Medical systems and devices with disposable features

Abstract

The medical device includes a handle including a port, a shaft extending distally from the handle, the shaft including a channel extending along at least a portion of the length of the shaft, the channel including a longitudinal opening on a radially outer surface of the shaft, and a removable portion extending through the channel, the removable portion including a first lumen and configured to be separable from the handle and the shaft.

Description

[Technical Field]

[0001] The present disclosure relates generally to medical systems and devices. Specifically, the present disclosure relates to medical systems and devices that include a removable disposable mechanism. This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 484,241, filed February 10, 2023, which is incorporated herein by reference in its entirety. [Background technology]

[0002] Medical imaging devices, such as endoscopes, allow physicians to visualize tissues, anatomical structures, and pathologies in a minimally invasive manner. These imaging devices are typically cleaned and reused multiple times. Sterilization of such imaging devices is essential to avoid cross-contamination between patients. Unfortunately, inadequate sterilization of imaging devices is a continuing and dangerous problem. Therefore, there is a need for medical imaging devices that have disposable elements. Summary of the Invention

[0003] According to one embodiment, a medical device may include a handle including a port, a shaft extending distally from the handle, the shaft including a channel extending along at least a portion of the length of the shaft, the channel including a longitudinal opening on a radially outer surface of the shaft, and a removable portion extending through the channel, the removable portion including a first lumen and configured to be separable from the handle and the shaft.

[0004] In one embodiment, the channel in the shaft may be off-center from a central longitudinal axis of the shaft, and the channel may be configured to prevent the removable portion from passing through the longitudinal opening of the channel.

[0005] In one embodiment, the longitudinal opening of the channel may include a notch, groove, or slit extending along the entire length of the shaft. In one embodiment, the shaft may include a distal end including an abutment that defines a distal opening of the channel, the abutment configured to inhibit distal translation of the removable portion beyond the distal end.

[0006] In one embodiment, the removable portion may include a second lumen. In one embodiment, the removable portion may be comprised of a first lumen and a second lumen.

[0007] In one embodiment, the removable portion may include a proximal adapter. The proximal adapter may include a first port in fluid communication with the first lumen of the removable portion. The proximal adapter may be configured to releasably engage the port of the handle. The proximal adapter may include an actuator configured to release the proximal adapter from the port of the handle. The proximal adapter may be a y-shaped adapter including the first port of the proximal adapter and a second port of the proximal adapter.

[0008] In one embodiment, the first lumen may include an elevator configured to adjust the orientation of a tool or instrument inserted within the first lumen. In one embodiment, the removable portion may have a generally teardrop-shaped cross section.

[0009] In one embodiment, the removable portion may include a second lumen, and only the removable portion may be configured to receive fluid through the first lumen and / or the second lumen.

[0010] In one embodiment, the detachable portion can be configured to be completely removed from the handle and the shaft by pulling the detachable portion proximally from the port in the handle.

[0011] According to another embodiment, a medical device may include a handle including a cavity, a shaft extending distally from the handle, the shaft including a channel extending along at least a portion of the length of the shaft, the channel including a longitudinal opening on a radially outer surface of the shaft, and a removable portion extending through the cavity and the channel, the removable portion including a first lumen and configured to be separable from the handle and the shaft.

[0012] In one embodiment, the cavity may be partially open, thereby exposing at least a portion of the removable portion. In one embodiment, the detachable portion may include a body and an extension portion. The body may include a port configured to receive a medical instrument.

[0013] According to another embodiment, a medical device may include a handle including a port; a shaft extending distally from the handle, the shaft including a channel extending along at least a portion of the length of the shaft; a removable portion extending through the channel, the removable portion including at least one lumen and configured to be removable from the handle and the shaft via the port; and a liner positioned between the channel and the removable portion, the liner configured to transition between a deflated state and an inflated state.

[0014] In one embodiment, the liner may be secured to at least a portion of a surface of the removable portion. The removable portion and the liner may be configured to be completely removed from the handle and the shaft by pulling the removable portion proximally from the port in the handle. [Brief explanation of the drawings]

[0015] [Figure 1] FIG. 1 is a partial cross-sectional view of a system including a medical device according to some embodiments of the present disclosure. [Figure 2A-2B] 2A and 2B are perspective views of one embodiment of the medical device of FIG. [Figure 2C-2D] 2C and 2D are perspective views of another embodiment of the medical device of FIG. [Figure 3A-3B] 3A and 3B are perspective views of a medical device according to another embodiment of the present disclosure. [Figure 4] FIG. 4 is a partial cross-sectional view of a system including a medical device according to another embodiment of the present disclosure. [Figure 5A-5B] 5A and 5B are perspective views of one embodiment of the medical device of FIGS. 3A and 3B. [Figures 6A-6C] 6A, 6B, and 6C are perspective views of a medical device according to another embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0016] Reference will now be made in detail to aspects of the present disclosure, examples of which are illustrated in the accompanying drawings. The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate various exemplary embodiments and, together with the description, serve to explain the principles of the disclosed embodiments. Wherever possible, the same or similar reference numbers will be used throughout the drawings to refer to the same or similar parts. The term "distal" refers to the location or portion of a medical device that is furthest from a user of the device, e.g., when introducing the device into a subject (e.g., a patient). In contrast, the term "proximal" refers to the location or portion of a medical device that is closest to a user, e.g., when placing the device into a subject.

[0017] Both the foregoing general description and the following detailed description are exemplary and explanatory only and are not limiting of the claimed features. As used herein, the terms "comprises," "has," "includes," or other variations thereof are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus comprising a list of elements does not include only those elements, but may also include other elements not expressly listed or inherent in such process, method, article, or apparatus. In this disclosure, relative terms such as "about," "substantially," "generally," and "approximately" are used to indicate a possible variation of ±10% in a stated value or characteristic.

[0018] Embodiments of the present disclosure include medical systems and devices that include a detachable portion. In some examples, the detachable portion may be disposed of after a single use (i.e., disposable). The detachable portion may include elements of the imaging device that may be difficult to clean / sterilize and may be a major source of contamination. Such elements may include one or more of the working channel, elevator mechanism (e.g., that may be present within the working channel), fluid / suction channels, and / or other elements that may come into contact with fluids (e.g., bodily fluids), anatomy, etc. that may contaminate the elements. The detachable portion may be a separate component from the handle and shaft of an exemplary medical device, such that the handle and shaft may be sealed to and kept separate from one or more channels / features of the detachable portion. The detachable portion may also be electronically tagged or marked by any suitable method to prevent reuse. The handle, shaft, and shaft features (e.g., camera, light source, etc.) may be cleaned and sterilized and reused with a new detachable portion inserted into an exemplary medical device. Such exemplary medical devices may help reduce the cost of endoscopic procedures, reduce waste of hazardous materials, and reduce the risk of cross-contamination between patients. In other examples, removable portions of another exemplary medical device may include a camera, a light source, etc. In such examples, a disposable shaft may include one or more channels (e.g., a working channel, an air / water channel, and / or an aspiration channel), an elevator mechanism, etc. Removable portions of such exemplary devices may be cleaned / sterilized and reused, while the remaining features of such medical devices (e.g., a handle, a shaft, etc.) may be disposed of after a single use. Such exemplary medical systems and devices are described in further detail below.

[0019] 1, a medical system 5 is shown including a medical device 10, e.g., an endoscope, in accordance with one or more embodiments of the present disclosure. The medical device 10 includes a flexible shaft 50 (e.g., a catheter) and a handle 52 connected to the proximal end of the flexible shaft 50.

[0020] The handle 52 may be configured to actuate or control mechanisms of the medical system 5 and / or one or more tools or devices associated with the medical system 5, without limitation. As shown, the handle 52 includes first and second actuators 42, 43, which control the articulation of the shaft 50, e.g., an articulation joint at or proximal to the distal end of the shaft 50. For example, the actuators 42, 43 may control movement of the shaft 50 in multiple directions, e.g., along different planes. The actuators 42, 43 may include, for example, rotatable knobs that rotate to push or pull cables or wires coupled to the shaft 50. For example, one or more cables or wires may comprise medical-grade plastic or metal and may extend distally from the respective actuators 42, 43 to connect to and control movement of the flexible shaft 50. The distal ends of the cables or wires may extend through the shaft 50 and terminate at an articulation joint and / or the distal tip of the shaft 50. For example, one or more cables or wires may be connected to the articulation joint, and the cables or wires may be controlled by rotation of the actuators 42, 43 to actuate the articulation joint and / or the distal end of the shaft 50, e.g., along multiple directions. According to some embodiments of the present disclosure, one or more electrical cables (not shown) may extend from the proximal end of the system 5 to the distal end of the shaft 50 to provide electrical control for imaging, lighting, and / or other electronics at the distal end of the shaft 50. The electrical cables may carry imaging signals that are received at the distal end of the shaft 50 and processed and / or displayed on a display. The handle 52 may include at least one port, such as port 54 shown in the example of FIG. 1, for introducing and / or removing tools, fluids, pressure (e.g., negative pressure or suction), or other materials from a subject (e.g., a patient) via a detachable portion 70 (described in further detail below). The handle 52 may include a lumen 53 that may extend between the opening of the port 54 and the proximal opening of the channel 83 of the shaft 50 (described in more detail below).Lumen 53 may define a passageway of any suitable dimensions through which removable portion 70 may be guided towards channel 83 .

[0021] Handle 52 also includes port 46 that can be removably connected to umbilical portion 8 for introducing wiring for electronic components disposed at the distal end of shaft 50. Thus, in some embodiments, umbilical portion 8 can be detached from port 46 and handle 52 when handle 52 is discarded. Handle 52 can further include an additional lumen (not shown) extending between port 46 and shaft 50 to provide passage for wiring associated with electronic components of shaft 50. Alternatively, handle 52 can be fixedly attached to umbilical portion 8 and port 46 can be omitted.

[0022] 1, shaft 50 includes reusable portion 82 and detachable portion 70. Reusable portion 82 may extend between distal end 50d and proximal end 50p. Proximal end 50p may be coupled to the distal portion of handle 52 by any suitable means. Proximal end 50p may include an opening (not shown) that may communicate with a lumen or cavity of handle 52.

[0023] The reusable portion 82 may be constructed of, but is not limited to, any suitable biocompatible material. As shown in FIGS. 2A and 2B , the reusable portion 82 may include a distal surface 84 that includes various electronic mechanisms, including an imaging device (e.g., a camera) 194 and / or a light source mechanism 192 (e.g., an LED). Various cables / wiring associated with each of the imaging device 194 and light source mechanism 192 may extend throughout the length of the shaft portion 82 and through openings in the proximal end 50 p and lumens or cavities in the handle 52 toward the port 46 and umbilical 8. In some examples, the reusable portion 82 may not have channels or lumens configured to receive medical tools / instruments, suction, or fluids, as shown in FIGS. 2A and 2B . Thus, the reusable portion 82 (along with the handle 52) may be easily cleaned, sterilized, and reused. The reusable portion 82 may further include a longitudinal channel 83 (shown in FIG. 2B ) that may extend between the distal end 50 d and the proximal end 50 p. The channel 83 may be configured with any suitable dimensions configured to receive, without limitation, the extension portion 72 of the removable portion 70. In some examples, the reusable portion 82 may include a longitudinal opening that extends between the distal end 50 d and the proximal end 50 p and partially exposes the passage defined by the channel 83. For example, the channel 83 may open radially outwardly of the reusable portion 82, as well as at the distal end of the channel 83. In such examples, the channel 83 may include a notch, groove, or slit formed in the outer surface (e.g., the radial outer surface) of the reusable portion 82 longitudinally along the reusable portion 82. That is, channel 83 may be "partially open" to expose a portion of the surface of extension portion 72 of removable portion 70, as shown in Figure 2A (or channel 83 when removable portion 70 is removed, as shown in Figure 2B). However, while partially open, channel 83 is configured to surround extension portion 72 to a sufficient extent / amount to retain removable portion 70, thereby holding extension portion 72 in place (preventing extension portion 72 from passing through a radial opening in reusable portion 82).As a result, the partially open channel may provide a user with the option of inserting the extension portion 72 of the disposable portion 70 through the port 54 and the channel 53 until the disposable portion 70 reaches the distal end 50 d, or the option of inserting the extension portion 72 of the disposable portion 70 at the distal end 50 d and pushing the extension portion 70 into the channel 83 while pushing the extension portion 70 through the proximal end 50 d and the channel 53. The channel 83 may be rigid enough to hold the disposable portion 70 in place, yet flexible enough to allow the disposable portion 70 to be pushed into the channel 83 with sufficient force. The partially open channel 83 may also provide design flexibility in the disposable portion 70 such that the size and shape of the extension portion 72 are not constrained by a closed channel. In other examples, the channel 83 may be closed, thereby surrounding the entire periphery of the extension portion 72 (e.g., the entire periphery if the extension portion 72 has a circular cross-section).

[0024] The cross-sectional shape / size of channel 83 is not particularly limited and may correspond to the cross-sectional shape / size of extension portion 72. In other words, the cross-sectional shape of channel 83 may match / complement / mate with the cross-sectional shape of extension portion 72. In some examples, channel 83 may have a C-shaped, U-shaped, teardrop-shaped, or circular cross-section. Such cross-sections may be suitable for holding or clamping extension portion 172, but are not necessarily limited thereto.

[0025] Distal surface 84 of reusable portion 82 may further include an abutment 86 that defines the contours of the distal opening of channel 83. Abutment 86 may be configured to inhibit further distal translation of removable portion 70 beyond distal surface 84. For example, abutment 86 may include a protrusion that extends inwardly along the periphery of channel 83 such that the distal opening of channel 83 has (a) a smaller circumference than a more proximal portion of channel 83 and (b) a smaller circumference than extension portion 72.

[0026] The removable portion 70 includes an extension portion 72 that can extend the entire length of the channel 83. The material of the extension portion 72 is not limited to, but may include, any suitable biocompatible material. As shown in FIGS. 2C and 2D , the extension portion 72 can include a working channel 75 and a second channel 77. The working channel 75 can be, but is not limited to, any suitable channel configured to receive at least one medical instrument, tool, or accessory. Similarly, the second channel 77 can be, but is not limited to, any suitable channel configured to receive and / or deliver suction, fluid, etc. The extension portion 72 is not necessarily limited to channels 75 and 77 and, in some instances, can include additional lumens or be limited to only one lumen. The relative positions and sizes of the channels 75 and 77 shown in FIGS. 2C and 2D are merely exemplary; any suitable arrangement can be utilized.

[0027] The extension portion 72 may also include an elevator mechanism (not shown) for changing the orientation of a medical instrument inserted within the working channel 75 and / or within another lumen configured to receive the medical instrument. Such an elevator mechanism may be referred to as a swing stand, pivot stand, raising base, or any other suitable term. The elevator mechanism may be pivotable by an actuation wire or other control element (not shown) that extends the entire length of the extension portion 72 (e.g., through a separate lumen in the extension portion 72) and to a corresponding actuator or control (e.g., a lever) (not shown) located on the handle 52 or the removable portion 70.

[0028] In some examples, the removable portion 70 may not have electronics or circuitry, and the removable portion 70 may be disposable after the procedure. The cross-section of the extension portion 72 may be, but is not necessarily limited to, circular, elliptical, teardrop-shaped, oval-shaped, etc. As described above, the cross-sectional shape / size of the extension portion 72 may correspond to the cross-sectional shape / size of the channel 83 such that the extension portion 72 may fit securely within the channel 83. In other words, the extension portion 72 may mate with / be secured to the channel 83.

[0029] As shown in FIGS. 2C and 2D , the extension portion 72 may further include a liner 79 surrounding at least a portion of the outer surface of the extension portion 72. The amount of surface covered by the liner 79 is not particularly limited, and the liner 79 may cover part or all of the circumference of the extension portion 72 and extend part or all of the length of the extension portion 72. The liner 79 may define one or more inflatable chambers. Each of the one or more inflatable chambers may extend longitudinally along the length of the extension portion 72. A proximal portion of the liner 79 may include one or more openings or valves (not shown) configured to receive and / or exhaust air or fluid from an external source. Thus, the extension portion 72 with the liner 79 can transition between a default deflated state, as shown in FIG. 2C , and an inflated state, as shown in FIG. 2D . The extension portion 72 may be inserted into the channel 83 of the reusable portion 82 while in the deflated state, allowing for easier insertion of the extension portion 72 through the port 54 and the channel 83. The extension portion 72 may be expanded while within the channel 83, increasing the pressure between the surface of the channel 83 and the liner 79 to further secure the extension portion 72 within the channel 83. After treatment, the extension portion 72 may be returned to a contracted state while within the channel 83, decreasing the pressure between the surface of the channel 83 and the liner 79, thereby allowing the extension portion 72 to be more easily removed from the channel 83 through the port 54. In other examples, in addition to or instead of the liner 79 surrounding the extension portion 72, an inflatable liner may cover the surface of the channel 83. Such an inflatable liner may function similarly to the liner 79.

[0030] As shown in FIG. 1 , the removable portion 70 may further include a proximal adapter 90. The proximal adapter 90 may be constructed of, but is not limited to, any suitable biocompatible material. In some embodiments, the proximal adapter 90 may be constructed of a material that is softer than the material of the handle 52. The proximal adapter 90 is coupled to the proximal end of the extension portion 72 in any suitable manner. The proximal adapter 90 may be any adapter configured to releasably engage with the port 54 of the handle 52, such as a Y-port adapter (a Y-shaped adapter / port). The proximal adapter 90 may include a first port 92 in fluid communication with the second channel 77, a second port 94 in communication with the working channel 75, and a connecting end 96 configured to releasably couple to the port 54. The port 92 may be configured to receive, but is not limited to, any tubing that connects to a suction or fluid source and may include an additional control or button (not shown) configured to control suction or fluid delivery. Similarly, the port 94 may be configured to receive, without limitation, additional medical tools, instruments, and / or accessories.

[0031] The connection end 96 may also include, without limitation, any suitable mechanism for coupling to the port 54. For example, the connection end 96 may include at least one mating mechanism (not shown) (e.g., a peg of any suitable shape (rectangular, square, etc.)), and the port 54 may include a corresponding mating mechanism (not shown) (e.g., a detent, an opening, a receiving mechanism, etc.) configured to receive the at least one mating mechanism of the end 96. Alternatively, the connection end 96 may include at least one mating mechanism configured to receive the at least one mating mechanism of the port 54. Furthermore, the connection end 96 or the port 54 may include a biasing mechanism (e.g., a spring-locking detent) (not shown) that may be configured to bias the coupling between the connection end 96 and the port 54 into a locked and secured state. In some examples, the proximal adapter may further include an actuator 98 (e.g., a button, a control, etc.) configured to lock and / or release the corresponding mating mechanisms of the connection end 96 and the port 54.

[0032] The extension portion 72 may fit into and extend through the channel 83 via an opening in the port 54. The removable portion 70 may be secured (and locked) to the handle 52 via a coupling between the connecting end 96 and the port 54. The removable portion 70 may also be completely detached from the reusable portion 82 and the handle 52 by releasing the connecting end 96 from the port 54 (in some embodiments, by an actuator 98) and pulling the extension portion 72 from the channel 83 through the port 54. Thus, a user can remove and discard the removable portion 70 after use in a procedure and introduce a new removable portion 70 into the reusable portion 82 and the handle 52 for the next procedure (after cleaning and sterilizing the reusable portion 82 and the handle 52).

[0033] 3A and 3B illustrate another exemplary shaft 50′. The shaft 50′ is similar in many respects to the shaft 50, and like reference numerals (e.g., reusable portion 82′ and reusable portion 82) refer to like parts. Like the shaft 50, the shaft 50′ includes a reusable portion 82′ and a removable portion 70′. The reusable portion 82′ includes a distal surface 84′ that includes various electronic features, including an imaging device (e.g., a camera) 194 and / or a light source feature 192 (e.g., one or more LEDs), and in some embodiments, may not have a channel or lumen configured to receive a medical tool / instrument, suction, or fluid. The reusable portion 82′ further includes a channel 83′ (as shown in FIG. 3B) extending between a distal end 50d′ of the shaft 50′ and a proximal end (not shown) of the shaft 50′. Unlike channel 83 having a U-shaped or C-shaped cross-section, channel 83' may have a round, circular cross-section configured to receive extension portion 72' of removable portion 70'. As shown in FIG. 3B, channel 83 may extend radially inward from the surface of shaft 50', such that channel 83 may be off-center from the central longitudinal axis of shaft 50'.

[0034] The removable portion 70′ includes an extension portion 72′ that can extend the entire length of the channel 83′. Like the extension portion 72, the extension portion 72′ can include a working channel 75′ and a second channel 77′, as well as other additional mechanisms (e.g., an elevator mechanism), but may not have electronics or circuitry. Unlike the extension portion 72, the cross-section of the extension portion 72′ can be round / circular so that it can fit within and extend through the channel 83′, and has a corresponding circular cross-section, as described above. The dimensions (e.g., diameter, cross-sectional area, etc.) of the extension portion 72′ are not particularly limited, and the extension portion 72′ can have any suitable dimensions that correspond to the dimensions of the channel 83′. In some embodiments, the cross-sectional area of ​​the extension portion 72′ can be less than the cross-sectional area of ​​the extension portion 72, or vice versa.

[0035] FIG. 4 illustrates another exemplary medical device system 15 including a medical device 20. The medical device 20 is similar in many respects to the medical device 10, with like reference numerals referring to like parts. Like the medical device 10, the medical device 20 includes a handle 152 and a shaft 150. The handle 152 is similar to the handle 52 and may include first and second actuators 142, 143 that control articulation of the shaft 150. The handle 152 further includes a port 154 for introducing and / or removing tools, fluids, pressure (e.g., vacuum or suction), or other materials from a subject (e.g., a patient) via the disposable portion 182 of the shaft 150. Like the handle 52, the handle 152 may include one or more lumens (not shown) extending between the port 154 and the shaft 150. The one or more lumens may define passageways that communicate with various channels (e.g., a working channel 185 and a second channel 187) of the shaft 150. Handle 152 also includes a port 146 that can be removably connected to umbilical portion 18 for introducing wiring for electronic components disposed at the distal end of shaft 150. Handle 152 includes a lumen 153 that can extend between the opening of port 146 and the proximal opening of channel 183 in shaft 150 (described in further detail below). Lumen 153 can define a passageway of any suitable shape or size through which removable portion 170 can be guided toward channel 183 (described in further detail below). Thus, in some embodiments, umbilical portion 18 can be removed from port 46. Removable portion 170 can then be removed by withdrawing it proximally through the opening of port 146, and the remaining portions of device 20 (e.g., handle 152 and disposable portion 182) can be disposed of.

[0036] Shaft 150 includes disposable portion 182 and detachable portion 170. Disposable portion 182 may extend between distal end 150d and proximal end 150p of shaft 150. Proximal end 150p may be coupled to the distal portion of handle 152 by any suitable means. Proximal end 150p may include one or more openings (not shown) that may communicate with one or more lumens (not shown) extending from shaft 150 to various portions of handle 152 (e.g., port 154, suction / fluid valve (not shown), etc.). Disposable portion 182 may be constructed from, but is not limited to, any suitable biocompatible material. As shown in FIGS. 5A and 5B , unlike shaft 50 of device 10, disposable portion 182 includes working channel 185 and second channel 187. Second channel 187 may be any suitable channel configured to receive and / or deliver suction, fluid, etc. The disposable portion 182 is not necessarily limited to channels 185 and 187, and in some examples, may include additional features (e.g., an elevator mechanism) along with additional lumens or only one lumen. The arrangement of channels 185 and 187 in FIGS. 5A and 5B is merely exemplary, and any suitable arrangement may be utilized. In some examples, the disposable portion 182 may not have electronics or circuitry. The disposable portion 182 may communicate with port 154 through one or more lumens, as shown in FIG. 4. Port 154 may engage adapter 190. The adapter 190 may include, but is not limited to, a first port 292 that may be in fluid communication with second channel 187, a second port 294 that may be in fluid communication with working channel 185, and a connection end 196 that engages port 154. The disposable portion 182, along with the handle 152 and adapter 190, may be disposable after a procedure.

[0037] Disposable portion 182 may further include a longitudinal channel 183 (as shown in FIGS. 5A and 5B ) that may extend between distal end 150 d and proximal end 150 p of shaft 150. Channel 183 may communicate with port 146 via lumen 153, as described above. Channel 183 may have any suitable dimensions configured to receive extension portion 172 of removable portion 170, without being limited thereto. Like channel 83, channel 183 may be “partially open,” as shown in FIGS. 5A and 5B and described above with respect to channel 83, but may be configured to encircle extension portion 172 to a sufficient extent / amount to hold removable portion 170 in place (prevent extension portion 172 from passing through a radial opening in disposable portion 182). In other examples, channel 183 may be closed, thereby encircling the entire circumference of extension portion 172. The cross-section of channel 183 is also not particularly limited and may correspond to the cross-section of extension portion 172. As shown in FIG. 5A , channel 183 may have a round circular cross-section, but is not necessarily limited thereto. The cross-sectional shape of channel 183 may match / complement / mate with the cross-sectional shape of extension portion 172. In other examples, channel 183 may have a C-shaped, U-shaped, or teardrop-shaped cross-section, which may be suitable for holding or clamping extension portion 172. Similar to reusable portion 82, distal surface 184 of disposable portion 182 may further include an abutment 186 that defines the contour of the distal opening of channel 183. This abutment is configured to prevent further distal translation of removable portion 170 beyond distal surface 184. For example, the abutment portion 86 may include a protrusion that extends inwardly around the periphery of the channel 183 such that the distal opening of the channel 183 has (a) a smaller circumference than the more proximal portion of the channel 183 and (b) a smaller circumference than the extension portion 172.

[0038] The removable portion 170 includes an extension portion 172 that can extend within the umbilical portion 18 the length of the channel 183 and the length of the lumen 153 of the handle 152. The material of the extension portion 172 is not particularly limited and can include any suitable biocompatible material. As shown in FIG. 4, the extension portion 172 can include a distal surface 174 that includes various electronic mechanisms, including one or more imaging devices (e.g., cameras) 194 and / or light source mechanisms 192 (e.g., LEDs). The relative positions and sizes of the imaging devices 194 and light source mechanisms 192 shown in FIG. 5A are exemplary only, and any suitable arrangement can be utilized. The various cables / wiring associated with each of the imaging devices 194 and light source mechanisms 192 can extend the entire length of the extension portion 172. 5A may not have channels or lumens configured to receive medical tools / instruments, suction, or fluids so that extension portion 172 can be easily cleaned, sterilized, and reused after a procedure. In some examples, an inflatable liner may cover a surface of extension portion 172 (similar to a surface of extension portion 72 shown in FIGS. 2C and 2D ) and / or a surface of channel 183 to aid in securing extension portion 172 within channel 183 or removing extension portion 172 from channel 183.

[0039] Unlike extension portion 72, extension portion 172 may fit into and extend through channel 183 via the opening of port 146. The distal end of removable portion 170 may be secured by abutment 186. The proximal portion of removable portion 170 may extend into umbilical portion 18. The proximal portion of removable portion 170 may also be coupled to any unit, processor, etc. capable of supporting the various electronic mechanisms present on distal face 174. Removable portion 170 may also be completely detached from disposable portion 182 and handle 152 by pulling extension portion 172 through port 146, out of channel 183, lumen 153, and umbilical portion 18. Thus, a user can remove removable portion 170 after use in a procedure and clean and sterilize removable portion 170 for reuse. The disposable portion 182 and handle 152 can be disposed of after use in a procedure, and the sterilized removable portion 170 can be inserted into a new disposable portion 182 and handle 152 for a subsequent procedure.

[0040] FIG. 6A illustrates another exemplary medical device system 25 including a medical device 30. The medical device 30 is similar in some respects to the medical device 10, and like reference numerals refer to like parts where possible. The medical device 30 may include a reusable portion 32 and a disposable portion 270. Like the medical device 10, the reusable portion 32 of the medical device 30 includes a handle 252 and a shaft 250. The handle 252 is similar to the handle 52 and may include first and second actuators 242, 243 that control articulation of the shaft 250. The handle 252 also includes a port 246 that may be fixedly or removably connected to the umbilical portion 28 for introducing wiring for electronic components disposed at the distal end of the shaft 250. Like the handle 52, the handle 252 may include one or more lumens (not shown) extending between the port 246 and the shaft 250. The one or more lumens may define passageways that communicate with various channels (not shown) of the shaft 250. The one or more lumens may accommodate various cables, wires, circuits, etc. that extend within umbilical portion 28 and through port 246 .

[0041] The handle 252 includes a recess or cavity 254 extending between the proximal portion 256a and the distal portion 256b of the handle 252. The cavity 254 may have any suitable size and / or shape configured to receive at least a portion of the disposable portion 270, without limitation. For example, as shown in FIG. 6A , the cavity 254 may receive the body 271 of the disposable portion 270. Furthermore, the cavity 254 may be partially open or exposed so that a portion of the disposable portion 270, e.g., the body 271, is visible and accessible to a user when the portion is within the cavity 254. As shown in FIG. 6A , the cavity 254 may have a longitudinal axis that extends generally parallel to or coaxial with the central longitudinal axis of the handle 252 / shaft 250. The cavity 254 has a generally square or rectangular cross-section perpendicular to the longitudinal axis of the cavity 254, with two sides of the cavity being open. The walls of cavity 254 may have a generally "L" shape at the cavity 254 portion. The proximal portion of handle 252 may include a proximal opening or proximal passageway 257 extending from one side of handle 252 to the other. Proximal passageway 257 may have a longitudinal axis extending transversely relative to the central longitudinal axis of handle 252 and shaft 250. Proximal passageway 257 may be configured to provide a passageway for cable 279 extending from the proximal portion of disposable portion 270. An opening 258 of passageway 257 through which cable 279 extends may be adjacent port 246, such that umbilical portion 28 and cable 279 extend generally perpendicularly away from handle 252. As shown in FIG. 6A , proximal passageway 257 may be fluidly connected to cavity 254, forming a continuous passageway or space. Like cavity 254, passageway 257 may also be partially open or exposed. Thus, passageway 257 may expose cable 279, allowing a user to view and access cable 279. For example, as shown in FIG. 6A , passageway 257 has a generally square or rectangular cross section perpendicular to the longitudinal axis of passageway 257, with one side of the cavity open. The walls of passageway 257 may have an angular "U" shape.

[0042] The proximal portion of the handle 252 may further include, but is not necessarily limited to, a lip 260 configured to protrude toward / into the cavity 254. The lip 260 may be, but is not limited to, any suitable lip configured to engage a corresponding surface or ridge 713 of the body 271, such that the lip 260 and ridge 713 may form, but are not limited to, a snap-fit ​​connection between the handle 252 and the disposable portion 270. However, the connection between the handle 252 and the disposable portion 270 is not limited to a snap-fit ​​connection, and the handle 252 and the disposable portion 270 may each include features for any suitable coupling means (e.g., friction fit, hooks, latches, etc.).

[0043] The distal portion of the handle 252 may include an opening or passageway 532 that leads to the channel 283 of the shaft 250. The opening 532 may have any suitable shape and / or size configured to receive the extension portion 272 of the disposable portion 270, including, but not limited to, the opening 532. For example, the opening 532 may have a diameter equal to or approximately equal to the diameter of the channel 283 that receives the extension portion 272, as described below.

[0044] Shaft 250 is similar to shaft 50 and, in some instances, may be identical to shaft 50, such that shaft 250 may include all of the features described above with respect to shaft 50. For example, like shaft 50, shaft 250 includes a reusable portion 282 extending between distal end 250d and proximal end 250p, and a disposable portion 270. Proximal end 250p may be coupled to the distal portion of handle 52 by any suitable means and connects with an opening 532 in handle 252. Reusable portion 282 may include a distal face (not shown) that includes various electronic features, including an imaging device (e.g., a camera) and / or a light source feature (e.g., an LED). Various cables / wiring associated with the electronics may extend throughout the length of reusable portion 282 and may extend through openings in proximal end 250p and one or more lumens (not shown) or cavities 254 in handle 252 toward port 246 and umbilical 28. In some examples, reusable portion 282 may not have a channel or lumen configured to receive a medical tool / instrument, suction, or fluid so that reusable portion 282 (along with handle 252) can be easily cleaned, sterilized, and reused. Reusable portion 282 includes longitudinal channel 283, which may have any suitable dimensions, configured to receive extension portion 272 of disposable portion 270. Similar to channel 283, channel 283 may open radially outward, as well as at the distal end of channel 283. In some examples, the sides of channel 283 may open along the entire length of reusable portion 250 between proximal end 282p and distal end 250d. As a result, the partially open channel may provide the user with the option of inserting the extension portion 272 of the disposable portion 270 into the cavity 254 of the handle 252 and pushing the disposable portion 270 through the channel 283 until it reaches the distal end 270d, or inserting the extension portion 272 of the disposable portion 250 at the distal end 250d and pushing the extension portion 272 into the channel 283 and into the body 271 of the cavity 254.Alternatively, the extension portion 272 can be inserted through the open side of the channel 283 rather than advancing the extension portion 272 proximally or distally. The channel 283 can be rigid enough to hold the disposable portion 270 in place, yet flexible enough to allow the disposable portion 270 to be pushed into the channel 283 with sufficient force. Also, a partially open channel 283 can provide design flexibility in the disposable portion 270 such that the size and shape of the extension portion 272 are not constrained by a closed channel. However, in other examples, the channel 283 can be closed, thereby surrounding the entire periphery of the extension portion 272 (e.g., the entire periphery if the extension portion 272 has a circular cross-section).

[0045] Similar to disposable portion 70, disposable portion 270 may not have electronics or circuitry, and disposable portion 270 may be disposable after the procedure. Disposable portion 270 includes a body 271 that is received by cavity 254 and an extension portion 272 that may extend the entire length of channel 283.

[0046] The body 271 may have any suitable shape or size configured to be received within the cavity 254 of the handle 252. The body 271 includes a port 274. The port 274 may be any suitable port, such as a Y-port, including an opening 274a for introducing and / or removing a tool or other material from a subject (e.g., a patient), without limitation. The body 271 may include a lumen (not shown) that may extend between the opening 274a of the port 274 and a proximal opening of the channel in the extension portion 272. The proximal portion of the body 271 may further include at least one cable 279 and additional controls or buttons 721, 723. The buttons 721, 723 may be used, for example, to control fluids (e.g., air, water, or suction) and / or electronics (e.g., light brightness, imaging, or other mechanisms). The cable 279 may include, but is not limited to, one or more channels configured to receive fluid and / or pressure (e.g., negative pressure or suction) from a fluid and / or pressure source and / or wire / cable. Thus, the cable 279 may extend between a proximal portion of the body 271 (which may therefore pass through the proximal passageway 257 of the handle 252) and a fluid and / or pressure source. One or more channels of the cable 279 may be in fluid communication with one or more lumens (not shown) of the body 271, which may extend between a distal opening (not shown) of the cable 279 and a proximal opening of a corresponding channel extending the length of the extension portion 272. The controls 721, 732 may be, but are not limited to, any suitable actuators or valves configured to control the delivery of suction or fluid to the distal end of the extension portion 272.

[0047] Elongated portion 272 can be similar to or identical to elongated portions 72, 72′, without being limited thereto. Like elongated portion 72, elongated portion 272 can include an elevator mechanism (not shown) for redirecting a medical instrument inserted within a channel of elongated portion 272. This elevator mechanism can be pivotable by an actuation wire or another control element (not shown) that extends the entire length of elongated portion 272 (e.g., through a separate lumen in elongated portion 272) and to a corresponding actuator located on handle 252 or body 271 of removable portion 270.

[0048] 6B and 6C show an exemplary actuation mechanism of the elevator mechanism. As shown in FIG. 6B, the removable portion 270 may further include a slider 740 on the main body 271. The slider 740 includes a through-hole 742 configured to receive a corresponding actuation peg, such as peg 249. The slider 740 may extend / be movable in the same longitudinal direction as the longitudinal axis of the main body 271 and may be located on a surface 271a of the main body 271 adjacent to a surface 252a of the handle 252, which may be the inner surface of the handle 252 (e.g., a wall of the cavity 254). An outer surface 252b of the handle 252 may include a lever 247 (described in further detail below). The surfaces 252a and 252b may be the inner and outer surfaces, respectively, of the same side of the handle 252. Slider 740 may be an actuatable mechanism coupled to or engaging an actuation wire or another control element associated with an elevator mechanism of extension portion 720. Slider 740 may be any suitable mechanism configured to translate in a first direction (e.g., proximally) and a second direction (e.g., distally), as represented by the directions of the arrows shown in FIG. 6B, without being limited thereto. Additionally, slider 740 may be biased toward one direction by any suitable mechanism (e.g., a spring bias). For example, when slider 740 translates in a first direction, the elevator mechanism may orient the medical instrument within extension portion 272 in a first orientation, and when slider 740 translates in a second direction (opposite the first direction), the elevator mechanism may orient the medical instrument in the second orientation. In some embodiments, moving slider 740 in a first direction may cause the elevator to rise, and moving slider 740 in a second direction may cause the elevator to fall.

[0049] The handle 252 includes an actuator configured to engage the slider 740. The actuator may be, for example, but is not limited to, a lever 247. The lever 247 may be located on the side of the handle 252 that includes the actuators 242 and 243 for ergonomic reasons, but is not necessarily limited to this. The actuators 242 and 243 may be knobs. The lever 247 is coupled to a peg 249 that may extend through the wall of the handle 252 to the inner surface 252a, as shown in FIGS. 6B and 6C. Furthermore, the peg 249 may reside within a longitudinal slot 259 that extends in the same direction as the slider 740. The length of the slot 259 may correspond to, but is not limited to, the distance the slider 740 may translate in the first and second directions. Furthermore, the peg 249 may translate within the slot 259 upon actuation of the lever 247, as represented by the direction of the arrow shown in FIG. 6C. The direction of translation of peg 249 can correspond to the direction of translation of slider 740 so that when peg 249 is engaged within through-hole 742, translation of peg 249 simultaneously translates slider 740, thereby actuating the elevator mechanism.

[0050] It will be apparent to those skilled in the art that various modifications and variations can be made in the disclosed apparatus without departing from the scope of the present disclosure. Other embodiments of the present disclosure will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only, with the true scope and spirit of the invention being indicated by the following claims.

Claims

1. A medical device comprising: a handle containing a port; a shaft extending distally from the handle, the shaft including a channel extending along at least a portion of the length of the shaft, the channel including a longitudinal opening on a radially outer surface of the shaft; a removable portion extending through the channel, the removable portion including a first lumen and configured to be separable from the handle and the shaft; A medical device comprising:

2. The medical device of claim 1 , wherein the channel of the shaft is off-center from a central longitudinal axis of the shaft.

3. The medical device of claim 2 , wherein the channel is configured to prevent the removable portion from passing through the longitudinal opening of the channel.

4. The medical device of any one of claims 1 to 3, wherein the longitudinal opening of the channel comprises a notch, groove, or slit extending along the entire length of the shaft.

5. 5. The medical device of claim 1, wherein the shaft includes a distal end, the distal end including an abutment that defines a distal opening of the channel, the abutment configured to prevent distal translation of the detachable portion beyond the distal end.

6. The medical device of any one of claims 1 to 5, wherein the removable portion comprises a second lumen.

7. The medical device of any one of claims 1 to 6, wherein the removable portion comprises the first lumen and the second lumen.

8. The medical device of any one of claims 1 to 7, wherein the removable portion includes a proximal adapter, the proximal adapter including a first port in fluid communication with the first lumen of the removable portion.

9. The medical device of claim 8 , wherein the proximal adapter is configured to releasably engage the port of the handle.

10. The medical device of claim 9 , wherein the proximal adapter includes an actuator configured to release the proximal adapter from the port of the handle.

11. 11. The medical device of claim 9 or 10, wherein the proximal adaptor is a y-shaped adaptor including the first port of the proximal adaptor and a second port of the proximal adaptor.

12. The medical device of any one of claims 1 to 11, wherein the first lumen includes an elevator configured to adjust the orientation of a tool or instrument inserted within the first lumen.

13. The medical device of any one of claims 1 to 12, wherein the removable portion has a generally teardrop-shaped cross section.

14. 14. The medical device of claim 1, wherein the removable portion includes a second lumen, and wherein only the removable portion is configured to receive fluid through the first lumen and / or the second lumen.

15. 15. The medical device of any one of claims 1 to 14, wherein the detachable portion is configured to be completely removed from the handle and shaft by pulling the detachable portion proximally from the port in the handle.

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