Defibrillation protection for medical equipment sensing circuitry

Abstract

A medical device includes a therapy component for performing a therapy program on a patient. The therapy component includes sensing circuitry for sensing electrical signals from one or more sensing electrodes of the therapy component placed on and / or in the patient. With the medical device powered on, it is determined when the therapy component is actively engaged in performing the therapy program on the patient. When the therapy component is actively engaged in performing the therapy program on the patient, the one or more sensing electrodes of the therapy component are electrically connected with the sensing circuitry. When it is determined that the therapy component is not actively engaged in performing the therapy program on the patient, the one or more sensing electrodes of the therapy component are electrically isolated from the sensing circuitry.

Description

Cross-reference to related applications

[0001] This application claims priority to U.S. Provisional Application No. 63 / 620,270, filed January 12, 2024, the entire disclosure of which is incorporated herein by reference. Technical Field

[0002] This disclosure relates to medical devices, and more specifically to defibrillation protection in the sensing circuitry of medical devices. Background Technology

[0003] Medical devices typically include sensing circuitry systems for detecting physiological and / or other electrical signals within or on a patient's body. Such sensing circuitry can be damaged by a defibrillation shock applied to the patient's body by the defibrillator. Some defibrillators have built-in defibrillation protection circuitry that is activated when the defibrillator actively delivers a defibrillation shock to help protect the defibrillator's sensing circuitry from the defibrillator-delivered shock. In many cases, sensing circuitry with defibrillator protection can measure signals representing higher impedance measurements (e.g., greater than 100 kiloohms), such as EKG signals.

[0004] It will be desirable to have a protection circuit for a medical device that protects the device from surges from a defibrillator, which is isolated from the protected device. It will also be desirable to have a defibrillation protection circuit suitable for protecting sensing circuits configured to sense signals representing low-impedance measurements (e.g., less than 50 kiloohms), such as signals indicating blood clots or the like during thrombectomy procedures, without negatively impacting the performance of any external defibrillator. Summary of the Invention

[0005] This disclosure provides alternatives to the design, materials, manufacturing methods, and uses of medical devices. An example can be found in a method for operating a medical device configured to perform a treatment procedure on a patient. The medical device includes a treatment component for performing a treatment procedure on a patient, the treatment component including: one or more sensing electrodes adapted to be placed on and / or inside a patient; and a sensing circuit system for sensing electrical signals from the one or more sensing electrodes. The method includes: determining, while the medical device is energized, when the treatment component actively participates in performing a treatment procedure on the patient. When it is determined that the treatment component actively participates in performing a treatment procedure on the patient, the method includes electrically connecting one or more sensing electrodes of the treatment component to the sensing circuit system of the treatment component. When it is determined that the treatment component does not actively participate in performing a treatment procedure on the patient, the method includes electrically isolating one or more sensing electrodes of the treatment component from the sensing circuit system of the treatment component.

[0006] Alternatively or additionally, when it is determined that the treatment component is not actively involved in performing a treatment procedure on the patient, each of the one or more sensing electrodes can be electrically isolated from the sensing circuit system by a corresponding relay that is in the open state.

[0007] Alternatively or additionally, when it is determined that the treatment component actively participates in performing a treatment procedure on the patient, each of the one or more sensing electrodes can be electrically connected to the sensing circuit system through a corresponding relay that is in a closed state.

[0008] Alternatively or additionally, the method may further include filtering the respective electrical signals before each electrical signal transmitted through the respective relay in the closed state reaches the sensing circuit system.

[0009] Alternatively or additionally, each corresponding relay may be a normally open relay, which is switched to its closed state by allowing control current to pass through the relay coil.

[0010] Alternatively or additionally, each corresponding normally open relay may be a high-voltage relay with a rated voltage of at least 5,000 volts.

[0011] Alternatively or additionally, the method may further include closing one or more normally open relays when it is determined that the treatment component is actively involved in performing a treatment procedure on the patient, wherein the one or more normally open relays electrically connect one or more sensing electrodes to the sensing circuit system when closed. The method may further include opening the one or more normally open relays when it is determined that the treatment component is not actively involved in performing a treatment procedure on the patient, wherein the one or more normally open relays electrically isolate one or more sensing electrodes from the sensing circuit system when open.

[0012] Alternatively or additionally, one or more electrical signals may be low-impedance measurement signals for measuring impedance less than 10K ohms.

[0013] Alternatively or additionally, one or more low-impedance measurement signals may correspond to clot impedance measurement signals and / or blood coagulation measurement signals.

[0014] Alternatively or additionally, the medical device may include a thrombectomy device, and the treatment procedure may include a thrombectomy procedure.

[0015] Alternatively or additionally, the method may further include enabling a switch to switch between enabling the treatment component to actively participate in performing a treatment procedure on the patient and not enabling the treatment component to actively participate in performing a treatment procedure on the patient.

[0016] Alternatively or additionally, the switch may be a manually operated switch that is manually operated by the operator of the medical device.

[0017] Alternatively or additionally, the switch can be operated by wired or wireless control signals provided by the medical device.

[0018] Another example can be found in a medical device for performing treatment procedures on a patient. The medical device includes a treatment component for performing treatment procedures on a patient, the treatment component including a sensing circuitry system for sensing electrical signals from one or more sensing electrodes placed on and / or inside the patient. The medical device includes a control switch for switching between actively engaging the treatment component in performing treatment procedures on the patient and disengaging the treatment component from actively performing treatment procedures on the patient. The medical device includes a sensing circuitry protection switch operatively coupled between one or more sensing electrodes of the treatment component and the sensing circuitry system. The sensing circuitry protection switch is configured to electrically connect one or more sensing electrodes to the sensing circuitry system when the control switch engages the treatment component in actively performing treatment procedures on the patient; and to electrically disconnect one or more sensing electrodes from the sensing circuitry system when the control switch disengages the treatment component from performing treatment procedures on the patient.

[0019] Alternatively or additionally, the sensing circuit protection switch may include one or more relays for selectively connecting one or more sensing electrodes of the treatment component to the sensing circuit system when in a closed state, and selectively isolating one or more sensing electrodes of the treatment component from the sensing circuit system when in an open state.

[0020] Alternatively or additionally, one or more relays may switch between an open and closed state based on the position of a control switch.

[0021] Another example can be found in a defibrillation protection device for a medical device. This defibrillation protection device may include a housing. One or more signal inputs are accessible from outside the housing and are used to receive one or more low-impedance measurement signals from one or more sensing electrodes, the low-impedance measurement signals measuring an impedance of less than 10 kΩ. One or more signal outputs are accessible from outside the housing and are used to transmit the one or more low-impedance measurement signals to the sensing circuitry of the medical device. The defibrillation protection device includes a control input and a defibrillation protection circuit housed in the housing and operatively coupled between the one or more signal inputs and the one or more signal outputs. The defibrillation protection circuit is configured to: electrically connect the one or more signal inputs to the one or more signal outputs when the control input is in a first state; and electrically disconnect the one or more signal inputs from the one or more signal outputs when the control input is in a second state.

[0022] Alternatively or additionally, this control input may correspond to a manually operated switch.

[0023] Alternatively or additionally, the control input may correspond to a wired or wireless signal provided by the medical device, which indicates when the medical device actively participates in performing treatment procedures on the patient.

[0024] Alternatively or additionally, the defibrillation protection circuit may include one or more relays that, when the control input is in a first state, close to electrically connect one or more signal inputs to one or more signal outputs, and when the control input is in a second state, open to electrically disconnect one or more signal inputs from one or more signal outputs.

[0025] The above overview of some example embodiments is not intended to describe every disclosed embodiment or every implementation of this disclosure. Attached Figure Description

[0026] This disclosure can be more fully understood by taking into consideration the following detailed description of different embodiments in conjunction with the accompanying drawings, in which:

[0027] Figure 1 It is a three-dimensional diagram illustrating the thrombectomy system;

[0028] Figure 2 yes Figure 1 A partially exploded stereoscopic view of a part of a thrombectomy system;

[0029] Figure 3 This is a schematic diagram of a part of an illustrative thrombectomy system;

[0030] Figure 4 It is a schematic block diagram illustrating a medical device;

[0031] Figure 5 It shows that it can be used Figure 4 A flowchart illustrating the illustrative methods performed by the illustrative medical device;

[0032] Figure 6 This is a schematic block diagram illustrating an illustrative defibrillation protection device;

[0033] Figure 7 It shows, as Figure 3 A schematic diagram illustrating an illustrative embodiment of the sensing circuit protection switch; and

[0034] Figure 8 It shows, as Figure 3 The diagram shows an illustrative circuit diagram of the sensing circuit protection switch.

[0035] While this disclosure can be modified and alternatively implemented in various ways, its details have been illustrated by way of example in the accompanying drawings and will be described in detail. However, it should be understood that it is not intended to limit all aspects of this disclosure to the specific embodiments described. Rather, it is intended to cover all modifications, equivalents, and alternatives that fall within the spirit and scope of this disclosure. Detailed Implementation

[0036] This document assumes that all numerical values ​​are modified by the term "about," whether explicitly stated or not. The term "about" generally refers to a range of numerical values ​​that a person skilled in the art would consider equivalent to the listed values ​​(e.g., having the same function or result). In many cases, the term "about" can indicate a numerical value that includes rounding to the nearest significant figure.

[0037] Enumerating numerical ranges by endpoints includes all numerical values ​​within that range (for example, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0038] Although some suitable dimensions, ranges and / or values ​​relating to various components, features and / or specifications are disclosed, those skilled in the art inspired by this disclosure will understand that expected dimensions, ranges and / or values ​​may deviate from those explicitly disclosed.

[0039] As used in this specification and the appended claims, unless the context clearly indicates otherwise, the singular forms “a” and “the” include plural references. As used in this specification and the appended claims, the term “or” is generally used in its sense that it includes “and / or”, unless the context clearly indicates otherwise.

[0040] The following detailed description should be read with reference to the accompanying drawings, in which the same elements in different drawings are given the same reference numerals. The description and drawings (not necessarily drawn to scale) depict illustrative embodiments and are not intended to limit the scope of this disclosure. The depicted illustrative embodiments are intended to be exemplified only. Unless expressly indicated otherwise, selected features of any illustrative embodiment may be incorporated into additional embodiments.

[0041] A defibrillation protection circuit for a medical device is disclosed. In some cases, the defibrillation protection circuit is deactivated (e.g., allowing sensing signals to pass through) when the medical device is involved in delivering treatment to a patient, and activated (e.g., blocking sensing signals from passing through) when the medical device is not involved in delivering treatment to a patient. In some cases, the defibrillation protection circuit is configured to protect a sensing circuit that senses signals representing low-impedance measurements (e.g., less than 50 kiloohms), such as signals indicating blood clots, blood clotting, and / or the like during thrombectomy or other medical procedures. It is conceivable that this defibrillation protection circuit can be used in conjunction with a wide variety of medical devices, including, for example, thrombectomy systems, intracardiac signal detection / mapping, ECG, electrical impedance tomography (EIM), electrical impedance tomography, bipolar RF ablation, irreversible electroporation, and other devices. For specific examples, the use of the defibrillation protection circuit in a thrombectomy system is described below.

[0042] Thrombectomy catheters and systems can be used to remove thrombi, plaques, lesions, clots, etc. from veins or arteries. Figure 1 This is a perspective view of an illustrative thrombectomy system 10. The thrombectomy system 10 may include a control console 12 (including a drive unit) and a pump / catheter assembly 14. In some instances, the pump / catheter assembly 14 may be a disposable single-use device, wherein a new pump / catheter assembly 14 can be used with the console 12 for each medical procedure. The console 12 may include a housing enclosing the internal structure of the console 12. Multiple removable panels 16a-16n are shown surrounding and along the internal structure of the console 12. The illustrative console 12 is described in U.S. Patent No. 7,935,077, owned by the same assignee, entitled “THROMBECTOMY CATHETER DEPLOYMENT SYSTEM,” the disclosure of which is hereby incorporated by reference. Located at the center of console 12 and aligned with the lower region of panel 16g are automatically opening loading hatch assemblies (not explicitly shown). These loading hatch assemblies open to expose the interior of console 12 for access to carriage assembly 22 and close during use of pump / catheter assembly 14. Illustrative loading hatches and assemblies are described in U.S. Patent Application No. 63 / 452,517, entitled “Thrombectomy System with Loading Bay Doors,” owned by the same assignee, the disclosure of which is hereby incorporated by reference.

[0043] Console 12 may include a catch basin or drip tray 24 for collecting fluid leaks from components of pump / catheter assembly 14. In some instances, drip tray 24 may be removable. Other configurations of the catch basin are also envisioned. Drip tray 24 and / or receiving portion 26 may together support and accommodate an effluent collection bag, such as effluent collection bag 28 of pump / catheter assembly 14. In other instances, console 12 may include different configurations, such as hooks for suspending effluent collection bag 28 or shelves for placing effluent collection bag 28. An effluent waste tube 68 may also be positioned between tube guides in roller pump 40, wherein effluent collection bag 28 is connected to effluent waste tube 68. The effluent collection bag 28 may be appropriately positioned for collecting effluent during medical procedures. The pump rollers (not shown) of the roller pump 40 can be rotatably engaged with the effluent waste pipe 68 to control the flow of the effluent material through the effluent waste pipe 68 to the effluent collection bag 28.

[0044] In an example where the carriage assembly 22 is movable, a carriage assembly enable switch (not explicitly shown) may be provided on the console 12, such as on panel 16g, to selectively position the carriage assembly 22 inward or outward. In other examples, a control panel and / or user interface 32 may be used to position or move the carriage assembly 22. The console 12 may be provided with a user interface 32 including memory and / or processing power, such as located in the upper region of the console 12, between the upper regions of the upper side panels 16e and 16f. The user interface 32 may be a guided user interface (GUI) including a touchscreen display, allowing the user to provide input to the user interface 32 and view information on the same display screen. However, this is not necessary. In other examples, user input may be separate from the display screen.

[0045] Saline bag hooks 34 and 36 can extend through panels 16e and 16f to suspend saline bags thereon. The console 12 may include a handle 42, as well as multiple wheels 52a-52n and a brake pedal 54 for locking the wheels to assist medical personnel in operating the console 12.

[0046] exist Figure 1In this configuration, the pump / catheter assembly 14 is shown separate from the console 12. The pump / catheter assembly 14 includes an inflow pump 56 and a thrombectomy device 58. In some embodiments, the inflow pump 56 may be configured to provide fluid inflow through the thrombectomy device 58. During use, a portion of the pump / catheter assembly 14 may be secured within a portion of the console 12. In some embodiments, the pump / catheter assembly 14 may include an air bubble trap 60 attached to the inflow pump 56, a connecting manifold assembly 62 connected to the air bubble trap 60, a fastener 140, an effluent return tube 66 connecting the connecting manifold assembly 62 and the thrombectomy device 58, a high-pressure fluid supply tube 64 (which may be coaxially arranged inside the effluent return tube 66) attached between the output of the inflow pump 56 and the thrombectomy device 58, a transition fastener 69 between the distal end of the effluent return tube 66 and the proximal end of the thrombectomy device 58, an effluent waste tube 68 connecting the effluent collection bag 28 to the connecting manifold assembly 62, and a fluid supply tube 70 having a bag puncture needle 71 that connects a fluid supply bag (e.g., a saline bag) (not explicitly shown) to the connecting manifold assembly 62. The fluid supply tube 70 may be in fluid communication with the interior of the bubble trap 60 to supply fluid from the fluid supply bag to the inflow pump 56, and then to the thrombectomy device 58 via the high-pressure fluid supply tube 64.

[0047] The control console 12 may include a reciprocating linear actuator 84 configured to engage the pump piston head 116 of the inflow pump 56 when the inflow pump 56 is engaged with the carriage assembly 22 (see, for example, see...). Figure 2 The reciprocating linear actuator 84 can be disposed inside the control console 12 and, when the inflow pump 56 is disposed inside the control console 12, can be coupled with the pump piston head 116 (e.g., Figure 2 Alignment. The reciprocating linear actuator 84 can be actuated such that the reciprocating (e.g., up and down) stroke of the reciprocating linear actuator 84 drives the inflow pump 56 in response to the activation of a user-enabled switch (not explicitly shown) or a control command from the controller 33. In some embodiments, the user-enabled switch may be a foot switch. In some embodiments, when the user-enabled switch is pressed, the reciprocating linear actuator 84 and / or the inflow pump 56 is enabled and / or operated, and when the user-enabled switch is released, the reciprocating linear actuator 84 and / or the inflow pump 56 stops and / or ceases operation.

[0048] The console 12 may include a controller 33 that electronically communicates with the user interface 32, the reciprocating linear actuator 84, the inflow pump 56, and / or the thrombectomy device 58. In some cases, the controller 33 may be part of or otherwise integrated into the user interface 32. In some embodiments, the console 12 and / or the controller 33 may include a data acquisition device 35. In some embodiments, the data acquisition device 35 may be disposed within the console 12. For example, the data acquisition device 35 may be positioned on or near the carriage assembly 22. In some embodiments, the data acquisition device 35 may be configured to communicate wirelessly. Other configurations are also contemplated. The data acquisition device 35 may be a radio frequency identification reader and / or a barcode reader. Other types of data acquisition devices 35 may be used as needed. In some embodiments, a user enable switch may electronically communicate with the console 12 and / or the controller 33. In some embodiments, the user enable switch may electronically communicate with the console 12 and / or the controller 33 via a wire or cable. In some embodiments, the user enable switch may electronically communicate with the console 12 and / or the controller 33 wirelessly.

[0049] Figure 2 It is the pump / conduit assembly 14 (e.g., Figure 1 A partially exploded perspective view of several components (typically including inflow pump 56, bubble trap 60, connecting manifold assembly 62, and fastener 140) of the carriage assembly 22. The inflow pump 56 is centered on a tubular body 112. Components are positioned around the lower region of the tubular body 112, including a base 109 having an upper portion 110 and a lower portion 111, both positioned around the lower region of the tubular body 112. An annular surface 117 is included at the top of the upper portion 110 of the base 109 for contact with the carriage assembly 22 (e.g., ...). Figure 1 The capturing tabs are in close contact to retain the inflow pump 56 within and / or engage with the carriage assembly 22. A top body 114 is positioned around the upper region of the tubular body 112. For example, the base 109, the top body 114, and the connecting panel 115 may be molded or otherwise suitably constructed to surround a large portion of the tubular body 112.

[0050] In some embodiments, the pump / catheter assembly 14 may also include a data board 113 for including barcodes, radio frequency identification (RFID) tags, data storage chips, information displays, etc., to store, transmit, and / or otherwise determine specifications and / or operating parameters associated with the pump / catheter assembly 14, the thrombectomy device 58, the inflow pump 56, and / or its components. In at least some embodiments, the data acquisition device 35 (e.g., Figure 1The data acquisition device 35 can be configured to communicate with the data board 113 (e.g., barcode, RFID tag, data storage chip, etc.), pump / catheter assembly 14, thrombectomy device 58, inflow pump 56, etc., to obtain specifications and / or operating parameters associated with the pump / catheter assembly 14, thrombectomy device 58, inflow pump 56, etc., and / or their components. In some embodiments, the data acquisition device 35 (e.g., Figure 1 The device can be configured to communicate with data board 113 (e.g., barcode, RFID tag, data storage chip, etc.), pump / catheter assembly 14, thrombectomy device 58, inflow pump 56, etc., to obtain identification information associated with it and stored in the memory of user interface 32 and / or controller 33, relating to specifications and / or operating parameters. The identification information can be used by user interface 32 and / or controller 33 to access the specifications and / or operating parameters stored in memory associated with the pump / catheter assembly 14, thrombectomy device 58, inflow pump 56, etc., in use.

[0051] In some embodiments, the inflow pump 56 may include a hemispherical pump piston head 116 having a flexible sheath 118 that connects to and extends between the top body 114 and the pump piston head 116. In some instances, the lower portion 111 of the base 109 may serve as a mounting base for the first end of the bubble trap 60.

[0052] The connecting manifold assembly 62 can be directly attached to the second end of the bubble trap 60, and in some instances, may include a support 120 comprising a fluid (e.g., brine) inlet port 122, an effluent outlet port 124, a Luer-type effluent return port 126 and / or an auxiliary port 128, and a cap 130. Connectors 132 and 134 extending between the connecting manifold assembly 62 and the upper portion 110 of the base 109 are also shown.

[0053] The bubble trap 60 may include two mating halves, with a first bubble trap half 60a shown. A hydrophobic filter 136 may be included in the upper forward region of the first bubble trap half 60a. In some embodiments, a second hydrophobic filter may be included on the second bubble trap half (not explicitly shown), opposite to the hydrophobic filter 136 on the first bubble trap half 60a.

[0054] The fastener 140 and its associated components assist in supporting and connecting the effluent return pipe 66 to the effluent return port 126 via the connector 142, which is continuously coupled to the connecting pipe 144, and also assist in supporting, threading, and connecting the fluid supply pipe 70 to the fluid inlet port 122. The fastener 140 may include outwardly extending, vertically aligned, and opposing tabs 141a and 141b that prevent the fastener 140 and the associated effluent return pipe 66 and fluid supply pipe 70, which house the high-pressure fluid supply pipe 64, from contacting the roller pump 40 disposed on the control console 12 (e.g., ...). Figure 1 Roller pumps, for example, are located in or adjacent to carriage assembly 22.

[0055] In some embodiments, the effluent waste pipe 68 may be positioned within and / or through the roller pump, wherein the effluent collection bag 28 (e.g., Figure 1 The effluent collection bag 28 can be appropriately positioned to collect effluent during the procedure. The pump rollers of the roller pump 40 can engage the effluent collection bag 68 to control the flow of effluent from the effluent outlet port 124 through the effluent collection bag 68 to the effluent collection bag 28. In some embodiments, other pump types and / or configurations may be used instead of the roller pump.

[0056] At appropriate times, a perfusion procedure can be performed on the thrombectomy device 58 to purge any air from it. For example, the tip of the thrombectomy device 58 can be placed in a bowl of sterile saline or other fluid, and the inflow pump 56 can be operated by actuating the reciprocating linear actuator 84 (e.g., by enabling and / or pressing a user-enabled switch) to perfuse the thrombectomy device 58. Subsequently, a medical professional can insert the thrombectomy device 58 into the patient's vascular system and can begin operation of the thrombectomy system 10, which incorporates the user interface 32 and a user-enabled switch (not shown), as needed. The reciprocating linear actuator 84 is actuated according to operating parameters to influence fluid inflow pressure, pump speed, flow rate, etc., thereby operating the inflow pump 56 to deliver pressurized fluid to the thrombectomy device 58 via a high-pressure fluid supply line 64 located in the effluent return line 66. The supply fluid is directed through the bubble trap 60, can be pressurized by the inflow pump 56, and is directed through the high-pressure fluid supply line 64 to the thrombectomy device 58 for use in thrombectomy procedures or other related procedures. The effluent can be returned to the connecting manifold assembly 62 via the effluent return pipe 66, and collected in the effluent collection bag 28 via the effluent waste pipe 68 (e.g., Figure 1 In this process, this can be controlled by roller pump 40.

[0057] Figure 3A cross-sectional view of the distal region of an example thrombectomy catheter 300 is illustrated. The thrombectomy catheter 300 can be considered as an example of a thrombectomy device 58. In some instances, the thrombectomy catheter 300 may include a tubular member or catheter body 302 extending from a proximal region (not explicitly shown) configured to remain outside the body to a distal region 304. The catheter body 302 may be an illustrative example of the effluent return tube 66 of the aforementioned thrombectomy device 58 or may be in fluid communication with it. A lumen 306 may extend from the proximal region of the catheter body 302 to the distal region 304. The catheter body 302 may terminate at a distally facing distal opening 308 at the distal end of the catheter body 302. In some instances, the distal opening 308 may be located in a plane generally orthogonal to the longitudinal axis of the catheter body 302. In other instances, the distal opening 308 may be located in a plane generally inclined to the longitudinal axis of the catheter body 302.

[0058] The thrombectomy catheter 300 may further include a high-pressure fluid supply tube 310. The high-pressure fluid supply tube 310 may be an illustrative example of the high-pressure fluid supply tube 64 of the aforementioned thrombectomy device 58 or may be in fluid communication with it. The high-pressure fluid supply tube 310 may be disposed within and extend through the lumen 306 of the catheter body 302. The high-pressure fluid supply tube 310 may include a supply tube wall 312 defining a lumen or fluid passage 314 extending through it. In at least some instances, the high-pressure fluid supply tube 310 may have a closed distal end 316. Because of this, fluid can be able to pass distally through the fluid passage 314 without leaving the distal end. The high-pressure fluid supply tube 310 may extend along the length of the catheter body 302, with the distal end 316 located within the lumen 306 of the catheter body 302, proximal to the distal opening 308 at the distal end of the catheter body 302. The proximal end of the high-pressure fluid supply line 310 may be in fluid communication with the pump 56 described herein to supply high-pressure fluid to the fluid passage 314 of the high-pressure fluid supply line 310.

[0059] The thrombectomy catheter 300 may include one or more jet holes 318, which may be defined along the supply tube wall 312. Although Figure 3Only one ejection orifice is depicted, but it will be understood that the supply wall 312 may include one, two, three, four, five, six, or more ejection orifices 318. When the kinetic fluid is infused through the lumen 314 of the supply wall 312, the fluid can be ejected through the ejection orifices (e.g., one or more ejection orifices 318) and generate a proximal-guided suction force through the catheter body 302. Further, entrainment material can enter the distal opening 308 and then be proximal via momentum transfer. As the mixture of ejected kinetic fluid 320 and entrainment material moves proximally, the material can sequentially approach multiple ejection orifices (e.g., one or more ejection orifices 318) positioned along the supply wall 312. Upon interaction with the ejected kinetic fluid 320 from each individual ejection orifice 318, the momentum in the entrainment material mixture can increase, and the thrombus-forming material can more easily flow proximally through the catheter body 302 for removal.

[0060] In some instances, the thrombectomy catheter 300 may include a first electrode 322a positioned within the wall 326 of the catheter body 302 and a second electrode 322b positioned within the wall 326 of the catheter body 302. It is understood that the first electrode 322a may be radially, axially, and / or circumferentially spaced (e.g., offset, etc.) from the second electrode 322b at any location along the catheter body 302 (e.g., longitudinally). As an example, the first electrode 322a and the second electrode 322b may be positioned distally toward surface 325 of the catheter body 302. In some cases, the first electrode 322a and / or the second electrode 322b may be axially positioned along any portion of the distal region 304 of the catheter body 302. For example, the first electrode 322a and / or the second electrode 322b can be positioned anywhere proximal to the distal end of the catheter body 302 (e.g., the first electrode 322a and / or the second electrode 322b can be positioned anywhere proximal to the surface 325 on the distal side of the catheter body 302 within the wall 326 of the catheter body 302). In some cases, the first electrode 322a can be attached to the first lead 324a. The first lead 324a can be positioned within the wall 326 of the catheter body 302. In some instances, the second electrode 322b can be attached to the second lead 324b. The second lead 324b can also be positioned within the wall 326 of the catheter body 302.

[0061] Although the first electrode 322a and the second electrode 322b are shown positioned within the wall 326 of the catheter body 302, it is understood that either the first electrode 322a, the second electrode 322b, or both the first electrode 322a and the second electrode 322b may be positioned substantially flush with the inner surface of the catheter body 302. Furthermore, it is understood that either the first electrode 322a, the second electrode 322b, or both the first electrode 322a and the second electrode 322b may be positioned substantially flush with the outer surface of the catheter body 302. Furthermore, it is understood that either the first lead 324a, the second lead 324b, or both the first lead 324a and the second lead 324b may be positioned substantially flush with the inner surface of the catheter body 302. Furthermore, it is understood that either the first lead 324a, the second lead 324b, or both the first lead 324a and the second lead 324b may be positioned substantially flush with the outer surface of the catheter body 302.

[0062] Figure 3 Further illustration shows that the first lead 324a and the second lead 324b can extend from the first electrode 322a and the second electrode 322b, respectively, through the wall 326 of the catheter body, and ultimately operatively coupled to the sensing circuitry system 342. In some instances, the sensing circuitry system 342 can be separate from the processor 332. In some instances, the sensing circuitry system 342 can be considered part of the processor 332, as shown by the dashed lines surrounding the processor 332 and the sensing circuitry system 342. The thrombectomy system may include an enable switch 350, which can be used to actuate and de-actuate a reciprocating linear actuator 84 to drive the inflow pump 56. The switch 350 may be, for example, a foot switch or a handheld switch. The switch 350 may be wired to the thrombectomy system or may be coupled to the thrombectomy system via a wireless connection. In some cases, when switch 350 is pressed, reciprocating linear actuator 84 and / or inflow pump 56 are enabled and / or operated, and when switch 350 is released, reciprocating linear actuator 84 and / or inflow pump 56 are stopped and / or stopped operating.

[0063] In some instances, switch 350 may be operatively coupled to sensing circuit protection switch 340. Sensing circuit protection switch 340 may be an example of defibrillation protection circuitry for sensing circuit system 342. Sensing circuit protection switch 340 may be configured to selectively connect and disconnect electrodes 322a and 322b from sensing circuit system 342 to protect sensing circuit system 342 from power surges (e.g., defibrillation shock therapy) that may occur when other electrical devices, such as defibrillators, are actuated inside or on a patient. Switch 350 may be coupled to sensing circuit protection switch 340 such that sensing circuit protection switch 340 can determine whether switch 350 is open or closed and control sensing circuit protection switch 340 based on the state of switch 350. In some cases, when switch 350 is closed and the thrombectomy system 10 is involved in delivering treatment to the patient, the sensing circuit protection switch 340 is deactivated (e.g., allowing sensing signals from electrodes 322a and 322b to pass through), and when the thrombectomy system 10 is not involved in delivering treatment to the patient, the sensing circuit protection switch is activated (e.g., blocking sensing signals from electrodes 322a and 322b to pass through). In some cases, the sensing circuit protection switch 340 is configured to introduce a low impedance when the sensing circuit protection switch 340 is deactivated (e.g., allowing sensing signals from electrodes 322a and 322b to pass through) to allow the sensing circuit system 342 to perform low-impedance measurements (e.g., less than 50 kiloohms), such as measurements indicating blood clots or the like during thrombectomy procedures.

[0064] The thrombectomy system 10 can be configured to transmit an electrical signal from processor 332 to first electrode 322a via first wire 324a, whereby the electrical signal travels from first electrode 322a through body material present in a distal region of catheter body 302 (e.g., through body material positioned between first electrode 322a and second electrode 322b), whereby the electrical signal is subsequently received by second electrode 322b. It can be further understood that the electrical signal can then be transmitted from second electrode 322b back to sensing circuitry 342 via second wire 324b. Sensing circuitry 342 can be configured to determine the impedance of this electrical path, which includes the impedance of body material positioned adjacent to first electrode 322a and second electrode 322b. The impedance of body material positioned adjacent to first electrode 322a and second electrode 322b can be less than 50 kΩ, less than 20 kΩ, less than 10 kΩ, less than 1 kΩ, and / or in the range of 100 Ω to 1 kΩ. Because the measurement may be a low-impedance measurement (less than 50 kiloohms), the impedance introduced by the sensing circuit protection switch 340 must be low enough not to mask, interfere with, and / or otherwise significantly reduce the accuracy of the low-impedance measurement of the body material located adjacent to the first electrode 322a and the second electrode 322b.

[0065] In some instances, the sensing circuitry 342 can identify a measure of the impedance (resistive impedance and / or reactive impedance) of bodily material located between the first electrode 322a and the second electrode 322b. Further, the sensing circuitry 342 can be configured to compare the measured impedance with approximate, preset (e.g., pre-programmed) blood impedance ranges and clot (e.g., plaque, thrombus, etc.) impedance ranges. The preset (e.g., pre-programmed) blood impedance ranges and clot (e.g., plaque, thrombus, etc.) impedance ranges can be stored in memory accessible to the sensing circuitry 342. In other examples, the blood impedance ranges and clot (e.g., plaque, thrombus, etc.) impedance ranges can be input into the system 10 by a clinician via a touchpad on the console 330. In other words, the sensing circuitry 342 can be configured to compare the impedance sensed between the first electrode 322a and the second electrode 322b with pre-programmed values ​​for bodily material located adjacent to the first electrode 322a and the second electrode 322b.

[0066] It can be further understood that system 10 can be configured such that when the measured impedance is within the range indicating that the tip of catheter 300 is adjacent to a clot (e.g., plaque, thrombus, etc.), sensing circuitry 342 and / or processor 332 can send a signal to enable the circuitry of starting pump 56. In some cases, sensing circuitry 342 and / or processor 332 may alternatively send a signal to notify the user to start pump 56. As discussed herein, starting pump 56 can cause the driving fluid to be infused through lumen 314 of supply tube wall 312, such that the fluid is ejected through injection orifices (e.g., one or more injection orifices 318) and generates a proximal-guided suction force through catheter body 312 to remove clots (e.g., plaque, thrombus, etc.).

[0067] The sensing circuit protection switch 340 can be configured to protect the low-impedance measurement system so as not to significantly interfere with the low-impedance measurement. The thrombectomy system 10 is an example of a medical device with a circuitry that can benefit from such low-impedance measurements. However, other medical systems can also benefit, including those operating at higher impedance, such as intracardiac signal detection and mapping, electrocardiography (ECG), electrical impedance myometry (EIM), and electrical impedance tomography. In some instances, ablation devices such as bipolar radiofrequency (RF) ablation and irreversible electroporation can benefit from including the sensing circuit protection switch 340. The Farapulse™, commercially available from Boston Scientific, is an example of an electroporation device.

[0068] Figure 4This is a schematic block diagram illustrating an illustrative medical device 360. The illustrative medical device 360 ​​may represent a thrombectomy system 10, a thrombectomy catheter 300, or any of a variety of different medical devices that may benefit from including protective circuitry configured to protect sensitive sensing circuitry from excessive electrical impulses caused, for example, by defibrillator discharge. The illustrative medical device 360 ​​includes a treatment component 362 configured to perform a treatment procedure on a patient. The treatment component 362 includes a sensing circuitry system 364 for sensing electrical signals from sensing electrodes 366 associated with the treatment component 362. The sensing electrodes 366 may be configured to be disposed within the patient's body. In some instances, the sensing electrodes 366 may be configured to be disposed externally to the patient (e.g., on the patient's skin). The sensing circuitry system 364 can be considered as... Figure 3 An example of the sensing circuit system 342 is shown. The sensing circuit protection switch 368 (which can be considered as...) Figure 3 (An example of the sensing circuit protection switch 340 shown) is disposed between the sensing electrode 366 and the sensing circuit system 364. The control switch 370 can be used to actively engage or alternatively actively disengage the sensing circuit protection switch 368, the treatment component 362, and / or the medical device 360, even when the medical device 360 ​​itself is powered. The sensing circuit protection switch 368 can be considered an example of a defibrillation protection circuit.

[0069] In some instances, control switch 370 is operatively coupled to sensing circuit protection switch 368, such that sensing circuit protection switch 368 can determine when control switch 370 is in the open position and when control switch 370 is in the closed position. In some instances, sensing circuit protection switch 368 may be configured to electrically connect sensing electrode 366 to sensing circuit system 364 when treatment component 362 actively participates in performing a treatment procedure on the patient. In some instances, sensing circuit protection switch 368 may be configured to electrically disconnect sensing electrode 366 from sensing circuit system 364 when treatment component 362 is not actively participating in performing a treatment procedure on the patient. In some instances, sensing circuit protection switch 368 may include one or more relays for selectively connecting sensing electrode 366 to sensing circuit system 364 when in a closed state and selectively isolating sensing electrode 366 from sensing circuit system 364 when in an open state. When closed, the relay provides a low-impedance path between the sensing electrode 366 and the sensing circuitry 364, which can be useful when attempting to sense signals indicating low impedance measurements (e.g., less than 50 kiloohms), such as signals indicating blood clots or the like during thrombectomy procedures. In some cases, one or more relays may be toggled between open and closed states based on the position of the control switch 370. The control switch 370 may be a foot switch, a manual switch, and / or any other suitable switch. In some cases, the switch 370 may be activated (e.g., pressed and held) by the operator of the medical device 360 ​​to activate the treatment component 362 of the medical device 360 ​​and deactivate (e.g., allow sensing signals to pass) the sensing circuitry protection switch 368, and deactivated (e.g., released) by the operator of the medical device 360 ​​to deactivate the treatment component 362 of the medical device 360 ​​and activate (e.g., block sensing signals from passing) the sensing circuitry protection switch 368.

[0070] Figure 5 This is a flowchart illustrating an illustrative method 380 that can be performed in a medical device (such as medical device 360). With the medical device powered on, the illustrative method 380 includes determining when a treatment component actively participates in performing a treatment procedure on a patient, as shown in box 382. When it is determined that the treatment component is actively participating in performing a treatment procedure on the patient, one or more sensing electrodes of the treatment component are electrically connected to the sensing circuitry system of the treatment component, as shown in box 384. In some instances, each sensing electrode may be electrically connected to the sensing circuitry system via a corresponding relay in a closed state. When it is determined that the treatment component is not actively participating in performing a treatment procedure on the patient, one or more sensing electrodes of the treatment component are electrically isolated from the sensing circuitry system of the treatment component, as shown in box 386. In some instances, each sensing electrode may be electrically disconnected from the sensing circuitry system via a corresponding relay in an open state.

[0071] In some instances, method 380 may further include filtering the respective electrical signals, as shown in box 388, before each electrical signal transmitted through a corresponding relay in a closed state reaches the sensing circuit system. In some cases, each corresponding relay may be a normally open relay that is switched to its closed state by allowing control current to pass through the relay coil of the corresponding relay. As an example, each corresponding normally open relay may be a high-voltage relay with a rated voltage of at least 5,000 volts. In some instances, one or more electrical signals may be low-impedance measurement signals that measure impedance less than 10,000 (10K) ohms. As an example, one or more low-impedance measurement signals may correspond to clot impedance measurement signals and / or blood coagulation measurement signals. In some instances, the medical device may be a thrombectomy device, and the treatment procedure may include a thrombectomy procedure.

[0072] In some instances, method 380 may include closing one or more normally open relays when it is determined that the treatment component is actively involved in performing a treatment procedure on the patient, wherein the one or more normally open relays electrically connect one or more sensing electrodes to the sensing circuitry system when closed, as shown in box 390. Method 380 may further include opening the one or more normally open relays when it is determined that the treatment component is not actively involved in performing a treatment procedure on the patient, wherein the one or more normally open relays electrically isolate one or more sensing electrodes from the sensing circuitry system when open, as shown in box 392.

[0073] In some cases, method 380 may include an enable switch to toggle between enabling the treatment component to actively participate in the treatment procedure on the patient and closing the corresponding relay, and not enabling the treatment component to actively participate in the treatment procedure on the patient and opening the corresponding relay, as shown in box 394. In some cases, the switch may be a manually operated switch that is manually operated by the operator of the medical device. In some instances, the switch may be operated by a wired or wireless control signal provided by the medical device.

[0074] In some instances, existing medical devices can be retrofitted to include the functionality of a sensing circuit protection switch. Figure 6This is a schematic block diagram illustrating an illustrative defibrillation protection device 400 that can be used in conjunction with any of a variety of different medical devices. The defibrillation protection device 400 includes a housing 402. The defibrillation protection device 400 includes a signal input terminal 404 accessible from the outside of the housing 402. The signal input terminal 404 is configured to receive one or more low-impedance measurement signals from sensing electrodes 406 located outside the housing 402. In some cases, the low-impedance measurement signals can measure an impedance of less than 10 kΩ. The defibrillation protection device 400 includes a signal output terminal 408 accessible from the outside of the housing 402. The signal output terminal 408 is configured to transmit one or more low-impedance measurement signals to sensing circuitry 410 located outside the housing 402. A control input terminal 412 is disposed within the housing 402 and accessible from the outside of the housing 402, such that the control input terminal 412 can receive a signal from a switch 414. For example, a signal from switch 414 can provide an indication of whether switch 414 is in an open or closed position. In some instances, the switch 414 connected to control input 412 may be a manually operated switch. In other cases, the switch 414 connected to control input 412 may be a wired or wireless signal provided by the medical device, indicating when the medical device actively intervenes to perform a treatment procedure on the patient.

[0075] The housing 402 houses a defibrillation protection circuit 416. The defibrillation protection circuit 416 is operatively coupled between a signal input terminal 404 and a signal output terminal 408, and is configured to electrically connect the signal input terminal 404 and the signal output terminal 408 when the control input terminal 412 is in a first state, and to electrically disconnect the signal input terminal 404 and the signal output terminal 408 when the control input terminal 412 is in a second state. In some embodiments, the defibrillation protection circuit 416 may include one or more relays, wherein when the control input terminal 412 is in the first state, the one or more relays are closed to electrically connect the signal input terminal 404 and the signal output terminal 408, and when the control input terminal 412 is in the second state, the one or more relays are open to electrically disconnect or isolate the signal input terminal 404 and the signal output terminal 408.

[0076] Figure 7This is a schematic block diagram illustrating an illustrative implementation of a sensing circuit protection circuit 420 (such as sensing circuit protection switch 340, sensing circuit protection switch 368, or defibrillation protection circuit 416). The sensing circuit protection circuit 420 includes a detection and output control circuitry system 422. An actively-held switch 424 can be used to selectively actuate or de-actuate the medical device, and in the illustrated example, it is coupled to the detection and output control circuitry system 422. The sensing circuit protection circuit 420 includes one or more switches 426, labeled 426a and 426b, respectively. Although two switches 426 are shown, this is merely illustrative, as the sensing circuit protection circuit 420 can include any number of switches as needed, each corresponding to a sensing electrode. Each switch 426 can be a normally open, high-isolation switch, isolated when the actively-held switch 424 is not enabled, or when power is off or a fault exists. When enabled, the switch 426 is preferably low-impedance. For example, switch 426 can be a relay, a transistor (e.g., a power FET), etc.

[0077] Each switch 426 is positioned between an input signal 428, labeled 428a and 428b respectively, and an output signal 430, labeled 430a and 430b respectively. For example, the input signal 428 is an incoming signal from a sensing electrode. The output signal 430 is directed to a sensing circuit system (not shown). In some instances, if desired, the output signal 430 may be protected by additional defibrillation electronics before reaching the sensing circuit system (not shown).

[0078] During use, when switch 426 is a normally open relay, and when the actively held switch 424 is pressed and held by the operator to indicate that treatment is being performed, the detection and output control circuitry 422 provides a control current to the coil of the normally open switch 426, causing the normally open switch 426 to close and providing a low-impedance path between the corresponding input signal 428 and the output signal 430. When the operator releases the actively held switch 424 to indicate that treatment is not being performed, the detection and output control circuitry 422 removes the control current supplied to the coil of the normally open switch 426, causing the normally open switch 426 to open and disconnecting or isolating the input signal 428 from the output signal 430. When switch 426 is a normally closed switch, and when the actively held switch 424 is pressed and held by the operator to indicate that treatment is being performed, the detection and output control circuitry 422 does not provide a control current to the coil of the normally closed switch 426, causing the normally closed switch 426 to close and providing a low-impedance path between the corresponding input signal 428 and the output signal 430. When the operator releases the actively held switch 424 to indicate that no treatment has been performed, the detection and output control circuitry 422 provides a control current to the coil of the normally closed switch 426, causing the normally closed switch 426 to open and disconnect or isolate the input signal 428 from the output signal 430. In some cases, the switch 426 may be a latching relay, and the detection and output control circuitry 422 may be configured to provide a temporary state-setting current with the desired polarity to the coil of the relay to set the state of the latching relay to a desired open or closed state based on the action of the actively held switch 424. The latching relay remains in the latched state until the state is changed again by applying a subsequent temporary state-setting current.

[0079] Figure 8 This is a schematic block diagram illustrating an illustrative implementation of a sensing circuit protection circuit 440 (such as a sensing circuit protection switch 340, a sensing circuit protection switch 368, or a defibrillation protection circuit 416). The sensing circuit protection circuit 440 includes an input 442 that receives, for example, a signal from a foot pedal that actuates or de-actuates a corresponding therapeutic component of a medical device. A sensing input 444 receives sensing signals from each of a plurality of sensing electrodes (not shown). A switch 426 selectively allows input signals 428 (e.g., 428a and 428b) from the sensing input 444 to pass through the corresponding switch 426 to an output signal 430 (e.g., 430a and 430b), or prevents input signals 428 from the sensing input 444 from passing through the corresponding switch 426.

[0080] When the foot switch is activated (e.g., closed), the switch electrically connects terminals 441a and 441b, completing a current path from power supply 443 to ground 445 via pull-down resistor 447. This causes node 449 to go low. Inverter 451 inverts this signal and causes relay control node 453 to go high, thereby providing control current to the coils of normally open switches 426a and 426b. This allows the input signal 428 from sensing input 444 to pass through the corresponding switch 426 to the output signal 430 and then to the sensing circuitry (not shown).

[0081] When the foot switch is deactivated (e.g., activated), the switch electrically disconnects terminals 441a and 441b, thereby blocking the current path from power supply 443 to ground 445 through pull-down resistor 447. This causes node 449 to go high. Inverter 451 inverts this signal and causes relay control node 453 to go low, thereby removing the control current supplied to the coils of normally open switches 426a and 426b. This prevents the input signal 428 from sensing input 444 from reaching the sensing circuitry (not shown) through the corresponding switch 426.

[0082] It should be understood that this disclosure is illustrative in many respects only. Changes in detail, particularly in shape, size, and arrangement of steps, may be made without departing from the scope of this disclosure. To the appropriate extent, this may include using any feature of one example embodiment in other embodiments. Of course, the scope of this disclosure is defined by the language of the appended claims.

Claims

1. A method for operating a medical device configured to perform a treatment procedure on a patient, the medical device including a treatment component for performing the treatment procedure on the patient, the treatment component including a sensing circuitry system for sensing electrical signals from one or more sensing electrodes placed on and / or inside the patient by the treatment component, the method comprising: When the medical device is powered on, it is determined when the treatment component actively participates in performing the treatment procedure on the patient; When it is determined that the treatment component actively participates in performing the treatment procedure on the patient, one or more sensing electrodes of the treatment component are electrically connected to the sensing circuit system of the treatment component; as well as When it is determined that the treatment component is not actively involved in performing the treatment procedure on the patient, one or more sensing electrodes of the treatment component are electrically isolated from the sensing circuit system of the treatment component.

2. The method according to claim 1, wherein, When it is determined that the treatment component is not actively involved in performing the treatment procedure on the patient, each of the one or more sensing electrodes is electrically isolated from the sensing circuit system through a corresponding relay that is in the open state.

3. The method according to any one of claims 1 or 2, wherein, When it is determined that the treatment component actively participates in performing the treatment procedure on the patient, each of the one or more sensing electrodes is electrically connected to the sensing circuit system through a corresponding relay that is in a closed state.

4. The method according to any one of claims 2 or 3, further comprising filtering the respective electrical signals before each electrical signal transmitted through the respective relay in the closed state reaches the sensing circuit system.

5. The method according to any one of claims 2 to 4, wherein, Each corresponding relay is a normally open relay, which is switched to its closed state by allowing control current to pass through the relay coil.

6. The method according to any one of claims 1 to 5, wherein, One or more of the electrical signals are low-impedance measurement signals corresponding to clot impedance measurement signals and / or blood coagulation measurement signals.

7. The method according to any one of claims 1 to 6, wherein, The medical device includes a thrombectomy device, and the treatment procedure includes a thrombectomy procedure.

8. The method according to any one of claims 1 to 7, further comprising enabling a switch to switch between enabling the treatment component to actively participate in performing the treatment procedure on the patient and not enabling the treatment component to actively participate in performing the treatment procedure on the patient.

9. The method according to claim 8, wherein, The switch is a manually operated switch that is manually operated by the operator of the medical device.

10. The method according to claim 8, wherein, The switch is operated by a wired or wireless control signal provided by the medical device.

11. A medical device for performing treatment procedures on a patient, the medical device comprising: A treatment component for performing the treatment procedure on the patient, the treatment component including a sensing circuit system for sensing electrical signals from one or more sensing electrodes placed on and / or inside the patient; A control switch, the control switch being used to switch between enabling the treatment component to actively participate in performing the treatment procedure on the patient and enabling the treatment component to disengage from actively performing the treatment procedure on the patient; A sensing circuit protection switch, operably coupled between one or more sensing electrodes of the treatment component and the sensing circuit system, the sensing circuit protection switch being configured to: When the control switch causes the treatment component to actively participate in performing the treatment procedure on the patient, the one or more sensing electrodes are electrically connected to the sensing circuit system; as well as When the control switch disengages the treatment component from performing the treatment procedure on the patient, it electrically disconnects the one or more sensing electrodes from the sensing circuit system.

12. The medical device according to claim 11, wherein, The sensing circuit protection switch includes one or more relays, which are used to selectively connect one or more sensing electrodes of the treatment component to the sensing circuit system when in a closed state, and to selectively isolate one or more sensing electrodes of the treatment component from the sensing circuit system when in an open state.

13. The medical device according to any one of claims 11 or 12, wherein, The one or more relays switch between the open state and the closed state based on the position of the control switch.

14. A defibrillation protection device for a medical device, the defibrillation protection device comprising: case; One or more signal input terminals are accessible from outside the housing, and the one or more signal input terminals are used to receive one or more low-impedance measurement signals from one or more sensing electrodes, the low-impedance measurement signals measuring an impedance of less than 10K ohms; One or more signal output terminals, which are accessible from the outside of the housing, are used to transmit one or more low-impedance measurement signals to the sensing circuit of the medical device. Control input terminal; The defibrillation protection circuit, housed within the housing, is operatively coupled between the one or more signal input terminals and the one or more signal output terminals, and is configured to: When the control input terminal is in the first state, the one or more signal input terminals are electrically connected to the one or more signal output terminals; as well as When the control input terminal is in the second state, the one or more signal input terminals are electrically disconnected from the one or more signal output terminals.

15. The defibrillation protection device according to claim 14, wherein, The defibrillation protection circuit includes one or more relays, wherein when the control input terminal is in the first state, the one or more relays are closed to electrically connect the one or more signal input terminals to the one or more signal output terminals, and when the control input terminal is in the second state, the one or more relays are open to electrically disconnect the one or more signal input terminals from the one or more signal output terminals.

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