Medical device locking assembly and methods of using the same
By introducing first and second actuators and a rack structure into the medical device, the problem of unstable positioning of the medical device in minimally invasive surgery is solved, achieving more efficient control and positioning of the target treatment site, reducing surgical complexity and patient injury risk.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Filing Date
- 2020-12-29
- Publication Date
- 2026-03-17
AI Technical Summary
In minimally invasive surgery, the reliability of positioning and holding medical devices inside the patient is insufficient, leading to increased surgical complexity and potential risks of patient injury.
A medical device with first and second actuators is used to selectively move and lock the tool and sheath through a rack and pinion structure and a spring biasing mechanism, ensuring stable positioning of the device at the target treatment site.
It improves the control and positioning reliability of medical devices at the target treatment site, simplifies surgical procedures, and reduces the risk of injury to patients.
Smart Images

Figure CN114929128B_ABST
Abstract
Description
[0001] Cross-references to related applications
[0002] This application claims priority to U.S. Provisional Patent Application No. 62 / 957,553, filed January 6, 2020, the entire contents of which are incorporated herein by reference. Technical Field
[0003] Various aspects of this disclosure generally relate to medical systems, devices, and related methods. As examples, this disclosure relates to systems, devices, and related methods for securely positioning and / or locking one or more medical devices inside a patient during surgery, among other aspects. Background Technology
[0004] Technological advancements have provided users of medical systems, devices, and methods with the ability to perform increasingly complex surgeries on patients. One challenge in minimally invasive surgery (such as endoscopy, laparoscopy, and thoracoscopic procedures, among others) relates to providing access to and control over medical devices during surgery. Placing such devices inside the patient can be difficult. Furthermore, maintaining the desired position of the device after placement without requiring continuous manual control is unreliable. Restrictions on medical devices that facilitate the placement of other instruments can prolong procedures, limit their effectiveness, and / or lead to patient injury due to device failure or breakage. Summary of the Invention
[0005] Furthermore, aspects of this disclosure relate to systems, apparatuses, and methods for approaching a target treatment site with a medical device having a locking component that facilitates device positioning, as well as other aspects. Each aspect of the disclosed aspects may include one or more of the described features associated with any other disclosed aspect.
[0006] According to one example, the medical device includes: a handle, a sheath extending from the handle, and a tool located within the sheath and movable relative to the sheath. The handle includes an inner body and an outer body disposed above the inner body. The outer body is movable relative to the inner body. The handle includes a first actuator fixed to the tool. The first actuator has an actuated state that allows movement of the tool relative to the sheath in response to movement of the outer body relative to the inner body. The handle includes a second actuator fixed to the sheath. The second actuator has an actuated state that allows movement of the sheath relative to the tool in response to movement of the second actuator relative to the outer body. The de-actuated states of the first and second actuators prevent movement of the tool relative to the sheath.
[0007] Any medical device described herein may have any of the following features. Longitudinal movement of the second actuator causes longitudinal movement of the sheath relative to the inner and outer bodies. When in an undriven state, the first actuator prevents movement of the outer body relative to the inner body. When in an undriven state, the second actuator prevents movement of the sheath relative to the inner and outer bodies. The inner body includes a plurality of teeth extending along the outer surface of the inner body. The first actuator includes one or more teeth configured to engage with one or more teeth of the plurality of teeth of the inner body when in the undriven state. A first spring is also included, disposed between the first actuator and the outer body, wherein the first spring is configured to radially outwardly bias the first actuator relative to the outer body and hold the first actuator in the undriven state. Wherein, when a radially inward force exceeding the bias of the first spring is applied to the first actuator, the first actuator is in an driven state, and one or more teeth of the first actuator are spaced apart from all of the plurality of teeth of the inner body. The inner body includes a plurality of teeth extending along the outer surface of the inner body. The second actuator includes one or more teeth configured to engage with one or more teeth of a plurality of teeth of the inner body when in an undriven state. A second spring is also included, disposed between the second actuator and the outer body, wherein the second spring is configured to radially outwardly bias the second actuator relative to the outer body and hold the second actuator in an undriven state. When a radially inward force exceeding the bias of the second spring is applied to the actuator, the second actuator is in a driven state, and one or more teeth of the second actuator are spaced apart from all of the plurality of teeth of the inner body. The first actuator includes one or more first teeth configured to engage with one or more teeth of a plurality of teeth of the inner body when in an undriven state. A first spring is also included, disposed between the first actuator and the outer body, wherein the first spring is configured to radially outwardly bias the first actuator relative to the outer body and hold the first actuator in an undriven state. When the first actuator is in a driven state, one or more teeth of the first actuator are spaced apart from all of the plurality of teeth of the inner body. The handle also includes an active connector configured to communicatively connect the sheath to the high-frequency surgical electrosurgical unit, and the sheath contains conductive material, wherein the active connector is connected to the sheath via a second actuator.
[0008] According to another example, a medical device includes: a sheath, a tool located within the sheath and movable relative to the sheath, and a handle disposed above the sheath and movable relative to the sheath. The handle includes: an inner body, an outer body disposed above the inner body and movable relative to the inner body, a first actuator configured to move the tool relative to the sheath and the inner body when in an actuated state, and a second actuator configured to move the sheath relative to the inner body, the outer body, and the tool when in an actuated state. The first and second actuators engage with the inner body when in an unacted state to prevent movement of the tool and the sheath.
[0009] Any medical device described herein may have any of the following features: It also includes a plurality of teeth extending along the exterior of the inner body, and one or more teeth extending from the first actuator and configured to engage with one or more teeth of the plurality of teeth of the inner body when in an undriven state. It also includes a first spring disposed between the first actuator and the outer body, the first spring being configured to radially outwardly bias the first actuator relative to the outer body to hold the first actuator in an undriven state. Wherein, when a radially inward force exceeding the bias of the first spring is applied to the first actuator, the first actuator is in an driven state, and one or more teeth of the first actuator are spaced apart from all of the plurality of teeth of the inner body. It also includes one or more teeth extending from the second actuator and configured to engage with one or more teeth of the plurality of teeth of the inner body when in an undriven state. It also includes a second spring disposed between the second actuator and the outer body, the second spring being configured to radially outwardly bias the second actuator relative to the outer body to hold the second actuator in an undriven state. When a radial inward force exceeding the bias of the second spring is applied to the second actuator, the second actuator is in a driven state, and one or more teeth of the second actuator are spaced apart from all the teeth of the inner body.
[0010] According to another example, a medical device includes a sheath and a tool movable within the sheath. The medical device includes a first actuator, a second actuator, an outer body, and an inner body movable within the outer body. When in an actuated state, the first actuator is operably permitted to allow movement of the tool relative to the sheath and of the outer body relative to the inner body. When in an actuated state, the second actuator is operably permitted to allow movement of the sheath relative to the tool and relative to both the outer and inner bodies. When in an unactuated state, the first and second actuators together operably prevent movement of the tool relative to the sheath and of the sheath relative to both the tool and the inner body.
[0011] It is understood that the foregoing overview and the following detailed description are merely exemplary and illustrative, and not intended to limit the invention as claimed. Attached Figure Description
[0012] The accompanying drawings, which are incorporated in and form part of this specification, illustrate exemplary aspects of this disclosure and, together with the description, are used to explain the principles of this disclosure.
[0013] Figure 1 This is a side view of an exemplary medical system including a medical device and a medical apparatus according to various aspects of this disclosure, wherein the medical device has a first actuator and a second actuator;
[0014] Figure 2 Based on all aspects of this disclosure Figure 1 A top view of a medical device;
[0015] Figure 3 Based on all aspects of this disclosure Figure 1 A partially exploded side view of a medical device;
[0016] Figure 4 It is in a driven state according to various aspects of this disclosure. Figure 1 A cross-sectional side view of the first actuator of a medical device;
[0017] Figure 5 Based on all aspects of this disclosure Figure 1 Exploded side view of the first actuator of the medical device;
[0018] Figure 6 It is in an undriven state according to various aspects of this disclosure. Figure 1 A cross-sectional side view of the second actuator of the medical device;
[0019] Figure 7 Based on all aspects of this disclosure Figure 1 Exploded side view of the second actuator of the medical device;
[0020] Figure 8 This is a side view of another exemplary medical system including a medical device and a medical apparatus according to various aspects of this disclosure, wherein the medical device includes a first actuator and a second actuator;
[0021] Figure 9 It is locked according to all aspects of this disclosure. Figure 8 A cross-sectional side view of the second actuator of the medical device; and
[0022] Figure 10 Based on all aspects of this disclosure Figure 8 An exploded side view of the second actuator of the medical device. Detailed Implementation
[0023] Examples of this disclosure include systems, devices, and methods for controlling one or more components of a medical device at a target site located inside the body, wherein these components generally require manual control or manipulation to approach the target site. Examples of various aspects of the invention will now be described in detail with reference to the accompanying drawings. Wherever possible, the same or similar reference numerals will be used throughout the drawings to refer to the same or similar components. The term “distal” refers to the portion furthest from the user when the device is inserted into the patient. Conversely, the term “proximal” refers to the portion closest to the user when the device is placed into the patient. The words “comprising,” “including,” or any other variations thereof, as used herein, are intended to cover non-exclusive inclusion, such that a process, method, article, or device that comprises a list of elements does not necessarily include only those elements, but may include other elements not expressly listed or inherent to such process, method, article, or device. The word “exemplary” is used in the sense of “example” rather than “ideal.” The words “about,” “approximately,” and “about”, as used herein, represent a range of values within + / - 10% of the stated values.
[0024] The various embodiments of this disclosure can be used to facilitate the control and positioning of a medical device at a target treatment site by providing one or more mechanisms and / or components for securing the tool / device to the target treatment site. For example, some embodiments employ a first actuator and a second actuator on the medical device for selective control and / or manipulation of a medical device received within the medical device. The medical device may include: an inner body (which defines an inner cavity configured to receive a medical device therein), and an outer body disposed above the inner body and movable relative to the inner body. The medical device may include a sheath and a tool disposed within the sheath. The first actuator may be located on the outer body and coupled to the tool of the medical device (e.g., an access cannula, needle, etc.), and the second actuator may be located on the outer body and coupled to the sheath of the medical device. The first actuator may be configured to move the tool relative to the sheath and move the outer body relative to the inner body, and the second actuator may be configured to move the tool relative to the sheath and move the second actuator relative to the outer body.
[0025] Examples of this disclosure may relate to apparatus and methods for performing various medical procedures and / or treating portions of the large intestine (colon), small intestine, cecum, esophagus, gastrointestinal tract, and any other portion, and / or any other suitable patient anatomical site (collectively referred to herein as a "target treatment site"). These apparatuses and related methods may be used with a laparoscope or endoscope, or for any other open or minimally invasive surgery (including thoracoscopic and otolaryngological surgeries). Reference will now be made in detail to the examples of this disclosure described above and illustrated in the accompanying drawings. Wherever possible, the same reference numerals will be used throughout the drawings to refer to the same or similar components.
[0026] Figure 1 A schematic diagram of an exemplary medical system 100 is shown. The medical system 100 may include a medical device 110 and a medical instrument 170. In this example, the medical device 110 has a handle including an outer body 112 and an inner body 120, wherein the outer body 112 has a longitudinal length defining an inner cavity, the size and shape of which are designed and configured to receive the inner body 120. As described in more detail herein, the outer body 112 is configured to move relative to the inner body 120, and vice versa, the inner body 120 is configured to move relative to the outer body 112. The inner body 120 of the medical device 110 has a longitudinal length defining an inner cavity, the size and shape of which are designed and configured to receive the medical instrument 170.
[0027] In this example, the inner body 120 includes a rack portion having a plurality of teeth 122 extending along the outer surface of the inner body 120. The plurality of teeth 122 extend in a predetermined portion (e.g., longitudinal length) of the inner body 120, which corresponds to a range of motion of the outer body 112 relative to the inner body 120. Therefore, it should be understood that, without departing from the scope of this disclosure, the rack portion including the plurality of teeth 122 may extend along various other suitable lengths and / or surfaces of the inner body 120, from only a portion of the longitudinal length of the inner body 120 to at most the entire longitudinal length of the inner body 120, different from those illustrated and described herein. The medical device 110 may also include: an end cap 114, an active pin or connector 116, and a rotating assembly 118 disposed on and / or coupled to the outer body 112. The end cap 114 of the medical device 110 may be located proximal to the outer body 112 and configured to close the cavity of the outer body 112.
[0028] Furthermore, the medical device 170 of the medical system 100 may include a catheter having a sheath 172, a cannula 176, and a needle 179. The cannula 176 may be disposed within the lumen of the sheath 172, and the needle 179 may be disposed within the lumen of the cannula 176 and may extend at least partially outward from the tip 178 of the cannula 176. Although the needle 179 is described herein, it should be understood that the exemplary medical device 170 of this disclosure may be a tool having any end effector (including, but not limited to, a gripper, a snare, forceps, scissors, etc.). In this example, the position, orientation, and / or configuration of the needle 179 relative to the cannula 176 is fixed such that the distal end of the needle 179 is held in an extended position relative to the tip 178 of the cannula 176. The sheath 172 includes a tip 174 and has a longitudinal length defined by the distance between the tip 174 and the proximal end (not shown) of the sheath 172. The cannula 176 of the medical device 170 includes a tip 178 and has a longitudinal length defined by the distance between the tip 178 and the proximal end (not shown) of the cannula 176. As described in more detail herein, one or more components of the medical device 110 may be configured and operatively positioned relative to a target treatment site within a patient (e.g., a patient anatomical site). For example, the medical device 170 may operatively puncture a target treatment site with the needle 179 when the needle 179 is extended distally to the tip 174, or may be capable of performing a medical procedure with a desired end effector.
[0029] Still refer to Figure 1 In some instances, the medical device 170 can be operatively facilitated by a cannula 176 to allow one or more tools and / or devices (including a needle 179 and / or together with the needle 179) to reach a target treatment site. In this case, when the needle 179 is removed from the lumen of the cannula 176, one or more additional tools and / or devices can be received through the lumen of the cannula 176 and extend outwardly and distally therefrom via the tip 178 of the cannula 176. Furthermore, in some instances, the medical device 170 can be operatively operatively ablated by electrosurgical ablation of the target treatment site using a sheath 172. In this case, the sheath 172 includes an electrosurgical sheath and the tip 174 includes an electrosurgical tip. It should be understood that in other instances, the medical device 170 may include a variety of other suitable tools, configurations, hypotubes, and / or components different from those illustrated and described herein. By way of illustrative examples, in some instances, medical device 170 may include an electrosurgical end (e.g., a cyst incision needle) with the tip 178 omitted, for example, for delivering a stent during surgery. In other instances, medical device 170 omits components for electrical activation.
[0030] As in Figure 2As seen, the outer body 112 of the medical device 110 may include one or more slots 109 arranged through the outer body 112. In this case, the inner cavity of the outer body 112 can be accessed via one or more slots 109. In this example, the outer body 112 includes a pair of slots 109 formed along the longitudinal length of the outer body 112 and positioned along opposite sides of the outer body 112 (e.g., along the upper and lower surfaces of the outer body 112). As described in more detail below, one or more slots 109 of the outer body 112 are configured to slidably receive one or more components of the medical device 110, such as the second actuator 140.
[0031] In this example, the inner body 120 of the medical device 110 may further include one or more slots 124 disposed through the inner body 120. In this case, the interior of the inner body 120 can be accessed via one or more slots 124. In this example, the inner body 120 includes a pair of slots 124 formed along the longitudinal length of the inner body 120, the pair of slots being positioned along opposite sides of the inner body 120 (e.g., along the upper and lower surfaces of the inner body 120). As described in more detail below, one or more slots 124 of the inner body 120 are configured to slidably receive one or more components of the medical device 100, such as the first actuator 130 and / or the second actuator 140. As shown, one or more slots 109 of the outer body 112 are radially aligned with one or more slots 124 of the inner body 120; however, it should be understood that in other examples, the slots 109 may be radially offset relative to the slots 124.
[0032] Now refer to Figure 3 The end cap 114 may include one or more snap-fit features 115 arranged along the exterior of the end cap 114 for attaching the end cap 114 to the outer body 112. In this example, one or more snap-fit features 115 are configured to engage and snap into an aperture 113 formed on the distal end of the outer body 112. An active pin 116 of the medical device 110 may be attached to the end cap 114, and the active pin 116 is operatively electrically connected to a medical device 170 disposed within the cavity of the inner body 120. For example, the active pin 116 may include a connector 117 extending from the active pin 116, the connector being configured to be received within the end cap 114 and operatively communicatively attaching the active pin 116 to one or more components of the medical device 170 (e.g., an electrosurgical sheath 172). In this configuration, the active pin 116 operatively establishes an electrosurgical connection between the electrosurgical sheath 172 of the medical device 170 and auxiliary devices (e.g., a high-frequency electrosurgical unit (electrosurgical generator) operatively generating high-frequency or radiofrequency current, a power supply, a controller, etc. (not shown)).
[0033] Still refer to Figure 3The rotating component 118 of the medical device 110 can be coupled to the end cap 114 proximally on the opposite side of the outer body 112. For example, the rotating component 118 may include a coupling feature 119 received within the end cap 114 for securing the rotating component 118 thereto. In this case, i.e., the rotating component 118 is coupled to the end cap 114 and the end cap 114 is coupled to the outer body 112 via a snap-fit feature 115, it should be appreciated that the end cap 114 and the rotating component 118 can move simultaneously with the outer body 112. In this example, at least a portion of the rotating component 118 extends outward and proximally from the end cap 114 to allow the rotating component 118 to reach the user of the medical system 100. The coupling feature 119 of the rotating component 118 is further configured to engage proximally with a medical device 170 disposed within the cavity of the inner body 120 when the coupling feature 119 is received within the end cap 114. The rotating assembly 118 engages and connects to the cannula 176 of the medical device 170 inside the inner body 120.
[0034] In this example, the rotating assembly 118 is configured to move (e.g., rotate) relative to the end cap 114, the outer body 112, and the inner body 120. Therefore, since the rotating assembly 118 is coupled to the medical device 170 via the coupling feature 119, the rotating assembly 118 is operatively capable of moving (e.g., rotating) the cannula 176 of the medical device 170 relative to the medical device 110. For example, the rotating assembly 118 causes the medical device 170 to rotate within the cavities of the outer body 112 and the inner body 120. As described above, since the needle 179 is arranged inside the cannula 176, it should be appreciated that the rotating assembly 118 is operatively capable of moving (e.g., rotating or driving) the needle 179 together with the cannula 176 relative to the outer body 112 and the inner body 120. In some embodiments, the rotating assembly 118 may include a rotatable knob, a wheel, and / or various other suitable actuators for rotating the cannula 176 of the medical device 170 relative to the medical device 110. It should be recognized that, in other instances, the rotating component 118 may engage with other and / or additional components of the medical device 170 that are different from those illustrated and described herein.
[0035] Although not illustrated, it should be understood that the rotating assembly 118 includes an inner lumen extending through the rotating assembly 118 and the coupling feature 119. The size and shape of the inner lumen of the rotating assembly 118 may be designed and configured to receive one or more tools and / or devices (e.g., needle 179) of the medical device 170 therein. In this example (where the rotating assembly 118 is coupled to the cannula 176), it should be understood that the inner lumen of the rotating assembly 118 may be aligned with, coupled to, and / or communicate with the inner lumen of the cannula 176. Therefore, the rotating assembly 118 may be configured and operably facilitate access to the inner lumen of the cannula 176, to the tip 178 of the cannula 176. Figures 1-2 As seen, the proximal end of needle 179 is received through rotating assembly 118, and the pointed distal end of needle 179 can be positioned adjacent to the tip 178 of sleeve 176. In some embodiments, needle 179 can be removed from the cavity of sleeve 176 by retracting needle 179 proximally through the cavity of rotating assembly 118.
[0036] Refer again Figure 1 The medical device 110 may also include a first actuator 130 and a second actuator 140 positioned on the outer body 112. In this example, the first actuator 130 and the second actuator 140 are arranged above (along the outer body 112) and movable relative to each other. As described in more detail herein, the first actuator 130 is fastened and / or coupled to the outer body 112 and configured to move the outer body 112 relative to the inner body 120 in response to actuation of the first actuator 130. In this example, the first actuator 130 is integrated with the outer body 112, such that the first actuator 130 and the outer body 112 form a monolithic structure. However, it should be appreciated that in other examples, a monolithic structure of the first actuator 130 and the outer body 112 is not required. Furthermore, the second actuator 140 is fastened and / or coupled to the inner body 120 and configured to move the inner body 120 relative to the outer body 112 upon actuation of the second actuator 140. For example, the second actuator 140 may be coupled to the inner body 120 via the outer body 112, for example, via one or more pairs of slots 109 formed on the outer body 112.
[0037] The medical device 110 also includes a distal housing 160 positioned distal to an inner body 120 opposite to an outer body 112. The distal housing 160 defines an inner cavity sized and shaped to receive one or more components of the medical device 110 therein (e.g., at least a portion of the inner body 120, a medical device 170, etc.). The distal housing 160 may also include a housing tip 162 and a screw (fastener) 164. In this example, the housing tip 162 includes an opening sized and shaped to facilitate exit of the medical device 170 from the inner cavity of the distal housing 160 and / or the inner cavity of the inner body 120. The screw 164 is configured to engage an outer surface of the inner body 120 (i.e., a portion of which is disposed within the inner cavity of the distal housing 160) to securely attach the inner body 120 to the distal housing 160. In this configuration, the screw 164 may be movable (e.g., rotatable) relative to the distal housing 160 to selectively engage and / or disengage from the inner body 120 received therein. It should be appreciated that various other suitable fastening elements, clamps, pins, etc., are conceivable without departing from the scope of this disclosure.
[0038] Now refer to Figures 4-5 A schematic diagram of a first actuator 130 is depicted, wherein an outer body 112 and an inner body 120 are disposed within the first actuator 130. The first actuator 130 of the medical device 110 is positioned at the distal end 111 of the outer body 112. In this example, the body of the first actuator 130 may include an upper housing 132 and a lower housing 134 interconnected, wherein the outer body 112 and the inner body 120 are disposed between the two. Furthermore, the upper housing 132 and the lower housing 134 are positioned relative to the outer body 112 such that at least a portion of the housings 132, 134 is disposed above the distal end 111 of the outer body 112. The first actuator 130 may also include a button top 133 received within the upper housing 132 and a button bottom 135 received within the lower housing 134. It should be understood that the button top 133 and button bottom 135 of the first actuator 130 may be an integral structure (e.g., a ring arranged around the outer body 112), such that buttons 133 and 135 are integral with each other. In other instances, button top 133 and button bottom 135 may be interconnected to form an assembly, such that movement of button top 133 and / or button bottom 135 provides a corresponding movement of relative buttons 133 and 135.
[0039] The upper housing 132 of the first actuator 130 includes a recess 131 for receiving a button top 133 such that the button top 133 extends at least partially outward from the upper housing 132. In this configuration, the button top 133 is partially exposed at the recess 131 to allow actuation by the user of the medical device 110 to reach the button top 133. The button bottom 135 of the first actuator 130 is disposed within the lower housing 134 such that the button bottom 135 is completely enclosed therein. In other embodiments, the button bottom 135 may extend at least partially outward from the lower housing 134, thereby exposing the button bottom 135 therein. As described above, the button top 133 and button bottom 135 of the first actuator 130 form an integral structure such that the button bottom 135 is configured to move simultaneously with the button top 133. Therefore, when the first actuator 130 is actuated, manual pressing of the top 133 of the button (e.g., toward the outer body 112) can provide simultaneous pressing and / or movement of the bottom 135 of the button (e.g., away from the outer body 112).
[0040] Still referencing Figures 4-5 The first actuator 130 may also include a biasing mechanism 138. In this example, the biasing mechanism 138 includes a spring disposed in the top housing 132, for example, the biasing mechanism 138 being positioned between the button top 133 and the outer surface of the outer body 112. More specifically, the exterior of the outer body 112 includes a cavity 139 adjacent to the distal end 111 of the outer body 112, the cavity 139 being sized and shaped to receive the biasing mechanism 138 therein. In other examples, without departing from the scope of this disclosure, the biasing mechanism 138 may include a variety of other suitable devices different from those illustrated and described herein. Since the biasing mechanism 138 is disposed below the button top 133, it should be understood that in a stationary state, the biasing mechanism 138 is configured to apply a radially outward force to the button top 133 (e.g., away from the outer body 112). Thus, the biasing mechanism 138 biases the button top 133 to an extended position (i.e., an undriven state), such as... Figure 4 As shown in the diagram. As described in more detail herein, a press of the first actuator 130 can be provided in response to the application of a radially inward force exceeding the radially outward force generated by the biasing mechanism 138 on the top of the button 133.
[0041] Now for reference Figure 4The button base 135 of the first actuator 130 may include one or more teeth 136 extending outward and toward the rack portion of the inner body 120. For example, since the first actuator 130 is arranged and / or at least partially extends over the distal end 111 of the outer body 112, one or more teeth 136 of the button base 135 may be configured to engage at least a portion of a plurality of teeth 122 (i.e., rack portions) of the inner body 112 located adjacent to the distal end 111. In this example, the button base 135 of the first actuator 130 includes a pair of teeth 136; however, it should be understood that in other examples, the button base 135 may include additional and / or fewer teeth 136. Because the button top 133 is interconnected with the button base 135, it should be recognized that the biasing mechanism 138 is configured to bias the button base 135 and the one or more teeth 136 thereon into a locked position.
[0042] As described in more detail herein, the first actuator 130 is configured such that when the first actuator 130 is in an unactuated and stationary state (i.e., unpressed position), the teeth 136 of the button base 135 engage with a plurality of teeth 122 of the inner body 120, as... Figure 4 As shown in the diagram. In this configuration, the outer body 112 (to which the first actuator 130 is fastened) is longitudinally fixed relative to the inner body 120 because the teeth 136 of the first actuator 130 engage (interlock) with one or more teeth 122 of the inner body 120. Therefore, it should be understood that actuation of the first actuator 130 (i.e., manual pressing of the button top 133) allows the teeth 136 of the button bottom 135 to move radially away from the teeth 122 of the inner body 120 and disengage from them. In this configuration, because the first actuator 130 is disengaged from the inner body 120, the first actuator 130 can cause the outer body 112 to move (e.g., translate) relative to the inner body 120. When the radial inward force acting on the top 133 of the button of the first actuator 130 is released, the biasing mechanism 138 pushes the bottom 135 of the button back to the locked position, and one or more teeth 136 engage with at least some of the teeth of the plurality of teeth 122 on the inner body 120.
[0043] Now refer to Figures 6-7A schematic diagram of a second actuator 140 is depicted, wherein portions of an outer body 112 and an inner body 120 are arranged within the second actuator 140. In this example, the main body of the second actuator 140 may include an upper housing 142 and a lower housing 144 interconnected, with portions of the outer body 112 and the inner body 120 arranged between them. The second actuator 140 may also include a button top 143 received within the upper housing 142 and a button bottom 145 received within the lower housing 144. It should be understood that the button top 143 and the button bottom 145 of the second actuator 140 may be an integral structure (e.g., a ring arranged around the outer body 112), such that buttons 143 and 145 are integral with each other. In other examples, the button top 143 and the button bottom 145 may be interconnected to form an assembly, such that movement of the button top 143 and / or the button bottom 145 provides a corresponding movement relative to the button portions 143 and 145.
[0044] The upper housing 142 of the second actuator 140 includes a recess 141 for receiving a button top 143, such that the button top 143 extends at least partially outward from the upper housing 142. In this configuration, the button top 143 is partially exposed at the recess 141 to allow actuation by the user of the medical device 110 to reach the button top 143. The button bottom 145 of the second actuator 140 is disposed within the lower housing 144, such that the button bottom 145 is completely enclosed therein. In other embodiments, the button bottom 145 may extend at least partially outward from the lower housing 144, thereby exposing the button bottom 145 therein. As described above, the button top 143 and button bottom 145 of the second actuator 140 form an integral structure such that the button bottom 145 is configured to move simultaneously with the button top 143. Therefore, when the second actuator 140 is driven, manual pressing of the top 143 of the button (e.g., toward the outer body 112) can provide simultaneous pressing and / or movement of the bottom 145 of the button (e.g., away from the outer body 112).
[0045] Still referencing Figures 6-7The second actuator 140 may also include a biasing mechanism 148. In this example, the biasing mechanism 148 includes a spring disposed in the top housing 142, for example, the biasing mechanism 148 being positioned between the button top 143 and the retainer 147 of the second actuator 140. In other examples, the biasing mechanism 148 may include various other suitable means different from those illustrated and described herein without departing from the scope of this disclosure. Since the biasing mechanism 148 is disposed below the button top 143, it should be understood that the biasing mechanism 148 is configured to apply a radially outward force to the button top 143 (e.g., away from the outer body 112). Thus, biasing the button top 143 into an extended position provides a response to radially inward or outward forces applied to the button top 143 (e.g., in direction A) exceeding the radially outward force generated by the biasing mechanism 148, providing manual pressing of the second actuator 140. As further described herein, pressing the second actuator 140 provides separation of the button bottom 145 from the inner body 120.
[0046] The retainer 147 is at least partially disposed within the upper housing 142 of the second actuator 140 and positioned between the button top 143 and the outer body 112. The retainer 147 is configured to receive a biasing mechanism 148 along its upper surface and includes one or more engagement features 149 positioned along the lower surface of the retainer 147. The one or more engagement features 149 may include a protrusion extending outward from the lower surface of the retainer 147. In this example, the engagement features 149 of the retainer 147 are via a groove 109 formed along the upper surface of the outer body 112 and a groove 124 formed along the upper surface of the inner body 120 (see...). Figure 2 The outer body 112 and the inner body 120 are received within the inner cavity of the inner body 120. It should be understood that the slots 109, 124 of the outer body 112 and the inner body 120 may be radially aligned and / or mutually aligned, such that the engagement feature 149 of the retainer 147 extends through each pair of slots 109, 124 and into the inner cavity of the inner body 120.
[0047] Still refer to Figures 6-7The second actuator 140 may further include a slide 150 disposed within the cavity of the inner body 120. In this example, the slide 150 includes one or more orifices 152 formed along the upper surface of the slide 150. The size, shape, and number of orifices 152 may correspond to one or more engagement features 149 (e.g., protrusions) of the retainer 147. Thus, the retainer 147 is configured to engage the top of the button 143 to the slide 150 by receiving the engagement features 149 within the orifices 152. In this example, the slide 150 is arranged to surround and be secured to the medical device 170 (e.g., a sheath 172). For example, the slide 150 may be attached to the sheath 172 of the medical device 170 by adhesive, such that the slide 150 is secured relative to the medical device 170. In this case, in response to movement of the slide 150, such as by means of movement of the second actuator 140, the medical device 170 may move relative to the cavity of the inner body 120. It should be understood that in other instances, slide 150 may be attached to sheath 172 of medical device 170 using various other means and / or mechanisms suitable for securing slide 150 to medical device 170.
[0048] Now for reference Figure 6 The button bottom 145 of the second actuator 140 may include one or more teeth 146 extending outward from therein and toward the rack portion of the inner body 120. For example, since the second actuator 140 is arranged above and / or extends above the outer body 112, the one or more teeth 146 of the button bottom 145 may be configured to engage with at least some teeth of the plurality of teeth 122 (i.e., the rack portion) of the inner body 112 via a groove 109 formed along the lower surface of the outer body 112. In this example, the button bottom 145 of the second actuator 140 includes a pair of teeth 146; however, it should be understood that in other examples, the button bottom 145 may include additional and / or fewer teeth 146. Because the button top 143 is interconnected with the button bottom 145, it should be appreciated that the biasing mechanism 148 is configured to bias the button bottom 14 and the one or more teeth 146 5 located thereon into a locked position.
[0049] As described in more detail herein, the second actuator 140 is configured such that when the second actuator 140 is in an undriven and stationary state (i.e., unpressed position), the teeth 146 of the button base 145 engage with a plurality of teeth 122 of the inner body 120. In this case, the teeth 146 of the second actuator 140 engage (interlock) with one or more teeth of the plurality of teeth 122 of the inner body 120, the position of the inner body 120 being longitudinally fixed relative to the outer body 112 and the sheath 172. Therefore, it should be appreciated that actuation of the second actuator 140 (i.e., manual pressing of the button top 143 in direction A) allows the teeth 146 of the button base 145 to move radially away from the plurality of teeth 122 and disengage the plurality of teeth 122 of the inner body 120. In this configuration, the second actuator 140 is disengaged from the inner body 120, and the second actuator 140 allows the sheath 172 of the medical device to move (e.g., translate) relative to the outer body 112, the inner body 120, and / or the cannula 176. When the radially inward force acting on the button top 143 of the second actuator 140 is released, the biasing mechanism 148 pushes the button bottom 145 back to the locked position, wherein one or more teeth 146 engage at least a portion of the teeth 122 on the inner body 120.
[0050] According to the exemplary method of using the medical system 100, the medical system 100 can be applied to various endoscopy procedures to treat target sites (e.g., patient anatomical sites). Initially, the medical device 170 may be received within the medical device 110, wherein the sheath 172 extends distally from the distal housing 160 at least its distal portion. By positioning the first actuator 130 proximally and / or near the inner body 120, the tip 178 of the cannula 176 can be arranged within the sheath 172 of the medical device 170, as... Figure 1 As shown in the diagram. Furthermore, by positioning the second actuator 140 at and / or near the distal end 111 of the outer body 112, the sheath 172 of the medical device 170 can be arranged above the tip 178 of the cannula 176, as shown. Figure 1 As shown in the diagram. In this case, the needle 179 is received within the lumen of the sleeve 176 and extends at least partially outward via the tip 178, with the tip 174 of the sheath 172 enclosing the distal tip of the needle 179 therein.
[0051] When the medical system 100 is positioned at and / or near a target site, the user of the medical system 100 can actuate one or more components of the medical system 100 to apply components of the medical device 170 (e.g., sheath 172, cannula 176, and / or needle 179) to the target site. In an example where the sheath 172 includes an electrosurgical sheath and the tip 174 includes an electrosurgical tip, the sheath 172 and / or tip 174 can be operatively enlarged and / or ablated in an electrosurgical manner upon actuation of an auxiliary device (e.g., a high-frequency electrosurgical unit) coupled to the medical device 170 via an active pin 116.
[0052] By further example, a user can actuate the second actuator 140 by applying a radially inward force (e.g., across the longitudinal length of the outer body 112) to the top 143 of the button to press the biasing mechanism 148 and disengage the teeth 146 of the bottom 145 of the button from the plurality of teeth of the inner body 120. It should be understood that the radially inward force should be greater than the opposing radially outward force applied by the biasing mechanism 148 to the top 143 of the button on the second actuator 140. In this case, where the second actuator 140 is separated from the inner body 120, the user can move the second actuator 140 relative to the outer body 112 by applying a sliding force (e.g., parallel to the longitudinal length of the outer body 112) to the second actuator 140.
[0053] By means of a slide 150 fixed to a sheath 172 of a medical device 170 and a second actuator 140 fixed to the slide 150 via a retainer 147 (see Figures 6-7 The movement of the second actuator 140 provides simultaneous movement of the sheath 172 relative to the outer body 112, the inner body 120, and the sleeve 176. Therefore, the second actuator 140 moves from the distal end 111 of the outer body 112 (see...) Figure 1 Movement toward the proximal portion of the outer body 112 (e.g., adjacent to the end cap 114) provides retraction of the sheath 172 into the lumen of the outer body 112, thereby exposing the cannula 176 and the needle 179. In this configuration, the tip 174 of the sheath 172 can be positioned proximally relative to the distal tip of the needle 179 and the tip 178 of the cannula 176 for use at the target site during surgery (see [link to surgical procedure]). Figure 8 ).
[0054] The user locks the second actuator 140 by releasing the top of button 43, thereby fixing the position of the second actuator 140 relative to the outer body 112 and causing the fixed sheath 172 and tip 174 to be positioned relative to the cannula 176 and needle 179. For example, removing the radial inward force from the top of button 143 allows the biasing force of the biasing mechanism 148 to be replaced, thereby returning the second actuator 140 to an undriven state (where the teeth 146 of the bottom of button 145 engage at least a portion of the teeth 122 of the inner body 120). Thus, the position of the second actuator 140 relative to the outer body 112 and the position of the sheath 172 relative to the cannula 176 and needle 179 remain fixed without the user's continuous actuation (e.g., pressing) of the second actuator 140. As the distal tip of the needle 179 is exposed from inside the sheath 172, the user can guide the needle 179 toward the target treatment site to pierce the target site with the distal tip of the needle 179.
[0055] As the target site is expanded, ablated, and / or punctured by the medical device 170, the user can further actuate the medical system 100 to apply the medical device 110 and / or one or more other components of the medical device 170 to the target site. By way of illustrative example, the user can actuate the first actuator 130 by applying a radially inward force (e.g., perpendicular to the longitudinal length of the outer body 112) to the top 133 of the button to press the biasing mechanism 138 and disengage the teeth 136 of the bottom 135 of the button from the plurality of teeth 122 of the inner body 120. It should be understood that the radially inward force should be greater than the opposing biasing force applied by the biasing mechanism 138 to the top 133 of the button of the first actuator 130.
[0056] In this configuration, as the first actuator 130 separates from the inner body 120, the user can move the outer body 112 relative to the inner body 120 by applying a sliding force (e.g., parallel to the longitudinal length of the outer body 112) to the first actuator 130. Since the rotating assembly 118 is secured to the cannula 176 of the medical device 170 and the outer body 112 is secured to the rotating assembly 118, movement of the first actuator 130 provides simultaneous movement of the rotating assembly 118 and the cannula 176 relative to the sheath 172. Therefore, actuation of the first actuator 130 allows the tip 178 of the cannula 176 to move relative to the tip 174 of the sheath 172 and / or relative to the target site. In this scenario, for example, the tip 178 of the cannula 176 can be extended distally relative to the tip 174 of the sheath 172 by translating the first actuator 130 distally along the inner body 120 to position the distal tip of the needle 179 at another location on the target site for piercing the target site. Additionally and / or alternatively, the needle 179 can be removed from the inner cavity of the cannula 176 via the lumen of the rotating assembly 118 and replaced with one or more other tools / instruments.
[0057] The user can lock the first actuator 130 by releasing the top of button 133, thereby fixing the position of the outer body 112 relative to the inner body 120 and the position of the sleeve 176 relative to the sheath 172. For example, removing the radial inward force from the top of button 133 allows the biasing force of the biasing mechanism 138 to be replaced, thereby restoring the first actuator 130 to an undriven state (see...). Figure 4 The teeth 136 of the button bottom 135 engage with at least a portion of the teeth 122 of the inner body 120. Therefore, the positions of the outer body 112 relative to the inner body 120 and the sheath 176 relative to the sheath 172 of the medical device 170 remain longitudinally fixed without the need for continuous actuation (e.g., pressing) of the first actuator 130 by the user.
[0058] When the cannula 176 and needle 179 puncture the target site, the user can actuate the first actuator 130 and / or the second actuator 140 to reposition the cannula 176 and needle 179 within the lumen of the sheath 172. For example, the first actuator 130 (as described in detail above) can be actuated proximally relative to the inner body 120 to retract the cannula 176 and needle 179 into the sheath 172. Alternatively, the second actuator 140 (as described above) can be actuated distally relative to the outer body 112 so that the tip 174 of the sheath 172 extends over the cannula 176 and needle 179. In this case (where the cannula 176 and needle 179 are fully positioned within the lumen of the cannula 172), the user can apply the sheath 172 during the procedure. Furthermore, the actuation of the medical system 100 can be performed by the user during surgery to apply components of the medical device 110 and / or medical instrument 170 to the target site, for example, by driving the first actuator 130 and / or the second actuator 140 according to the steps described above. It should be understood that the steps described herein and the order in which they occur are merely illustrative, and additional and / or fewer steps may be included without departing from the scope of this disclosure.
[0059] Figure 8 A schematic diagram of an exemplary medical system 200 according to an example of this disclosure is shown. In addition to the description below, it should be understood that medical system 200 may be configured and may operate as with medical system 100 illustrated and described above, and thus similar reference numerals are used to denote similar components. Therefore, it should be appreciated that, except for the differences explicitly pointed out herein, medical system 200 operates in a manner similar to medical system 100.
[0060] For example, medical system 200 may include medical device 210 and medical device 170 disposed at least partially within inner body 120 of medical device 210. Outer body 112 of medical device 210 may include a first actuator 130 and a second actuator 240 disposed along the exterior of outer body 112. In this example, the second actuator 240 is generally similar to the second actuator 140 of the medical system 100 illustrated and described above, except that the second actuator 240 includes an active pin (connector) 216 extending outward therefrom.
[0061] Now for reference Figures 9-10 The lower housing 244 of the second actuator 240 includes a port 212, the size and shape of which are designed to accommodate the active pin 216, such that the lower housing 244 is configured to receive the active pin 216 via the port 212. It should be understood that the active pin 216 of the medical device 210 is configured and can operate similarly to the active pin 116 of the medical device 110 illustrated and described above. In this case, the active pin 216 of the medical device 210 is received within the cavity of the inner body 120 and coupled to the medical device 170 disposed therein via the second actuator 240. The connector 217 of the active pin 216 is received within the lower housing 244 of the second actuator 240 via the port 212, rather than being received in the end cap 114 as illustrated and described above with respect to the medical device 110 of the medical system 100.
[0062] Therefore, it should be recognized that, in response to the movement of the second actuator 240 relative to the outer body 112, the active pin 216 of the medical device 210 is operably moved relative to the outer body 112. In this case, during surgery, during use of the medical system 200, for example when the sheath 172 is moved relative to the outer body 112, the inner body 120, etc., the active pin 216 remains in a position adjacent to the sheath 172 of the medical device 170.
[0063] Each of the aforementioned devices, components, and methods can be used to facilitate access to the target treatment site and provide enhanced control over the assistive tools / devices used at the target treatment site. By providing a medical device with a pair of actuators capable of controlling and automatically locking multiple tools / devices of a medical device coupled to the medical device, the user can interact with the target treatment site using the various tools / devices of the medical device during surgery without the need for continuous manual control of the medical device. In this case, the user can reduce overall surgical time, improve surgical efficiency, and / or avoid unnecessary harm to the patient's body due to limited control over the assistive tools / devices.
[0064] It will be apparent to those skilled in the art that various modifications and variations may be made to the disclosed apparatus and methods without departing from the scope of this disclosure. Other aspects of this disclosure will be apparent to those skilled in the art based on consideration of this specification and practice with the features disclosed herein. It is intended that this specification and examples be considered merely exemplary.
Claims
1. A medical device comprising: a handle; a sheath extending from the handle; and a tool inside the sheath and movable relative to the sheath; wherein the handle comprises: an inner body; an outer body disposed over the inner body, wherein the outer body is movable relative to the inner body; a first actuator secured to the tool and coupled to the outer body, wherein the first actuator has a driven state that allows the tool to move relative to the sheath in response to moving the outer body relative to the inner body; a second actuator secured to the sheath and coupled to the inner body, wherein the second actuator has a driven state that allows the sheath to move longitudinally relative to the tool in response to moving the second actuator longitudinally relative to the outer body; wherein an undriven state of the first actuator and an undriven state of the second actuator prevent the tool from moving relative to the sheath. Longitudinal movement of the first actuator moves the outer body longitudinally relative to the second actuator.
2. The medical device of claim 1, wherein, The first actuator, when in an undriven state, prevents movement of the outer body relative to the inner body, and wherein the second actuator, when in an undriven state, prevents movement of the sheath relative to the inner body and the outer body.
3. The medical device of any of the preceding claims 1-2, wherein, The second actuator, when in an undriven state, prevents movement of the sheath relative to the inner body and the outer body.
4. The medical device of any of the preceding claims 1-2, wherein, The inner body comprises a plurality of teeth extending along an exterior of the inner body; and 5. The medical device of any of the preceding claims 1-2, wherein, wherein the first actuator comprises one or more teeth configured to engage one or more of the plurality of teeth of the inner body when in an undriven state. The first spring is configured to (i) bias the first actuator radially outward relative to the outer body and (ii) maintain the first actuator in an undriven state.
6. The medical device of claim 5, further comprising a first spring disposed between the first actuator and the outer body and within a lumen of the outer body, wherein, When a radially inward force exceeding the bias of the first spring is applied to the first actuator, the first actuator is in a driven state, the one or more teeth of the first actuator disengage from all of the plurality of teeth of the inner body.
7. The medical device of claim 6, wherein, The inner body comprises a plurality of teeth extending along an exterior of the inner body, 8. The medical device of any of the preceding claims 1-2, wherein, wherein the second actuator comprises one or more teeth configured to engage one or more of the plurality of teeth of the inner body when in an undriven state, further comprising: a slide fixedly connected to the sheath, the slide comprising a hole; and a retainer comprising a protrusion that is received within the hole to connect the retainer to the slide. The second spring is configured to bias the second actuator radially outward relative to the outer body and maintain the second actuator in an undriven state.
9. The medical device of claim 8, further comprising a second spring disposed between the second actuator and the outer body, wherein, When a radially inward force exceeding the bias of the second spring is applied to the second actuator, the second actuator is in a driven state, the one or more teeth of the second actuator disengage from all of the plurality of teeth of the inner body.
10. The medical device of claim 9, wherein, The first actuator comprises one or more first teeth configured to engage one or more of the plurality of teeth of the inner body when in an undriven state.
11. The medical device of any of claims 1-2, wherein, 12. The medical device of any of claims 1-2, further comprising a first spring disposed between the first actuator and the outer body, wherein the first spring is configured to bias the first actuator radially outward relative to the outer body and to maintain the first actuator in an un-driven state.
13. The medical device of any of the preceding claims 1-2, wherein, The handle further comprises an active connector configured to communicatively couple the sheath to a high frequency surgical electrosurgical knife, and the sheath comprises an electrically conductive material, wherein the active connector is coupled to the sheath via the second actuator.
14. The medical device of claim 1, further comprising a housing, wherein the housing comprises an opening that houses the second actuator, a radially inner portion of the second actuator comprises a protrusion, such that a surface of the protrusion interacts with a surface of the opening in the un-driven state.
15. The medical device of claim 1 or 2, further comprising: a slide fixedly connected to the sheath, the slide comprising a hole; and a retainer comprising a protrusion, the protrusion housed within the hole to connect the retainer to the slide.
16. The medical device of claim 6, further comprising a housing, wherein the housing defines a recess for housing the first actuator, and the housing defines an opening through which the first spring extends in the un-driven state.
17. The medical device of claim 1, wherein: the first actuator is coupled to a distal end of the outer body; the second actuator is proximal to the first actuator on the outer body; and the second actuator is coupled to the inner body through the outer body.
18. The medical device of claim 17, wherein the first actuator is fastened to a distal end of the outer body; and the second actuator is fastened to the inner body through the outer body.
Citation Information
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