Multi-channel flexible ureteroscope
By designing a multi-channel flexible ureteroscopy system, using the combination of external channels and coupling mechanisms, the problems of small-diameter restriction of working channels and poor operability of dual-channel systems in the prior art are solved, and a more efficient medical device passage and object extraction effect is achieved.
Patent Information
- Application Number
- CN201980054792.1
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Priority Date
- 2018-09-24
- Filing Date
- 2019-08-15
- Publication Date
- 2025-05-16
- Estimated Expiration
- 2039-08-15
AI Technical Summary
Due to the limitation of the working channel diameter, existing single-channel flexible ureteroscopes are difficult to pass multiple medical devices at the same time or effectively extract larger objects, and the dual-channel flexible ureteroscopes have poor operability and high cost.
A multi-channel flexible ureteroscope system is designed, including a handle, an elongated shaft, an external channel and a coupling mechanism. The external channel has a size to receive the inner diameter of the medical device and is connected to the elongated shaft through a coupling mechanism to realize the function of the multi-channel.
The system can use multiple medical devices at the same time, improve operational flexibility and efficiency in a small space, and effectively solve the problem of extracting larger objects and reduce operating costs.
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Figure CN112584736B_ABST
Abstract
Description
[0001] CROSS-REFERENCE TO RELATED APPLICATIONS
[0002] This disclosure claims priority to U.S. Provisional Patent Application Serial No. 62 / 735,721, filed on September 24, 2018, the disclosure of which is incorporated herein by reference. Technical Field
[0003] The present disclosure generally relates to devices and related systems and methods for retrieving objects from a living subject. Background Art
[0004] Single channel flexible ureteroscopes typically have a working channel with a small diameter (about 3.6 French (F) or about 0.47 inches). This small diameter limits the size or number of devices that can fit through the working channel, as well as the size of objects (e.g., stone fragments) that can be extracted while the device (i.e., a laser fiber used to break up kidney stones using laser energy) remains within the working channel. Typically, the laser fiber must be removed from the channel before suction is applied through the working channel to extract the stone fragments. The laser fiber must then be reintroduced into the working channel to continue breaking up the kidney stone.
[0005] Dual-channel flexible ureteroscopes are available but are generally not as efficient as single-channel flexible ureteroscopes. For example, dual-channel flexible ureteroscopes are often less maneuverable and provide poorer visualization due to the additional space in the ureteroscope shaft dedicated to the second channel. Additionally, dual-channel ureteroscopes are more expensive to acquire and maintain. Summary of the invention
[0006] The present disclosure relates to a ureteroscope system, which includes: a handle configured to be retained outside the body; an elongated shaft extending from the handle to a distal end and including a working channel, the working channel being open at the distal end of the shaft, the shaft being configured to be inserted through a body lumen to a target surgical site; an external channel extending from a proximal end to a distal end and configured to be coupled to the elongated shaft, the external channel including a proximal hub and a tube extending distally from the hub and defining a second channel therein, the second channel having an inner diameter sized to receive a medical device therethrough; and a coupling mechanism defining a first tube and a second tube and configured to couple the distal end of the external channel to the distal end of the elongated shaft, the first tube defining a first lumen and the second tube defining a second lumen, the second lumen being sized and shaped to receive the distal end of the external channel, the proximal portion of the first tube being sized and shaped to be inserted into the distal portion of the elongated shaft so that the lumen leads to the working channel.
[0007] In one embodiment, the system further includes an end cap coupled to the distal end of the elongated shaft, the end cap including a channel extending therethrough such that when the end cap is coupled to the elongated shaft, the end cap channel opens into the working channel.
[0008] In one embodiment, the diameter of the end cap channel is substantially the same as the inner diameter of the working channel.
[0009] In one embodiment, the coupling mechanism includes an engagement feature configured to cooperate with an engagement feature on an inner wall of the end cap channel to lock the coupling mechanism to the end cap.
[0010] In one embodiment, the coupling mechanism is one of a barb or a thread.
[0011] In one embodiment, the tube of the outer passage has an inner diameter of approximately 3 French.
[0012] In one embodiment, the system further includes a clamp configured to couple the outer channel to the proximal portion of the shaft, the clamp including a first slotted channel and a second slotted channel, each of the first slotted channel and the second slotted channel configured to receive one of the shaft and the outer channel therethrough.
[0013] In one embodiment, the outer channel is slidable relative to the clamp.
[0014] The present disclosure also relates to a debris removal system, which includes a scope assembly, the scope assembly including: a handle, which is configured to be retained outside the body; an elongated shaft, which extends from the handle to a distal end and includes a working channel, the working channel is open at the distal end of the shaft, the shaft is configured to be inserted through a body lumen to a target surgical site; an external channel, which extends from the proximal end to the distal end and is configured to be coupled to the elongated shaft, the external channel including a proximal hub and a tube extending distally from the hub and defining a second channel therein, the second channel having a sized The outer channel has an inner diameter of 1.5 to 1.5 inches to receive a medical device therethrough; and a coupling mechanism defining a first tube and a second tube and configured to couple the distal end of the outer channel to the distal end of the elongated shaft, the first tube defining a first lumen and the second tube defining a second lumen, the first tube being configured to couple to the elongated shaft and the second lumen being configured to couple to the outer channel; a medical device assembly configured to couple to the endoscope assembly via the hub of the outer channel, the medical device assembly including a medical device configured to be inserted through the outer channel into a target surgical site.
[0015] In one embodiment, the medical device assembly is a laser fiber assembly including a valve seal at a proximal end thereof configured to mate with a proximal end of the hub to seal the laser fiber assembly to the scope assembly.
[0016] In one embodiment, the distal end of the elongated shaft is sized and shaped for insertion into a first lumen of a first tube of the coupling mechanism, and the distal end of the outer channel is sized and shaped for insertion into a second lumen of a second tube.
[0017] In one embodiment, the first and second tubes of the coupling mechanism are slotted clamps, the first slotted clamp is configured to snap onto the distal end of the outer channel, and the second slotted clamp is configured to snap onto the distal end of the outer channel.
[0018] In one embodiment, the system further includes an end cap coupled to the distal end of the elongated shaft, the end cap including a channel extending therethrough such that when the end cap is coupled to the elongated shaft, the end cap channel opens into the working channel.
[0019] In one embodiment, the system further includes a clamp configured to couple the outer channel to the proximal portion of the shaft, the clamp including a first slotted channel and a second slotted channel, each of the first slotted channel and the second slotted channel configured to receive one of the shaft and the outer channel therethrough.
[0020] In one embodiment, the system further includes a vacuum source connected to the working channel via the handle and configured to apply suction through the working channel to vacuum debris from the target surgical site through the working channel.
[0021] The present disclosure also relates to a method for removing debris from a target surgical site, comprising: inserting a distal portion of a scope assembly into a target lumen, the distal portion of the scope assembly comprising: an elongated shaft extending from a handle to a distal end and comprising a working channel, the working channel being open at the distal end of the shaft, the shaft being configured to be inserted through a body lumen into the target surgical site; an external channel extending from a proximal end to a distal end and configured to be coupled to the elongated shaft, the external channel comprising a proximal hub and a tube extending distally from the hub and defining a second channel therein, the second channel having an inner diameter sized to receive a medical instrument therethrough; and a coupling mechanism , which defines a first tube and a second tube and is configured to connect the distal end of the outer channel to the distal end of the slender shaft, the first tube defines a first lumen and the second tube defines a second lumen, the second lumen is sized and shaped to receive the distal end of the outer channel, the proximal portion of the first tube is sized and shaped to be inserted into the distal portion of the slender shaft so that the lumen leads to the working channel; inserting a medical device through the outer channel until the distal end of the medical device enters the target surgical site, the medical device being configured to decompose debris in the target surgical site; and vacuuming the debris from the target surgical site through the working channel via a vacuum pump fluidly connected to the slender shaft.
[0022] In one embodiment, the method further includes inserting a guidewire into the body lumen to the target surgical site, and guiding the distal portion of the scope assembly to the target surgical site via the guidewire.
[0023] In one embodiment, the medical device is a laser fiber assembly including a valve seal at a proximal end thereof configured to mate with a proximal end of a hub to seal the laser fiber assembly to the scope assembly.
[0024] In one embodiment, the method further includes coupling an end cap to the distal end of the elongated shaft, the end cap including a channel extending therethrough such that the end cap channel opens into the working channel when the end cap is coupled to the elongated shaft.
[0025] In one embodiment, the method further comprises injecting fluid via the fluid source through the external channel to irrigate the target surgical site.
[0026] The present disclosure also relates to a ureteroscope system, which includes: a handle, which is configured to be retained outside the body; a slender shaft, which extends from the handle to a distal end and includes a working channel, which is open at the distal end of the shaft, and the shaft is configured to be inserted through a body lumen to a target surgical site; an external channel, which extends from a proximal end to a distal end and is configured to be connected to the slender shaft, the external channel including a proximal hub and a tube extending distally from the hub and defining a second channel and a third channel therein, each of the second channel and the third channel having an inner diameter sized to receive a medical device passing therethrough; and a coupling mechanism, which defines a first tube and a second tube and is configured to connect the distal end of the external channel to the distal end of the slender shaft, the first tube defining a first lumen and the second tube defining a second lumen, the second lumen being sized and shaped to receive the distal end of the external channel, and the proximal portion of the first tube being sized and shaped to be inserted into the distal portion of the slender shaft so that the lumen leads to the working channel.
[0027] In one embodiment, the second tube has a substantially elliptical inner profile configured to match the substantially elliptical outer profile of the outer passage.
[0028] In one embodiment, a second channel of the outer channel is sized and shaped to receive a laser fiber, and a third channel of the outer channel is sized and shaped to receive a retrieval basket. BRIEF DESCRIPTION OF THE DRAWINGS
[0029] Figure 1 shows a side view of a ureteroscopic system according to an exemplary embodiment of the present disclosure;
[0030] Figure 2 Shows Figure 1 Magnified side view of the distal portion of the ureteroscope system;
[0031] Figure 3 The first exemplary embodiment is shown. Figure 1 A perspective view of the end cap of a ureteroscope;
[0032] Figure 4 The second exemplary embodiment is shown. Figure 1 A perspective view of the end cap of a ureteroscope;
[0033] Figure 5 According to the third exemplary embodiment, Figure 1 A front view of the end cap of the ureteroscope;
[0034] Figure 6 shows a side view of a ureteroscopic system with a laser fiber assembly according to an exemplary embodiment of the present disclosure;
[0035] Figure 7 shows a perspective view of a ureteroscopic system according to a second exemplary embodiment of the present disclosure;
[0036] Figure 8 The first exemplary embodiment is shown. Figure 7 A perspective view of an end cap tube of a system;
[0037] Fig. 9 The second exemplary embodiment is shown. Figure 7 A perspective view of an end cap and an end cap tube of a system;
[0038] Fig.10 The first exemplary embodiment is shown. Figure 1 A perspective view of a connector of the system;
[0039] Fig.11 The second exemplary embodiment is shown. Figure 1 A perspective view of a connector of the system;
[0040] Fig.12 According to the third exemplary embodiment, Figure 1 A perspective view of a connector of the system; and
[0041] Fig.13 The fourth exemplary embodiment according to the present invention is shown. Figure 1 A perspective view of a connector of a system. DETAILED DESCRIPTION
[0042] The present disclosure may be further understood with reference to the accompanying drawings and the following description, in which like elements are indicated by like reference numerals. The present disclosure relates to ureteroscopic devices and methods for decomposing and extracting objects from a living body. Specifically, the present disclosure relates to a multi-channel flexible ureteroscope having an internal working channel and at least one external working channel. In some embodiments, the external channel may be coupled to or removably coupled to an existing flexible single-channel ureteroscope. In other embodiments, the external channel and one or more accessories may be coupled to a disposable or reusable ureteroscope. In some embodiments, the accessory may be an elongated medical device, such as, for example, a laser fiber, a retrieval device, a guidewire, an injection catheter, a drainage catheter, a dilatation balloon catheter, etc., or any combination thereof. It should be noted that, as used herein, the terms "proximal" and "distal" are intended to refer to the direction toward (proximal) and away from (distal) the user (e.g., physician) of the device.
[0043] Figure 1 A ureteroscope system 100 is depicted in accordance with an exemplary embodiment of the present disclosure. The system 100 includes an external channel 108 and a scope assembly 102, which includes a handle 104 and a shaft 106 that are retained outside the living body. The shaft 106 and external channel 108 provide access to a body lumen (e.g., along a tortuous path of a natural body lumen entered via a naturally occurring body orifice). The scope assembly 102 can be a ureteroscope (e.g., Boston Scientific's LithoVue TM single-use digital flexible ureteroscope), endoscope, hysteroscope, bronchoscope, cystoscope, or any other similar device.
[0044] exist Figure 1-2 In the exemplary embodiment shown in , a scope assembly 102 (such as, for example, a ureteroscope) applies vacuum pressure to a target cavity to extract debris (such as kidney stone fragments or dust) from the target cavity into the scope assembly 102 for removal from the body. As described above, the scope assembly 102 includes a scope shaft 106, which is sized and shaped to be inserted into the target cavity through a body lumen. The shaft 106 has an inner diameter that defines a working channel 110. In an exemplary embodiment, the working channel 110 has a diameter of 3.6F, wherein the shaft 106 has an outer diameter of approximately 9.5F, so that the shaft 106 can pass through small lumens in the human body, as understood by those skilled in the art. The shaft 106 extends from a proximal end 112 connected to a distal end 114 of the handle 104 to a distal end 116 connected to an end cap 118, which will be described in further detail below. As Figure 1As shown, the endoscope assembly 102 can be connected to a vacuum pump (not shown) via a supply line (i.e., a pipeline). The pipeline (not shown) can be connected to a T-connector 120 through the handle 104, and the T-connector is in fluid communication with the working channel 110. Therefore, the vacuum pump provides a vacuum pressure source to a target cavity leading to a target site in the living body through the pipeline and the working channel 110 of the shaft 106, and the distal end of the shaft 106 is positioned at the target site. In an exemplary embodiment, the endoscope assembly 102 may include at least one sensor incorporated therein. For example, in one embodiment, the endoscope 106 includes a camera 124, which is used to visualize the target lumen or target cavity into which the shaft 106 is inserted. The endoscope assembly 102 according to this embodiment also includes a light source 125 for illuminating the body cavity, such as Figure 3 In one embodiment, the handle 104 allows the user to control the vacuum pump and / or sensor via an on / off switch. For example, the handle 104 may include a vacuum on / off button (not shown) so that the user has the discretion to turn on the vacuum when debris, fluid, etc. are in the target cavity and to turn off the vacuum when suction is not necessary.
[0045] External channel 108 (such as Figure 1 118 (shown in the accompanying drawings) includes an elongated tube 126 and a proximal hub 128. The elongated tube 126 extends from a proximal end 130 coupled to a distal end of a hub 130 (in this embodiment) to a distal end 132 coupled to an end cap 118. The tube 126 can be made of a polymer such as, for example, polyimide, PTFE, nylon, PE, and in this embodiment, is reinforced with a braid or coil. The tube 126 defines a second channel 134 extending through the tube from the hub 128 to the distal end 132. The second channel 134 has an inner diameter of approximately 3F or less to accommodate medical devices such as laser wires of approximately 3F or less. In another embodiment, the second channel 134 can be sized and shaped to allow fluid to flow from the hub 128 to the distal end 132. As from Figure 1-2 As can be seen in the figure, the second channel 134 of the tube 126 is smaller than the working channel 110 of the shaft 106 to manage channel efficiency and minimize the outer profile of the endoscope assembly 102. However, those skilled in the art will understand that the second channel 134 can be sized and shaped as needed to meet the specific needs of different procedures. For example, the second channel 134 can be configured as a flat or oval low-profile tube to accommodate a circular laser fiber so that a fluid can be injected into the gap space between the laser fiber and the inner wall of the second channel 134. In another example, the second channel 134 can have a larger diameter similar to the working channel 110 and can be used to discharge debris or stone dust. In this embodiment, the second channel 134 is connected to the vacuum pump 120 instead of the working channel 110.
[0046] The tube 126 is coupled to the hub 128 via a connector 136 at the proximal end of the tube 126. For example, in one embodiment, the connector 136 is a medical female Luer connector. The hub 128 is substantially tubular, thereby defining an internal lumen 135 that communicates with the second channel 134, and is configured to fit within the clamp 140. Specifically, the hub 128 is fixedly connected to the proximal portion 138 of the shaft 106 via the clamp 140. The clamp 140 includes a first slotted channel and a second slotted channel 141, 143, which are configured to be removably snapped onto the hub 128 and the shaft 106, respectively, so that the external channel 108 can be removed from the scope assembly 102 as needed. The outer diameter of the hub 128 is sized so that the hub 128 can slide proximally or distally within the clamp 140 along the longitudinal axis of the first slotted channel 141 to allow for adjustment of the length of the outer channel 108 during distal deflection of the scope assembly 102. In one embodiment, the proximal end of the hub 128 is configured to receive a medical device such as a laser fiber. The hub 128 can also be connected to a fluid source to allow fluid to flow in the interstitial space between the laser fiber and the inner wall of the second channel 134. However, in another embodiment, the hub 128 can be connected to a vacuum pump 120 to provide suction through the second channel 134 for vacuuming debris from the target cavity.
[0047] It should be understood that while the clamp 140 of the present embodiment is configured to couple to the shaft 106 and the hub 128, the clamp 140 can be modified to couple the external channel 108 to the scope assembly 102 or any other component in any desired manner. For example, in one embodiment, the clamp 140 can be mounted on the handle 104, thereby coupling the external channel 108 thereto. In another example, the clamp 140 can be configured to couple the shaft 106 to the shaft of an accessory medical device. In addition, the slotted channels 141, 143 can be sized and shaped to receive any size of the shaft 106, the external channel 108, etc. For example, in one embodiment, the first slotted channel 141 can be sized and shaped to accommodate two hubs instead of one.
[0048] The distal end 132 of the tube 126 is coupled to the shaft 106 via an end cap 118. The end cap 118 allows for a low profile attachment of the tube 126 to the shaft 106. The distal end 132 is connected to the end cap 118 via a distal coupler or end cap tube 142, such as Figure 214, thereby defining an end cap tube channel 144. The end cap tube 142 is sized and shaped to be received in the lumen 146 of the end cap 118 to serve as an extension of the working channel 110. Specifically, the outer diameter of the end cap tube channel 144 is substantially equal to the inner diameter of the end cap lumen 146, and the inner diameter of the end cap tube channel 144 is substantially equal to the inner diameter of the working channel 110. Therefore, the lumen 146 is in communication with the working channel 110 so that when the end cap tube 142 is inserted therein, the end cap tube channel 144 leads to the working channel 110. In another embodiment, the end cap tube 142 has external self-tapping threads on its proximal portion that are configured to be threaded into the inner wall of the end cap lumen 146. In one embodiment, the end cap tube 142 includes a barb 143 or taper at its proximal end that is configured to engage the inner dimensions of the end cap lumen 146, thereby providing an interference fit between the two components. In another exemplary embodiment, the end cap tube 142 may be press-fit, insert molded, or integrally molded with the end cap 118. Figure 1-2 As shown, the tube 126 is connected to the end cap tube 142 via a connecting tube 148. The connecting tube 148 can be, for example, a heat shrink tube through which the distal end 132 of the tube 126 is inserted. Figure 4 , the connecting tube 148 can be positioned anywhere on the exterior surface of the end cap tube 142, such as, for example, on the side of the end cap tube 142 opposite the hub 128. In another embodiment, the tube 126 can be glued to the connecting tube 148. In another exemplary embodiment, the tube 126 can be heat shrunk directly to the distal portion of the shaft 106 using a thin wall heat shrink tubing in the range of 0.125 inches in diameter having a wall having a thickness of approximately 0.001 inches.
[0049] When coupled to the end cap tube 142, the distal end of the tube 126 can be disposed proximal to the distal end of the end cap tube 142. Thus, the length D of the end cap tube 142 extending from the end cap 118 can be the focal length of the camera 124, such that the distal end of the end cap tube 142 is visible to the user in the field of view of the camera 124. In one embodiment, the end cap 118 and the end cap tube 142 are formed of a clear or transparent polymer to allow greater visibility to the camera 124. In one embodiment, the end cap tube 142 can also be used as a nozzle to reach deep into a body lumen, such as, for example, a renal calyx, to aspirate or blow out stone fragments. In another embodiment, the end cap tube 142 is capable of collapsing / retracting a sheathless self-expanding retrieval basket inserted therein.
[0050] Figure 4-5Another exemplary end cap 118' is depicted. In this embodiment, the end cap 118' includes a slotted clamp 148' formed on its outer wall and sized and shaped to receive the distal end 132 of the tube 126. The tube 126 of the outer passage 108 can be installed or glued into the lumen 149' of the slotted clamp 148' in place of the end cap tube. This configuration will result in a similarly sized outer profile to that achieved by the end cap 118 and end cap tube 142 of the scope assembly 102.
[0051] Figure 6 An exemplary method of assembling a ureteroscope system 100 is depicted, wherein the system 100 uses a laser fiber assembly 150 capable of simultaneously breaking up and expelling stone fragments. The laser fiber assembly 150 includes a proximal seal assembly 160 (such as a Touhy-Borst valve), a side port 162, a proximal plug connector 164, and a laser fiber 166. It is understood that although the present embodiment describes the use of the laser fiber assembly 150, any medical device may be used, such as, for example, a guidewire, a retrieval device, a cauterization device, a needle device, etc. In a preferred embodiment, the outer channel 108 is coupled to the scope assembly 102 by inserting the proximal end of the end cap tube 142 into the distal end of the end cap 118, so that the end cap tube channel 144 communicates with the working channel 110 of the shaft 106. As previously described, the tube 126 of the outer channel 108 can be coupled to the end cap tube 142 via a connecting tube 148 (the end cap tube 142 and the connecting tube 148 can be preformed or premolded as a single piece). In an exemplary embodiment, the end cap tube 142 can be loaded into the end cap 118 using a loader tool 154. The loader tool 154 includes a handle 156 and a rod 158. The rod 158 is inserted into the end cap tube 142 to assist in pushing or rotating the end cap tube 142 in a proximal direction into the lumen 146 of the end cap 118. When the end cap tube 142 is pushed into the end cap 118 via the loader tool 154, the barbs 143 engage a step (not shown) of the end cap lumen 146 to provide an interference fit between the end cap 118 and the end cap tube 142 and prevent the end cap tube 142 from being withdrawn from the end cap 118. At this point, the channel 144 of the end cap tube 142 abuts against the working channel 110 such that the diameters of the end cap tube 142 and the working channel 110 match to provide an internal transition between the two components. The loader tool 154 is then removed from the scope assembly 102 , leaving the external channel 108 coupled to the scope assembly 102 .
[0052] The hub 128 is then attached to the proximal portion 138 of the shaft 106 via the clamp 140. Specifically, the shaft 106 may first be clamped within the second slotted channel 143 of the clamp, and the hub 128 may thereafter be clamped within the first slotted channel 141. However, it should be understood that the shaft 106 and hub 128 may be clamped to the slotted channels 141, 143 in any order. The laser fiber assembly 150 is connected to the hub 128 by inserting the Touhy-Borst valve 160 into the proximal end of the hub 128, thereby providing a proximal seal around the laser fiber 166 and the side port 162, which allows fluid communication from the Touhy-Borst valve 160 to the distal end of the tube 126. The laser fiber 166 can then be slidably inserted into the Touhy-Borst valve 160 until the plug connector 164 is positioned in the Touhy-Borst valve 160, thereby providing a sealed connection between the endoscope assembly 102 and the laser fiber assembly 150. It should be noted that because the external channel 108 is external to the shaft 106 of the endoscope assembly 102, the external channel has minimal effect on the deflection of the distal portion of the shaft 106. In addition, there is no change in the visibility of the visual image. In contrast, the described manner of coupling the tube 126 to the shaft 106 via the end cap tube 142 provides a secure and very low profile connection.
[0053] An exemplary method for breaking up and removing debris or kidney stones from a body cavity includes inserting a guide wire or 11 / 13F access sheath into a body lumen to reach a target body cavity, such as a kidney. The shaft 106 with an external channel 108 attached thereto is then inserted into the body and guided by the guide wire or access member until the distal end 112 of the shaft 106 is positioned within the target cavity. The guide wire / access sheath is removed from the body. The laser fiber 166 is inserted into the hub 128 and advances through the tube 126 until its distal end extends beyond the distal end 132 of the tube 126. The inlet fluid can be injected / pumped from a fluid source attached to the side port 162. When the fluid and stone fragments are aspirated out, the inlet fluid is used to maintain a constant volume / pressure within the kidney. When the laser fiber 166 fragments the kidney stone, the stone fragments are aspirated through the working channel 110 to be removed. Fragmentation, fluid injection, and aspiration may continue at the physician's discretion or until the kidney stone is completely removed from the kidney.
[0054] like Figure 7-8 As shown in , system 200 according to an exemplary embodiment of the present disclosure is substantially similar to system 100 except as described herein. Specifically, system 200 includes a second external channel 270 that can be used, for example, to inject / pump fluid into the kidney for a stone fragmentation procedure. In another example, second external channel 270 can receive a retrieval basket to stabilize the kidney stone during fragmentation. Figure 8As shown, in one embodiment, the end cap tube 242 is molded with two slots or clamps 272, 274. The tube 226 of the outer channel 208 is glued into the slot 272, and the tube of the second outer channel 270 is glued into the slot 274. In this embodiment, the end cap tube 242 can be inserted, press-fitted, insert molded, or integrally molded to the end cap 218.
[0055] In another embodiment, Fig. 9 As shown, the end cap tube 242' can include a connecting tube 248' having an oval shaped lumen 276' configured to receive the tube 226'. However, in this embodiment, the tube 226' can be a dual lumen extrusion having an oval outer profile that matches the inner profile of the lumen 276'. Thus, the tube 226' can be received and glued within the end cap tube 242'. As in the previous embodiment, in this embodiment, the end cap tube 242' can be inserted, press-fit, insert molded, or integrally molded to the end cap 218'.
[0056] Figure 10-13 An alternative arrangement is depicted in place of the end cap tube 142 for connecting the external channel 108 to the scope assembly 102. Fig.10 , the coupler 170 is substantially similar to the end cap tube 142 except as described herein. The coupler 170 is depicted as including a first tube 172 defining a first passage 174 and a second tube 176 defining a second passage 178. The first and second tubes 172, 174 are connected by a distal connection portion 173. As can be seen in the figure, the first tube 172 has a diameter that is greater than the diameter of the second tube 176. Specifically, the outer diameter of the first tube 172 is substantially the same as the diameter of the end cap lumen 146, so that the first tube 172 can be slidably inserted therein. The outer diameter of the second tube 176 is substantially the same as the diameter of the second passage 134 of the tube 126, so that the second tube 176 can be slidably inserted therein, thereby coupling the external passage 108 to the scope assembly 102. The distal connection portion 173 extends from the first tube 172 in the end cap lumen 146 to the second tube 174 in the second passage 178 at the distal abutting edges of the end cap 118 and the tube 126. In an exemplary embodiment, the first and second tubes 172 , 176 may be glued in place within the end cap 118 and tube 126 , respectively.
[0057] Fig.11 Another exemplary embodiment of a coupler 170' is depicted that is substantially similar to coupler 170 except as described herein. Specifically, a connecting portion 173' of coupler 170' extends laterally from first tube 172' to second tube 174', rather than extending distally. Thus, coupler 170' can be manufactured using a single piece, such as a thin sheet of metal, rather than a molded thin-walled polymer part.
[0058] Fig.12 Another exemplary embodiment of a connector 170" is depicted which is substantially similar to connectors 170, 170' except as described herein. Specifically, connector 170" includes a first slotted clamp portion 180" defining a first channel 182" and a second slotted clamp portion 184" defining a second channel 186". The first slotted clamp portion 180" is configured to snap onto an outer diameter of the end cap 118, and the second slotted clamp portion 184" is configured to snap onto an outer diameter of the tube 126. In this embodiment, the end cap 118 may include at least one stop positioned on an outer surface thereof to prevent the connector 170" from sliding proximally or distally relative thereto.
[0059] Fig.13 Another exemplary embodiment of a connector 170'" is depicted that is substantially similar to connectors 170, 170', 170". Specifically, connector 170'" includes a tube 190'" defining a channel 192'" and a wire 194'"'. Channel 192'" has a diameter substantially the same as the outer diameter of tube 126 so that tube 126 can be inserted therein. Wire 194'" is configured to be inserted into a hole (not shown) drilled into end cap 118 to connect external channel 108 to endoscope assembly 102. In this embodiment, the hole (not shown) is separated from the working channel 110 of shaft 106 and end cap lumen 146 so that wire 194'" does not interfere with the function of either.
[0060] Those skilled in the art will appreciate that the present devices and methods are not limited to the disclosed embodiments. For example, the disclosed system 100 can be used in various other procedures, such as, for example, hysteroscopy, cystoscopy, etc. Thus, the system 100 is not limited to use with a ureteroscope, and can be used with other devices, such as a cystoscope, a hysteroscope, or any other device whose shaft is inserted into a body passage / lumen / cavity.
[0061] Those skilled in the art will appreciate that the above-described embodiments may be modified without departing from the inventive concept of the embodiments. It should also be understood that the structural features and methods associated with one of the embodiments may be incorporated into other embodiments. Therefore, it should be understood that the present invention is not limited to the specific embodiments disclosed, but modifications are also encompassed within the scope of the present invention as defined by the appended claims.
Claims
1. A ureteroscope system, comprising: a handle configured to be retained external to the body; an elongated shaft extending from the handle to a distal end and comprising a working channel, the working channel being open at the distal end of the elongated shaft, the elongated shaft being configured to be inserted through a body lumen to a target surgical site; an outer member extending from a proximal end to a distal end and configured to be coupled to the elongated shaft, the outer member including a proximal hub and a tube extending distally from the hub and defining a first outer passage therein, the first outer passage having an inner diameter sized to receive a medical device therethrough; as well as A connecting mechanism, the connecting mechanism defines a first tube and a second tube and is configured to connect the distal end of the outer member to the distal end of the slender shaft, the first tube defines a first lumen and the second tube defines a second lumen, the second lumen is sized and shaped to receive the distal end of the outer member, and the proximal portion of the first tube is sized and shaped to be inserted into the distal portion of the slender shaft so that the first lumen leads to the working channel.
2. The system according to claim 1, wherein: The elongated shaft includes an end cap coupled to a distal end thereof, the end cap including a channel extending therethrough such that when the end cap is coupled to the elongated shaft, the end cap channel opens into the working channel.
3. The system according to any one of claims 1 and 2, wherein: The diameter of the end cap channel is substantially the same as the inner diameter of the working channel.
4. The system according to claim 2, wherein: The coupling mechanism includes a first engagement feature configured to mate with a second engagement feature on an inner wall of the end cap channel to lock the coupling mechanism to the end cap.
5. The system according to claim 4, wherein: The coupling mechanism is one of a barb or a thread.
6. The system according to any one of claims 1 to 2, wherein: The tube of the outer member has an inner diameter of approximately 3 French.
7. The system of any one of claims 1 to 2, further comprising a clamp configured to couple the outer member to a proximal portion of the shaft, the clamp comprising a first slotted channel and a second slotted channel, each of the first slotted channel and the second slotted channel being configured to receive one of the shaft and the outer member therethrough.
8. The system according to claim 7, wherein: The outer member includes a second outer lumen therethrough extending from a proximal end of the outer member to a distal end of the outer member.
9. A debris removal system comprising: Sightglass assembly, comprising: a handle configured to be retained external to the body; an elongated shaft extending from the handle to a distal end and comprising a working channel, the working channel being open at the distal end of the elongated shaft, the elongated shaft being configured to be inserted through a body lumen to a target surgical site; an outer passage extending from a proximal end to a distal end and configured to be coupled to the elongated shaft, the outer passage comprising a proximal hub and a tube extending distally from the hub and defining a second passage therein, the second passage having an inner diameter sized to receive a medical device therethrough; and a coupling mechanism defining a first tube and a second tube and configured to couple a distal end of the outer channel to a distal end of the elongated shaft, the first tube defining a first lumen and the second tube defining a second lumen, a proximal portion of the first tube being sized and shaped to be inserted into the distal portion of the elongated shaft such that the first lumen opens into the working channel, and the second lumen being configured to couple to the outer channel; A medical device assembly is configured to be coupled to the scope assembly via the hub of the external channel, the medical device assembly including a medical device that is inserted through the external channel into the target surgical site.
10. The system according to claim 9, wherein: The medical device assembly is a laser fiber assembly including a valve seal at a proximal end thereof configured to mate with the proximal end of the hub to seal the laser fiber assembly to the scope assembly.
11. The system according to claim 9, wherein: The distal end of the outer channel is sized and shaped to be inserted into the second lumen of the second tube.
12. The system of any one of claims 9 to 11, further comprising an end cap coupled to the distal end of the elongated shaft, the end cap comprising a channel extending therethrough such that when the end cap is coupled to the elongated shaft, the end cap channel opens to the working channel.
13. The system of any one of claims 9 to 11, further comprising a clamp configured to couple the outer channel to a proximal portion of the shaft, the clamp comprising a first slotted channel and a second slotted channel, each of the first slotted channel and the second slotted channel being configured to receive one of the shaft and the outer channel therethrough.
14. The system of any one of claims 9 to 11, further comprising a vacuum source connected to the working channel via the handle and configured to apply suction through the working channel to vacuum debris from a target surgical site through the working channel.
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