Medical device with biasing member

Abstract

A sampling device for use with an endoscope can include a distal portion extendable beyond a distal end of the endoscope, a needle actuator operable to extend or retract a sampling needle from the distal portion, and a biasing member operably coupled to the needle actuator to bias the needle actuator toward a retracted position unless actively engaged by an operator.

Description

Declaration of Priority

[0001] This patent application claims the benefit of priority to U.S. Patent Application Serial No. 63 / 563,669 (Attorney’s File No. 5409.944PRV), filed March 11, 2024, entitled “MEDICAL DEVICE WITH BIASING MEMBER”, filed by Anthony Florindi, and U.S. Patent Application Serial No. 63 / 718,230 (Attorney’s File No. 5409.944PV2), filed November 8, 2024, entitled “MEDICAL DEVICE WITH BIASING MEMBER”, each of which is incorporated herein by reference in its entirety. Technical Field

[0002] The examples described herein generally relate to medical devices. More specifically, the examples described herein generally relate to medical devices having mechanisms for preventing needle insertion in the actuated state. Background Technology

[0003] Traditional sampling devices delivered through the working channel of an endoscope (e.g., a bronchoscope) have several drawbacks. One such problem is the risk of withdrawing the sampling device into the working channel with the needle extended, which could damage the bronchoscope or injure the patient. Another problem is that some needle actuation handles allow for needle withdrawal and insertion regardless of the actuation state, potentially leading to premature needle advancement within the patient. Additionally, if the distal end of the sampling device is within the working channel and the needle is reinserted, it may impinge on the inner wall of the bronchoscope's working channel, potentially causing damage to the needle or the bronchoscope. Summary of the Invention

[0004] In the example, a sampling device for use with an endoscope may include: a distal portion that extends beyond the distal end of the endoscope; a needle actuator operable to extend or retract a sampling needle from the distal portion of the sampling device; and a biasing member operablely coupled to the needle actuator to bias the needle actuator toward the retracted position unless actively engaged by an operator.

[0005] In the example, the medical device may include: a flexible lumen catheter; a device actuator configured to deploy a device within the flexible lumen catheter; and a biasing member configured to bias the device actuator to an undeployed state, wherein, in the undeployed state, the device is retracted within the flexible lumen catheter.

[0006] In the example, a medical device for sampling a patient's tissue may include: an endoscope including a lumen extending to a distal end of the endoscope; a sampling device configured to be inserted into the lumen of the endoscope and beyond the distal end of the endoscope, the sampling device including: a needle actuator operable to deploy a sampling needle through the needle lumen of the sampling device; a distal portion including an ultrasound transducer configured to capture ultrasound images within a field of view; a side-exit oblique channel disposed proximally to the distal portion, the side-exit oblique channel being configured to guide the sampling needle toward the field of view of the ultrasound transducer; and a biasing member coupled to the needle actuator and configured to bias the needle actuator in an undeployed state such that the sampling needle is retracted within the needle lumen. Attached Figure Description

[0007] Various examples are shown in the figures below. Such examples are illustrative and are not intended to be exhaustive or exclusive examples of the subject matter.

[0008] Figure 1 A schematic diagram of an example medical device system is shown.

[0009] Figure 2 A schematic diagram illustrating an example of the imaging and control system of a medical device system is shown.

[0010] Figure 3 A schematic diagram of an example sampling device is shown.

[0011] Figure 4 A partial cross-sectional view of an example sampling device in an unactuated position is shown.

[0012] Figure 5 A partial cross-sectional view of an example sampling device in the actuated position is shown.

[0013] Figure 6A An enlarged view of the distal end of the endoscope and the sampling device in the non-actuated position is shown.

[0014] Figure 6B An enlarged view of the distal end of the endoscope and the sampling device in the actuated position is shown.

[0015] Figure 7 A block diagram is shown illustrating an example of a machine on which one or more examples can be implemented. Detailed Implementation

[0016] The sampling device can be inserted directly into the patient or via another endoscope (e.g., a bronchoscope), forming an endoscope-accessory relationship (sometimes referred to as a mother-daughter relationship) between the bronchoscope and the sampling device. Thus, the endoscope can be inserted into the desired location within the patient. After the endoscope is in the desired position, the sub-device (e.g., the sampling device) can be inserted into the endoscope (e.g., via the working channel) and extend from the distal end of the endoscope. The sub-device can typically have a smaller diameter than the endoscope, allowing it to extend into the patient's passage, which has a smaller diameter than that achievable using the endoscope alone. The sub-device (e.g., the sampling device) can then extend from the distal end of the endoscope to reach a target area within the patient, and instruments of the sub-device (e.g., biopsy needles, ablation probes, etc.) can be deployed to extend from the distal end of the sub-device and obtain tissue samples from the patient and / or (e.g., via ablation, drug delivery, etc.) treat the patient's tissue. Although other use cases are envisioned, this paper primarily discusses the sub-device in the specific context of a sampling device with a side exit port, such that the instrument is a biopsy needle that can extend at an acute angle relative to the longitudinal axis of the sampling device into the patient's tissue.

[0017] To facilitate device deployment, sampling devices may include device actuators (sometimes called needle actuators). Unintended extension of the device from the sampling device can lead to undesirable outcomes. For example, if a sampling device actuator is actuated and the device is reinserted into the sampling device, the device may engage with the patient's tissue along with the endoscope (e.g., the mother device) or the sampling device (e.g., the daughter device). In another example, if the sampling device is actuated and the device is reinserted into the sampling device while the sampling device is inside the endoscope (or other mother device), the device may engage with the mother device, potentially leading to damage to either the device or the mother device.

[0018] Some sampling devices may include removable instruments with a core. The removable instrument can be attached to the sampling device via a Luer connector. The removable instrument allows for the removal of the obtained tissue sample without removing the parent device or sampling device from the target area within the patient. The core can provide support for the instrument during insertion into the patient. The core can also be pulled proximally to create aspiration within the instrument, thereby aiding in sample acquisition within the instrument.

[0019] Unintended deployment of the device from the sampling device may cause the device to extend beyond the distal end of the sampling device before a healthcare professional intends to extend it from the device. Such unintended deployment may cause the device to come into contact with the patient's tissue, which could lead to unintended harm to the patient or make it more difficult to insert the device or needle into the device actuator. If the sampling device remains within the mother device, the device may come into contact with the working channel of the bronchoscope, which may prevent the removable device or needle from attaching to the Luer connector of the device actuator due to the engagement between the device and the working channel of the mother device.

[0020] This disclosure addresses the potential problems discussed above by introducing a sampling device with an improved device actuation mechanism. The sampling device may include a biasing member mounted within the device handle to bias the actuation mechanism toward a non-actuated state. This biasing mechanism ensures that the device automatically retracts when not engaged by a healthcare professional, thereby preventing accidental extension of the device during withdrawal or reinsertion into a bronchoscope or into a patient.

[0021] By preventing the instrument from unintentionally extending from the sampling device, the sampling device disclosed herein reduces the likelihood of patient injury during operation. The sampling device of this disclosure also reduces the likelihood of damage to the bronchoscope or the instrument itself during removal from or insertion of the sampling device from the parent device, as the needle is biased to retract when not actively engaged by a healthcare professional. The biasing member in the actuator also ensures consistent retraction of the instrument, thereby simplifying operation and reducing the chance of operator error by healthcare professionals using the sampling device. The sampling device of this disclosure is also designed to be compatible with current medical devices and can be seamlessly integrated into existing workflows without requiring significant changes to standard operating procedures.

[0022] The foregoing discussion is intended to provide an overview of the subject matter of this patent application. It is not intended to provide an exclusive or exhaustive description of the invention. The following description is included to provide additional information regarding this patent application.

[0023] Figure 1 This is a schematic diagram of an endoscope system 100, which may include: a control system 102; and an endobronchial ultrasound sampling device, which includes an endoscope 104 and a medical device 108, which may be attached to the endoscope 104 and includes a distal end 110 extending from the distal end of the endoscope 104 via a distal working channel port (e.g., working channel port 112). Figure 1 The system described herein is an illustrative example of an endoscope system suitable for use with the systems, apparatus and methods described herein.

[0024] Endoscope 104 may be insertable into an anatomical region for imaging, or (e.g., via tethering) attached to one or more sampling devices for biopsy or for treating a disease condition associated with the anatomical region. Endoscope 104 may engage with or be connected to control system 102. Endoscope 104 is described in this example as a bronchoscope, but other types of endoscopes for use with the features and teachings of this disclosure are contemplated. Control system 102 may include control unit 114, display unit 116, input unit 118, light source 120, fluid source 122, and suction pump 124.

[0025] The control system 102 may include various ports for coupling with the endoscope system 100. For example, the control unit 114 may include a data input port for receiving data from the endoscope 104 and a data output port for transmitting data to the endoscope 104. The light source 120 may include an output port for transmitting light, for example, via an optical fiber link, to the endoscope 104. The fluid source 122 may include a port for transmitting fluid to the endoscope 104. The fluid source 122 may include, for example, a pump and a fluid tank, or may be connected to an external tank, container, or storage unit. The suction pump 124 may include a port for evacuating the endoscope 104 to generate suction, for example, for drawing fluid from an anatomical region in which the endoscope 104 is inserted. The display unit 116 and the input unit 118 may be used by the operator of the endoscope system 100 to control the functions of the endoscope system 100 and view the output of the endoscope 104. The control unit 114 may also generate signals or other outputs for treating the anatomical region in which the endoscope 104 is inserted. In the example, the control unit 114 can generate electrical output, acoustic output, fluid output, etc., for treating anatomical areas by means of methods such as cauterization, cutting, or freezing.

[0026] Endoscope 104 may include an insertion section 126, a functional section 128, and a handle section 130, which may be coupled to a cable section 132 and a coupler section 134. The insertion section 126 may extend distally from the handle section 130, and the cable section 132 may extend proximally from the handle section 130. The insertion section 126 may be elongated and include a curved section and a distal end to which the functional section 128 may be attached. The curved section may be controllable (e.g., controlled by a steering controller 136 on the handle section 130) to manipulate the distal end through tortuous anatomical pathways (e.g., stomach, duodenum, kidney, ureter, trachea, lung, etc.). The insertion section 126 may also include one or more working channels (e.g., internal lumens), which may be elongated and may support the insertion of one or more therapeutic instruments (e.g., a bronchoscope) into the functional section 128. The working channel can extend between the handle section 130 and the functional section 128. Additional functions, such as fluid passages, guide wires, and traction wires, can also be provided by the insertion section 126 (e.g., via suction or flushing passages).

[0027] The coupler section 134 can be connected to the control unit 114 to connect the endoscope 104 to various features of the control unit 114, such as the input unit 118, the light source 120, the fluid source 122, and the suction pump 124.

[0028] Handle section 130 may include a steering controller 136 and a port 138. Steering controller 136 may be a knob, lever, or other actuation mechanism for navigating endoscope 104 within the patient's body. Steering controller 136 may be connected to a traction cable or other actuation mechanism extending through insertion section 126. Port 138 and other ports may be configured to couple various cables, guide wires, auxiliary endoscopes, tissue collection devices, fluid tubing, etc., to handle section 130, for example, for coupling with insertion section 126. Port 140 may be configured to receive medical device 108 and guide medical device 108 to working channel port 112. Figure 1 and Figure 2 The example shown is an example of endoscope 104.

[0029] According to the example, the control system 102 can be configured to include a light source 120, a suction pump 124, and an image processing unit 202. Figure 2 On the moving platform of the shelves (e.g., trolley 142), etc. Alternatively, Figure 1 and Figure 2 The components of the control system 102 shown can be directly mounted on the endoscope 104, so that the endoscope is "self-contained".

[0030] Functional segment 128 may include components for treating and diagnosing a patient’s anatomy. Functional segment 128 may include an imaging device 144 (e.g., a tip-on-chip image sensor based on complementary metal-oxide-semiconductor (CMOS), an illumination device 146 (e.g., a light-emitting diode), and a working channel port 112 located at the distal end of functional segment 128.

[0031] like Figure 1 As shown, medical device 108 can extend from the working channel port 112 at the distal end face of the functional segment 128 of endoscope 104. Medical device 108 can be configured to attach to port 140 such that it extends through the working channel of endoscope 104 (e.g., through the insertion segment 126 to the working channel port 112) and protrudes from the distal end of endoscope 104. Medical device 108 may include: a sheath extension mechanism 148 for advancing or retracting the insertion segment 126 within the working channel to control how far the distal end of medical device 108 extends distally from the working channel port 112; an instrument actuator 150 (e.g., for actuating a biopsy needle from a side exit port of medical device 108); and a distal end 110. Sheath extension mechanism 148 can be configured to extend medical device 108 beyond the distal end of endoscope 104, for example, to navigate medical device 108 to a target area within a patient's body. The sheath extension mechanism 148 can slide along the housing 152 of the medical device 108. The housing 152 may include markings that indicate the amount of extension of the medical device 108 beyond the distal end of the endoscope 104 (e.g., beyond the working channel port 112). The instrument actuator 150 can be configured to extend an instrument from the medical device 108 to obtain a tissue sample from the patient. The biasing member 404 (first in...) Figure 4 (As shown in the diagram) It can be coupled to instrument actuator 150 to bias instrument actuator 150 to an undeployed position. The distal end 110 of medical device 108 may include a transducer (or other imaging device) and a side exit port located at the proximal end of the transducer for guiding an instrument configured to obtain a tissue sample from a patient to the transducer's field of view. Medical device 108 will be discussed in more detail herein.

[0032] Figure 2 It includes a control system 102 and an endobronchial ultrasound device. Figure 1 A schematic diagram of an endoscope system 100, the endobronchial ultrasound device including an endoscope 104 and a medical device 108 extendable via a distal working channel port of the endoscope 104. Figure 2Components of a control system 102 coupled to an endoscope 104 are schematically shown. The control system 102 may include a control unit 114, which may include or be coupled to an image processing unit 202, a treatment generator 204 and a drive unit 206, as well as a light source 120, an input unit 118 and a display unit 116. The control unit 114 may include, or communicate with, an endoscope, surgical instruments and an endoscopic system, which may include means configured to engage tissue and collect and store a portion of that tissue, and an imaging device (e.g., a camera device) may be used to observe target tissue via the endoscope, surgical instruments and the endoscopic system through materials and components including optical enhancements. The control unit 114 may be configured to activate the camera device to view target tissue distal to the endoscopic system. Similarly, control unit 114 can be configured to enable light source 120 to illuminate a surgical instrument, which may include selected components configured to reflect light in a particular manner, such as a tissue cutter enhanced with reflective particles.

[0033] Coupler section 134 can be connected to control unit 114 to connect endoscope 104 to various features of control unit 114, such as image processing unit 202, treatment generator 204, etc. In this example, port 138 can be used to insert another instrument or device (e.g., a sub-scope or auxiliary scope, or a sampling needle, biopsy needle, ablation instrument, scalpel, etc.) into endoscope 104. Such instruments and devices can be independently connected to control unit 114 via cable section 132. In this example, port 140 can be used to connect coupler section 134 to various inputs and outputs, such as video, air, light, and electricity.

[0034] Image processing unit 202, ultrasound image processing unit 208, and light source 120 can each be coupled to endoscope 104 (e.g., at functional section 128) or medical device 108 via wired or wireless connections. Therefore, control system 102 can illuminate the anatomical region, collect signals representing the anatomical region, process the signals representing the anatomical region, and display an image representing the anatomical region on display unit 116. Ultrasound image processing unit 208 can be configured to receive ultrasound signals from either endoscope 104 or medical device 108, which can be converted into an ultrasound image and transmitted to display unit 116 or any other component of endoscope system 100. Control system 102 may include light source 120 illuminating the anatomical region using light of a desired spectrum (e.g., broadband white light, narrowband imaging using electromagnetic wavelengths, etc.). Control system 102 can be connected to endoscope 104 (e.g., via endoscope connector) for signal transmission (e.g., light output from the light source, video signals from the imaging system in the distal end, diagnostic and sensor signals from diagnostic devices, etc.).

[0035] Fluid source 122 ( Figure 1 The endoscope 104 (shown in the diagram) can communicate with control unit 114 and may include one or more air sources, saline sources, or other fluid sources, as well as associated fluid paths (e.g., air passages, flushing passages, suction passages, etc.) and connectors (barbed fittings, fluid seals, valves, etc.). Control system 102 may also include drive unit 206, which may include a motorized actuator for advancing the distal segment of endoscope 104.

[0036] Figure 3 Sampling device 300 is shown (e.g., medical device 108, see...). Figure 1 The above is a schematic diagram of an example. The sampling device 300 may include a sheath extension mechanism 302, a housing 304, an instrument actuator 306, and an engagement depth setter 308.

[0037] The sheath extension mechanism 302 can be configured to control the sampling device 300 within the endoscope (e.g., endoscope 104, see...). Figure 1 The sampling device 300 extends and retracts within its working channel. The housing 304 can form the main body of the sampling device 300 and can accommodate internal components.

[0038] The instrument actuator 306 is operable to extend or retract the sampling needle from the distal portion of the sampling device 300. The instrument actuator 306 may include a handle configured to be held by an operator and may be designed to provide precise control over the position of the instrument relative to the distal end of the sampling device throughout the surgical procedure.

[0039] The engagement depth setter 308 can be configured to be engaged by a user (e.g., a medical professional) to actuate the device actuator 306 and disengage the device from the medical device. Figure 1 The distal end 110 () Figure 1 The engagement depth setter 308 can extend from the interior to the exterior of the instrument actuator 306 so that a medical professional using the sampling device 300 can access the engagement depth setter 308.

[0040] Engagement depth setter 308 can serve as an interface between instrument actuator 306 and a medical professional, facilitating controlled movement of the instrument for the sampling procedure. Engagement depth setter 308 can operate in conjunction with instrument actuator 306 to extend and retract the instrument from the distal end of sampling device 300 (e.g., distal end 110 of medical device 108). When a medical professional actuates engagement depth setter 308, engagement depth setter 308 can translate engagement from the medical professional into the linear movement required to advance or retract the instrument relative to the distal end of sampling device 300. Therefore, engagement depth setter 308 enables the medical professional to precisely control the position of the instrument relative to the distal end of the sampling device throughout the surgical procedure.

[0041] The engagement depth setter 308 can be designed to ensure a secure and stable connection between the medical professional and the instrument. Therefore, the engagement depth setter 308 can withstand forces applied during actuation without slipping or disengaging, which could lead to unintended needle movement. The material and geometry of the engagement depth setter 308 can be selected to provide durability and reliability throughout the device's lifespan.

[0042] Figure 4 A partial cross-sectional view of an example of a sampling device 300 in the non-actuated position 402 is shown. The sampling device 300 may include a sheath extension mechanism 302, a housing 304, an instrument actuator 306, an engagement depth setter 308, and a biasing member 404.

[0043] A biasing member 404 may be mounted within the instrument actuator 306 and may be configured to bias the instrument actuator 306 in a non-actuated position 402. In an example, the biasing member 404 may include a spring mechanism that allows operation of the instrument actuator 306 when the engagement depth setter 308 is engaged by a medical professional. The biasing member 404 (e.g., the length of the biasing member 404 or the stiffness of the spring mechanism) may be adjusted to determine the magnitude of the force required to be applied to the engagement depth setter 308 to operate the instrument actuator 306.

[0044] The biasing member 404 can be configured to automatically bias the instrument actuator 306 toward the non-actuated position 402. When a medical professional engages and operates the sampling device 300 into the non-actuated position 402, the biasing member 404 can compress and allow the instrument to extend beyond the distal end of the sampling device to obtain tissue samples from the target site of a surgical procedure. When the medical professional disengages from the engagement depth setter 308, the biasing member 404 can return the instrument actuator 306 (and more specifically, the engagement depth setter 308) to the non-actuated position 402, which allows the instrument to be retracted within the distal end of the sampling device 300. The automatic bias toward the non-actuated position 402 provided by the biasing member 404 simplifies the operation of the sampling device 300. For example, the biasing member 404 eliminates the need for the operator to manually ensure that the instrument actuator 306 is in the non-actuated position 402, and therefore, the instrument is retracted within the distal end of the sampling device 300 before withdrawal or reinsertion into the bronchoscope.

[0045] The biasing member 404 can also provide a consistent biasing force for the engagement depth setter 308, which can make the operation of the sampling device 300 more predictable and reliable. Therefore, medical professionals can become accustomed to the consistency of the pressure required to actuate the engagement depth setter 308 and move the device actuator 306 to the actuation position 502. Figure 5 The biasing member 404 can provide a fail-safe mechanism that ensures that: when a medical professional is removing endoscope 104 from a patient (… Figure 1 In the event that the sampling device 300 is interrupted or distracted while it is being removed from or inserted into the endoscope 104, the instrument retracts within the distal end of the sampling device 300 to move the sampling device 300 to the safest operating mode (e.g., non-actuated position 402) without the need for intervention by a medical professional.

[0046] The sampling device 300 may include anti-warping features 406 within the housing 304 to help ensure alignment and prevent warping of the bias member 404. These anti-warping features 406 may be configured to engage with the bias member 404 and maintain the proper orientation of the bias member 404 during operation of the instrument actuator 306. The anti-warping features 406 may include structures such as internal ribs, guides, or channels that can constrain lateral movement of the bias member 404 while allowing the bias member 404 to compress and extend along the longitudinal axis of the sampling device 300. By preventing lateral deformation or misalignment of the bias member 404, the anti-warping features 406 help ensure consistent and reliable operation of the instrument actuator 306, thereby maintaining the intended bias force toward the non-actuated position 402. These features may also potentially extend the operational life of the bias member 404 by reducing wear and stress from improper bending or warping during repeated actuation of the sampling device 300.

[0047] Figure 5 A partial cross-sectional view of an example of a sampling device 300 in the actuated position 502 is shown. In this view, the internal components of the sampling device 300 are shown, highlighting the interactions between various elements when the device is in the actuated state.

[0048] The sampling device 300 may include a sheath extension mechanism 302, a housing 304, an instrument actuator 306, an engagement depth setter 308, a biasing member 404, and an anti-warping feature 406. In the actuated position 502, the instrument actuator 306 may be moved to the actuated position, and the biasing member 404 may be in a compressed state.

[0049] The sheath extension mechanism 302 is responsible for controlling the extension and retraction of the sampling device 300 within the working channel of the endoscope. The housing 304 forms the main body of the sampling device 300 and can accommodate internal components, including the instrument actuator 306 and the biasing member 404.

[0050] The instrument actuator 306 is operable to extend or retract the sampling needle from the distal portion of the sampling device 300. An engagement depth setter 308, which can be coupled to a handle of the instrument actuator 306, can be engaged by an operator to operate the needle actuator and extend the sampling needle. When engaged by an operator, the engagement depth setter 308 can translate the user's engagement into the linear movement required to advance the sampling needle (e.g., or other medical device) beyond the distal end of the sampling device 300.

[0051] A biasing member 404, which can be mounted within the instrument actuator 306, can be configured to bias the instrument actuator 306 toward a non-actuated position when not engaged by the operator. In the actuated position 502, the biasing member 404 can be compressed to store potential energy, which can be used to automatically return the instrument actuator 306 and the engagement depth setter 308 to the non-actuated position when the operator disengages from the engagement depth setter 308. This automatic retraction mechanism helps prevent unintended extension of the sampling needle, thereby reducing the risk of accidental tissue damage or injury during endoscopic procedures.

[0052] Anti-warping features 406 within housing 304 help ensure alignment and prevent warping of bias member 404. These features may include structures such as internal ribs, guides, or channels that constrain lateral movement of bias member 404 while allowing compression and extension along the longitudinal axis of sampling device 300. By preventing lateral deformation or misalignment of bias member 404, anti-warping features 406 help ensure consistent and reliable operation of instrument actuator 306, thereby maintaining the intended bias force toward the non-actuated position.

[0053] on the whole, Figure 5 The configuration and interaction of components within the sampling device 300 when in the actuated position 502 can be demonstrated, highlighting the role of the bias member 404 and the anti-warping feature 406 in ensuring reliable and safe operation of the device during medical procedures.

[0054] Figure 6A Endoscope 104 is shown. Figure 1 The insertion segment 126 () Figure 1 An enlarged view of the sampling device 300 in the non-actuated position 402. Figure 6A As shown, the device can be in Figure 4 The location described in the text.

[0055] In the non-actuated position 402, the instrument actuator 306 may be in a state in which the sampling needle is retracted within the distal portion of the sampling device 300. The biasing member 404 ensures that the instrument actuator 306 remains in this position when not engaged by the operator, thereby preventing unintended extension of the sampling needle.

[0056] on the whole, Figure 6A The configuration and interaction of components within the sampling device 300 when in the non-actuated position 402 can be demonstrated, highlighting the role of the bias member 404 and the anti-warping feature 406 in ensuring reliable and safe operation of the device during medical procedures.

[0057] Figure 6B Endoscope 104 is shown. Figure 1 The insertion segment 126 () Figure 1 An enlarged view of the sampling device 300 in the actuated position 502. (See also:) Figure 6B As shown, the device can be in Figure 5 The location described in the text.

[0058] In the actuated position 502, the instrument actuator 306 can be engaged, causing the sampling needle to extend beyond the distal portion of the sampling device 300. The bias member 404 can be in a compressed state, thereby storing potential energy for returning the instrument actuator 306 to the non-actuated position once the engagement depth setter 308 disengages.

[0059] on the whole, Figure 6B The configuration and interaction of components within the sampling device 300 when in the actuated position 502 can be demonstrated, highlighting the role of the bias member 404 and the anti-warping feature 406 in ensuring reliable and safe operation of the device during medical procedures.

[0060] Figure 7A block diagram of an example machine 700 on which any or more of the techniques (e.g., methods) discussed herein may be performed. As described herein, the example may include, or be operated by, logic or components or mechanisms in the machine 700. A circuit (e.g., a processing circuit) is a collection of circuits implemented in a tangible entity of the machine 700, including hardware (e.g., simple circuits, gates, logic, etc.). The relationships between circuit components can be flexible over time. A circuit includes components that can perform a specified operation individually or in combination during operation. In some examples, the hardware of the circuit may be designed in an immutable manner to perform a specific operation (e.g., hardwired). In the example, the hardware of the circuit may include physical components (e.g., execution units, transistors, simple circuits, etc.) connected in a variable manner to encode instructions for a specific operation, said variablely connected physical components including machine-readable media that are physically modified (e.g., in the form of magnetic, electrical, movable placement of invariant mass particles, etc.). When connecting physical components, the underlying electrical properties of the hardware composition change, for example, from an insulator to a conductor, or vice versa. The instructions enable embedded hardware (e.g., an execution unit or loading mechanism) to create components of a circuit within the hardware via variable connections, portions of which perform specific operations during operation. Thus, in the example, a machine-readable medium element is part of the circuit, or communicatively coupled to other components of the circuit during device operation. In the example, any physical component can be used in more than one component within more than one circuit. For example, during operation, an execution unit can be used at one point in time in a first circuit of a first circuit, and reused at a different time by a second circuit in the first circuit or by a third circuit in the second circuit. Additional examples of these components of machine 700 are given below.

[0061] In alternative examples, machine 700 may operate as a standalone device or may be connected (e.g., networked) to other machines. In a networked deployment, machine 700 may operate as a server machine, a client machine, or both in a server-client network environment. In the examples, machine 700 may act as a peer-to-peer (P2P) (or other distributed) network environment. Machine 700 may be a personal computer (PC), tablet PC, set-top box (STB), personal digital assistant (PDA), mobile phone, web device, network router, switch, or bridge, or any machine capable of (sequentially or otherwise) executing instructions specifying actions to be taken by that machine. Furthermore, although only a single machine is shown, the term "machine" should also be considered as any collection of machines that individually or jointly execute a set (or more) of instructions to perform any or more of the methods discussed herein, such as cloud computing, Software as a Service (SaaS), and other computer cluster configurations.

[0062] Machine 700 may include a hardware processor 702 (e.g., a central processing unit (CPU), graphics processing unit (GPU), hardware processor core, or any combination thereof), main memory 704, static memory (e.g., memory or storage device for firmware, microcode, basic input / output (BIOS), etc.), and mass storage device 708 (e.g., hard disk drive, tape drive, flash memory, or other block device), some or all of which may communicate with each other via interconnect 730 (e.g., bus). Machine 700 may also include a display unit 710, an alphanumeric input device 712 (e.g., keyboard), and a user interface (UI) navigation device 714 (e.g., mouse). In the example, display unit 710, input device 712, and UI navigation device 714 may be a touch screen display. Machine 700 may also include a signal generation device 718 (e.g., speaker), a network interface device 720, and one or more sensors 716, such as a global positioning system (GPS) sensor, compass, accelerometer, other sensor types, etc. Machine 700 may include an output controller 728, which may be connected serially (e.g., Universal Serial Bus (USB)), in parallel, or otherwise wired or wireless (e.g., infrared (IR), near field communication (NFC), etc.) to communicate with or control one or more peripheral devices (e.g., printers, card readers, etc.).

[0063] The registers of processor 702, main memory 704, static memory 706, or mass storage device 708 may be or include a machine-readable medium 722 on which one or more sets of data structures or instructions 724 (e.g., software) are stored, said set of one or more sets of data structures or instructions 724 embodying or utilized by any or more of the techniques or functions described herein. During execution of instructions 724 by machine 700, instructions 724 may also reside wholly or at least partially in any register of processor 702, main memory 704, static memory 706, or mass storage device 708. In this example, one or any combination of hardware processor 702, main memory 704, static memory 706, or mass storage device 708 may constitute machine-readable medium 722. Although machine-readable medium 722 is shown as a single medium, the term "machine-readable medium" can include a single medium or multiple media (e.g., a centralized or distributed database, and / or associated caches and servers) configured to store one or more instructions 724.

[0064] The term "machine-readable medium" can include any medium capable of storing, encoding, or carrying instructions for use by machine 700 and to cause machine 700 to perform any one or more of the techniques of this disclosure, or capable of storing, encoding, or carrying data structures used by or associated with such instructions. Examples of non-limiting machine-readable media can include solid-state memory, optical media, magnetic media, and signals (e.g., radio frequency signals, other photon-based signals, sound signals, etc.). In examples, non-transitory machine-readable media includes machine-readable media having a plurality of particles with invariant (e.g., stationary) mass and thus being a composition of matter. Therefore, a non-transitory machine-readable medium is a machine-readable medium that does not include transiently propagating signals. Specific examples of non-transitory machine-readable media can include: non-volatile memory, such as semiconductor memory devices (e.g., electrically programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM)) and flash memory devices; magnetic disks, such as internal hard disks and removable disks; magneto-optical disks; and CD-ROM and DVD-ROM disks.

[0065] Information stored on or otherwise provided on machine-readable medium 722 may represent instructions 724, such as instructions 724 itself or a format from which instructions 724 can be derived. Such a format from which instructions 724 can be derived may include source code, encoded instructions (e.g., in compressed or encrypted form), packaged instructions (e.g., split into multiple packages), etc. The information representing instructions 724 in machine-readable medium 722 may be processed by processing circuitry into instructions to implement any of the operations discussed herein. For example, deriving instructions 724 from information (e.g., processed by processing circuitry) may include: (e.g., from source code, object code, etc.) compiling, interpreting, loading, organizing (e.g., dynamic or static linking), encoding, decoding, encrypting, deencrypting, packaging, unpacking, or otherwise manipulating the information into instructions 724.

[0066] The derivation of instruction 724 may include (e.g., via processing circuitry) assembling, compiling, or interpreting information to create instruction 724 according to some intermediate or preprocessed format provided by machine-readable medium 722. Information provided in multiple parts may be combined, unpacked, and modified to create instruction 724. For example, information may be in multiple compressed source code packages (or object code, or binary executable code, etc.) on one or more remote servers. The source code packages may be encrypted during network transmission and, if necessary, decrypted, decompressed, assembled (e.g., linked), and compiled or interpreted at the local machine (e.g., compiled or interpreted into libraries, standalone executables, etc.), and executed by the local machine.

[0067] Commands 724 can also be sent or received via the communication network 726 through the network interface device 720 using a transmission medium, utilizing any of several transport protocols (e.g., Frame Relay, Internet Protocol (IP), Transmission Control Protocol (TCP), User Datagram Protocol (UDP), Hypertext Transfer Protocol (HTTP), etc.). Example communication networks may include local area networks (LANs), wide area networks (WANs), packet data networks (e.g., the Internet), LoRa / LoRaWAN or satellite communication networks, mobile phone networks (e.g., cellular networks, such as cellular networks compliant with 3G, 4G LTE / LTE-A, or 5G standards), conventional telephone (POTS) networks, and wireless data networks (e.g., networks known as Wi-Fi). ®The network interface device 720 may include one or more physical jacks (e.g., Ethernet, coaxial, or telephone jacks) or one or more antennas for connecting to the communication network 726. The network interface device 720 may include multiple antennas for wireless communication using at least one of single-input multiple-output (SIMO), multiple-input multiple-output (MIMO), or multiple-input single-output (MISO) technologies. The term "transmission medium" should be considered to include any intangible medium capable of storing, encoding, or carrying instructions executable by the machine 700, and includes digital or analog communication signals or other intangible media to facilitate communication of such software. The transmission medium is a machine-readable medium.

[0068] The following non-limiting examples illustrate certain aspects of this topic to address challenges and provide the benefits discussed herein.

[0069] Example 1 is a sampling device for use with an endoscope, the sampling device being configured to be coupled to the endoscope, the sampling device comprising: a distal portion configured to extend beyond the distal end of the endoscope; a needle actuator operable to extend or retract a sampling needle from the distal portion of the sampling device; and a biasing member operablely coupled to the needle actuator to bias the needle actuator toward a retracted position unless actively engaged by an operator.

[0070] In Example 2, according to the subject matter described in Example 1, the needle actuator includes: a handle configured to be held by an operator; and an engagement member coupled to the handle, which can be engaged by the operator to operate the needle actuator and extend the sampling needle.

[0071] In Example 3, based on the subject of Examples 1 to 2, a biasing member is disposed within the handle and configured to engage with an engaging member such that the engaging member and the needle actuator are biased in the retracted position.

[0072] In Example 4, based on the subject of Examples 1 to 3, the handle includes: an anti-warping feature configured to engage with a bias member and prevent warping of the bias member.

[0073] In Example 5, based on the subject of Example 4, the anti-warping feature includes a sleeve integral with the handle and configured to at least partially surround the bias member.

[0074] In Example 6, based on the subject of Example 4, the anti-warping feature includes a sleeve that can be inserted into a handle and is configured to at least partially surround the bias member.

[0075] In Example 7, based on the subject of Example 4, the anti-warping feature includes one or more tracks integral with the handle and configured to at least partially surround the bias member.

[0076] In Example 8, based on the subject of Example 4, the anti-warping feature includes one or more tracks disposed within the handle and configured to at least partially surround the bias member.

[0077] In Example 9, based on the subject of Examples 1 to 3, the biasing member includes a spring mechanism.

[0078] In Example 10, following the theme of Example 9, the stiffness of the spring mechanism is adjustable to change the force required to actuate the needle actuator.

[0079] In Example 11, a medical device includes: a flexible lumen catheter; a device actuator configured to deploy a device within the flexible lumen catheter; and a biasing member configured to bias the device actuator to an undeployed state, wherein, in the undeployed state, the device is retracted within the flexible lumen catheter.

[0080] In Example 12, based on the subject matter of Example 11, the instrument actuator includes: a handle configured to be held by an operator; and an engagement member coupled to the handle, which can be engaged by the operator to operate the instrument actuator and deploy the instrument.

[0081] In Example 13, based on the subject of Examples 11 to 12, a biasing member is disposed within a handle and configured to engage with an engagement member to bias the engagement member and the instrument actuator in an undeployed state.

[0082] In Example 14, based on the subject of Examples 11 to 13, the handle includes an anti-warping feature configured to engage with a bias member and prevent warping of the bias member.

[0083] In Example 15, based on the subject of Example 14, the anti-warping feature includes a sleeve integral with the handle and configured to at least partially surround the bias member.

[0084] In Example 16, based on the subject of Example 14, the anti-warping feature includes a sleeve that can be inserted into a handle and is configured to at least partially surround the bias member.

[0085] In Example 17, based on the subject of Example 14, the anti-warping feature includes one or more tracks integral with the handle and configured to at least partially surround the bias member.

[0086] In Example 18, based on the subject of Example 14, the anti-warping feature includes one or more tracks disposed within the handle and configured to at least partially surround the bias member.

[0087] In Example 19, a medical device for sampling tissue from a patient includes: an endoscope including a lumen extending to a distal end of the endoscope; a sampling device configured to be inserted into the lumen of the endoscope and beyond the distal end of the endoscope, the sampling device including: a needle actuator operable to deploy a sampling needle through the needle lumen of the sampling device; a distal portion including an ultrasound transducer configured to capture ultrasound images within a field of view; a side-exit oblique channel disposed proximally to the distal portion, the side-exit oblique channel being configured to guide the sampling needle toward the field of view of the ultrasound transducer; and a biasing member coupled to the needle actuator and configured to bias the needle actuator in an undeployed state such that the sampling needle is retracted within the needle lumen.

[0088] In Example 20, based on the subject matter of Example 19, the needle actuator includes: a handle configured to be held by an operator, the handle including: an anti-warping feature configured to engage with a bias member to prevent warping of the bias member; and an engagement member coupled to the handle, the engagement member being engageable by an operator to operate the needle actuator and deploy a sampling needle.

[0089] Example 21 is a sampling device for use with an endoscope, the sampling device being configured to be coupled to the endoscope, the sampling device comprising: a distal portion configured to extend beyond the distal end of the endoscope; a needle actuator operable to extend or retract a sampling needle relative to the distal portion of the sampling device; and a biasing member operablely coupled to the needle actuator to bias the needle actuator toward a retracted position unless actively engaged by an operator.

[0090] In Example 22, the subject matter of Example 21 may optionally include, wherein the needle actuator includes: a handle configured to be held by an operator; and an engagement member coupled to the handle, the engagement member being engageable by the operator to operate the needle actuator and extend the sampling needle.

[0091] In Example 23, the subject matter of Example 22 may optionally include a biasing member disposed within the handle and configured to engage with an engaging member such that the engaging member and the needle actuator are biased in a retracted position.

[0092] In Example 24, the subject matter of Example 23 may optionally include, wherein the handle includes: an anti-warping feature configured to engage with the bias member and prevent warping of the bias member.

[0093] In Example 25, the subject matter of Example 24 may optionally include, wherein the anti-warping feature includes a sleeve integral with the handle and configured to at least partially surround the bias member.

[0094] In Example 26, the subject matter of any one or more of Examples 24 to 25 may optionally include, wherein the anti-warping feature includes a sleeve that can be inserted into a handle and is configured to at least partially surround the bias member.

[0095] In Example 27, the subject matter of any one or more of Examples 24 to 26 may optionally include, wherein the anti-warping feature includes one or more tracks integral with the handle and configured to at least partially surround the bias member.

[0096] In Example 28, the subject matter of any one or more of Examples 24 to 27 may optionally include, wherein the anti-warping feature includes one or more tracks disposed within the handle and configured to at least partially surround the bias member.

[0097] In Example 29, the subject matter of any one or more of Examples 21 to 28 may optionally include, wherein the biasing member includes a spring mechanism.

[0098] In Example 30, the subject matter of Example 29 may optionally include, wherein the stiffness of the spring mechanism is adjustable to change the force required to actuate the needle actuator.

[0099] Example 31 is a medical device comprising: a flexible lumen catheter; a device actuator configured to deploy a device within the flexible lumen catheter; and a biasing member configured to bias the device actuator to an undeployed state, wherein, in the undeployed state, the device is retracted within the flexible lumen catheter.

[0100] In Example 32, the subject matter of Example 31 may optionally include, wherein the instrument actuator includes: a handle configured to be held by an operator; and an engagement member coupled to the handle, the engagement member being engageable by the operator to operate the instrument actuator and deploy the instrument.

[0101] In Example 33, the subject matter of Example 32 may optionally include a biasing member disposed within the handle and configured to engage with an engagement member to bias the engagement member and the instrument actuator in an undeployed state.

[0102] In Example 34, the subject matter of Example 33 may optionally include, wherein the handle includes: an anti-warping feature configured to engage with the bias member and prevent warping of the bias member.

[0103] In Example 35, the subject matter of Example 34 may optionally include, wherein the anti-warping feature includes a sleeve integral with the handle and configured to at least partially surround the bias member.

[0104] In Example 36, the subject matter of any one or more of Examples 34 to 35 may optionally include, wherein the anti-warping feature includes a sleeve that can be inserted into the handle and configured to at least partially surround the bias member.

[0105] In Example 37, the subject matter of any one or more of Examples 34 to 36 may optionally include, wherein the anti-warping feature includes one or more tracks integral with the handle and configured to at least partially surround the bias member.

[0106] In Example 38, the subject matter of any one or more of Examples 34 to 37 may optionally include, wherein the anti-warping feature includes one or more tracks disposed within the handle and configured to at least partially surround the bias member.

[0107] Example 39 is a medical device for sampling tissue from a patient, the medical device comprising: an endoscope including a lumen extending to a distal end of the endoscope; and a sampling device configured to be inserted into the lumen of the endoscope and beyond the distal end of the endoscope, the sampling device comprising: a needle actuator operable to deploy a sampling needle through the needle lumen of the sampling device; a distal portion including an ultrasound transducer configured to capture ultrasound images within a field of view; a side exit oblique channel disposed proximally to the distal portion, the side exit oblique channel being configured to guide the sampling needle toward the field of view of the ultrasound transducer; and a biasing member coupled to the needle actuator and configured to bias the needle actuator in an undeployed state such that the sampling needle is retracted within the needle lumen.

[0108] In Example 40, the subject matter of Example 39 may optionally include, wherein the needle actuator includes: a handle configured to be held by an operator, the handle including: an anti-warping feature configured to engage with a bias member to prevent warping of the bias member; and an engagement member coupled to the handle, the engagement member being engageable by an operator to operate the needle actuator and deploy a sampling needle.

[0109] Example 41 includes an apparatus, system, method, or sampling device that includes any element of any of Examples 1 to 40.

[0110] The above detailed description includes reference to the accompanying drawings, which form a part of the detailed description. The drawings illustrate specific examples that can be practiced by way of illustration. These embodiments are also referred to herein as "examples". Such examples may include elements other than those shown or described. However, the inventors also contemplate examples in which only those elements shown or described are provided. Furthermore, the inventors also contemplate examples (or one or more aspects thereof) using any combination or arrangement of those elements shown or described relative to a particular example (or one or more aspects thereof) shown or described herein, or relative to other examples (or one or more aspects thereof).

[0111] All publications, patents, and patent documents mentioned in this document are incorporated herein by reference in their entirety, as if they were incorporated individually by reference. In the event of any inconsistency between the usage in this document and those incorporated by reference, the usage in the incorporated reference shall be considered supplementary to the usage in this document; in the case of irreconcilable inconsistencies, the usage in this document shall prevail.

[0112] In this document, as is common in patent literature, the terms "a" or "an" are used to include one or more, regardless of any other instance or usage of "at least one" or "one or more". In this document, unless otherwise indicated, 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". In the appended claims, the terms "comprising" and "in" are used as concise English equivalents to the corresponding terms "including" and "wherein". Furthermore, in the appended claims, the terms "comprising" and "including" are open-ended, meaning that a system, apparatus, article, or process that includes elements other than those listed in the claims following such terms is still considered to fall within the scope of the claim. Additionally, in the appended claims, the terms "first", "second", and "third", etc., are used merely as designations and are not intended to impose numerical requirements on their objects.

[0113] As used herein, the term “about” means approximately, within a range, roughly, or around. When the term “about” is used in conjunction with a numerical range, it modifies the range by extending the boundaries above and below the stated numerical value. Typically, the term “about” is used herein to modify numerical values ​​above and below the stated value by a change of 10%. In one aspect, the term “about” means plus or minus 10% of the numerical value of the number to which the term is used. Thus, about 50% means a range of 45% to 55%. The numerical ranges listed in this document by endpoints include all numbers and fractions contained within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.90, 4, 4.24, and 5). Similarly, the numerical ranges listed by endpoints in this document include subranges contained within those ranges (e.g., 1 to 5 includes 1 to 1.5, 1.5 to 2, 2 to 2.75, 2.75 to 3, 3 to 3.90, 3.90 to 4, 4 to 4.24, 4.24 to 5, 2 to 5, 3 to 5, 1 to 4, and 2 to 4). It should also be understood that all numbers and their fractions are assumed to be modified by the term “about”.

[0114] The foregoing description is intended to be illustrative and not restrictive. For example, the examples described above (or one or more aspects thereof) may be used in combination with each other. Other examples may be used by one of ordinary skill in the art upon reading the foregoing description. The abstract is intended to enable the reader to quickly determine the nature of the technical disclosure and is provided with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Furthermore, in the foregoing detailed description, various features may be combined to simplify the disclosure. This should not be construed as implying that any unclaimed disclosed feature is necessary for any claim. Rather, the subject matter of the invention may lie in fewer than all features of a particular disclosed embodiment. Therefore, the appended claims are hereby incorporated into the detailed description, wherein each claim exists independently as a separate embodiment. The scope of the examples should be determined by reference to the full scope of the appended claims together with the equivalents conferred by those claims.

[0115] The devices disclosed herein may be designed for single-use post-treatment or for multiple-use applications. However, in either case, the device may be repaired for reuse after at least one use. Repair may include a combination of the following steps: disassembly of the device, subsequent cleaning or replacement of specific parts, and subsequent reassembly. Specifically, the device may be disassembled, and any number of specific parts or components of the device may be selectively replaced or removed in any combination. After cleaning and / or replacement of specific parts, the device may be reassembled at a repair facility or immediately before a surgical procedure by a surgical team for subsequent use. Those skilled in the art will understand that the repair of the device can utilize a variety of different techniques for disassembly, cleaning / replacement, and reassembly. The use of such techniques and the resulting repair devices are within the scope of this application.

[0116] Preferably, the invention described herein involves pre-operative processing. First, new or used instruments are obtained and, if necessary, cleaned. The instruments can then be sterilized. In one sterilization technique, the instruments are placed in a closed and sealed container, such as a plastic bag or TYVEK. ® The device is placed in a bag. The container and instrument are then placed in a radiation field, such as gamma radiation, X-rays, or high-energy electrons, that can penetrate the container. The radiation kills bacteria on the instrument and in the container. The sterile instrument can then be stored in a sterile container. The container is sealed to keep the instrument sterile until it is opened in a medical facility. The device can also be sterilized using any other techniques known in the art, including but not limited to beta or gamma radiation, ethylene oxide, or vapor.

Claims

1. A sampling device for use with an endoscope, the sampling device being configured to be coupled to the endoscope, the sampling device comprising: The distal portion is configured to extend beyond the distal end of the endoscope; A needle actuator that is operable to extend or retract a sampling needle relative to the distal portion of the sampling device; as well as A biasing member, which is operatively coupled to the needle actuator to bias the needle actuator toward a retracted position unless actively engaged by the operator.

2. The sampling device according to claim 1, wherein, The needle actuator includes: A handle, configured to be held by the operator; and A connecting member, coupled to the handle, which can be engaged by the operator to operate the needle actuator and extend the sampling needle.

3. The sampling device according to claim 2, wherein, The biasing member is disposed within the handle and configured to engage with the engaging member to bias the engaging member and the needle actuator in the retracted position.

4. The sampling device according to claim 3, wherein, The handle includes: An anti-warping feature is configured to engage with the bias member and prevent warping of the bias member.

5. The sampling device according to claim 4, wherein, The anti-warping feature includes a sleeve integral with the handle and configured to at least partially surround the biasing member.

6. The sampling device according to any one of claims 4 to 5, wherein, The anti-warping feature includes a sleeve that can be inserted into the handle and is configured to at least partially surround the biasing member.

7. The sampling device according to any one of claims 4 to 6, wherein, The anti-warping feature includes one or more tracks integral with the handle and configured to at least partially surround the bias member.

8. The sampling device according to any one of claims 4 to 7, wherein, The anti-warping feature includes one or more tracks disposed within the handle and configured to at least partially surround the bias member.

9. The sampling device according to any one of claims 1 to 8, wherein, The biasing component includes a spring mechanism.

10. The sampling device according to claim 9, wherein, The stiffness of the spring mechanism can be adjusted to change the force required to actuate the needle actuator.

11. A medical device comprising: Flexible lumen catheter; A device actuator configured to deploy a device within the flexible lumen catheter; as well as A biasing member is configured to bias the instrument actuator to an undeployed state, wherein, in the undeployed state, the instrument is retracted within the flexible lumen catheter.

12. The medical device according to claim 11, wherein, The device actuator includes: A handle, configured to be held by the operator; and A connecting member coupled to the handle, the connecting member being engageable by the operator to operate the instrument actuator and deploy the instrument.

13. The medical device according to claim 12, wherein, The biasing member is disposed within the handle and configured to engage with the engagement member to bias the engagement member and the instrument actuator in the undeployed state.

14. The medical device according to claim 13, wherein, The handle includes: An anti-warping feature is configured to engage with the bias member and prevent warping of the bias member.

15. The medical device according to claim 14, wherein, The anti-warping feature includes a sleeve integral with the handle and configured to at least partially surround the biasing member.

16. The medical device according to any one of claims 14 to 15, wherein, The anti-warping feature includes a sleeve that can be inserted into the handle and is configured to at least partially surround the biasing member.

17. The medical device according to any one of claims 14 to 16, wherein, The anti-warping feature includes one or more tracks integral with the handle and configured to at least partially surround the bias member.

18. The medical device according to any one of claims 14 to 17, wherein, The anti-warping feature includes one or more tracks disposed within the handle and configured to at least partially surround the bias member.

19. A medical device for sampling tissue from a patient, the medical device comprising: An endoscope, comprising a lumen extending to the distal end of the endoscope; as well as A sampling device configured to be inserted into the lumen of the endoscope and extend beyond the distal end of the endoscope, the sampling device comprising: A needle actuator that is operable to deploy a sampling needle through the needle lumen of the sampling device; The distal portion includes an ultrasonic transducer configured to capture ultrasonic images within the field of view. A side outlet oblique channel, disposed proximally on the distal portion, is configured to guide the sampling needle toward the field of view of the ultrasonic transducer; and A biasing member, coupled to the needle actuator and configured to bias the needle actuator in an undeployed state, such that the sampling needle is retracted into the needle lumen.

20. The medical device according to claim 19, wherein, The needle actuator includes: A handle configured to be held by an operator, the handle comprising: An anti-warping feature, configured to engage with the biasing member to prevent warping of the biasing member; and A connecting member, coupled to the handle, which can be engaged by the operator to operate the needle actuator and deploy the sampling needle.

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