Feedback device, lithotripsy system and method of performing lithotripsy procedure

Abstract

The invention relates to a feedback device, a lithotripsy system and a method of performing lithotripsy surgery. A lithotripsy device includes a feedback device for providing a force marker generated during a lithotripsy procedure. The feedback device includes a slider configured to be attached to a handpiece of the lithotripsy device, a positioning device connected to the slider to adjust a position of the slider relative to the handpiece, and a feedback indicator connected to the slider to provide feedback related to a force applied to the slider to displace the slider relative to the handpiece. A method of performing a lithotripsy procedure includes contacting a stone with a shaft extending from a handle of a lithotripsy device; applying energy from the shaft to the stone to break the stone; applying a force from the shaft to the stone via the handle to facilitate transfer of energy to the stone; and an output providing an amount of force that the shaft contacts the stone.

Description

Technical Field

[0001] The present disclosure generally relates to, but is not limited to, medical devices that can be used to break obstacles such as physiological stones or "stones" using lithotripsy.

[0002] More specifically, the present disclosure relates to, but is not limited to, systems, devices, and methods for a lithotripsy system for applying a breaking force to stone fragments. Background Art

[0003] Medical endoscopes were first developed in the early 19th century and have been used to examine the interior of the body. A typical endoscope includes a distal end and a proximal end. The distal end includes an optical or electronic imaging system, while the proximal end has control means for manipulating tools and means for viewing images, wherein a solid or tubular elongated shaft connects the ends. Some endoscopes allow a doctor to pass tools or treatments along one or more hollow working channels, such as excising tissue or retrieving an object.

[0004] In the past few decades, some progress has been made in the field of endoscopes, and particularly in the fragmentation of physiological stones in the bile duct, urethra, kidney, and gallbladder. Physiological stones in these areas can block ducts and cause patients to experience severe pain. Therefore, these stones are usually fragmented for surgical removal or biological excretion. Different techniques and procedures have been developed for lithotripsy, which include ultrasonic lithotripsy, pneumatic lithotripsy, electrohydraulic lithotripsy (EHL), and laser lithotripsy, including using green light, YAG, or holmium lasers to dissolve stones. Summary of the Invention

[0005] The inventors have recognized that one of the problems to be solved in performing a lithotripsy procedure is that it is difficult to apply force from a lithotripsy device to a stone. For example, a lithotripsy device may involve using a shaft to transmit acoustic energy to break a stone. The acoustic energy can include sound waves, sonic waves, ultrasonic waves, or shock waves, or any combination thereof. To transmit the acoustic energy to the stone, it is desirable to contact the end of the lithotripsy shaft with the stone. Therefore, applying the acoustic energy to the stone requires skill. In particular, the inventors have recognized that within a specific force range, the stone can be most effectively fragmented while applying the end of the lithotripsy shaft to the stone. For example, not applying enough force to the stone may result in insufficient acoustic energy being transmitted to the stone, thereby causing the fragmentation process to take longer. Additionally, if too much force is applied to the stone, the end of the lithotripsy shaft may be blocked and the acoustic energy may not be properly formed, thereby slowing down the fragmentation process.

[0006] The present subject matter can provide a solution to this and other problems by providing a lithotripsy device that includes an indication of the magnitude of the force applied by the lithotripsy device to the stone. In particular, the present subject matter can provide an indication of the magnitude of the force applied by a user to a lithotripsy shaft in real time such that the user can make intraoperative adjustments. In an example, the force control device of the present disclosure can provide an analog or digital output, such as visual, audio, or tactile feedback, to indicate how much force the user is applying to the handle of the lithotripsy shaft, which replicates the magnitude of the force applied by the lithotripsy shaft to the stone. In an example, the force control device of the present disclosure can include an additional component that can be attached to the handle of the lithotripsy device but can additionally include an integrated device. In an example, the force control device of the present disclosure can be combined with other additional features such as filters and suction control valves.

[0007] In one example, the lithotripsy device can include a feedback device for providing a force signature generated during a lithotripsy procedure. The feedback device can include: a slider configured to be attached to a handpiece of the lithotripsy device; a positioning device connected to the slider to adjust the position of the slider relative to the handpiece; and a feedback indicator connected to the slider to provide feedback related to the force applied to the slider to displace the slider relative to the handpiece.

[0008] In another example, a method of performing a lithotripsy procedure can include: contacting a stone with a shaft extending from a handle of a lithotripsy device; applying energy from the shaft to the stone to fragment the stone; applying force from the shaft to the stone via the handle to facilitate transfer of the energy to the stone; and providing an output of a quantity of force when the shaft contacts the stone.

[0009] This summary is intended to provide an overview of the subject matter of this patent application. It is not intended to provide an exclusive or exhaustive explanation of the invention. The detailed description is included to provide further information about the patent application. Brief Description of the Drawings

[0010] Figure 1 is a schematic diagram of an exemplary lithotripsy system, with which various stone fragment capture devices and systems of the present disclosure can be used.

[0011] Figure 2 is a perspective view of a lithotripsy system including a handheld probe configured to deliver high frequency and ultrasonic energy for fragmenting a stone.

[0012] Figure 3 is applicable to be used with Figure 2 a perspective view of a suction pump and a stone capture canister of a lithotripsy system.

[0013] Figure 4 is in the user's hand Figure 2 A close-up perspective view of the handle of a handheld probe.

[0014] Figure 5 is Figures 2 to 4 A schematic diagram of the components of a lithotripsy system and a suction system that interact with the kidney.

[0015] Figure 6 A schematic diagram of a lithotripsy shaft that interacts with a stone.

[0016] Figure 7 A perspective view of the handle of a lithotripsy device having a force indicator and a filter element of the present disclosure attached thereto.

[0017] Figure 8 A partial cross-sectional view of a lithotripsy handle and a force control device of the present disclosure, illustrating a biasing element and a force indicator located in a slot.

[0018] Figure 9 A perspective view of the handle of a lithotripsy device having an outflow controller of the present disclosure connected to a filter element.

[0019] Figure 10 A schematic diagram showing the handle of a lithotripsy device positioned relative to a force indicating device of the present disclosure, illustrating fluid flow through a filter element.

[0020] Figure 11 A schematic diagram of an output device suitable for use with a force indicator device of the present disclosure.

[0021] Figure 12 A block diagram illustrating a method for determining the force applied by a lithotripsy device during a lithotripsy procedure using a device of the present disclosure.

[0022] In the drawings (not necessarily to scale), the same numbers may describe similar components in different views. Similar numbers with different letter suffixes may represent different instances of similar components. The drawings generally illustrate, by way of example and not limitation, the various embodiments discussed in the present disclosure. Detailed Description

[0023] Examples of devices, systems, and methods are provided that can help address problems associated with fragmenting stones during lithotripsy procedures. In particular, examples of devices, systems, and methods are provided that can be used to monitor and control the engagement of a lithotripsy device with a biological target (e.g., a physiological stone or "stone"). For example, the devices, systems, and methods of the present disclosure can provide an output (e.g., visual, auditory, or tactile feedback) that provides an indication of the magnitude of the force applied by the lithotripsy device to the stone. The output can additionally provide an indication if the force applied is too small, appropriate, or too large. Benefits of the methods described herein include, among other things, improving the ability of the lithotripsy device to fragment or break up the stone into smaller pieces, which can facilitate the extraction of the stone fragments, and reducing the time required to break up the stone, which can shorten the procedure time.

[0024] Figure 1 An isometric view of an example of a lithotripsy system 100 including a lithotripter 102 having a housing 104 (e.g., a handle) is illustrated. The lithotripter 102 can include a delivery member 106 that can be delivered through the working channel WC of an endoscope E to a treatment site. The endoscope E can also include a light source LS and a camera C.

[0025] The delivery member 106 can include an elongate shaft 108 having a tubular structure that can be flexible or rigid. Suitable materials for the delivery member include, but are not limited to, polytetrafluoroethylene ("PTFE"), polyethylene ("PE"), and polyamide. The elongate shaft 108 can include an outer surface 110 and at least one lumen 112 extending therethrough that is adapted to pass components and materials that communicate with the end effector described herein.

[0026] The delivery member 106 can include an end effector such as a probe 114 located at the distal end that can be delivered to a treatment site. The probe 114 can be configured to deliver energy to fragment a mobile stone, such as a stone located in the bile duct, urethra, kidney, or gallbladder. The probe 114 of the lithotripter 102 can be introduced into a patient and is driven by the delivery member 106 through the working channel WC of an endoscope E or a similar instrument. The probe 114 can be flexible or rigid.

[0027] The lithotripter 102 can be connected to a signal generator 116. The signal generator 116 can include a power supply 118 or can be coupled to an external power supply. The signal generator 116 can also include an input terminal 120 to receive instructions from an operator and can include a controller 122 having a processing circuit for determining an action based on the operator input and for sending a control signal via an output terminal 124 to communicate with the lithotripter 102. The signal generator 116 can include a power supply that can generate a signal and send the signal to the probe 114 of the lithotripter 102 to cause the probe 114 to emit acoustic energy. The acoustic energy can include sound waves, sonic waves, ultrasonic waves, or shock waves, or any combination thereof. The acoustic energy can be transmitted to the stone S to degrade and break it, thereby fragmenting the stone S. The examples herein are described with reference to a combination of ultrasonic and shock wave applications, but any suitable acoustic energy or combination thereof can be provided for breaking the stone. The terms sonic wave and ultrasonic wave can be used interchangeably herein and can include any suitable acoustic energy for fragmenting the stone. In additional examples, the lithotripter 102 can be configured to deliver pneumatic, hydraulic, or laser energy.

[0028] The characteristics of the probe 114 can improve the fragmentation of the stone S. For example, the probe 114 can include a drill bit 126 (which does not need to include a rotating drill bit), such as an ultrasonic drill bit that emits acoustic energy in a longitudinal direction A1 to drill a hole in the stone. In an example, the longitudinal direction A1 can extend in a proximal P to distal D direction. The probe 114 can also include one or more lateral ultrasonic emitters 128, such as lateral ultrasonic transducers, to transmit acoustic energy inside the hole to break the stone from the inside out, such as by applying acoustic energy in a radial or lateral direction A2. The lateral ultrasonic emitter 128 can emit ultrasonic energy radially with respect to the axis of the delivery member 106.

[0029] The drill bit 126 can be coupled to the elongate shaft 108 and can be located at the distal end of the probe 114. The drill bit 126 can include at least a portion extending to the distal end of the elongate shaft 108. In Figure 1 an example, the drill bit 126 can be configured to emit ultrasonic energy in the longitudinal direction A1. The drill bit 126 can mechanically modify or break the stone S by generating pulsating shock waves that generally move along the longitudinal direction A1. The drill bit 126 can be configured to drill a hole, such as a recess in the stone S or a passage through the stone S. Figure 1 An example including the drill bit 126 that has passed through the stone S is shown.

[0030] The drill bit 126 can be an ultrasonic transmitter that receives ultrasonic energy from a remotely located ultrasonic drill bit transducer, which for clarity will be referred to as the drill bit transducer 136 compared to other transmitters and transducers in the present disclosure. For example, the drill bit transducer 136 can be located in the housing 104 of the lithotripter 102. The drill bit transducer 136 can transmit ultrasonic energy distally outside the housing 104 along a generally longitudinal direction A1. The ultrasonic energy can be transmitted from the drill bit transducer 136 to the drill bit 126 via an ultrasonic transmission member 138. The ultrasonic transmission member 138 can be coupled to the drill bit transducer 136 at the proximal end and to the drill bit 126 at the distal end. The ultrasonic transmission member 138 can be formed of any material (including but not limited to metals, metal alloys, shape memory alloys, polymers, ceramics, fibers, crystals, or composites thereof) capable of transmitting ultrasonic energy from the drill bit transducer 136 to the drill bit 126.

[0031] The drill bit transducer 136 can be electrically coupled to the signal generator 116, for example, via a connector 140, to receive signals for operating the drill bit 126. The drill bit transducer 136 can be actuated, for example, by an operator depressing a foot pedal 132 that is in electrical communication with the signal generator 116, or can be actuated by a drill bit actuator 134 coupled to the housing 104 that is in electrical communication with the signal generator 116. Additionally or alternatively, the drill bit transducer 136 can operate based on an input 120 from the operator and / or an action determined by the controller 122. Any other suitable actuator for controlling the activation of the drill bit 126 can be provided.

[0032] In addition to using the ultrasonic transmitter for drilling, the probe 114 can also include at least one lateral ultrasonic transmitter 128 that is configured to direct ultrasonic energy outwardly and away from the longitudinal direction A1 (e.g., toward the inner surface of the stone S (e.g., an internal passage)) along a radial or lateral direction A2. In Figure 1 an example, the at least one lateral ultrasonic transmitter 128 includes a plurality of lateral ultrasonic transmitters 128 or an array of lateral ultrasonic transmitters 128.

[0033] Each of the lateral ultrasonic transmitters 128 can direct ultrasonic energy in a lateral direction A2, where each of the lateral ultrasonic transmitters 128 is positioned along a different longitudinal position on the probe 114. In some examples, the lateral ultrasonic transmitters 128 can be spaced apart along the longitudinal direction A1. The lateral ultrasonic transmitters 128 can extend laterally or radially around the probe 114. In some examples, the lateral ultrasonic transmitters 128 can extend around the entire 360-degree circumference of the probe 114, or can extend around the perimeter of the probe 114 when the probe has a non-circular cross-section in a direction transverse or perpendicular to the longitudinal direction A1. In other examples, the lateral ultrasonic transmitters 128 can only partially wrap around the probe 114.

[0034] The lateral ultrasonic transmitter 128 can be located at the proximal end of the drill bit 126. The advantage of this arrangement is that the lateral ultrasonic transmitter 128 can follow the drill bit 126 such that after the drill bit 126 has prepared an internal channel in the stone S, the lateral ultrasonic receiver 128 can advance through the internal channel. When activated, for example, by a lateral transmitter actuator 142 that is in electrical communication with the lateral ultrasonic transmitter 128 via an electrical component 144 such as a wire, the lateral ultrasonic transmitter 128 can be configured to emit ultrasonic energy into the internal channel and the stone S to fragment the stone S from the inside of the stone S.

[0035] Similar to the drill bit transducer 136, the lateral ultrasonic transmitter 128 can include an ultrasonic transducer or other acoustic transducer. An electroacoustic transducer is a component that can convert an electrical signal into a change in a physical quantity such as a sound wave or pressure. The ultrasonic transducer can include a linear piezoelectric stack having piezoelectric elements located between two metal plates. In other examples, a magnetic confinement stack can be used. Such piezoelectric elements can convert electrical energy (e.g., an electric current) into mechanical energy (e.g., a sound wave, an acoustic wave, an ultrasonic wave, a shock wave). The piezoelectric element can include a crystal, such as quartz, which has a physical property that causes the crystal to be mechanically stressed when subjected to an electric field, causing the crystal to change size or shape. The piezoelectric element or alternatively expands and contracts in response to an alternating electric field, which can be provided, for example, by a signal generator 116. Such expansion and contraction can generate a sound wave that can be transmitted to the stone S to fragment the stone S.

[0036] To assist in positioning the stone S to be relatively stationary with respect to the working channel WC of the endoscope E and relatively stationary with respect to the probe 114 (except for the longitudinal movement when the probe 114 passes through the stone) while drilling, a suction force 130 as shown by the arrow can be applied through the working channel WC. The suction force 130 can "capture" the stone S by pulling the stone S towards the working channel WC and thus towards the drill bit 126 of the probe 114 for drilling. When the stone S is fragmented, the stone fragments can be suctioned into the working channel WC.

[0037] Some of the lithotripsy systems described herein can include a fluid input 166 for receiving fluid from a fluid reservoir FS and delivering the fluid to the treatment site. For example, a flushing fluid or a lavage fluid can be transmitted through the endoscope E or the elongate shaft 108. A typical stone fragment recovery system involves simply collecting the mixture of solids and liquids retrieved from the patient while performing the procedure. For example, a suction force 130 can be applied at the distal end of the endoscope E or the elongate shaft 108, and a vacuum can be drawn through the suction force 130 to deposit materials (e.g., stone fragments and waste fluid) into a waste container. In an example, a tube 150 can be connected to the housing 104 to fluidly couple the lumen extending through the working channel WC of the endoscope E to a collection container 152. The tube 150 can additionally be connected to a suction device 154 or a pump to draw a vacuum through the working channel WC, as shown by the arrow of the suction force 130, as explained in more detail. Figure 3 As shown by the arrow of the suction force 130.

[0038] As described herein, the ability of the probe 114 to apply acoustic energy to the stone S may depend on the magnitude of the force applied by the delivery member 106 to the stone S to apply the drill bit 126 and the lateral ultrasonic emitter 128. For example, the ideal way to transfer ultrasonic energy from the drill bit 126 may depend on the magnitude of the force applied by the probe 114 to the stone S in the longitudinal direction A1, while the ideal way to transfer ultrasonic energy from the lateral ultrasonic emitter 28 may depend on the magnitude of the force applied by the probe 114 to the stone S in the radial or lateral direction A2. Through the present disclosure, the lithotripsy system 100 can be equipped with a feedback system to provide an indication of the magnitude of the amount applied by the probe 114 to the stone and feedback or guidance on how to appropriately adjust the force to achieve the desired result.

[0039] Figure 2is a perspective view of a lithotripsy system 200 including a handheld probe 202 configured to deliver high frequency and ultrasonic energy for fragmentation of stones. In an example, the lithotripsy system 200 may include an oscillating lithotriptor as described in the patent to St. George et al., U.S. Patent No. 9,974,552, titled "Vibratory Lithotriptor" and assigned to Gyrus ACMI, Inc., the entire content of which is incorporated herein. Features of the present disclosure may be added to the lithotripsy system 200. Additionally, the lithotripsy system 200 may include Figure 1 an example of the lithotripsy system 100.

[0040] The handheld probe 202 may include a handpiece or handle 204 and a shaft 206. The handheld probe 202 may be connected, for example, via a cable 210 to a generator console 208. A collection tube 212 may be connected to a storage container, such as a fluid reservoir FS ( Figure 1 ) or a container 232 ( Figure 3 ) to collect fluid and other biological materials collected via the shaft 206. The shaft 206 may extend from a proximal end 214 to a distal end 216 and may include an inner lumen. The handle 204 may also include buttons 218A and 218B for controlling the activation energy and a knob 219 for controlling the suction level.

[0041] Figure 3 is a perspective view of a suction pump 220 and a lithotripsy canister 222. The suction pump 220 may include a housing 224, a power switch 226, a suction knob 228, and an indicator 230. The lithotripsy canister 222 may include a container 232 and a lid 234. The lithotripsy canister 222 may be connected to the suction pump 220 via a tube 236.

[0042] Figure 4 is a perspective view of the handle 204 in a user's hand 240. The handle 204 may include a handpiece 242. The knob 219 may be positioned at the proximal end of the handpiece 242, and a nose cone 244 may be positioned at the distal end of the handpiece 242. The cable 210 and the collection tube 212 may also be connected to the proximal end of the handpiece 242.

[0043] Figure 5 is Figures 2 to 4 a schematic view of the components of the lithotripsy system 200 and the suction pump 220 interacting with a stone 250 in a kidney 252. As referenced in Figure 3 , Figure 4 and Figure 5As discussed, the lithotripsy system 200 can include a handheld probe 202, a suction pump 220, and a lithotripsy canister 222. The handheld probe 202 can include a shaft 206 and a handle 204. The handle 204 can be connected to a generator console 208 via a cable 210. The handle 204 can be connected to the lithotripsy canister 222 via a collection tube 212, and the lithotripsy canister 222 can be connected to the suction pump 220.

[0044] Meanwhile, the discussion Figures 2 to 5 .

[0045] Figure 1 The lithotripsy system 100 and Figure 2 The lithotripsy system 200 are examples of lithotripsy systems that can be used with the force indicator and filtration device of the present disclosure and the related methods described herein. For example, the force indicator device can be connected to the housing 104 ( Figure 1 ) or the handle 204 ( Figure 2 ) to provide an indication to the user of how much force the elongate shaft 108 or the shaft 206 is applying to a stone or other biological element. Similarly, as discussed with reference to Figure 9 , the force indicator device of the present disclosure can include a filtration member and a suction flow control member that are configured to filter stone fragments from the suction fluid before the suction fluid enters the collection tube 212. Although the present application is described with reference to a lithotripsy system for removing stones, other types of surgical devices and endoscopic devices can also be used with the force indicator and filtration device and method disclosed herein. For example, any surgical device that can be configured to be inserted into a patient and that involves applying force along an axis or a body can benefit from the present disclosure. Examples of surgical devices that can be used with the present disclosure can utilize various energy sources, such as laser energy, ultrasonic energy, etc., for fragmenting, pulverizing, and / or dusting particles, such as stones and other solid or rigid objects.

[0046] Specifically referring to Figure 2 , the handle 204 can include any device suitable for facilitating the manipulation and operation of the shaft 206. The handle 204 can be located at the proximal end 214 of the shaft 206 or at another suitable location along the shaft 206. In an example, the handle 204 can include a pistol grip, a knob, a hand grip, etc. In addition to or in place of the buttons 218A and 218B and the knob 219, the handle 204 can also include one or more of buttons, triggers, levers, knobs, dials, etc. for controlling energy activation, suction, irrigation, etc.

[0047] In various examples, the distal end 216 of the shaft 206 or another suitable location along the shaft 206 may include a surgical device that may include components or devices for interacting with a patient, such as those configured to cut and cauterize tissue and / or produce a desired tissue effect in the patient. In an example, the surgical tool may include forceps, cutting tools, ablation electrodes, cryogenic needles or applicators, ultrasonic probe tips, etc. and combinations thereof. Thus, the handheld probe 202 may be equipped with linkages, such as a mechanical linkage for actuating forceps or cutting tools, an electrical linkage for activating ablation electrodes, an acoustic linkage, a fluid conduit (e.g., for delivering cryogenic argon), etc., and combinations thereof. In an example, the surgical device may be included on a device used in conjunction with the handheld probe 202. In additional examples, the handheld probe 202 may include a device for viewing the patient (e.g., including an optical device of an endoscope (e.g., Figure 1 endoscope E) and a fiber endoscope), or may be combined with such a device.

[0048] The generator console 208 may include an energy source for the handheld probe 202. For example, the generator console 208 may be configured to provide electrical power for performing ablation and cauterization functions and / or ultrasonic energy for providing cutting, coagulation, fragmentation, or other types of surgical functions. In an example, the generator console 208 may provide ultrasonic energy, while the intermittent ballistic shock wave energy is provided via an oscillating free mass within the handle 204.

[0049] The shaft 206 may include an elongate member configured to deliver energy for fragmenting a calculus into the patient's body. The shaft 206 may be rigid and formed of a metal or plastic material. In an example, the size of the shaft 206 may be designed to perform lithotripsy in combination with an endoscope. Thus, the shaft 206 may be inserted into an incision in the patient's epidermis, passed through the patient's body cavity and into an organ. Thus, it is desirable for the diameter or cross-sectional shape of the shaft 206 to be as small as possible to facilitate minimally invasive surgery. However, the shaft 206 may also contain a lumen to allow for the removal of calculus fragments generated by the fragmentation energy via aspiration, etc. Thus, the size of the shaft 206 and the lumen extending therethrough must be balanced to allow for achieving minimal invasiveness and adequate removal of calculus fragments. For example, a lumen that is too small will increase the time required to fragment the calculus into appropriate small pieces. However, the removal of calculus fragments may be achieved through a lumen within the delivery range (e.g., Figure 1 working channel WC of endoscope E).

[0050] Specifically referring to Figure 3 the cover 234 of the lithotripsy canister 222 may be connected to the suction line of the lithotripsy device, such as Figure 2Collection tube 212. The suction pump 220 may include a pump device within a housing 224 to create a vacuum within a container 232 to draw liquid and stone fragments from the lithotripter device into the container 232. The liquid and stone fragments within the collection tube 212 may enter into the container 232. The liquid and stone fragments may be deposited on the bottom of the container 232. A filter or trapping device within the container 232 may prevent the stone fragments from passing through the container 232. A plurality of lithotripsy cans 222 may be connected in series to collect a volume of fluid and stone fragments that is larger than the volume that the container 232 can provide. A user may use a suction knob 228 to set the level, amplitude, or amount of suction force generated by the suction pump 220. An indicator 230 may provide an indication of the amount of suction force being generated. A power switch 226 may be used to turn on or off the power provided to the pump device within the suction pump 220.

[0051] The cable 210 may supply power to the handle 204 and communicate electronically with the handle 204. For example, the cable 210 may supply power to a transducer within the shaft 206 or the nose cone 244 to provide energy to break up the stone. The cable 210 may also conduct ultrasonic energy. Buttons 218A and 218B may control the operation of the transducer within the shaft 206 or the nose cone 244, such as by providing different activation levels, such as power, to the transducer.

[0052] The collection tube 212 may be connected to a barb 248 located on the handpiece 242. The barb 248 and the collection tube 212 may be in fluid communication with the interior of the shaft 206. The suction force from the suction pump 220 may be applied through the collection tube 212, the barb 248, and the shaft 206. A knob 219 may be rotated to control the amount of suction force provided to the shaft 206.

[0053] Specifically referring to Figure 4, during operation, the user's hand 240 can grasp or hold the handheld member 242, wherein the thumb is positioned towards the knob 219 and the buttons 218A and 218B are positioned close to the fingertips. Thus, the thumb can be used to push the knob 219 back and forth to adjust the suction level, while the fingertips can be used to adjust the transducer power level. Additionally, the hand 240 can be moved distally (e.g., along the direction of the shaft 206) to engage the end of the shaft 206 with the stone. Thus, the user can control the suction level and activate the energy simultaneously while pushing the shaft 206 into the stone. The level of force applied by the shaft 206 to the stone is typically manually controlled by the user. Thus, the user typically uses skill and experience to determine how much force is being applied to the stone and how much force should be applied to the stone. As previously mentioned, the effective transfer of energy from the transducer through the shaft 206 may depend on the magnitude of the force applied by the shaft 206 to the stone. Through the present disclosure, the handle 204 can include a force indicator that can provide an indication of the magnitude of the force being applied to the stone. Additionally, the force indicator of the present disclosure can provide guidance as to whether the force being applied is insufficient, sufficient, or excessive.

[0054] Figure 6 is a schematic diagram of the interaction between the shaft 206 and the stone 250. The user can push the distal end 216 of the shaft 206 into the stone 250 with a force F. The distal end 216 can be configured to emit acoustic energy AE. If the force F is insufficient, the acoustic energy AE may dissipate around the stone 250 without being transmitted to the stone 250. If the force F is excessive, the acoustic energy AE cannot be properly discharged from the shaft 206 and can thus be muted or silenced relative to the acoustic energy that is expected to be generated. An ideal or appropriate level of the force F can ensure that the acoustic energy can leave the shaft 206 and enter the stone 250, thereby being fully transmitted from the shaft 206 to the stone 250. However, as previously mentioned, the ability of the shaft 206 to engage the stone 250 may depend on various factors, such as the skill and experience of the surgeon, the amount by which the stone 250 floats within the anatomy (e.g., the amount by which the stone 250 is fixed within the anatomy by surrounding tissue, etc.), and the amount of suction force used to engage the stone 250 with the distal end 216. Through the present disclosure, a force feedback device can be incorporated into the lithotripsy system 200 to provide the user with cues, such as visual, audio, or tactile feedback, that can provide information related to the transmission of the acoustic energy AE to the stone 250. The cues can provide the user with specific information to allow for corrective action to be taken, thereby eliminating guesswork and estimation when applying the force F using the shaft 206.

[0055] Figure 7 is a perspective view of a lithotripsy device 300, which can include an example of a handheld probe 202( Figure 2 ) to which the force indicator device 302 of the present disclosure is attached. The lithotripsy device 300 can have the same as Figures 2 to 5a handpiece 304 with a similar configuration to the handle 204. The aspiration knob 306 can be located at the proximal end of the handpiece 304. The handpiece 304 can include buttons 308A and 308B to control the activation energy. The handpiece 304 can include a barb 310 for connecting to a collection tube such as the collection tube 212( Figure 2 ), and a cable 312, which can include an example of the cable 210. The shaft 314 can extend from the handpiece 304 and can include an example of the shaft 206.

[0056] The force indicator device 302 can include a slider 320, a bracket 321, and a force indicator 322. As Figure 10 visible, the bracket 321 can be configured as an attachment to the handpiece 304, and the slider 320 can be configured to surround the bracket 321 and move relative to the bracket 321. In an example, a filter element 324 can be incorporated into the force indicator device 302. The filter element 324 can include a body attached to or integral or single-piece with the bracket 321. The filter element 324 can include a device configured to provide filtration of fluid entering the distal end of the handpiece 304 from the shaft (e.g., Figure 2 the shaft 206) and exiting the handpiece 304 proximally at the barb 310. The force indicator device 302 can include an indicator 330 and markings 332. The indicator 330 can include a post 334 and a slot 335. The markings 332 can include a first marking 336A, a second marking 336B, and a third marking 336C. The post 334 can be configured to move relative to the slot 335 within the slider 320. The post 334 can include a column integral or single-piece with the material of the bracket 321. In an example, the post 334 can be located on the slider 320, and the markings 332 can be located on the bracket 321. In another example, the bracket 321 can be omitted, and the post 334 can be included in the manufacturing process of the handpiece 304 or can include an additional feature as part of an upgrade feature for the lithotripsy device 300, which can be attached to the handpiece 304 via threaded fasteners, an interference fit in a hole, or chemical bonding means (e.g., welding, adhesives, or glue).

[0057] The bracket 321 can be configured as an additional device for the handpiece 304. That is, the bracket 321 can be configured to be attached to and removed from the handpiece 304 by the user. The bracket 321 can include a cylindrical body that can fit around the handpiece 304. For example, the bracket 321 can include a 360-degree body that can slide over one end of the handpiece 304. In an example, the bracket 321 can have a C-shaped cross-sectional profile to allow the bracket 321 to be clipped to one side of the handpiece 304. The bracket 321 can be attached to the handpiece 304 to be stationary relative thereto. As described above, in an example, the bracket 321 can be omitted, and the stake 334 can be attached to the handpiece 304 or otherwise extend directly from the handpiece 304.

[0058] The slider 320 can include a cylindrical body that can fit around the bracket 321. For example, the slider 320 can include a 360-degree body that can slide over one end of the bracket 321. In an example, the slider 320 can have a C-shaped cross-sectional profile to allow the slider 320 to be clipped to one side of the bracket 321. As described above, the slider 320 can be configured to slide or translate along the handpiece 304 without using the bracket 321.

[0059] The slider 320 can include a notch 326, and the bracket 321 can include a notch 327 to accommodate buttons 308A and 308B. Additionally, an opening 328 can be located on the force indicator device 302, such as between the bracket 321 and the filter element 324, to accommodate the suction knob 306. The bracket 321 can be connected to the filter element 324 via an extension 361.

[0060] The slider 320 can be configured to move relative to the handpiece 304 and the bracket 321. In particular, the slider 320 can be configured to move relative to the bracket 321 (relative to the central axis CA), such as slide axially along the bracket 321. The slider 320 can include a gripping feature for the user of the lithotripter device 300. Thus, by gripping the slider 320, the functions of the lithotripter device 300 can be controlled, and the shaft 314 can be pushed into the stone.

[0061] In use, the slider 320 can be gripped by the user, which is similar to that described for the handpiece 242 with reference to Figure 4 Thus, the thumb can be positioned close to the suction knob 306, and the fingertips can be positioned close to the buttons 308A and 308B. The palm can be placed around the slider 320. When the user pushes the slider 320 downward, the handpiece 304 can apply a downward force F with the shaft 314 ( Figure 6)。The handheld member 304 can move upward relative to the slider 320 along the central axis CA (relative to the Figure 7 orientation), which can cause the stake 334 to move within the slot 335. Thus, the stake 334 can additionally move relative to the first marker 336A, the second marker 336B, and the third marker 336C. In an example, the stake 334 can start at one end of the slot 335, and as a greater downward force is applied to the slider 320, the stake can move toward the other end of the slot 335. Thus, in the example, the stake 334 can start near the third marker 336C, and the third marker 336C can indicate an insufficient applied force, the second marker 336B can indicate a sufficient applied force, and the first marker 336A can indicate an excessive applied force. As discussed in more detail below with reference to Figure 8 , the fragmentation device 300 can include one or more of a biasing element (e.g., biasing element 340) and a force sensor (e.g., sensor 342), the biasing element for providing resistance to the movement of the slider 320 relative to the handheld member 304, and the force sensor for determining the magnitude of the force applied to the slider 320.

[0062] Figure 8 is a partial cross-sectional view of the fragmentation device 300, which shows the slider 320, the bracket 321, the biasing element 340, and the sensor 342.

[0063] The slider 320 can be arranged around the bracket 321. As previously described, each component can include a cylinder surrounding the central axis CA. The slider 320 can be configured to axially displace or move relative to the bracket 321 along the central axis CA. In an example, the slider 320 can freely float relative to the bracket 321 and be connected to the bracket 321 by the biasing element 340. In an example, the slider 320 can be attached to the bracket 321 to allow the slider 320 to slide against the bracket 321. For example, the bracket 321 and the slider 320 can include a track system (not illustrated) to allow the slider 320 to axially slide relative to the central axis CA and prevent rotation about the central axis CA. For example, the bracket 320 can include one or more longitudinally extending slots having a dovetail cross-section recessed therein, and the slider 320 can have one or more longitudinally extending tracks having a dovetail cross-section that mates with the slots.

[0064] The biasing element 340 can be positioned between the slider 320 and the bracket 321 to bias the slider 320 to a first position, such as a starting position. In particular, the bracket 321 can include a flange 344, and the slider 320 can include a lip 346, and the biasing element can be positioned between the flange and the lip, thereby allowing the biasing element 340 to provide an indication of the magnitude of the longitudinal or axial force applied by the shaft 314 relative to the central axis of the shaft 314. In an example, a single instance of the biasing element 340 can include a single flange 344 and a single lip 346. In an additional example, as Figure 10 shown, multiple instances of the flange 344, the lip 346, and the biasing element 340 can be spaced circumferentially around the lithotripter device 300 and around the central axis CA for engagement with multiple biasing elements 340. In an additional example, the flange 344 and the lip 346 can extend completely around the handpiece 304 and the slider 320, for example, a 360-degree shelf can be formed. For example, the biasing element 340 can be configured to push the slider 320 upward away from the shaft 314 such that a downward movement of the slider 320 by the user will compress or contract the length or height of the biasing element 340. In an example, the biasing element 340 can include a coil spring or a compression spring as illustrated. In an additional example, the biasing element 340 can include a tension spring, wherein the movement of the slider 320 is configured to elongate or stretch the compression spring. For example, the biasing element 340 can be arranged between the flange 344 and the post 334. In an additional example, the biasing element 340 can include a disc spring, an air piston, or other variable stiffness devices. In an additional example, the biasing element can include one or more pieces of compressible or stretchable material, such as foam, rubber, or a compressible polymer. Such a piece of compressible material can have an annular or donut shape. In an example, the biasing element 340 or another biasing element can be configured to provide an indication of the magnitude of the lateral or radial force applied by the shaft 314 relative to the central axis of the shaft 314. For example, the biasing element can be positioned to extend radially from the bracket 321 to engage the slider 320.

[0065] The compression and extension lengths of the biasing element 340, the length of the slot 335, and the spring force of the biasing element 320 can be selected to provide feedback on how much force is applied to the slider 320. Thus, for example, a biasing element 340 that is compressed 0% can correspond to when no force is applied to the slider 320, a fully compressed biasing element 340 can correspond to when a force greater than any desired force to be applied to a physiological stone or calculus is applied to the slider 320, and a semi-compressed biasing element 340 can correspond to when the desired force is applied to fragment the stone, applying a sufficient amount of force to the stone 250, such as the desired level of force F( Figure 6), to allow ultrasonic energy to be effectively transmitted therebetween. Empirical tests can be performed to determine the appropriate configuration of the biasing element 340, the length of the slot 335, and the spring force of the biasing element 340. In additional examples, the biasing element 340 can be configured to be elastically deflectable without permanent deformation, such as metal. In an example, the biasing element 340 can be configured in a trolley spring type structure.

[0066] In an example, the biasing element 340 can be configured to push the slider 320 upward with reference to Figure 7 and Figure 8 's orientation. Thus, the third marker 336C can include a yellow marker indicating insufficient force, the second marker 336B can include a green marker indicating appropriate force, and the first marker 336A can include a red marker indicating excessive force. In an example, the first marker 336A, the second marker 336B, and the third marker 336C can include mechanical indicators, such as coatings or stickers applied to the slider 320. The first marker 336A, the second marker 336B, and the third marker 336C can have various shapes, such as circular, square, rectangular, octagonal, hexagonal, etc. Each of these shapes can be very small to form dots or dot patterns on the slider 320.

[0067] In an example, the first marker 336A, the second marker 336B, and the third marker 336C can include light emitters, such as light emitting diodes (LEDs) or bulbs. For example, the first marker 336A to the third marker 336C can be configured to Figure 11 markers 406A to marker 406E.

[0068] In additional examples, the force indicator device 302 can be configured to provide audio feedback. In these examples, the force indicator device 302 can include an output device, such as a speaker. For example, the force indicator device 302 can include Figure 11 audio driver 404.

[0069] In an example, the force indicator device 302 can be configured to provide tactile feedback. In these examples, the force indicator device 302 can include an output device, such as a motor. For example, the force indicator device 302 can be Figure 11 tactile motor 409.

[0070] In an example, the marker 332 can provide written text or markings to convey additional information or instructions to the user. For example, the marker 332 can be configured to provide feedback regarding different degrees of breakage applied to the stone. For example, the first marker 336A can provide feedback indicating the "fragmentation" level of the force applied to the stone to break the stone into smaller fragments, while the third marker 336C can provide feedback indicating the "pulverization" level of the force applied to the stone to break the stone into powder, and the second marker 336B can provide an intermediate level of force.

[0071] In an example, the marker 332 can be configured to provide feedback regarding sufficient force levels applied to different types of stones. For example, kidney stones can include calcium stones, travertine stones, uric acid stones, and cystine stones. These stones can have different levels of hardness, which can correspondingly benefit from different levels of force to fragment or break them. Thus, the first marker 336A can include a marker indicating "calcium stone" to provide a feedback indication of the force to be applied to break the calcium stone into small pieces, the second marker 336B can include a marker indicating "travertine stone" to provide a feedback indication of the force to be applied to break the travertine stone into small pieces, and the third marker 336C can include a marker indicating "uric acid stone" to provide a feedback indication of the force to be applied to break the uric acid stone into small pieces. Empirical testing can be performed to arrange the stone label markings according to appropriate hardness levels corresponding to the operation of the biasing element 340. For example, in cases where the biasing element 340 is compressed more, harder stones can be listed.

[0072] In an example, the sensor 342 can be used to obtain electronic feedback from the lithotripsy device 300. Specifically, the sensor 342 can be used to obtain from the lithotripsy device 300 the force applied by the shaft 314 to the stone 250 ( Figure 6) electronic feedback related to the magnitude of the force, which corresponds to the magnitude of the force applied by the user to the slider 320. The sensor 342 can be configured to engage with the readable feature 348. In an example, the sensor 342 can include a limit switch that can sense the position of the slider 320 relative to the bracket 321. Thus, the sensor 342 can be configured to mechanically engage with the readable feature 348 of the bracket 321 that includes a protrusion. In an example, the sensor 342 can be configured as a roller lever sensor or a plunger sensor, and the bracket 321 can include a pair of protrusions similar to the pile 334 but shorter to engage with the limit switch at two positions. The sensor 342 can also be configured to obtain position information from the bracket 321 electronically, wirelessly, or non - contactingly. In an example, the sensor 342 can be configured as a magnetic position sensor, and the readable feature 348 can include one or more pieces of magnetic material to engage with the magnetic position sensor at different positions of the slider 320. In an example, the sensor 342 can be configured as a capacitive position sensor, and the readable feature 348 can include one or more pieces of capacitive suspension material (e.g., aluminum, tantalum, ceramic, and polycarbonate) to engage with the magnetic position sensor at different positions of the slider 320. In an example, the sensor 342 can be configured as an encoder, and the readable feature 348 can include a track with hash marks or scale marks that can be read by the encoder, allowing the encoder to count the marks as the slider 320 translates along the bracket 321. As discussed in reference Figure 11 In more detail, the output of the sensor 342 can be processed by an electronic device to provide a marker or feedback to the user.

[0073] Figure 9 is a perspective view of the force indicator device 302 for the lithotripter device 300, which has the outflow controller 350 of the present disclosure connected to the filter element 324. The outflow controller 350 can include a rod 352, a valve 354, and barbs 310. The filter element 324 can include a filter body 360. Figure 10 is a schematic view showing the handpiece 304 of the lithotripter device 300 positioned relative to the force indicating device 302 of the present disclosure, which shows the fluid flow through the filter element 324. At the same time, discuss Figure 9 and Figure 10 .

[0074] The filter element 324 can be positioned on the slider 320 to fluidly position the filter body 360 between the fluid passage 362 within the shaft 314 and a passage (e.g., barb 310) for the lithotripsy canister 222. The filter element 324 can be connected to the slider 320 by an extension 361. As described herein, the suction pump 220 can apply a vacuum force to the shaft 314 to draw fluid and stone fragments into the fluid passage 362. The fluid and stone fragments can flow from the shaft 314 through the cap 364 and into the outlet barb 366. After leaving the lithotripsy device 300, the fluid and stone fragments can enter the filter element 324. In the illustrated example, the filter element 324 is directly attached to the handpiece 304 of the lithotripsy device 300 at the outlet barb 366. Thus, the outlet barb 366 can be inserted into a socket 368 within the filter element 324. However, a tube can be positioned between the outlet barb 366 and the socket 368. The filter body 360 can be disposed within a waterproof housing of the filter element 324 to prevent fluid and stone fragments from passing through the filter element 324 rather than the barb 310. The filter body 360 can include a material that allows fluid to pass through but prevents solids from passing through. In an example, the filter body 360 can include foam, wire mesh, cellulose filter material, polypropylene film, etc. The filter body 360 can form a bag 370 in which stone fragments can be trapped. Thus, the fluid and stone fragments can flow from the socket 368 into the bag 370, and the fluid can flow through the filter body 360 and into the rod 352 while the stone fragments remain in the bag 370. The barb 310 can be positioned at the distal end of the rod 352 to allow connection to a hose, such as Figure 2 the collection tube 212. Thus, the filter element 324 can prevent the collection tube 212 ( Figure 2 ) from being clogged by stone fragments. A valve 354 can be positioned within the rod 352 to provide a means for controlling, for example, the flow out of the rod 352 through the lithotripsy device 300. The valve 354 can include an on / off valve or a valve that allows intermediate flow levels between open and closed. In an example, the valve 354 can comprise a needle valve, ball valve, butterfly valve, etc. The valve 354 can be manually operated by a user of the lithotripsy device 300 to control the amount of suction force applied at the distal end of the shaft 314 at the fluid passage 362. The valve 354 can be used to replace the suction knob 306. In an example, the slider 320 can be configured to disable the suction knob 306. Thus, even if the suction knob 306 is interfered with by the slider 320, the user of the indicator device 302 can obtain the ability to control the suction force, such as in an example where the opening 328 is omitted.

[0075] Figure 11Schematic diagram of an output device 400 suitable for use with the force feedback device disclosed herein. The output device 400 may include a visual display 402 and an audio driver 404. The visual display 402 may include output markers 406A to 406E, a dial 408, and a haptic motor 409. The output device 400 may include an electronic module 410 or may communicate with the electronic module 410. The electronic module 410 may include a processor 412, a memory 414, a power supply 416, and a communication device 418. The processor 412 may communicate with the sensor 342.

[0076] In an example, the sensor 342 may communicate with the output device 400 via the electronic module 410. In an example, the sensor 342 may communicate directly with the output device 400.

[0077] In an example, the output device 400 and the electronic module 410 may be located on or within the force indicator device 302 ( Figure 7 ). Thus, the force indicator device 302 may include a stand-alone device. In an example, the output device 400 and the electronic module 410 may be located on or within the generator console 208 ( Figure 2 ). Thus, the force indicator device 302 may include a communication device, such as the communication device 418 in the absence of other components of the electronic module 410, such as a wireless transmitter or a wired connection, to enable the output of the sensor 342 to communicate with the generator console 208.

[0078] The visual display 402 may include an active display unit, such as a liquid crystal display, a plasma screen, an organic light emitting diode display, etc. The visual display 402 may include a touch screen device. In an example, the processor 412 may include the generator console 208 ( Figure 2) or as part of the generator console 208. Thus, the visual display 402 can be programmed to provide various outputs and receive various user inputs. As described herein, the sensor 342 can include a position sensor, a presence sensor, a proximity sensor, etc. The memory 414 can include information related to markers and instructions to be displayed on the visual display 402, such as the magnitude of the force, the adequacy of the force, the required fragmentation level, the type of stone, etc. Thus, the processor 412 can receive inputs from the sensor 342, consult a look-up table stored in the memory 414 to find the output markers for the corresponding outputs of the sensor 342, and display them on the visual display 402, or provide another feedback output regarding the magnitude of the force, the adequacy of the force, the type of stone suitable for using the force, etc. Activating at least one of the markers 406A to 406E and the audio driver 404, the dial 408, and the haptic motor 409 can provide an indication of the force, pressure, type of stone, fragmentation function (e.g., fragmentation or pulverization), etc. For example, regarding Figure 11 , the markers 406A to 406E can respond to electrical or mechanical parameters sensed by the sensor 342.

[0079] In an example, each of the markers 406A to 406E can be activated to indicate an increasing magnitude or level of force. Each of the markers 406A to 406E can include a light-emitting diode. In an example, the marker 406E at the bottom of the output device 400 and the marker 406A at the top of the output device 400 can be activated in an opposite manner to indicate the opposite ends of the force application range. Thus, the marker 406E can be activated to show a first level of force, for example, the magnitude of the force applied by the distal end 216 of the shaft 314 or the shaft 206 to the stone 250 ( Figure 5 ) is just above zero, and the marker 406A can be activated to show a second level of force, for example, the magnitude of the force applied by the shaft 314 or the shaft 206 to the stone 250 at the maximum or threshold level. The markers 406B, 406C, and 406D can be activated to indicate different levels between the first level and the second level, so that a continuous range or a gradual change in light activation can be provided. The markers 406A to 406E can be updated in real time to indicate the magnitude of the force. Thus, when the surgeon manipulates the lithotripter device 300 to engage the shaft 314 with the stone 250, an indication of the magnitude of the force applied by the shaft 314 to the stone 250 can be provided. In other examples, all of the markers 406A to 406E can be activated or lit up, and the color can be changed to indicate the magnitude of the electrical parameter. For example, a lighter color can be used to indicate a lower applied force, while a darker color can be used to indicate a higher applied force.

[0080] In an example, markers 406A through 406E and the dial 408 can be provided with labels to translate the magnitude of the sensed applied force into an anatomical description. For example, a high level of force can be translated into a first type of calculus, while a low level of force can be translated into a second type of calculus.

[0081] In an example, markers 406A through 406E and the dial 408 can be provided with labels to translate the magnitude of the sensed applied force into a fragmentation description. For example, a high level of force can be translated into a first type of fragmentation, such as a fracture, while a low level of force can be translated into a second type of fragmentation, such as powder.

[0082] In one example, the visual display 402 can include the dial 408. The dial 408 can include graduations to indicate different magnitudes of force, and a needle can move to indicate the magnitude of the force being actively applied.

[0083] In an example, an audible alert can be used to provide feedback indicative of the magnitude of the applied force, such as by using the audio driver 404. For example, a steady signal can be emitted that changes pitch, volume, or tone based on the magnitude of the sensed force. In other examples, an intermittent signal can be emitted that changes the interval based on the magnitude of the applied force.

[0084] In an example, a tactile alert can be used to provide feedback indicative of the magnitude of the applied force, such as by using the tactile motor 409. For example, a steady vibration can be emitted that changes speed, such as frequency, based on the magnitude of the sensed force. In other examples, an intermittent signal can be emitted that changes the interval based on the magnitude of the applied force.

[0085] Figure 12 is a line graph that illustrates a method 500 for applying a lithotripsy force to a calculus using a lithotripsy system including a force feedback device of the present disclosure. The method 500 illustrates various exemplary operations of the lithotripsy process. Other operations described herein can be included, and some steps can be omitted. Additionally, the illustrated and described operations can be performed in a different order.

[0086] In operation 502, a shaft extending from the handle of the lithotripsy device can contact a physiological calculus or calculus. For example, the shaft 314 of the lithotripsy device 300( Figure 7 ) can be applied to the calculus 250( Figure 6 ). The shaft 314 can be inserted into the patient's anatomy to reach the calculus. In an example, the shaft 314 can be inserted through the working channel WC of the endoscope E( Figure 1 ).

[0087] At operation 504, energy from the shaft can be applied to the stone to fragment the stone. In an example, sound can emanate from the shaft 314. The acoustic energy can include sound waves, sonic waves, ultrasonic waves, or shock waves, or any combination thereof. Additionally, the shaft 314 can be configured to emit pneumatic lithotripsy, electrohydraulic lithotripsy (EHL), and laser lithotripsy including using green light, YAG, or holmium lasers to dissolve the stone. The lithotripsy energy can be generated within the lithotripsy device 300 within the handpiece 304 or the shaft 314, or can be generated within the signal generator 116( Figure 1 ). The lithotripsy energy can be configured to be emitted from the distal end of the shaft 314, which is similar to the distal end 216 of the shaft 206. As described herein, the lithotripsy energy can be transmitted through the shaft 314 and can pass through the material of the shaft 314. Accordingly, it is desirable to engage the shaft 314 with the stone 250, e.g., to make contact between the shaft 314 and the stone 250.

[0088] At operation 506, a force from the shaft can be applied to the stone via the handle to facilitate the transfer of energy to the stone. The user can push down on the handpiece 304 to push the shaft 314 into the stone 250. In particular, the user can push down on the slider 320 of the indicator device 302 to transfer the force to the handpiece 304 via the biasing element 340 and the bracket 321. The downward force on the handpiece 304 can cause the shaft 314 to be pushed into the stone 250. When the force applied to the slider 320 exceeds the spring force of the biasing element 340, assuming the stone 250 is completely immobile within the anatomy, the biasing element 340 can begin to activate, e.g., compress or expand, depending on the arrangement. The activation of the biasing element 340 can cause a relative displacement between the slider 320 and the bracket 321 (including the handpiece 304). The relative movement between the slider 320 and the bracket 321 can be used to determine the magnitude of the force applied by the user to the handpiece 304.

[0089] At operation 508, a certain amount of force applied by the shaft to the stone can be output. This output can include a marker that ensures an appropriate amount of fragmentation energy generated by or passing through shaft 314 and transmitted to stone 250 to provide a desired result. For example, the desired result can be to fragment the stone as effectively as possible to reduce the surgical time and quickly break the stone into small pieces. Thus, it may be desirable to allow most of the fragmentation energy from shaft 314 to be transmitted to stone 250. This can benefit from shaft 314 engaging stone 250 at an optimal level, e.g., not too much force to prevent shaft 314 from being blocked (e.g., prevent the generation of fragmentation energy), and not too little force to ensure the fragmentation energy is transmitted to stone 250. However, in some cases, it may be desirable to have less fragmentation energy emitted from shaft 314, e.g., to break the stone into larger fragments or to break a softer type of stone. This can benefit from shaft 314 engaging stone 250 in a less than or greater than optimal manner to reduce the generation or transmission of fragmentation energy.

[0090] The magnitude of the force applied by the distal end of shaft 314 to stone 250 can be output in a human-readable format. In additional examples, the magnitude of the lateral or radial force applied by shaft 314 to stone 250 can be output. In an example, this output can be read directly by a person, e.g., by using mechanical indicators such as indicator 330 and marker 332. In an example, this output can be read indirectly by a person, e.g., by using electronic module 410 to convert the electrical output of sensor 342 into an electronic form that is visible (visual), audible (audible), or sensible (tactile) to a human. Additionally, the force output can be converted into an instruction to adjust the force output. In an example, this instruction can provide a human-readable marker for applying more or less force, for the desired magnitude of force for certain types of stones, or for the desired magnitude of force for different degrees of fragmentation.

[0091] At operation 510, the force applied from the shaft can be adjusted to provide a desired stone fragmentation. For example, the user can manually adjust the magnitude of the force applied to handpiece 304 via slider 320. The user can increase the downward force on slider 320 to provide a greater force to stone 250. The user can decrease the downward force on slider 320 to provide a smaller force to stone 250. The magnitude of the applied force can be proportional to the magnitude of the fragmentation energy applied to stone 250 and thus correspond to the speed at which stone 250 breaks or the size of the fragments into which stone 250 breaks.

[0092] The present disclosure addresses the problem of kidney stone fragments clogging the aspiration system during lithotripsy, which results in surgical downtime and potential equipment repair or replacement. The present disclosure provides a force indicating device that assists a user in applying the correct amount of force to a kidney stone to facilitate the desired transmission of fragmentation energy (e.g., acoustic energy) from the lithotripter shaft to the stone. Feedback can provide an indication of the force level or magnitude, instructions to apply more or less force, and instructions to apply force to different types of stones.

[0093] Various considerations and examples

[0094] For the purposes of the present disclosure, "proximal" refers to the end of the system that is closer to the device operator during use, while "distal" refers to the end of the system that is farther or more distant from the device operator during use.

[0095] The above detailed description includes references to the accompanying drawings that form a part of that detailed description. The drawings illustrate, by way of example, specific embodiments in which the invention may be practiced. These embodiments are also referred to herein as "examples." These examples may include elements other than those shown or described. However, the inventors also contemplate examples in which only the elements shown or described are provided. Additionally, the inventors also contemplate examples using any combination or permutation of those elements (or one or more aspects thereof), whether with respect to a particular example (or one or more aspects thereof) or with respect to other examples shown or described herein (one or more aspects thereof).

[0096] In this document, the term "a" is used, as is common in patent documents, to include one or more, independent of any other instances or uses of "at least one" or "one or more." In this document, the term "or" is used to refer to a non-exclusive "or" such that "A or B" includes "A but not B," "B but not A," and "A and B," unless otherwise stated. In this document, the terms "comprising" and "wherein" are used as the plain English equivalents of the respective terms "including" and "wherein." Additionally, in the following claims, the term "comprising" is open-ended, meaning that a system, device, article, composition, formulation, or method that includes elements other than those listed after the term in the claim is still considered to fall within the scope of that claim. Further, in the following claims, the terms "first," "second," and "third," etc. are used only as labels and are not intended to impose numerical requirements on their objects.

[0097] The foregoing description is illustrative and not restrictive. For example, the above examples (or one or more aspects thereof) may be used in combination with each other. Other embodiments may be used, such as by one of ordinary skill in the art upon review of the above description. The abstract is provided to enable the reader to quickly ascertain the nature of the technical disclosure. It should be understood that this document is not intended to interpret or limit the scope or meaning of the claims. Additionally, in the above detailed description, various features may be grouped together to simplify the disclosure. This should not be construed as intending that the disclosed features not claimed are essential to any claim. Rather, the subject matter of the invention may be less than all the features of a particular disclosed embodiment. Accordingly, the following claims are hereby incorporated into the detailed description as examples or embodiments, with each claim standing on its own as a separate embodiment, and it is contemplated that these embodiments may be combined with each other in various combinations or permutations. The scope of the invention should be determined with reference to the appended claims and the full scope of equivalents to which those claims are entitled.

[0098] Example 1 is a feedback device for providing feedback on a force signature generated during lithotripsy, the feedback device comprising: a slider configured to be attached to a handpiece of a lithotripsy device; a positioning device connected to the slider to adjust the position of the slider relative to the handpiece; and a feedback indicator connected to the slider to provide feedback related to a force applied to the slider to displace the slider relative to the handpiece.

[0099] In Example 2, the subject matter of Example 1 optionally includes, wherein the positioning device includes a biasing element; and the feedback indicator generates feedback related to the relative position of the slider relative to the handpiece.

[0100] In Example 3, the subject matter of any one or more of Examples 1 to 2 optionally includes, wherein the feedback indicator includes at least one of a visual output indicator, an audio output indicator, or a tactile output indicator.

[0101] In Example 4, the subject matter of Example 3 optionally includes, wherein the feedback indicator further includes a sensor configured to determine the relative position between the slider and the handpiece.

[0102] In Embodiment 5, the subject matter of any one or more of Examples 1 to 4 optionally includes, wherein the handpiece includes a suction knob and an energy button; and the slider includes one or more slots through which the suction knob or the energy button extends to allow the slider to be assembled onto the handpiece.

[0103] Example 6 is a lithotripsy system, the lithotripsy system comprising: a handpiece configured to be held by a user; a power supply configured to generate energy for shattering a physiological stone; a shaft having a proximal end extending from the handpiece and a distal end configured to engage a physiological stone; and a force indicating device connected to the handpiece, the force indicating device being configured to provide feedback related to the force applied by the user at the handpiece to the physiological stone via the distal end of the shaft.

[0104] In Example 7, the subject matter of Example 6 optionally includes, wherein the force indicating device includes: a slider movable relative to the handpiece; an indicating post mounted to one of the slider and the handpiece; and a marker located on the other of the slider and the handpiece; wherein the indicating post is movable relative to the marker to provide feedback.

[0105] In Example 8, the subject matter of Example 7 optionally includes, wherein the force indicating device further includes a spring arranged to resist the movement of the slider.

[0106] In Example 9, the subject matter of any one or more of Examples 7 to 8 optionally includes, wherein the feedback includes: a first visual indicator on the handpiece indicating excessive force; a second visual indicator on the handpiece indicating insufficient force; wherein when the indicating post is positioned between the first visual indicator and the second visual indicator, a desired force range is indicated.

[0107] In Example 10, the subject matter of Example 9 optionally includes, wherein the first visual indicator and the second visual indicator are colored shapes or LED lights.

[0108] In Example 11, the subject matter of any one or more of Examples 6 to 10 optionally includes, wherein the feedback includes haptic feedback based on the applied force.

[0109] In Example 12, the subject matter of any one or more of Examples 6 to 11 optionally includes a filter connected to the handpiece.

[0110] In Example 13, the subject matter of any one or more of Examples 6 to 12 optionally includes an outflow controller on the handpiece configured to control the suction flow rate through the shaft.

[0111] Example 14 is a method of performing a lithotripsy procedure, the method comprising: contacting a stone with a shaft extending from a handle of a lithotripsy device; applying energy from the shaft to the stone to shatter the stone; applying a force from the shaft to the stone via the handle to facilitate energy transfer to the stone; and providing an output of an amount of force of the shaft contacting the stone.

[0112] In Example 15, the subject matter of Example 14 optionally includes: adjusting the applied force based on the output.

[0113] In Example 16, the subject matter of Example 15 optionally includes, wherein the output includes a visual output.

[0114] In Example 17, the subject matter of Example 16 optionally includes: determining whether the applied force is within the desired range between a first visual indicator and a second visual indicator respectively indicating excessive force and insufficient force.

[0115] In Example 18, the subject matter of any one or more of Examples 14 to 17 optionally includes, wherein the output includes tactile feedback related to the applied force.

[0116] In Example 19, the subject matter of any one or more of Examples 14 to 18 optionally includes, wherein the output includes audio feedback related to the applied force.

[0117] In Example 20, the subject matter of any one or more of Examples 14 to 19 optionally includes, wherein the output includes markings indicating different types of stones.

[0118] In Example 21, the subject matter of any one or more of Examples 14 to 20 optionally includes, wherein the energy includes ultrasonic energy, laser energy, ultrasonic energy, pneumatic energy, or hydraulic energy.

[0119] Each of these non-limiting examples can exist independently, or can be arranged or combined in various ways with one or more other examples.

Claims

1. A feedback device for providing feedback on the force markers generated during lithotripsy, the feedback device comprising: A slider configured to be attached to the handpiece of a lithotripsy device; A positioning device connected to the slider to adjust the position of the slider relative to the handpiece; And A feedback indicator connected to the slider to provide feedback related to the force applied to the slider to displace the slider relative to the handpiece.

2. The feedback device according to claim 1, wherein The positioning device includes a biasing element; and The feedback indicator generates feedback related to the relative position of the slider relative to the handpiece.

3. The feedback device according to claim 1, wherein, The feedback indicator includes at least one of a visual output indicator, an audio output indicator, or a tactile output indicator.

4. The feedback device according to claim 3, wherein, The feedback indicator further includes: A sensor configured to determine the relative position between the slider and the handpiece.

5. The feedback device according to claim 1, wherein The handpiece includes a suction knob and an energy button; and The slider includes one or more cutouts through which the suction knob or the energy button extends to allow the slider to be assembled onto the handpiece.

6. A lithotripsy system, the lithotripsy system comprising: A handpiece configured to be held by a user; A power supply configured to generate energy for breaking a physiological calculus; A shaft having a proximal end extending from the handpiece and a distal end configured to engage the physiological calculus; And A force indicating device connected to the handpiece, the force indicating device being configured to provide feedback related to the force applied by the user at the handpiece to the physiological calculus through the distal end of the shaft.

7. The gravel system according to claim 6, wherein, The force indicating device includes: A slider movable relative to the handpiece; An indicating post mounted to one of the slider and the handpiece; and A marker located on the other of the slider and the handpiece; Wherein the indicating post is movable relative to the marker to provide the feedback.

8. The gravel system according to claim 7, wherein, The force indicating device further includes a spring arranged to resist the movement of the slider.

9. The gravel system according to claim 7, wherein, The feedback includes: A first visual indicator on the handpiece indicating excessive force; and A second visual indicator on the handpiece indicating insufficient force; Wherein when the indicating post is positioned between the first visual indicator and the second visual indicator, a desired force range is indicated.

10. The gravel system according to claim 9, wherein, The first visual indicator and the second visual indicator are colored shapes or LED lights.

11. The gravel system according to claim 6, wherein, The feedback includes tactile feedback based on the applied force.

12. The lithotripsy system according to claim 6, the lithotripsy system further including a filter connected to the handpiece.

13. The lithotripsy system according to claim 6, the lithotripsy system further including an outflow controller on the handpiece configured to control the suction flow rate through the shaft.

14. A method of performing lithotripsy, the method comprising: Contact the calculus with a shaft extending from a handle of a lithotripter device; Apply energy from the shaft to the calculus to fragment the calculus; Via the handle, apply a force from the shaft to the calculus to facilitate the transfer of energy to the calculus; and Provide an output of an amount of force with which the shaft contacts the calculus.

15. The method according to claim 14, the method further comprising: Adjust the applied force based on the output.

16. The method according to claim 15, wherein, The output includes a visual output.

17. The method according to claim 16, wherein the method further comprises: Determine whether the applied force is within a desired range between a first visual indicator and a second visual indicator respectively indicating excessive force and insufficient force.

18. The method according to claim 14, wherein, The output includes tactile feedback related to the applied force.

19. The method according to claim 14, wherein, The output includes audio feedback related to the applied force.

20. The method according to claim 14, wherein The output includes markings indicating different types of calculi.

21. The method according to claim 14, wherein, The energy includes ultrasonic energy, laser energy, supersonic energy, pneumatic energy or hydraulic energy.

Images