Endoscope handle and deployment device

JP7911823B2Active Publication Date: 2026-08-27BOSTON SCIENTIFIC SCIMED INC
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Patent Information

Application Number
JP2023558494
Authority / Receiving Office
JP · JP
Patent Type
Patents
Current Assignee / Owner
Priority Date
2021-03-24
Filing Date
2022-03-18
Publication Date
2026-08-27
Estimated Expiration
2042-03-18

AI Technical Summary

Benefits of technology

【0032】 本発明の開示は、以下の詳細説明を添付図面に関連付けて考察するとより完全に理解することができる。全ての図面が必ずしも縮尺通りに描かれておらず、及び/又は選択された要素が要素の明確な図及び/又は要素の明確な理解を容易にするために図面内で縮尺を変更する場合があることに注意されたい。縮尺の変更は、当業者には明らかであり、明示的に識別する必要はないであろう。

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Abstract

The objective is to provide design, materials, manufacturing methods, and use alternatives for medical devices. An endoscope configured to be actuated using a first hand of a user includes a handle having a proximal handle portion and a distal handle portion, and an elongated shaft extending distally from the distal handle portion, the elongated shaft including a distal tip deflectable using a first actuation mechanism secured to the proximal handle portion, the handle including a port in communication with the elongated shaft, and an actuable medical instrument configured to be slidably disposed within the elongated shaft and the port. A proximal end of the actuable medical instrument can be operably connected to a second actuation mechanism secured to the proximal handle portion. The first actuation mechanism can be configured to be actuated by the thumb of the first hand. The second actuation mechanism can be configured to be actuated by the thumb of the first hand.
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Description

Technical Field

[0001] [Cross - Reference to Related Applications] This application claims the benefit and priority of U.S. Provisional Patent Application No. 63 / 165,356, filed Mar. 24, 2021, the disclosure of which is incorporated herein by reference.

[0002] The disclosure of the present invention relates to medical devices and systems, and methods of manufacturing and using medical devices and systems. More specifically, the disclosure of the present invention relates to endoscopes, their components, and methods of manufacturing and using endoscopes.

Background Art

[0003] Endoscopes are used for diagnostic and therapeutic purposes during medical procedures. For example, flexible ureteroscopes are utilized for the examination and treatment of the kidneys and may generally include features that improve access to the treatment site and patient comfort. Flexible endoscopes, including ureteroscopes, may be provided with a flexible tip section that is controlled by a physician through the manipulation of various components attached to the handle of the scope. Such manipulation enables the physician to maneuver the tip of the scope to various locations within the body (e.g., various locations within the kidney). In addition to this, endoscopes such as ureteroscopes and other endoscope devices are generally used in combination with other medical devices during medical procedures. For example, urologists may use a flexible ureteroscope in combination with both a laser fiber and a retrieval device (e.g., a retrieval basket) to fragment kidney stones and / or remove fragments from the body. Thus, these procedures may require not only the manipulation of various features of the endoscope to control the tip of the scope, but also the introduction and operation of auxiliary devices used in combination with the endoscope. The ergonomics of the device can be particularly important to the user. There remains a need to provide alternative endoscopes and their components, as well as alternative methods for manufacturing and using such endoscope devices.

Summary of the Invention

[0004] The disclosure of this invention provides designs, materials, manufacturing methods, and alternative uses for medical devices. [Means for solving the problem]

[0005] One example is an endoscope configured to be operated using the user's first hand. The endoscope includes a handle comprising a proximal handle portion and a distal handle portion. An elongated shaft extends distally from the distal handle portion. The elongated shaft includes a distal tip that can be deflected using a first actuation mechanism fixed to the proximal handle portion. The handle includes a port communicating with the elongated shaft. An actuated medical device is also provided and configured to be slidably positioned within the elongated shaft and the port. The proximal end of the actuated medical device is operably connected to a second actuation mechanism fixed to the proximal handle portion. The first actuation mechanism is configured to be operated by the thumb of the first hand. The second actuation mechanism is also configured to be operated by the thumb of the first hand.

[0006] In addition to or as an alternative to any of the embodiments described above, the first operating mechanism is self-locking.

[0007] In place of or in addition to any of the embodiments described above, the first actuation mechanism includes a first hinged arm, a first biasing element, and a first tooth formed on the first hinged arm, the first tooth being configured to releasably engage with a plurality of first teeth formed on the proximal handle portion.

[0008] In place of or in addition to any of the embodiments described above, the first actuation mechanism includes a first gear slidably disposed on an elongated shaft within a proximal handle portion, and a second gear disposed within the proximal handle portion and operably connected to the first gear. The first gear is operably connected to the distal tip, and the second gear is operably connected to a first hinged arm.

[0009] In addition to or as an alternative to any of the embodiments described above, rotational movement of the first hinged arm by the thumb of the first hand causes the first gear to be translated axially along the elongated shaft, and this axial translation of the first gear causes deflection of the distal tip.

[0010] In addition to or as an alternative to any of the embodiments described above, the elongated shaft is rotatable relative to the proximal handle portion.

[0011] In place of or in addition to any of the embodiments described above, the second operating mechanism includes an operating housing comprising a base portion and a cover portion configured to rotate relative to the base portion.

[0012] In place of or in addition to any of the embodiments described above, the second operating mechanism is self-locking.

[0013] In place of or in addition to any of the embodiments described above, the second actuation mechanism includes a second hinged arm, a second biasing element, and a second tooth formed on the second hinged arm, the second tooth being configured to releasably engage with a second plurality of teeth formed on the actuation housing.

[0014] In place of or in addition to any of the embodiments described above, the operable medical device includes an outer sheath having an annular strain relief positioned around the proximal end of the outer sheath, and an inner wire slidably disposed within the outer sheath.

[0015] In addition to or as an alternative to any of the embodiments described above, the annular strain relief is fixedly mounted to the base portion of the operating housing, and the internal wire is mounted to the cover portion.

[0016] In addition to or as an alternative to any of the embodiments described above, the outer sheath is fixedly attached to the base portion of the operating housing.

[0017] In addition to or as an alternative to any of the embodiments described above, the outer sheath is axially movable within the annular strain relief.

[0018] In addition to or as an alternative to any of the embodiments described above, the base portion includes a mounting slot configured to receive the proximal end of the outer sheath. The outer sheath includes a stop fixed to the proximal end of the outer sheath. The second actuation mechanism includes a compression spring positioned within the mounting slot and configured to bias the outer sheath toward the distal end of the mounting slot.

[0019] In addition to or as an alternative to any of the embodiments described above, the operating housing is removably fixed to the proximal handle portion.

[0020] Another example is an endoscope configured to be operated using the user's first hand. The endoscope includes a handle having a proximal handle portion and a distal handle portion extending along a central longitudinal axis. An elongated shaft extends distally from the distal handle portion. The elongated shaft includes a distal tip that can be deflected using a first actuation mechanism fixed to the proximal handle portion. The handle includes a port communicating with a lumen extending through the elongated shaft. The first actuation mechanism is configured to be operated by the first hand at a first position relative to the handle. The first actuation mechanism includes a first hinged arm having a first free end and a first hinged end opposite the first free end, a first biasing element, and first teeth formed on the first hinged end, the first teeth being configured to releasably engage with a first set of teeth formed on the proximal handle portion. The first biasing element biases the first hinged arm toward a first locked position, and the first free end of the first hinged arm is biased toward away from the handle.

[0021] As an alternative to or in addition to any of the above embodiments, the endoscope further includes an operable medical instrument configured to be slidably disposed within the lumen and port of the elongate shaft. The proximal end of the operable medical instrument is operably connected to a second actuation mechanism configured to be fixed to the proximal handle portion.

[0022] As an alternative to or in addition to any of the above embodiments, the second actuation mechanism is configured to be actuated by a first hand at a first position with respect to the handle.

[0023] As an alternative to or in addition to any of the above embodiments, the second actuation mechanism includes a second hinged arm having a second free end and a second hinged end opposite the second free end, a second biasing element, and a second tooth formed at the second hinged end, the second tooth being configured to releasably engage a second plurality of teeth.

[0024] As an alternative to or in addition to any of the above embodiments, the second biasing element biases the second hinged arm toward a second locked position, and the second free end of the second hinged arm is biased away from the handle.

[0025] As an alternative to or in addition to any of the above embodiments, the second actuation mechanism includes an actuation housing having a base portion and a cover portion configured to rotate with respect to the base portion.

[0026] As an alternative to or in addition to any of the above embodiments, the proximal handle portion includes a deflection indicator disposed on an outer surface of the proximal handle portion. The deflection indicator is visible when the first hinged arm is moved away from a fixed position with respect to the proximal handle portion.

[0027] Another example is an endoscope configured to be actuated using a user's first hand. The endoscope includes a handle having a proximal handle portion and a distal handle portion detachably coupled to the proximal handle portion. The endoscope also includes an elongate shaft having a distal portion extending distally from the distal handle portion and a proximal portion extending proximally from the distal handle portion into the proximal handle portion. A first actuation mechanism is configured to deflect the distal tip of the elongate shaft. A first gear or linkage of the first actuation mechanism is coupled to the proximal portion of the elongate shaft, and a second gear or linkage of the first actuation mechanism is coupled to the proximal handle portion. The first gear or linkage engages the second gear or linkage when the distal handle portion is coupled to the proximal handle portion.

[0028] As an alternative to or in addition to any of the above-described embodiments, the distal handle portion and the elongate shaft are rotatably coupled to the proximal handle portion.

[0029] As an alternative to or in addition to any of the above-described embodiments, the first gear or linkage is a worm gear slidable longitudinally along the proximal portion of the elongate shaft.

[0030] As an alternative to or in addition to any of the above-described embodiments, the endoscope includes a plurality of tension wires extending from the worm gear to the distal tip.

[0031] The above summaries of some embodiments, aspects, and / or examples are not intended to describe every embodiment or implementation of the present disclosure. The following drawings and detailed description illustrate these embodiments more specifically.

[0032] The disclosure of this invention can be better understood by considering the following detailed description in relation to the accompanying drawings. Note that not all drawings are necessarily drawn to scale, and / or selected elements may be scaled in the drawings to facilitate a clearer depiction and / or clearer understanding of the elements. The scale changes will be obvious to those skilled in the art and will not need to be explicitly identified. [Brief explanation of the drawing]

[0033] [Figure 1] This is a diagram illustrating exemplary medical devices. [Figure 2] This is a diagram illustrating exemplary medical devices. [Figure 3] This figure shows the exemplary medical devices described in Figures 1 and 2 being held in the user's hand. [Figure 4] This is a partially exploded assembly diagram of the first operating mechanism associated with an exemplary medical device. [Figure 5] This figure shows an embodiment of the first hinged arm of the first operating mechanism. [Figure 6] This figure shows the configuration of the first operating mechanism in operation. [Figure 7] This figure shows the configuration of the first operating mechanism in operation. [Figure 8] This figure shows an embodiment of a second operating mechanism associated with an exemplary medical device. [Figure 9] This is a partially disassembled assembly diagram of the second operating mechanism. [Figure 10] This figure shows an embodiment of an operable medical device associated with a second operating mechanism in a crush configuration. [Figure 11] This figure shows an embodiment of an operable medical device associated with a second operating mechanism in an extended configuration. [Figure 12] This figure shows an embodiment of an operable medical device associated with a second operating mechanism in a partial collapse configuration. [Figure 13] This figure shows the deformation of one of the components of a disassembled medical device. [Figure 14] This is a magnified view of detail A in Figure 13. [Figure 15] This is a magnified view of detail B in Figure 13. [Figure 16] This is a magnified view of detail C in Figure 13. [Figure 17] This diagram shows the components of the medical device in its assembled state, as shown in Figure 13. [Figure 18] This is a magnified view of detail D in Figure 17. [Figure 19] This figure shows another deformation of the components of a disassembled medical device. [Figure 20] This is a magnified view of detail A in Figure 19. [Figure 21] This is a magnified view of detail B in Figure 19. [Figure 22] This is a magnified view of detail C in Figure 19. [Figure 23] This diagram shows the components of the medical device in its assembled state, as shown in Figure 19. [Figure 24] This is a magnified view of detail D in Figure 23. [Figure 25] This figure shows another deformation of the components of a disassembled medical device. [Figure 26] This diagram shows the components of the medical device in its assembled state (Figure 25). [Figure 27] This figure shows alternative configurations for the handle and operating mechanism of a medical device.

[0034] The aspects of the disclosure of this invention are open to various modifications and variations, which are described in detail below with illustrative examples in the drawings. However, it should be understood that the aspects of the disclosure of this invention are not intended to be limited to the specific embodiments described. Rather, they are intended to cover all modifications, equivalents, and substitutes that fall within the spirit and scope of the disclosure of this invention. [Modes for carrying out the invention]

[0035] The following description must be interpreted with reference to drawings, which may not necessarily be to the exact scale, and similar reference numbers in some figures indicate similar elements. The detailed description and drawings are intended to illustrate, and not limit, the disclosure of the present invention. Those skilled in the art will recognize that various elements described and / or illustrated can be arranged in various combinations and configurations without departing from the scope of the disclosure of the present invention. The detailed description and drawings illustrate exemplary embodiments of the disclosure of the present invention. However, not all features and / or elements may be shown in each drawing for the purpose of clarity and ease of understanding, but it can be understood that these features and / or elements exist unless otherwise specified.

[0036] Unless otherwise provided in the claims or elsewhere in this specification, the following definitions of terms shall apply.

[0037] In this specification, whether expressly indicated or not, all numerical values ​​are assumed to be modified by the translation of the term "about." In numerical contexts, the translation of "about" generally means a range of numbers that a person skilled in the art would consider equivalent to (e.g., having the same function or result as) the values ​​listed. In many cases, the translation of "about" may include numbers rounded to the nearest significant figure. Other translations of the term "about" (e.g., in non-numerical contexts) can be assumed, unless otherwise specified, to have the usual and customary definitions of the term that are understood in relation to this specification and are not inconsistent therewith.

[0038] Listing a range of numbers by an endpoint includes all numbers within that range, including the endpoint (for example, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0039] While some appropriate dimensions, ranges, and / or values ​​relating to various components, features, and / or specifications are disclosed, those skilled in the art, as evoked by the disclosure of this invention, will understand that desirable dimensions, ranges, and / or values ​​may deviate from those expressly disclosed.

[0040] As used herein and in the claims, the singular forms “a,” “an,” and “the” include singular and plural nouns unless the context otherwise explicitly states. As used herein and in the claims, the term “or” is used generally to include “and / or” unless the context otherwise explicitly states. For ease of understanding, certain features of the disclosure of the present invention can be described singularly, but it should be noted that these features may be plural or repeated within the embodiments of the disclosure of the present invention. Each instance of these features may, unless otherwise explicitly stated, include and / or be encompassed by the singular disclosure. For the purposes of simplification and clarity, not all elements of the disclosure of the present invention will necessarily be shown in each figure and discussed in detail below. However, where there are more than one component, it should be understood that, unless otherwise explicitly stated, the following discussion may apply equally to any and / or all of these components. Furthermore, for the purposes of clarity, not all instances of some elements or features will be shown in each figure.

[0041] Relative terms such as “proximal,” “distal,” “forward,” “backward,” and variations thereof can generally be determined in relation to the positioning, orientation, and / or operation of various elements of a device relative to the user / operator / manipulator. “Proximal” and “backward” indicate or mean toward or toward the user, while “distal” and “forward” indicate or mean toward or away from the user. In some cases, the terms “proximal” and “distal” may be arbitrarily assigned in an attempt to facilitate understanding of the disclosure of the present invention, but such cases will be immediately apparent to those skilled in the art. Other relative terms such as “upstream,” “downstream,” “inflow,” and “outflow” refer to the direction of fluid flow within a lumen or device, such as a body lumen, blood vessel, etc. Further relative terms such as “axial,” “circumferential,” “longitudinal,” “lateral,” “radial,” and / or variations thereof generally refer to the direction and / or orientation relative to the central longitudinal axis of the structure or device disclosed in the present invention.

[0042] The term “extension” can be understood to mean the minimum measurement of the dimension being described or identified. Unless “minimum” is not prefixed to such extension or dimension, or these extensions or dimensions are identified as “minimum,” it can be understood to mean the maximum measurement of the dimension being described or identified. For example, “outer extension” can be understood to mean the outer dimension, “radial extension” can be understood to mean the radial dimension, and “longitudinal extension” can be understood to mean the longitudinal dimension, and so forth. Each example of “extension” may differ (e.g., axial, longitudinal, transverse, radial, circumferential, etc.), which will be apparent to those skilled in the art from the individual context of use. Generally, “extension” can be considered the maximum possible dimension measured according to the intended use, while “minimum extension” can be considered the smallest possible dimension measured according to the intended use. In some cases, “extension” can generally be measured orthogonally within a plane and / or cross-section, but as will be apparent from the specific context, it can be measured in other ways, such as angular, radial, circumferential (e.g., along an arc), but not limited to these.

[0043] The terms “monolithic” and “single” generally refer to one or more elements manufactured or composed from a single structure or basic unit / element. Monolithic elements and / or single elements exclude structures and / or features manufactured by assembling or joining together multiple separate structures or elements.

[0044] References to “embodiments,” “some embodiments,” and “other embodiments” in this specification should be noted to indicate that the embodiments described may include certain features, structures, or characteristics, but not all embodiments may necessarily include these particular features, structures, or characteristics. Furthermore, such phrases do not necessarily refer to the same embodiments. Moreover, when describing certain features, structures, or characteristics in relation to embodiments, whether explicitly described or not, it is assumed that implementing these particular features, structures, or characteristics in relation to other embodiments is within the realm of knowledge for those skilled in the art. That is, as will be understood by those skilled in the art, it is still assumed that the various individual elements described below, even if not specified in particular combinations, can be combined or arranged to form other additional embodiments or to complement and / or extend the embodiments described.

[0045] For the purpose of clarity, certain descriptive numerical nomenclature (e.g., 1st, 2nd, 3rd, 4th, etc.) may be used throughout this specification and / or claims to name and / or distinguish between various features described and / or claimed. It should be understood that this numerical nomenclature is not intended to be restrictive but is merely illustrative. In some embodiments, for the purpose of brevity and clarity, modifications and deviations from previously used numerical nomenclature may be made. That is, a feature previously identified as the "1st" element may later be referred to as the "2nd" element, the "3rd" element, etc., or may be completely excluded and / or a different feature may be referred to as the "1st" element. The meaning and / or designation in each instance will be obvious to those skilled in the art.

[0046] The following diagrams illustrate typical components and / or arrangements of medical devices and / or medical systems and methods of using these devices and / or systems. It should be noted that, for the sake of simplification, some features may be omitted or only schematically shown in any given diagram. Further details regarding some of the components of implants and / or systems can be illustrated in more detail in other diagrams. While discussed in the context of accessing and treating the urinary tract, these implants and / or systems can be used in other therapeutic interventions and / or percutaneous medical procedures within a patient's body. Similarly, the devices and methods described herein with respect to percutaneous deployment can be used in other types of surgical procedures as needed. For example, in some cases, the devices can be used in non-percutaneous procedures. The devices and methods disclosed herein can be adapted and configured to suit other uses within anatomical structures.

[0047] Figure 1 shows a selected embodiment of a medical device (e.g., an endoscope) 100. The medical device 100 may include a handle 110 extending along its longitudinal axis, comprising a proximal handle portion 112 and a distal handle portion 114. In some embodiments, the medical device 100 may include an elongated shaft 140 extending distally from the distal handle portion 114. The elongated shaft 140 may include a distal tip 142 that can be deflected using a first actuation mechanism 150 fixed to the proximal handle portion 112. In some embodiments, the distal tip 142 may be deflectable within a deflection plane. In some embodiments, the distal tip 142 may be deflectable by approximately plus or minus 90 degrees, approximately plus or minus 180 degrees, approximately plus or minus 270 degrees, approximately plus or minus 360 degrees, or by any other amount as needed.

[0048] In some embodiments, the elongated shaft 140 can have a length of approximately 26.5 inches (approximately 67.3 centimeters). In some embodiments, the elongated shaft 140 can have lengths of approximately 15 inches (approximately 38.1 centimeters), approximately 20 inches (approximately 50.8 centimeters), approximately 25 inches (approximately 63.5 centimeters), approximately 28 inches (approximately 71.1 centimeters), approximately 30 inches (approximately 76.2 centimeters), and approximately 35 inches (approximately 88.9 centimeters). Generally, the elongated shaft 140 can take the form of a polymer tube or, in some cases, a rigid metal tube. In some embodiments, the elongated shaft 140 can be constructed using reinforcing braids, liners, woven fabrics, textiles, etc.

[0049] The elongated shaft 140 may include a lumen (e.g., an operating channel) extending through it from the handle 110 to the distal tip 142. In some embodiments, the proximal handle portion 112 may include a proximal port 116 communicating with the lumen of the elongated shaft 140. In some embodiments, the distal handle portion 114 may include a lateral port 118 communicating with the lumen of the elongated shaft 140. In some embodiments, the medical device 100 and / or the handle 110 may include the proximal port 116 and the lateral port 118. In some embodiments, the proximal port 116 and / or the lateral port 118 may include a Luer connector, a Y-connector, a one-way valve, or other suitable connection. In some embodiments, the elongated shaft 140 may include multiple lumen (e.g., multiple operating channels) extending through it.

[0050] In some embodiments, the distal end 142 of the elongated shaft 140 of the medical device 100 may include an optical system and illumination means positioned thereon. The optical system and illumination means may be configured to provide optical visualization of the area being treated and / or passed through at the distal end 142. The handle 110 of the medical device 100 may include an electronics connector and / or optical connector 124 configured to connect the optical system and illumination means of the medical device 100 to a controller, monitor, display, computer, etc. Other configurations, including but not limited to wireless communication, have also been considered.

[0051] The elongated shaft 140 can be configured as a ureteroscope shaft, flexible ureteroscope shaft, double-lumen flexible ureteroscope shaft, cystoscope shaft, duodenoscope shaft, colonoscope shaft, or other endoscopic shaft suitable for the desired use.

[0052] In some embodiments, the medical device 100 may include an operable medical device 190 configured to be slidably positioned inside the lumen and proximal port 116 of the elongated shaft 140. In some embodiments, the operable medical device 190 may be configured to be slidably positioned inside the lumen and lateral port 118 of the elongated shaft 140. In some embodiments, the operable medical device 190 may be configured to be slidably positioned inside the lumen and proximal port 116 and either the proximal port 116 or the lateral port 118 of the elongated shaft 140. In some embodiments, the operable medical device 190 may be removed from the lumen and proximal port 116 of the elongated shaft 140 during a procedure and positioned inside the lumen and lateral port 118 of the elongated shaft 140. In some embodiments, the operable medical device 190 may be removed from the lumen and lateral port 118 of the elongated shaft 140 during a procedure and positioned inside the lumen and proximal port 116 of the elongated shaft 140. In some embodiments, the proximal end of the actuarial medical device 190 can be actuarially connected to a second actuation mechanism 170 fixed to the proximal handle portion 112. In some embodiments, the distal end of the actuarial medical device 190 can be configured to be located within the lumen of the elongated shaft 140, adjacent to, and / or inside, the distal tip 142 of the elongated shaft 140.

[0053] In some embodiments, the operable medical device 190 may include a laser fiber, a retrieval device such as a retrieval basket or retrieval net, forceps, an immobilization device, a lithotripping device, or another end effector. Other configurations and / or exemplary operable medical devices are also conceivable. In some embodiments, the operable medical device 190 may include an outer sheath 192 in which a lumen extends. In some embodiments, the outer sheath 192 may have an annular strain relief 194 positioned around its proximal end. In at least some embodiments, the operable medical device 190 may include an inner wire 196 (e.g., Figures 10-11) slidably disposed within the outer sheath 192. In some embodiments, the inner wire 196 may include an end effector 199 (e.g., Figure 11) at its distal end and / or adjacent thereto. In some embodiments, the end effector 199 may include and / or be formed from a shape memory material. In some embodiments, the outer sheath 192 can be made axially movable within and / or relative to the annular strain relief 194. In some embodiments, the distal end of the operable medical device 190 and / or the inner wire 196 can be positioned within the lumen of the elongated shaft 140, adjacent to and / or within the distal tip 142 of the elongated shaft 140, in a crushed or closed configuration.

[0054] In some embodiments, the proximal handle portion 112 may include a deflection indicator 120 (see Figure 2) positioned on its outer surface. In some embodiments, the deflection indicator 120 may include a colored mark on the outer surface of the proximal handle portion 112. In some embodiments, the deflection indicator 120 may include a light and / or light-emitting diode (LED). The deflection indicator 120 may be adapted and configured to provide the user with a visual warning that the distal tip 142 is in a deflected configuration, as shown in Figure 2. In some embodiments, the deflection indicator 120 may be hidden (e.g., by a part or component such as a first operating mechanism) and / or disabled when the distal tip 142 is in a straight configuration (e.g., not deflected). In some embodiments, the deflection indicator 120 may be made visible and / or enabled when the distal tip 142 is in a deflected configuration (e.g., not straight).

[0055] The medical device 100 and / or handle 110 can be adapted and configured to be grasped, held, and / or operated using the user's first hand 10 in a first position relative to the handle 110, as can be seen in Figure 3. A first actuation mechanism 150 can be configured to be operated by the thumb 12 of the first hand 10 in a first position relative to the handle 110, and a second actuation mechanism 170 can be configured to be operated by the same thumb 12 of the first hand 10 in a first position relative to the handle 110. Thus, the medical device 100 can be configured to be operated using one hand (e.g., the first hand 10) in a first position relative to the handle 110. In some embodiments, the operable medical device 190 and / or the outer sheath 192 can be advanced and / or retracted relative to the elongated shaft 140 by using a second hand (not shown), distinct from the first hand 10, to grasp the outer sheath 192 proximal to the proximal port 116 (or, if appropriate, the lateral port 118) with the thumb and index finger of the second hand while the first hand 10 is grasping and / or holding the handle 110.

[0056] In some embodiments, the handle 110 may include one or more buttons 122 configured to control and / or activate various functions (e.g., perfusion, laser activation, suction, etc.) that may relate to the medical device 100 and / or the procedure being performed. In some embodiments, one or more buttons 122 may include and / or be an electronic controller. In some embodiments, one or more buttons 122 may be positioned and / or configured to be activated by the thumb 12 of a first hand 10 in a first position relative to the handle 110. In some embodiments, one or more buttons 122 may be positioned and / or configured to be activated by fingers other than the thumb of the first hand 10. In some alternative embodiments, one or more buttons 122 may be positioned and / or configured to be activated by fingers other than the thumb of a second hand (not shown).

[0057] In some embodiments, the medical device 100 and / or handle 110 may include a second button pad containing one or more buttons positioned substantially opposite one or more buttons 122 with respect to the longitudinal axis of the handle 110 and which can be operated using the index finger of the first hand 10. In some embodiments, one or more buttons on the second button pad may be configured to activate and / or activate a device and / or feature that could cause harm if unintentionally activated, such as a laser or cauterizing device. In some embodiments, it may be necessary to activate one or more of the buttons 122 as a safety mechanism before one or more buttons on the second button pad can be activated or activated. Other configurations are also conceivable.

[0058] Figure 4 is a partially exploded assembly view showing a selected embodiment of the first actuation mechanism 150. In some embodiments, the first actuation mechanism 150 may include a first hinged arm 152 (shown in detail in Figure 5) having a first free end 154 and a first hinged end 156 on the opposite side, a first biasing element (e.g., a spring) 158, and a first tooth 160 formed on the first hinged end 156 of the first hinged arm 152, the first tooth 160 being configured to releasably engage with a first plurality of teeth 162 formed on the proximal handle portion 112. In some embodiments, the first tooth 160 may include and / or be a plurality of teeth. In at least some embodiments, the first hinged arm 152 may engage with a cover 164, the cover 164 may be configured to engage with the proximal handle portion 112. The cover 164 and / or the first hinged arm 152 may be configured to rotate about a first rotation axis 102 that extends laterally through the proximal handle portion 112 substantially perpendicular to the longitudinal axis of the handle 110. In some embodiments, the cover 164 may engage with the proximal handle portion 112 by one or more protrusions, snaps, friction fits, mechanical engagements, or other suitable means.

[0059] In at least some embodiments, the first set of teeth 162 formed on the proximal handle portion 112 can be formed around a first rotation axis 102. In some embodiments, the first set of teeth 162 formed on the proximal handle portion 112 can be formed around the first rotation axis 102, for example, in a continuous circular pattern or a semicircular pattern. In some embodiments, the first set of teeth 162 formed on the proximal handle portion 112 can be formed around the first rotation axis 102 in a discontinuous circular pattern. Other configurations are also possible.

[0060] The first hinged arm 152 may include one or more projections 155 extending therefrom. One or more projections 155 may form and / or define a first pivot axis of the first hinged arm 152 with respect to the cover 164 and / or handle 110. In at least some embodiments, one or more projections 155 may be configured to be received and / or engage with one or more recesses 165 formed in the cover 164. A first biasing element 158 ​​may be configured to bias the first hinged arm 152 around its first pivot axis. The first biasing element 158 ​​may be configured to bias the first hinged arm 152 toward a first locked position, so that the first free end 154 of the first hinged arm 152 is biased away from the handle 110, as shown in Figure 6. In the first locked position, the first teeth 160 and / or the first hinged end 156 of the first hinged arm 152 can be biased toward the handle 110 and / or engage with a plurality of first teeth 162 (not shown). Thus, in at least some embodiments, the first actuation mechanism 150 can be self-locking. In the first locked position, the first actuation mechanism 150 and / or the first hinged arm 152 are prevented from rotating relative to the proximal handle portion 112 with the first teeth 160 engaged with the plurality of first teeth 162.

[0061] In some embodiments, the first end of the first biasing element 158 ​​may be fixedly attached to, positioned within, and / or embedded within the first hinged end 156 of the first hinged arm 152. The second end of the first biasing element 158, opposite the first end, may be configured to engage with the cover 164 (shown in partial cross-section). In at least some embodiments, the cover 164 may include a slot sized and configured to slidably receive the second end of the first biasing element 158.

[0062] In an alternative configuration, the first end of the first biasing element 158 ​​may be fixedly attached to, positioned in, and / or embedded in the cover 164. The second end of the first biasing element 158, opposite to the first end, may be configured to engage with the first hinged end 156 of the first hinged arm 152. In at least some embodiments, the first hinged end 156 of the first hinged arm 152 may include a slot sized and configured to slidably receive the second end of the first biasing element 158.

[0063] In some embodiments, the first biasing element 158 ​​may include a leaf spring and / or an elastic material strip. In some embodiments, the first biasing element 158 ​​may be formed from polymer materials, metallic materials, and / or composite materials, including but not limited to stainless steel and nickel-titanium alloys. Some suitable but non-limiting examples of materials are discussed below.

[0064] The first hinged arm 152 of the first actuation mechanism 150 can be moved from a first locked position to a first unlocked actuation position when the first free end 154 of the first hinged arm 152 of the first actuation mechanism 150 is pressed toward the handle 110, for example by the thumb 12 of the first hand 10. When the first free end 154 of the first hinged arm 152 of the first actuation mechanism 150 is pressed toward the handle 110, the first biasing element 158 ​​bends and / or deflects as the first hinged arm 152 pivots around the first pivot axis and / or one or more protrusions 155, thereby moving the first tooth 160 away from the handle 110 and / or disengaging the first tooth 160 from a plurality of first teeth 162 (not shown), as shown in Figure 7. Accordingly, in the first operating position, the first tooth 160 can be translated outward away from the handle 110 and / or disengaged from the first set of teeth 162 (not shown), allowing the first hinged arm 152 to rotate together with the cover 164 around the first pivot axis 102.

[0065] The first hinged arm 152 of the first actuation mechanism 150 can be positioned over the deflection indicator 120 and / or the first hinged arm 152 can cover the deflection indicator 120 so that the deflection indicator 120 is hidden from view when the first hinged arm 152 of the first actuation mechanism 150 is positioned relative to the proximal handle portion 112 (e.g., Figure 1). The distal tip 142 can be configured in a straight line when the first hinged arm 152 of the first actuation mechanism 150 is positioned relative to the proximal handle portion 112. When the first hinged arm 152 of the first actuation mechanism 150 is rotated around the first rotation axis 102 and moved away from its position relative to the proximal handle portion 112, the deflection indicator 120 can be made visible to the user and / or the distal tip 142 can be configured in a deflected state (e.g., Figure 2).

[0066] Figure 8 shows a selected embodiment of a second actuation mechanism 170 fixed to the proximal handle portion 112 of the handle 110, and Figure 9 is a partially exploded assembly view of a selected embodiment of the second actuation mechanism 170. The medical device 100 may include an elongated shaft 140 (not shown) and an actuated medical device 190 configured to be slidably positioned within the proximal port 116. The actuated medical device 190 can be actuatedly connected to the second actuation mechanism 170. The second actuation mechanism 170 may include a base portion 186 and a cover portion 184 configured to rotate relative to it. The base portion 186 may include an extension portion 187 configured to extend around at least a portion of the proximal handle portion 112. In at least some embodiments, the extension portion 187 may include a flange extending laterally from the extension portion 187, configured to engage with a slot 115 formed on the outer surface of the proximal handle portion 112. In some embodiments, the slot 115 may extend longitudinally and / or substantially parallel to the longitudinal axis of the handle 110. In some embodiments, the engagement of the flange of the extension 187 with the slot 115 may allow the base portion 186 to be rotatably fixed to the proximal handle portion 112 of the handle 110. Thus, rotation of the base portion 186 relative to the proximal handle portion 112 can be prevented. In some embodiments, the operating housing and / or the base portion 186 may be detachably fixed to the proximal handle portion 112. In some embodiments, the base portion 186 may include a fixing element (not shown) extending from its rear side, which is configured to slidably engage with a mounting slot 113 formed in the proximal handle portion 112. Other engagement means such as snap-type, friction-type, and twist-lock types have also been considered.

[0067] In some embodiments, the second actuation mechanism 170 may include a second hinged arm 172 (similar to the first hinged arm 152 shown in Figure 5) having a second free end 174 and a second hinged end 176 on the opposite side, a second biasing element (e.g., a spring) 178, and a second tooth 180 formed on the second hinged end 176 of the second hinged arm 172, the second tooth 180 being configured to releasably engage with a second set of teeth 182 formed on the base portion 186. In some embodiments, the second tooth 180 may include and / or be a set of teeth. In at least some embodiments, the second hinged arm 172 may engage with a cover portion 184. The cover portion 184 may be configured to rotatably engage with the base portion 186 and / or the proximal handle portion 112 of the handle 110. The cover portion 184 and / or the second hinged arm 172 may be configured to rotate about a second rotation axis 104 that extends laterally through the proximal handle portion 112 substantially perpendicular to the longitudinal axis of the handle 110. In some embodiments, the second rotation axis 104 may be parallel to and / or coaxial with the first rotation axis 102 (e.g., Figure 4). In some embodiments, the cover portion 184 may engage with the base portion 186 by one or more protrusions, snaps, friction fits, mechanical engagements, or other suitable means. In some embodiments, the cover portion 184 may be removably fixed, connected to, and / or mounted to the proximal handle portion 112 through mounting slots 113, and the base portion 186 and / or the operating housing may be removably fixed to the proximal handle portion 112 through mounting slots 113. For example, a fixing element of the cover portion 184, configured to be removably fixed to the proximal handle portion 112, can extend through an opening formed in the base portion 186. Other configurations are also conceivable.

[0068] In at least some embodiments, the second set of teeth 182 formed on the base portion 186 can be formed around the second axis of rotation 104. In some embodiments, the second set of teeth 182 formed on the base portion 186 can be formed around the second axis of rotation 104, for example, in a continuous circular pattern or a semicircular pattern. In some embodiments, the second set of teeth 182 formed on the base portion 186 can be formed around the second axis of rotation 104 in a discontinuous circular pattern. Other configurations are also possible.

[0069] The second hinged arm 172 may include one or more projections 175 extending therefrom. One or more projections 175 may form and / or define a second pivot axis of the second hinged arm 172 with respect to the cover portion 184 and / or the handle 110. In at least some embodiments, one or more projections 175 may be configured to be received and / or engage with one or more recesses 185 formed in the cover portion 184. A second biasing element 178 may be configured to bias the second hinged arm 172 around its second pivot axis. The second biasing element 178 may be configured to bias the second hinged arm 172 toward a second locked position, so that the second free end 174 of the second hinged arm 172 is biased away from the handle 110 as shown with respect to the first hinged arm 152 in Figure 6. In the second locked position, the second teeth 180 and / or the second hinged end 176 of the second hinged arm 172 can be biased toward the handle 110 and / or engage with the second set of teeth 182. Thus, in at least some embodiments, the second actuation mechanism 170 can be self-locking. In the second locked position, the second actuation mechanism 170 and / or the second hinged arm 172 are prevented from rotating relative to the base portion 186 and / or the proximal handle portion 112 with the second teeth 180 engaged with the second set of teeth 182.

[0070] In some embodiments, the first end of the second biasing element 178 may be fixedly attached to, positioned within, and / or embedded within the second hinged end 176 of the second hinged arm 172. The second end of the second biasing element 178 opposite the first end may be configured to engage with the cover 184, as shown with respect to the first biasing element 158 ​​in Figures 6-7. In at least some embodiments, the partial cover 184 may include a slot sized and configured to slidably receive the second end of the second biasing element 178.

[0071] In an alternative configuration, the first end of the second biasing element 178 may be fixedly attached to, positioned within, and / or embedded within the partial cover 184. The second end of the second biasing element 178, opposite to the first end, may be configured to engage with the second hinged end 176 of the second hinged arm 172. In at least some embodiments, the second hinged end 176 of the second hinged arm 172 may include a slot sized and configured to slidably receive the second end of the second biasing element 178.

[0072] In some embodiments, the second biasing element 178 may include a leaf spring and / or an elastic material strip. In some embodiments, the second biasing element 178 may be formed from polymer materials, metallic materials, and / or composite materials, including but not limited to stainless steel and nickel-titanium alloys. Some suitable but non-limiting examples of materials are discussed below.

[0073] The second hinged arm 172 of the second actuation mechanism 170 can be moved from a second locked position to a second unlocked actuation position when the second free end 174 of the second hinged arm 172 of the second actuation mechanism 170 is pressed toward the handle 110, for example by the thumb 12 of the first hand 10. When the second free end 174 of the second hinged arm 172 of the second actuation mechanism 170 is pressed toward the handle 110, the second biasing element 178 bends and / or deflects as the second hinged arm 172 pivots around the second pivot axis and / or one or more protrusions 175, thereby moving the second teeth 180 away from the base portion 186 and / or the handle 110 and / or disengaging the second teeth 180 from the second set of teeth 182, as shown with respect to the first actuation mechanism in Figure 7. Therefore, in the second operating position, the second tooth 180 can be translated outward away from the handle 110 and / or disengaged from the second set of teeth 182, allowing the second hinged arm 172 to rotate together with the cover portion 184 around the second pivot axis 104.

[0074] As discussed herein, the actuated medical device 190 may include an inner wire 196. Figure 9 shows an inner wire 196 engaged with and / or mounted to a cover portion 184 of the actuated housing of a second actuated mechanism 170. The inner wire 196 may be slidable longitudinally within the outer sheath 192 of the actuated medical device 190. As the second hinged arm 172 and the cover portion 184 rotate together around the second pivot axis 104, the inner wire 196 can be translated longitudinally and / or axially relative to the outer sheath 192. Thus, the second actuated mechanism 170 may be configured to actuate and / or translate an end effector 199 (e.g., Figure 11) toward the distal end of the inner wire 196 by the longitudinal movement of the inner wire 196 relative to the outer sheath 192. The base portion 186 of the actuated housing includes an actuated slot 188 formed therein. The proximal portion of the inner wire 196 may extend between the proximal end of the inner wire 196, which is engaged and / or connected to the outer sheath 192 and the cover portion 184 within the operating slot 188.

[0075] As can also be seen in Figure 9, the base portion 186 may include a stroke limiting slot 181 formed therein. The stroke limiting slot 181 may be configured to receive and / or engage with a stroke length projection 181B (e.g., Figure 10) extending from the bottom of the cover portion 184. The stroke limiting slot 181 may be configured to limit the translation (e.g., rotational translation, etc.) and / or stroke length of the second hinged arm 172 and the cover portion 184 relative to the base portion 186 and / or the proximal handle portion 112. In some embodiments, a stroke limiting element 181A may be placed within the stroke limiting slot 181. The stroke limiting element 181A may be replaceable and / or interchangeable to receive different sized end effectors 199 (e.g., Figure 11) at the distal end of the inner wire 196 and / or the actuated medical device 190. The limits at both ends of the stroke limiting slot 181 (which may or may not have a stroke limiting element 181A depending on the end effector 199) can allow for a fully open end effector 199 and a fully closed end effector 199. In other embodiments, the second actuation mechanism may include different stroke limiting mechanisms, such as a projection that moves between end stops.

[0076] In some embodiments, the base portion 186 of the operating housing of the second operating mechanism 170 may include a mounting slot 183 configured to receive the proximal end of the outer sheath 192 and / or the proximal end of the annular strain relief 194. In some embodiments, the proximal end of the annular strain relief 194 of the operable medical device 190 may be fixedly attached to the base portion 186 of the operating housing of the second operating mechanism 170, and the inner wire 196 may engage with, connect to, and / or attach to the cover portion 184 of the operating housing of the second operating mechanism 170. For example, the cover portion 184 of the operating housing may include an operating projection 189 (e.g., Figure 10) extending from its bottom and configured to be received in an operating slot 188. The proximal end of the inner wire 196 can be connected to and / or attached to the operating projection 189, such that the rotation of the second hinged arm 172 and the cover portion 184 causes axial translation of the inner wire 196 relative to the outer sheath 192 of the actuarial medical device 190. In some embodiments, the proximal end of the outer sheath 192 can be fixedly attached to the base portion 186 of the operating housing.

[0077] In some embodiments, the outer sheath 192 can be made axially movable within an annular strain relief 194. In some embodiments, the outer sheath 192 may include a stop 193 (e.g., Figure 10) fixed to its proximal end. In some embodiments, the second actuation mechanism 170 may optionally include a compression spring 198 associated with the proximal end of the actuated medical device 190 and / or the proximal end of the outer sheath 192. The compression spring 198 may be positioned in communication with the mounting slot 183 and / or the actuation slot 188 within an enlarged portion of the mounting slot 183 (e.g., secondary slot 183A). In at least some embodiments, the proximal portion of the inner wire 196 may extend from the proximal end of the outer sheath 192 through the compression spring 198 in the secondary slot 183A into the actuation slot 188. In some embodiments, the stop 193 may be positioned within an enlarged portion of the mounting slot 183 (e.g., secondary slot 183A). The compression spring 198 can be configured to bias the stop 193 and / or the outer sheath 192 toward the distal end of the mounting slot 183 and / or the secondary slot 183A.

[0078] Figures 10–12 illustrate the operation of the second actuation mechanism 170 and the actuarial medical device 190. For clarity, only some elements of the second actuation mechanism 170 are shown. In at least some embodiments, the second actuation mechanism 170 and the actuarial medical device 190 can be formed as subassemblies that can be replaced and / or swapped as needed on the medical device 100. As discussed herein, the actuarial medical device 190 may include an end effector 199 (e.g., Figure 11) positioned at the distal end of the inner wire 196. In Figure 10, the end effector 199 is positioned in a crushing configuration. The end effector 199 can be extended or otherwise deployed using the second actuation mechanism 170 when the distal tip 142 of the elongated shaft 140 is positioned in the area of ​​interest for treatment.

[0079] The following description relates to a second actuation mechanism 170 in which a cover portion 184 (not shown) is oriented toward the user. Those skilled in the art will recognize that it is not necessary for the medical device 100 and / or the second actuation mechanism 170 to be oriented and / or positioned in this manner during use. Rather, the foregoing references regarding the orientation of the second actuation mechanism 170 are for illustrative purposes only and are not intended to be limiting. The thumb 12 of the first hand 10 (e.g., Figure 3) can be used to translate, move, and / or actuate the second hinged arm 172 of the second actuation mechanism 170. The thumb 12 can also be used to press and hold the second actuation mechanism 170 inward toward the handle 110 (not shown) so as to unlock the second actuation mechanism 170 by disengaging a second tooth 180 (not shown) from a plurality of second teeth 182. Next, while the second actuation mechanism 170 is unlocked, the thumb 12 can move and / or rotate the second hinged arm 172 of the second actuation mechanism 170 relative to the base portion 186 and / or proximal handle portion 112 to actuate the inner wire 196 of the actuated medical device 190 relative to the outer sheath 192 of the actuated medical device 190 and / or move it longitudinally. Figure 10 shows an end effector 199 positioned in a crushed configuration within the distal end of the outer sheath 192, which can therefore be considered to define the fixed position of the second hinged arm 172 of the second actuation mechanism 170.

[0080] As shown in Figure 10, the proximal portion of the inner wire 196 extends from the proximal end and / or stop 193 of the outer sheath 192 to the operating projection 189 within the secondary slot 183A and the operating slot 188. The proximal end of the inner wire 196 can engage with, connect to, and / or attach to the operating projection 189, which extends distally (in the direction of viewing the drawing) from the cover portion 184 and / or away from the user into the operating slot 188. Thus, when the second hinged arm 172 and cover portion 184 of the second actuation mechanism 170 are rotated relative to the base portion 186, the operating projection 189 is translated parallel to the second hinged arm 172 and / or cover portion 184 of the second actuation mechanism 170 along an arc-shaped path within the operating slot 188 in the same direction as the rotation of the second hinged arm 172 and / or cover portion 184 of the second actuation mechanism 170. For example, Figure 11 shows the second actuation mechanism 170 after the second hinged arm 172 and cover portion 184 (not shown) of the second actuation mechanism 170 have been rotated clockwise relative to the base portion 186. Following this rotation, the actuation projection 189 extending from the cover portion 184 is rotated clockwise within the actuation slot 188. Since the proximal end of the inner wire 196 engages with, connects to, and / or attaches to the actuation projection 189, the inner wire 196 is also translated in the same clockwise direction, and therefore the inner wire 196 is translated distally within the outer sheath 192, deploying the end effector 199 outside the distal end of the outer sheath 192. As a result of releasing the second hinged arm 172 of the second actuation mechanism 170, the second biasing element 178 biases the second hinged arm 172 of the second actuation mechanism 170 back to the second locked position, and the second teeth 180 engage with the second set of teeth 182.

[0081] In some embodiments, the end effector 199 can be configured to expand to an extended configuration when deployed and / or when unconstrained. In some embodiments, the end effector 199 can be biased toward an extended configuration. In some embodiments, the end effector 199 can self-bias toward an extended configuration. Thus, in at least some embodiments, the end effector 199 can be self-expanding. In the illustrated example, the end effector 199 is shown as a collection basket or collection cage configured to capture kidney stones or other fragments. However, other end effector configurations are also conceivable.

[0082] The operation and movement of the stroke limiting feature of the second actuation mechanism 170 can be seen in Figures 10 to 12, as well as the movement of the actuation projection 189 within the actuation slot 188. As discussed herein, the base portion 186 of the second actuation mechanism 170 may include a stroke limiting slot 181 formed therein. The stroke limiting slot 181 may be configured to receive and / or engage with a stroke length projection 181B that extends distally (in the direction of viewing the drawing) from the cover portion 184 and / or away from the user into the stroke limiting slot 181. The stroke limiting slot 181 may be configured to limit the translation (e.g., rotational translation) and / or stroke length of the second hinged arm 172 and the cover portion 184 relative to the base portion 186 and / or the proximal handle portion 112. In some embodiments, the stroke limiting element 181A can be positioned within the stroke limiting slot 181 and can be replaced and / or interchangeable to accommodate different sized end effectors 199 at the distal end of the inner wire 196 and / or the operable medical device 190. The limits at both ends of the stroke limiting slot 181 (which may or may not have the stroke limiting element 181A depending on the end effector 199) can allow for both a fully open end effector 199 and a fully closed end effector 199. In some embodiments, it may be advantageous to limit the retraction of the end effector 199 and / or the inner wire 196. Thus, the stroke limiting element 181A can have a longer length and engage with the stroke length projection 181B, thereby reducing the distance the inner wire 196 and / or end effector 199 retract by preventing the second hinged arm 172 and cover portion 184 from rotating counterclockwise past the desired position relative to the base portion 186.

[0083] In some embodiments, the second actuation mechanism 170 may include a compression spring 198 positioned within the mounting slot 183 and / or its enlarged portion (e.g., secondary slot 183A). The compression spring 198 may be positioned along, across, on, and / or around the proximal portion of the inner wire 196. The compression spring 198 may be configured to engage with the proximal end of the mounting slot 183 and / or the enlarged portion of the mounting slot 183 (e.g., secondary slot 183A), and may be configured to engage with a stop 193 fixed to the proximal end of the outer sheath 192. As discussed herein, the compression spring 198 may be configured to bias the outer sheath 192 and / or the stop 193 toward the distal end of the mounting slot 183 and / or the enlarged portion of the mounting slot 183 (e.g., secondary slot 183A). Similarly, the compression spring 198 may be configured to allow and / or prevent proximal axial translation of the stop 193 and / or the outer sheath 192 within the mounting slot 183 and / or its enlarged portion (e.g., secondary slot 183A). In some embodiments, the outer sheath 192 may be axially movable and / or translatably movable within the annular strain relief 194. In some embodiments, this may be advantageous when capturing fragments 18 (e.g., Figure 12), such as kidney stones, having an outer diameter larger than the inner diameter of the outer sheath 192. Attempting to forcibly retract the inner wire 196 and / or end effector 199 while holding the fragment 18 may cause undesirable compressive forces within the outer sheath 192 and / or damage to the distal end of the outer sheath 192 and / or the end effector 199 and / or trauma to the patient.

[0084] Accordingly, in some embodiments, as can be seen in Figure 12, a second actuation mechanism 170 may be included to allow the outer sheath 192 to be moved proximal in the mounting slot 183 and / or its enlarged portion (e.g., secondary slot 183A) when the end effector 199 captures a fragment 18 and / or when the end effector 199 encounters resistance to retraction at the distal end of the outer sheath 192. The compression spring 198 may be configured to provide resistance to the proximal movement of the outer sheath 192, thereby acting as a "buffer". When the end effector 199 retracts, the outer sheath 192 and / or a stop 193 fixed to its proximal end may exert a proximal force on the compression spring 198. The compression spring 198 may be configured to exert a restorative force on the outer sheath 192 and / or the stop 193 fixed to its proximal end. When a proximal force exceeds and / or is greater than the restorative force of the compression spring 198, the compression spring 198 can be compressed and / or displaced proximal to the outer sheath 192 and / or the stop 193 fixed to its proximal end. Thus, the outer sheath 192 can move axially and / or be translated proximal to the annular strain relief 194. The compression spring 198 can be configured to compress at a known rate that can be used to limit the maximum allowable load between the outer sheath 192 and the end effector 199. In at least some embodiments, the maximum allowable load is preferably less than the smaller of the breaking strength of the outer sheath 192 and / or the breaking strength of the end effector 199. The movement of the compression spring 198 and the associated second actuation mechanism 170 can allow the end effector 199 to partially collapse against the distal end of the outer sheath 192 and / or allow the distal tip 142 of the elongated shaft 140 to capture and retain the fragments 18 distal to the distal end of the outer sheath 192 and / or distal to the distal tip 142 of the elongated shaft 140.

[0085] In an alternative configuration, the second actuation mechanism 170 can be configured to be non-self-locking. Thus, the second actuation mechanism 170 can lack and / or be absent the second biasing element 178. Furthermore, the end effector 199 can be configured to be self-closing and / or biased toward a crushing configuration. In one example, a second compression spring (not shown) can be positioned within the actuation slot 188 along, across, on, and / or around the inner wire 196. The second compression spring can be positioned between the distal end of the actuation slot 188 of the base portion 186 and the actuation projection 189 of the cover portion 184. The second compression spring can be configured to bias the actuation projection 189 toward the distal end of the actuation slot 188 when the second actuation mechanism 170 and / or the second hinged arm 172 are released by the first hand 10. A second compression spring may be configured to return the second hinged arm 172 and / or cover portion 184 to their fixed position. When returning to the fixed position, the inner wire 196 may be retracted relative to the outer sheath 192 and / or the end effector 199 may be moved toward and / or to the crush configuration. If necessary, the second hinged arm 172 may be provided with a manual locking mechanism that allows the second hinged arm 172 to maintain a displaced position away from its fixed position when the manual locking mechanism is engaged.

[0086] Figures 13 to 26 show selected embodiments of the medical device 100 and / or the first actuation mechanism 150. For clarity, some or all elements of the medical device 100 and / or the first actuation mechanism 150 are not shown. Furthermore, the shape and / or configuration of some features, such as but not limited to the handle 110, may differ. In some embodiments, the medical device 100 may include a proximal portion 144 of an elongated shaft 140 located within and / or extending longitudinally within the handle 110. The proximal portion 144 of the elongated shaft 140 can be in fluid communication with a proximal port 116 and / or a lateral port 118.

[0087] Figure 13 shows one variation of the medical device 100 in a disassembled state, and Figure 17 shows this variation of the medical device in an assembled state. In the variation shown in Figure 13, the proximal handle portion 112 can be coupled to the distal handle portion 114 and the elongated shaft 140 extending therefrom, for example, in a detachable manner. In such an example, the proximal handle portion 112, including the electronics connector and / or optical connector 124, can be a reusable component of the medical device 100, while the distal handle portion 114 and the elongated shaft 140 can be disposable components of the medical device 100. Therefore, the distal handle portion 114 and the elongated shaft 140 can be separated from the proximal handle portion 112 when it is desirable to replace them with another distal handle portion 114 and elongated shaft 140 at the completion of a medical procedure or during a medical procedure, and a new distal handle portion 114 and elongated shaft 140 can be attached to the proximal handle portion 112 for subsequent use during this medical procedure or in subsequent medical procedures such as after sterilization of the proximal handle portion 112.

[0088] As shown in Figure 13, the proximal portion 144 of the elongated shaft 140 can extend proximal to the distal handle portion 114 so as to extend into and / or through the proximal handle portion 112. When the distal handle portion 114 is assembled with the proximal handle portion 112, the proximal end of the proximal portion 144 of the elongated shaft 140 can be guided into and / or through an opening 147 (see Figure 18) in the proximal handle portion 112. In some cases, the opening 147 may include a bell-shaped region with a tapered or chamfered surface to facilitate guiding the proximal end of the proximal portion 144 of the elongated shaft 140 into it.

[0089] The proximal portion 144 of the elongated shaft 140 can have a proximal port 116 that is in fluid communication with an operating lumen that extends through the elongated shaft 140 to the distal tip 142. Furthermore, a lateral port 118 can be provided on the distal handle portion 114, which can also be in fluid communication with an operating lumen or an additional lumen that extends through the elongated shaft 140 to the distal tip 142. In other embodiments, only the lateral port 118 is present and is in fluid communication with the operating lumen of the elongated shaft 140. In such cases, the proximal shaft 144 may be lumen-less, and the proximal shaft 144 can provide support for the components of the first operating mechanism 150. In other embodiments, only the proximal port 116 is present and is in fluid communication with the operating lumen of the elongated shaft 140.

[0090] As shown in Figure 14, in some embodiments, the proximal portion 144 of the elongated shaft 140 may include a proximal lock 146 configured to axially lock the elongated shaft 140 and / or its proximal portion 144 with respect to the handle 110 and / or proximal handle portion 112 when the distal handle portion 114 is coupled to the proximal handle portion 112. For example, as shown in Figure 17, when the distal handle portion 114 is fully coupled to the proximal handle portion 112, the proximal lock 146 may extend from and / or engage with the proximal surface of the proximal handle portion 112. For example, the proximal lock 146 may include a deflectable tab configured to engage with the proximal surface of the proximal handle portion 112 when the distal handle portion 114 is coupled to the proximal handle portion 112. Other locking mechanisms have also been considered.

[0091] As shown in Figure 16, in some cases, the distal handle portion 114 may, in place of or in addition to, include a distal lock 148 configured to engage with the proximal handle portion 112 when fully engaged with the proximal handle portion 112. For example, the distal handle portion 114 may include one or more tabs configured to engage with a mating locking structure (e.g., a slot, groove, etc.) of the proximal handle portion 114. In some cases, each tab can be engaged by rotation into a corresponding slot formed in the proximal handle portion 112. In this case, the tab can be inserted longitudinally into the corresponding slot, and then the distal handle portion 114 can be rotated relative to the proximal handle portion 112 until the tab is in the locked position. Other locking mechanisms have also been considered. The proximal surface of the distal handle portion 114 may include a lip 149 configured to mate into the proximal handle portion 112 when fully engaged with the proximal handle portion 112. The distal lock 148 is configured to lock the distal handle portion 114 by rotation relative to the proximal handle portion 112. However, in other embodiments, such as other variations described herein, the distal lock 148 may allow relative rotation of the distal handle portion 114 and the elongated shaft 140 relative to the proximal handle portion 112.

[0092] The distal handle portion 114 may include an electrical interface, such as an electrical / data plug or connector, configured to complete a detachable electrical connection with a mating electrical interface on the proximal handle portion 112 when fully coupled with the proximal handle portion 112. Thus, the mating electrical interface can electrically connect the electronics connector and / or optical connector 124 of the proximal handle portion 112 to an optical system and / or illumination means extending through the elongated shaft 140 to the distal tip 142.

[0093] Next, the details of the first actuation mechanism 150 will be described in more detail below. Referring to Figure 15, the first actuation mechanism 150 may include a first gear 130 positioned along, across, on, and / or around the proximal portion 144 of the elongated shaft 140 and positionable within the proximal handle portion 112. The first gear 130 may be operably connected to the distal end 142 of the elongated shaft 140 by one or more tension wires 128. Thus, the tension wires 128 can extend from the first gear 130 to the distal end 142 and be fixed therein. In some embodiments, the first actuation mechanism 150 may include a second gear 132 positioned within the proximal handle portion 112 and configured to operably connect to and / or engage with the first gear 130 when the distal handle portion 114 is fully coupled to the proximal handle portion 112. A third drive gear 134 can be operably connected to the first hinged arm 152 of the first actuation mechanism 150. However, in some embodiments, a second gear 132 can be operably connected to the first hinged arm 152 of the first actuation mechanism 150. It is understood that any desired arrangement and / or quantity of gears can be used as needed. In some embodiments, one or more additional gears can be provided as means for changing and / or adjusting the gear ratio, torque transmission rate, or other factors between the first gear 130, the second gear 132, the third gear 134, and / or one or more additional gears. The second gear 132 can engage with the third drive gear 134 such that the third drive gear 134 causes the second gear 132 to rotate in the opposite direction. Therefore, as shown in the detailed view of Figure 18, the user's operation of the first hinged arm 152 results in the rotation of the first gear 130 by the corresponding rotations of the third drive gear 134 and the second gear 132, which in turn results in longitudinal movement of the tension wire 128 and deflects the distal tip 142.

[0094] As shown in Figure 18, the first gear 130 of the first actuation mechanism 150 may have a substantially circular cross-sectional shape, and the central axis of the first gear 130 is oriented substantially perpendicular to the central longitudinal axis of the proximal portion 144 of the elongated shaft 140. The first gear 130 can be rotatably fixed to the proximal portion 144 of the elongated shaft 140. Thus, the first gear 130 of the first actuation mechanism 150 can be configured to rotate about the central axis of the first gear 130 relative to the proximal portion 144 of the elongated shaft 140. Movement of the first gear 130 along the axial and / or longitudinal directions of the proximal portion 144 of the elongated shaft 140 can be prevented.

[0095] The first gear 130 of the first actuation mechanism 150 may include a first plurality of gear teeth extending around it. The second gear 132 of the first actuation mechanism 150 may include a second plurality of gear teeth extending around at least a portion of it. The first plurality of gear teeth of the first gear 130 of the first actuation mechanism 150 may be configured to engage with the second plurality of gear teeth of the second gear 132 of the first actuation mechanism 150.

[0096] In some cases, the proximal portion 144 of the elongated shaft 140 is deflected away from the longitudinal axis to allow the first gear 130 to engage with the second gear 132 when the distal handle portion 114 is coupled to the proximal handle portion 112. The deflection of the proximal portion 144 of the elongated shaft 140 can generate a deflection force that facilitates the engagement of the gear teeth of the first gear 130 with the gear teeth of the second gear 132. To maintain the engagement and alignment between the first set of gear teeth of the first gear 130 and the second set of gear teeth of the second gear 132, the distal handle portion 114 and the elongated shaft 140 can be made immobile relative to the proximal handle portion 112.

[0097] The tension wire 128 may include a first wire having opposing ends fixed to the distal end 142 of the elongated shaft 140. The first wire can be wound around the first gear 130 so as to define a first portion extending from the pulley 136 to the distal end 142 and a second portion extending from the pulley 136 to the distal end 142. In an alternative configuration, the proximal end of the tension wire 128 can be fixed to the first gear 130 of the first actuation mechanism 150, and the distal end of the tension wire 128 can be fixed to the distal end 142 of the elongated shaft 140.

[0098] When the first hinged arm 152 rotates counterclockwise (as shown in Figure 18), the first gear 130 can be rotated counterclockwise with respect to the proximal portion 144 of the elongated shaft 140. In this case, tension is applied to one of the tension wires 128, thereby deflecting the distal tip 142 in a first direction within a deflection plane substantially aligned with the side port 118 to provide a visual indication of the orientation of the distal tip 142. Similarly, when the first hinged arm 152 rotates clockwise (as shown in Figure 18), the first gear 130 can be rotated clockwise with respect to the proximal portion 144 of the elongated shaft 140. In this case, tension is applied to the other of the tension wires 128, thereby deflecting the distal tip 142 in a second direction substantially opposite to the first direction within the deflection plane.

[0099] Figures 19 to 24 illustrate another variant of the medical device 100. This variant shares many features of the embodiments described with respect to Figures 13 to 18. Figure 19 shows the medical device 100 in a disassembled state, and Figure 23 shows this variant of the medical device in an assembled state. In the variant shown in Figure 19, the proximal handle portion 112 is coupled to the distal handle portion 114 and the elongated shaft 140 extending therefrom, and can be coupled, for example, detachably. In such a case, the proximal handle portion 112, including the electronics connector and / or optical connector 124, can be a reusable component of the medical device 100, while the distal handle portion 114 and the elongated shaft 140 can be disposable components of the medical device 100. Therefore, the distal handle portion 114 and elongated shaft 140 can be separated from the proximal handle portion 112 when it is desirable to replace them with another distal handle portion 114 and elongated shaft 140 at the completion of a medical procedure or during a medical procedure, and the new distal handle portion 114 and elongated shaft 140 can be attached to the proximal handle portion 112 for subsequent use during this medical procedure or in subsequent medical procedures such as after sterilization of the proximal handle portion 112.

[0100] The elongated shaft 140 and / or the distal handle portion 114 may include a lock for connecting them to the proximal handle portion 112. For example, the proximal portion 144 of the elongated shaft 140 may include a proximal lock 146, as shown in Figure 20, configured to axially lock the elongated shaft 140 and / or its proximal portion 144 with respect to the handle 110 and / or the proximal handle portion 112 when the distal handle portion 114 is connected to the proximal handle portion 112. For example, as shown in Figure 24, when the distal handle portion 114 is fully connected to the proximal handle portion 112, the proximal lock 146 may extend from and / or engage with the proximal surface of the proximal handle portion 112. For example, the proximal lock 146 may include a deflectable tab configured to engage with the proximal surface of the proximal handle portion 112 when the distal handle portion 114 is connected to the proximal handle portion 112. Other locking mechanisms have also been considered. The proximal lock 146 (e.g., a locking tab) can allow relative rotation of the elongated shaft 140 (and therefore the distal handle portion 114) with respect to the proximal handle portion 112 while preventing longitudinal movement between them.

[0101] In the variations shown in Figures 19 to 24, the distal handle portion 114 and the elongated shaft 140 are configured to rotate relative to the proximal handle portion 112 when coupled to it. For example, as shown in Figure 24, when the distal handle portion 114 is fully coupled to the proximal handle portion 112, the proximal lock 146 can extend from and / or engage with the proximal surface of the proximal handle portion 112. For example, the proximal lock 146 may include a deflectable tab configured to engage with the proximal surface of the proximal handle portion 112 when the distal handle portion 114 is coupled to it. Other locking mechanisms have also been considered. Furthermore, as shown in Figure 22, the proximal surface of the distal handle portion 114 may include a lip 149 configured to fit into the proximal handle portion 112 when fully engaged with it. The lip 149 enables rotational engagement between the distal handle portion 114 and the proximal handle portion 112 when the distal handle portion 114 is coupled to the proximal handle portion 112.

[0102] The distal handle portion 114 may include an electrical interface, such as an electrical / data plug or connector, configured to complete a detachable electrical connection with a mating electrical interface on the proximal handle portion 112 when fully coupled with the proximal handle portion 112. Thus, the mating electrical interface can electrically connect the electronics connector and / or optical connector 124 of the proximal handle portion 112 to an optical system and / or illumination means extending through the elongated shaft 140 to the distal tip 142.

[0103] The proximal portion 144 of the elongated shaft 140 can have a proximal port 116 that is in fluid communication with an operating lumen extending through the elongated shaft 140 to the distal tip 142. Furthermore, a distal handle portion 114 can be provided in the side port 118, which can also be in fluid communication with an operating lumen extending through the elongated shaft 140 to the distal tip 142 or with an additional lumen. In this variation, when the elongated shaft 140 is rotated relative to the proximal handle portion 112 while remaining rotatably coupled to the proximal handle portion 112, the proximal portion 144 of the elongated shaft, including the proximal port 116, and the side port 118 provided in the distal handle portion 114 can rotate relative to the proximal handle portion 112. In another embodiment, only the side port 118 exists and is in fluid communication with the operating lumen of the elongated shaft 140. In such cases, the proximal shaft 144 may be without a lumen, and the proximal shaft 144 can provide support to the components of the first actuation mechanism 150. In other embodiments, only the proximal port 116 is present and is in fluid communication with the actuation lumen of the elongated shaft 140.

[0104] In this modification, the first actuation mechanism 150 can enable rotation of the distal handle portion 114 and the elongated shaft 140 relative to the proximal handle portion 112. As shown in Figure 21, the first gear 130 of the first actuation mechanism 150, which can be a worm gear, can have a substantially circular cross-sectional shape, and the central axis of the first gear 130 is oriented substantially parallel to the central longitudinal axis of the proximal portion 144 of the elongated shaft 140. In at least some embodiments, the central axis of the first gear 130 can be coaxial with the central longitudinal axis of the proximal portion 144 of the elongated shaft 140. In some embodiments, the first gear 130 of the first actuation mechanism 150 can be substantially cylindrical. The first gear 130 may include a central lumen extending axially through it. In some embodiments, the first gear 130 of the first actuation mechanism 150 can be slidably positioned along, across, on, and / or around the proximal portion 144 of the elongated shaft 140. In some embodiments, the proximal portion 144 of the elongated shaft 140 can extend axially through the central lumen of the first gear 130. Thus, the first gear 130 of the first actuation mechanism 150 can be configured to move and / or slide axially relative to the proximal portion 144 of the elongated shaft 140. In at least some embodiments, the proximal portion 144 of the elongated shaft 140 may include a radially outward-extending axial rib 131 configured to engage with a corresponding recess (not shown) formed in the first gear 130, thereby preventing relative rotational movement between the first gear 130 and the proximal portion 144 of the elongated shaft 140. Other configurations (e.g., set screws, hook features, non-circular proximal portion 144, etc.) have also been considered to prevent relative rotational movement between the first gear 130 and the proximal portion 144 of the elongated shaft 140.

[0105] The first gear 130 of the first actuation mechanism 150 may include a plurality of first gear teeth extending along its length. Each tooth of the plurality of first gear teeth may extend circumferentially around the first gear 130 of the first actuation mechanism 150. The second gear 132 of the first actuation mechanism 150 may include a plurality of second gear teeth extending around at least a portion of it. The plurality of first gear teeth of the first gear 130 of the first actuation mechanism 150 may be configured to engage with a plurality of second gear teeth of the second gear 132 of the first actuation mechanism 150.

[0106] The proximal end of the tension wire 128 can be fixed to the first gear 130 of the first actuation mechanism 150, and the distal end of the tension wire 128 can be fixed to the distal tip 142 of the elongated shaft 140. As shown in Figure 21, the tension wire 128 includes a first wire fixed to the distal surface of the first gear 130 and extending distally from there to the distal tip 142, and a second wire fixed to the proximal surface of the first gear 130 and extending proximal from there to the pulley 136, extending around the pulley 136, and then distally from the pulley 136 through a passage 131 formed in the first gear 130 to the distal tip 142.

[0107] As shown in Figure 24, when the first hinged arm 152 rotates counterclockwise, the first gear 130 can be axially translated proximal along the proximal portion 144 of the elongated shaft 140. At this time, tension is applied to the first wire of one or more wires 128, thereby deflecting the distal tip 142 in a first direction within a deflection plane substantially aligned with the side port 118 to provide a visual indication of the orientation of the distal tip 142. Similarly, when the first hinged arm 152 rotates clockwise (as seen in Figure 24), the first gear 130 can be axially translated distal along the proximal portion 144 of the elongated shaft 140. At this time, tension is applied to the second wire of one or more tension wires 128, thereby deflecting the distal tip 142 in a second direction substantially opposite to the first direction within the deflection plane.

[0108] In this modification, the elongated shaft 140 is fixedly attached to the distal handle portion 114 of the handle 110, but can still be attached so as to be rotatable relative to the proximal handle portion 112 of the handle 110. Thus, the distal handle portion 114 can be rotatable relative to the proximal handle portion 112. The first set of gear teeth on the first gear 130 (e.g., a worm gear) allows engagement with the second set of gear teeth on the second gear 132 regardless of the direction of rotation of the elongated shaft 140 relative to the proximal handle portion 112. The first gear 130 and pulley 136 can be configured to be immobile around the circumferential direction of the elongated shaft 140. Therefore, the first gear 130 and pulley 136 can rotate within the proximal handle portion 112 so as the elongated shaft 140 rotates relative to the proximal handle portion 112, the relative orientation of one or more wires 128 with respect to the elongated shaft 140 and / or distal tip 142 is maintained without twisting or entanglement of one or more wires 128.

[0109] Figures 25 and 26 show another variant of the medical device 100. This variant shares many features of the embodiments described with respect to Figures 13 to 18. Figure 25 shows the medical device 100 in a disassembled state, and Figure 26 shows this variant of the medical device in an assembled state. In the variant shown in Figures 25 and 26, the proximal handle portion 112 is coupled to the distal handle portion 114 and the elongated shaft 140 extending therefrom, and can be coupled, for example, detachably. In such a case, the proximal handle portion 112, including the electronics connector and / or optical connector 124, can be a reusable component of the medical device 100, while the distal handle portion 114 and the elongated shaft 140 can be disposable components of the medical device 100. Therefore, the distal handle portion 114 and elongated shaft 140 can be separated from the proximal handle portion 112 when it is desirable to replace them with another distal handle portion 114 and elongated shaft 140 at the completion of a medical procedure or during a medical procedure, and the new distal handle portion 114 and elongated shaft 140 can be attached to the proximal handle portion 112 for subsequent use during this medical procedure or in subsequent medical procedures such as after sterilization of the proximal handle portion 112.

[0110] The elongated shaft 140 and / or the distal handle portion 114 may include a lock for connecting them to the proximal handle portion 112. For example, the proximal portion 144 of the elongated shaft 140 may include a proximal lock 146 similar to those described above, configured to axially lock the elongated shaft 140 and / or its proximal portion 144 with respect to the handle 110 and / or the proximal handle portion 112 when the distal handle portion 114 is connected to the proximal handle portion 112. For example, as shown in Figure 26, when the distal handle portion 114 is fully connected to the proximal handle portion 112, the proximal lock 146 may extend from and / or engage with the proximal surface of the proximal handle portion 112. For example, the proximal lock 146 may include a deflectable tab configured to engage with the proximal surface of the proximal handle portion 112 when the distal handle portion 114 is connected to the proximal handle portion 112. In the modifications shown in Figures 25 and 26, the distal handle portion 114 and the elongated shaft 140 are configured to be fixed to the proximal handle portion 112 by rotation when they are coupled to the proximal handle portion 112. Other locking mechanisms have also been considered.

[0111] Furthermore, similar to the feature portion illustrated in Figure 16 above, the proximal surface of the distal handle portion 114 may also include a distal lock configured to engage with the proximal handle portion 112 when fully engaged with it. For example, the distal handle portion 114 may include one or more tabs configured to engage with a mating locking structure (e.g., a slot, groove, etc.) of the proximal handle portion 112. In some cases, each tab can be engaged by rotation into a corresponding slot formed in the proximal handle portion 112. In this case, the tab can be inserted longitudinally into the corresponding slot, and then the distal handle portion 114 can be rotated relative to the proximal handle portion 112 until the tab is in the locked position. Other locking mechanisms have also been considered. The proximal surface of the distal handle portion 114 may include a lip configured to mate into the proximal handle portion 112 when fully engaged with it. The distal lock is configured to lock the distal handle portion 114 relative to the proximal handle portion 112 by rotation. However, in other embodiments, such as the other modifications described herein, the distal lock may allow relative rotation of the distal handle portion 114 and the elongated shaft 140 with respect to the proximal handle portion 112.

[0112] The proximal portion 144 of the elongated shaft 140 can have a proximal port 116 that is in fluid communication with an operating lumen that extends through the elongated shaft 140 to the distal tip 142. Furthermore, a lateral port 118 can be provided on the distal handle portion 114, which can be in fluid communication with the operating lumen that extends through the elongated shaft 140 to the distal tip 142 or with an additional lumen. In other embodiments, only the lateral port 118 is present and is in fluid communication with the operating lumen of the elongated shaft 140. In such cases, the proximal shaft 144 may be lumen-less and can provide support for the components of the first actuation mechanism 150. In other embodiments, only the proximal port 116 is present and is in fluid communication with the operating lumen of the elongated shaft 140.

[0113] The details of the first actuation mechanism 150 are described in more detail below. The first actuation mechanism 150 may include a first linkage member 137 positioned along, across, on, and / or around the proximal portion 144 of the elongated shaft 140 and positionable within the proximal handle portion 112. The first linkage member 137 may be operably connected to the distal end 142 of the elongated shaft 140 by one or more tension wires 128. Thus, the tension wires 128 can extend from the first linkage member 137 to the distal end 142 and be fixed therein. The first linkage member 137 may rotate around a rotation axis that extends perpendicular to the central longitudinal axis of the elongated shaft 140.

[0114] The first actuation mechanism 150 may include a second linkage member 135 positioned within the proximal handle portion 112 and configured to operably connect to and / or engage with the first linkage member 137 when the distal handle portion 114 is fully coupled to the proximal handle portion 112. For example, the second linkage member 135 may include a cavity or recess 129 configured to receive the first linkage member 137 when the distal handle portion 114 is fully engaged with the proximal handle portion 112. In the engagement configuration, the engagement surface of the first linkage member 137 can be in direct contact with and juxtaposed with the engagement surface of the second linkage member 135, thereby enabling the transmission of force between the first linkage member 137 and the second linkage member 135. The user's operation of the first hinged arm 152 results in the rotation of the linkage member 137 by the corresponding rotation of the second linkage member 135, and thus results in longitudinal movement of the tension wire 128 that deflects the distal tip 142.

[0115] Figure 27 shows alternative configurations of the handle 110, the first actuation mechanism 150, and the second actuation mechanism 170. While this may be acknowledged, the shape, form, and / or configuration of some feature components may differ. In the illustrated configuration, the first actuation mechanism 150 may be modified by replacing the first hinged arm 152, which is configured to be operated using the thumb 12 of the first hand 10 (Figure 3), with a first trigger arm 252, which is configured to be operated using the fingers of the first hand 10 other than the thumb. This configuration still allows for one-handed operation and / or activation of the handle 110, the first actuation mechanism 150, and the second actuation mechanism 170. In some alternative embodiments, it may be acknowledged that the second hinged arm 172 of the second actuation mechanism 170, which is configured to be operated using the thumb 12 of the first hand 10 (e.g., Figure 3), may be replaced with a second trigger arm, which is configured to be operated using the fingers of the first hand 10 other than the thumb, instead of using the first trigger arm 252. In yet another alternative configuration, the first hinged arm 152 can be replaced with the first trigger arm 252, and the second hinged arm 172 can be replaced with the second trigger arm, so that both the first actuation mechanism 150 and the second actuation mechanism 170 can be actuated using their respective trigger arms. Other configurations are also considered.

[0116] The first trigger arm 252 and / or the second trigger arm can constitute and / or include many of the same features as those found on the first hinged arm 152 and / or the second hinged arm 172, respectively. For example, the first trigger arm 252 may include a first biasing element 158 ​​configured as in the first hinged arm 152. In another example, the first trigger arm 252 may include one or more projections 155 configured as in the first hinged arm 152. In yet another example, the first trigger arm 252 may include a first tooth 160 configured as in the first hinged arm 152. With respect to the second hinged arm 172, similar structures and / or features can be applied to the second trigger arm. In another example, the first trigger arm 252 and / or the second trigger arm may be self-locking with respect to the first hinged arm 152 and / or the second hinged arm 172, respectively, as described herein. Other configurations are also conceivable.

[0117] The various components of the medical systems disclosed herein and the materials that can be used for those various components may include those generally associated with medical systems and / or medical devices. For the sake of simplicity, the following discussion relates to medical systems. However, this discussion relating to medical systems is not intended to limit the devices and methods described herein, as it can be applied to other elements, members, components, or devices disclosed herein, such as but not limited to the handle 110, the elongated shaft 140, the first actuation mechanism 150, the second actuation mechanism 170, the actuariable medical device 190, and / or these elements or components.

[0118] In some embodiments, the medical system and / or its components may be made from metals, metal alloys, polymers (some examples of which are disclosed below), metal-polymer composites, ceramics, and combinations thereof, or other suitable materials.

[0119] Some examples of suitable polymers include polytetrafluoroethylene (PTFE), ethylenetetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN® available from DuPont), polyether block esters, polyurethane (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether esters (e.g., ARNITEL® available from DSM Engineering Plastics), ether-based or ester-based copolymers (e.g., butylene / poly(alkylene ether) phthalates and / or other polyester elastomers, e.g., HYTREL® available from DuPont), and polyamides (e.g., DURETHAN® or Elf available from Bayer). Available from Atochem: CRISTAMID®, elastic polyamides, block polyamides / ethers, polyether block amides (PEBA, e.g., available under the trade name PEBAX®), ethylene vinyl acetate copolymer (EVA), silicone, polyethylene (PE), MARLEX® high-density polyethylene, MARLEX® low-density polyethylene, linear low-density polyethylene (e.g., REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyether ether ketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly-p-phenylene terephthalamide (e.g., KEVLAR®), polysulfone, nylon, nylon 12 (EMS American)This may include materials such as GRILAMID® (available from Grilon), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefins, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS50A), polycarbonate, polyurethane silicone copolymers (e.g., ElastEon® from Aortech Biomaterials or ChronoSil® from AdvanSource Biomaterials), biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers, and polymer / metal composites thereof. In some embodiments, the sheath may be compounded with liquid crystalline polymer (LCP). For example, this mixture may contain up to about 6 percent LCP.

[0120] Some examples of suitable metals and metal alloys include stainless steels such as 304V stainless steel, 304L stainless steel, and 316LV stainless steel, mild steel, nickel-titanium alloys such as linear elastic nitinol and / or superelastic nitinol, other nickel alloys, such as nickel-chromium-molybdenum alloys (e.g., UNS:N06625 like INCONEL® 625, UNS:N06022 like HASTELLOY® C-22, HASTELLOY® C UNS:N10276, such as 276 (registered trademark) and other HASTELLOY (registered trademark) alloys; nickel-copper alloys (e.g., UNS:N04400, such as MONEL (registered trademark) 400, NICKELVAC (registered trademark) 400, and NICORROS (registered trademark) 400); nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R30035, such as MP35-N (registered trademark)); nickel-molybdenum alloys (e.g., HASTELLOY (registered trademark) ALLOY Cobalt-chromium alloys, cobalt-chromium-molybdenum alloys (such as UNS:R30003, e.g., ELGILOY® and PHYNOX®), platinum-enriched stainless steel, titanium, platinum, palladium, gold, combinations thereof, or any other suitable material, including UNS:N10665, other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, and other nickel-tungsten alloys or tungsten alloys.

[0121] In some embodiments, linearly elastic and / or non-superelastic nickel-titanium alloys may have nickel within about 50 to about 60 weight percent, with the remainder being essentially titanium. In some embodiments, the composition is within about 54 to 57 weight percent nickel. An example of a suitable nickel-titanium alloy is the commercially available FHP-NT alloy from Furukawa Techno Material Co., Japan. Other suitable materials may include ULTANIUM® (available from Neo-Metrics) and GUM METAL® (available from Toyota). In some other embodiments, superelastic alloys, such as superelastic nitinol, may be used to achieve desired properties.

[0122] In at least some embodiments, a medical system and / or some or all of its components may be doped, manufactured, or otherwise incorporate radiopaque materials. Radiopaque materials are understood to be materials that have the ability to produce relatively high-intensity images on a fluoroscopic screen or in other imaging techniques during a medical procedure. These relatively high-intensity images help the user of the medical system in determining its location. Some examples of radiopaque materials may include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, and polymer materials filled with radiopaque fillers. In addition, other radiopaque marker bands and / or coils may be incorporated into the design of the medical system to achieve the same result.

[0123] In some embodiments, a certain degree of magnetic resonance imaging (MRI) suitability is imparted to the medical systems and / or other elements disclosed herein. For example, the medical systems and / or their components or parts may be manufactured from materials that do not substantially distort the image and do not produce substantial distortions (i.e., gaps in the image). For example, certain ferromagnetic materials may be unsuitable because they may produce distortions in MRI images. The medical systems or parts thereof may be manufactured from materials that can be imaged by an MRI machine. Some materials exhibiting these properties include, for example, tungsten, cobalt-chromium-molybdenum alloys (UNS:R30003, e.g., ELGILOY® and PHYNOX®), nickel-cobalt-chromium-molybdenum alloys (UNS:R30035, e.g., MP35-N®), and nitinol, as well as others.

[0124] In some embodiments, the medical systems and / or other elements disclosed herein may include woven materials across or placed within a structure. The woven materials may include biocompatible materials such as polymeric materials or biomaterials adapted to promote tissue endothelial growth. In some embodiments, the woven materials may include bioabsorbable materials. Some examples of suitable woven materials include, but are not limited to, polyethylene glycol (PEG), nylon, polytetrafluoroethylene (PTFE, ePTFE), polyolefin materials such as polyethylene, polypropylene, polyester, polyurethane, and / or mixtures or combinations thereof.

[0125] In some embodiments, the medical systems and / or other elements disclosed herein may include and / or be formed from woven materials. Some examples of suitable woven materials include synthetic yarns which may be flat woven materials, molded woven materials, twisted woven materials, textured woven materials, shrink-resistant woven materials, and unshrunk-resistant woven materials. Biocompatible synthetic yarns suitable for use in the disclosure of the present invention include, but are not limited to, polyesters containing polyethylene terephthalate (PET) polyester, polypropylene, polyethylene, polyurethane, polyolefin, polyvinyl, polymethyl acetate, polyamide, naphthalenedicarboxylene derivatives, natural silk yarns, and polytetrafluoroethylene. Furthermore, at least one of the synthetic yarns may be a metallic yarn or a glass or ceramic yarn or fiber. Advantageous metallic yarns include yarns made from or containing stainless steel, platinum, gold, titanium, tantalum, or Ni-Co-Cr alloys. These yarns may further include carbon, glass, or ceramic fibers. Preferably, the yarns include, but are not limited to, polyester, polypropylene, polyethylene, polyurethane, polynaphthalene, and polytetrafluoroethylene. The yarns can be multifilamentous, monofilamentous, or spun. The selected yarn type and denier can be chosen to form a biocompatible implantable prosthesis, more specifically, a vascular structure having desirable properties.

[0126] In some embodiments, the medical systems and / or other elements disclosed herein may include and / or be used to treat appropriate therapeutic agents. Some examples of appropriate therapeutic agents include antithrombotic agents (such as heparin, heparin derivatives, urokinase, and PPack (dextrophenylalanine proline arginine chloromethyl ketone)), antiproliferative agents (such as enoxaparin, angiopeptin, monoclonal antibodies that inhibit the proliferation of smooth muscle cells, hirudin, and acetylsalicylic acid), anti-inflammatory agents (such as dexamethasone, prednisolone, corticosterone, budesonide, estrogen, sulfasalazine, and mesalamine), antitumor / antiproliferative / antimitotic agents (such as paclitaxel, 5-fluorouracil, cisplatin, vinblastine, vincristine, epothilon, endostatin, angiostatin, and thymidine kinase inhibitors), anesthetic agents (such as lidocaine, bupivacaine, and ropiodin). This may include agents such as vacaine, anticoagulants (D-Phe-Pro-Arg chloromethyl ketone, RGD peptide-containing compounds, heparin, antithrombin compounds, platelet receptor antagonists, antithrombin antibodies, antiplatelet receptor antibodies, aspirin, prostaglandin inhibitors, platelet inhibitors, and mite antiplatelet peptides), vasoconstrictors (growth factor inhibitors, growth factor receptor antagonists, transcription activators, and translation promoters), vasoconstrictors (growth factor inhibitors, growth factor receptor antagonists, transcription repressors, translation repressors, replication inhibitors, inhibitory antibodies, antibodies against growth factors, bifunctional molecules composed of growth factors and cytotoxicities, bifunctional molecules composed of antibodies and cytotoxicities), cholesterol lowering agents, vasodilators, and agents that interfere with the intrinsic vasoactive mechanism.

[0127] It should be understood that the disclosure of this invention is merely illustrative in many respects. Modifications can be made without exceeding the scope of the disclosure of this invention, particularly with respect to details, shape, size, and arrangement of steps. Such modifications may include the use of any feature of one exemplary embodiment in another embodiment, as appropriate. The scope of the disclosure of this invention is, of course, defined by the language in which the appended claims are expressed. [Explanation of Symbols]

[0128] 100 medical devices 110 Handle 118 side ports 142 Distal tip 194 Annular distortion relief

Claims

1. An endoscope configured to be operated using the user's first hand, A handle comprising a proximal handle portion and a distal handle portion, A slender shaft extending distally from the distal handle portion, Equipped with, The elongated shaft includes a distal tip that can be deflected using a first operating mechanism fixed to the proximal handle portion, The handle includes a port that communicates with the elongated shaft, Endoscopes, An operable medical device configured to be slidably positioned within the elongated shaft and the port, Equipped with, The proximal end of the operable medical device is operably connected to a second operating mechanism fixed to the proximal handle portion, the second operating mechanism includes an operating housing having a base portion and a cover portion rotatable relative to the base portion, and the proximal end of the operable medical device is fixed to the cover portion. The first operating mechanism is configured to be operated by the thumb of the first hand, The second operating mechanism is configured to be operated by the thumb of the first hand, The first operating mechanism includes a first hinged arm, a first biasing element, and a first tooth formed on the first hinged arm, the first tooth being configured to releasably engage with a plurality of first teeth formed on the proximal handle portion. The second operating mechanism includes a second hinged arm, a second biasing element, and a second tooth formed on the second hinged arm, the second tooth being configured to releasably engage with a plurality of second teeth formed on the base portion of the operating housing. An endoscope characterized by the following features.

2. The first operating mechanism is, A first gear is slidably disposed on the elongated shaft within the proximal handle portion, A second gear is disposed within the proximal handle portion and operably connected to the first gear, Includes, The first gear is operably connected to the distal tip, The second gear is operably connected to the first hinged arm. The endoscope according to feature 1.

3. The rotational movement of the first hinged arm by the thumb of the first hand causes the first gear to move parallel to the axial direction along the elongated shaft, The axial translation of the first gear causes the deflection of the distal tip. The endoscope according to feature 2.

4. The endoscope according to claim 3, characterized in that the elongated shaft is rotatable with respect to the proximal handle portion.

5. The aforementioned operable medical device is The outer sheath has an annular strain relief positioned around the proximal end of the outer sheath, An inner wire slidably disposed within the outer sheath, including, The endoscope according to feature 1.

6. The endoscope according to claim 5, characterized in that the operating housing is detachably fixed to the proximal handle portion.

7. The proximal handle portion includes a deflection indicator disposed on the outer surface of the proximal handle portion, The deflection indicator is visible when the first operating mechanism is moved away from its fixed position relative to the proximal handle portion. The endoscope according to any one of claims 1 to 6.

8. The distal handle portion is detachably connected to the proximal handle portion. The elongated shaft has a distal portion extending distally from the distal handle portion and a proximal portion extending proximal to the proximal handle portion from the distal handle portion. The first gear or linkage located within the proximal handle portion engages with the second gear or linkage connected to the proximal handle portion when the distal handle portion is connected to the proximal handle portion. The endoscope according to feature 1.

9. The first gear or linkage is a worm gear that is slidable longitudinally along the proximal portion of the elongated shaft, The aforementioned second gear or linkage is a second gear, The worm gear is configured to engage with the second gear, The device further comprises a plurality of tension wires extending from the worm gear to the distal tip, The distal handle portion and the elongated shaft are rotatably coupled to the proximal handle portion. The endoscope according to feature 8.

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