Reinforced catheter device and method

Abstract

Various embodiments disclosed relate to medical devices. Examples of medical devices include sampling devices. Medical devices and associated methods can be used with an endoscope. Medical devices and associated methods shown include a first cylindrical reinforcing structure, a second cylindrical reinforcing structure around the first cylindrical reinforcing structure, and a polymer layer, wherein a portion of the polymer layer at least partially impregnates the second cylindrical reinforcing structure.

Description

REINFORCED CATHETER DEVICE AND METHODPRIORITY CLAIM

[0001] This application claims the benefit of priority to U.S. Provisional Patent Application Serial No. 63 / 719,479, filed November 12, 2024, the contents of which are incorporated herein by reference.TECHNICAL FIELD

[0002] Examples disclosed herein generally relate to medical devices for use with an endoscope or by themselves. Example medical devices include sampling devices and / or treatment devices introduced through a catheter or other elongated device.BACKGROUND

[0003] Medical devices such as sampling devices are often introduced to a target region of a subject using an endoscope. The process of pushing and twisting a medical device such as a sampling device puts stresses on the medical device that are compensated for using structures and materials that stand up to the necessary forces. Improved configurations and materials are desired to further provide robust devices with small dimensions that are capable of performing mechanically and reaching small areas of interest within a subject.BRIEF DESCRIPTION OF THE DRAWINGS

[0004] In the drawings, which are not necessarily drawn to scale, like numerals may describe similar components in different views. Like numerals having different letter suffixes may represent different instances of similar components. The drawings illustrate generally, by way of example, but not by way of limitation, various embodiments discussed in the present document.

[0005] FIG. 1 illustrates a schematic diagram of an example of a medical device system.

[0006] FIG. 2 illustrates a schematic diagram of an example of an imaging and control system of a medical device system.

[0007] FIG. 3 A illustrates a portion of a sampling device in accordance with some example embodiments.

[0008] FIG. 3B illustrates a cross section of a portion of the sampling device from Figure 3 A in accordance with some example embodiments.

[0009] FIG. 4A illustrates a portion of a sampling device in accordance with some example embodiments.

[0010] FIG. 4B illustrates a cross section of the sampling device portion from Figure 4A in accordance with some example embodiments.

[0011] FIG. 5 illustrates a cross section of a portion of a sampling device in accordance with some example embodiments.

[0012] FIG. 6 illustrates a cross section of a portion of a sampling device in accordance with some example embodiments.

[0013] FIG. 7 illustrates a cross section of a portion of a sampling device in accordance with some example embodiments.

[0014] FIG. 8 illustrates a flow diagram of a method of manufacture in accordance with some example embodiments.DETAILED DESCRIPTION

[0015] In the following detailed description, reference is made to the accompanying drawings which form a part hereof, and in which is shown, by way of illustration, specific embodiments in which the invention may be practiced. In the drawings, like numerals describe substantially similar components throughout the several views. These embodiments are described in sufficient detail to enable those skilled in the art to practice the invention. Other embodiments may be utilized and structural, or logical changes, etc. may be made without departing from the scope of the present invention.

[0016] 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.

[0017] 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 104can interface or connect to the control system 102. The endoscope 104 is described in the present example as a bronchoscope, though other types of 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.

[0018] 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. 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. The control unit 114 can also generate signals or other outputs from treating the anatomical region into which 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.

[0019] 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 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 can 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 fluidpassages, guide wires, and pull wires, can also be provided by the insertion section 126 (e.g., via suction or irrigation passageways, or the like).

[0020] 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.

[0021] The handle section 130 can include the steering control 136 as well as a cable attachment portion 138, which may include a stress relief boot to shield the endoscope cable from mechanical stress (e.g., bending and / or twisting). The steering control 136 can be a knob, lever, or other actuation mechanism or the like, which can be used to navigate 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 140, as well as other ports, 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.

[0022] According to examples, the control system 102 can be provided on a mobile platform (e.g., a cart 142) with shelves for 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.”

[0023] 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.

[0024] As shown in FIG. 1, a medical device 108 can extend from the working channel port 112 at the distal face of the functional section 128 of the medical device 108. In one example, the medical device 108 includes a sampling device (e.g., a biopsy needle, a cytology brush, or other types of devices for capturing biological samples) as described in more detail below. The medical device 108 can be configured to be attached to port 140 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 mechanism148 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.

[0025]

[0026] 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.

[0027] 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.

[0028] 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 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.

[0029] FIG. 2 is a schematic diagram of the endoscopy system 100 of FIG. 1 including the 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 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.

[0030] 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, a port 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.

[0031] 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 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 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).

[0032] 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.

[0033] Figure 3A shows a distal end 300 of an elongate portion 302 of a sampling device according to one example. The distal end 300 includes an imaging transducer 310, and a side port 320 adjacent to the imaging transducer 310. Figure 3 A shows a field of view 312 of the imaging transducer 310 indicated in dashed lines. In one example, the imaging transducer 310 includes an ultrasound transducer, although other imaging devices are also within the scope of the present disclosure. The imaging transducer 310 is depicted in FIGS. 3 A and 3B as a linear ultrasound transducer and may be a Piezoelectric Micromachined Ultrasonic Transducer (PMUT), a Capacitive micromachined ultrasonic transducer (CMUT), or other type of linear ultrasound transducer.

[0034] In Figure 3 A, an instrument 322, such as a biopsy needle or other sampling device, is shown exiting the side port 320. As shown in Figure 3 A, as the instrument 322 exits the side port 320, it passes through the field of view 312 of the imaging transducer 310.This arrangement is advantageous, because it allows tissue in the field of view 312 to be imaged as the instrument 322 is moved to a desired location. The ability to view the instrument 322 with the imaging transducer 310 aids in location of a target tissue, and helps to inform a user when the instrument 322 is in a correct location to sample the target tissue. As shown in FIGS. 3 A and 3B, the field of view 312 and the side port 320 are configured to coincide such that a patient anatomy (not shown) at a particular side of the sampling device is imaged and sampled. Accordingly, in practice the sampling device will typically be controllably rotated within the patient anatomy until a targeted tissue region is identified within the field of view 312. Then, once the targeted tissue is properly aligned within the field of view 312, the instrument actuator 150 of FIG. 1 may be manipulated to advance the instrument 322 into the targeted tissue to, for example, obtain a biopsy sample and / or perform a treatment (e.g., monopolar or bipolar radio frequency ablation). Accordingly, in order to facilitate granular fine-tuned alignment of the targeted tissue within the field of view 312 and the side port 320, it is desirable for the elongate portion 302 of the sampling device to effectively transmit both axial and rotational movements imparted on the sampling device at the proximal end (e.g., at a handle outside of the patient) to the distal end having the transducer 310 and side port 320. Various configurations of the sample device include multicomponent elongate portion 302, where a 1stcomponent is configured to transmit axial movement while a 2ndcomponent is configured to transmit rotational movements, and the 1stand 2ndcomponents are bonded together with a polymer.

[0035] Figure 3B shows a cross section of the distal end 300 from Figure 3A. The imaging transducer 310 and the side port 320 are shown. A first lumen 305 is included within the elongate portion 302 that leads to a first lumen exit 304 adjacent to the side port 320. In use, the instrument 322 passes through the first lumen 305 and exits the side port 320 as shown in Figure 3B.

[0036] One or more coils 330 are shown adjacent to the imaging transducer 310. The coils 330 can be used to locate and orient the distal end 300 within a patient using detection hardware and signals that locate the coils 330 within a magnetic field. Although coils 330 are used as an example, other location device shapes apart from coils that provide location and / or orientation are within the scope of the invention.

[0037] Figure 3B further shows a second lumen 306 within the elongate portion 302. In one example, the second lumen 306 contains wiring or other communication lines that communicate with the imaging transducer 310 and / or the coils 330. In the example of Figure3B, a local circuit 340 in included, and is located between the imaging transducer 310 and the second lumen 306. In use, the imaging transducer 310 can require a number of communication pathways to communicate the large amount of data generated by the imaging transducer 310. In one example, the local circuit 340 provides local processing of data from the imaging transducer 310 before it is communicated to communication pathway in the second lumen 306. In one example, data from the imaging transducer 310 is multiplexed locally using the local circuit 340. Although multiplexing is used as an example, other processing in the local circuit 340 is also within the scope of the invention. By processing the data from the imaging transducer 310 locally using the local circuit 340, a number of wires 342 or other communication pathways is reduced. Reducing the number of wires 342 or other communication pathways allows the second lumen 306 to be smaller in diameter, and as a result, the elongate portion 302 can be made smaller in diameter. It is advantageous to have a smaller diameter elongate portion 302 because it allows the elongate portion 302 and the distal end 300 to pass into smaller and more detailed tissue locations. Smaller devices also are less invasive, which is generally desirable.

[0038] As noted, smaller diameter devices are desired. One technical challenge with smaller diameter devices, in particular smaller diameter elongated portions, is that when guiding them to a target location, axial forces and twisting forces become more difficult to transmit in a reliable way from a proximal location (such as the instrument actuator 150 from Figure 1) to the distal end 300 as shown in Figures 3 A - 3B. Figures 4A - Figure 7 show selected examples of reinforcement configurations that provide good control when applying axial and / or twisting forces, while maintaining desired small diameter dimensions.

[0039] Figure 4A shows an elongate portion 400 of a sampling device, similar to elongate portion 302 from Figures 3A-3B. The elongate portion 400 includes a first cylindrical reinforcing structure 402 and second cylindrical reinforcing structure 404 around the first cylindrical reinforcing structure 402. A polymer layer 410 is further shown in Figure 4A. In the example of Figure 4A, a portion of the polymer layer 410 at least partially impregnates the second reinforcing structure 404.

[0040] Figure 4B shows a cross section of the elongate portion 400 from Figure 4A. The first cylindrical reinforcing structure 402 can be seen in Figure 4B contacting, or otherwise forming a direct interface with the second cylindrical reinforcing structure 404. The polymer layer 410 is further shown in Figure 4B at least partially impregnating the second reinforcing structure 404. In the example of Figure 4B, the polymer layer 410 impregnates, andencapsulates the second reinforcing structure 404, and conforms to a surface structure of the first cylindrical reinforcing structure 402. Other levels of impregnation are discussed in more detail in examples below.

[0041] At least partial impregnation of the polymer layer 410 provides multiple functions. Impregnation of the polymer layer 410 forms a composite structure with a dispersed phase, or reinforcing phase, and a matrix that is continuous, and at least partially impregnates the reinforcing phase. In the example of Figure 4A, the reinforcing structures 402, 404 are the reinforcing phase, and the polymer layer 410 is the matrix. A composite structure as described benefits from resilience and resistance to fracture that is provided by the matrix phase, and strength and rigidity that is provided by the reinforcing phase. Another benefit provided by at least partial impregnation of the polymer layer 410 includes a reduced outer diameter of the elongate portion 400, which as noted above, is beneficial to reach smaller tissue regions in a less invasive manner.

[0042] The inclusion of multiple reinforcing phases provides tuned mechanical properties such as stiffness in selected directions and flexibility in other directions. Each of the reinforcing structures 402, 404 provides a desired mechanical property, which facilitates improved selectability of desired mechanical properties. For example, the elongate portion 400 can include enhanced stiffness in an axial direction, while maintaining flexibility in lateral directions from the first reinforcing structure 402. The elongate portion 400 can further include enhanced twisting stiffness from the second reinforcing structure 404. By combining the first reinforcing phase 402 and the second reinforcing phase 404, all of these properties are incorporated into a single device. By at least partially impregnating one or both reinforcing structures 402, 404 with the polymer layer 410, a small outer diameter is maintained, and the reinforcing structures 402, 404 are held in place.

[0043] In one example, the first reinforcing structure 402 and the second reinforcing structure 404 are in direct contact with one another, without any intervening layers. In other examples, a separating layer, for example, a polymer layer is located between the first reinforcing structure 402 and the second reinforcing structure 404. By utilizing direct contact, a small outer diameter is maintained, while still maintaining the mechanical benefits of each of the reinforcing structures 402, 404.

[0044] In one example, the first reinforcing structure 402 and the second reinforcing structure 404 are bonded at one or more locations. For example, at one or more ends, with a collar 406 as shown in Figure 4A. In other examples, locations along a length of the elongateportion 400 are selectively bonded. In one example, the first reinforcing structure 402 and the second reinforcing structure 404 are bonded along an entire length. Bonds can include adhesives or welding in the case of metallic reinforcing structures. Bonding between the reinforcing structures 402, 404 provides yet another way to further configure selective mechanical properties of the elongate portion 400 at desired locations along a length of the elongate portion 400.

[0045] In one example, one or both reinforcing structures include fibers or windings. In one example, windings are directly adjacent to one another, as shown with first reinforcing structure 402. In Figure 4A, the first reinforcing structure 402 includes spiral windings that abut one another, forming an uninterrupted sidewall. This structure provides good mechanical reaction force when the elongate portion 400 is pushed forward along a central axis. In other examples, one or more of the reinforcing structures includes windings with spaces between windings. In Figure 4A, the second reinforcing structure 404 includes spiral windings with spaces between windings. In one example, two or more windings are crossed. In one example, two or more windings are woven. In one example, two or more windings are wound in different directions. For example, in Figure 4A, the second reinforcing structure 404 includes spiral windings that cross one another, bur are not woven. Windings in the second reinforcing structure 404 include two different winding directions (clockwise and counterclockwise) crossed over one another. Although Figure 4A illustrates one example of reinforcing structures 402, 404, the invention is not so limited. In one example, the second reinforcing structure 404 includes a braided structure. A braided structure includes intertwining multiple strands or fibers in a regular, substantially repeating pattern.Interweaving of strands provides flexibility, strength, and resilience due to the interwoven nature of the components. In one example, the first reinforcing structure 402 includes a braided structure.

[0046] Any of a number of possible materials can be used for the reinforcing structures 402, 404. Examples include polymers such as rigid polymers with a durometer sufficient to provide desired stiffness and other mechanical properties. Other example materials include metals, such as stainless steel, titanium, etc. Composite materials are also within the scope of the present disclosure, such as polymer coated metals.

[0047] In one example, one or more reinforcing structures include variable density portions along a long axis of the elongated portion 400. In one example, variable density of a reinforcing structure includes a wire mesh that is stretched out over a portion, such as an endportion. By varying a density of a reinforcing structure, mechanical properties can be further tailored to specific portions. For example, an end portion of an elongated portion 400 can be more flexible laterally than other portions due to stretching of the reinforcing structure near the end portion. In other examples density of a reinforcing structure is varied using other manufacturing techniques, such as etching or forming a metal cylinder with varying features sizes along a length.

[0048] A number of materials are possible for use as the matrix in the polymer layer 410. In one example, the polymer layer 410 includes a polymer flexible at room temperature. In one example, the polymer layer 410 includes an elastomer. In one example, the polymer layer 410 includes a poly ether block amide polymer, although the invention is not so limited. In one example, the polymer layer 410 includes variable density portions along a long axis of the elongated portion 400.

[0049] Variable density in the polymer layer 410 can be attainted using a number of manufacturing methods. In one example, the polymer layer 410 is extruded onto the elongated portion 400 as the elongated portion 400 is drawn over a mandrel or out of a die. In an extruded example, a polymer source material can be varied as the elongated portion 400 is drawn to produce a polymer layer 410 with variable density and variable mechanical properties. In one example, reinforcing structures 402, 404 are placed over a mandrel and a polymer tube is placed over the reinforcing structures 402, 404. A shrink wrap is then placed over the reinforcing structures 402, 404 and the polymer tube and heat is applied. The shrink wrap constricts and forces the melted polymer tube into one or more of the reinforcing structures 402, 404. In a variable density example two or more different polymer tubes are places over different sections of the reinforcing structures 402, 404 and shrink wrap is applied with heat. The different polymer tubes will create variable density portions along a long axis of the elongated portion 400.

[0050] Figure 5 shows a cross section of a segment of an elongated portion 500. A lumen 502 is shown within sidewalls 510 of the elongated portion 500. Although a single lumen 502 is used for illustration, multiple lumens are within the scope of the invention, as shown in Figure 3B above. The sidewall in Figure 5 includes a first cylindrical reinforcing structure 512 and a second cylindrical reinforcing structure 514. In the example of Figure 5, the reinforcing structures 512, 514 include windings of round wire or round fibers, although the invention is not so limited. In the example of Figure 5, the first cylindrical reinforcing structure 512 includes spiral windings that abut one another, forming an uninterruptedsidewall. In the example of Figure 5, the second cylindrical reinforcing structure 514 includes pairs of windings separated by spaces. A polymer layer 516 is shown impregnating the reinforcing structures 512, 514 and forming a continuous matrix within the reinforcing structures 512, 514.

[0051] In the example of Figure 5, an outer diameter of the polymer layer 516 and an outer diameter of the second cylindrical reinforcing structure 514 are coextensive. Dashed line 517 indicates an outer diameter of the elongated portion 500. As shown, the dashed line 517 is level with an outer surface of the polymer layer 516, and an outer surface of individual wires in the second cylindrical reinforcing structure 514. Further in the example of Figure 5, an inner diameter of the polymer layer 516 and an inner diameter of the first cylindrical reinforcing structure 512 are coextensive. Dashed line 519 indicates an inner diameter of the elongated portion 500. As shown, the dashed line 519 is level with an inner surface of the polymer layer 516, and an inner surface of individual wires in the first cylindrical reinforcing structure 512. As such, the first cylindrical reinforcing structure 512 and the second cylindrical reinforcing structure 514 are encapsulated, or fully impregnated by the polymer layer 516.

[0052] Figure 6 shows another example of a cross section of a segment of an elongated portion 600. A lumen 602 is shown within sidewalls 610 of the elongated portion 600. Similar to the example of Figure 5, although a single lumen 602 is used for illustration, multiple lumens are within the scope of the invention. The sidewall 610 in Figure 6 includes a first cylindrical reinforcing structure 612 and a second cylindrical reinforcing structure 614. A polymer layer 616 is shown impregnating the reinforcing structures 612, 614 and forming a continuous matrix within the reinforcing structures 612, 614. In Figure 6, polymer layer 616 includes conforming features 618 that correspond to the second cylindrical reinforcing structure 614. In selected manufacturing methods, the polymer layer 616 is compressed into the second cylindrical reinforcing structure 614 leaving behind the conforming features 618. In the example of Figure 6, an inner diameter 619 of the elongated portion 600 is smooth, and does not include any conforming features similar to conforming features 618. In a compression forming operation, the inner diameter 619 can be formed over a smooth mandrel, which results in a smoother inner diameter surface.

[0053] In one example, an inner diameter surface of an elongated portion 500, 600, etc. can include a lubricious coating to further enhance movement of an instrument that can pass through a lumen 602, 602, etc. In one example, an outer diameter surface of an elongatedportion 500, 600, etc. can include a lubricious coating to further enhance movement of the elongated portion 500, 600, etc. within a passage of an endoscope.

[0054] Figure 7 shows another example of a cross section of a segment of an elongated portion 700. A lumen 702 is shown within sidewalls 710 of the elongated portion 700. Similar to the example of Figures 5 and 6, although a single lumen 702 is used for illustration, multiple lumens are within the scope of the invention. The sidewall 710 in Figure 7 includes a first cylindrical reinforcing structure 712 and a second cylindrical reinforcing structure 714. A polymer layer 716 is shown impregnating the reinforcing structures 712, 714 and forming a continuous matrix within the reinforcing structures 712, 714. In the example of Figure 7, an outer diameter of the polymer layer 716 and an outer diameter 717 of the second cylindrical reinforcing structure 714 are coextensive. In the example of Figure 7, the polymer layer 716 impregnates a portion of the first cylindrical reinforcing structure 712, but does not encapsulate the first cylindrical reinforcing structure 712.

[0055] Figure 8 shows a flow diagram of an example method of manufacture of a sampling device. In operation 802, a first cylindrical reinforcing structure is placed on a mandrel. In operation 804, a second cylindrical reinforcing structure is placed around the first cylindrical reinforcing structure. In operation 806, at least one of the first cylindrical reinforcing structure and the second cylindrical reinforcing structure are impregnated with a polymer to form a continuous polymer matrix. In one example, impregnating includes placing a polymer tube over the second cylindrical reinforcing structure, shrink wrapping the polymer tube and the second cylindrical reinforcing structure together, and applying heat to melt the polymer tube and press the melted polymer tube into at least a portion of the second cylindrical reinforcing structure. In one example, multiple polymer tubes of different durometer are placed over different linear sections of the second cylindrical reinforcing structure to provide different mechanical properties. In one example, impregnating includes extruding a polymer into a die along with the first cylindrical reinforcing structure and the second cylindrical reinforcing structure.Various Notes & Examples

[0056] Aspect 1. A sampling device, comprising: an elongated portion, including: a first cylindrical reinforcing structure; a second cylindrical reinforcing structure around the first cylindrical reinforcing structure; and a polymer layer, wherein a portion of the polymer layerat least partially impregnates the second cylindrical reinforcing structure; an imaging transducer at a distal end of the elongated portion; and a lumen within the elongated portion, the lumen exiting the elongated portion at a side port adjacent to the imaging transducer.

[0057] Aspect 2. The sampling device of aspect 1, wherein the first and second cylindrical reinforcing structures are encapsulated.

[0058] Aspect 3. The sampling device of aspect 1, wherein an outer diameter of the polymer layer and an outer diameter of the second cylindrical reinforcing structure are coextensive.

[0059] Aspect 4. The sampling device of aspect 1, wherein an outer surface of the polymer layer includes conforming features that correspond to the second cylindrical reinforcing structure.

[0060] Aspect 5. The sampling device of aspect 1, wherein the imaging transducer includes an ultrasound transducer.

[0061] Aspect 6. The sampling device of aspect 1, wherein the lumen is configured to guide a needle to extend into a field of view of the imaging transducer.

[0062] Aspect 7. The sampling device of aspect 6, wherein the field of view includes an imaging plane parallel to a path of the needle.

[0063] Aspect 8. The sampling device of aspect 1, further including a fixture configured to couple to an accessory port of an endoscope.

[0064] Aspect 9. The sampling device of aspect 1, further including a lubricious coating on a surface of the polymer layer.

[0065] Aspect 10. The sampling device of aspect 1, wherein the first cylindrical reinforcing structure is in direct contact with the second cylindrical reinforcing structure.

[0066] Aspect 11. The sampling device of aspect 1, wherein the polymer layer includes variable density portions along a long axis of the elongated portion.

[0067] Aspect 12. The sampling device of aspect 1, wherein the first cylindrical reinforcing structure is secured to the second cylindrical reinforcing structure at one or more ends of the elongated portion.

[0068] Aspect 13. A sampling device, comprising: an elongated portion, including: a first cylindrical reinforcing structure; a second cylindrical reinforcing structure around the first cylindrical reinforcing structure; and a polymer layer, wherein a portion of the polymer layer at least partially impregnates the second cylindrical reinforcing structure; and an imaging transducer at a distal end of the elongated portion.

[0069] Aspect 14. The sampling device of aspect 11, further including a multiplexing circuit located locally at the distal end of the elongated portion, adjacent to the imaging transducer.

[0070] Aspect 15. The sampling device of aspect 14, further including a wiring channel coupled between the multiplexing circuit and a proximal end of the elongated portion.

[0071] Aspect 16. The sampling device of aspect 11, wherein the first cylindrical reinforcing structure includes a coil structure, and wherein the second cylindrical reinforcing structure includes a braided structure.

[0072] Aspect 17. A sampling device, comprising: an elongated portion, including: a first cylindrical reinforcing structure; a second cylindrical reinforcing structure around the first cylindrical reinforcing structure; and a polymer layer, wherein a portion of the polymer layer at least partially impregnates the second cylindrical reinforcing structure; and a lumen within the elongated portion, the lumen exiting the elongated portion at a side port adjacent to a distal end of the elongated portion.

[0073] Aspect 18. The sampling device of aspect 17, wherein the second cylindrical reinforcing structure includes variable density portions along a long axis of the elongated portion.

[0074] Aspect 19. The sampling device of aspect 18, wherein the polymer layer includes variable density portions along a long axis of the elongated portion.

[0075] Aspect 20. The sampling device of aspect 17, wherein the first cylindrical reinforcing structure is in direct contact with the second cylindrical reinforcing structure.

[0076] Aspect 21. The sampling device of aspect 20, wherein the first cylindrical reinforcing structure is secured to the second cylindrical reinforcing structure.

[0077] Aspect 22. A method, comprising: placing a first cylindrical reinforcing structure on a mandrel; placing a second cylindrical reinforcing structure around the first cylindrical reinforcing structure; and impregnating at least one of the first cylindrical reinforcing structure and the second cylindrical reinforcing structure with a polymer to form a continuous polymer matrix.

[0078] Aspect 23. The method of aspect 22, wherein impregnating includes impregnating the first cylindrical reinforcing structure and the second cylindrical reinforcing structure with a polymer to form a continuous polymer matrix from an outer diameter to an inner diameter of an elongated cylinder.

[0079] Aspect 24. The method of aspect 22, wherein impregnating at least one of the first cylindrical reinforcing structure and the second cylindrical reinforcing structure includes placing a polymer tube over the second cylindrical reinforcing structure; shrink wrapping the polymer tube and the second cylindrical reinforcing structure; and applying heat to melt the polymer tube and press the melted polymer tube into at least a portion of the second cylindrical reinforcing structure.

[0080] Aspect 25. The method of aspect 23, wherein placing a polymer tube over the second cylindrical reinforcing structure includes placing multiple polymer tubes of different durometer over different linear sections of the second cylindrical reinforcing structure.

[0081] Aspect 26. The method of aspect 22, wherein impregnating at least one of the first cylindrical reinforcing structure and the second cylindrical reinforcing structure includes extruding a polymer into a die along with the first cylindrical reinforcing structure and the second cylindrical reinforcing structure.

[0082] Each of these non-limiting aspects can stand on its own, or can be combined in various permutations or combinations with one or more of the other aspects.

[0083] 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 embodiments in which the invention 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.

[0084] In the event of inconsistent usages between this document and any documents so incorporated by reference, the usage in this document controls.

[0085] 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 this document, 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, composition, formulation, 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.

[0086] Method examples described herein can be machine or computer-implemented at least in part. Some examples can include a computer-readable medium or machine-readable medium encoded with instructions operable to configure an electronic device to perform methods as described in the above examples. An implementation of such methods can include code, such as microcode, assembly language code, a higher-level language code, or the like. Such code can include computer readable instructions for performing various methods. The code can form portions of computer program products. Further, in an example, the code can be tangibly stored on one or more volatile, non-transitory, or nonvolatile tangible computer-readable media, such as during execution or at other times.Examples of these tangible computer-readable media can include, but are not limited to, hard disks, removable magnetic disks, removable optical disks (e.g., compact disks and digital video disks), magnetic cassettes, memory cards or sticks, random access memories (RAMs), read only memories (ROMs), and the like.

[0087] 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 embodiments can be used, such as by one of ordinary skill in the art upon reviewing the above description. The Abstract is provided to allow the reader to quickly ascertain the nature of the technical disclosure. It 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 intending that 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 as examples or embodiments, with each claim standing on its own as a separate embodiment, and it is contemplated that such embodiments can be combined with each other in various combinations or permutations. The scope of theinvention should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.

Claims

CLAIMSWhat is claimed is:

1. A sampling device, comprising:an elongated portion, including:a first cylindrical reinforcing structure;a second cylindrical reinforcing structure around the first cylindrical reinforcing structure; anda polymer layer, wherein a portion of the polymer layer at least partially impregnates the second cylindrical reinforcing structure;an imaging transducer at a distal end of the elongated portion; anda lumen within the elongated portion, the lumen exiting the elongated portion at a side port adjacent to the imaging transducer.

2. The sampling device of claim 1, wherein the first and second cylindrical reinforcing structures are encapsulated.

3. The sampling device of claim 1 or 2, wherein an outer diameter of the polymer layer and an outer diameter of the second cylindrical reinforcing structure are coextensive.

4. The sampling device of claim 1 or 2, wherein an outer surface of the polymer layer includes conforming features that correspond to the second cylindrical reinforcing structure.

5. The sampling device of claim 1 or 2, wherein the imaging transducer includes an ultrasound transducer.

6. The sampling device of any one of claims 1-5, wherein the lumen is configured to guide a needle to extend into a field of view of the imaging transducer.

7. The sampling device of claim 6, wherein the field of view includes an imaging plane parallel to a path of the needle.

8. The sampling device of any one of claims 1-7, further including a fixture configured to couple to an accessory port of an endoscope.

9. The sampling device of any one of claims 1-5, further including a lubricious coating on a surface of the polymer layer.

10. The sampling device of any one of claims 1-5, wherein the first cylindrical reinforcing structure is in direct contact with the second cylindrical reinforcing structure.

11. The sampling device of any one of claims 1-5, wherein the polymer layer includes variable density portions along a long axis of the elongated portion.

12. The sampling device of any one of claims 1-5, wherein the first cylindrical reinforcing structure is secured to the second cylindrical reinforcing structure at one or more ends of the elongated portion.

13. The sampling device of any one of claims 1-12, further including a multiplexing circuit located locally at the distal end of the elongated portion, adjacent to the imaging transducer.

14. The sampling device of claim 13, further including a wiring channel coupled between the multiplexing circuit and a proximal end of the elongated portion.

15. The sampling device of claim 14, wherein the first cylindrical reinforcing structure includes a coil structure, and wherein the second cylindrical reinforcing structure includes a braided structure.

16. A sampling device, comprising:an elongated portion, including:a first cylindrical reinforcing structure;a second cylindrical reinforcing structure around the first cylindrical reinforcing structure; anda polymer layer, wherein a portion of the polymer layer at least partially impregnates the second cylindrical reinforcing structure; andan imaging transducer at a distal end of the elongated portion.

17. The sampling device of claim 16, further including a multiplexing circuit located locally at the distal end of the elongated portion, adjacent to the imaging transducer.

18. The sampling device of claim 17, further including a wiring channel coupled between the multiplexing circuit and a proximal end of the elongated portion.

19. The sampling device of claim 16, wherein the first cylindrical reinforcing structure includes a coil structure, and wherein the second cylindrical reinforcing structure includes a braided structure.

20. A sampling device, comprising:an elongated portion, including:a first cylindrical reinforcing structure;a second cylindrical reinforcing structure around the first cylindrical reinforcing structure; anda polymer layer, wherein a portion of the polymer layer at least partially impregnates the second cylindrical reinforcing structure; anda lumen within the elongated portion, the lumen exiting the elongated portion at a side port adjacent to a distal end of the elongated portion.

21. The sampling device of claim 20, wherein the second cylindrical reinforcing structure includes variable density portions along a long axis of the elongated portion.

22. The sampling device of claim 21, wherein the polymer layer includes variable density portions along a long axis of the elongated portion.

23. The sampling device of claim 20, wherein the first cylindrical reinforcing structure is in direct contact with the second cylindrical reinforcing structure.

124. The sampling device of claim 23, wherein the first cylindrical reinforcing structure is secured to the second cylindrical reinforcing structure.

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