Operation and adjustment of multiple instruments using a single actuator for medical devices

Abstract

A system for a medical device that can operate multiple actuated instruments with sophisticated and individual motion profiles using a single user actuator. The system has a handle with a pair of slots for each instrument, and an actuator positioned within the handle for movement between a first position and a second position, with a groove for each instrument. Each instrument couples a barrel to the handle that is captured in the pair of slots and driven by the groove in the actuator. The shape of the pair of slots and the corresponding groove combine to provide a motion profile for the instrument that is independent of any other instrument with its own pair of slots and groove. Thus, multiple instruments may be actuated simultaneously and may have complex and coordinated movements based on user manipulation of a single actuator.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims priority to U.S. Provisional Patent Application No. 63 / 220,735, filed Oct. 26, 2021, and U.S. Provisional Patent Application No. 63 / 321,062, filed Mar. 17, 2022.

[0002] Technical Field The present disclosure relates to medical devices, and more particularly, to an approach for manipulating and coordinating the movement of multiple instruments within a medical device having a single user actuator.

Background Art

[0003] Description of Related Art Medical devices may have multiple actuated instruments (formed wire instruments, machined instruments, tubular instruments, etc.), each of which requires sophisticated and individual operating profiles relative to each other and relative to their actuators (buttons, sliders, levers, etc.) to enable the medical device to perform a particular task, including moving in coordination with each other.

Summary of the Invention

[0004] The inventors recognize that there are limitations associated with conventional or existing medical devices having multiple actuating instruments (as discussed above). Conventional approaches require the use of multiple actuators and rely on the user to appropriately time and coordinate the operation of the multiple instruments. These approaches also lack the ability to control the relative operating speeds of the multiple instruments and the amount of operating force applied, including cases where one instrument needs to temporarily stop until another instrument has moved to a predetermined position. Accordingly, there is a need for an improved approach for operating a multiple-instrument medical device that can control the operation of multiple instruments, adjust their relative movement, and control the movement speed and associated forces throughout the use of a single user-operated actuator. In various aspects of the design, a refined operating profile for one or more actuating instruments can be achieved with only one single movement of the actuator by the user, thereby enabling the performance of more complex operations of the multiple actuating instruments, resulting in greater simplification of use for the user of the medical device, reducing the potential for user error, and enabling medical device functions that otherwise could not be achieved because the user cannot manually perform the complex and coordinated operations required.

[0005] In one aspect, a medical device includes a handle having a first slot pair and a second slot pair, an actuator positioned within the handle for movement between a first position and a second position and including a first groove and a second groove, a first instrument connected to a first barrel that extends between the first slot pair of the handle, is positioned therein, and is captured within the first groove of the actuator, and a second instrument connected to a second barrel that extends between the second slot pair of the handle, is positioned therein, and is captured within the second groove of the actuator. The first groove may have a first shape and the second groove may have a second shape that is different from the first shape. The first slot pair may define a first path and the second slot pair may define a second path that is different from the first path. Movement of the actuator between the first position and the second position causes the first groove to translate the first barrel along the first path of the first slot pair and the second groove to translate the second barrel along the second path of the second slot pair. Movement of the actuator between the first position and the second position moves the first instrument in a first operation profile and moves the second instrument in a second operation profile that is different from the first operation profile.

[0006] In another aspect, a trocar through which a suture can be attached is formed by a handle having a first slot pair and a second slot pair, an actuator positioned within the handle for movement between a first position and a second position and including a first groove and a second groove, a hook extending between the first slot pair of the handle, positioned therein, and connected to a first barrel captured within the first groove of the actuator, and a grommet extending between the second slot pair of the handle, positioned therein, and connected to a second barrel captured within the second groove of the actuator. The first groove may have a first shape and the second groove may have a second shape different from the first shape. The first slot pair may define a first path and the second slot pair may define a second path different from the first path. Movement of the actuator between the first position and the second position causes the first groove to translate the first barrel along the first path of the first slot pair and the second groove to translate the second barrel along the second path of the second slot pair. Movement of the actuator between the first position and the second position moves the hook in a first motion profile and the grommet in a second motion profile different from the first motion profile.

[0007] In a further aspect, a method of independently controlling at least two instruments via a single user action is implemented by providing a medical device that includes a handle having a first slot pair and a second slot pair, an actuator including a first groove and a second groove positioned within the handle for movement between a first position and a second position, a first instrument that extends between the first slot pair of the handle, is positioned therein, and is connected to a first barrel captured within the first groove of the actuator, and a second instrument that extends between the second slot pair of the handle, is positioned therein, and is connected to a second barrel captured within the second groove of the actuator. Next, a button coupled to the actuator may be used to move the actuator between the first position and the second position, such that the first groove drives the first barrel to move within the first slot pair, the second groove causes the second barrel to move within the second slot pair, the movement of the first barrel drives the movement of the first instrument, and the movement of the second barrel drives the movement of the second instrument. The movement of the first barrel is controlled by a first shape of the first groove, and the movement of the second barrel is controlled by a second shape of the second groove that is different from the first shape. The movement of the first barrel is additionally controlled by a first path of the first slot pair, and the movement of the second barrel is additionally controlled by a second path of the second slot pair that is different from the first path. The movement of the actuator between the first position and the second position causes the first groove to translate the first barrel along the first path of the first slot pair, and the second groove to translate the second barrel along the second path of the second slot pair. The movement of the actuator between the first position and the second position moves the first instrument in a first operation profile and moves the second instrument in a second operation profile that is different from the first operation profile. The medical device of the method may be a trocar in which the first instrument is a hook and the second instrument is a stay suture. The movement of the actuator between the first position and the second position causes the hook and the stay suture to capture a suture positioned proximate the tip of the trocar.The hook and the loop cord capture the suture thread by a hook that moves through a first motion profile and a loop cord that moves through a second motion profile different from the first motion profile when the actuator moves from the first position to the second position.

Brief Description of the Drawings

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[0009] Referring to the figures, throughout the text, like numerals refer to like parts, and FIG. 1 shows an example of a system 10 for providing movement of a plurality of actuating instruments 12 within a medical device 14 via user operation of a single user operation actuator 16. The system 10 may provide a complex motion profile having multiple speeds, multiple forces, and complex, coordinated motions. In the figure, the system 10 is illustrated for use with a suture passer, such as those used in arthroscopic hip labral repair surgery, but may be used in conjunction with many different types of medical devices having a plurality of actuating instruments that require different motion profiles, including adjustments between the actuating instruments, throughout the use of a single user actuator.

[0010] Medical device 14 includes a curved cannula needle 20 as seen in FIG. 2, which houses two instruments 12, namely, a hook 22 and a grommet 24 that extend from the tip 26 of the needle 20 and cooperate to attach a suture. In an example of a suture passer as the medical device 14, the hook 22 may extend separately from the grommet 24, for example, by including pre-bending in the grommet 24 and / or the wire of the hook, etc., to form a suture capture opening between the hook 22 and the grommet 24. As further seen in FIG. 2, the hook 22 and the grommet 24 are such that any suture positioned between the hook 22 and the grommet 24 remains snagged there, the hook 22 is captured at the end of the grommet 24, and both are drawn into the puncture needle 20, thereby securely gripping the suture, and may be drawn in independently and through different motion profiles. As seen in FIGS. 3A - 3C, the hook 22 and the grommet 24 are formed from an elastic wire and assume a predetermined configuration by a spring when extended from the tip 26 that aids in suture capture, and are formed to interlock with the hook 22 captured by the grommet 24 when drawn into the needle 20. To capture the suture, the hook 22 and the grommet 24 cross each other independently at different motion profiles, i.e., different distances, with different operating speeds and different forces applied to most effectively capture the suture and at least partially return to the tip 26 to firmly grip the suture. When the suture is attached, as seen in FIG. 3C, the suture is captured by the hook 22 with a bend or other feature, and deviation is prevented by the loop 24. It should be recognized that the bend or contour of the hook 22 may be of a size and cross-section sufficient to allow the suture to be inserted while sliding the suture in a transverse direction to enable the user to manually slide the suture after capture. Alternatively and additionally, when the bend or opening of the hook 22 is drawn proximally into the cannula of the shaft 20 to a size where the shaft 20 closes or partially closes the opening or bend, this draw applies sufficient force to pinch the suture and make it impossible to slide the suture in a transverse direction, thereby providing a suture holding function.Medical device 14 may include different instruments, such as cutting blades, jaws, or pivot joints, and thus the instruments may be constructed from structures other than wires, as shown in FIG. 3 as an example of system 10.

[0011] Referring to FIG. 4, the handle 30 of the medical device 14 is coupled to the needle 20 via a shaft 32, enabling the user to manually direct and position the needle 20. The handle 30 includes an actuator 34 having an accessible button 36 that extends outwardly from the handle 30 that the user can move. In the example of FIG. 4, the movement is illustrated parallel to the longitudinal axis X-X of the medical device 14, but can be in any direction with respect to the medical device 14, such as a diagonal or lateral direction. The handle 30 is shown as a two-piece structure with one side removed for illustrative purposes, but it should be understood that the opposite side of the handle 30 is a mirror image of the side shown in FIG. 4. The handle 30 may also be asymmetric, provided that any assembly of asymmetric pieces results in the structure described herein.

[0012] Referring to FIG. 5, each instrument that is independently operated and controlled by the system 10 is interconnected to the handle 30 by a wire 40 that extends through the shaft 32 and is fixed to a barrel 42 that extends transversely across the interior of the handle 30. This embodiment has two instruments and thus two wires 40 and two barrels 42, but the medical device 14 may include additional instruments having corresponding wires 40 and barrels 42. The hook 22 and the lanyard 24 are each coupled to the handle 30 at its proximal end via a corresponding barrel 42 that extends transversely across the handle 30. The hook 22 and the lanyard 24 are shown as being directly connected to the barrel 42 since they are formed from wires, but non-wire instruments may be connected to the handle 30 using a dedicated wire 40. Of course, different structures may be used in place of the wires, provided that such structures are rigid enough to transmit force in the same manner as the wires.

[0013] Referring to FIGS. 6 and 7, the middle portion of each barrel 42 is captured in a corresponding groove 44 formed in the actuator 34, and the ends of each barrel 42 are captured in opposing slots 46 formed in the inner surface of each side of the handle 30. The shape of each groove 44 and the path defined by the corresponding slots 46 control the movement of the barrels 42 captured within those grooves 44 and their slots 46 when the actuator 34 is moved by the user. The groove 44 has a specific contour that abuts the barrel 42, and thus may apply a force to the barrel when the actuator 34 is moved so that the barrel 42 moves along each slot 46. Thus, the angle of the path formed by the groove 44 applies a force to the barrel 42 in the groove 44 when the actuator 34 is moved by the user, although for simplicity it is illustrated as parallel to the axis X-X, and when the groove 44 extends along the same axis and the movement axis of the actuator 34, the force applied to the barrel 42 may be zero. As further shown in FIG. 6, the grooves 44 may be shaped independently of each other to provide different forces at different points of movement of the actuator 34. As further shown in FIG. 7, the slots 46 inside the handle 30 also extend along a predetermined path that manages the movement of the barrel 42 in response to the force provided by the groove 44, and each slot 46 may have a different path shape so that the movement of the barrel 42 within the slot 46 is independently controlled.

[0014] Referring to FIG. 8, the actuator 34 may comprise a body 50 that defines the groove 44 and has a post 52 that extends from the handle 30 and supports the user button 36. The body 50 slidably engages the inside of the handle 30, provides stability to the actuator 34, and may include any number of outwardly extending features 54 that allow the actuator 34 to slide along the inner handle 30 in response to a force applied to the button 36 by the user. The actuator 34 may also include a latch 56 for releasably capturing the actuator 34 in the home position within the handle 30.

[0015] Referring to FIG. 9, the barrel 42 is positioned at a specific location within the handle 30 where the groove 44 of the actuator 34 for a given barrel 42 intersects the corresponding slot 46 of the handle 30 for that barrel 42. Thus, each barrel 42 is in a position determined by the intersection of a given groove 44 of the actuator 34 with the corresponding slot 46 of the handle 30. Thus, the specific and relative geometric shapes of the groove 44 and the slot 46 may provide several advantageous operations as described herein.

[0016] Referring to FIG. 10, the system 10 may stop the movement of one or more actuating instruments despite the continuous movement of the actuator 34. If it is desirable for the instrument to stop moving, the corresponding groove 44 may extend parallel to the movement of the actuator 34 shown along the longitudinal axis X-X of the device. For example, as seen in FIG. 10, the horizontal movement of the actuator 34 from the upper panel to the lower panel and to the left does not result in the movement of any barrel 42 because the groove 44 extends in the same direction as the movement of the actuator 34 (shown as horizontal in FIG. 10) and the slot 46 extends perpendicular to the direction of movement (shown as vertical in FIG. 10). Thus, the system 10 may provide a dead zone for the movement of the actuator 34 where no corresponding operation occurs for the instrument.

[0017] Referring to FIG. 11, the system 10 may be configured to provide a position where the actuating instrument cannot be returned by the application of any load to the actuating instrument. As seen in FIG. 11, when the barrel 42 is positioned at a location where the groove 44 is parallel to the direction of movement and the slot 46 is perpendicular to the direction of movement (shown as horizontal and vertical respectively), any axial force applied to the wire 40 causes the barrel 42 to be pushed into the vertical (perpendicular) wall of the slot 46, and as a result, the movement of the barrel cannot occur. Thus, when the barrel 42 is in a position within the operating profile shown in FIG. 11, any instrument connected to the barrel 42 cannot be backdriven.

[0018] Referring to FIG. 12, system 10 may provide mechanical force amplification and mechanical speed reduction of the operation of the actuating device with respect to the input operation of actuator 34. When barrel 42 is within regions of grooves 44 and slots 46 that are inclined but have different amounts of inclination, barrel 42 moves differently. For example, if slot 46 of handle 30 is inclined more steeply than corresponding groove 44, the axial movement of actuator 34 results in a relatively small amount of vertical movement of barrel 42 within slot 46, and thus a smaller amount of axial movement of wire 40 coupled to barrel 42, thereby providing a mechanical advantage. More specifically, the force generated by this arrangement is greater than the force input by the user of the device, and the operating speed of the actuating device is less than the operating speed of actuator 34, thus providing the user with a greater ability to create fine movements of the actuating device.

[0019] Referring to FIG. 13, the system 10 also enables the operating instrument to be moved into position and then locked in place against further movement until the actuator 34 is moved by the user. Thus, the system 10 can be arranged such that the operating instrument is configured to deploy a significant force through the operation, but when the user's force application is stopped, the rest position of the instrument is maintained by the system 10 without any sustained user force input, providing an operating profile. Similar to preventing backdrive, the system 10 may employ a shallow groove 44 and a steeply inclined slot such that when the barrel 42 is in motion (i.e., when the barrel 42 is not in the retention area or dead zone), the barrel 42 maintains a force on the instrument even if the force applied by the user is removed. As seen in FIG. 13, the steeply inclined slot 46 of the handle 30 (shown as more vertical than horizontal) combined with the shallow groove 44 (shown as more horizontal than vertical) is sized such that the tangent of the angle of the slot 46 with respect to the direction of tension of the wire 40 is less than the coefficient of friction of the barrel of the slot 46, creating a configuration in which the barrel 42 is locked in place by the tension applied to the wire 40 and preventing the barrel 42 from being backdriven (pulled to the left in the lower image) by the tension of the wire 40 pulling the barrel distally. As a result, the user can release the actuator button 36 while holding the force on the barrel.

[0020] Referring to FIG. 14, the system 10 may allow a plurality of actuating instruments to execute a plurality of complex motion profiles in a manner adjusted by only a single actuator means applied by the user. As shown in FIG. 14, the movement of the actuator from the more proximal position of the right panel to the distal position of the left panel causes the lower barrel 42 to operate when the button moves to the left, while the upper barrel 42 moves only a short distance into a region where no movement occurs. The movement of the upper barrel 42, although limited, had to be at a faster speed than the lower barrel 42 due to the different inclinations of the corresponding groove 44. Thus, the system 10 may provide a plurality of slots 46 in the handle 30 that cooperate with the plurality of grooves 44 of the button 36 such that each barrel 42 moves separately and independently, but may be adjusted with any other barrel 42 to achieve the desired effect.

[0021] The description and figures depict and describe a crescent-shaped piercing element at the distal end of the instrument 10, but arthroscopically, more generally in surgical procedures, many tip shapes are employed that are specific to the needs of a particular procedure, which may include, but are not limited to, a large-radius sweeping arc, a straight piercing tip, a straight piercing element having a relatively sharp bend along its length, a piercing element that incorporates a bend to the left or right (lateral) in addition to the bend in the sagittal plane of the device, and various corkscrew-like shapes that penetrate when applied to tissue in a rotary manner.

[0022] The description and figures depict a plurality of wires 40 that move axially back and forth within the inner diameter of shaft 34. However, it is predictable that the addition of a low-friction material such as a sleeve inside the inner diameter of shaft 32 will also serve to reduce the friction of hook 22, loop 24, and wires 40 when moving axially back and forth within device 10. Further, rather than having only one cannula in the hole of the low-friction sleeve, instead having two, three, or even more cannulas, with each cannula of the low-friction sleeve having only the wire 40 within it, this results in improved control of those wires 40 at the inner diameter of shaft 32, thereby predictably resulting in improved accuracy, smoothness, and control of the elements of the present invention operated by wires 40 with respect to the input made by the user via user-operated actuator 16.

[0023] Various medical devices having multiple actuating instruments are all set to complex and adjusted operating profiles, and at any part or portion of the operating profile, any number of instruments within the device where mechanical force amplification is done with respect to the force applied to the actuator means may benefit, whereby the actuating instrument is enabled to deploy a force exceeding the force input by the user via the actuator means (such as a button, slider, lever, etc.). Various medical devices having multiple actuating instruments may also benefit from any actuating instrument within the device where a reduction in the movement speed of the actuator is brought about, such as when reducing the movement speed of one actuating instrument and enabling very fine movement of another actuating instrument in response to a greater movement of the user actuator. The operating profile of each actuating instrument may have varying speeds and forces, including a period that generates a dead band where the actuating instrument comes to a complete stop or dwells, regardless of the operation of the user actuator that stops the actuating instrument at a particular position, thereby causing the operation of the actuator to result in zero movement of the actuating instrument. The paths discussed herein may include various shapes and sizes, adjusted for a particular use of the medical device in question (for example, for greater force, speed, etc., as discussed herein). For example, the path may be parallel to or angled from the central axis or other longitudinal axis of the body of the medical device (if applicable), or other parts of the medical device such as the device handle. The path may include parallel and / or differently angled portions. Further, at least one path may have similar and / or different, parallel and / or angled portions compared to at least one other path within the device.

Claims

1. A medical device, a handle having a first slot pair and a second slot pair, an actuator positioned within the handle for movement between a first position and a second position, the actuator including a first groove and a second groove, a first instrument connected to a first barrel that extends between the first slot pair of the handle, is positioned therein, and is captured within the first groove of the actuator, a second instrument connected to a second barrel that extends between the second slot pair of the handle, is positioned therein, and is captured within the second groove of the actuator, the medical device comprising.

2. The medical device according to claim 1, wherein the first groove has a first shape and the second groove has a second shape different from the first shape.

3. The medical device according to claim 2, wherein the first slot pair defines a first path and the second slot pair defines a second path different from the first path.

4. By movement of the actuator between the first position and the second position, the first groove translates the first barrel along the first path of the first slot pair in parallel, and the second groove translates the second barrel along the second path of the second slot pair in parallel, the medical device according to claim 3.

5. The medical device according to claim 4, wherein movement of the actuator between the first position and the second position moves the first instrument in a first operating profile and moves the second instrument in a second operating profile different from the first operating profile.

6. A trocar capable of attaching a suture, a handle having a first slot pair and a second slot pair, an actuator positioned within the handle for movement between a first position and a second position, the actuator including a first groove and a second groove, a hook connected to a first barrel that extends between the first slot pair of the handle, is positioned therein, and is captured within the first groove of the actuator, A cord connected to a second barrel, extending between the second slot pair of the handle, positioned therein, and captured in the second groove of the actuator. A puncture needle, wherein by movement of the hook and the cord, a suture positioned proximate the tip of the puncture needle is attached to the hook and the cord. **Claim 7** The puncture needle according to claim 6, wherein the first groove has a first shape and the second groove has a second shape different from the first shape. **Claim 8** The puncture needle according to claim 7, wherein the first slot pair defines a first path and the second slot pair defines a second path different from the first path. **Claim 9** The puncture needle according to claim 8, wherein by movement of the actuator between the first position and the second position, the first groove translates the first barrel parallel along the first path of the first slot pair, and the second groove translates the second barrel parallel along the second path of the second slot pair. **Claim 10** The puncture needle according to claim 9, wherein movement of the actuator between the first position and the second position moves the hook in a first motion profile and moves the cord in a second motion profile different from the first motion profile. **Claim 11** The puncture needle according to claim 10, enabling attachment of the suture, positioned proximate the tip of the puncture needle, to the hook and the cord by movement of the hook along the first motion profile and movement of the cord along the second motion profile.

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