below. Alternatively, other valve designs may be integrated with the fluid transfer plate 1602 to open and close the respective fluid ports 1706.

[0105] In a first operation with the V3 valve open, the L2, L3, and L4 outlets may be in fluid communication with one another, and the L1 and L5 outlets may be isolated from other outlets in the lower fluid circuit 1704. Thus, the syringe piston 702 of the syringe barrel 408 may be retracted to draw fluid from the fluid reservoir into the syringe cavity 1404. More specifically, the cooling fluid 603 may pass from the fluid reservoir into the L4 outlet 1718, through the fluid port 1706 in the V3 valve seat 1734, into the front fluid channel 1604, and out the L2 outlet 1714 into the conduit 1406 connected to the syringe barrel 408. At this stage, a pressure sensor connected to the L3 outlet 1716 may sense the pressure of the transmitted cooling fluid 603, for example, in the syringe cavity 1404.

[0106] In a second operation, the V3 valve is closed and the V2 valve is opened. At this stage, the L1, L2, L3, and L5 outlets can be in fluid communication with each other, and the L4 outlet 1718 can be isolated from other outlets in the lower fluid circuit 1704. Thus, the syringe piston 702 of the syringe barrel 408 can advance to push the fluid in the syringe cavity 1404 into the inlet line of the balloon catheter 101. More specifically, the cooling fluid 603 can pass from the syringe cavity 1404 into the L2 outlet 1714 through the fluid port 1706 in the V2 valve seat 1732, and out of the L1 outlet 1712 into the inlet line of the balloon catheter 101. At this stage, a pressure sensor connected to the L5 outlet 1720 can sense the pressure of the transmitted cooling fluid 603, for example, in the balloon catheter 101.

[0107] In a third operation with the V1 valve open, the U1, U2, U3, and U4 outlets may be in fluid communication with one another. Thus, the syringe piston 702 of the second syringe barrel 412 may be retracted to draw fluid from the outlet line of the balloon catheter 101 into the syringe cavity 1404. More specifically, the cooling fluid 603 may pass from the outlet line of the balloon catheter 101 into the U4 outlet 1728, through the front fluid channel 1604 and the fluid port 1706 at the V1 valve seat 1730, into the rear fluid channel 1804, and out the U1 outlet 1722 into the conduit 1406 connected to the second syringe barrel 412. The conduit 1406 connecting the U2 outlet 1724 to the fluid reservoir may have a one-way check valve to prevent backflow, so that suction cannot be applied to the fluid reservoir at the U2 outlet 1724. At this stage, a pressure sensor connected to U3 outlet 1726 can sense the pressure of the transferred cooling fluid 603, for example, within syringe cavity 1404.

[0108] In a fourth operation, the V1 valve is closed. At this stage, the U1 and U2 outlets 1724 can be in fluid communication with each other, and the U3 and U4 outlets 1728 can be isolated from other outlets in the upper fluid circuit 1702. Thus, the syringe piston 702 of the second syringe barrel 412 can advance to push fluid out of the syringe cavity 1404 and into the fluid reservoir. More specifically, the cooling fluid 603 can pass from the syringe cavity 1404 into the U1 outlet 1722, through the rear fluid channel 1804 of the upper fluid circuit 1702, and out of the U2 outlet 1724 through the conduit 1406 (and check valve) to fill the fluid reservoir.

[0109] The operations described above can be performed in series and / or in parallel to circulate the cooling fluid 603 through the balloon catheter 101. For example, adding fluid to the balloon in a second operation can be performed simultaneously with removing fluid from the balloon in a third operation to balance the positive and negative pressures in the balloon, such that the balloon diameter remains constant and maintains the temperature of the cooling fluid 603 within the balloon. Control of the operations can be provided based in part on pressure data fed back to one or more processors by a pressure sensor connected to the cartridge manifold 1402.

[0110] 19, a perspective view of a cartridge manifold piston is shown, according to one embodiment. The valves used to open and close the fluid ports 1706 can include pistons 1610. More specifically, the pistons 1610 can interact with the fluid transfer plate 1602 to seal and unseal the fluid ports 1706. In one embodiment, the pistons 1610 include end seals 1902. As described below, the pistons 1610 can be placed in an open position where the end seals 1902 unseal (unblock) the corresponding fluid ports 1706 to allow the cooling fluid 603 to pass through the fluid ports 1706. The pistons 1610 can be moved from the open position to a closed position where the end seals 1902 seal (block) the corresponding fluid ports 1706 to stop the cooling fluid 603 from passing through the fluid ports 1706. Thus, the piston 1610 acts as a valve by covering or exposing the fluid port 1706 to control the flow of fluid therebetween.

[0111] In one embodiment, the end seal 1902 has a circular distal surface. The distal surface can be flat. The seal can include a resilient, cylindrical plug that rests within the body of the piston 1610. The face of the plug can extend distally from the body to seal against an opposing surface. For example, the end seal 1902 can press against the back plate surface 1802 of the fluid transfer plate 1602. More specifically, the face of the end seal 1902 can seal against the back plate surface 1802 at a corresponding valve seat around a corresponding fluid port 1706 to close the valve. Thus, the end seal 1902 can be sized larger than the fluid port 1706. For example, the diameter of the face of the end seal 1902 can be larger than the diameter of the fluid port 1706, e.g., about twice as large.

[0112] As described above, the piston 1610 can be spring suspended. The piston 1610 can include a spring groove 1904. The spring groove 1904 can include an annular groove sized and shaped to receive a proximal end of the spring 1612. The spring 1612 can be a helical compression spring 1612. A distal end of the spring 1612 can be similarly engaged with a corresponding spring groove 1904 in the valve seat. The spring groove 1904 can stabilize the spring 1612 and allow the spring 1612 to act against both the back plate surface 1802 and the piston 1610. Thus, the spring 1612 can bias the piston 1610 outwardly to maintain the piston 1610 in a normal open position with the end seal 1902 offset from the back plate surface 1802 to allow fluid flow through the fluid port 1706.

[0113] The piston 1610 may include a side seal 1906 for sealing against one of the manifold plates. For example, the side seal 1906 may seal against the aft plate 1504. Thus, the piston 1610 may include an end seal 1902 for pressing against the aft plate surface 1802 of the fluid transfer plate 1602, and a side seal 1906 for sealing against the aft plate 1504. In one embodiment, the side seal 1906 may include an O-ring that fits within a groove in the body of the piston 1610. Thus, the end seal 1902 may have an annular distal surface. The O-ring may extend laterally beyond the cylindrical wall of the body, such that when the piston body is inserted into a receiving hole in the aft plate 1504, the side seal 1906 may press against and seal to the aft plate 1504. The side seal 1906 can maintain a seal and slide against the stern plate 1504 so that the piston 1610 can be moved axially within the stern plate 1504. Thus, the piston 1610 can be advanced to block the corresponding fluid port 1706 or retracted to open the corresponding fluid port 1706.

[0114] Referring to FIG. 20, a perspective view of a cartridge manifold piston is shown, according to one embodiment. The end seal 1902 may include an O-ring. The O-ring may be set in a groove in the end of the piston 1610. For example, the groove may be machined and the O-ring may be pressed into the groove. Alternatively, the body of the piston 1610 may be overmolded around the O-ring to create a more secure retention of the O-ring. Thus, the end seal 1902 may be firmly seated within the body of the piston 1610. In either case, the end seal 1902 may extend distally from the body of the piston 1610 such that when the piston 1610 moves to the closed position, the seal may press against the back plate surface 1802. The outer diameter of the annular end seal 1902 may be sized larger than the fluid port 1706. For example, the outer diameter of the O-ring end seal 1902 may be larger, e.g., twice as large, than the diameter of the fluid port 1706.

[0115] 21, a cross-sectional view taken along line AA of FIG. 18 of a cartridge manifold piston in an open position according to one embodiment is shown. The piston 1610 can be a free-floating piston 1610 having a side seal 1906 for radially sealing against the stern 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 maintain the end seal 1902 spaced apart from the fluid port 1706. Additionally, fluid pressure in the fluid channel forward of the end face 604 can press against the end face 604, biasing the piston 1610 to the open position. Thus, the cooling fluid 603 can flow through the front fluid channel 1604 and the fluid port 1706 into the rear fluid channel 1804.

[0116] 22, a cross-sectional view taken along line AA of FIG. 18 of the piston of the cartridge manifold in a closed position is shown, according to one embodiment. A solenoid 2202 (force vectors are shown, but the solenoid 2202 is omitted) can be actuated to urge the piston 1610 forward. The force of the solenoid 2202 can overcome the spring 1612 and fluid pressure acting against the piston 1610 in the opposite direction to move the piston 1610 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, the cooling fluid 603 is stopped from flowing to or from the front fluid channel 1604 through the fluid port 1706.

[0117] In particular, the solenoid 2202 can close the valve using a force of less than 10 lbf, e.g., 5 lbf or less. Such a closing force compares favorably to alternative valve designs, such as pinch valves, which squeeze the tubing of the conduit 1406. As a result, the cartridge manifold 1402 can also be designed to withstand lower squeeze forces, allowing less material to be used in the design and a smaller form factor to be achieved.

[0118] The valve can be reversibly moved from the closed position of Figure 22 to the open position of Figure 21 by de-energizing the solenoid 2202. When the solenoid 2202 is no longer energized, the compression spring 1612 can act on the piston 1610 to return the piston 1610 to the open position.

[0119] As illustrated in Figures 21-22, the rear surface 2102 of the piston 1610 can be aft of the back surface 2104 of the stern plate 1504 in both the open position (Figure 21) and the closed position (Figure 22). By maintaining the rear surface 2102 relative to the back surface 2104 in both piston 1610 positions, contact between the solenoid 2202 and the piston 1610 is promoted. More specifically, the likelihood of the solenoid 2202 losing contact with the rear surface 2102 is reduced because the rear surface 2102 is not recessed 1210 into the hole in the stern plate 1504 below the rear surface 2104.

[0120] Non-invasive Pressure / Flow Sensors As explained above, the pressure sensor used to monitor the balloon inflation can be integrated directly into the system's configuration, for example, the fluid transfer cartridge 204. The pressure sensor is invasive, meaning that the pressure sensor is in direct contact with the inflation fluid. As a result of the direct contact, the pressure sensor must be discarded after each procedure. Pressure sensors are expensive, so the current practice of using non-invasive pressure sensing drives up the cost per procedure.

[0121] 23, a side view of a generator of an ultrasound-based treatment system is shown, according to one embodiment. The pressure and / or flow sensors can be integrated into the generator 202, rather than being built into the fluid transfer cartridge 204. Additionally, pressure and / or flow sensors located on the generator can be non-invasive, meaning that they do not come into direct contact with the inflation fluid used to inflate the balloon. Non-invasive sensors can be used for multiple procedures, thus reducing the cost of consumables by removing costly sensors from the cartridge design.

[0122] In one embodiment, the pressure fitting 2302 is mounted on the generator housing 304. As described above, the generator housing 304 has a cartridge receptacle 302 configured to receive the fluid transfer cartridge 204. Thus, when the fluid transfer cartridge 204 is loaded into the cartridge receptacle 302 of the generator 202, the pressure fitting 2302 can be behind the cartridge. The pressure fitting 2302 can be configured to connect to one or more conduits 1406 of the fluid transfer cartridge 204. For example, when the fluid transfer cartridge 204 is loaded into the generator 202, a fitting of the fluid transfer cartridge 204 connected to the conduit 1406 can engage with the pressure fitting 2302 of the generator 202. In one embodiment, the pressure fitting 2302 can be connected to the cartridge manifold 1402, for example, to an outlet of the manifold, through the conduit 1406. Thus, the pressure fitting 2302 can be used to transfer pressure from the cartridge manifold 1402 to the generator 202 .

[0123] 24, a cross-sectional view taken along line AA in FIG. 23 of a generator for an ultrasound-based treatment system according to one embodiment is shown. In one aspect, the generator 202 incorporates a non-invasive pressure sensor 2402 for monitoring and measuring fluid delivered, e.g., to a balloon, through the fluid delivery cartridge 204. In one embodiment, the generator 202 includes a pressure sensor 2402 in the generator housing 304. The pressure sensor 2402 integrated in the generator 202 is separate from the fluid delivery cartridge 204. The pressure sensor 2402 may be configured to sense pressure at the pressure fitting 2302. Thus, the pressure sensor 2402 may be used to measure the fluid pressure delivered to the balloon through the fluid delivery cartridge 204. Nevertheless, the pressure sensor 2402 may remain (and be reused) in the generator 202 when the cartridge is removed and discarded.

[0124] The generator-located pressure sensor 2402, which may replace the cartridge-located pressure sensor described above, may sense the inflation fluid non-invasively. For example, the pressure fitting 2302 may have a diaphragm that contacts the cooling fluid 603 but separates the cooling fluid 603 from the generator cavity. Thus, the pressure sensor 2402 may connect to a fluid line that, for example, fluidly connects to a fluid line in the cartridge, but the pressure sensor and / or flow sensor in the generator 202 may be isolated from the fluid in the cartridge. Thus, the cooling fluid 603 fed to the balloon may be sensed without being contacted by the pressure sensor 2402. The sensor in the generator 202 may effectively monitor the fluid fed to the balloon without being contaminated. Thus, the pressure sensor 2402 may be non-invasive and reusable, thereby reducing the cost of the consumable portion of the treatment system 100.

[0125] In one embodiment, the diaphragm of the pressure fitting 2302 acts against a fluid, such as air, in a line between the pressure fitting 2302 and a pressure sensor 2402. For example, a chamber, such as an air chamber 2404, can be interposed between the pressure fitting 2302 (and thus the fluid line in the cartridge) and the fluid line in the generator 202. The chamber can have a chamber inlet 2406 connected to the pressure fitting 2302 and a chamber outlet 2408 connected to the pressure sensor 2402. The air in the chamber can compress as the diaphragm acts against the fluid in the cartridge, and thus the air pressure can change with changes in the balloon inflation pressure. The change can be sensed by the pressure sensor 2402.

[0126] As will be further described below, several types of non-invasive sensors are contemplated. In an alternative embodiment, the chamber is a fluid chamber that may be filled with a liquid rather than filled with air. More specifically, the chamber and / or lines between the diaphragm of the pressure fitting 2302 and the pressure sensor 2402 may be filled with an incompressible fluid. Such an incompressible fluid may be acted upon by the diaphragm to relay pressure from the fluid transfer cartridge 204 to the generator 202 for non-invasive sensing.

[0127] 25, a perspective view of a non-invasive sensor is shown, according to one embodiment. The pressure sensor 2402 can alternatively be a flow sensor. The non-invasive pressure sensor and / or flow sensor in the generator 202 can be an ultrasonic sensor. Such a sensor can use an ultrasonic signal directed into the fluid line in the generator 202 to detect a Doppler shift in the reflected signal. A processor in the generator 202 can receive the detected signal and determine the fluid flow in the fluid line based on the Doppler shift. The sensor is non-invasive because the ultrasonic sensor does not come into contact with the fluid being fed into the balloon and the information is communicated through a plastic tube.

[0128] Referring to FIG. 26, a perspective view of a non-invasive sensor is shown, according to one embodiment. The non-invasive fluid sensor can include a rotatable element mounted in a housing having an inlet and an outlet. The inlet and outlet can be connected to a fluid line in the generator 202, which in turn is in fluid communication with the fluid line in the cartridge. As fluid flows through the housing, vanes of the rotatable element are driven. An optical sensor mounted outside the housing can detect the speed of the vanes through the housing wall. The sensed signal can be provided to a processor of the generator 202 to determine the pressure and / or flow of the fluid in the fluid line based on the movement of the vanes.

[0129] It will be appreciated that other non-invasive sensor types may be used. For example, the motor 1108 may drive a plunger of a cartridge to deliver fluid to and remove fluid from the balloon. The force required to drive the motor 1108 or the torque output of the motor 1108 may be sensed. The sensed motor parameters (either input parameters or output parameters) can be used by the processor of the generator 202 to determine the pressure and / or flow of the fluid delivered to the balloon without the need for the sensor to actually contact the fluid.

[0130] In one embodiment, the force sensor can detect a force applied to the sensor by the fluid line. For example, the fluid line can include a compliant tubing section that can be positioned against the force sensor. As pressure increases or decreases in the compliant tubing, the force applied to the sensor increases or decreases because the tubing walls expand or contract. The sensed force can be provided to a processor of the generator to determine the pressure or flow of the fluid in the fluid line based on the force. The force sensor does not directly contact the fluid and is therefore a non-invasive sensor that can be used in multiple procedures.

[0131] The use of a non-invasive sensor in the generator 202 to monitor fluid delivery to / from the balloon, rather than using an invasive sensor in the fluid transfer cartridge 204, allows the cost of manufacturing the cartridge to be reduced and the fluid monitoring sensor to be used for multiple procedures, thus reducing the cost per procedure.

[0132] Pneumatic Syringe Actuation As described above, the fluid drive system may be mechanically driven. More specifically, the drive system may include a stepper motor and a transmission having several gears and a worm screw. However, the mechanical system components may increase the cost and space requirements of the system. Furthermore, the drive system may be complex.

[0133] The mechanically driven fluid drive system may be replaced with a pneumatically driven fluid drive system. More specifically, the screw drive may be replaced with a pneumatic pressure line. The screw drive moves the syringe shaft by gearing that advances a worm screw, whereas the pneumatic pressure line may advance / retract the stopper 608 using positive and negative pressure.

[0134] 24, the system can integrate a pneumatic drive system 2410 to advance and / or retract a stopper 608 of a syringe that feeds inflation fluid to the balloon. The generator 202 can include a pneumatic fitting 2304 (FIG. 23) connected to the pneumatic drive system 2410. More specifically, the pneumatic fitting 2304 can be mounted on the generator housing 304.

[0135] The pneumatic fitting 2304 can be connected to a pneumatic drive system 2410. The pneumatic drive system 2410 can be within the generator housing 304. The pneumatic drive system 2410 can be configured to apply one or more of a positive pressure or a negative pressure to the pneumatic fitting 2304. For example, the pneumatic drive system 2410 can include an air pump and / or a vacuum pump that increases or decreases pressure at the pneumatic fitting 2304.

[0136] 27, a front view of an internal portion of the fluid transfer cartridge is shown, according to one embodiment. The pneumatic drive system 2410 can be connected to a pressure line 2702 that connects to a syringe. The pressure line 2702 can be, for example, a section of tubing extending from a pneumatic fitting 2304 to a syringe connector that attaches to the base of the syringe barrel 408. By applying positive and negative pressure to the pressure line 2702, the stopper 608 of the syringe can be driven back and forth within the syringe barrel 408. More specifically, positive pressure delivered to the pressure line 2702 through the pneumatic fitting 2304 can drive the stopper 608 upward to advance the cooling fluid 603 into the distal fluid line, and negative pressure applied to the pressure line 2702 through the pneumatic fitting 2304 can drive the stopper 608 downward to withdraw the expansion fluid from the fluid line. Thus, inflation fluid can be delivered to and removed from the balloon during the procedure.

[0137] 28, a cross-sectional view of an internal portion of a fluid transfer cartridge having a pneumatically actuated syringe is shown, according to one embodiment. The syringes can include respective stoppers 608. The stoppers 608 can be disposed within the syringe barrel 408 between a distal syringe cavity 2802 and a proximal syringe cavity 2804. The proximal syringe cavity 2804 is in fluid communication with the pneumatic fitting 2304, and the distal syringe cavity 2802 is in fluid communication with a fluid network distal to the syringes. As discussed above, the fluid network can include a fluid reservoir. Thus, the distal syringe cavity 2802 can be in fluid communication with the fluid reservoir, for example, via the cartridge manifold 1402. When the pneumatic fitting 2304 delivers positive pressure to the proximal syringe cavity 2804, the stopper 608 advances to expel cooling fluid 603 from the distal syringe cavity 2802. When the pneumatic fitting 2304 draws a vacuum from the proximal syringe cavity 2804, the stopper 608 retracts to draw cooling fluid 603 into the syringe barrel 408.

[0138] The use of the pneumatic drive system 2410 simplifies the fluid drive design. The pneumatic system requires fewer consumables because it replaces gears and worm screws with simple pressure lines 2702. Thus, the complexity and cost of the system can be reduced.

[0139] In one embodiment, the syringe may be entirely removed from the cartridge and relocated next to the fluid reservoir. Alternatively, the syringe may be provided as part of an assembly including the syringe and fluid reservoir, and the assembly may then be connected to the generator 202. In either case, it may be possible to entirely remove the cartridge, since the fluid transfer function may be performed directly by the generator 202. In such a case, the generator 202 may have inlet / outlet fluid lines that transfer fluid directly from the fluid reservoir to the balloon without being transferred through the cartridge. The generator 202 may include a pressure line 2702 that connects to the syringe, and the syringe may receive / output fluid directly to the reservoir. The generator 202 may include a pinch valve that connects to the syringe, and the syringe may receive / output fluid directly to the reservoir. Thus, transitioning from a mechanically driven paradigm to a pneumatically driven paradigm holds the promise of substantially reducing the complexity and cost of the treatment system 100.

[0140] Non-contact syringe position detection The positioning of the syringe piston 702 can be sensed by a switch, as described above. More specifically, mechanical and / or magnetic switches can be used to sense the position of the piston end. Position feedback can be used by one or more processors of the generator 202 to detect and / or determine when the syringe is empty or full. Mechanical switches can be prone to failure. Furthermore, such switches require precise placement within the generator 202 to provide accurate data. Magnetic switches tend to provide lower position resolution. Thus, precision of such switches is required. Thus, the treatment system 100 can benefit from position sensing components that are robust, durable, and accurate. The system can also benefit from information regarding the position of the syringe piston 702 over the entire stroke, not just in the empty or full positions.

[0141] 29, a cross-sectional view of an internal portion of a fluid transfer cartridge having a non-contact position sensor is shown, according to one embodiment. The generator 202 can include a non-contact position sensor 2904 mounted within the generator housing 304. The non-contact position sensor 2904 can be configured to detect the position of the syringe piston 702 1610. More specifically, the non-contact position sensor 2904 can be positioned and oriented such that the line of sight 2906 of the sensor is directed to the portion of the syringe connected to the stopper 608. For example, the sensor can direct radiation, e.g., light, toward the piston and detect reflected radiation indicative of the position of the piston end 2902.

[0142] In one embodiment, the non-contact position sensor 2904 includes a time-of-flight sensor 2908. The time-of-flight sensor 2908 may be oriented parallel to a central axis of the syringe and / or syringe piston 702. For example, the time-of-flight sensor 2908 may be mounted on a bottom wall of the generator housing 304 facing upward toward the syringe. Thus, the sensor may be oriented longitudinally, which is the direction of shaft travel.

[0143] The time-of-flight sensor 2908 can emit radiation towards the piston end 2902, and some amount of the 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 syringe stopper 608, information regarding the volume of the cooling fluid 603 in the syringe can be determined.

[0144] In one embodiment, the non-contact position sensor 2904 includes a proximity sensor 2910. The proximity sensor 2910 may be oriented parallel to the direction of shaft movement, as described above. However, in one embodiment, the proximity sensor 2910 has a line of sight 2906 perpendicular to the direction of shaft movement. For example, the non-contact position sensor 2904 may be mounted on a sidewall of the generator housing 304 and oriented radially through a cavity that receives the syringe piston 702 during syringe operation.

[0145] The proximity sensor 2910 can provide a go or no go indication of whether the piston end 2902 has reached a predetermined position along the direction of travel. As the piston end 2902 moves downward to a position within the cavity, the proximity sensor 2910 detects the presence of the piston end 2902. More specifically, the intensity of the reflected radiation detected by the proximity sensor 2910 changes when the piston end 2902 passes the line of sight 2906. Thus, the proximity sensor 2910 can detect the position of the piston end 2902. Several proximity sensors 2910 can be placed along the sidewall to detect different positions of the piston end 2902 corresponding to the fluid level of the syringe. For example, several proximity sensors 2910 detect piston positions corresponding to a syringe that is full, half, and empty of cooling fluid.

[0146] The syringe position data generated by the non-contact position sensor 2904 can be used to determine the volume of fluid delivered to the balloon catheter 101. The data can be continuous, for example, over the entire stroke of the syringe, thus providing an indication of the position of the syringe for each position along the stroke. Furthermore, the non-contact position sensors 2904 can be stably mounted on the generator housing 304 and their positions can be calibrated, so the position data can be accurate. Time-of-flight sensors, proximity sensors, and other types of non-contact position sensors 2904 are inexpensive and thus can be implemented at low cost.

[0147] It will be appreciated that alternative sensors and sensor arrangements may be used. For example, the non-contact position sensor 2904 may include an acoustic sensor rather than an optical sensor. The acoustic sensor emits and receives sound signals to determine the presence and distance to a surface (such as the piston end 2902).

[0148] The location of the sensor may also move to any location within the generator 202. For example, a structure other than the generator housing 304 may provide a mounting location for the non-contact position sensor 2904. In one embodiment, the non-contact position sensor 2904 may be mounted on a structure other than the generator 202. For example, the sensor may be placed on the syringe shaft 704. In such a case, a time-of-flight sensor 2908 may be mounted on the shaft end 706. The sensor may be oriented in the direction of shaft movement to detect movement of the shaft 704 based on the changing distance between the sensor and an adjacent surface, for example, the generator housing 304.

[0149] The location of the sensor may also move to any location within the cartridge. For example, a structure other than the cartridge housing may provide a mounting location for the non-contact position sensor 2904. In one embodiment, the non-contact position sensor 2904 may be mounted on a structure other than the cartridge. For example, the sensor is placed on the syringe shaft 704. In such a case, a time-of-flight sensor 2908 may be mounted on the shaft end 706. The sensor may be oriented in the direction of shaft movement to detect movement of the shaft 704 based on the changing distance between the sensor and an adjacent surface, such as the cartridge housing.

[0150] Fluid Reservoir Detection The treatment system 100 includes a fluid reservoir that contains a cooling fluid 603 circulated through the balloon catheter 101. The fluid reservoir can be a container that holds the cooling fluid 603. For example, the container can be a bag that contains the cooling fluid 603. The cooling fluid 603 can be selected based on the procedure and / or device being used. For example, some balloon catheters 101 may work optimally with sterile water, while others may function using saline. Thus, the presence and type of fluid reservoir, e.g., its volume and contents, is important to proper system performance. In one embodiment, the treatment system 100 has the ability to detect the presence and / or type of fluid reservoir being used during a procedure.

[0151] 30, a perspective view of an ultrasound treatment system is shown, according to one embodiment. The treatment system 100 can include a fluid reservoir holder 3004 for holding a fluid reservoir 3002. The fluid reservoir holder 3004 can have an attachment 3006, e.g., a hook, for holding the reservoir. For example, the fluid reservoir 3002 can be a sterile water-filled bag with a loop, which can be placed on the attachment 3006 to suspend the bag from the fluid reservoir holder 3004.

[0152] In one embodiment, the system includes a sensor for sensing the presence and / or a characteristic of the fluid reservoir 3002. The characteristic can be the weight of the fluid reservoir 3002. For example, the weight sensor 3008 can be coupled to the attachment 3006 to generate weight data based on the weight of the fluid reservoir 3002. The weight sensor 3008 can be mounted in or on the generator housing 304. Alternatively, the weight sensor 3008 can be integrated with the fluid reservoir holder 3004. For example, the weight sensor 3008 can include a deflection gauge having an end connected to the attachment 3006 and an end connected to a crossbar or upright end of the bag suspension structure 3004. Thus, the deflection gauge can be located anywhere that is subject to tension, compression, or bending moment as a result of the fluid reservoir weight. Thus, the weight sensor 3008 can detect and / or measure physical strain resulting from such load to generate data corresponding to the weight of the fluid reservoir 3002.

[0153] The generated data may be used by the one or more processors to determine information regarding the fluid reservoir 3002. More specifically, the one or more processors may receive weight data from the weight sensor 3008 and may determine information corresponding to the fluid reservoir 3002 based on the weight data.

[0154] In one embodiment, the one or more processors determine whether the fluid reservoir 3002 is present. Presence detection can be used to verify that the fluid reservoir 3002 is available at the correct time in a procedure (or to determine if it is removed). The fluid reservoir 3002 may be essential to one or more procedural operations, such as priming and inflating the balloon catheter 101. When the fluid reservoir 3002 is not present, for example when a fluid bag is not suspended on a bag stand, those procedural operations may fail and may undesirably lengthen the procedure.

[0155] The one or more processors can determine the presence of the fluid reservoir 3002 based on the weight data being above a predetermined weight threshold or within a predetermined range of weight. The one or more processors can generate a presence signal based on the weight. The presence signal can be used as a gate to a logic sequence in a procedure. For example, the presence signal can enable a user interface to proceed to a subsequent action in a preparation procedure or otherwise generate an error message prompting a user to fill or replace the fluid reservoir 3002.

[0156] In addition to being a logic gate, the weight data can be used as an interlock to other system components. For example, when the fluid reservoir 3002 is not present, the syringe drive system can be disabled to prevent operation when there is no cooling fluid 603 available to fill the syringe barrel 408. Presence is only one characteristic that can drive the above decision. Other characteristics that can be sensed include fluid reservoir type (including cooling fluid type) and / or leak detection.

[0157] In one embodiment, the one or more processors determine whether the fluid reservoir is a predetermined fluid reservoir. The weight of the fluid reservoir 3002 may be known based on the volume and density of the cooling fluid 603 stored in the reservoir. For example, a particular volume of saline may have a different weight than the same volume of sterile water. Furthermore, the fluid reservoirs may be made of different materials, such as vinyl or silicone, which may also affect the predetermined weight of the fluid reservoir 3002. The treatment system 100 may be calibrated or programmed with the known weight of a particular fluid reservoir. Thus, the weight data may be used by the one or more processors to determine whether a particular fluid reservoir is mounted on the fluid reservoir holder 3004 with a specified cooling fluid volume and / or type.

[0158] Some balloon catheters 101 may use transducers 108 that work best with sterile water as the cooling fluid 603. For example, using saline rather than sterile water with such a transducer may cause the transducer to malfunction. Thus, the one or more processors may determine whether the fluid reservoir 3002 contains sterile water or saline based on the weight of the bag. When the one or more processors determine that the fluid reservoir 3002 contains sterile water, the procedure may be allowed to proceed. If the bag instead contains saline, the one or more processors may generate an error signal and / or lock out operation of other system components to prevent damage to the transducer 108. For example, if a particular weight is not detected, the system may prompt the user to verify that sterile water (or glucose, etc.) is being used. Thus, the weight sensor 3008 may be used to detect whether the correct fluid is being used based on a bag having a particular weight and unique weight.

[0159] In one embodiment, the one or more processors determine whether there is a leak in the fluid reservoir 3002. The weight data can be used to detect that the bag weight is changing during the procedure. More specifically, the one or more processors can detect a change in the weight of the fluid reservoir 3002 during the procedure, which can indicate a loss of fluid due to a leak. In response to a 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.

[0160] Referring to FIG. 31, a cross-sectional view of a drive mechanism of a fluid transfer cartridge is shown, according to one embodiment. As described above with respect to FIG. 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 the external thread 802. In one embodiment, the external thread 802 and the internal thread 1109 are configured to avoid binding between the threads. Binding between the threads may occur, for example, when a standard thread design is used that does not allow sufficient clearance between the crest and root of the engaged thread. More specifically, binding may occur more frequently when the working heights 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 heights. For example, the external thread 802 can have an external working height 3102 and the internal thread 1109 can have an internal working height 3104. The external working height 3102 can be greater than the internal working height 3104. For example, the outer working height 3102 can be at least 25%, such as 50%, greater than the inner working height 3104. The different working heights allow the threads to tightly engage without binding as the shaft 704 is driven by the gear 804.

[0161] Referring to FIG. 32, a block diagram of a controller of a treatment system is shown according to one embodiment. The block diagram represents an implementation of the controller example introduced above. The controller 3200 is shown as including one or more processors 3202, 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 be in communication with the memory 3204, which may include a non-transitory computer-readable medium that stores instructions. The processor 3202 may execute instructions to cause the treatment system 100 to perform the methods described herein. The user interface 3206 interacts with the processor 3202 to cause transmission of electrical signals at selected operating frequencies to the ultrasound transducer 108 via wires of the connecting cable and cabling extending through the catheter shaft 704. Those wires electrically couple the controller 3200 to the transducer 108 such that the controller 3200 can transmit electrical signals to and receive electrical signals from the transducer 108. The processor 3202 can control the ultrasonic excitation source 3208 to control the amplitude and timing of the electrical signals to control 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 processing parameters used to perform the ultrasonic processing. In certain embodiments, the excitation source can also detect electrical signals generated by the transducer 108 and communicate such signals to the processor 3202 and / or circuitry of the control board.Although the ultrasonic excitation source 3208 in FIG. 32 is shown as being part of the controller 3200, it is possible that the ultrasonic excitation source 3208 is external to the controller 3200 and still be controlled by the controller 3200, and more specifically, by the processor 3202 of the controller 3200.

[0162] The user interface 3206 may include a touch screen and / or buttons, switches, etc., for allowing an operator (user) to input patient data, select processing parameters, view records stored in a storage / retrieval unit (not shown), and / or otherwise communicate with the processor 3202. The user interface 3206 may include a voice activation mechanism for inputting patient data or may be capable of communicating with additional equipment such that control of the controller 3200 is through a separate user interface 3206, such as a wired or wireless remote control. In some embodiments, the user interface 3206 is configured to receive operator-defined inputs, which may include, for example, patient parameters such as duration of energy delivery, one or more other timing aspects of the energy delivery pulses (e.g., frequency, duty cycle, etc.), power, body lumen length, mode of operation, arterial diameter, height and weight, and / or validation, or combinations thereof. Example modes of operation can include, but are not limited to, system initialization and setup, catheter preparation, inflating the balloon, verifying balloon apposition, pre-cooling, sonication, post-cooling, deflating the balloon, and catheter removal. In certain embodiments, the user interface 3206 provides a graphical user interface (GUI) that instructs the user how to properly operate the treatment system 100. The user interface 3206 can also be used to display processed data for review and / or download, to enable software updates, and / or the like.

[0163] 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) in the catheter shaft, which is in turn fluidly coupled to the balloon. The cooling fluid supply subsystem 3210 may be configured to circulate cooling liquid through the catheter 101 to the transducer 108 within the balloon. The cooling fluid supply subsystem 3210 may include elements such as a fluid reservoir 3002 for holding cooling fluid 603, a pump (e.g., a syringe), a refrigeration coil (not shown), or the like to provide a supply of cooling fluid 603 to the interior space of the balloon at a controlled temperature, desirably at or below body temperature. The processor 3202 interfaces with the cooling fluid supply subsystem 3210 to control the flow of cooling fluid 603 into and out of the balloon. For example, the processor 3202 can control a motor control device coupled to drive a motor 1108 associated with a pump to control the speed of operation of the pump (e.g., a syringe). Such a motor control device can be used, for example, when the pump is a positive displacement pump such as a peristaltic pump. Alternatively, or in addition, the control circuit can include structures such as controllable valves connected in the fluid circuit to vary the resistance of the circuit to fluid flow (not shown). The 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 the catheter 101 and the balloon. Pressure sensors can also be used to determine if there is a blockage and / or leak in the catheter 101.While the balloon is in an inflated state, the pressure sensor can be used to maintain a desired pressure in the balloon, for example, but not limited to, a pressure of 10 psi to 30 psi. As described in additional detail below, the processor 3202 can use sensor measurements from the pressure sensor 2402 and / or one or more of the other sensors to estimate the interior diameter of the body lumen to determine when the balloon is in apposition with the body lumen and to select an appropriate volume of ultrasound energy to be delivered to treat tissue surrounding the body lumen.

[0164] The controller 3200 can control the operation of the generator 202 and the fluid transfer cartridge 204 components to drive the inflation of the balloon before or during an interventional procedure. For example, the controller 3200 can control a priming process. The priming process can fill one or more of the syringes, fluid manifolds, fluid conduit lines, and balloons of the treatment system 100 with fluid and can remove bubbles from the system. More specifically, the priming process can purge air from the fluid system and can prepare the treatment system 100 for delivery into the patient. The priming process can include expelling fluid from the return syringe before filling the injection syringe to avoid pumping air into the injection syringe, as described below. The controller 3200 can also control the inflation procedure, as described above, by driving the syringe piston 702 vertically to move the stopper 608 within the syringe, thereby drawing fluid into the syringe or expelling fluid out of the syringe.

[0165] 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, which drives the syringe piston 702 to determine the stopper position. For example, the motor 1108 can provide data corresponding to the number of revolutions of the gear 804, and the controller 3200 can determine the distance the stopper 608 has traveled within the syringe based on the revolutions and the known thread pitch information. Additionally, as described above, a magnetic or optical sensor can detect the position of the shaft end 706, e.g., the home position 1102. When the shaft end 706 is at the home position 1102, the stopper 608 can be at a known position within the syringe.

[0166] Although the feedback of the motor 1108 and the home position sensor can provide a precise determination of the home position 1102, system slippage in the gear teeth or the motor 1108 can lead to some inaccuracy as to whether the stopper 608 is exactly located at the same home position 1102 after each expansion / contraction cycle. More specifically, as the piston is driven up and down in the syringe over several cycles, the shaft end 706 can be driven to a different home position 1102 based on the rotation of the motor 1108 where the home sensor is not triggered. When this occurs, an error can be generated by the system. However, there can only be a slightly different amount of fluid remaining in the syringe when the error is triggered compared to when the stopper 608 was in the original home position 1102, which can create annoyances requiring the user to rehome the system even when there is no actual effect on system efficacy.

[0167] To avoid such complications, a homing process can be used that dynamically adjusts the home position when changes in the home position do not adversely affect system operation, and generates errors when changes may adversely affect system operation.

[0168] During operation, the fluid transfer cartridge 204 is loaded into the generator 202. When operation begins, the shaft end 706 of the fluid transfer cartridge 204 is either detected by the homing sensor or not. If the shaft end 706 is not detected, the controller 3200 can determine that the syringe should be homed before proceeding with fluid priming and / or balloon inflation / deflation. If the shaft end 706 is detected, the syringe can already be determined to be homed.

[0169] In the first case, when the shaft end 706 is not initially detected, the controller 3200 can drive the motor 1108 to raise the syringe piston 702 until the shaft end 706 is detected by the position sensor. This is the initial home position. The controller 3200 can set the encoder volume to zero at the initial home position. More specifically, the controller 3200 can determine a position value of the encoder of the motor 1108, and the position value can be set as the initial home position (corresponding to the home position of the shaft end 706).

[0170] The switch includes an always on position, an always off position, and an intermediate position (between always on and always off). In one embodiment, the shaft end 706 can be in either the always on position or an intermediate position when it reaches the initial home position. If the initial home position is in the always on position, lowering and raising the shaft end 706 to the initial home position should trigger the home position sensor. If the initial home position is in the intermediate position, lowering and raising the shaft end 706 to the initial home position may or may not trigger the home position sensor.

[0171] It will be appreciated that by monitoring the shaft end position and the motor encoder, a comparison of the shaft end 706 position and the remaining fluid volume can be performed. For example, at either position, the motor 1108 encoder information can be used to determine the stopper position and thus how much cooling fluid 603 remains in the syringe. In one embodiment, when the home position sensor is triggered, the controller 3200 can determine the remaining fluid volume in the syringe. When the shaft end 706 is detected by the position sensor when the remaining fluid volume is less than a predetermined volume, e.g., 3-5 mL, the controller 3200 can set the motor position as a new home position even if the motor encoder is not in the same position as the initial home position. Alternatively, if the remaining volume is greater than a predetermined volume, e.g., greater than 5 mL, the controller 3200 can generate an error to require the user to repair the system and reset the system to the origin again. In either case, the motor encoder can be used to determine the cooling fluid volume in the syringe at all states of the priming process and / or the inflation / deflation process.

[0172] In the second case, when the shaft end 706 is first detected, the controller 3200 can drive the motor 1108 to lower the syringe piston 702 and draw a predetermined volume of cooling fluid 603, for example 3-5 mL, into the syringe. The home position sensor can be monitored during the lowering step. If the home position sensor turns off during the downward movement, the motor encoder position can be set as the new home position by the controller 3200. The controller 3200 can continue to control the system to perform the priming step and / or the inflation / deflation step. Alternatively, if the home position sensor is still on after lowering the syringe and drawing the predetermined volume of cooling fluid 603 into the syringe, the controller 3200 can generate an error to require the user to repair the system and start the system again. More specifically, a sensor that remains on after lowering the syringe likely indicates that the sensor is malfunctioning and the user can be notified accordingly. In either case, the motor encoder can be driven to perform the priming step and / or the inflation / deflation step.

[0173] 33, a perspective view of a shaft end having an optical tab is shown, according to one embodiment. As described above, the shaft end 706 can include a feature for triggering a position sensor. For example, the feature can be an optical tab 3302, also referred to as an optical feature. The optical tab 3302 can include a tab, prong, flag, etc. for triggering the optical sensor. In one embodiment, the optical tab 3302 extends radially outward from the shaft axis 3304. The shaft axis 3304 can be the longitudinal axis of the shaft 704. The radial extension can protrude 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 shaft axis 3304 can reflect off the optical tab 3302. Thus, the optical tab 3302 can block the optical sensor to trigger the sensor, indicating to the controller 3200 that the shaft 704 and stopper 608 are in a particular position.

[0174]

[0013] Examples of treatment systems are described above. More specifically, examples of treatment systems are described either explicitly or implicitly. The following paragraphs summarize some of the described examples.

[0175] In one embodiment, the fluid transfer cartridge includes a cartridge shell defining a cartridge cavity between a front face and a rear face. The front face includes an opening. The fluid transfer cartridge includes a handle extending from the front face of the cartridge shell across the opening. The fluid transfer cartridge includes a syringe barrel disposed within the cartridge cavity and visibly exposed through the opening on a first side of the handle.

[0176] In one embodiment, the fluid transfer cartridge includes a second syringe barrel disposed within the cartridge cavity and visibly exposed through an opening on a second side of the handle.

[0177] In one embodiment, the handle extends vertically from the top of the opening to the bottom of the opening.

[0178] In one embodiment, the syringe barrel has a syringe axis that extends vertically within the cartridge cavity.

[0179] In one embodiment, the fluid transfer cartridge includes a light source within the cartridge cavity, the light source being directed through the syringe barrel.

[0180] In one embodiment, the light source is directed through the end face of the syringe barrel.

[0181] In one embodiment, the light source emits blue light.

[0182] In one embodiment, the light source emits light of a first color when the syringe barrel is filled with a first volume of fluid and the light source emits light of a second color when the syringe barrel is filled with a second volume of fluid.

[0183] In one embodiment, the fluid transfer cartridge includes a syringe holder mounted within the cartridge cavity, the syringe holder retaining the syringe barrel such that rotation of the syringe barrel relative to the cartridge shell is restricted.

[0184] In one embodiment, the cartridge cavity is defined between a front surface, a rear surface, a top surface, and a bottom surface and further includes a syringe piston disposed within the syringe barrel. The syringe piston includes a stopper and a shaft extending from the stopper to a shaft end. The shaft end is flush with the bottom surface when the stopper is in a home position within the syringe barrel. The shaft end is below the bottom surface when the stopper is in an end position within the syringe barrel.

[0185] In one embodiment, the shaft includes external threads and further includes a gear mounted on the cartridge shell, the gear including internal threads that engage the external threads.

[0186] In one embodiment, the external threads and the internal threads have different working heights.

[0187] In one embodiment, the shaft includes a notch extending longitudinally between the stopper and the shaft end.

[0188] In one embodiment, the syringe piston includes an optical tab disposed on the shaft at the shaft end.

[0189] In one embodiment, the rear face includes a ridge. The fluid transfer cartridge includes one or more electrical contact pads exposed through the rear face near an upper end of the ridge.

[0190] In one embodiment, the ridge includes four or more depressions distributed around the ridge perimeter of the ridge.

[0191] In one embodiment, the cartridge shell includes a conduit routing plate that engages the front surface along an edge, the conduit routing plate and the front surface including respective notches at the edge, the respective notches combining to form conduit routing ports through which fluid conduits are routed.

[0192] In one embodiment, the treatment system includes a fluid transfer cartridge, the fluid transfer cartridge including a cartridge shell defining a cartridge cavity between a front side and a rear side. The front side includes an opening, a handle extending from the front side of the cartridge shell across the opening, and a syringe barrel disposed within the cartridge cavity and visibly exposed through the opening on a first side of the handle. The treatment system includes a generator having a generator housing, the generator housing including a cartridge receptacle configured to receive the fluid transfer cartridge.

[0193] In one embodiment, the cartridge cavity is defined between a front surface, a rear surface, a top surface, and a bottom surface and further includes a syringe piston disposed within the syringe barrel. The syringe piston includes a stopper and a shaft extending from the stopper to a shaft end. The shaft end is flush with the bottom surface when the stopper is in a home position within the syringe barrel. The shaft end is below the bottom surface when the stopper is in an end position within the syringe barrel.

[0194] In one embodiment, the generator includes an optical switch and the shaft includes an optical tab for interrupting the optical switch to indicate the position of the shaft.

[0195] In one embodiment, the generator includes one or more processors configured to determine travel of the one or more syringes based on the position of the shaft.

[0196] In one embodiment, the run of the one or more syringes includes a home position of the syringe piston where the syringe piston removes bubbles from the one or more syringes.

[0197] In one embodiment, the generator includes a motor operably coupled to the shaft, and the one or more processors are configured to actuate the motor to move a syringe piston during preparation of the syringe for fluid delivery.

[0198] In one embodiment, the one or more processors are configured to drive the motor to fill the syringe with cooling fluid. The one or more processors are configured to determine that the syringe is filled with a predetermined amount of cooling fluid. The one or more processors are configured to drive the motor to empty the cooling fluid from the syringe. The one or more processors are configured to determine that the syringe is empty.

[0199] In one embodiment, the fluid transfer cartridge shell includes a front surface having a front perimeter and a handle extending across the opening. The fluid transfer cartridge shell includes a rear surface having a rear perimeter. When the front perimeter is engaged with the rear perimeter, a cartridge cavity is defined between the front and rear surfaces such that the cartridge cavity is visibly exposed through the opening on a first side of the handle.

[0200] In one embodiment, the handle extends vertically from the top of the opening to the bottom of the opening.

[0201] In one embodiment, the fluid transfer cartridge shell includes a light source within the cartridge cavity. The light source emits blue light.

[0202] In one embodiment, the rear surface includes a ridge. The generator includes one or more electrical contact pads exposed through the rear surface near an upper end of the ridge.

[0203] In one embodiment, the ridge includes four or more depressions distributed around the ridge perimeter of the ridge.

[0204] In one embodiment, the cartridge shell includes a conduit routing plate that engages the front face along an edge, the conduit routing plate and the front face including respective notches at the edge that combine to form conduit routing ports through which fluid conduits are routed.

[0205] In one embodiment, the fluid transfer cartridge includes a cartridge shell having a cartridge cavity between a front surface and a rear surface. The fluid transfer cartridge includes a syringe barrel disposed within the cartridge cavity and having a syringe cavity. The fluid transfer cartridge includes a cartridge manifold within the cartridge 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 through the fluid transfer plate from the front fluid channel to the rear fluid channel. The front fluid channel, the rear fluid channel, and the fluid port are in fluid communication with the syringe cavity.

[0206] In one embodiment, the cartridge manifold includes a piston having an end seal movable from an open position where the end seal unseals the fluid port to allow cooling fluid to pass through the fluid port to a closed position where the end seal seals the fluid port to stop cooling fluid from passing through the fluid port.

[0207] In one embodiment, the end seal has a circular distal surface.

[0208] In one embodiment, the end seals include O-rings.

[0209] In one embodiment, the cartridge manifold includes an aft plate juxtaposed with the aft plate surface of the fluid transfer plate. The cartridge manifold includes a channel seal extending around the aft fluid channel. The channel seal is sandwiched between the aft plate surface and the aft plate.

[0210] In one embodiment, the rear surface of the piston is aft of the rear surface of the stern plate in the closed and open positions.

[0211] In one embodiment, the end seals press against the aft plate surface and side seals of the fluid transfer plate to seal against the stern plate.

[0212] In one embodiment, the piston is spring suspended to move the piston from the open position to the closed position.

[0213] In one embodiment, the piston includes an annular groove for receiving a spring to provide spring suspension for the piston.

[0214] In one embodiment, the fluid transfer plate is sandwiched between a bow plate and a stern plate. The bow plate is snap-fitted to the stern plate.

[0215] In one embodiment, the treatment system includes a fluid transfer cartridge including a cartridge shell having a cartridge cavity between a front surface and a rear surface, a syringe barrel disposed within the cartridge cavity and having a syringe cavity, and a cartridge manifold within the cartridge 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 through the fluid transfer plate from the front fluid channel to the rear fluid channel. The front fluid channel, the rear fluid channel, and the fluid port are in fluid communication with the syringe cavity, and a generator having a generator housing includes a cartridge receptacle configured to receive the fluid transfer cartridge.

[0216] In one embodiment, the cartridge manifold includes a piston having an end seal movable from an open position where the end seal unseals the fluid port to allow cooling fluid to pass through the fluid port to a closed position where the end seal seals the fluid port to stop cooling fluid from passing through the fluid port.

[0217] In one embodiment, the end seal has a circular distal surface.

[0218] In one embodiment, the end seals include O-rings.

[0219] In one embodiment, the cartridge manifold includes an aft plate juxtaposed with the aft plate surface of the fluid transfer plate. The cartridge manifold includes a channel seal extending around the aft fluid channel. The channel seal is sandwiched between the aft plate surface and the aft plate.

[0220] In one embodiment, the rear surface of the piston is aft of the rear surface of the stern plate in the closed and open positions.

[0221] In one embodiment, the end seals press against the aft plate surface and side seals of the fluid transfer plate to seal against the stern plate.

[0222] In one embodiment, the piston is spring suspended to move the piston from the open position to the closed position.

[0223] In one embodiment, the piston includes an annular groove for receiving a spring to provide spring suspension for the piston.

[0224] In one embodiment, the fluid transfer plate is sandwiched between a bow plate and a stern plate. The bow plate is snap-fitted to the stern plate.

[0225] In one embodiment, 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 through the fluid transfer plate from the front fluid channel to the rear fluid channel. The cartridge manifold includes a piston having an end seal. The piston is movable from an open position, in which the end seal unseals the fluid port to allow cooling fluid to pass through the fluid port to a closed position, and in which the end seal seals the fluid port to stop cooling fluid from passing through the fluid port.

[0226] In one embodiment, the end seal has a circular distal surface.

[0227] In one embodiment, the end seals include O-rings.

[0228] In one embodiment, the cartridge manifold includes an aft plate juxtaposed with the aft plate surface of the fluid transfer plate. The cartridge manifold includes a channel seal extending around the aft fluid channel. The channel seal is sandwiched between the aft plate surface and the aft plate.

[0229] In one embodiment, the rear surface of the piston is aft of the rear surface of the stern plate in the closed and open positions.

[0230] In one embodiment, the end seals press against the aft plate surface and side seals of the fluid transfer plate to seal against the stern plate.

[0231] In one embodiment, the piston is spring suspended to move the piston from the open position to the closed position.

[0232] In one embodiment, the piston includes an annular groove for receiving a spring to provide spring suspension for the piston.

[0233] In one embodiment, the fluid transfer plate is sandwiched between a bow plate and a stern plate. The bow plate is snap-fitted to the stern plate.

[0234] In one embodiment, a fluid transfer cartridge for an ultrasound-based treatment system includes a cartridge shell defining a cartridge cavity between a front and a rear face. The front face includes an opening. The fluid transfer cartridge includes a handle extending from the front face of the cartridge shell across the opening. The fluid transfer cartridge includes a syringe barrel disposed within the cartridge cavity and visibly exposed through the opening on a first side of the handle.

[0235] In one embodiment, the fluid transfer cartridge includes a second syringe barrel disposed within the cartridge cavity and visibly exposed through an opening on a second side of the handle.

[0236] In one embodiment, the handle extends vertically from the top of the opening to the bottom of the opening.

[0237] In one embodiment, the syringe barrel has a syringe axis that extends vertically within the cartridge cavity.

[0238] In one embodiment, a fluid transfer cartridge for an ultrasound-based treatment system includes a cartridge shell defining a cartridge cavity between a front and a rear face. The front face includes a window. The fluid transfer cartridge includes a handle extending from the front face of the cartridge shell across the window. The fluid transfer cartridge includes a syringe barrel disposed within the cartridge cavity and visibly exposed through an opening on a first side of the handle.

[0239] In one embodiment, the fluid transfer cartridge includes a second syringe barrel disposed within the cartridge cavity and visibly exposed through a window on a second side of the handle.

[0240] In one embodiment, the handle extends vertically from the top edge of the window to the bottom edge of the window.

[0241] In one embodiment, the syringe barrel has a syringe axis that extends vertically within the cartridge cavity.

[0242] In one embodiment, a fluid transfer cartridge for an ultrasound-based treatment system includes a cartridge shell defining a cartridge cavity between a front face and a rear face. The fluid transfer cartridge includes a syringe barrel visibly exposed within the cartridge cavity. The fluid transfer cartridge includes a light source within the cartridge cavity. The light source is directed through an end face of the syringe barrel.

[0243] In one embodiment, the light source emits blue light.

[0244] In one embodiment, the light source emits light of a first color when the syringe barrel is filled with a first volume of fluid and the light source emits light of a second color when the syringe barrel is filled with a second volume of fluid.

[0245] In one embodiment, a fluid transfer cartridge for an ultrasound-based treatment system includes a cartridge shell defining a cartridge cavity between a front surface and a rear surface. The fluid transfer cartridge includes a syringe barrel visibly exposed within the cartridge cavity. The fluid transfer cartridge includes a light source within the cartridge cavity. The light source is directed through the syringe barrel.

[0246] In one embodiment, the light source emits blue light.

[0247] In one embodiment, the light source emits light of a first color when the syringe barrel is filled with a first volume of fluid and the light source emits light of a second color when the syringe barrel is filled with a second volume of fluid.

[0248] In one embodiment, a fluid transfer cartridge for an ultrasound-based treatment system includes a cartridge shell defining a cartridge cavity between a front face and a rear face. The fluid transfer cartridge includes a syringe barrel visibly exposed within the cartridge cavity. The fluid transfer cartridge includes a syringe holder mounted within the cartridge cavity. The syringe holder holds the syringe barrel such that rotation of the syringe barrel relative to the cartridge shell is restricted.

[0249] In one embodiment, the fluid transfer cartridge includes a cartridge shell defining a cartridge cavity between a front face and a rear face. The fluid transfer cartridge includes one or more syringes disposed within the cartridge cavity. Each of the one or more syringes includes a syringe piston disposed within the syringe barrel. The syringe piston includes a stopper and a shaft extending from the stopper to a shaft end. The shaft end is disposed within the cartridge cavity when the stopper is in a home position within the syringe barrel. The shaft end is disposed outside of the cartridge cavity when the stopper is in an end position within the syringe barrel.

[0250] In one embodiment, the shaft includes external threads. The fluid transfer cartridge includes a gear mounted on the cartridge shell. The gear includes internal threads that engage the external threads.

[0251] In one embodiment, the shaft includes a notch extending longitudinally between the stopper and the shaft end.

[0252] In one embodiment, the fluid transfer cartridge includes a cartridge shell defining a cartridge cavity between a front face and a rear face. The fluid transfer cartridge includes one or more syringes disposed within the cartridge 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 on the shaft at the shaft end.

[0253] In one embodiment, the magnet moves contacts of a magnetic switch of the treatment system to indicate the proximity between the magnet and the magnetic switch.

[0254] In one embodiment, the treatment system includes one or more processors configured to determine travel of the one or more syringes based on the proximity between a magnet and a magnetic switch.

[0255] In one embodiment, the run of the one or more syringes includes a home position of the syringe piston where the syringe piston removes bubbles from the one or more syringes.

[0256] In one embodiment, the one or more processors are configured to actuate a motor operably coupled to the shaft to move a syringe piston during preparation of the one or more syringes for fluid delivery.

[0257] In one embodiment, the 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 emptie the cooling fluid from the one or more syringes, and determine that the one or more syringes are empty.

[0258] In one embodiment, the method includes filling a number of syringes of the fluid transfer cartridge with cooling fluid. Each of the number of 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 disposed within a cartridge cavity of the fluid transfer cartridge when the stopper is in a home position within the syringe barrel. The shaft end is disposed outside of the cartridge cavity when the stopper is in an end position within the syringe barrel. The method includes determining, by the one or more processors, when the number of syringes are filled 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 bubbles from the fluid path and the number of syringes.

[0259] In one embodiment, determining whether some syringes are filled with a predetermined amount of cooling fluid includes detecting whether a stopper is in an end position.

[0260] In one embodiment, removing bubbles from the fluid path and the several syringes includes filling the several syringes with cooling fluid, determining that the several syringes are filled with cooling fluid based on the stopper being in an end position, emptying the cooling fluid from the several syringes, determining that the several syringes are empty based on the stopper being in a home position, and filling the several syringes with cooling fluid.

[0261] In one embodiment, the fluid transfer cartridge includes a cartridge shell defining a cartridge cavity between a front face and a rear face. The fluid transfer cartridge includes one or more syringes disposed within the cartridge 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.

[0262] In one embodiment, the shaft end emits or reflects light to an optical sensor of the treatment system to indicate the proximity between the shaft end and the optical sensor.

[0263] In one embodiment, the treatment system includes one or more processors configured to determine travel of the one or more syringes based on the proximity between the shaft end and the optical sensor.

[0264] In one embodiment, the run of the one or more syringes includes a home position of the syringe piston where the syringe piston removes bubbles from the one or more syringes.

[0265] In one embodiment, the one or more processors are configured to actuate a motor operably coupled to the shaft to move a syringe piston during preparation of the one or more syringes for fluid delivery.

[0266] In one embodiment, the 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 emptie the cooling fluid from the one or more syringes, and determine that the one or more syringes are empty.

[0267] In one embodiment, the method includes filling a number of syringes of the fluid transfer cartridge with cooling fluid. Each of the number of 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 disposed within a cartridge cavity of the fluid transfer cartridge when the stopper is in a home position within the syringe barrel. The shaft end is disposed outside of the cartridge cavity when the stopper is in an end position within the syringe barrel. The method includes determining, by the one or more processors, when the number of syringes are filled 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 bubbles from the fluid path and the number of syringes.

[0268] In one embodiment, determining whether some syringes are filled with a predetermined amount of cooling fluid includes detecting whether a stopper is in an end position.

[0269] In one embodiment, removing bubbles from the fluid path and the several syringes includes filling the several syringes with cooling fluid, determining that the several syringes are filled with cooling fluid based on the stopper being in an end position, emptying the cooling fluid from the several syringes, determining that the several syringes are empty based on the stopper being in a home position, and filling the several syringes with cooling fluid.

[0270] In one embodiment, the fluid transfer cartridge includes a cartridge shell defining a cartridge cavity between a front face and a rear face. The rear face includes a ridge. The fluid transfer cartridge includes one or more spring-loaded electrical contact pins exposed through the rear face near an upper end of the ridge.

[0271] In one embodiment, the ridge includes four or more depressions distributed around the ridge perimeter of the ridge.

[0272] In one embodiment, the cartridge shell includes a conduit routing plate that engages the front surface along an edge, the conduit routing plate and the front surface including respective notches at the edge, the respective notches combining to form conduit routing ports through which fluid conduits are routed.

[0273] In one embodiment, a generator for an ultrasound treatment system includes a generator housing having a cartridge receptacle configured to receive a fluid transfer cartridge. The generator includes a locking mechanism including a release button movable between a latched position and an unlatched position. The generator includes a number of spring-loaded catches operably coupled to the release button such that moving the release button from the latched position to the unlatched position moves the number of spring-loaded catches out of the cartridge receptacle.

[0274] In one embodiment, the cartridge receptacle includes a rear recess for receiving a ridge of the fluid transfer cartridge. The rear recess has a recess perimeter. Some spring-loaded catches include four or more spring-loaded catches distributed around the recess perimeter.

[0275] In one embodiment, a generator for an ultrasound treatment system includes a generator housing having a cartridge receptacle configured to receive a fluid transfer cartridge. The generator includes a locking mechanism including a release button movable between a latched position and an unlatched position. The generator includes one or more catches operably coupled to the release button such that moving the release button from the latched position to the unlatched position moves the one or more catches out of the cartridge receptacle.

[0276] In one embodiment, the generator includes one or more springs operably coupled to the release button for biasing the release button toward the latched position.

[0277] In one embodiment, the one or more springs include a single spring, the one or more catches include several catches, and the release button is operably coupled to a linkage that interconnects the several catches to the single spring to bias the several catches into the cartridge receptacle.

[0278] In one embodiment, the cartridge receptacle includes a rear recess for receiving a ridge of the fluid transfer cartridge, the rear recess having a recess perimeter, and the one or more fasteners include four or more spring-loaded fasteners distributed about the recess perimeter.

[0279] In one embodiment, a generator for an ultrasound-based treatment system includes a generator housing having a cartridge receptacle configured to receive a fluid delivery cartridge, the generator including a well below the cartridge receptacle for receiving a syringe piston of the fluid delivery cartridge.

[0280] In one embodiment, the generator includes one or more magnetic switches mounted within the wells to detect magnets located on the syringe piston of the fluid transfer cartridge.

[0281] In one embodiment, an ultrasonic treatment system includes a generator having a cartridge receptacle. The ultrasonic treatment system includes a fluid transfer cartridge. The ultrasonic treatment system includes one or more processors configured to determine whether the fluid transfer cartridge is receivable within the cartridge receptacle and, in response to determining that the fluid transfer cartridge is receivable within the cartridge receptacle, activate a light source of the fluid transfer cartridge. The light source is directed toward a syringe of the fluid transfer cartridge.

[0282] In one embodiment, the generator includes an electrical connector and an indicator light, the one or more processors 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 an illumination mode of the indicator light.

[0283] In one embodiment, the change in lighting mode is from a first lighting mode in which the indicator light emits light intermittently to a second lighting mode in which the indicator light emits light continuously.

[0284] 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.

[0285] In one embodiment, the indicator light includes an indicator light ring that extends around the electrical connector.

[0286] In one embodiment, a fluid transfer cartridge for an ultrasound-based treatment system includes a cartridge shell defining a cartridge cavity between a front and a rear face. The front face includes an opening. The fluid transfer cartridge includes a handle extending from the front face of the cartridge shell across the opening. The fluid transfer cartridge includes a syringe barrel disposed within the cartridge cavity and visibly exposed through the opening on a first side of the handle.

[0287] In one embodiment, the fluid transfer cartridge includes a second syringe barrel disposed within the cartridge cavity and visibly exposed through an opening on a second side of the handle.

[0288] In one embodiment, the handle extends vertically from the top of the opening to the bottom of the opening.

[0289] In one embodiment, the syringe barrel has a syringe axis that extends vertically within the cartridge cavity.

[0290] In one embodiment, a fluid transfer cartridge for an ultrasound-based treatment system includes a cartridge shell defining a cartridge cavity between a front and a rear face. The front face includes a window. The fluid transfer cartridge includes a handle extending from the front face of the cartridge shell across the window. The fluid transfer cartridge includes a syringe barrel disposed within the cartridge cavity and visibly exposed through an opening on a first side of the handle.

[0291] In one embodiment, the fluid transfer cartridge includes a second syringe barrel disposed within the cartridge cavity and visibly exposed through a window on a second side of the handle.

[0292] In one embodiment, the handle extends vertically from the top edge of the window to the bottom edge of the window.

[0293] In one embodiment, the syringe barrel has a syringe axis that extends vertically within the cartridge cavity.

[0294] In one embodiment, a fluid transfer cartridge for an ultrasound-based treatment system includes a cartridge shell defining a cartridge cavity between a front face and a rear face. The fluid transfer cartridge includes a syringe barrel visibly exposed within the cartridge cavity. The fluid transfer cartridge includes a light source within the cartridge cavity. The light source is directed through an end face of the syringe barrel.

[0295] In one embodiment, the light source emits blue light.

[0296] In one embodiment, the light source emits light of a first color when the syringe barrel is filled with a first volume of fluid and the light source emits light of a second color when the syringe barrel is filled with a second volume of fluid.

[0297] In one embodiment, a fluid transfer cartridge for an ultrasound-based treatment system includes a cartridge shell defining a cartridge cavity between a front surface and a rear surface. The fluid transfer cartridge includes a syringe barrel visibly exposed within the cartridge cavity. The fluid transfer cartridge includes a light source within the cartridge cavity. The light source is directed through the syringe barrel.

[0298] In one embodiment, the light source emits blue light.

[0299] In one embodiment, the light source emits light of a first color when the syringe barrel is filled with a first volume of fluid and the light source emits light of a second color when the syringe barrel is filled with a second volume of fluid.

[0300] In one embodiment, a fluid transfer cartridge for an ultrasound-based treatment system includes a cartridge shell defining a cartridge cavity between a front face and a rear face. The fluid transfer cartridge includes a syringe barrel visibly exposed within the cartridge cavity. The fluid transfer cartridge includes a syringe holder mounted within the cartridge cavity. The syringe holder holds the syringe barrel such that rotation of the syringe barrel relative to the cartridge shell is restricted.

[0301] In one embodiment, the fluid transfer cartridge includes a cartridge shell defining a cartridge cavity between a front face and a rear face. The fluid transfer cartridge includes one or more syringes disposed within the cartridge cavity. Each of the one or more syringes includes a syringe piston disposed within the syringe barrel. The syringe piston includes a stopper and a shaft extending from the stopper to a shaft end. The shaft end is disposed within the cartridge cavity when the stopper is in a home position within the syringe barrel. The shaft end is disposed outside of the cartridge cavity when the stopper is in an end position within the syringe barrel.

[0302] In one embodiment, the shaft includes external threads. The fluid transfer cartridge includes a gear mounted on the cartridge shell. The gear includes internal threads that engage the external threads.

[0303] In one embodiment, the shaft includes a notch extending longitudinally between the stopper and the shaft end.

[0304] In one embodiment, the fluid transfer cartridge includes a cartridge shell defining a cartridge cavity between a front face and a rear face. The fluid transfer cartridge includes one or more syringes disposed within the cartridge 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 on the shaft at the shaft end.

[0305] In one embodiment, the magnet moves contacts of a magnetic switch of the treatment system to indicate the proximity between the magnet and the magnetic switch.

[0306] In one embodiment, the treatment system includes one or more processors configured to determine travel of the one or more syringes based on the proximity between a magnet and a magnetic switch.

[0307] In one embodiment, the run of the one or more syringes includes a home position of the syringe piston where the syringe piston removes bubbles from the one or more syringes.

[0308] In one embodiment, the one or more processors are configured to actuate a motor operably coupled to the shaft to move a syringe piston during preparation of the one or more syringes for fluid delivery.

[0309] In one embodiment, the 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 emptie the cooling fluid from the one or more syringes, and determine that the one or more syringes are empty.

[0310] In one embodiment, the method includes filling a number of syringes of the fluid transfer cartridge with cooling fluid. Each of the number of 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 disposed within a cartridge cavity of the fluid transfer cartridge when the stopper is in a home position within the syringe barrel. The shaft end is disposed outside of the cartridge cavity when the stopper is in an end position within the syringe barrel. The method includes determining, by the one or more processors, when the number of syringes are filled 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 bubbles from the fluid path and the number of syringes.

[0311] In one embodiment, determining whether some syringes are filled with a predetermined amount of cooling fluid includes detecting whether a stopper is in an end position.

[0312] In one embodiment, removing bubbles from the fluid path and the several syringes includes filling the several syringes with cooling fluid, determining that the several syringes are filled with cooling fluid based on the stopper being in an end position, emptying the cooling fluid from the several syringes, determining that the several syringes are empty based on the stopper being in a home position, and filling the several syringes with cooling fluid.

[0313] In one embodiment, the fluid transfer cartridge includes a cartridge shell defining a cartridge cavity between a front face and a rear face, and one or more syringes disposed within the cartridge 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.

[0314] In one embodiment, the shaft end emits or reflects light to an optical sensor of the treatment system to indicate the proximity between the shaft end and the optical sensor.

[0315] In one embodiment, the treatment system includes one or more processors configured to determine travel of the one or more syringes based on the proximity between the shaft end and the optical sensor.

[0316] In one embodiment, the run of the one or more syringes includes a home position of the syringe piston where the syringe piston removes bubbles from the one or more syringes.

[0317] In one embodiment, the one or more processors are configured to actuate a motor operably coupled to the shaft to move a syringe piston during preparation of the one or more syringes for fluid delivery.

[0318] In one embodiment, the 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 emptie the cooling fluid from the one or more syringes, and determine that the one or more syringes are empty.

[0319] In one embodiment, the method includes filling a number of syringes of the fluid transfer cartridge with cooling fluid. Each of the number of 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 disposed within a cartridge cavity of the fluid transfer cartridge when the stopper is in a home position within the syringe barrel. The shaft end is disposed outside of the cartridge cavity when the stopper is in an end position within the syringe barrel. The method includes determining, by the one or more processors, when the number of syringes are filled 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 bubbles from the fluid path and the number of syringes.

[0320] In one embodiment, determining whether some syringes are filled with a predetermined amount of cooling fluid includes detecting whether a stopper is in an end position.

[0321] In one embodiment, removing bubbles from the fluid path and the several syringes includes filling the several syringes with cooling fluid, determining that the several syringes are filled with cooling fluid based on the stopper being in an end position, emptying the cooling fluid from the several syringes, determining that the several syringes are empty based on the stopper being in a home position, and filling the several syringes with cooling fluid.

[0322] In one embodiment, the fluid transfer cartridge includes a cartridge shell defining a cartridge cavity between a front face and a rear face. The rear face includes a ridge. The fluid transfer cartridge includes one or more spring-loaded electrical contact pins exposed through the rear face near an upper end of the ridge.

[0323] In one embodiment, the ridge includes four or more depressions distributed around the ridge perimeter of the ridge.

[0324] In one embodiment, the cartridge shell includes a conduit routing plate that engages the front face along an edge, the conduit routing plate and the front face including respective notches at the edge that combine to form conduit routing ports through which fluid conduits are routed.

[0325] In one embodiment, a generator for an ultrasound treatment system includes a generator housing having a cartridge receptacle configured to receive a fluid delivery cartridge, the generator includes a locking mechanism including a release button movable between a latched position and an unlatched position, and a number of spring-loaded catches operably coupled to the release button such that moving the release button from the latched position to the unlatched position moves the number of spring-loaded catches out of the cartridge receptacle.

[0326] In one embodiment, the cartridge receptacle includes a rear recess for receiving a ridge of the fluid transfer cartridge. The rear recess has a recess perimeter. Some spring-loaded catches include four or more spring-loaded catches distributed around the recess perimeter.

[0327] In one embodiment, a generator for an ultrasound treatment system includes a generator housing having a cartridge receptacle configured to receive a fluid transfer cartridge, the generator includes a locking mechanism including a release button movable between a latched position and an unlatched position, and one or more catches operably coupled to the release button, such that moving the release button from the latched position to the unlatched position moves the one or more catches out of the cartridge receptacle.

[0328] In one embodiment, the generator includes one or more springs operably coupled to the release button for biasing the release button toward the latched position.

[0329] In one embodiment, the one or more springs include a single spring, the one or more catches include several catches, and the release button is operably coupled to a linkage that interconnects the several catches with the single spring to bias the several catches into the cartridge receptacle.

[0330] In one embodiment, the cartridge receptacle includes a rear recess for receiving a ridge of the fluid transfer cartridge, the rear recess having a recess perimeter, and the one or more fasteners include four or more spring-loaded fasteners distributed about the recess perimeter.

[0331] In one embodiment, a generator for an ultrasound-based treatment system includes a generator housing having a cartridge receptacle configured to receive a fluid delivery cartridge, the generator including a well below the cartridge receptacle for receiving a syringe piston of the fluid delivery cartridge.

[0332] In one embodiment, the generator includes one or more magnetic switches mounted within the wells to detect magnets located on the syringe piston of the fluid transfer cartridge.

[0333] In one embodiment, an ultrasonic treatment system includes a generator having a cartridge receptacle. The ultrasonic treatment system includes a fluid transfer cartridge. The ultrasonic treatment system includes one or more processors configured to determine whether the fluid transfer cartridge is receivable within the cartridge receptacle and, in response to determining that the fluid transfer cartridge is receivable within the cartridge receptacle, activate a light source of the fluid transfer cartridge. The light source is directed toward a syringe of the fluid transfer cartridge.

[0334] In one embodiment, the generator includes an electrical connector and an indicator light, the one or more processors 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 an illumination mode of the indicator light.

[0335] In one embodiment, the change in lighting mode is from a first lighting mode in which the indicator light emits light intermittently to a second lighting mode in which the indicator light emits light continuously.

[0336] 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.

[0337] In one embodiment, the indicator light includes an indicator light ring that extends around the electrical connector.

[0338] In one embodiment, a fluid transfer cartridge for an ultrasound-based treatment system includes a cartridge shell having a cartridge cavity between a front surface and a rear surface. The fluid transfer cartridge includes a syringe barrel disposed within the cartridge cavity and having a syringe cavity. The fluid transfer cartridge includes a cartridge manifold within the cartridge 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 through the fluid transfer plate from the front fluid channel to the rear fluid channel. The front fluid channel, the rear fluid channel, and the fluid port are in fluid communication with the syringe cavity.

[0339] In one embodiment, the cartridge manifold includes a piston having an end seal movable from an open position where the end seal unseals the fluid port to allow cooling fluid to pass through the fluid port to a closed position where the end seal seals the fluid port to stop cooling fluid from passing through the fluid port.

[0340] In one embodiment, the cartridge manifold includes an aft plate juxtaposed with the aft plate surface of the fluid transfer plate. The cartridge manifold includes a channel seal extending around the aft fluid channel. The channel seal is sandwiched between the aft plate surface and the aft plate.

[0341] In one embodiment, the end seals press against the aft plate surface and side seals of the fluid transfer plate to seal against the stern plate.

[0342] In one embodiment, the piston is spring suspended to move the piston from the open position to the closed position.

[0343] In one embodiment, a generator for an ultrasound-based treatment system includes a generator housing having a cartridge receptacle configured to receive a fluid delivery 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 delivery cartridge. The generator includes a pressure sensor within the generator housing. The pressure sensor is configured to sense pressure at the pressure fitting.

[0344] 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.

[0345] In one embodiment, an ultrasonic treatment system includes a generator, the generator including a generator housing. The ultrasonic treatment system includes a pneumatic fitting mounted on the generator housing. The ultrasonic treatment system includes a pneumatic drive system 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 pressure or a negative pressure to the pneumatic fitting.

[0346] In one embodiment, the ultrasonic treatment system includes one or more syringes, each of which includes a stopper disposed within a syringe barrel between a distal syringe cavity and a proximal syringe cavity, the proximal syringe cavity in fluid communication with a pneumatic fitting, and the distal syringe cavity in fluid communication with a fluid reservoir.

[0347] In one embodiment, a generator for an ultrasound-based treatment system includes a generator housing having a cartridge receptacle configured to receive a fluid delivery cartridge, the generator including a non-contact position sensor mounted within the generator housing, the non-contact position sensor configured to detect a position of a syringe piston of the fluid delivery cartridge.

[0348] In one embodiment, the non-contact position sensor includes one or more time-of-flight sensors.

[0349] In one embodiment, the non-contact position sensor includes one or more proximity sensors.

[0350] In one embodiment, an ultrasonic treatment system includes a fluid reservoir holder having an attachment for holding a fluid reservoir, a weight sensor coupled to the attachment for generating weight data based on a weight of the fluid reservoir, and one or more processors configured to receive the weight data from the weight sensor and determine whether the fluid reservoir is a predetermined fluid reservoir based on the weight data.

[0351] In one embodiment, the one or more processors are further configured to detect a leak in the fluid reservoir based on the weight data.

[0352] In the foregoing specification, the invention has been described with reference to specific exemplary embodiments thereof. It will be apparent that various modifications may be made thereto without departing from the scope of the invention as set forth in the following claims. The specification and drawings are therefore to be regarded in an illustrative rather than a restrictive sense.

Claims

1. a cartridge shell (306) defining a cartridge cavity (402) between a front face (404) and a rear face (407), said front face (404) including an opening (406); a handle (307) extending from the front surface (404) of the cartridge shell (306) across the opening (406); a syringe barrel (408) disposed within the cartridge cavity (402) and visibly exposed through the opening (406) on a first side (410) of the handle (307); A fluid transfer cartridge (204) comprising:

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

3. The fluid transfer cartridge of claim 1 or 2, wherein the handle (307) extends perpendicularly from an upper end (416) of the opening (406) to a lower end (418) of the opening (406).

4. The fluid transfer cartridge of any one of claims 1 to 3, wherein the syringe barrel (408) has a syringe axis (420) that extends vertically within the cartridge cavity (402).

5. The fluid transfer cartridge of claim 1 , further comprising a light source (602) within the cartridge cavity (402), the light source (602) being directed through the syringe barrel (408).

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

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

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

9. 9. The fluid transfer cartridge of claim 1, further comprising a syringe holder (513) mounted within the cartridge cavity (402), the syringe holder (513) holding the syringe barrel (408) such that rotation of the syringe barrel (408) relative to the cartridge shell (306) is restricted.

10. 10. The fluid transfer cartridge of claim 1, wherein the cartridge cavity is defined between the front surface, the rear surface, the top surface, and the bottom surface, and further comprises a syringe piston disposed within the syringe barrel, the syringe piston including a stopper and a shaft extending from the stopper to a shaft end, the shaft end being flush with the bottom surface when the stopper is in a home position within the syringe barrel, and the shaft end being below the bottom surface when the stopper is in an end position within the syringe barrel.

11. 11. The fluid transfer cartridge of claim 10, wherein the shaft (704) includes an external thread (802) and further comprises a gear (804) mounted on the cartridge shell (306), the gear (804) including an internal thread that engages with the external thread (802).

12. The fluid transfer cartridge of claim 11 , wherein the external threads (802) and the internal threads have different working heights.

13. The fluid transfer cartridge of any one of claims 10 to 12, wherein the shaft (704) includes a notch (806) extending longitudinally between the stopper (608) and the shaft end (706).

14. The fluid transfer cartridge of any one of claims 10 to 13, 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 of any one of claims 1 to 14, wherein the rear surface (407) includes a ridge (1202) and further comprises one or more electrical contact pads (1208) exposed through the rear surface (407) near an upper end of the ridge (1202).

16. The fluid transfer cartridge of claim 15, wherein the ridge (1202) includes four or more depressions (1210) distributed around a ridge periphery (1204) of the ridge (1202).

17. 17. The fluid transfer cartridge of claim 1, wherein the cartridge shell (306) includes a conduit routing plate (1002) that engages with the front surface (404) along an edge (1004), the conduit routing plate (1002) and the front surface (404) including respective notches (1006) at the edge (1004), the respective notches (1006) combining to form conduit routing ports (1008) through which the fluid conduits (206) are routed.

18. A fluid transfer cartridge (204) according to any one of claims 1 to 17; a generator (202) having a generator housing including a cartridge receptacle (302) configured to receive the fluid transfer cartridge (204); A treatment system (100).

19. 19. The treatment system of claim 18, wherein the fluid transfer cartridge (204) is a fluid transfer cartridge (204) of any one of claims 10 to 14, the generator (202) includes an optical switch, and the shaft (704) includes an optical tab (3302) for blocking the optical switch to indicate the position of the shaft (704).

20. The treatment system of claim 18 or 19, wherein the fluid transfer cartridge (204) is a fluid transfer cartridge (204) described in any one of claims 10 to 14, and the generator (202) includes one or more processors configured to determine travel of one or more syringes based on the position of the shaft (704).

21. 21. The treatment system of claim 20, wherein the travel of the one or more syringes includes a home position of the syringe piston (702) where the syringe piston (702) removes bubbles from the one or more syringes.

22. 22. The treatment system of claim 20 or 21, wherein the generator (202) includes a motor (1108) operably coupled to the shaft (704), and the one or more processors are configured to operate the motor (1108) to move the syringe piston (702) during preparation of the syringe for fluid delivery.

23. The one or more processors: Driving the motor (1108) to fill the syringe with cooling fluid; determining that the syringe is filled with a predetermined amount of the cooling fluid; Driving the motor (1108) to empty the cooling fluid from the syringe; determining that the syringe is empty; The treatment system of claim 22 , configured as follows:

24. a front surface (404) having a front periphery (511) and a handle (307) extending across an opening (406); and a rear face (407) having a rear periphery (512), wherein when the front periphery (511) is engaged with the rear periphery (512), a cartridge cavity (402) is defined between the front face (404) and the rear face (407) such that the cartridge cavity (402) is visibly exposed through the opening (406) on a first side of the handle (307).

25. 25. The fluid transfer cartridge shell of claim 24, wherein the handle (307) extends perpendicularly from an upper end (416) of the opening (406) to a lower end (418) of the opening (406).

26. 26. The fluid transfer cartridge shell of claim 24 or 25, further comprising a light source (602) within the cartridge cavity (402), the light source (602) emitting blue light.

27. 27. The fluid transfer cartridge shell of claim 24, wherein the rear surface (407) includes a ridge (1202) and further comprises one or more electrical contact pads (1208) exposed through the rear surface (407) near an upper end of the ridge (1202).

28. 28. The fluid transfer cartridge shell of claim 27, wherein the ridge (1202) includes four or more depressions (1210) distributed around a ridge periphery (1204) of the ridge (1202).

29. 29. The fluid transfer cartridge shell of claim 24, wherein the cartridge shell (306) includes a conduit routing plate (1002) that engages the front surface (404) along an edge (1004), the conduit routing plate (1002) and the front surface (404) including respective notches (1006) at the edge (1004), the respective notches (1006) combining to form conduit routing ports (1008) through which the fluid conduits (206) are routed.

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