Side exit RAMP roof liner

Abstract

A medical device can be configured to extend an instrument through a working channel of the medical device. The medical device can include a coupler including a side-exit ramp. The side-exit ramp can be configured to direct the instrument from the working channel and out a side of the coupler. A roof liner can be disposed within the coupler to engage with the instrument as the instrument extends out of the side-exit ramp.

Description

SIDE EXIT RAMP ROOF LINERCLAIM OF PRIORITY

[0001] This patent application claims the benefit of priority, under 35 U.S.C. Section 119(e), to U.S. Provisional Patent Application Serial Number 63 / 594,848, entitled “SIDE EXIT RAMP ROOF LINER,” filed on October 31 , 2023 (Attorney Docket No. 5409.889PRV), which is hereby incorporated by reference herein in its entirety.TECHNICAL FIELD

[0002] Examples described herein generally relate to medical devices and, more specifically, to medical devices including a side exit ramp having a roof liner for facilitating extension of a medical instrument from the side exit ramp.BACKGROUND

[0003] Conventional endoscopes can be used in a variety of clinical procedures, including, for example, illuminating, imaging, detecting and diagnosing one or more disease states, providing fluid delivery (e.g., saline or other preparations via a fluid channel) toward an anatomical region, providing passage (e.g., via a working channel) of one or more therapeutic devices for sampling ortreating an anatomical region, providing suction passageways for collecting fluids (e.g., saline or other preparations), and the like. Such anatomical regions can include the gastrointestinal tract (e.g., esophagus, stomach, duodenum, pancreaticobiliary duct, intestines, colon, and the like), renal area (e.g., kidney(s), ureter, bladder, urethra), other internal organs (e.g., reproductive systems, sinus cavities, submucosal regions, respiratory tract), and the like.

[0004] Sampling devices, which can be a type of endoscope or delivered via a working channel of an endoscope, can be used to take samples of target tissue within the patient for medical purposes. For example, some sampling devices can be deployed within the airways of the lungs to capture samples of target nodules within the lungs or beyond airway walls of a patient. The samples of the target nodules can be extracted to help in medical procedure planning, diagnosis, or the like.SUMMARY

[0005] In examples, a medical device can include an elongated member configured to be inserted within a patient. The elongated member can include a lumen extending therethrough. An instrument actuator can be configured to deploy an instrument through the lumen. An ultrasonic transducer can be disposed in a distal section of the medical device. The ultrasonic transducer can be configured to capture ultrasonic images within a field of view of the ultrasonic transducer. A coupler can be coupled to the distal section proximal to the ultrasonic transducer. The coupler can include a side-exit ramp configured to direct the instrument from the lumen and into the field of view of the ultrasonic transducer. A roof liner can be disposed within the couplerto engage with the instrument as the instrument extends out of the side-exit ramp.

[0006] In examples, a medical device can be configured to extend an instrument through a working channel of the medical device. The medical device can include a coupler including a side-exit ramp. The side-exit ramp can be configured to direct the instrument from the working channel and out a side of the coupler. A roof liner can be disposed within the coupler to engage with the instrument as the instrument extends out of the side-exit ramp.

[0007] In examples, an ultrasonic sampling device can include an elongated member configured to be inserted within a patient. The elongated member can include a lumen extending therethrough. A sampling needle can be deployable into the patient via the lumen. A needle actuator can be configured to deploy the sampling needle through the lumen. An ultrasonic transducer can be disposed in a distal section of the ultrasonic sampling device. The ultrasonic transducer can be configured to capture ultrasonic images within a field of view of the ultrasonic transducer. A coupler can be coupled to the distal section proximal to the ultrasonic transducer. The coupler can include a side-exit ramp configured to direct the sampling needle from the lumen and into the field of view of the ultrasonic transducer. A roof liner can be disposed within the coupler to engage with the sampling needle as the sampling needle extends out of the sideexit ramp.BRIEF DESCRIPTION OF THE DRAWINGS

[0008] 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.

[0009] FIG. 1 illustrates a schematic diagram of an example of a medical device system.

[0010] FIG. 2 illustrates a schematic diagram of an example of an imaging and control system of a medical device system.

[0011] FIG. 3 illustrates a cross-sectional view of a portion of an example of an ultrasonic sampling device.

[0012] FIG. 4A illustrates an enlarged cross-sectional view of a portion of an example of an ultrasonic sampling device.

[0013] FIG. 4B illustrates an enlarged cross-sectional view of a portion of an example of an ultrasonic sampling device.

[0014] FIG. 5 illustrates a perspective view of an example of a coupler of an ultrasonic sampling device.

[0015] FIG. 6 illustrates a perspective view of an example of a coupler of an ultrasonic sampling device with a roof liner installed therein.

[0016] FIG. 7 illustrates a perspective view of an example of a coupler of an ultrasonic sampling device with a sleeve installed thereon.

[0017] FIG. 8 illustrates a perspective view of an example of a coupler, including attachment interfaces for a roof liner.

[0018] FIG. 9 illustrates a schematic view of an example coupler, including a first and second die insert to mold the roof liner.DETAILED DESCRIPTION

[0019] Ultrasound enables sampling devices to help obtain biopsies from target nodules within the patient. For example, a lung lesion biopsy can be performed by inserting an endobronchial ultrasound (EBUS) sampling device into a patient’s lung via a working channel of an endoscope. When the sampling device is inserted into the patient adjacent to a target nodule, a sampling instrument (e.g., flexible biopsy needle, cutting blade, scissor, razor, or other endeffector) can be extended from the sampling device into the target nodule. For example, the sampling instrument can be extended from a side-exit ramp through an airway wall into a targeted lung nodule. When extended from the side-exit ramp, the instrument can puncture the tissue of the patient, such as, for example, an airway wall within the lung.

[0020] As the instrument is advanced out of or retracted back into the side-exit ramp, the instrument can contact specific portions of the side-exit ramp (which in some embodiment be defined by a coupler as described in more detail below). Contact between the instrument and these portions of the side-exit ramp can result in increased friction and can even scrape portions of the instrument, such as, for example, an external coating of the instrument. In some situations, this friction or scraping can result in undesirable debris near an outlet of the sideexit ramp. As an example, some biopsy needles include various laser cut patterns to increase the flexibility of the biopsy needle. Such laser-cut biopsy needles typically include an outer layer of heat-shrink material covering the laser cuts to enable a slight vacuum inside the needle lumen to draw adequate tissue for cytology. In situations in which the outer heat shrink material (which can be soft relative to a hard plastic or metal used to construct the side-exit ramp) comes into contact with and rubs against the side-exit ramp as the needle is advanced into the patient’s tissue, the heat shrink material can become scraped off or otherwise damaged.

[0021] Therefore, the inventors of the present disclosure have recognized a clinical need for improved side exit ramps which include a side exit ramp roof liner to mitigate the undesirable effects of friction and / or scraping as described above. Any of the features or techniques described herein can be included in an example system, device, or method.

[0022] In examples, a medical device can include an elongated member configured to be inserted within a patient. The elongated member can include a lumen extending therethrough. An instrument actuator can be configured to deploy an instrument through the lumen. An ultrasonic transducer can be disposed in a distal section of the medical device. The ultrasonic transducer can be configured to capture ultrasonic images within a field of view of the ultrasonictransducer. A coupler can be coupled to the distal section proximal to the ultrasonic transducer. The coupler can include a side-exit ramp configured to direct the instrument from the lumen and into the field of view of the ultrasonic transducer. A roof liner can be disposed within the couplerto engage with the instrument as the instrument extends out of the side-exit ramp.

[0023] In examples, a medical device can be configured to extend an instrument through a working channel of the medical device. The medical device can include a coupler including a side-exit ramp. The side-exit ramp can direct the instrument from the working channel and out a side of the coupler. A roof liner can be disposed within the coupler to engage with the instrument as the instrument extends out of the side-exit ramp.

[0024] In examples, an ultrasonic sampling device can include an elongated member configured to be inserted within a patient. The elongated member can include a lumen extending therethrough. A sampling needle can be deployable into the patient via the lumen. A needle actuator can be configured to deploy the sampling needle through the lumen. An ultrasonic transducer can be disposed in a distal section of the ultrasonic sampling device. The ultrasonic transducer can be configured to capture ultrasonic images within a field of view of the ultrasonic transducer. A coupler can be coupled to the distal section proximal to the ultrasonic transducer. The coupler can include a side-exit ramp configured to direct the sampling needle from the lumen and into the field of view of the ultrasonic transducer. A roof liner can be disposed within the coupler to engage with the sampling needle as the sampling needle extends out of the sideexit ramp.

[0025] FIG. 1 is a schematic diagram of an endoscopy system 100 that can include a control system 102 and an endobronchial ultrasound sampling 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.

[0026] 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.

[0027] 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 orvideo 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 treating 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.

[0028] The endoscope 104 can include an insertion section 126, a functional section 128, and a handle section 130, which can be coupled to acable 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 maneuver the 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).

[0029] 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.

[0030] 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 coupling with the insertion section 126. The examples shown in FIG. 1 and FIG. 2 are examples of endoscopes 104.

[0031] 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.”

[0032] The functional section 128 can include components for treating 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.

[0033] 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 extension 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.

[0034] 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 and store a portion of that tissue 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 endoscopysystem. 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 and / or illumination device 146 can enable an operator to visualize in real time 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.

[0035] 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, orthe 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.

[0036] 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) orthe medical device 108 by wired orwireless 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 104 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 endoscopysystem 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).

[0037] 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.

[0038] FIG. 3 illustrates a cross-sectional view of a portion of an example of an ultrasonic sampling device 306. The ultrasonic sampling device 306 can be configured to be inserted within a lumen 304 (e.g., defined by the inner walls of the air passages or airways of the lungs or any other lumen defined by the inner walls or tissue of the patient). In examples, the ultrasonic sampling device 306 can be directly inserted into the lumen 304 or can be extended from a mother scope that can guide the ultrasonic sampling device 306 toward a target location within the lumen 304. For example, the specific portion of the ultrasonic sampling device 306 shown in FIG. 3 can be representative of the distal end 110 of the medical device 108 illustrated in FIGS. 1 and 2. The ultrasonic sampling device 306 can include a coupler 308 which can mechanically couple a housing 318 to a flexible sheath such as the flexible sheath of medical device 108 which is configured for advancement and retraction within the working channel of endoscope 104 via manipulation of the sheath extension mechanism 148.

[0039] The coupler 308 can extend from a proximal portion 310 to a distal portion 312. The coupler 308 can include a side-exit ramp 314. The side-exit ramp 314 can extend within the coupler 308 from the proximal portion 310 and through a side of the coupler 308. The side-exit ramp 314 can direct an instrument 316(e.g., a sampling needle, cutting device, light source, liquid source, or the like) through the side of the coupler 308 and toward the tissue 288 that defines the lumen 304. For example, the proximal portion 310 of the coupler 308 can be mechanically affixed to a needle lumen extending from the instrument actuator 150 to the coupler 308. The needle lumen can be flexible similarto the flexible sheath so as to enable navigation of the combination of the endoscope 104 and / or medical device 108 through tortuous pathway within the patient’s anatomy (e.g., tight radius curves and bends within a patient’s airway).

[0040] The housing 318 can extend along a central axis 320 from a proximal section 322 (which is coupled to distal portion 312 of coupler 308) to a distal section 324. The housing can include a mount feature 326 that can be configured to receive a transducer 328. The transducer 328 can include elements (e.g., Piezoelectric Micro-machined Ultrasonic Transducer (pMUT), a Capacitive Micromachined Ultrasonic Transducer (CMUT)) to transmit an ultrasonic signal and receive the ultrasonic signals reflected by the tissue of the patient to generate an ultrasound image.

[0041] The transducer 328 can be connected to one or more components of the ultrasonic sampling device 306, such as, for example, one or more of the control unit 114 (FIG. 1 or FIG. 2), the treatment generator 204 (FIG. 2), the display unit 116 (FIG. 1 ), the input unit 118 (FIG. 1 or FIG. 2), the image processing unit 202 (FIG. 2), or the like. The transducer 328 can be configured to generate a signal indicative of an ultrasound image. The ultrasound image can be generated by the image processing unit 202 and transmitted by the control unit 114 to another component of the endoscopy system 100 (FIG. 1 or FIG. 2).

[0042] As shown in FIG. 3, the instrument 316 can include a sampling needle 330 and a needle liner 332, which can include a flexible portion 334 and a transition 336. The sampling needle 330 can be configured to extend beyond a distal end of the needle liner 332 to extend into the patient and capture a sample of a target nodule 300. The needle liner 332 can be configured to protect the sampling needle 330 as the instrument 316 is deployed within the ultrasonic sampling device 306 and the sampling needle 330 extends beyond the side-exit ramp 314. The needle liner 332 can include a medical-grade hypodermic tube,which can also be called a hypotube. The needle liner 332 can also include a coating, which can encompass the hypotube and seal the instrument 316 to prevent liquid or air from permeating through the needle liner 332. The transition 336 can be a zone of transition between the flexible portion 334 and the rigid portions of the needle liner 332. While the instrument 316 is being used, such as being inserted into the ultrasonic sampling device 306 toward the side-exit ramp 314, the needle liner 332 (including the hypotube or the coating) can engage with the coupler 308 or the side-exit ramp 314, which can result in skiving or scraping of the needle liner 332.

[0043] As shown in FIG. 3, the side-exit ramp 314 is a ramp that can be machined or otherwise manufactured into the design of the coupler 308. Thus, the side-exit ramp 314 can be made from any of the materials used to make the coupler 308, such as, for example, aluminum, titanium, stainless steel, any alloy or combination thereof, any other biocompatible material, or the like. As the sideexit ramp 314 can provide an angled transition for the instrument 316 orthe sampling needle 330 to pass through and out of the coupler 308, the side-exit ramp 314 can bend the instrument 316 or the sampling needle 330 as the instrument 316 or the sampling needle 330 extend through and beyond the sideexit ramp 314. Moreover, the sampling needle 330 can bend and buckle from forces during the sampling of the target nodule 300 beyond the opening of the side-exit ramp 314, which can further cause bending or buckling, which can cause contact between the instrument 316 and the side-exit ramp 314 or other parts of the coupler 308. This contact can result in the skiving or scraping referred to herein.

[0044] To help prevent the skiving or scraping of the needle liner 332, the coupler 308 can include a roof liner 338, and a sleeve 340. The roof liner 338 can be configured to contact the needle liner 332 as the instrument 316 moves through the coupler 308 and out of the side-exit ramp 314. The sleeve 340 can be configured to fit over the roof liner 338, such as holding the roof liner 338 in position within the coupler 308. The roof liner 338 can be formed from a material having a relatively lower coefficient of friction as compared to the coupler 308. For example, the roof liner 338 can be formed from a high-density polyethylene(HDPE) material (which is generally considered to be self-lubricating due to its low coefficient of friction) while the coupler 308 can be formed from stainless steel or other material suitable for medical applications. The needle liner 332, the roof liner 338, and the sleeve 340 will be discussed in more detail with reference to FIG. 4 - FIG. 9.

[0045] FIGS. 4A and 4B illustrate an enlarged cross-sectional view of a portion of an example of an ultrasonic sampling device 306. FIG. 4B illustrates better details of some of the features shown in FIG. 3 and FIG. 4A. For example, the roof liner 338 can extend beyond a distal end of the instrument 316 and the needle liner 332. As such, the roof liner 338 can function as a stop to prevent the needle liner 332 from extending further toward an exit of the side-exit ramp 314. Once the needle liner 332 contacts the roof liner 338, the clinician can extend the sampling needle 330 and out of the side-exit ramp 314. Therefore, as the sampling needle 330 extends from the needle liner 332, the sampling needle 330 can contact the roof liner 338, which can help guide the sampling needle 330 out of the side-exit ramp 314 without damaging the sampling needle 330 or the needle liner 332.

[0046] In another example, the roof liner 338 can be formed such that the roof liner 338 extends adjacent to the side-exit ramp 314 but does not prevent the needle liner 332 from extending within the side-exit ramp 314. Here, the roof liner 338 can be used to help decrease scrapping and skiving of the roof liner 338 as the instrument 316 extends beyond the side-exit ramp 314.

[0047] FIG. 5 illustrates a perspective view of an example of a coupler 308. The coupler 308 can include a roof liner receptacle 502. The roof liner receptacle 502 can extend on either side of the side-exit ramp 314 and can be configured to receive (e.g., pressed into, molded into, or the like) the roof liner 338. The size of the roof liner receptacle 502 can be adjusted to be able to accommodate various sizes of the roof liner 338. As such, different coupler 308, including different sizes of the roof liner receptacle 502 can be made to address the many uses that the ultrasonic sampling device 306 can be used.

[0048] FIG. 6 illustrates a perspective view of an example of a coupler 308 with a roof liner 338 installed therein. As shown in FIG. 6, the roof liner 338 can beinstalled (e.g., pressed, molded, or the like) such that the roof liner 338 is aligned with a periphery 602 of the proximal portion 310 of the coupler 308. As such, the sleeve 340 (FIG. 3 and FIG. 7) can easily fit around the proximal portion 310 of the coupler 308 with the roof liner 338 installed therein.

[0049] The roof liner 338 can be manufactured with the roof liner 338 extending radially beyond the periphery 602 of the proximal portion 310 of the coupler 308. Installing the sleeve 340 can slightly compress the roof liner 338 to help hold the roof liner 338 in position and limit slop or play of the roof liner 338 within the roof liner receptacle 502 (FIG. 5).

[0050] The roof liner 338 can be radially within the periphery 602 of the proximal portion 310 of the coupler 308. Thus, the roof liner 338 can include some play to help absorb energy from the instrument 316 or the sampling needle 330 beingtwisted, buckled, or kinked during the medical procedure.

[0051] FIG. 7 illustrates a perspective view of an example of a coupler 308 with a sleeve 340 installed thereon. As described herein, the sleeve 340 can be slid overthe proximal portion 310 of the coupler 308 to help secure the roof liner 338 within the roof liner receptacle 502 of the coupler 308. The sleeve 340 can be made from aluminum, titanium, rubbers, polymers, any other biocompatible material, any alloy, composite, or combination thereof, or the like.

[0052] FIG. 8 illustrates a perspective view of an example of a coupler 802 (e.g., the coupler 308, see FIG. 3), including an anchor 810 for a roof liner (e.g., roof liner 338, see FIG. 3). As discussed herein, and shown in FIG. 8, the needle lumen 806 (e.g., lumen 304, FIG. 3) can be connected to the side-exit ramp 804 such that the side-exit ramp 804 can direct an instrument (e.g., instrument 316, FIG. 3) from the needle lumen 806 and out a side of the coupler 802. As the sideexit ramp 804 directs the instrument 316 out the side of the coupler 802, the instrument can contact the coupler 802 above the side-exit ramp 804 toward the proximal end of the side-exit ramp 804. The engagement between the instrument and the coupler 802 can cause rubbing, skiving, or scraping of the instrument (or the needle liner 332, FIG. 3) as the instrument extends from the side-exit ramp804.

[0053] The roof liner receptacle 808 can be configured to receive a roof liner (e.g., roof liner 338, FIG. 3) to decrease these effects of the contact between the instrument and the coupler 802. To aid in the securing of the roof liner within the roof liner receptacle 808, the roof liner receptacle 808 can include one or more anchors 810. For example, the anchor 810 can be formed in the roof liner receptacle 808. As shown in FIG. 8, the anchor 810 can be formed in the roof liner receptacle 808 on both sides of the side-exit ramp 804. In another example, the anchor 810 can be formed on just a single side of the side-exit ramp 804. As the anchor 810 or anchors 810 helps to hold the roof liner within the roof liner receptacle 808, the roof liner can be installed without the sleeve (e.g., sleeve 340, FIG. 3). When the roof liner is installed without a sleeve, the coupler 802 can include a first diameter 812, which can be equal to the second diameter 604 to maintain the diameter of the coupler 802 from distal end to proximal end. In another example, the anchor 810 or anchors 810 can be used in the coupler 308, as shown in FIGS. 3-7, such that a sleeve (e.g., the sleeve 340) still surrounds the roof liner and the proximal end of the coupler 308 to maintain an outer diameter of the coupler 308 (including the sleeve) from the proximal end to the distal end.

[0054] FIG. 9 illustrates a schematic view of an example coupler 308 including a first die insert 902 and a second die insert 908 to mold the roof liner 338. As the roof liner 338 can be inserted and molded into the roof liner receptacle 502 of the coupler 308, the roof liner 338 can include high-density polyethylene (HDPE), other polymers or rubbers, any combination thereof, any other moldable biocompatible material, or the like. The roof liner 338 can be installed in the roof liner receptacle 502 to cover exposed surfaces of the coupler 308 opposite the side-exit ramp 314 to provide a durable, slick surface along the path of the instrument 316 and the sampling needle 330 through the side-exit ramp 314. Therefore, the roof liner 338 can increase the predictability of travel of the instrument 316, or the sampling needle 330, as it extends through the coupler 308.

[0055] In molding the roof liner 338, the first die insert 902 can be installed into the side-exit ramp 314 to define a distal edge and radial outward surface of the roof liner 338. In examples the first die insert 902 can be installed in the firstinstallation direction 906. The first die insert 902 can include the channel 904 to provide a working channel through which the material of the roof liner 338 can be shot during the molding process. The second die insert 908 can be installed through the proximal portion 310 of the coupler 308 to define a radially inner surface of the roof liner 338. The second die insert 908 can be installed in the coupler 308 in the second installation direction 910.

[0056] The following non-limiting examples detail certain aspects of the present subject matter that solve the challenges and provide the benefits discussed herein, among other things.

[0057] Example 1 is a medical device comprising: an elongated member configured to be inserted within a patient, the elongated member including a lumen extending therethrough; an instrument actuator configured to deploy an instrument through the lumen; an ultrasonic transducer disposed in a distal section of the medical device, the ultrasonic transducer configured to capture ultrasonic images within a field of view of the ultrasonic transducer; a coupler coupled to the distal section proximal to the ultrasonic transducer, the coupler including a side-exit ramp configured to direct the instrument from the lumen and into the field of view of the ultrasonic transducer; and a roof liner disposed within the coupler to engage with the instrument as the instrument extends out of the side-exit ramp.

[0058] In Example 2, the subject matter of Example 1 optionally includes wherein the coupler comprises a roof liner receptacle, the roof liner receptacle configured to receive the roof liner and position the roof liner adjacent to an exit of the side-exit ramp.

[0059] In Example 3, the subject matter of Example 2 optionally includes wherein the roof liner receptacle comprises: an anchor configured to receive the roof liner to couple the roof liner to the roof liner receptacle.

[0060] In Example 4, the subject matter of Example 3 optionally includes a sleeve configured to be installed around the roof liner and the coupler to help secure the roof liner within the coupler.

[0061] In Example 5, the subject matter of any one or more of Examples 2- 4 optionally include a sleeve configured to be installed around the roof liner and the coupler to help secure the roof liner within the coupler.

[0062] In Example 6, the subject matter of Example 5 optionally includes wherein a proximal portion of the coupler includes a first diameter and a distal portion of the coupler includes a second diameter, and wherein the first diameter is smaller than the second diameter.

[0063] In Example 7, the subject matter of Example 6 optionally includes wherein an outside diameter of the sleeve matches the second diameter of the coupler.

[0064] In Example 8, the subject matter of any one or more of Examples 2-7 optionally include wherein the coupler is configured to receive a molding die through at least one of a proximal end of the coupler or the side-exit ramp to permit injection molding of the roof liner within the roof liner receptacle.

[0065] In Example 9, the subject matter of any one or more of Examples 1-8 optionally include wherein the coupler is configured to be manufactured with additive manufacturing techniques.

[0066] Example 10 is a medical device configured to extend an instrument through a working channel of the medical device, the medical device comprising: a coupler including a side-exit ramp, the side-exit ramp configured to direct the instrument from the working channel and out a side of the coupler; and a roof liner disposed within the coupler to engage with the instrument as the instrument extends out of the side-exit ramp.

[0067] In Example 11 , the subject matter of Example 10 optionally includes wherein the coupler comprises a roof liner receptacle, the roof liner receptacle configured to receive the roof liner and position the roof liner adjacent to an exit of the side-exit ramp.

[0068] In Example 12, the subject matter of Example 11 optionally includes wherein the roof liner receptacle comprises: an anchor configured to receive the roof liner to couple the roof liner to the roof liner receptacle.

[0069] In Example 13, the subject matter of Example 12 optionally includes a sleeve configured to be installed around the roof liner and the coupler to help secure the roof liner within the coupler.

[0070] In Example 14, the subject matter of any one or more of Examples 11-13 optionally include a sleeve configured to be installed around the roof liner and the coupler to help secure the roof liner within the coupler.

[0071] In Example 15, the subject matter of Example 14 optionally includes wherein a proximal portion of the coupler includes a first diameter and a distal portion of the coupler includes a second diameter, and wherein the first diameter is smallerthan the second diameter.

[0072] In Example 16, the subject matter of Example 15 optionally includes wherein an outside diameter of the sleeve matches the second diameter of the coupler.

[0073] In Example 17, the subject matter of any one or more of Examples 11-16 optionally include wherein the coupler is configured to receive a molding die through at least one of a proximal end of the coupler or the side-exit ramp to permit injection molding of the roof liner within the roof liner receptacle.

[0074] In Example 18, the subject matter of any one or more of Examples 10-17 optionally include wherein the coupler is configured to be manufactured with additive manufacturing techniques.

[0075] Example 19 is an ultrasonic sampling device comprising: an elongated member configured to be inserted within a patient, the elongated member including a lumen extending therethrough; a sampling needle deployable into the patient via the lumen; a needle actuator configured to deploy the sampling needle through the lumen; an ultrasonic transducer disposed in a distal section of the ultrasonic sampling device, the ultrasonic transducer configured to capture ultrasonic images within a field of view of the ultrasonic transducer; a coupler coupled to the distal section proximal to the ultrasonic transducer, the coupler including a side-exit ramp configured to direct the sampling needle from the lumen and into the field of view of the ultrasonic transducer; and a roof liner disposed within the coupler to engage with the sampling needle as the sampling needle extends out of the side-exit ramp.

[0076] In Example 20, the subject matter of Example 19 optionally includes wherein the roof liner includes materials with a first hardness, and the coupler includes materials with a second hardness, and wherein the first hardness is less than the second hardness.

[0077] Example 21 includes an apparatus, device, system, or method, including any element of any of Examples 1-20.

[0078] 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 can be practiced. These embodiments are also referred to herein as “examples.” Such examples can 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.

[0079] 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.

[0080] 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.

[0081] 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 set forth. 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.”

[0082] The above description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more aspects thereof) can be used in combination with each other. Other examples can 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 understanding that it will not be used to interpret or limit the scope or meaning of the claims. Also, in the above Detailed Description, various features can be grouped together to streamline the disclosure. This should not be interpreted as intendingthat an unclaimed disclosed feature is essential to any claim. Rather, inventive subject matter can 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 examplesshould be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.

[0083] The devices disclosed herein can be designed to be disposed of after a single use, orthey 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.

[0084] 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 can also be sterilized using any other technique known in the art, including but limited to beta or gamma radiation, ethylene oxide, or steam.

Claims

CLAIMSWhat is claimed is:

1. A medical device comprising: an elongated member configured to be inserted within a patient, the elongated member including a lumen extending therethrough; an instrument actuator configured to deploy an instrument through the lumen; an ultrasonic transducer disposed at a distal section of the medical device, the ultrasonic transducer configured to capture ultrasonic images within a field of view of the ultrasonic transducer; a coupler coupled to the distal section proximal to the ultrasonic transducer, the coupler including a side-exit ramp configured to direct the instrument from the lumen and into the field of view of the ultrasonic transducer; and a roof liner disposed within the coupler to engage with the instrument as the instrument extends out of the side-exit ramp.

2. The medical device of claim 1 , wherein the coupler comprises a roof liner receptacle, the roof liner receptacle configured to receive the roof liner and position the roof liner adjacent to an exit of the side-exit ramp.

3. The medical device of claim 2, wherein the roof liner receptacle comprises: an anchor configured to receive the roof liner to couple the roof liner to the roof liner receptacle.

4. The medical device of claim 3, comprising: a sleeve configured to be installed around the roof liner and the coupler to help secure the roof liner within the coupler.

5. The medical device of claim 2, comprising:a sleeve configured to be installed around the roof liner and the coupler to help secure the roof liner within the coupler.

6. The medical device of claim 5, wherein a proximal portion of the coupler includes a first diameter and a distal portion of the coupler includes a second diameter, and wherein the first diameter is smallerthan the second diameter.

7. The medical device of claim 6, wherein an outside diameter of the sleeve matches the second diameter of the coupler.

8. The medical device of claim 2, wherein the coupler is configured to receive a molding die through at least one of a proximal end of the coupler or the side-exit ramp to permit injection molding of the roof liner within the roof liner receptacle.

9. The medical device of claim 1 , wherein the coupler includes materials having a first coefficient of friction and the roof liner includes materials having a second coefficient of friction, and wherein the second coefficient of friction is less than the first coefficient of friction.

10. A medical device configured to extend an instrument through a working channel of the medical device, the medical device comprising: a coupler including a side-exit ramp, the side-exit ramp configured to direct the instrument from the working channel and out a side of the coupler; and a roof liner disposed within the coupler to engage with the instrument as the instrument extends out of the side-exit ramp.11 . The medical device of claim 10, wherein the coupler comprises a roof liner receptacle, the roof liner receptacle configured to receive the roof liner and position the roof liner adjacent to an exit of the side-exit ramp.

12. The medical device of claim 11 , wherein the roof liner receptacle comprises: an anchor configured to receive the roof liner to couple the roof liner to the roof liner receptacle.

13. The medical device of claim 12, comprising: a sleeve configured to be installed around the roof liner and the coupler to help secure the roof liner within the coupler.

14. The medical device of claim 11 , comprising: a sleeve configured to be installed around the roof liner and the coupler to help secure the roof liner within the coupler.

15. The medical device of claim 14, wherein a proximal portion of the coupler includes a first diameter and a distal portion of the coupler includes a second diameter, and wherein the first diameter is smallerthan the second diameter.

16. The medical device of claim 15, wherein an outside diameter of the sleeve matches the second diameter of the coupler.

17. The medical device of claim 11 , wherein the coupler is configured to receive a molding die through at least one of a proximal end of the coupler or the side-exit ramp to permit injection molding of the roof liner within the roof liner receptacle.

18. The medical device of claim 10, wherein the coupler is manufactured using additive manufacturing techniques.

19. An ultrasonic sampling device comprising: an elongated member configured to be inserted within a patient, the elongated member including a lumen extending therethrough; a sampling needle deployable into the patient via the lumen;a needle actuator configured to deploy the sampling needle through the lumen; an ultrasonic transducer disposed in a distal section of the ultrasonic sampling device, the ultrasonic transducer configured to capture ultrasonic images within a field of view of the ultrasonic transducer; a coupler coupled to the distal section proximal to the ultrasonic transducer, the coupler including a side-exit ramp configured to direct the sampling needle from the lumen and into the field of view of the ultrasonic transducer; and a roof liner disposed within the coupler to engage with the sampling needle as the sampling needle extends out of the side-exit ramp.

20. The ultrasonic sampling device of claim 19, wherein the roof liner includes materials with a first hardness, and the coupler includes materials with a second hardness, and wherein the first hardness is less than the second hardness.

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