Medical devices and related methods

Abstract

Medical devices and related methods are described, including a medical device that includes a handle that includes a housing. The housing may include a grip and an actuator. The handle may also include an imaging module including a printed circuit board, and a laser module including a first laser source configured to be coupled to the first laser fiber and a second laser source configured to be coupled to the second laser fiber. The laser module and the imaging module may be contained within the housing, or the imaging module, the laser module, or both the imaging module and the laser module may be selectively attachable to and detachable from the housing.

Description

Cross-references to related applications

[0001] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 585,330, filed September 26, 2023, which is incorporated herein by reference in its entirety. Technical Field

[0002] The various aspects of this disclosure generally relate to medical devices and methods of using them. In particular, they relate to medical devices and methods useful for surgeries involving imaging and the use of laser fibers. Background Technology

[0003] Laser devices and systems are used during various medical procedures, such as ureteroscopy and / or endoscopy. For example, laser fibers can be used to estimate the size of kidney stones and / or to break them up. Laser devices and systems are typically expensive, and the distance the fiber travels from the laser source to the treatment area can cause distortion. Summary of the Invention

[0004] According to some aspects of this disclosure, a medical device may include a handle, the handle including a housing, the housing including a grip and an actuator. The handle may also include an imaging module including a printed circuit board. The handle may include a laser module including a first laser source configured to be coupled to a first laser fiber and a second laser source configured to be coupled to a second laser fiber. The laser module and the imaging module may be contained within the housing; or the imaging module, the laser module, or both the imaging module and the laser module may be selectively attachable to and detachable from the housing.

[0005] According to some aspects, the medical device may also include an axis extending from a handle to a distal end. The distal end may include an imaging device and a light source, each operatively coupled to an imaging module. In some examples, the medical device may also include a first laser fiber and a second laser fiber. The first laser fiber may be coupled to a first laser source, and the second laser fiber may be coupled to a second laser source, and each of the first and second laser fibers may extend distally through the axis to the distal end. In some examples, the handle may include a port, and the axis may include a lumen in fluid communication with the port, and the lumen may terminate at the most distal side of the distal end. In some examples, the laser module and the imaging module may be contained within a housing, and the laser module may further include a first coupler at least partially surrounding the first laser source and / or a second coupler at least partially surrounding the second laser source. In some examples, the handle may include a user element selectable by a user to control a first wavelength of the first laser source and a second wavelength of the second laser source. In some examples, the user element may include a knob, switch, or button configured to select the first and second wavelengths, and the second wavelength may be different from the first wavelength. In some examples, the first wavelength can be red, green, or blue light. In some examples, the imaging module and the laser module can be coupled to and detached from the housing. In some examples, the imaging module and the laser module can be contained within a single unit, which is selectively attachable to and detachable from the housing. The single unit can be coupled to and detachable from the portion of the housing distal to the grip. When the single unit is attached to the housing, it can form an angle of 90 degrees or less relative to the longitudinal axis of the housing. The imaging module and the laser module can be contained within separate units, each coupled to and detachable from the housing independently of the other units.

[0006] According to some aspects, the medical device may include a handle comprising a housing including a grip, a port, and an actuator. The handle may include an imaging module coupled to and selectively detachable from the housing, and may include a laser module coupled to and selectively detachable from the housing, the laser module including a first laser source and a second laser source. The medical device may also include a shaft extending from the handle to a distal end, the shaft including a lumen in fluid communication with the port, and the actuator being configured to control movement of the shaft. In some examples, the distal end of the shaft may include an imaging device and a light source, each operatively coupled to the imaging module, and the lumen of the shaft may terminate at the distal end. In some examples, the first laser source may be coupled to a first laser fiber, and the second laser source may be coupled to a second laser fiber, each of the first and second laser fibers passing through a corresponding opening in the shaft extending to the distal end. In some examples, the imaging module and the laser module may be contained in separate units, each independently detachable from the housing. In some examples, the imaging module and the laser module may be contained within a single unit that is coupled to and detachable from the housing.

[0007] According to some aspects, the medical device may include a handle comprising a housing including a grip and an actuator. The handle may include an imaging module coupled to and selectively detachable from the housing, and may include a laser module coupled to and selectively detachable from the housing, the laser module including a first laser source and a second laser source. The medical device may also include an axis extending from the handle to a distal end, the distal end including an imaging device and a light source. The imaging device and the light source may be operatively coupled to the imaging module, and the actuator may be configured to control movement of the axis. In some examples, the first laser source may be coupled to a first laser fiber, and the second laser source may be coupled to a second laser fiber, and each of the first and second laser fibers may extend through the axis to the distal end. Attached Figure Description

[0008] The accompanying drawings, which are incorporated in and constitute a part of this application, illustrate exemplary aspects of this disclosure and, together with the description, serve to explain the principles of this disclosure.

[0009] Figures 1A-1F An exemplary medical device according to some aspects of this disclosure is shown.

[0010] Figure 2 Another exemplary medical device according to some aspects of this disclosure is shown.

[0011] Figure 3A and Figure 3BComponents useful for an exemplary medical device according to some aspects of this disclosure are shown.

[0012] Figure 4A and Figure 4B An exemplary medical device according to some aspects of this disclosure is shown. Detailed Implementation

[0013] Specific aspects of this disclosure are described below in more detail. In the event of any conflict between the terms and definitions provided herein and those incorporated by reference, the terms and definitions provided herein shall prevail.

[0014] The terms “proximal” and “distal” are used herein to refer to the relative positions of components of the exemplary medical device. As used herein, “proximal” refers to a position relatively closer to the outside of the body or closer to the operator using the medical device. Conversely, “distal” refers to a position relatively further away from the operator using the medical device or closer to the inside of the body.

[0015] As used herein, the terms “comprise,” “comprising,” “include,” “including,” “has,” “having,” or any other variations thereof are intended to cover a non-exclusive inclusion relationship, such that a process, method, article, or apparatus that includes a list of elements includes not only those elements but may also include other elements not expressly listed or inherent to such a process, method, article, or apparatus. The term “exemplary” is used in the sense of “example” rather than “ideal.”

[0016] In addition, relative terms such as “about,” “substantially,” and “approximately” are used to indicate possible variations of ±10% within a specified value or range.

[0017] Although ureteroscopes and endoscopes are mentioned herein for illustrative purposes, it will be understood that this disclosure covers any suitable medical device configured to allow an operator to access and view the internal body anatomy of a subject (e.g., a patient) and / or to deliver medical instruments (such as biopsy forceps, graspers, baskets, snares, probes, scissors, retrieval devices, lasers, and other tools) into the body of a subject. The medical devices described herein can be inserted into various body lumens and / or chambers, such as, for example, the urinary tract or gastrointestinal tract. It will be understood that, unless otherwise stated, bronchoscopes, duodenoscopes, endoscopes, gastroscopes, endoscopic ultrasonography (“endoscopic ultrasonography”, EUS) endoscopes, colonoscopes, ureteroscopes, bronchoscopes, laparoscopes, cystoscopes, aspiration endoscopes, sheaths, catheters, or any other suitable delivery device or medical device that can be used in conjunction with the features described herein.

[0018] Features of the medical device described herein can help reduce or minimize distortion of the output laser beam (or laser) and / or reduce loss of output laser beam integrity. According to some aspects of this disclosure, the medical device may include a laser module and an imaging module. The laser module may include one or more laser sources, for example, housed within or detachably coupled to the handle of the medical device. The laser module and imaging module may be separate components or may be combined as a single component (e.g., each module includes electronic components mounted to or otherwise coupled to a common substrate). The laser source may be coupled to or configured to be coupled to a laser fiber extending through an axis through the medical device to a distal end of the medical device, for example, for treating a target site in a body lumen. The laser fiber may be, for example, holmium fiber or other suitable fiber. The medical device may include one or more actuators to allow a user to control the laser source and / or select the wavelength of the laser source during medical procedures. The imaging module may include a printed circuit board (PCB). The PCB may include or be operatively coupled to a processor and may be configured to couple to a display external to the medical device for image display. PCBs can use conductive traces, pads, etc. to electronically connect processors and various imaging components.

[0019] Figure 1A An exemplary medical device 102 illustrating some aspects of this disclosure is shown. In this example, the device includes an imaging module and a laser module, both of which are contained within a housing of a handle (e.g., integrated into the handle and not detachable from the housing).

[0020] The medical device 102 includes a handle 104 and a shaft 106 coupled to the handle 104. For example... Figure 1A and Figure 1BAs shown, the handle 104 includes a housing 110, which contains various electronic components. In some examples, the handle 104 is integrally formed with the shaft 106. In other examples, the handle 104 is detachably coupled to or otherwise detachable from the shaft 106. The shaft 106 may be flexible to facilitate navigation through tortuous anatomical passages within the body. The shaft 106 may include one or more lumens and a distal portion terminating at a distal end 108. The distal end 108 may include imaging components, such as an imaging device 146 (e.g., a camera, imager, etc.) coupled to the PCB 162 of the imaging module 114, and one or more light sources 154 (e.g., LEDs, optical fibers, etc.). Figure 1F The distal end 108 is shown at its most distal side 152, which includes a distal opening of lumen 140, an imaging device 146, and a light source 154. Handle 104 may include a port 138 communicating with lumen 140 of shaft 106, for example for inserting instruments and / or delivering aspiration or fluid via the distal opening at the most distal side 152.

[0021] Handle 104 may include one or more actuators for controlling aspects of the medical device 102, such as via user input. The one or more actuators may include, for example, levers, switches, buttons, knobs, and / or any other suitable type of mechanism for receiving and transmitting user input. For example, housing 110 may include an actuator 142 at the proximal portion 105 of handle 104 to facilitate articulation, steering, deflection, and / or other movements of shaft 106 and distal end 108. One or more other actuators of handle 104 may be configured to capture video and / or still images using imaging device 146 at distal end 108, and / or control laser sources 116, 118. A portion of housing 110 may provide a grip portion 156 to allow an operator to grasp handle 104 during medical procedures. Handle 104 may be operatively coupled to one or more auxiliary devices, such as controllers, processors, displays, power supplies, etc., such as via an umbilicus 150. The umbilical cable 150 can be configured to deliver power to the handle 104 and / or shaft 106 to power one or more components of the handle 104 and / or shaft 106.

[0022] Laser module 112 may include a first laser source 116 (in Figure 1B and Figure 1C (as shown in the image) and the second laser source 118 ( Figure 1D (As shown in the diagram). Each laser source 116, 118 can be configured to emit light of one or more wavelengths, such as visible light. For example, each laser source 116, 118 may be able to generate red, green, and / or blue light. Laser sources 116, 118 may be electrically coupled to a power source, for example, via an umbilical cable 150.

[0023] Optionally, couplers 120, 122 (in) Figure 1C and Figure 1D (Seen in a side view) Couplers 120 and 122 may partially or completely surround laser sources 116 and 118. Couplers 120 and 122 may each include a cavity for receiving each laser source and / or coupling each laser source to a corresponding laser fiber. As shown, for example, couplers 120 and 122 define cavities 164 and 166, each cavity having an open proximal end for receiving laser sources 116 and 118 and an open distal end for receiving laser fibers 124 and 126. Optionally, couplers 120 and 122 may be secured to housing 110 by any suitable adhesive or fastener.

[0024] Laser fibers 124 and 126 can extend from laser sources 116 and 118 through axis 106, for example, to the farthest side 152 of the distal end 108. In some examples, each laser fiber 124 and 126 may comprise a single, continuous, monolithic fiber segment. In some examples, one or both of laser fibers 124 and 126 may comprise multiple fiber segments in optical communication (e.g., joined together by couplers, connectors, or fused together). For example, as... Figure 1E As shown, the first laser fiber 124 may include a first fiber segment 130 and a second fiber segment 132 joined together by a fiber-to-fiber connector 128. The connector 128 may include a proximal section 134 having a larger outer diameter than the distal section 136 of the connector 128. The proximal section 134 may receive the first fiber segment 130, and the distal section 136 may receive the second fiber segment 132 to optically couple the fiber segments 130 and 132.

[0025] like Figure 1F As shown, laser fibers 124 and 126 can extend to corresponding holes or openings on the farthest side 152 of the distal end 108. In this example, the distal end 108 is configured such that laser fibers 124 and 126 are on radially opposite sides of the lumen 140. However, it will be understood that other configurations are also contemplated herein.

[0026] As mentioned above, the laser module and / or imaging module can be detachably coupled to the handle of the medical device. Figure 2An exemplary handle 204 of a medical device 202 according to some aspects of this disclosure is shown, wherein the laser module 212 and the imaging module 214 are each detachable from the handle 204. The handle 204 may be used in conjunction with an axis (e.g., axis 106 of the medical device 102) (e.g., in place of the handle 104), or may be used in conjunction with any feature of the axis 106 of the medical device 102. Furthermore, the handle 204 may include any feature of the handle 104 (e.g., port 138, actuator 142, etc.), unless otherwise stated herein.

[0027] Similar to laser module 112, laser module 212 may include two laser sources 216 and 218. Figure 2 A side view of the laser module 212 detached from the handle 204 is shown, with the second laser source 218 located behind the first laser source 216. The portion of the handle 204 to which the laser module 212 is attached may have suitable electronic, optical, and / or mechanical connectors to facilitate securing the laser module 212 to the handle 204 and to provide electrical connections from the laser sources 216, 218 to a laser fiber extending from the handle and / or axially distal side of the medical device 202. For example, the laser module 212 may include an optical or electronic connector 290 configured to be detachably coupled to a complementary optical or electronic connector 292 of the handle 204 to operatively couple the laser module 212 to the handle 204 and / or an in-axis laser fiber coupled to the handle 204.

[0028] Optionally, the laser module 212 may include laser fibers 248 and 260 coupled to corresponding laser sources 216 and 218 via couplers 220 and 222. The laser fibers 248 and 260 may be coupled to or configured to be coupled to corresponding laser fibers extending through an axis (e.g., similar to axis 106 of the medical device 102).

[0029] Imaging module 214 includes PCB 262 and is configured to be attached to handle 204 via complementary electronic connectors, for example, to provide electronic communication between PCB 262 and / or other components of imaging module 214 and imaging components of medical device 202. Imaging module 214 may include electronic connector 295 configured to be detachably coupled to electronic connector 297 (e.g., complementary pins 293 and apertures 291) of handle 204.

[0030] Figure 3A and Figure 3BA schematic diagram of an exemplary component 303 is shown, which can be used to select between different wavelengths of light from a laser in the device described herein, and can be used in conjunction with any feature of medical devices 102, 202. As mentioned above, each laser source 116, 118 of laser module 112 can be configured to emit different wavelengths, such as different wavelengths of visible light, such as a first wavelength 315, a second wavelength 317, and / or a third wavelength 319. For example, the first wavelength 315 could be red light (e.g., 630-670 nm), the second wavelength 317 could be green light (e.g., 532 nm), and the third wavelength 319 could be blue light (e.g., 400-500 nm). Component 303 can allow an operator to select the wavelength of light emitted by each laser of the medical device.

[0031] like Figure 3A As shown, component 303 includes an actuator, such as user element 323, like an adjustable or rotatable knob. User element 323 may be incorporated into the handle 104 of medical device 102, for example, coupled to housing 110, and is accessible to the operator's hand during use of the device. User element 323 may be coupled to laser sources 116, 118 to adjust and / or control the wavelength of the emitted light. For example, the operator may actuate user element 323 to select a set of two wavelengths from a total of three wavelengths. For example, the operator may actuate user element 323 (e.g., rotate the knob) to select red light and green light (in... Figure 3B The images show settings for 310a and 310b respectively, green light and blue light (in...) Figure 3B The images show settings for 310b and 310c respectively, or blue and red light (in...). Figure 3B The figures are shown as 310c and 310a respectively.

[0032] Based on some examples in this article, the imaging module and laser module can be detached from the handle via the same detachable unit. This is in Figure 4A and Figure 4B shown in . Specifically, Figure 4A and Figure 4B Two different versions of another exemplary medical device 402 according to some aspects of this disclosure are shown, the medical device including a handle 404 coupled to a shaft 406. The handle 404 may include any features of handles 104, 204, and the shaft 406 may include any features of shaft 106, unless otherwise stated herein. The handle 404 includes a housing 410, a port 438, an actuator 442, and a grip 456.

[0033] The medical device 402 also includes a laser module 412 and an imaging module 414, which are contained in a single unit 451. The single unit 451 can be attached to a handle 404 for use of the medical device 402 and can be detached from the handle 404 when not in use. Figure 4A The diagram shows a configuration in which unit 451, in a substantially vertical orientation, can be attached to handle 404, while Figure 4B The unit 451 is shown to be attachable to the handle 404 to form an acute angle with the housing 410 of the handle 404. For example, the unit 451 may form an angle of 90 degrees or less relative to the longitudinal axis of the housing 410. Other configurations and orientations are contemplated. The laser module 412 may include a first laser source 416 and a second laser source 418 respectively coupled to a first laser fiber 424 and a second laser fiber 426. The laser fibers 424, 426 may be coupled to or configured to be coupled to corresponding laser fibers extending through the shaft 406 and / or the housing 410. Optionally, the laser module 412 may include laser sources 416, 418 configured to be coupled to corresponding laser fibers extending through the shaft 406 and / or the housing 410.

[0034] The imaging module 414 includes a PCB 462 configured to be coupled to an imaging component (e.g., an imaging device and light source similar to the imaging device 146 and light source 154 of the medical device 102).

[0035] Unit 451 can be configured to be selectively attached to and detached from the housing 410 of the handle 404 so as not to interfere with the operation of the medical device 402. For example, as Figure 4A and Figure 4B As shown, unit 451 may be attached to the portion of housing 410 distal to the grip portion 456. In other examples, unit 451 may be attached to the portion of housing 410 proximal to the grip portion 456. Although unit 451 is shown as having a generally rectangular shape, it will be understood that unit 451 may be any other shape and / or size suitable for including laser module 412 and imaging module 414.

[0036] Unit 451 may include an electronic connector 475, complementary to the electronic connector of handle 404, for operatively coupling imaging module 414 to the imaging component of medical device 402 and laser module 412 to the laser component of medical device 402. Alternatively or additionally, imaging module 414 may be coupled to the imaging component of medical device 402 via direct wiring. Unit 451 may also be configured to receive power from a power source and / or be coupled to a display. For example, unit 451 includes an electronic connector 471 or adapter configured to receive power from an external power source and / or configured to communicate electronically with a display or other electronic components.

[0037] It will be apparent to those skilled in the art that various modifications and variations can be made to the disclosed apparatus and methods without departing from the scope of this disclosure. Other aspects of this disclosure will be apparent to those skilled in the art from consideration of practice with this specification and the features disclosed herein. This specification and embodiments are intended to be considered exemplary only.

Claims

1. A medical device, the medical device comprising: The handle includes a housing, the housing including a grip and an actuator, and the handle further includes: An imaging module, the imaging module including a printed circuit board; and The laser module includes a first laser source configured to be coupled to a first laser fiber and a second laser source configured to be coupled to a second laser fiber. The laser module and the imaging module are contained within the housing; or The imaging module, the laser module, or both the imaging module and the laser module are selectively attachable to and detachable from the housing.

2. The medical device according to claim 1, further comprising: An axis extending from the handle to a distal end, the distal end including an imaging device and a light source, each operatively coupled to the imaging module.

3. The medical device according to claim 2, further comprising: The first laser fiber and the second laser fiber, wherein the first laser fiber is coupled to the first laser source and the second laser fiber is coupled to the second laser source, and wherein each of the first laser fiber and the second laser fiber extends through the axial distal side to the distal end.

4. The medical device according to claim 2 or 3, wherein, The handle includes a port, and the shaft includes a lumen in fluid communication with the port, the lumen terminating at the farthest side of the distal end.

5. The medical device according to any one of the preceding claims, wherein, The laser module and the imaging module are contained within the housing, and the laser module further includes a first coupler at least partially surrounding the first laser source and a second coupler at least partially surrounding the second laser source.

6. The medical device according to any one of the preceding claims, wherein, The handle includes a user element that can be selected by the user to control a first wavelength of the first laser source and a second wavelength of the second laser source.

7. The medical device according to claim 6, wherein, The user element includes a knob, switch, or button configured to select the first wavelength and the second wavelength, wherein the second wavelength is different from the first wavelength.

8. The medical device according to claim 6 or 7, wherein, The first wavelength is red, green, or blue light.

9. The medical device according to any one of claims 1 to 4 or claims 6 to 8, wherein, Both the imaging module and the laser module are coupled to the housing and can be detached from the housing.

10. The medical device according to any one of claims 1 to 4 or claims 6 to 9, wherein, The imaging module and the laser module are contained within a single unit, which is selectively attachable to and detachable from the housing.

11. The medical device according to claim 10, wherein, The individual unit is coupled to the portion of the housing distal to the grip and is detachable from the portion of the housing distal to the grip.

12. The medical device according to claim 10 or 11, wherein, When the individual unit is attached to the housing, the individual unit forms an angle of 90 degrees or less relative to the longitudinal axis of the housing.

13. The medical device according to any one of the preceding claims, wherein, The laser module includes the first laser fiber and the second laser fiber.

14. The medical device according to any one of claims 1 to 9 or 13, wherein, The imaging module and the laser module are contained in separate units, each of which is coupled to the housing independently of the other units and can be detached from the housing.

15. The medical device according to claim 14, wherein, The laser module includes a first laser source coupled to a third laser fiber and a second laser source coupled to a fourth laser fiber, wherein the third laser fiber is configured to be coupled to the first laser fiber, and wherein the fourth laser fiber is configured to be coupled to the second laser fiber.

Images