Endoscope distal end with integral peripheral expansion system

Abstract

A device having a handle and an elongate member extending from the handle is provided. The device has a distal tip assembly coupled with a distal end of the elongate member. The distal tip assembly includes a rigid distal cap having a first diameter and an expandable portion extending between the rigid distal cap at a first end of the radially expandable portion and the distal end of the elongate member at a second end of the expandable portion. The expandable portion is expandable between a first configuration when the first end is a first distance from the second end and a second configuration when the first end is a second distance from the second end that is less than the first distance. The expandable portion has the first diameter in the first configuration and a second diameter greater than the first diameter in the second configuration.

Description

ENDOSCOPE DISTAL END WITH INTEGRAL PERIPHERAL EXPANSION SYSTEMPRIORITY CLAIM

[0001] This application claims the benefit of priority to U.S. Provisional Patent Application Serial No. 63 / 636,967, filed April 22, 2024, the contents of which are hereby incorporated by reference.TECHNICAL FIELD

[0002] This document pertains generally, but not by way of limitation, to medical devices that can be used for various medical procedures. More specifically, but not by way of limitation, the present application relates to a medical device that can be used to occlude a lumen for various reasons such as to take samples from a target site beyond the distal end of the medical device.BACKGROUND

[0003] When a practitioner desires to gather a sample at a target site, such as a lung tissue sample obtained via a bronchial lavage, the practitioner maneuvers an endoscope to the target site and removes the sample. The sample is removed by applying a fluid at the target site and then removing the fluid. A syringe is used in conjunction with the endoscope to provide the fluid to the target site. In addition, the syringe is used to remove the fluid from the target site, where the fluid contains a sample from the target site.

[0004] In order to keep the fluid in front of the endoscope and to prevent seepage of the fluid from the target site, a seal should be formed between a distal tip of the endoscope and bronchi surrounding the distal tip of the endoscope. Typically, a wedge maneuver is performed where the distal tip of the endoscope is wedged within the bronchi. By wedging the distal tip into the bronchi, a seal can be formed between the distal tip and the bronchi surrounding the tip. However, the wedge maneuver can create a number of problems.

[0005] First, by wedging the distal tip into the bronchi, trauma can occur to the bronchi surrounding the distal tip. Second, even though the distal tip of the endoscope is wedged into the bronchi, there is no guarantee that a seal has actually been formed.A practitioner may not be able to determine that a proper seal has been formed until the procedure to retrieve a sample, i.e., apply the fluid at the target site, is already underway. Thus, fluid can seep into other areas of the lung. Moreover, during removal of the fluid, if a proper seal is not formed, instead of removing fluid, air could also be removed thereby leaving fluid in the lungs. Third, depending on the target site, such as if the target site is at a periphery of the bronchi versus closer in, various endoscopes having various distal tip sizes are required. Therefore, different endoscopes having differently sized distal tips may be necessary when trying to gather a sample from the target site.SUMMARY

[0006] Accordingly, what is needed is an endoscope that includes a distal tip assembly that is variably expandable. The distal tip assembly should have a first configuration, which allows for navigation to a target site. The distal tip assembly should also have a second configuration which can provide a seal at the target site. Thus, a bronchoscope having a distal tip assembly that includes a flexible portion disposed between a rigid distal cap and a distal end of the bronchoscope is provided. The rigid distal cap and the distal end of the bronchoscope can have a first diameter. The flexible portion can have a variable diameter where in a first configuration the flexible portion also has the first diameter. The flexible portion can have a second configuration where the flexible portion can expand to a second diameter that is greater than the first diameter. When the flexible portion is in the first configuration, the bronchoscope can freely navigate through bronchi to position a distal end of the bronchoscope adjacent to or just proximal from a target site. When the flexible portion is in the second configuration, the flexible portion can expand to seal the distal end of the bronchoscope to the bronchi to allow for fluid to enter the target site and then be removed from the target site. Furthermore, the seal can keep the fluid in front of the distal cap and minimize seepage of fluid from the target site.

[0007] The flexible portion can be formed from an elastomeric material that allows the flexible portion to have a plurality of diameters such as the first diameter and the second diameter. The plurality of diameters can account for bronchi at different targets sites having different widths such that the flexible portion can form a seal for differentbronchi regions having different widths. This functionality is of particular value in bronchi or other lumen structures having varied inner geometries which become progressively more narrow deeper within a patient’s anatomy. The elastomeric material can be formed such that in a resting state, the flexible portion has the second configuration where the flexible portion is in an expanded position having the second diameter. The flexible portion can be biased into the first configuration such that during navigation to a target site, the flexible portion can have the first diameter, thereby allowing for easier navigation through the anatomy of a patient to the target site. Once at the target site, the flexible portion can be expanded to form a seal at the target site.

[0008] A potential advantage of having a bronchoscope with a variably expandable distal tip assembly allows for a single device that can be used for both proximal and peripheral bronchi.

[0009] A potential advantage includes a device having the ability to access smaller pathways by having a smaller diameter distal tip assembly, which can expand to form a seal at a target site.

[0010] Another potential advantage relates to a device that can keep fluid provided to the target site in front of the device during sample collection.

[0011] A further potential advantage relates to more removal of the fluid having a sample from the anatomy of the patient.BRIEF DESCRIPTION OF FIGURES

[0012] Figure 1 illustrates a bronchoscope system, in accordance with some examples.

[0013] Figure 2 is a schematic diagram of the bronchoscope system of Figure 1, in accordance with some examples.

[0014] Figures 3 A and 3B illustrate a distal tip assembly of the bronchoscope ofFigure 1, in accordance with some examples.

[0015] Figure 4 shows a flexible portion of the distal tip assembly of Figures 3 A and 3B, in accordance with some examples.

[0016] Figures 5A and 5B show a sleeve that can be used to orient the flexible portion of Figure 4 between a first configuration and a second configuration, in accordance with some examples.

[0017] Figures 6A and 6B illustrate a sleeve in conjunction with a plunger that can be used to orient the flexible portion of Figure 4 between a first configuration and a second configuration, in accordance with some examples.

[0018] Figure 7 illustrates a method for navigating the bronchoscope of Figure 1 to a target site when a flexible portion of the distal tip assembly of Figures 3 A and 3B is in a first configuration and then placing the flexible portion into a second configuration once the bronchoscope is at a target site, in accordance with examples.

[0019] Figure 8 illustrates navigating the bronchoscope of Figure 1 to a target site when a flexible portion of the distal tip assembly of Figures 3 A and 3B is in a first configuration, in accordance with some examples.

[0020] Figure 9 shows the bronchoscope of Figure 1 at a target site and a flexible portion of the distal tip assembly of Figures 3 A and 3B configured to form a seal at the target site, in accordance with some examples.DETAILED DESCRIPTION

[0021] A bronchoscope can have distal tip assembly that includes a distal cap and a flexible portion extending between the distal cap and a distal end of the bronchoscope. The flexible portion can be in a first configuration when the bronchoscope is navigating to a target site. Once at the target site, the flexible portion can be put into a second configuration in order to form a seal with anatomy at the target site. An example of a bronchoscope 100 having this type of distal tip assembly 102 is shown in Figure 1.

[0022] Figure 1 is a schematic diagram of a bronchoscope system 104 that can include an imaging and control system 106 along with the bronchoscope 100. The bronchoscope system 104 is an illustrative example of a system suitable for use with the devices and methods described herein, such as a bronchoscope with an integrated stabilizer or cannulation elements.

[0023] The bronchoscope 100 can be insertable into a target site for imaging or to provide passage of or attachment to (e.g., via tethering) one or more sampling devicesfor biopsies, or one or more therapeutic devices for treatment of a disease state associated with the target site. The bronchoscope 100 can interface with and connect to imaging and control system 106. The bronchoscope 100 can also include a duodenoscope, though other types of endoscopes can be used with the features discussed herein. The imaging and control system 106 can include an output unit 110, an input unit 112, a light source 114, a fluid source 116, a suction pump 118, and a control unit 120.

[0024] The imaging and control system 106 can include various ports for coupling with the bronchoscope system 104. For example, the control unit 120 can include a data input / output port for receiving data from and communicating data to the bronchoscope 100. The light source 114 can include an output port for transmitting light to the bronchoscope 100, such as via a fiber optic link. The fluid source 116 can include a port for transmitting fluid to the bronchoscope 100. The fluid source 116 can include, for example, a pump and a tank of fluid or can be connected to an external tank, vessel or storage unit. A suction pump can include a port used to draw a vacuum from the bronchoscope 100 to generate suction, such as for withdrawing fluid from the target site into which the bronchoscope 100 is inserted and withdrawing samples from a target resected from the target with a resection element. The output unit 110 and the input unit 112 can be used by an operator of the bronchoscope system 104 to control functions of the bronchoscope system 104 and view output of the bronchoscope 100. The control unit 120 can additionally be used to generate signals or other outputs for treating the target site into which the bronchoscope 100 is inserted. The control unit 120 can generate electrical output, acoustic output, a fluid output and the like for treating the target site with cauterizing, cutting, freezing, and the like.

[0025] The control unit 120 can include an imaging engine that can receive ultrasound signal data from sensors at the end effector 102. The imaging engine can process the received ultrasound signal data to produce real-time ultrasound images for display on the output unit 110. While the control unit 120 is described as having this functionality, the bronchoscope system 104 can include separate componentry that provides an imaging engine and the functionality described herein.

[0026] The bronchoscope 100 can include an insertion section 122, a handle 124, which can be coupled to a cable section 126, and a coupler section 200 (Figure 2). Theinsertion section 122 can extend distally from the handle 124 to the end effector 102 and the cable section 200 can extend proximally from the handle 124. The insertion section 122 can be an elongate member and include a bending section, and a distal end to which the end effector 102 can be attached. The bending section can be controllable (e.g., by a control knob on the handle 124) to maneuver the distal end through tortuous passageways (e.g., stomach, duodenum, kidney, ureter, etc.). The insertion section 122 can also include one or more working channels (e.g., an internal lumen) that can be elongate and can support insertion of one or more therapeutic tools of the end effector 102. The working channel can extend between the handle 124 and the end effector 102. Additional functionalities, such as fluid passages, guide wires, and pull wires can also be provided by the insertion section 122 (e.g., via suction or irrigation passageways, or the like).

[0027] The coupler section 200 can be connected to the control unit 120 to connect the bronchoscope 100 to multiple features of the control unit 120, such as the input unit 112, the light source unit 114, the fluid source 118, and the suction pump.

[0028] The handle 124 can include a knob 128 as well as a port 202. The knob 128 can be connected to a pull wire, or other actuation mechanisms, extending through insertion the insertion section 122. As will be discussed in greater detail below, knob 128 can be used to control a flexible portion of the distal tip assembly 102. The port 202, 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 124, such as for coupling with the insertion section 122.

[0029] The imaging and control system 106 can be provided on a mobile platform (e.g., a cart 130) with shelves for housing the light source 114, the suction pump, an image processing unit 204 (Figure 2), etc. Alternatively, several components of imaging and the control system 106 can be provided directly on the bronchoscope 100 so as to make the endoscope “self-contained.”

[0030] Figure 2 is a schematic diagram of the bronchoscope system 104 including the imaging and control system 106 of Figure 1. The control unit 120 can include or can be coupled to the image processing unit 204, a treatment generator 206, and a drive unit 208, as well as the light source 114, the input unit 112, and the output unit 110. The control unit 120 can include, or can be in communication with, a surgicalinstrument, 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 inclusion of optically enhanced materials and components. The control unit 120 can be configured to activate a camera to view target tissue distal of the bronchoscope system 104 and the bronchoscope 100. Likewise, the control unit 120 can be configured to activate the light source unit 114 to shine light on the surgical instrument, which can include select components that are configured to reflect light in a particular manner, such as tissue cutters being enhanced with reflective particles. The light source 114 can be controlled to illuminate a target site using light of a desired spectrum (e.g., broadband white light, narrow-band imaging using preferred electromagnetic wavelengths, and the like).

[0031] The coupler section 200 can be connected to the control unit 120 to connect the bronchoscope 100 to multiple features of the control unit 120, such as the image processing unit 204 and the treatment generator 206. In examples, the port 40 can be used to insert another instrument or device, such as a daughter scope or auxiliary scope, into the bronchoscope 100. Such instruments and devices can be independently connected to the control unit 120 via the cable section 126.

[0032] The image processing unit 204 and the light source 114 can each interface with the bronchoscope 100 by wired or wireless electrical connections. The imaging and control system 106 can accordingly illuminate a target site, collect signals representing the target site, process signals representing the target site, and display images representing the target site on the display unit 110. The imaging and control system 106 can connect (e.g., via an endoscope connector) to the bronchoscope 100 for signal transmission (e.g., light output from a light source, video signals from an imaging system in the distal end, diagnostic and sensor signals from a diagnostic device, and the like).

[0033] The fluid source 116 can be in communication with the control unit 120 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 connectors (barb fittings, fluid seals, valves and the like). The fluid source 116 can be utilized as an activation energy source for a biasing device or a pressure-applying device of features discussed herein. The imaging and control system 106 can also include the drive unit208, which can include a motorized drive for advancing a distal section of bronchoscope 100.

[0034] Now making reference to Figure 3 A, the distal tip assembly 102 can include a distal cap 300 and a radially expandable portion 302 that extends between the distal cap 300 and a distal end 304 of the insertion section 122. In a first configuration, the radially expandable portion 302 can have a first diameter 306. The flexible portion can also include an expansion segment 308 that can expand as shown with reference to Figure 3B such that the radially expandable portion 302 has a second configuration having a second diameter which is relatively larger than the first diameter. Moreover, the distal cap 300 and the distal end 304 can have the first diameter 306. Thus, in the first configuration a medical device such as, for example, a bronchoscope can have a first diameter that is size appropriately for a distal segment to be freely navigated through a patient anatomy, and then subsequently caused to expand into the second configuration in which the medical device has the second diameter which causes a seal against the patient anatomy.

[0035] The radially expandable portion 302 can be formed from a material that allows the flexible portion to expand from the first configuration to the second configuration. The radially expandable portion 302 can be formed from an elastomeric material or from shape memory material 400, (Figure 4) such as Nitinol. In addition to Nitinol, other materials can be used for the radially expandable portion 302 that can allow for expansion and contraction as described herein. For example, various alloys and plastics that provide rigidity while at the same allowing for reliable and repeatable contraction and expansion can be used.

[0036] When the radially expandable portion 302 is formed from an elastomeric material, the radially expandable portion 302 can be injection molded and formed such that, when the radially expandable portion 302 is non-biased, the radially expandable portion 302 can have either the first configuration or the second configuration.

[0037] The radially expandable portion 302 can have a scaffolding configuration, a braided configuration, or any other type of configuration that allows for the radially expandable portion 302 to switch between the first configuration and the second configuration multiple times. When the radially expandable portion 302 is formed from shape memory material, the radially expandable portion 302 can be formed suchthat, when the radially expandable portion 302 is non-biased, the radially expandable portion 302 can have either the first configuration or the second configuration.

[0038] Now making reference to Figure 4, the radially expandable portion 302 can include struts 402 about which the expansion segment 308 is disposed and mechanically contacts. The struts 402 can be formed of the same material as the radially expandable portion. When the distal tip assembly 102 is subjected to a compressive force, by virtue of being formed with a material that is capable of expansion and contraction, the distal tip assembly 102 can move between the positions shown with reference to Figures 5A and 5B.

[0039] In order to move the radially expandable portion 302 between the first configuration and the second configuration, the bronchoscope 100 can include a sleeve 500 disposed about the insertion section 122 at the insertion section distal end 304, as shown in Figure 5A. The sleeve 500 can have a circular configuration and couple with the radially expandable portion 302 at a proximal end 502 of the radially expandable portion 302. The radially expandable portion 302 can also couple with the distal cap 300 at a distal end 504 of the radially expandable portion 302. The sleeve 500 can be moved along a direction A such that the expansion segment 308 expands to have a second diameter 506 and the radially expandable portion 302 has the second configuration, as can be seen in Figure 5B. Moreover, the second diameter 506 can be greater than the first diameter 306. The sleeve 500 can also be moved along a direction B such that the radially expandable portion 302 can move back into the first configuration of Figure 5 A.

[0040] The second diameter 506 can be variable such that the distal tip assembly 102 can be maneuvered and positioned to different target sites having different size constraints. In examples where the target site is located in the lung of a patient, different bronchi can have different widths. By virtue of the second diameter 506 being variable, the distal assembly 102 can be used with bronchi having different widths or inner diameters (e.g., airways which get progressively more narrow deeper within a patient). Thus, the bronchoscope 100 with the distal tip assembly 102 can be used regardless of the width of the bronchi at which a target site is located. Moreover, the bronchoscope 100 with the distal tip assembly 102 can be used at a target site atbronchi at any location in a lung, such as at interior lobes, middle lobes, and inferior lobes.

[0041] The sleeve 500 can be operatively coupled to a guidewire via an arm 508. The guidewire can be coupled with the knob 128 where a practitioner can move the knob in a first direction such that the sleeve 500 can move along the direction A in order to expand the radially expandable portion 302 and the expansion segment 308. In addition, the knob 128 can be moved in a second direction opposite the first direction such that the sleeve 500 can move in the direction B in order to retract the radially expandable portion 302 and the expansion segment 308.

[0042] In the example of Figures 5A and 5B, the radially expandable portion 302 can have a non-biased configuration where the radially expandable portion 302 is in the second configuration shown in Figure 5B. Thus, in the first configuration, the radially expandable portion 302 can be biased to have the first diameter 306 shown in Figure 5A where the expansion segment 308 is not expanded.

[0043] The distal cap 300 can be formed from a rigid material, such as aluminum, stainless steel, or the like. The distal cap 300 can be configured to assist with navigation to a target site. More specifically, the distal cap 300 can have a camera 10, which is capable of assisting navigation of the distal tip assembly 102 through anatomy of a patient to a target site. Examples of cameras that can be used for the camera 310 can include a Complimentary' Metal-Oxide Semiconductor (CMOS) camera or a charge-coupled device (CCD) camera.

[0044] The distal cap 300 can also include an illuminating feature 312, which can be used to provide illumination as the bronchoscope 100 navigates towards a target site. The illuminating feature 312 can also provide illumination at the target site. Examples for the illuminating feature can include a fiber optic, light emitting diodes, or any other type of illumination device capable of illuminating a field of view being viewed by the camera 310.

[0045] The bronchoscope 100 can be used to retrieve samples from a target site. Samples can be retrieved by providing a fluid, such as saline solution, to a target site via the distal cap 300. The distal cap can include a port 314, which can be used to deliver fluid to a target site from the fluid source 116. The port 314 can also be used toremove fluid from the target site when a vacuum is applied to the bronchoscope 100. The removed fluid can include samples from the target site.

[0046] In examples where the radially expandable portion 302 has a non-biased configuration where the radially expandable portion 302 is in the first configuration, the bronchoscope 100 can include a plunger 600 that can abut a side 602 of the sleeve 500, as shown in Figure 6A. The plunger 600 can be disposed between the insertion section distal end 304 and the radially expandable portion 302. The plunger 600 can be coupled with the sleeve 500. When a practitioner moves the knob 128 in the first direction, the plunger 600 can push against the sleeve side 602 along the direction A such that the radially expandable portion 302 can move from the first configuration (Figure 6A) into the second configuration (Figure 6B) where the expansion segment 308 is expanded. In addition, a practitioner can move the knob 128 in the second direction such that the plunger 600 moves along the direction B. As the plunger 600 moves along the direction B, the radially expandable portion 302 can return to the first configuration of Figure 6 A. Here, the plunger 600 can be used to bias the radially expandable portion 302 into the second configuration.

[0047] As noted above, the radially expandable portion 302 can be placed in the first configuration when navigating to a target site. Once the bronchoscope is at the target site, the flexible portion can be placed into the second configuration and can remain in the second configuration until a sample is removed from the target site. Figure 7 illustrates a method 700 for navigating a bronchoscope to a target site when the flexible portion is in the first configuration and then placing the flexible portion into the second configuration once the bronchoscope is at the target site, in accordance with examples.

[0048] During an operation 702, a flexible portion of a device can be placed into a first configuration where the flexible portion, a distal portion of the device, and a distal cap of the device have a first diameter. As an example of the method 700 and referred to herein as the “example,” reference is made to Figures 5A and 5B, where the radially expandable portion 302 can be placed into the first configuration by moving the sleeve 500 along the direction B such that the each of the distal cap 300, the radially expandable portion 302, and the insertion section distal end 304 have the first diameter 306.

[0049] Returning to Figure 7 and the method 700, once the flexible portion of the device is placed into the first configuration, the method 700 performs an operation 704 where the device is positioned at the target site when the flexible portion is in the first configuration. Positioning the device at the target site can include navigating the device through anatomy of a patient towards, and to, the target site. Thus, during the operation 704, since the flexible portion has the same diameter as the distal cap and the insertion section distal end, the device can travel through the anatomy, such as bronchi, to the target site.

[0050] Returning attention to the example, during the operation 704, the distal tip assembly can navigate through anatomy 800 of a patient when the radially expandable portion 302 is in the first position to a target site 900. In the example, the camera 310 along with the illuminating features 312 can be used to navigate the distal assembly 102 to the target site 900. Once at the target site 900, the distal assembly 102 along with the radially expandable portion 302 can be considered to be positioned at the target site 900.

[0051] After the flexible portion is positioned at the target site, the method 700 can perform an operation 706, where the distal end cap is moved from a first position to a second position. When the distal end cap moves from the first position to the second position, the flexible portion moves from the first configuration to a second configuration. As the flexible portion moves to the second position, an expansion segment of the flexible portion expands to form a seal at the target site. The seal can function to maintain fluid provided by the distal cap to the target site in a front area of the distal cap. The seal can also function to minimize seepage of the fluid from the target site to an area outside of the target site.

[0052] Going back to the example, during the operation 704, the sleeve 500 can be moved in the direction A (Figure 5 A) such that a seal 902 is formed by the expansion segment 308. By virtue of the seal 902, when the port 314 is used to provide fluid F to the target site 900, the seal 902 can prevent seepage of the fluid F from an area 904 in front of the distal cap 300 to an area 906 behind the distal cap 300. Moreover, when the fluid F is removed from the target site 900 with a sample from the target site 900, most, if not all, of the fluid can be removed from the target site 900. As such, the seal 902 minimizes the possibility of leaving remnants of fluid F in the anatomy of apatient. Moreover, since the fluid F is contained in the area 904, the possibility of removing air via the port 314 is also minimized.

[0053] After a sample is taken from the target site 900, the method performs an operation 708. During the operation 708, the distal end cap can be moved from the second position to the first position. As the distal end cap is moved from the second position to the first position, the flexible portion can move from the second configuration back to the first configuration. By moving the flexible portion back to the first configuration, the distal tip assembly can be removed from the target site and from the patient.

[0054] Once again referring to the example, during the operation 708, the sleeve 500 can be moved along the direction B (Figure 5B) such that the expansion segment 308 contracts and the radially expandable portion 302 moves from the second configuration as shown in Figure 9 to the first configuration of Figure 8. After the radially expandable portion 302 is moved to the first configuration, the distal tip assembly 102 can be removed from the target site 900 and the anatomy 800.

[0055] Having described various aspects and features of the inventive subject matter, the following numbered examples are provided as illustrative embodiments:

[0056] Example l is a medical device comprising: a handle; an elongate member extending from the handle; and a distal tip assembly coupled with a distal end of the elongate member, the distal tip assembly comprising: a rigid distal cap having a first diameter; and a radially expandable portion extending between the rigid distal cap at a first end of the radially expandable portion and the distal end of the elongate member at a second end of the radially expandable portion, the radially expandable portion expandable between a first configuration when the first end is a first distance from the second end and a second configuration when the first end is a second distance from the second end that is less than the first distance, the radially expandable portion having the first diameter in the first configuration and a second diameter that is greater than the first diameter in the second configuration, wherein the distal end of the elongate member has the first diameter.

[0057] In Example 2, the subject matter of Example 1 includes, wherein the radially expandable portion is formed from an elastomeric material.

[0058] In Example 3, the subject matter of Example 2 includes, wherein the radially expandable portion is biased into the first configuration.

[0059] In Example 4, the subject matter of Examples 2-3 includes, wherein the radially expandable portion is biased into the second configuration.

[0060] In Example 5, the subject matter of Example 4 includes, a plunger disposed between the distal end of the elongate member and the radially expandable portion.

[0061] In Example 6, the subject matter of Example 5 includes, a sleeve at an outer surface of the elongate member and coupled with the plunger, wherein the sleeve is moveable between a first position via the plunger when the radially expandable portion has the first configuration and a second position via the plunger when the radially expandable portion has the second configuration.

[0062] In Example 7, the subject matter of Examples 1-6 includes, a sleeve at an outer surface of the elongate member and coupled with the radially expandable portion at the distal end of the elongate member, wherein the sleeve is moveable between a first position when the radially expandable portion has the first configuration and a second position when the radially expandable portion has the second configuration.

[0063] In Example 8, the subject matter of Example 7 includes, wherein the sleeve is coupled to a guidewire and movable between the first position and the second position via the guidewire.

[0064] In Example 9, the subject matter of Examples 1-8 includes, wherein the radially expandable portion is formed from a shape memory material.

[0065] In Example 10, the subject matter of Example 9 includes, wherein the radially expandable portion is biased into the first configuration.

[0066] Example 11 is a method of positioning a device having a radially expandable portion extending between a rigid distal cap at a first end of the radially expandable portion and a distal portion of the device at a second end of the radially expandable portion where the distal portion and the rigid distal cap have a first diameter at a target site, the radially expandable portion expandable between a first configuration when the first end is a first distance from the second end and a second configuration when the first end is a second distance from the second end that is less than the first distance where the radially expandable portion has the first diameter in the first configuration and a second diameter greater than the second diameter in the secondconfiguration, the method comprising: placing the radially expandable portion into the first configuration such that each of the radially expandable portion, the distal portion of the device, and the rigid distal cap have the first diameter; positioning the radially expandable portion at a site when the radially expandable portion is in the first configuration; moving the rigid distal cap from a first position into a second position, wherein the radially expandable portion moves from the first configuration into the second configuration when the rigid distal cap moves from the first position to the second position; and moving the rigid distal cap from the second position to the first position, wherein the radially expandable portion moves from the second configuration into the first configuration when the rigid distal cap moves from the second position to the first position.

[0067] In Example 12, the subject matter of Example 11 includes, wherein the radially expandable portion is formed from an elastomeric material.

[0068] In Example 13, the subject matter of Example 12 includes, wherein the radially expandable portion is biased into the first configuration.

[0069] In Example 14, the subject matter of Examples 12-13 includes, wherein the radially expandable portion is biased into the second position.

[0070] In Example 15, the subject matter of Examples 11-14 includes, a sleeve at an outer surface of an elongate member of the device and coupled with the radially expandable portion at a distal end of the elongate member, wherein the sleeve moves the rigid distal cap between the first position when the radially expandable portion has the first configuration and the second position when the radially expandable portion has the second configuration.

[0071] In Example 16, the subject matter of Example 15 includes, wherein the sleeve is coupled to a guidewire and movable between the first position and the second position via the guidewire.

[0072] In Example 17, the subject matter of Examples 11-16 includes, wherein the radially expandable portion is formed from a shape memory material.

[0073] Example 18 is a medical device comprising: a handle; an elongate member extending from the handle; a distal tip assembly coupled with a distal end of the elongate member, the distal tip assembly comprising: a rigid distal cap having a first diameter; and a radially expandable portion extending between the rigid distal cap at afirst end of the radially expandable portion and the distal end of the elongate member at a second end of the radially expandable portion, the radially expandable portion expandable between a first configuration when the first end is a first distance from the second end and a second configuration when the first end is a second distance from the second end that is less than the first distance, the radially expandable portion having the first diameter in the first configuration and a second diameter that is greater than the first diameter in the second configuration, wherein the distal end of the elongate member has the first diameter; and a sleeve at an outer surface of the elongate member and coupled with the radially expandable portion at the distal end of the elongate member, wherein the sleeve is moveable between a first position when the radially expandable portion has the first configuration and a second position when the radially expandable portion has the second configuration.

[0074] In Example 19, the subject matter of Example 18 includes, wherein the radially expandable portion is formed from an elastomeric material.

[0075] In Example 20, the subject matter of Examples 18-19 includes, wherein the radially expandable portion is formed from a shape memory material.

[0076] Example 21 is an apparatus comprising means to implement of any of Examples 1-20.

[0077] Example 23 is a system to implement of any of Examples 1-20.

[0078] Example 24 is a method to implement of any of Examples 1-20.

[0079] 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 in which the invention can be practiced. These examples are also referred to herein as “examples.” Such examples can include elements in addition to those shown or described. However, the present inventor also contemplates examples in which only those elements shown or described are provided. Moreover, the present inventor also contemplates 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.

[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 orusages 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.

[0081] 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 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 example. Thus, the following claims are hereby incorporated into the Detailed Description as examples or examples, with each claim standing on its own as a separate example, and it is contemplated that such examples can be combined with each other in various combinations or permutations. The scope of the invention should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.

Claims

WHAT IS CLAIMED IS:

1. A medical device comprising: a handle; an elongate member extending from the handle; and a distal tip assembly coupled with a distal end of the elongate member, the distal tip assembly comprising: a rigid distal cap having a first diameter; and a radially expandable portion extending between the rigid distal cap at a first end of the radially expandable portion and the distal end of the elongate member at a second end of the radially expandable portion, the radially expandable portion expandable between a first configuration when the first end is a first distance from the second end and a second configuration when the first end is a second distance from the second end that is less than the first distance, the radially expandable portion having the first diameter in the first configuration and a second diameter that is greater than the first diameter in the second configuration, wherein the distal end of the elongate member has the first diameter.

2. The medical device of claim 1, wherein the radially expandable portion is formed from an elastomeric material.

3. The medical device of claim 2, wherein the radially expandable portion is biased into the first configuration.

4. The medical device of claim 2, wherein the radially expandable portion is biased into the second configuration.

5. The medical device of claim 4, further comprising a plunger disposed between the distal end of the elongate member and the radially expandable portion .

6. The medical device of claim 5, further comprising a sleeve at an outer surface of the elongate member and coupled with the plunger, wherein the sleeve is moveablebetween a first position via the plunger when the radially expandable portion has the first configuration and a second position via the plunger when the radially expandable portion has the second configuration.

7. The medical device of claim 1, further comprising a sleeve at an outer surface of the elongate member and coupled with the radially expandable portion at the distal end of the elongate member, wherein the sleeve is moveable between a first position when the radially expandable portion has the first configuration and a second position when the radially expandable portion has the second configuration.

8. The medical device of claim 7, wherein the sleeve is coupled to a guidewire and movable between the first position and the second position via the guidewire.

9. The medical device of claim 1, wherein the radially expandable portion is formed from a shape memory material.

10. The medical device of claim 9, wherein the radially expandable portion is biased into the first configuration.

11. A method of positioning a device having a radially expandable portion extending between a rigid distal cap at a first end of the radially expandable portion and a distal portion of the device at a second end of the radially expandable portion where the distal portion and the rigid distal cap have a first diameter at a target site, the radially expandable portion expandable between a first configuration when the first end is a first distance from the second end and a second configuration when the first end is a second distance from the second end that is less than the first distance where the radially expandable portion has the first diameter in the first configuration and a second diameter greater than the second diameter in the second configuration, the method comprising: placing the radially expandable portion into the first configuration such that each of the radially expandable portion, the distal portion of the device, and the rigid distal cap have the first diameter;positioning the radially expandable portion at a site when the radially expandable portion is in the first configuration; moving the rigid distal cap from a first position into a second position, wherein the radially expandable portion moves from the first configuration into the second configuration when the rigid distal cap moves from the first position to the second position; and moving the rigid distal cap from the second position to the first position, wherein the radially expandable portion moves from the second configuration into the first configuration when the rigid distal cap moves from the second position to the first position.

12. The method of claim 11, wherein the radially expandable portion is formed from an elastomeric material.

13. The method of claim 12, wherein the radially expandable portion is biased into the first configuration.

14. The method of claim 12, wherein the radially expandable portion is biased into the second position.

15. The method of claim 11, further comprising a sleeve at an outer surface of an elongate member of the device and coupled with the radially expandable portion at a distal end of the elongate member, wherein the sleeve moves the rigid distal cap between the first position when the radially expandable portion has the first configuration and the second position when the radially expandable portion has the second configuration.

16. The method of claim 15, wherein the sleeve is coupled to a guidewire and movable between the first position and the second position via the guidewire.

17. The method of claim 11, wherein the radially expandable portion is formed from a shape memory material.

18. A medical device comprising: a handle; an elongate member extending from the handle; a distal tip assembly coupled with a distal end of the elongate member, the distal tip assembly comprising: a rigid distal cap having a first diameter; and a radially expandable portion extending between the rigid distal cap at a first end of the radially expandable portion and the distal end of the elongate member at a second end of the radially expandable portion, the radially expandable portion expandable between a first configuration when the first end is a first distance from the second end and a second configuration when the first end is a second distance from the second end that is less than the first distance, the radially expandable portion having the first diameter in the first configuration and a second diameter that is greater than the first diameter in the second configuration, wherein the distal end of the elongate member has the first diameter; and a sleeve at an outer surface of the elongate member and coupled with the radially expandable portion at the distal end of the elongate member, wherein the sleeve is moveable between a first position when the radially expandable portion has the first configuration and a second position when the radially expandable portion has the second configuration.

19. The medical device of claim 18, wherein the radially expandable portion is formed from an elastomeric material.

20. The medical device of claim 18, wherein the radially expandable portion is formed from a shape memory material.

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