Mechanism to prevent needle insertion in actuated state

Abstract

A medical device can include a handle, an instrument actuator, and a lockout mechanism. The handle can be configured to couple to an endoscope and include an instrument lumen extending therethrough. The instrument actuator can be operatively connected to the handle. The instrument actuator can be operable to advance an instrument relative to the instrument lumen. The lockout mechanism can be disposed within the handle. The lockout mechanism can be movable between an open configuration where the instrument lumen is not blocked and a closed configuration where the instrument lumen is blocked. Actuation of the instrument actuator to advance the instrument can cause movement of the lockout mechanism from the open configuration to the closed configuration to prevent reinsertion of the instrument into the instrument lumen.

Description

Docket No. VTP24007-RDFO-US1 / / 5409.947PRVMECHANISM TO PREVENT NEEDLE INSERTION IN ACTUATED STATEPRIORITY CLAIM

[0001] This application claims the benefit of priority to U.S. Provisional Patent Application Serial No. 63 / 718,080, filed November 8, 2024, the contents of which are incorporated herein by reference.TECHNICAL FIELD

[0002] Examples described herein generally relate to medical devices. More specifically, examples described herein generally relate to medical devices with a mechanism to prevent needle insertion in the actuated state.BACKGROUND

[0003] A biopsy sample of a targeted tissue may be obtained by placing a sampling device adjacent to a target before extending a biopsy needle from the sampling device into the target. In some cases, the sampling device may be equipped with a sensor to enable target imaging and assist with target confirmation and needle trajectory alignment. Then, once the target location is confirmed and aligned with an expected needle trajectory, a user may manipulate a needle actuator located at the proximal end of the sampling device to advance the needle out of the sampling device and into the target tissue. After the advancement of the needle actuator causes the biopsy needle to enter the target, a user may withdraw the biopsy needle from the entire sampling device to expel the biopsy sample for pathology / cytology analysis.

[0004] In some instances, the biopsy needle may be withdrawn from the sampling device without the needle actuator being retracted back into a neutral (e.g., non-sampling) position. Once the biopsy needle is withdrawn, current designs permit reinsertion of the biopsy needle without ensuring the needle actuator is in the non-sampling position. One potential risk associated with these instances is that if multiple biopsy samples of the target are desired, the user may inadvertently reinsert a needle into the sampling device while the needle actuator remains advanced, which can result in the needle becoming advanced into the patient tissue upon reinsertion.Docket No. VTP24007-RDFO-US1 / / 5409.947PRVSUMMARY

[0005] In examples, a medical device can include a handle, an instrument actuator, and a lockout mechanism. The handle can be configured to couple to an endoscope and can include an instrument lumen extending therethrough. The instrument actuator can be operatively connected to the handle. The instrument actuator can be operable to advance an instrument relative to the instrument lumen. The lockout mechanism can be disposed within the handle. The lockout mechanism can be movable between an open configuration where the instrument lumen is not blocked and a closed configuration where the instrument lumen is blocked. Actuation of the instrument actuator to advance the instrument can cause movement of the lockout mechanism from the open configuration to the closed configuration to prevent reinsertion of the instrument into the instrument lumen.

[0006] In examples, a sampling device can include a handle, a needle actuator, and a lockout mechanism. The handle can be configured to attach to an endoscope and can include an needle lumen extending therethrough. The needle actuator can be operatively connected to the handle. The needle actuator can be operable to advance a sampling needle relative to the needle lumen. The lockout mechanism can be disposed within the handle. The lockout mechanism can be movable between an open configuration where the needle lumen is not blocked and a closed configuration where the needle lumen is blocked. Actuation of the needle actuator to advance the sampling needle can cause movement of the lockout mechanism from the open configuration to the closed configuration to prevent reinsertion of the sampling needle into the needle lumen.BRIEF DESCRIPTION OF THE DRAWINGS

[0007] Various examples are illustrated in the figures of the accompanying drawings. Such examples are demonstrative and not intended to be exhaustive or exclusive examples of the present subject matter.

[0008] FIG. 1 illustrates a schematic diagram of an example of a medical device system.Docket No. VTP24007-RDFG-US1 / / 5409.947PRV

[0009] FIG. 2 illustrates a schematic diagram of an example of an imaging and control system of a medical device system.

[0010] FIG. 3 illustrates a side view of a portion of an example of an instrument actuator.

[0011] FIG. 4 illustrates a cross-sectional view of a portion of an example of an instrument actuator.

[0012] FIG. 5 illustrates an internal view of a portion of an example of an instrument actuator.

[0013] FIG. 6 illustrates an internal view of a portion of an example of an instrument actuator.

[0014] FIG. 7 illustrates an internal view of a portion of an example of an instrument actuator.

[0015] FIG. 8 illustrates an internal top view of a portion of an example of an instrument actuator.

[0016] FIG. 9 illustrates an internal perspective view of a portion of an example of an instrument actuator including an enlarged view of an example of a lockout mechanism.

[0017] FIG. 10 illustrates an internal perspective view of a portion of an example of an instrument actuator including an enlarged view of an example of a lockout mechanism.DETAILED DESCRIPTION

[0018] Medical devices can be inserted into the patient directly or through another endoscope (e.g., a bronchoscope) such that the bronchoscope and the medical device form an endoscope-accessory instrument relationship (sometimes referred to as a mother-child relationship). As such, the endoscope can be inserted into a desired position within the patient. Afterthe endoscope is in the desired position, the child device (e.g., the medical device) can be inserted into the endoscope (e.g., via a working channel) and out of a distal end. The child device can typically have a smaller diameter than the endoscope such that the child device can extend into passageways of the patient with smaller diameters than could be reached with the endoscope alone. The child device (e.g., medical device)Docket No. VTP24007-RDFO-US1 / / 5409.947PRV can then be extended from the distal end of the endoscope to a target area within the patient. An instrument (e.g., a biopsy needle, ablation probe, etc.) of the child device can be deployed to extend from the distal end of the child device and obtain a tissue sample from the patient or to treat tissue of the patient (e.g., via ablation, medical delivery, etc.). Although other use cases are contemplated, the child device is primarily discussed herein in the particular context of being a medical device having a side exit port such that the instrument is a biopsy needle that is extendable into the patient’s tissue at an acute angle with respect to a longitudinal axis of the medical device.

[0019] To facilitate the deployment of the instrument, the medical device can include an instrument actuator (sometimes referred to as an instrument actuator). Unintended extension of the instrument from the medical device can result in undesirable scenarios. For example, the instrument can engage with the tissue of the patient as the endoscope (e.g., the mother device) or the medical device (e.g., the child device) is removed from the patient. In contrast, the instrument is inadvertently extended from the medical device. In another example, the instrument can be unintentionally extended from the medical device as the medical device is being inserted into the mother device, such that the instrument engages with the mother device, which can cause damage to either the instrument orthe mother device.

[0020] Some medical devices can include a removable instrument (e.g., sampling needle) and a stylet that can attach to the instrument actuator via a luer fitting. The removable instrument can permit the removal of the obtained tissue sample without removing the mother device or the medical device from the target areas within the patient. The stylet can help maintain the stiffness of the instrument as the instrument extends through the instrument actuator and into the tissue of the patient. Here, unintended deployment of the instrument from the medical device can cause the needle to extend beyond the distal end of the medical device before the medical professional intends to extend the instrument from the medical device. Such unintended deployment of the instrument can cause the instrument to contact the tissue of the patient, which can cause unintended damage to the patient or make insertion of the stylet into theDocket No. VTP24007-RDFO-US1 / / 5409.947PRV instrument actuator more difficult. Suppose the medical device is still within the mother device. In that case, the instrument can contact the working channel of the bronchoscope, which can prevent the stylet from attaching to the luer fitting of the instrument actuator because of the engagement between the instrument and the working channel of the mother device.

[0021] The present disclosure addresses the potential problems discussed above by introducing a medical device with an improved instrument actuation mechanism. The medical device can include a biasing member installed within the instrument handle to bias the actuation mechanism toward a non-actuated state. This biasing mechanism can ensure thatthe instrument is retracted automatically when not engaged by a medical professional, thereby preventing accidental extension of the instrument when the device is withdrawn or reinserted into the bronchoscope or withdrawn or reinserted into the patient.

[0022] By preventing the instrument from being inadvertently extended from the medical device, this medical device disclosed herein can reduce the likelihood of patient injury during the operation of the medical device. The medical device of the present disclosure can also reduce the likelihood of damaging the bronchoscope or the instrument itself during the removal or insertion of the medical device from the mother device, as the needle is biased to retract when not actively engaged by medical professionals. The biasing member in the actuator can also ensure consistent retraction of the instrument, thereby simplifying the operation and reducing the chance of operator error by the medical professionals using the medical device. The medical device of the present disclosure is also designed to be compatible with current medical instruments. It can be integrated seamlessly into existing workflows without requiring significant changes to the standard operating procedures.

[0023] The above discussion is intended to provide an overview of the subject matter of the present patent application. It is not intended to provide an exclusive or exhaustive explanation of the invention. The description below provides further information about the present patent application.

[0024] FIG. 1 is a schematic diagram of an endoscopy system 100 that can include a control system 102 and an endobronchial ultrasound samplingDocket No. VTP24007-RDFO-US1 / / 5409.947PRV arrangement including an endoscope 104 and a medical device 108 that is attachable to the endoscope 104 and which includes a distal end 110 that extends from the distal end of the endoscope 104 via a distal working channel port (e.g., working channel port 112). The system of FIG. 1 is an illustrative example of an endoscopy system suitable for use with the systems, devices, and methods described herein.

[0025] The endoscope 104 can be insertable into an anatomical region for imaging or attachment to (e.g., via tethering) one or more sampling devices for biopsies or therapeutic devices for treating a disease state associated with the anatomical region. The endoscope 104 can interface with or connect to the control system 102. The endoscope 104 is described in the present example as a bronchoscope, though other endoscopes are contemplated for use with the features and teachings of the present disclosure. The control system 102 can include a control unit 114, a display unit 116, an input unit 118, a light source 120, a fluid source 122, and a suction pump 124.

[0026] The control system 102 can include various ports for coupling with the endoscopy system 100. For example, the control unit 114 can include a data input / output port for receiving data from and communicating data to the endoscope 104. The light source 120 can include an output port for transmitting light to the endoscope 104, such as via a fiber optic link. Additionally, or alternatively, the endoscope 104 can include one or more light sources disposed near the distal end 110 to illuminate an interior anatomy for capturing images (e.g., still images or video streams) thereof. The fluid source 122 can include a port for transmitting fluid to the endoscope 104. The fluid source 122 can include, for example, a pump and a fluid tank or can be connected to an external tank, vessel, or storage unit. The suction pump 124 can include a port to draw a vacuum from the endoscope 104 to generate suction, such as for withdrawing fluid from the anatomical region into which the endoscope 104 is inserted. The display unit 116 and the input unit 118 can be used by an operator of the endoscopy system 100 to control functions of the endoscopy system 100 and view the output of the endoscope 104 such as for example a live video stream provided by imaging device 144. The control unit 114 can also generate signals or other outputs from treatingDocket No. VTP24007-RDFO-US1 / / 5409.947PRV the anatomical region where the endoscope 104 is inserted. In examples, the control unit 114 can generate electrical output, acoustic output, fluid output, or the like for treating the anatomical region with, for example, cauterizing, cutting, freezing, or the like.

[0027] The endoscope 104 can include an insertion section 126, a functional section 128, and a handle section 130, which can be coupled to a cable section 132 and a coupler section 134. The insertion section 126 can extend distally from the handle section 130, and the cable section 132 can extend proximally from the handle section 130. The insertion section 126 can be elongated and include a bending section and a distal end to which the functional section 128 can be attached. The bending section can be controllable (e.g., by a steering control 136 on the handle section 130) to maneuverthe distal end through tortuous anatomical passageways (e.g., stomach, duodenum, kidney, ureter, trachea, lungs, or the like). The insertion section 126 can also include one or more working channels (e.g., an internal lumen) that can be elongated and support the insertion of one or more therapeutic tools of the functional section 128, such as a bronchoscope. The working channel can extend between the handle section 130 and the functional section 128. Additional functionalities, such as fluid passages, guide wires, and pull wires, can also be provided by the insertion section 126 (e.g., via suction or irrigation passageways, or the like).

[0028] A coupler section 134 can be connected to the control unit 114 to connect to the endoscope 104 to multiple 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.

[0029] The handle section 130 can include the steering control 136 and the port 138. The steering control 136 can be a knob, lever, or other actuation mechanism or the like, which can be used to control the advancement of the endoscope 104 within the patient. The steering control 136 can be connected to a pull wire or other actuation mechanisms, extending through the insertion section 126. The port 138, as well as other ports, such as a port 140 can be configured to couple various electrical cables, guide wires, auxiliary scopes, tissue collection devices, fluid tubes, and the like to the handle section 130, such as for couplingDocket No. VTP24007-RDFG-US1 / / 5409.947PRV with the insertion section 126. The examples shown in FIG. 1 and FIG. 2 are examples of endoscopes 104.

[0030] According to examples, the control system 102 can be provided on a mobile platform (e.g., a cart 142) with shelves housing the light source 120, the suction pump 124, an image processing unit 202 (FIG. 2), or the like. Alternatively, components of the control system 102, shown in FIG. 1 and FIG. 2, can be provided directly on the endoscope 104 to make the endoscope “self-contained.”

[0031] The functional section 128 can include components fortreating and diagnosing the anatomy of a patient. The functional section 128 can include an imaging device 144 (e.g., a complementary metal oxide semiconductor (CMOS) based, Chip-on-the-Tip image sensors), an illumination device 146 (e.g., a light emitting diode), and the working channel port 112 at a distal face of the functional section 128.

[0032] As shown in FIG. 1 , medical device 108 can extend from the working channel port 112 at the distal face of the functional section 128 of the endoscope 104. The medical device 108 can be configured to be attached to the port 138 (of the endoscope 104) such that the medical device 108 extends through a working channel (e.g., extending through the insertion section 126 to the working channel port 112) of the endoscope 104 and out the distal end of the endoscope 104. The medical device 108 can include a sheath extension mechanism 148 for advancing or retracting a flexible sheath of the medical device 108 within the working channel to control how far distally from the working channel port 112 the distal end of the medical device 108 extends. The medical device 108 can further include an instrument actuator 150 for controllably advancing and retracting a medical instrument (e.g., biopsy needle) within a lumen of the medical device 108, where the lumen extends from the medical device 108 handle through the lumen of the medical device 108 to a side exit ramp at or near the distal end. For example, manipulation of the instrument actuator 150 can control advancement or retraction of a biopsy needle from a side exit port of the medical device 108 while the distal end 110 of the medical device 108 is extended beyond the distal end of the endoscope 104, thereby facilitating treatment or biopsy of target anatomy within a patient beyond the distal end of the endoscope 104. The sheath extensionDocket No. VTP24007-RDFG-US1 / / 5409.947PRV mechanism 148 can be configured to extend the medical device 108 beyond a distal end of the endoscope 104, such as to navigate the medical device 108 to the target area within the patient. The sheath extension mechanism 148 can slide along a housing 152 of the medical device 108. The housing 152 can include indicia, which indicates an amount of extension of the medical device 108 beyond a distal end of the endoscope 104 (e.g., extension beyond the working channel port 112 indicated in inches, centimeters, or other suitable linear distance units). The instrument actuator 150 can be configured to extend an instrument from the medical device 108 to obtain a tissue sample from the patient. A distal end 110 of the medical device 108 can include a transducer (or other imaging device) and a side exit port having a roof liner configured to minimize the effects of friction and / or scraping against the instrument as it is extended or retraction from the side exit port. The side exit port can be located proximal from the transducer and configured to deflect the instrument at an acute angle with respect to a longitudinal axis of the distal end 110 of the medical device 108 such that a a tissue sample can be obtained from the patient while the instrument and tissue sample are within the field of view of the transducer. Stated alternatively, the configuration of the side exit port with respect to the transducer can facilitate real time visualization of the instrument within the target anatomy (e.g., visualization of a biopsy needle and target nodule being biopsied in real-time). The medical device 108 will be discussed in more detail herein.

[0033] FIG. 2 is a schematic diagram of the endoscopy system 100 of FIG. 1 includingthe control system 102 and the endobronchial ultrasound arrangement, which includes an endoscope 104 and a medical device 108 extendable via a distal working channel port of the endoscope 104. FIG. 2 schematically illustrates components of the control system 102 coupled to each of the endoscope 104 and medical device 108. The control system 102 can include the control unit 114, which can include or be coupled to an image processing unit 202, a treatment generator 204, and a drive unit 206, as well as the light source 120, the input unit 118, and the display unit 116. The control unit 114 can include or can be in communication with, an endoscope, a surgical instrument, and an endoscopy system, which can include a device configured to engage tissue and collect andDocket No. VTP24007-RDFO-US1 / / 5409.947PRV store a portion of thattissue and through which imaging equipment (e.g., a camera) can view target tissue via the inclusion of optically enhanced materials and components. The control unit 114 can activate a camera (e.g., imaging device 144) to view target tissues distal of the endoscopy system. Likewise, the control unit 114 can activate the light source 120 or illumination device 146 to illuminate a field of view of the camera. In the embodiments shown in FIGS. 1 and 2, activation of the camera and light source 120 or the illumination device 146 can enable an operator to visualize in real-time the internal anatomy of the patient as the distal end of the endoscope 104 is advanced and can further enable the operator to visualize the distal end of the medical device 108 being advanced beyond the distal end of the endoscope 104. As the outer profile or diameter of the medical device 108 is less than that of the endoscope 104 (e.g., since it fits within a working channel of the endoscope 104), advancement of the medical device 108 beyond the endoscope 104 can enable tissue treatment or sampling in anatomical regions (e.g., airways) that are too small for the endoscope 104 to be advanced through.

[0034] The coupler section 134 can be connected to the control unit 114 to connect to the endoscope 104 to multiple features of the control unit 114, such as the image processing unit 202, the treatment generator 204, or the like. In examples, the port 138 can be used to insert another instrument or device, such as a daughter scope or auxiliary scope, or a sampling needle, biopsy needle, ablation instrument, scalpel, or the like, into the endoscope 104. Such instruments and devices can be independently connected to the control unit 114 via the cable section 132. In examples, the port 140 can be used to connect the coupler section 134 to various inputs and outputs, such as video, air, light and electricity.

[0035] The image processing unit 202, the ultrasound image processing unit 208, and the light source 120 can each interface with the endoscope 104 (e.g., at the functional section 128) or the medical device 108 by wired or wireless electrical connections. The control system 102 can accordingly illuminate an anatomical region, collect signals representing the anatomical region, process signals representing the anatomical region, and display images representing the anatomical region on the display unit 116. The ultrasound image processing unit 208 can be configured to receive ultrasonic signals from either the endoscope 104Docket No. VTP24007-RDFG-US1 / / 5409.947PRV or the medical device 108, which can be converted into ultrasonic images and transmitted to the display unit 116 or any other component of the endoscopy system 100. The control system 102 can include the light source 120 to illuminate the anatomical region using light of a desired spectrum (e.g., broadband white light, narrow-band imaging using electromagnetic wavelengths, and the like). The control system 102 can connect (e.g., via an endoscope connector) to the endoscope 104 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 a diagnostic device, and the like).

[0036] The fluid source 122 (shown in FIG. 1) can be in communication with the control unit 114 and can include one or more sources of air, saline, or other fluids, as well as associated fluid pathways (e.g., air channels, irrigation channels, suction channels, and the like) and connectors (barb fittings, fluid seals, valves, and the like). The control system 102 can also include a drive unit 206, which can include a motorized drive for advancing a distal section of endoscope 104.

[0037] FIG. 3 and FIG. 4 illustrate examples of a medical device (e.g., medical device 108, see FIG. 1) having an instrument actuator 150 in the nonactuated state 338. FIG. 3 illustrates a side view of a portion of an example of an instrument actuator 304 (e.g., instrument actuator 150) for deploying an example of an instrument 306. FIG. 4 illustrates a side view of a portion of an example of instrument actuator 304 for deploying an example of the instrument 306.

[0038] As discussed above, the sheath extension mechanism 148 can be configured to deploy the medical device 108 within the endoscope 104 and include the instrument actuator 304 (e.g., instrument actuator 150, see FIG). The instrument actuator 304 can be operable to actuate an instrument 306 (needle, scalpel, ablation device, or the like) beyond a distal portion of a working channel (e.g., the working channel port 112, see FIG. 1 ) of the insertion section 126 (FIG. 1 ). In examples, the medical device 108 can include a handle 302, the instrument actuator 304, and a lockout mechanism 320.

[0039] The handle 302 (e.g., handle section 130, see FIG. 1) can be configured to couple the medical device 108 to the endoscope 104. The handle 302 can be designed to fit within the hand of a clinician for use during a medicalDocket No. VTP24007-RDFG-US1 / / 5409.947PRV procedure. The handle 302 can include an instrument lumen 308 extending therethrough.

[0040] The instrument actuator 304 can be operatively connected to the handle 302. The instrument actuator 304 can be operable to advance the instrument 306 relative to the instrument lumen 308. As shown in FIG. 3, the instrument actuator 304 can be disposed within the handle 302.

[0041] The lockout mechanism 320 can be disposed of within the handle 302. The lockout mechanism 320 can be moveable between an open configuration 340 (as shown in FIG. 3), and a closed configuration 506 (as shown in FIG. 5). In the open configuration 340, the instrument lumen 308 is not blocked by the lockout mechanism 320. In the closed configuration 506, as shown in FIG. 5, the instrument lumen 308 is blocked by the lockout mechanism 320. Actuation of the instrument actuator 304 to advance the instrument 306 can cause movement of the lockout mechanism 320 from the open configuration 340 to the closed configuration 506 to prevent reinsertion of the instrument 306 into the instrument lumen 308.

[0042] The lockout mechanism 320 can include a sleeve 310 and a rod 322. The sleeve 310 can be installed within the handle 302. The sleeve 310 can include a hollow cylinder extending between a proximal portion 312 and a distal portion 314 such that the instrument lumen 308 and the instrument 306 can extend through the sleeve 310 toward the endoscope 104. The sleeve 310 can include a groove 316 extending from the proximal portion 312 toward the distal portion 314. The rod 322 can extend between a first portion 324 and a second portion 326. The first portion 324 can include a blocking device 328. The blocking device 328 can extend from the rod 322 and be configured to engage with the instrument actuator 304 and rotate relative to the rotation of the rod 322. The second portion 326 can include a protrusion 332. The protrusion 332 can be configured to engage with the groove 316 to rotate the rod 322 as the protrusion 332 moves within the groove 316. The groove 316 can include a helical profile 318 (as shown in FIG. 3). The helical profile 318 can define the groove 316 as the groove 316 extends from the proximal portion 312 of the sleeve 310 toward the distal portion 314 of the sleeve 310.Docket No. VTP24007-RDFG-US1 / / 5409.947PRV

[0043] As shown in FIG. 3, FIG. 4, and FIG. 8, the handle 302 can be configured to receive the lockout mechanism 320 to hold the protrusion 332 within the groove 316 and permit rotation of the rod 322 as the protrusion 332 translates within the groove 316. As the instrument 306 is not actuated by the instrument actuator 304, the instrument actuator 304 can engage with the blocking device 328 to translate the rod 322 toward a proximal end of the groove 316. The translation of the protrusion 332 of the rod 322 within the groove 316 toward the proximal end of the groove 316 rotates the rod 322 (e.g., in the present example, the rod 322 rotates clockwise about a longitudinal axis of the rod 322) to move the lockout mechanism 320 into the open configuration 340 and permit insertion of an instrument 306 into the instrument lumen 308.

[0044] The instrument actuator 304 can deploy the instrument 306. As the instrument actuator 304 deploys the instrument 306, the instrument actuator 304 can engage with the blocking device 328 to translate the rod 322 and the protrusion 332 within the groove 316 toward a distal end of the groove 316. As the protrusion 332 translates within the groove 316, the rod rotates (e.g., in the present example, counterclockwise about a longitudinal axis of the rod 322). The rotation of the rod 322 can position the lockout mechanism 320 into the closed configuration 506, as shown in FIG. 5, to blockthe instrument lumen 308 and prevent the insertion of an instrument 306 into the instrument lumen 308.

[0045] The lockout mechanism 320 can also include a biasing member334. As shown in FIG. 3, the biasing member 334 can include a torsional spring 336. The torsional spring 336 can be attached to the rod 322, the blocking device 328, or any other component of the instrument actuator 150. The torsional spring 336 (or any other type of biasing member 334) can be configured to bias the lockout mechanism 320 toward the open configuration 340. The biasing member 334 can be configured to reduce the pressure applied to the instrument 306 by the biasing member 334 as the instrument 306 is installed within the instrument lumen 308 and the instrument actuator 150 deploys the instrument 306.

[0046] FIG. 5 illustrates an internal view of a portion of instrument actuator 150 in the actuated state 504. As the instrument actuator 150 moves away from the non-actuated state 338 toward the actuated state 504, the proximal surfaceDocket No. VTP24007-RDFG-US1 / / 5409.947PRV502 of the instrument lumen access cutout 330 can engage with the blocking device 328.

[0047] As the instrument actuator 304 moves distally, the engagement between the blocking device 328 and the proximal surface 502 of the instrument lumen access cutout 330 moves the rod 322 distally. As the rod 322 moves distally, the groove 316 of the sleeve 310 can guide the protrusion 332 along the helical profile 318 (FIG. 3) to rotate the rod 322 and the blocking device 328 accordingly. As the blocking device 328 rotates, the blocking device 328 can move into the closed configuration 506 to block the instrument lumen 308. As the blocking device 328 is in the closed configuration 506, the blocking device 328 can block the instrument lumen 308 to prevent or limit the reinsertion of an instrument 306 (FIG. 3) within the instrument lumen 308. Blocking the reinsertion of the instrument 306 into the instrument lumen 308 can help prevent unintended deployment of the instrument 306 to mitigate damage to the instrument 306, the endoscope 104 (FIG. 1 ), or the medical device 108 (FIG. 1).

[0048] FIG. 6 illustrates an internal view of a portion of an instrument actuator 150. As shown in FIG. 6, as the instrument actuator 304 can move backto the non-actuated state 338, the distal surface 702 (FIG. 7) of the instrument lumen access cutout 330 can engage the blocking device 328 to move the blocking device 328 and the rod 322 proximally. As the rod 322 moves proximally, the rod 322 and more specifically, the protrusion 332, moves along the helical profile 318 of the groove 316 to rotate the rod 322 and the blocking device 328 toward the open configuration 340. In the open configuration 340, the blocking device 328 permits re-insertion of the instrument 306 into the instrument lumen 308. As the instrument actuator 150 is in the non-actuated state 338, it is known that the instrument 306 will be within the lumen of either the endoscope 104 orthe medical device 108 and will not extend beyond either the endoscope 104 or the medical device 108.

[0049] FIG. 7 illustrates an internal view of a portion of an instrument actuator 150. FIG. 7 shows the blocking device 328 in the closed configuration 506, which blocks the instrument lumen 308 (first shown in FIG. 3) and preventsDocket No. VTP24007-RDFG-US1 / / 5409.947PRV reinsertion of an instrument until the instrument actuator 150 is returned to the non-actuated state 338 (first shown in FIG. 3).

[0050] FIG. 8 illustrates an internal top view of a portion of an instrument actuator 150 for deploying an example of a medical device (e.g., medical device 108, see FIG. 1 ) within an example of an endoscope (e.g., the endoscope 104, see FIG. 1). In FIG. 8, the instrument actuator 150 (FIG. 1 ) is in the non-actuated state 338, so the blocking device 328 does not block the instrument lumen 308. As the blocking device 328 does not block the instrument lumen 308, an instrument 306 (FIG. 3) can be reinserted within the instrument lumen 308. As the instrument actuator 150 is in the non-actuated state 338, the instrument 306 will be contained within the lumens of either of the endoscope 104 (FIG. 1 ) or the medical device 108 (FIG. 1 ), and not extend beyond either of the endoscope 104 or the medical device 108.

[0051] FIGS. 9 and 10 illustrate an internal perspective view of a portion of an example of an instrument actuator 304 including an enlarged view of an example of a lockout mechanism 320.

[0052] As shown in FIG. 9, as the instrument actuator 150 is in the nonactuated state 338, the lockout mechanism 320 can be in the open configuration 340. In the open configuration 340, the lockout mechanism 320 does not block the instrument lumen 308 such that the instrument 306 can be inserted therein the instrument lumen 308.

[0053] As shown in FIG. 10, as the instrument actuator 150 is in the actuated state 504 the lockout mechanism 320 can move from the open configuration 340 toward the closed configuration 506. As the instrument 306 is still in the instrument lumen 308, the 322 can contact the instrument 306. As discussed herein, the rod 322 can include the biasing member 334 to prevent an amount of force exerted on the instrument 306 by the lockout mechanism 320. As the instrument 306 is removed from the instrument lumen 308, the lockout mechanism 320 can move into the closed configuration 506 to block reinsertion of the instrument 306 after it is removed from the instrument lumen 308.Docket No. VTP24007-RDFO-US1 / / 5409.947PRV

[0054] The following non-limiting examples detail certain aspects of the present subject matter to solve the challenges and provide the benefits discussed herein, among others.

[0055] Example 1 is a medical device comprising: a handle configured to couple to an endoscope, the handle including an instrument lumen extending therethrough; an instrument actuator operatively connected to the handle, the instrument actuator operable to advance an instrument relative to the instrument lumen; and a lockout mechanism disposed within the handle, the lockout mechanism movable between an open configuration where the instrument lumen is not blocked and a closed configuration where the instrument lumen is blocked, wherein actuation of the instrument actuator to advance the instrument causes movement of the lockout mechanism from the open configuration to the closed configuration to prevent reinsertion of the instrument into the instrument lumen.

[0056] In Example 2, the subject matter of Example 1 optionally includes wherein the lockout mechanism comprises: a sleeve installed within the handle, the sleeve including: a groove extending from a proximal portion of the sleeve toward a distal portion of the sleeve; and a rod extending between: a first portion including: a blocking device extending from the rod and configured to engage with the instrument actuator and rotate relative to rotation of the rod; and a second portion including: a protrusion configured to engage with the groove to rotate the rod as the protrusion moves within the groove.

[0057] In Example 3, the subject matter of Example 2 optionally includes wherein the groove extends in a helical profile as it extends from the proximal portion of the sleeve toward the distal portion of the sleeve.

[0058] In Example 4, the subject matter of any one or more of Examples 2- 3 optionally include wherein the handle is configured to receive the lockout mechanism to hold the protrusion within the groove and to permit rotation of the rod as the protrusion translates within the groove.

[0059] In Example 5, the subject matter of Example 4 optionally includes wherein, when the instrument is not actuated by the instrument actuator, the instrument actuator engages with the blocking device to translate the rod towardDocket No. VTP24007-RDFO-US1 / / 5409.947PRV a proximal end of the groove and positions the lockout mechanism into the open configuration.

[0060] In Example 6, the subject matter of any one or more of Examples 4-5 optionally include wherein, as the instrument actuator deploys the instrument, the instrument actuator engages with the blocking device to translate the rod and the protrusion within the groove toward a distal end of the groove, and wherein as the protrusion translates within the groove the rod rotates, the rotation of the rod positions the lockout mechanism into the closed configuration.

[0061] In Example 7, the subject matter of any one or more of Examples 4-6 optionally include wherein the lockout mechanism comprises: a biasing member configured to bias the lockout mechanism toward the open configuration.

[0062] In Example 8, the subject matter of Example 7 optionally includes wherein the biasing member is a torsional spring attached to the rod.

[0063] In Example 9, the subject matter of any one or more of Examples 7-8 optionally include wherein the biasing member is a torsional spring attached to the blocking device.

[0064] In Example 10, the subject matter of any one or more of Examples 4-9 optionally include wherein the instrument actuator comprises: an instrument lumen access cutout configured to provide the blocking device access to the instrument lumen, the instrument lumen access cutout including: a proximal surface configured to engage the blocking device as the instrument actuator translates distally; and a distal surface configured to engage the blocking device as the instrument actuator translates proximally.

[0065] Example 11 is a sampling device comprising: a handle configured to attach to an endoscope, the handle including an needle lumen extending therethrough; an needle actuator operatively connected to the handle, the needle actuator operable to advance a sampling needle relative to the needle lumen; and a lockout mechanism disposed within the handle, the lockout mechanism movable between an open configuration where the needle lumen is not blocked and a closed configuration where the needle lumen is blocked, wherein actuation of the needle actuator to advance the sampling needle causes movement of theDocket No. VTP24007-RDFO-US1 / / 5409.947PRV lockout mechanism from the open configuration to the closed configuration to prevent reinsertion of the sampling needle into the needle lumen.

[0066] In Example 12, the subject matter of Example 11 optionally includes wherein the lockout mechanism comprises: a sleeve installed within the handle, the sleeve including: a groove extending from a proximal portion of the sleeve toward a distal portion of the sleeve; and a rod extending between: a first portion including: a blocking device extending from the rod and configured to engage with the needle actuator and rotate relative to rotation of the rod; and a second portion including: a protrusion configured to engage with the groove to rotate the rod as the protrusion moves within the groove.

[0067] In Example 13, the subject matter of Example 12 optionally includes wherein the groove extends in a helical profile as it extends from the proximal portion of the sleeve toward the distal portion of the sleeve.

[0068] In Example 14, the subject matter of any one or more of Examples 12-13 optionally include wherein the handle is configured to receive the lockout mechanism to hold the protrusion within the groove and permit rotation of the rod as the protrusion translates within the groove.

[0069] In Example 15, the subject matter of Example 14 optionally includes wherein, when the sampling needle is not actuated by the needle actuator, the needle actuator engages with the blocking device to translate the rod toward a proximal end of the groove and positions the lockout mechanism into the open configuration.

[0070] In Example 16, the subject matter of any one or more of Examples 14-15 optionally include wherein, as the needle actuator deploys the sampling needle, the needle actuator engages with the blocking device to translate the rod and the protrusion within the groove toward a distal end of the groove, and wherein as the protrusion translates within the groove the rod rotates, the rotation of the rode positions the lockout mechanism into the closed configuration.

[0071] In Example 17, the subject matter of any one or more of Examples 14-16 optionally include wherein the lockout mechanism comprises: a biasing member configured to bias the lockout mechanism toward the open configuration.Docket No. VTP24007-RDFO-US1 / / 5409.947PRV

[0072] In Example 18, the subject matter of Example 17 optionally includes wherein the biasing member is a torsional spring attached to the rod.

[0073] In Example 19, the subject matter of any one or more of Examples 17-18 optionally include wherein the biasing member is a torsional spring attached to the blocking device.

[0074] In Example 20, the subject matter of any one or more of Examples 14-19 optionally include wherein the needle actuator comprises: a needle lumen access cutout configured to provide the blocking device access to the needle lumen, the needle lumen access cutout including: a proximal surface configured to engage the blocking device as the needle actuator translates distally; and a distal surface configured to engage the blocking device as the needle actuator translates proximally.

[0075] Example 21 includes a system, method, device, or apparatus including any element of any of Examples 1-20.

[0076] The above-detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific examples that may be practiced. These embodiments are also referred to herein as “examples.” Such examples may include elements in addition to those shown or described. However, the present inventors also contemplate examples in which only those elements shown or described are provided. Moreover, the present inventors also contemplate examples using any combination or permutation of those elements shown or described (or one or more aspects thereof), either with respect to a particular example (or one or more aspects thereof), or with respect to other examples (or one or more aspects thereof) shown or described herein.

[0077] All publications, patents, and patent documents referred to in this document are incorporated by reference herein in their entirety, as though individually incorporated by reference. In the event of inconsistent usages between this document and those documents so incorporated by reference, the usage in the incorporated reference(s) should be considered supplementary to that of this document; for irreconcilable inconsistencies, the usage in this document controls.Docket No. VTP24007-RDFO-US1 / / 5409.947PRV

[0078] In this document, the terms “a” or “an” are used, as is common in patent documents, to include one or more than one, independent of any other instances or usages of “at least one” or “one or more.” In this document, the term “or” is used to refer to a nonexclusive or, such that “A or B” includes “A but not B,” “B but not A,” and “A and B,” unless otherwise indicated. In the appended claims, the terms “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” and “wherein.” Also, in the following claims, the terms “including” and “comprising” are open-ended, that is, a system, device, article, or process that includes elements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim. Moreover, in the following claims, the terms “first,” “second,” and “third,” etc. are used merely as labels, and are not intended to impose numerical requirements on their objects.

[0079] The term “about,” as used herein, means approximately, in the region of, roughly, or around. When the term “about” is used in conjunction with a numerical range, it modifies that range by extending the boundaries above and belowthe numerical values setforth. In general, the term “about” is used herein to modify a numerical value above and below the stated value by a variance of 10%. In one aspect, the term “about” means plus or minus 10% of the numerical value of the number with which it is being used. Therefore, about 50% means in the range of 45%-55%. Numerical ranges recited herein by endpoints include all numbers and fractions subsumed within that range (e.g., 1 to 5 includes 1 , 1.5, 2, 2.75, 3, 3.90, 4, 4.24, and 5). Similarly, numerical ranges recited herein by endpoints include subranges subsumed within that range (e.g., 1 to 5 includes 1 -1 .5, 1 .5-2, 2-2.75, 2.75-3, 3-3.90, 3.90-4, 4-4.24, 4.24-5, 2-5, 3-5, 1 -4, and 2-4). It is also to be understood that all numbers and fractions thereof are presumed to be modified by the term “about.”

[0080] The above description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more aspects thereof) may be used in combination with each other. Other examples may be used, such as by one of ordinary skill in the art upon reviewing the above description. The Abstract is to allow the reader to quickly ascertain the nature of the technical disclosure and is submitted with the understandingthat it will not beDocket No. VTP24007-RDFO-US1 / / 5409.947PRV used to interpret or limit the scope or meaning of the claims. Also, in the above Detailed Description, various features may be grouped together to streamline the disclosure. This should not be interpreted as intending that an unclaimed disclosed feature is essential to any claim. Rather, inventive subject matter may lie in less than all features of a particular disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description, with each claim standing on its own as a separate embodiment. The scope of the examples should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.

[0081] The devices disclosed herein can be designed to be disposed of after a single use, or they can be designed to be used multiple times. In either case, however, the device can be reconditioned for reuse after at least one use. Reconditioning can include a combination of the steps of disassembly of the device, followed by cleaning or replacement of particular pieces, and subsequent reassembly. In particular, the device can be disassembled, and any number of particular pieces or parts of the device can be selectively replaced or removed in any combination. Upon cleaning and / or replacement of particular parts, the device can be reassembled for subsequent use either at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure. Those of ordinary skill in the art will appreciate that the reconditioning of a device can utilize a variety of different techniques for disassembly, cleaning / replacement, and reassembly. Use of such techniques, and the resulting reconditioned device, are all within the scope of the present application.

[0082] Preferably, the invention described herein will be processed before surgery. First a new or used instrument is obtained and, if necessary, cleaned. The instrument can then be sterilized. In one sterilization technique, the instrument is placed in a closed and sealed container, such as a plastic or TYVEK® bag. The container and instrument are then placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or higher energy electrons. The radiation kills bacteria on the instrument and in the container. The sterilized instrument can then be stored in the sterile container. The sealed container keeps the instrument sterile until it is opened in the medical facility. The device may alsoDocket No. VTP24007-RDFO-US1 / / 5409.947PRV be sterilized using any other technique known in the art, including but limited to beta or gamma radiation, ethylene oxide, or steam.

Claims

Docket No. VTP24007-RDFO-US1 / / 5409.947PRVCLAIMSWhat is claimed is:

1. A medical device comprising: a handle configured to couple to an endoscope, the handle including an instrument lumen extending therethrough; an instrument actuator operatively connected to the handle, the instrument actuator operable to advance an instrument relative to the instrument lumen; and a lockout mechanism disposed within the handle, the lockout mechanism movable between an open configuration where the instrument lumen is not blocked and a closed configuration where the instrument lumen is blocked, wherein actuation of the instrument actuator to advance the instrument causes movement of the lockout mechanism from the open configuration to the closed configuration to prevent reinsertion of the instrument into the instrument lumen.

2. The medical device of claim 1 , wherein the lockout mechanism comprises: a sleeve installed within the handle, the sleeve including: a groove extending from a proximal portion of the sleeve toward a distal portion of the sleeve; and a rod extending between: a first portion including: a blocking device extending from the rod and configured to engage with the instrument actuator and rotate as the rod rotates due to translation within the groove; and a second portion including: a protrusion configured to engage with the groove to rotate the rod as the protrusion moves within the groove.

3. The medical device of claim 2, wherein the groove extends in a helical profile as it extends from the proximal portion of the sleeve toward the distal portion of the sleeve.Docket No. VTP24007-RDFO-US1 / / 5409.947PRV4. The medical device of any of claims 2-3, wherein the handle receives the lockout mechanism to hold the protrusion within the groove and permit rotation of the rod as the protrusion translates within the groove.

5. The medical device of claim 4, wherein, when the instrument is not actuated by the instrument actuator, the instrument actuator engages with the blocking device to translate the rod toward a proximal end of the groove and positions the lockout mechanism into the open configuration.

6. The medical device of any of claims 4-5, wherein, as the instrument actuator deploys the instrument, the instrument actuator engages with the blocking device to translate the rod and the protrusion within the groove toward a distal end of the groove, and wherein as the protrusion translates within the groove the rod rotates, the rotation of the rod positions the lockout mechanism into the closed configuration.

7. The medical device of any of claims 4-6, wherein the lockout mechanism comprises: a biasing member configured to bias the lockout mechanism toward the open configuration.

8. The medical device of claim 7, wherein the biasing member is a torsional spring attached to the rod.

9. The medical device of any of claims 7-8, wherein the biasing member is a torsional spring attached to the blocking device.

10. The medical device of any of claims 4-9, wherein the instrument actuator comprises: an instrument lumen access cutout to provide access to the instrument lumen for the blocking device, the instrument lumen access cutout including: a proximal surface configured to engage the blocking device as the instrument actuator translates distally; and a distal surface configured to engage the blocking device as the instrument actuator translates proximally.

11. A sampling device comprising: a handle configured to attach to an endoscope, the handle including a needle lumen extending therethrough;Docket No. VTP24007-RDFO-US1 / / 5409.947PRV a needle actuator operatively connected to the handle, the needle actuator operable to advance a sampling needle relative to the needle lumen; and a lockout mechanism disposed within the handle, the lockout mechanism movable between an open configuration where the needle lumen is not blocked and a closed configuration where the needle lumen is blocked, wherein actuation of the needle actuator to advance the sampling needle causes movement of the lockout mechanism from the open configuration to the closed configuration to prevent reinsertion of the sampling needle into the needle lumen.

12. The sampling device of claim 11 , wherein the lockout mechanism comprises: a sleeve installed within the handle, the sleeve including: a groove extending from a proximal portion of the sleeve toward a distal portion of the sleeve; and a rod extending between: a first portion including: a blocking device extending from the rod and configured to engage with the needle actuator as the rod rotates due to translation within the groove; and a second portion including: a protrusion configured to engage with the groove to rotate the rod as the protrusion moves within the groove.

13. The sampling device of claim 12, wherein the groove extends in a helical profile as it extends from the proximal portion of the sleeve toward the distal portion of the sleeve.

14. The sampling device of any of claims 12-13, wherein the handle is configured to receive the lockout mechanism to hold the protrusion within the groove and permit rotation of the rod as the protrusion translates within the groove.

15. The sampling device of claim 14, wherein, when the sampling needle is not actuated by the needle actuator, the needle actuator engages with theDocket No. VTP24007-RDFO-US1 / / 5409.947PRV blocking device to translate the rod toward a proximal end of the groove and positions the lockout mechanism into the open configuration.

16. The sampling device of any of claims 14-15, wherein, as the needle actuator deploys the sampling needle, the needle actuator engages with the blocking device to translate the rod and the protrusion within the groove toward a distal end of the groove, and wherein as the protrusion translates within the groove the rod rotates, the rotation of the rod positions the lockout mechanism into the closed configuration.

17. The sampling device of any of claims 14-16, wherein the lockout mechanism comprises: a biasing member configured to bias the lockout mechanism toward the open configuration.

18. The sampling device of claim 17, wherein the biasing member is a torsional spring attached to the rod.

19. The sampling device of any of claims 17-18, wherein the biasing member is a torsional spring attached to the blocking device.

20. The sampling device of any of claims 14-19, wherein the needle actuator comprises: a needle lumen access cutout to provide access to the needle lumen for the blocking device, the needle lumen access cutout including: a proximal surface configured to engage the blocking device as the needle actuator translates distally; and a distal surface configured to engage the blocking device as the needle actuator translates proximally.

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