Devices, systems, and methods for multiple biopsy collection

Abstract

Apparatus, systems, and methods for multiple biopsy acquisitions are described. The medical device may include a shaft defining a working channel extending from a proximal portion of the shaft to an opening at a distal end of the shaft. The distal end's most distal side may include an imaging device and a light source proximal to the opening. The working channel may have a first dimension at the opening and a second dimension proximal to the imaging device and light source, for example, the second dimension being larger than the first dimension. At least a portion of the shaft surrounding the opening may include an elastic material, allowing the opening to expand in a direction away from the imaging device and light source.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority to U.S. Provisional Application No. 63 / 552,723, filed February 13, 2024, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This disclosure generally relates to medical devices, systems, and related procedures. In particular, some aspects relate to medical systems, devices, and methods for performing biopsy collection in a patient's body. Background Technology

[0004] Medical endoscopes (such as ureteroscopes and endoscopes) typically integrate electronic components and a working channel. To traverse the patient's anatomy, endoscopes often have a reduced profile, which limits the number and type of instruments that can pass through the working channel. Furthermore, space is limited on the distal side of the endoscope to accommodate electronic components such as imaging and illumination features. Some medical procedures may require the use of multiple instruments throughout the procedure. Removing and replacing instruments during a procedure increases its duration and can lead to various complications. Summary of the Invention

[0005] This disclosure includes a medical device comprising a shaft defining a working channel extending from a proximal portion of the shaft to an opening at a distal end of the shaft, for example, the opening being expandable. The distal end may include an imaging device and a light source proximate to the opening. The working channel may have a first dimension at the opening and a second dimension proximal to the imaging device and light source, the second dimension being larger than the first dimension. At least a portion of the shaft surrounding the opening may include an elastic material such that the opening can expand in a direction away from the imaging device and light source. The elastic material may include a flexible elastic polymer, such as silicone or polyurethane. The portion of the shaft opposite the elastic material may be rigid. The rigid portion of the shaft may be adjacent to the imaging device and the light source. In some aspects, the second dimension of the working channel may be a diameter ranging from about 1.5 mm to less than 2.5 mm. The opening of the working channel may expand to a diameter of up to about 3 mm.

[0006] Furthermore, according to some aspects, the shaft may include at least one hinged wire adjacent to the working channel. In some examples, the shaft may have a uniform outer diameter when the opening is not expanded, optionally wherein the uniform outer diameter ranges from about 3 mm to about 3.5 mm. The walls of the working channel adjacent to the imaging device and the light source may be rigid. A portion of the shaft comprising an elastic material may have a thickness ranging from about 0.1 mm to about 0.4 mm. The elastic material may be integrated into the shaft in the form of a patch at the distal end.

[0007] According to some aspects, the medical device may include at least two instruments that are slidable along a working channel and through an opening, such as an expanded opening. For example, the combined cross-sectional dimension of the at least two instruments may be larger than a first dimension of the working channel. The medical device may include a handle coupled to a proximal portion of a shaft. The handle may include a port communicating with the working channel. The medical device can be used to treat a subject, such as to collect a biopsy sample of tissue from the subject.

[0008] This disclosure also includes a medical device comprising: a handle including a port; and a shaft coupled to the handle. The shaft may define a working channel communicating with the port and extending to an opening at a distal end of the shaft, for example, the opening being expandable. The farthest side of the distal end may include an imaging device and a light source proximate to the opening. The working channel may have a first dimension at the opening and a second dimension proximal to the imaging device and the light source. A portion of the shaft surrounding the opening and opposite to the imaging device and the light source may include an elastic material. The opening may expand in a direction away from the imaging device and the light source.

[0009] In some examples, the elastic material includes silicone or polyurethane. Additionally or alternatively, the portion of the shaft opposite the imaging device and the light source can be rigid. According to some aspects of this disclosure, the second dimension of the working channel can be a diameter ranging from about 1.5 mm to less than 2.5 mm. Additionally or alternatively, when the opening is not expanded, the shaft can have a uniform outer diameter ranging from about 3 mm to about 3.5 mm.

[0010] This disclosure also includes methods for treating a subject using medical devices described above and / or elsewhere herein. For example, the method may include inserting an axis of the medical device into a body cavity of the subject; and positioning the distal end of the axis near a target site. The most distal side of the distal end may include an opening of an imaging device, a light source, and a working channel of the axis. At least a portion of the axis surrounding the opening may include an elastic material such that the opening expands away from the imaging device and the light source. The method may further include moving at least one instrument distally along the working channel and through the opening. The cross-sectional dimension of the at least one instrument may be larger than the cross-sectional dimension of the opening such that the opening expands away from the imaging device and the light source as the at least one instrument passes through it. In some examples, at least one instrument comprises two instruments. For example, at least one of the two instruments may include forceps, for example, for collecting one or more tissue samples, such as in a biopsy procedure. Attached Figure Description

[0011] Exemplary aspects are illustrated in conjunction with the accompanying drawings, which form part of this specification, and serve, together with the written description, to explain the principles of this disclosure. Each drawing depicts one or more exemplary aspects of this disclosure, as follows:

[0012] Figure 1 An exemplary medical device according to some aspects of this disclosure is depicted, including a close-up cross-section of the distal end.

[0013] Figure 2A Depicting Figure 1 The distal end of the medical device is in a first configuration, wherein two instruments are located proximal to the distal end in the working channel.

[0014] Figure 2B Depicting Figure 2A The farthest side of the distal end.

[0015] Figure 2C Depicting Figure 2A The cross-section of the distal end.

[0016] Figure 3 Depicting Figure 1 The distal end of the medical device, in which one of the two instruments passes through an opening in the working channel.

[0017] Figure 4A Depicting Figure 1 The distal end of the medical device is in a second configuration, in which two instruments pass through an opening in the working channel.

[0018] Figure 4B Depicting Figure 4A The cross-section of the distal end. Detailed Implementation

[0019] Specific aspects of this disclosure will be described in more detail below. In the event of any conflict with terms and / or definitions incorporated by reference, the terms and definitions provided herein shall prevail. The terms “proximal” and “distal” are used herein to refer to the relative positions of components of the exemplary medical device. When used herein, “proximal” refers to a position relatively closer to the exterior of the body or closer to the operator using the medical device (see the proximal “P” and distal “D” directional arrows in the figures). Conversely, “distal” refers to a position relatively further away from the operator using the medical device or closer to the interior of the body.

[0020] As used herein, the terms “comprises,” “including,” “having,” or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements may include not only those elements but also other elements not expressly listed or inherent to such process, method, article, or apparatus. The term “exemplary” means “example,” not “ideal.” Relative terms such as “approximately,” “substantially,” and “approximately” are used to indicate possible variations of ±10% in the stated value or range.

[0021] Although a ureteroscope is cited herein for illustrative purposes, it should be understood that this disclosure includes any suitable medical device configured to allow an operator access to and observation of the internal anatomy of a subject (e.g., a patient) and / or to deliver medical instruments (such as biopsy forceps, grippers, baskets, snares, probes, scissors, retrieval devices, lasers, and other tools) into the subject's body. The medical devices described herein can be inserted into various body cavities and / or bodies (such as the urinary tract or gastrointestinal tract). It should be understood that, unless otherwise stated, bronchoscopes, duodenoscopes, endoscopes, gastroscopes, endoscopic ultrasound (“EUS”) endoscopes, colonoscopes, ureteroscopes, laparoscopes, cystoscopes, aspiration endoscopes, sheaths, catheters, or any other suitable delivery devices or medical devices may be used in conjunction with the features described herein.

[0022] This disclosure provides a medical device having an enlarged working channel (along a portion of an axis) and an expandable opening (at a distal end), for example, to facilitate the delivery of instruments for treating a subject. The medical device (e.g., a ureteroscope) can be inserted into a subject's body cavity (e.g., into the bladder or kidney) to perform medical procedures (e.g., biopsy collection, such as to collect one or more tissue samples). The distal end of the medical device may include various electronic components, such as imaging devices and / or light sources. For example, the medical device may include one or more light sources, such as light-emitting diodes (LEDs), optical fibers (e.g., plastic optical fibers (POF), other light guides, or combinations thereof), imaging devices (e.g., cameras, other components with imagers, and / or other optical elements, such as lenses), and / or other electronic components (e.g., capacitors, diodes, resistors, etc.). The electronic components of the components described herein may include electrical connectors and may also include various elements mounted to or otherwise connected to, for example, electrical connectors. According to some aspects of this document, the most distal side of the distal end includes the imaging device and / or light source, which is located near the opening of the working channel. The opening can be expandable, for example, provided by an elastic material surrounding at least a portion of the working channel of the shaft and an opening at the distal end. In this way, the operator can guide the medical device through tortuous anatomical structures while the distal end has a reduced profile, and deliver multiple instruments simultaneously through the working channel to the target site by temporary expansion of the working channel without permanently increasing the size of the distal end. The following figure illustrates various features and examples of such medical devices.

[0023] Figure 1 Aspects of an exemplary medical device 100 according to this disclosure are depicted. The medical device 100 includes a handle 102 and an insertion portion 104. The insertion portion 104 includes a shaft 106. The handle 102 can be configured for an operator to grip and use. The shaft 106 includes a distal end 107, which includes a distal distal end 108. The shaft 106 defines a working channel 150 extending longitudinally from a proximal portion of the shaft 106 to an opening. For example, the distal distal end 108 may include a distal opening 150a of the working channel 150. The distal opening 150a may be expandable, for example, wherein at least a portion of the shaft 106 surrounding the distal opening 150a includes an elastic material that allows a portion of the working channel 150 located proximal to the distal opening 150a to expand radially to accommodate one or more medical devices passing through it.

[0024] At least a portion of shaft 106 may be flexible, for example, to facilitate guidance through the subject's anatomy. Shaft 106 may include one or more lumens or channels, which may optionally contain wire (e.g., hinge members and / or wires for electrical / electronic connections), tubes, or other features passing through it. For example, one or more channels 110, 111 may extend from the proximal end of shaft 106 to the distal end 108 to accommodate one or more hinge members. One or more channels 110, 111 and corresponding hinge members accommodated within channels 110, 111 may be adjacent to working channel 150. The hinge members may include wire and / or cable configured to hinge shaft 106, including the distal end 108, in one or more directions.

[0025] Handle 102 may include mechanisms for controlling the articulation of medical device 100. For example, the mechanism may include an actuator, such as a link 112 coupled to the articulation member. For example, link 112 may be coupled to the articulation member such that movement control of link 112 includes articulation and steering of the shaft 106 at the distal end 108. It should be understood that any suitable actuator may be used to supplement or replace link 112, such as one or more knobs, buttons, sliders, switches, or joysticks. Handle 102 may include one or more locking mechanisms, such as for locking the position of link 112, and thus locking the orientation of the articulated portion of shaft 106 (e.g., locking the orientation of the distal end 108).

[0026] Port 114 of handle 102 may provide access to the working channel 150 of shaft 106, for example, port 114 is in fluid communication with the working channel 150. An operator may insert one or more instruments (or other devices) into port 114 and may extend the instruments distally through the working channel 150 and through distal opening 150a. Alternatively, in addition to port 114, handle 102 may include one or more ports, each capable of receiving one or more instruments and in fluid communication with the working channel 150, allowing an operator to extend one or more additional portions of the instrument through the working channel 150 and distal opening 150a. In some examples, handle 102 may include a suction valve and / or other types of valves, such as fluid supply valves (e.g., air valves and / or water valves), and / or valves that perform a combination of functions.

[0027] Still referencing Figure 1An umbilicus 118 may extend from the handle 102 and includes or carries wires, cables, and / or conduits configured to supply, for example, power, signals, or fluid to and / or from the handle 102. For example, the umbilicus 118 can connect the handle 102 to one or more user interfaces, monitors, control units, displays, etc. Figure 1 As shown, the distal end 108 includes the farthest side 108a of an opening 150a (e.g., distal opening 150a) that defines a working channel 150. The opening 150a may be expandable to accommodate one or more instruments that pass through it and extend distally beyond the opening 150a.

[0028] As described above and at least as Figure 2B As shown, the distal end 108 may include one or more light sources 108b (e.g., LEDs) and one or more imaging devices 108c (e.g., cameras). Although a light source 108b and an imaging device 108c are depicted in the figure, it should be understood that other combinations of the light source 108b and imaging device 108c may be utilized. The light source 108b and imaging device 108c may be separate components or may be combined in a single unit or device. The imaging device 108c may be configured to capture video and / or still images. The imaging device 108c may provide signals to a monitor or distally (e.g., via an umbilical cable 118 connection) so that an operator can view the images provided by the imaging device 108c while guiding the medical device 100 through the subject's body cavity.

[0029] The actuator of the imaging device 108c, operably coupled to the handle 102, allows the operator to control the imaging device 108c and capture images. For example, as Figure 1 As shown, the handle 102 includes a button 119 to allow an operator to capture still images and / or video images via the imaging device 108c. While the button 119 is shown on the proximal portion of the handle 102, the button 119 (or other actuator) may be located on another portion of the handle 102 within the operator's hand's reach during use. Figure 1 As shown, in some aspects, the medical device 100 may face forward. For example, features of the distal end 108 (e.g., opening 150a, light source 108b, and / or imaging device 108c) may face the same direction, such as the distal direction (i.e., facing forward of the distal / farthest side 108a). In some examples, opening 150a may be at an angle relative to the longitudinal axis of axis 106.

[0030] Figure 2A A cross-sectional view of the distal end 108 is shown. Figure 2BThe farthest side 108a is shown (the imaging device 108c and the light source 108b at the farthest side 108a are shown), while Figure 2C A near-side cross-sectional view of the imaging device 108c and the light source 108b is shown. Figure 2C Electronic connections 109 to the imaging device 108c and the light source 108b (e.g., powered and controlled via an umbilical cable 118 through the handle 102) and two channels 110, 111 for the hinge members are shown. Although a single electronic connection 109 (e.g. to the imaging device 108c and the light source 108b) is shown, in other examples, the imaging device 108c and the light source 108b may have separate electronic connections via shaft 106 and / or handle 102.

[0031] At least as Figures 2A-2C As shown, the dimension of at least a portion of the working channel 150 located near the opening 150a (e.g., the distal opening 150a) can be larger than the dimension of the opening 150a. For example, the working channel 150 located near the opening 150a (e.g., near the imaging device 108c and the light source 108b at the farthest side 108a) can have a first dimension that is larger than a second dimension at the opening 150a. In an example where the working channel 150 has a circular cross-section, the first dimension can have a first diameter (in... Figure 2A and Figure 2C (marked as 1D), and the second dimension can be a second diameter smaller than the first diameter (in Figure 2A and Figure 2B (Referring to 2D). The working channel 150 may include a transition portion located between the first diameter 1D and the second diameter 2D. Optionally, the minimum diameter 3D of the working channel 150 can be expanded in size due to the elastic material 154 of the shaft 106.

[0032] The working channel 150 can be sized and shaped to accommodate one or more instruments or other devices, such as accommodating two or more instruments simultaneously. In some examples, the working channel 150 may have a uniform cross-sectional dimension from the proximal portion of the shaft 106 to the distal end 108, for example, at the distal end 108, a portion of the cross-sectional dimension may be occupied by electronic components (such as imaging devices 108c and / or light sources 108b) at the distal end 108. Thus, for example, the working channel 150 may have a uniform diameter 1D up to the transition portion between dimensions 1D and 2D, and may have a smaller diameter 2D at the opening 150a. Initially, the second diameter 2D may accommodate only one instrument, but due to the elastic material 154, an expansion in size can be achieved, for example, by pushing another instrument distally toward the opening 150a within the working channel 150 and through that opening.

[0033] According to some aspects of this disclosure, the first dimension (e.g., first diameter) of the working channel 150 located near the imaging device 108c and the light source 108b is in the range of about 2 mm to about 3 mm, and the second dimension (e.g., second diameter) of the working channel 150 at the opening 150a is smaller than the first dimension when not expanded. For example, the first dimension may be about 2.5 mm to about 3 mm, and the second dimension may be about 1.5 mm to less than 2.5 mm or less than 3 mm. In some aspects, when the opening 150a is not expanded, the shaft 106 has a uniform outer diameter, for example, ranging from about 3 mm to about 3.5 mm, or from about 3.1 mm to about 3.3 mm.

[0034] As described above, the distal end 108 may include a region surrounding the opening 150a, which includes an elastic material 154. The elastic material 154 may define at least a portion of the opening 150a and the working channel 150. The elastic material 154 may take the form of a patch or lip of the distal end 107 of the shaft 106, for example, being integrated into the remaining / surrounding material forming the shaft 106 (which may be rigid, semi-rigid, or flexible but not elastic). The elastic material 154 may be present in a single continuous piece or may be embedded as multiple regions within a non-elastic material, which allows the portion of the shaft 106 including the elastic material 154 to expand radially outward.

[0035] The thickness of the elastic material 154 is, for example, in... Figure 1 The direction from proximal to distal shown can be uniform or tapered. The thickness of the elastic material 154 can range from about 0.1 mm to about 0.4 mm, for example from about 0.2 mm to about 0.3 mm. Exemplary elastic materials suitable for this disclosure include, but are not limited to, flexible elastic polymers such as silicone and polyurethane. The elastic material 154 can form at least a portion of the periphery surrounding the opening 150a of the distal end 108. In some aspects, the entire distal end 108 can be formed of or otherwise include an elastic material. In this case, one side (e.g., a portion) of the shaft 106 opposite to and / or adjacent to the opening 150a and the imaging device 108c and / or the light source 108b can be rigid (e.g., a rigid portion) due to proximity to rigid electronic components (such as the imaging device 108c and / or the light source 108b), causing the opening 150a to expand in a direction away from the imaging device 108c and the light source 108b.

[0036] Figures 2A-2C , Figure 3 and Figures 4A-4BThe diagram shows an opening 150a (e.g., distal opening 150a) in the working channel 150, which expands due to the passage of multiple instruments. For example, two instruments (e.g., instrument A and instrument B) can be inserted through port 114 (or a different port communicating with the working channel 150), extend (e.g., move) through the working channel 150, and extend (e.g., move) through the opening and distally relative to opening 150a. It should be understood that although the figures show two instruments, one or more instruments (e.g., at least two instruments) can slide along the working channel 150 and / or can advance along the working channel 150, for example, within the dimensional constraints of the working channel 150 and shaft 106. Each instrument A, B may include diameters DA and DB, respectively. It should be understood that although diameters DA and DB are shown as substantially the same diameter in the figures, diameters DA and DB can be any diameter, as long as the combined dimensions (e.g., combined cross-sectional dimensions) DA and DB are smaller than the cross-sectional dimension (diameter D1) of the working channel 150. For example, in some aspects, DA may be twice the diameter of DB. In another example, there may be only one instrument (such as instrument A) where the diameter DA is less than 1D, but larger than the size of the opening 150a (diameter 2D).

[0037] When one or more instruments A and B are larger than the size of opening 150a and pass through it, opening 150a can be expanded. For example, as Figure 3 As shown, the device B extends distally beyond the diameter 3D and the opening 150a (e.g., diameter 2D). However, the diameter DB is smaller than the diameter D3, so the device B can pass through the opening 150a without causing the elastic material 154 to expand. Figure 4A and Figure 4BInstruments A and B are shown extending simultaneously through opening 150a. Because their combined dimensions (diameters DA and DB) are greater than diameter D3, instruments A and B press against the wall of working channel 150, causing the elastic material 154 to expand in a direction away from imaging device 108c and light source 108b. When the dimensions of diameters DA, DB, and / or the combined dimensions of diameters DA and DB are greater than the dimensions of working channel 150 in the distal end 108 (e.g., diameter 3D), instruments A and B can cause the dimensions of working channel 150 (at and near opening 150a) to expand radially outward relative to the longitudinal axis of medical device 100, i.e., away from imaging device 108c and light source 108b. In this expanded configuration, diameters 2D and / or 3D can expand relative to their original dimensions and can optionally be greater than the dimensions of the proximal portion of working channel 150 (e.g., diameter 1D). Once instruments A and B retract, the elasticity of the resilient material 154 allows shaft 106 to return to its original dimensions, for example, having a reduced profile to facilitate guidance through the body cavity. It should be understood that, in response to one or more instruments A and B extending through the working channel 150 and opening 150a, the expansion of the working channel and opening will allow an operator to collect one or more tissue samples (e.g., one or more biopsy samples) with instruments A and B, wherein each instrument can be configured to receive / capture one or more tissue samples. For example, at least one or both of instruments A and B may include forceps, grippers, baskets, or other retrieval devices, etc.

[0038] Due to the elastic and flexible properties of the distal end 108, the opening 150a can be sized smaller than the size required to accommodate instruments that can pass through the working channel 150. The relatively small opening 150a allows the farthest side 108a to include various electronic devices and / or other components without increasing the overall profile of the shaft 106.

[0039] While this disclosure describes the principles of the disclosure with reference to illustrative aspects of specific medical uses and procedures, it is not limited thereto. Each aspect disclosed herein may include one or more features described in conjunction with any other aspects. Those skilled in the art and those who have received the teachings herein will recognize that alternative modifications, applications, aspects, and equivalents fall within the scope of the aspects described herein. Therefore, this disclosure should not be considered as limited to the foregoing description.

Claims

1. A medical device comprising: A shaft defines a working channel that extends from a proximal portion of the shaft to an opening at a distal end of the shaft, the farthest side of the distal end including an imaging device and a light source near the opening; The working channel has a first dimension at the opening and a second dimension near the imaging device and the light source, the second dimension being larger than the first dimension; and The shaft, at least a portion of which surrounds the opening, comprises an elastic material, allowing the opening to expand in a direction away from the imaging device and the light source.

2. The medical device according to claim 1, wherein, The elastic material includes a flexible elastic polymer.

3. The medical device according to claim 1 or 2, wherein, The elastic material includes silicone or polyurethane.

4. The medical device according to any one of the preceding claims, wherein, A portion of the shaft opposite the elastic material is rigid, and the rigid portion of the shaft is adjacent to the imaging device and the light source.

5. The medical device according to any one of the preceding claims, wherein, The second dimension is a diameter ranging from approximately 1.5 mm to less than 2.5 mm.

6. The medical device according to any one of the preceding claims, wherein, The opening can expand to a diameter of up to approximately 3 mm.

7. The medical device according to any one of the preceding claims, wherein, The shaft includes at least one hinged wire adjacent to the working channel.

8. The medical device according to any one of the preceding claims, wherein, When the opening is not expanded, the shaft has a uniform outer diameter, optionally, wherein the uniform outer diameter ranges from about 3 mm to about 3.5 mm.

9. The medical device according to any one of the preceding claims, wherein, The wall adjacent to the imaging device and the light source in the working channel is rigid.

10. The medical device according to any one of the preceding claims, wherein, The portion of the shaft containing the elastic material has a thickness ranging from approximately 0.1 mm to approximately 0.4 mm.

11. The medical device according to any one of the preceding claims, wherein, The elastic material is integrated into the shaft at the distal end in the form of a patch.

12. The medical device according to any one of the preceding claims, further comprising at least two instruments, said at least two instruments being slidable along said working channel and through said opening, wherein, The combined cross-sectional dimension of the at least two instruments is greater than the first dimension.

13. The medical device according to any one of the preceding claims, further comprising a handle coupled to the proximal portion of the shaft, wherein, The handle includes a port that communicates with the working channel.

14. The medical device according to any one of the preceding claims, wherein, The opening is at an angle relative to the longitudinal axis of the shaft.

15. Use of a medical device according to any one of the preceding claims for collecting biopsy samples of tissue from a subject.

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