Soft tissue cutting instruments with self-locking, multi-position, and linearly actuated sliding buttons, featuring retractable blades or hooks.

Abstract

A system and method for cutting soft tissue using a retractable surgical cutting device (10). The device (10) includes a handle (12), an actuator (18) located on the handle, and a sheath (14) attached to the handle, wherein the sheath (14) surrounds a shaft (4), the distal end of which is attached a blade (16). The device (10) further includes a drive and locking mechanism (100) connected to the actuator (18) and the shaft (4) located within the interior space of the handle (12), wherein the drive and locking mechanism (100) is configured to move the shaft (4) in the first direction and lock the shaft (4) in a first shaft position in response to movement of the actuator (18) in either the first or second direction, and wherein the drive mechanism (100) is configured to move the shaft (4) in the second direction and lock the shaft (4) in a second shaft position in response to movement of the actuator (18) in the other of the first or second directions.

Description

[0001] Cross-reference to related applications

[0002] This invention relates to and claims priority to U.S. Provisional Patent Application Serial No. 62 / 740500, filed October 3, 2018. This application also relates to PCT / US18 / 36414, which claims priority to U.S. Provisional Patent Application Serial No. 62 / 518803, filed June 13, 2017; U.S. Provisional Patent Application Serial No. 62 / 524769, filed June 26, 2017; U.S. Provisional Patent Application Serial No. 62 / 597612, filed December 12, 2017; and U.S. Provisional Patent Application Serial No. 62 / 652365, filed April 4, 2018. Background Technology 1. Technical Field

[0004] The present invention relates generally to surgical devices for cutting soft tissue, and more specifically, to soft tissue cutting instruments having retractable blades or hooks.

[0005] 2. Related technical descriptions

[0006] During surgery, soft tissue is cut by inserting a cutting device with a surgical blade or hook-shaped blade into a surgical site inside the body. Some current cutting devices have exposed surgical blades or hook-shaped blades. If the blades on the cutting device are exposed, they can cause injury to the user and the patient. In one instance, the user is at risk of injury from the exposed blade while operating the cutting device. In another instance, the patient is at risk of injury when the exposed blade enters or leaves the body. When the exposed blade enters or leaves the body, it may unintentionally cut soft tissue.

[0007] In addition, current cutting devices are not ergonomically designed for users, which could lead to misoperation and harm to users and patients.

[0008] Therefore, there is a need for an easy-to-use surgical instrument for cutting soft tissue that has a protective blade or hook-shaped blade.

[0009] Furthermore, in the field of handheld, manually actuated medical devices, it is generally desirable for the device to be actuated by the user's thumb / finger, thereby creating two or more discrete positions of one or more components relative to each other. Moreover, it is generally desirable to maintain these positions even after the user's finger / thumb has been removed from the device's buttons / switches / levers / slides, etc. Additionally, even when the device is subjected to external forces other than those applied by the user for actuation or de-actuation, such as reaction forces that the device may encounter when performing work on an object (patient, another medical device, etc.), it is generally desirable to maintain these positions of the components. The inventors of this disclosure have recognized that, without a locking mechanism, such forces could potentially "reverse drive" the device to an undesirable actuated / de-actuated state.

[0010] While many mechanisms exist for “locking” user-machine interfaces to prevent reverse actuation within the device, all of them have drawbacks. For example, a friction “pawl” is a common device for “locking” a mechanism to a specific position / construct. However, because friction holds the components of the mechanism in place, this holding ability can be overcome by an external force larger than the friction in the pawl mechanism. A “locking button” that holds, locks, or otherwise “pins in place” user-machine interface actuators (such as sliders, triggers, or levers) provides a forced lock to the interface that resists reverse actuation when an external force is applied. However, actuating the “locking button” itself requires the user to perform a secondary action in addition to the primary action of using the interface itself. Furthermore, the user must be careful to release the actuation “locking button” before attempting to disengage the device; otherwise, the actuation cannot be disengaged (at least not without damaging or destroying the mechanism). Actuators of the "gated shifter" type can be used, where, during actuation, there are "stop positions" where the actuator engages with one or more laterally offset positions, preventing further actuation of the actuator and preventing the mechanism from being reversed by external forces. However, the lateral movement required to place the actuator into one of the "stop positions" is not ambidextrous. While right-handed users can quickly press the actuator laterally in one direction, left-handed users may find it more difficult to perform the same actuation in the same direction (relative to the same direction of the instrument). Furthermore, in medical procedures, movement along multiple separate axes (e.g., longitudinal and lateral) may prove difficult and / or problematic, where movement along a single axis (linear movement) would be easier for the user.

[0011] Therefore, a mechanism is needed that allows actuation of the medical device and locks the medical device each time the actuator moves along a single axis (linear motion).

[0012] Disclaimer regarding the relevant technical sections: With regard to the specific patents / publications / products discussed in the relevant technical sections above or elsewhere in this disclosure, these discussions should not be construed as an admission that the patents / publications / products in question are prior art for patent law purposes. For example, some or all of the patents / publications / products in question may not be early enough in time, may not reflect topics developed early enough in time, and / or may not be sufficient to achieve prior art equivalent to the purposes of patent law. With regard to the specific patents / publications / products discussed in the relevant technical sections above and / or throughout the application, their descriptions / disclosures are incorporated herein by reference in their entirety. Summary of the Invention

[0013] This invention relates particularly to a system and method for cutting tissue using a retractable surgical cutting device. In one embodiment, the invention is a retractable surgical cutting device. The device includes a handle having a first channel extending therethrough. A switch is located on the handle, movable between a retracted position and an extended position. An actuator extends through the first channel and is connected to the switch within the handle. The actuator also includes a blade at its distal end. The blade may include, but is not limited to, blades of any shape, including straight blades, angled blades (angled with themselves and / or an axis), curved blades (curved with themselves and / or an axis), or hook-shaped blades, etc. An outer sheath is connected to the handle and surrounds at least a portion of the actuator and the blade. A drive mechanism is connected to the switch within the handle such that when the switch moves from the retracted position to the extended position, the actuator moves from the retracted position to the extended position. When the actuator is in the retracted position, the blade may (but is not required) be completely within the outer sheath (as in the preferred embodiment), while when the actuator is in the extended position, at least a portion of the blade is outside the outer sheath.

[0014] In another embodiment of the device, the device includes: a handle having a first channel extending therethrough; and a switch located on the handle. The switch is movable between a retracted position and an extended position. An actuator extends through the first channel and is connected to a proximal end of the first channel within the handle. The actuator has a blade at its distal end. An outer sheath surrounds at least a portion of the actuator and the blade. The outer sheath engages with the switch. A drive mechanism is connected to the switch within the handle such that when the switch moves from the retracted position to the extended position, the outer sheath moves from the retracted position to the extended position. When the outer sheath is in the retracted position, the blade is fully positioned within the outer sheath (but not necessarily) (as in a preferred embodiment), while when the outer sheath is in the extended position, at least a portion of the blade is positioned outside the outer sheath.

[0015] In one embodiment, the present invention provides a method for cutting tissue. The method includes the steps of: (i) providing a retractable surgical cutting device having: a handle having a first channel extending therethrough; a switch located on the handle, the switch being movable between a retracted position and an extended position; an actuator extending to a proximal end of the first channel; a blade located at a distal end of the actuator; an outer sheath engaging the switch, the outer sheath surrounding at least a portion of the actuator and the blade; and a drive mechanism connected to the switch within the handle; (ii) moving the switch in a first direction along a longitudinal x-axis extending through the device; (iii) moving the outer sheath relative to the actuator via the drive mechanism; and (iv) exposing at least a portion of the blade. The method may further include the steps of advancing the outer sheath into a surgical site and cutting tissue at the surgical site using the blade.

[0016] In another embodiment of the device, the device includes a handle including a proximal end, a distal end, an outer surface, and an internal space, the handle extending along a central longitudinal axis; an actuator located on the outer surface of the handle and movable in a first direction to a first actuator position and in a second direction to a second actuator position; a sheath extending along the central longitudinal axis and including a proximal end and a distal end, wherein the proximal end is positioned within the internal space of the handle, and wherein the sheath is configured to be movable in the first direction to the first sheath position and to be movable in the second direction to the second sheath position; and a shaft at least partially positioned within the sheath and extending along... The central longitudinal axis extends and includes a proximal end and a distal end, wherein the proximal end is connected to the inner surface of the shank and the distal end includes a blade; and a drive and locking mechanism is connected to the actuator and the sheath located within the internal space of the shank, wherein the drive and locking mechanism is configured to move the sheath in the first direction and lock the sheath in a first sheath position in response to movement of the actuator in one of the first or second directions, and wherein the drive mechanism is configured to move the sheath in the second direction and lock the sheath in a second sheath position in response to movement of the actuator in the other of the first or second directions.

[0017] In another embodiment of the device, the device includes a handle including a proximal end, a distal end, an outer surface, and an internal space, the handle extending along a central longitudinal axis; an actuator located on the outer surface of the handle and movable in a first direction to a first actuator position and in a second direction to a second actuator position; a sheath extending along the central longitudinal axis and including a proximal end and a distal end, wherein the proximal end is positioned within the internal space of the handle, and wherein the proximal end is connected to the inner surface of the handle; and a shaft at least partially positioned within the sheath and extending along the central longitudinal axis, including a proximal end and a distal end. The shaft is configured to move along the first direction to a first shaft position and to move along the second direction to a second shaft position; and a drive and locking mechanism is connected to the actuator and the shaft located within the internal space of the handle, wherein the drive and locking mechanism is configured to move the shaft along the first direction and lock the shaft in the first shaft position in response to movement of the actuator along either the first or the second direction, and wherein the drive mechanism is configured to move the shaft along the second direction and lock the shaft in the second shaft position in response to movement of the actuator along the other of the first or the second direction.

[0018] According to one embodiment, the actuation and locking mechanism achieves the main technical effect of allowing the user to lock the actuating components of a handheld, manually actuated surgical instrument at either end of its travel range to prevent "reverse drive" of any component, locking them in place without performing any additional action or movement, or engaging with any other switch or button to "lock" the actuation in place. In one embodiment, locking is not achieved through friction, but rather by overcoming any friction that could be used to temporarily hold the device in a specific actuated / de-actuated state to generate resistance to any component that reverse drives the device. This forced mechanical locking function is entirely integrated with the exact same movement used to induce actuation / de-actuation of the instrument. Attached Figure Description

[0019] One or more aspects of the invention are specifically pointed out and clearly claimed by way of example in the claims at the conclusion of the specification. The foregoing and other objects, features, and advantages of the invention will become apparent from the following description taken in conjunction with the accompanying drawings, wherein:

[0020] Figure 1 This is a side view schematic diagram illustrating an embodiment of a retractable surgical cutting device;

[0021] Figure 2 yes Figure 1 Exploded perspective view of an illustrative embodiment of a retractable surgical cutting device;

[0022] Figure 3A This is a top view schematic diagram illustrating an embodiment of the hook-shaped blade;

[0023] Figure 3B This is a top view schematic diagram illustrating an embodiment of the blade;

[0024] Figure 4 These are top and side views illustrating an embodiment of a two-piece actuator;

[0025] Figure 5A yes Figure 4 An illustrative embodiment of a two-piece actuator and a perspective view of the blade;

[0026] Figure 5B yes Figure 4 A top view schematic diagram illustrating an embodiment of a two-piece actuator connected to a blade;

[0027] Figure 5C yes Figure 4 A side view schematic diagram illustrating an embodiment of a two-piece actuator connected to a blade;

[0028] Figure 5D yes Figure 4 A perspective view of an illustrative embodiment of a two-piece actuator connected to a blade;

[0029] Figure 6 This is a side view schematic diagram of an illustrative embodiment of the outer sheath;

[0030] Figure 7 This is a close-up perspective view of an alternative illustrative embodiment of the outer sheath;

[0031] Figure 8A yes Figure 1 A cross-sectional side view of an illustrative embodiment of a retractable surgical cutting device in the retracted position;

[0032] Figure 8B yes Figure 1 A cross-sectional side view of an illustrative embodiment of a retractable surgical cutting device in the extended position.

[0033] Figure 9 yes Figure 1 A perspective view of an illustrative embodiment of the switch for a retractable surgical cutting device.

[0034] Figure 10 This is a perspective diagram illustrating an alternative illustrative implementation of the switch;

[0035] Figure 11 This is an exploded perspective view of an alternative illustrative embodiment of a retractable surgical cutting device;

[0036] Figure 12A yes Figure 11 A side view of an illustrative embodiment of a retractable surgical cutting device in the retracted position;

[0037] Figure 12B yes Figure 11 A side view schematic diagram illustrating an embodiment of a retractable surgical cutting device in the extended position;

[0038] Figure 13 This is an exploded side view schematic diagram of an alternative illustrative implementation of the drive mechanism;

[0039] Figure 14 It has Figure 13 An exploded perspective view of an illustrative embodiment of a retractable surgical cutting device with a drive mechanism.

[0040] Figure 15 yes Figure 14 A side view schematic diagram illustrating an embodiment of a retractable surgical cutting device in the extended position;

[0041] Figure 16A This is a side view schematic diagram of an alternative illustrative embodiment of the drive mechanism of a retractable surgical cutting device in the retracted position.

[0042] Figure 16B yes Figure 16A A side view schematic diagram illustrating an embodiment of the drive mechanism of a retractable surgical cutting device in the extended position.

[0043] Figure 17 This is a side view schematic diagram illustrating an additional embodiment of the retractable surgical cutting device;

[0044] Figure 18 This is a side view of an open schematic diagram of an illustrative embodiment of a retractable surgical cutting device in which the second part of the handle has been removed.

[0045] Figure 19 This is a side view schematic diagram illustrating an embodiment of the drive mechanism and slider of a retractable surgical cutting device;

[0046] Figure 20 This is a side view schematic diagram illustrating an embodiment of the drive mechanism and slider of a retractable surgical cutting device;

[0047] Figure 21 A side view schematic diagram illustrating an embodiment of the drive mechanism and slider of a retractable surgical cutting device; and

[0048] Figure 22 This is a side view schematic diagram of an illustrative embodiment of the drive mechanism and slider of a retractable surgical cutting device. Detailed Implementation

[0049] The invention, including its various aspects, features, advantages, and details, is explained more fully below with reference to the non-limiting examples shown in the accompanying drawings. Descriptions of well-known structures have been omitted to avoid unnecessarily obscuring the invention in detail. However, it should be understood that the detailed descriptions and specific non-limiting examples, while indicating aspects of the invention, are given by way of illustration only and not by way of limitation. Various substitutions, modifications, additions, and / or arrangements within the spirit and / or scope of the basic concept of the invention will be apparent to those skilled in the art based on this disclosure.

[0050] Now for reference Figure 1 This diagram shows a side view of an illustrative embodiment of a retractable surgical cutting device 10. The device 10 includes a handle 12 attached to an outer sheath 14 that extends to a distal blade 16. When an actuator (e.g., a button, switch, lever, or knob) 18 on the handle 12 is actuated, the blade 16 selectively extends and retracts, as will be explained in detail later. Figure 1 As shown, the handle 12 may include a thumb recess and finger recesses, making the shape of the handle 12 ergonomically designed. The ergonomic design of the handle 12 provides greater control for the intended use of the device 10. In other embodiments, the handle 12 may have fewer recesses or no recesses at all. In some embodiments, the handle 12 is made of plastic; however, the handle 12 may be made of stainless steel or other conventional materials suitable for surgical devices.

[0051] Now go to Figure 2 , showed Figure 1 An exploded view of an illustrative embodiment of the retractable surgical cutting device 10. In the depicted embodiment, the handle 12 of the device 10 includes two parts, namely a first part 20 and a second part 22, the first and second parts having one or more channels therethrough. It is contemplated that, in alternative embodiments, the handle 12 may be constituted from a single piece molded or otherwise formed around an internal component of the handle 12. Continuing to refer to Figure 2The shank 12 includes a first channel 24 whose dimensions, dimensions, and other configurations are designed for connection to an actuator 26 of the blade 16. The actuator 26 moves longitudinally in two directions along an x-axis within an outer sheath 14, the x-axis extending approximately through the center of the shank 12. The longitudinal movement of the actuator 26 is caused by a drive mechanism 28 within the shank 12, as will be described in detail later. In other embodiments, the actuator 26 remains stationary while the drive mechanism 28 moves the outer shaft 14 relative to the actuator 26 and the blade 16. In one embodiment, the actuator 26 includes a blade 16 machined at its distal end 30. Therefore, embodiments of the actuator 26 and the blade 16 can be monolithic.

[0052] Now for reference Figures 3A to 3B The diagram shows a top view of an illustrative embodiment of the blade. Figures 3A to 3B The blade 16 includes a hole 44 for connection to the actuator 26 in a two-piece embodiment of the actuator 26 and the blade 16. Figure 3A One embodiment is shown, wherein the blade 16 is a hook-shaped blade having at least one sharp edge 34 and one non-sharp edge 30. Figure 3B One embodiment is shown in which the blade 16 is a surgical blade having two sharp edges 34 (e.g., top and bottom). Any combination and number of sharp edges 34 and / or non-sharp edges 30 can be contemplated for the blade 16.

[0053] Now for reference Figure 4 The illustration shows a top view and a side view of an illustrative embodiment of the actuator 26, which consists of a two-piece actuator 26 and a blade 16. Compared to a one-piece actuator 26 that includes a blade 16, Figure 4 The actuator 26 is separate from the blade 16 and is not otherwise machined onto the blade. Figure 4 The actuator 26 includes one or more recesses for connecting to the blade 16 and the drive mechanism 28. At the proximal end 36 of the actuator 26, there is a recess 38 for connecting the actuator 26 to the drive mechanism 28. In another embodiment, the recess 38 at the proximal end 36 may be a hole or other means for attaching the drive mechanism 28 to the actuator 26. The actuator 26 may also include one or more recesses 40, 42 at its distal end 30. The recesses 40, 42 of the actuator 26 at the distal end 30 are configured for attaching to the blade 16.

[0054] Now go to Figures 5A to 5D Various schematic diagrams of illustrative embodiments of the two-piece actuator 26 and the distal end 30 of the blade 16 are shown. For example... Figure 5AAs shown, the distal end 30 of the actuator 26 has a first notch 40 and a second notch 42, while the blade 16 has a hole 44 at its proximal end 46. In the depicted embodiment, the first notch 40 and the second notch 42 have recesses extending in directions opposite to each other. To assemble the two-piece actuator 26 and blade 16, the distal end 30 of the actuator 26 is inserted at an angle into the hole 44 at the proximal end 46 of the blade 16. The distal end 30 of the actuator 26 is thus inserted until the second notch 42 passes through the hole 44. Thereafter, the proximal end 36 of the actuator 26 (as shown) Figure 4 (As shown) Rotate away from blade 16 and into the same plane as blade 16, thereby locking blade 16 in the appropriate position, as shown. Figures 5C to 5D As shown. The second notch 42 on the distal end 30 of the actuator 26 engages the blade 16 on the distal side 48 of the hole 44, while the first notch 40 engages the blade 16 on the proximal side 50 of the hole 44, as... Figure 5B As shown.

[0055] Now for reference Figure 6 The diagram shows a top view of an illustrative embodiment of the proximal end 52 and distal end 54 of the outer sheath 14. In the depicted embodiment, the outer sheath 14 is hollow, such that the outer sheath 14 has a first internal volume 56. The dimensions and dimensions of the outer sheath 14 are designed to assemble around at least a portion of the actuator 26 and the blade 16. In other words, the actuator 26 and the blade 16 are inserted into the first internal volume 56 of the outer sheath 14 such that the outer sheath 14 surrounds at least a portion of the actuator 26 and the blade 16 (e.g., Figure 1 (As shown). The outer sheath 14 is fixed to the handle 12 of the device 10, such that longitudinal movement of the actuator 26 (via the drive mechanism 28) causes the blade 16 to extend and retract from the outer sheath 14. In an alternative embodiment, the outer sheath 14 is fixed to the switch 18, and longitudinal movement of the switch along the x-axis causes the outer sheath 14 to move relative to the stationary actuator 26 and blade 16.

[0056] Figure 6 An embodiment in which the outer sheath 14 has a narrow portion 58 is also shown. The narrow portion 58 of the outer sheath 14 has a second internal volume 60, the diameter of which is smaller than the diameter of the first internal volume 56 of the outer sheath 14. In one embodiment, the narrow portion 58 tapers gradually in a direction toward the distal end 30 of the actuator 26 and the blade 16, such as... Figure 6As shown. However, the narrow portion 58 does not need to taper to have a second internal volume 60 with a diameter smaller than that of the first internal volume 56. The narrow portion 58 with a smaller diameter second internal volume 60 helps prevent the possibility of the blade 16 accidentally disengaging from the actuator 26 (in the two-piece embodiment). The narrow portion 58 can also provide a non-invasive tip to prevent injury at or near surgical sites based on its shape and / or being constructed of a non-metallic material such as PEEK. In the event of failure to secure the blade 16 to the notches 40, 42 of the actuator 26, the narrow portion 58 and the second internal space 60 retain the blade 16 within the outer sheath 14, rather than causing it to fall from the device 10.

[0057] Briefly turn Figure 7 A close-up perspective view of an alternative illustrative embodiment of the distal end 54 of the outer sheath 14 is shown. In the depicted embodiment, the distal end 54 does not have a narrow portion 58. The distal end 54 of the outer sheath 14 has an insert 62. The insert 62 is preferably made of a non-metallic material such as PEEK. The insert 62 provides a non-invasive tip to prevent injury at or near surgical sites. For example, the insert 62 is configured to prevent injury to cartilage structures within the joint space. Figure 7 A blade 16 recessed within the insert 62 is shown to allow the outer sheath 14 and blade 16 to be introduced into a surgical site (e.g., joint space) with or without a cannula.

[0058] Now for reference Figures 8A to 8B , showed Figure 1 A cross-sectional side view schematic diagram of an illustrative embodiment of a retractable surgical cutting device in a retracted and extended position. The handle 12 includes a drive mechanism 28 that facilitates longitudinal movement of the actuator 26 and the blade 16 along the x-axis in two directions within the outer sheath 14. Figures 8A to 8B In the illustrated embodiment, the drive mechanism 28 includes a pair of springs. The pair of springs includes a tension spring 64 and a flat spring 66 (or a thin metal sheet). In the depicted embodiment, the tension spring 64 is a helical spring, while the flat spring 66 is a leaf spring. Various spring combinations can be used to facilitate movement of the actuator 26 along the first channel 24.

[0059] Still referencing Figures 8A to 8BA tension spring 64 is connected at the proximal end 76 of a first channel 24 within the handle 12. The tension spring 64 may be attached via a screw or other connector. The free end of the tension spring 64 is connected to an actuator 26. The actuator 26 extends over a receiver 78 in the handle 12 through the first channel 24, the receiver extending from and connecting to the first channel. A flat spring 66 is attached to the receiver 78 via a screw or other connector. As shown in the depicted embodiment, both the tension spring 64 and the flat spring 66 extend longitudinally along the x-axis.

[0060] In one embodiment of the assembly device 10, the proximal end 36 of the actuator 26 is first attached to the switch 18 and hooked onto the tension spring 64. The tension spring 64 then surrounds a post located within the first channel 24 of the handle 12. A flat spring 66 is positioned near the distal end 80 of the handle 12, below the actuator 26. An outer sheath 14 is attached to the handle 12, and the two parts 20, 22 of the handle 12 are assembled together.

[0061] Still referencing Figures 8A to 8B A tension spring 64 is indirectly connected to the switch 18 via an actuator 26, facilitating longitudinal movement of the actuator 26 along the x-axis. The switch 18 extends from the outside of the handle 12 through a second channel 68. The second channel 68 extends from the outside of the handle 12 into a first channel 24. An illustrative embodiment of the switch 18 is described in... Figure 9 As shown in the figure. Switch 18 includes an outer portion 70 connected to the body portion 72. In the depicted embodiment, the width of the outer portion 70 is greater than the width of the second channel 68, such that the outer portion 70 of switch 18 remains outside the handle 12 (e.g., Figures 8A to 8B (As shown). Similarly in Figure 9 As shown in the implementation, switch 18 has an actuator slot 82 configured for connection to actuator 26.

[0062] Still referencing Figure 9 The main body 72 of switch 18 has a pair of flanges 74. These flanges 74 facilitate movement of the main body 72 of switch 18 along the second channel 68. Specifically, the flanges 74 and the outer portion 70 of switch 18 are sized to fit around the inner surface of the handle 12 on either side of the second channel 68, such that when the device 10 is in the retracted position, the outer portion 70 is above the second channel 68, and the flanges 74 are below the second channel 68. Figure 8A As shown. In the retracted position, the blade 16 is completely within the outer sheath 14. The fit of the outer portion 70 and the flange 74 around the shank 12 on either side of the second channel 68 should be loose enough to allow the switch 18 to slide longitudinally along the x-axis, thereby moving the device 10 to the extended position.

[0063] In use, when the switch 18 moves toward the distal end 80 of the handle 12, the tension spring 64 is stretched, and the switch 18 contacts the flat spring 66, as... Figure 8B As shown. The flat spring 66 forces the switch 18 upward and out through the second channel 68 until at least one of the flanges 74 contacts the shelf 84 within the second channel 68 of the handle 12. Specifically, as the switch 18 is forced upward and away from the flat spring 66, at least one of the flanges 74 on the switch 18 engages with the shelf 84 in the handle 12, thereby locking the switch 18 in place. The shelf 84 prevents the switch 18 from disengaging from the second channel 68 of the handle 12 or otherwise falling out of the second channel of the handle. When the switch 18 is locked in place against the shelf 84, the device 10 is locked in the extended position. In the extended position, the blade 16 extends from the outer sheath 14 and is exposed for use.

[0064] After use, switch 18 is pressed downward toward the flat spring 66 and moved proximally along the second channel 68. By pressing switch 18 downward, flange 74 is released from shelf 84, and switch 18 is unlocked or released to move proximally in the second channel 68. In one embodiment, device 10 emits an audible signal indicating that switch 18 has reached the locked and / or unlocked position. For example, engagement between flange 74 and shelf 84 may produce an audible click.

[0065] exist Figures 8A to 8B In the illustrated embodiment, switch 18 is located on the top side 86 of device 10. However, switch 18 can be configured to be positioned in any other location on device 10, for example... Figure 10 Switch 18 in the middle. Figure 10 The embodiment of the switch 18 depicted also includes an external portion 70 connected to the body portion 72. The body portion 72 of the switch 18 has a pair of flanges 74 that facilitate movement of the body portion 72 of the switch 18 along the second channel 68, similar to... Figures 8A to 9 The implementation scheme shown.

[0066] Figure 10 The switch 18 can be positioned on the bottom side 88 of the device 10, such as... Figure 11 As shown. In Figure 11 In the depicted embodiment, because the switch 18 is located near where the user grips the handle 12 of the device 10, the switch 18 is easily accessible to the user. (Connected to...) Figure 2 The first channel 24 of the actuator 26 in the illustrated embodiment extends through Figure 11 Switch 18 in the illustrated implementation scheme. Specifically, Figure 10The main body portion 72 of the switch 18 includes an aperture 90 for receiving and accommodating the actuator 26. In the depicted embodiment, an outer sheath 14 is connected to the switch 18, for example, at the outer periphery of the aperture 90.

[0067] Now for reference Figure 12A , showed Figure 11 A side view of an illustrative embodiment of the device in the retracted position. In the retracted position, the blade 16 is housed within the outer sheath 14, and the switch 18 is not actuated. From the retracted position, pressing (i.e., actuating) the switch 18 moves it proximally within the handle 12. As the switch 18 moves, it pulls the connected outer sheath 14 proximally, while the actuator 26 remains stationary. The proximal movement of the outer sheath 14 exposes the blade 16 at the distal end 30 of the actuator 26 for use, as... Figure 12B As shown.

[0068] Now for reference Figures 13 to 15 Various views of alternative embodiments of the drive mechanism 28 are shown. Figure 14 In the depicted embodiment, the drive mechanism 28 is a rack and pinion assembly, which includes a switch 18, a gear 92, and a rack 94 (or support surface) on an outer sheath 14. Figure 14 As shown, the outer sheath 14 extends through the first channel 24. A rack 94 on the outer sheath 14 engages with a gear 92 within the shank 12, which also engages with the bottom side 96 of the switch 18. The bottom side 96 of the switch 18 also includes a rack (or support surface) engaging with the gear 92. Moving the switch 18 distally from its retracted position causes the bottom side 96 of the switch 18 to rotate the gear 92. The rotation of the gear 92 pulls the outer sheath 14 proximally via the rack 94. As the outer sheath 14 moves proximally into the shank 12, the actuator 26 remains stationary, thus exposing at least a portion of the blade 16, as... Figure 15 As shown. According to another embodiment, a locking mechanism is provided that can be actuated by a user to selectively stop the ability of gear 92 to rotate over rack 94 (and be reversed / released to allow gear 92 to rotate over rack 94). Such a locking mechanism may include a button, lever arm, pawl, or other mechanism, for example, that prevents gear 92 from rotating over rack 94 (as should be understood by those skilled in the art in conjunction with a review of this disclosure).

[0069] In another implementation scheme, such as Figures 16A to 16B As shown, the drive mechanism 28 is a slide wire assembly. The slide wire assembly includes a switch 18, a wire (or flat strand) 98, and an outer sheath 14. In the depicted embodiment, the wire 98 is attached to both the switch 18 and the outer sheath 14 and is loosely accommodated by a screw, molded channel, or other known connector. Figure 16AA device 10 is shown, including a slide rail assembly in the retracted position. When the switch 18 moves distally toward the distal end 30 of the actuator 26 (e.g.) Figure 16B As shown, the wire 98 moves around the screw or within the molded channel, which in turn causes the outer sheath 14 to move proximally in the opposite direction to the movement of the wire 98 and the switch 18. As the outer sheath 14 moves proximally, the actuator 26 remains stationary, and the blade 16 is exposed for use. In one embodiment, the wire or flat strand 98 is made of stainless steel. However, any other suitable composition may be used.

[0070] An embodiment of the actuation and locking mechanism of the retractable surgical cutting device will now be described with reference to additional accompanying drawings. The manually actuated and retractable surgical device may have some or all of the construction and properties of the retractable surgical device described above, some of which will not be repeated here. The main difference lies in the actuation and locking mechanism, which can be used in conjunction with the previously described embodiments of the retractable surgical device, in place of any of the previously described actuation and / or locking mechanisms.

[0071] In short, one embodiment of the actuation and locking mechanism is an intermittent actuation / drive and locking mechanism (as should be understood by those skilled in the art in conjunction with this disclosure). The intermittent drive and locking mechanism is configured to convert continuous linear and rotary motion into intermittent rotary and linear motion.

[0072] For reference Figure 17 This diagram shows a side view of an illustrative additional embodiment of a retractable surgical cutting device 10. The device 10 extends along a central longitudinal axis and includes a handle 12 connected to an outer sheath 14 that extends to a distal blade 16. When an actuator (here, a button) 18 on the handle 12 is actuated (e.g., slid proximally or distally along an axis parallel to the central longitudinal axis of the device), the blade 16 selectively extends and retracts, as will be explained in detail later. Figure 17 As shown, the handle 12 may include a thumb recess and finger recesses, making the shape of the handle 12 ergonomically designed. The ergonomic design of the handle 12 provides greater control for the intended use of the device 10. In other embodiments, the handle 12 may have fewer recesses or no recesses at all. In some embodiments, the handle 12 is made of plastic; however, the handle 12 may be made of stainless steel or other conventional materials suitable for surgical devices.

[0073] See also Figure 17The handle 12 of the device 10 may include two parts (or half of a clamshell), namely a first part 20 and a second part 22, and may have one or more channels therethrough. The button 18 is movable distally toward the distal end of the instrument along an axis parallel to the central longitudinal axis, and is slidable proximally toward the proximal end of the device along an axis parallel to the central longitudinal axis. At the end of the range of motion of the button 18 (distally and proximally on the top surface of the device), there may be small finger-like protrusions 5 configured to provide a minimal amount of friction, just enough to hold the button 18 at the distal and proximal ends of its travel (which does not restrict the components of the mechanism to be actuated). In the illustrated embodiment, operation is to alternately actuate the retraction of the sheath 14 to avoid obscuring the blade 16 at the distal end of the sheath. Alternatively, it is also conceivable to actuate the blade 16 beyond the distal end of the sheath 16 and retract the blade 16 into the sheath 14 (partially and incompletely, or completely).

[0074] Go to Figure 18 The illustration shows a side-open schematic diagram of an illustrative embodiment of a retractable surgical cutting device 10 in which the second part 22 of the handle 12 is removed, according to one embodiment. Figure 18 The main components of the actuation and locking mechanism of one embodiment are shown. Any number of medical devices can incorporate such an actuation and locking mechanism, including but not limited to grippers, suture threaders, cutting instruments, scissors, etc. It should be noted that by mounting the tip 8 of the shaft 4 into the interior of the handle 12, the shaft 4 of the cutting blade 16 is rigidly positioned / engaged at its proximal end into the body 20, thereby substantially binding the two together and preventing movement of the shaft 4 (and the blade 16). According to one embodiment, the actuation and locking mechanism (described below) is configured to move the sheath 14 proximally and distally along the central longitudinal axis, thereby alternately extending it distally and preferably fully over the cutting blade 16 (to protect the user and patient when not in use), and retracting it proximally to expose the cutting blade 16 for use (essentially pulling it out).

[0075] An implementation plan with actuation and locking mechanism 100 in Figure 18 Partially shown in the middle, and in Figure 19-22The actuation and locking mechanism 100 is an intermittent actuation / drive and locking mechanism arranged linearly to produce two or more stop points at which the moving part is locked in place without requiring any further action by the user beyond the normal user interface, in which case the sliding button 18 is used. The button 18 is connected (directly or indirectly molded) to a rack 13, which includes teeth that mesh with the teeth of a pinion 6 positioned within a shank 12. The pinion 6 is (directly or indirectly) connected to an intermittent working wheel 15, which includes a pin 9 and a semi-circular cam 17. As shown, the pinion 6 is centered adjacent to a first surface of the intermittent working wheel 15, the pin 9 is positioned on the first surface and close to / adjacent to the periphery of the intermittent working wheel 15, and the semi-circular cam 17 is positioned on the first surface opposite to the pin 9 and at a predetermined distance from the periphery of the wheel 15 (so that the intermittent working wheel can operate optimally, as should be understood by one of ordinary skill in the art in conjunction with a review of this disclosure).

[0076] Button 18, rack 13, pinion 6, wheel 15, pin 9, and semi-circular cam 17 serve as the drive mechanism for slider 7. Figure 19 As shown, for example, the slider 7 includes a slot 11 located between two semi-circular grooves / concave surfaces 9 and 21 (multiple slots and / or more than two semi-circular grooves / concave surfaces 9 and 21 may be considered). The slot 11 is configured to receive the pin 9, and the two semi-circular grooves / concave surfaces 9 and 21 are configured to receive a semi-circular cam 17 when the drive mechanism moves. The slider 7 is movably attached to the sleeve 14 such that when the slider 7 moves in a proximal or distal direction along the central longitudinal axis via the drive mechanism (sliding the button 18 in either direction causes the rack 13 to move in the same direction, which causes the pinion 6 to rotate and the wheel 15 to move the semicircular cam 17 into one or more of the semicircular grooves / concave surfaces 9 and 21 and to move the pin 9 into the slot 11, thereby moving the slider 7 proximal or distal), the sleeve 14 moves in the same direction as the slider 7 to expose or cover the blade 16 (the relative connection of the shaft 4 of the sleeve 14 and the blade 16 (attached to the slider) will result in similar movement of the shaft 14 and the blade 16, as well as the fixation of the sleeve 14 (attached to the inner surface of the shank)).

[0077] For reference Figure 20-22In more detail, when pin 12 engages slot 11 of slider 7, pin 12 is configured to drive slider 7 (and sheath 14) in a proximal or distal direction (depending on the movement of button 18). When pin is positioned outside slot 11 and semicircular cam 17 engages either semicircular groove / concave surface 9 or 21, slider 7 (and sheath 14) is in a "paused" non-moving / locked configuration and position, while button 18 continues to move (and the drive mechanism as a whole remains engaged). The amount of movement of button 18 required to move slider 7 from one position to another can be controlled by the characteristics of the teeth on pinion 6 and / or rack 13. The stroke of slider 7 can be varied with the radius of rotation of pin 12.

[0078] Go to Figure 20 A side view schematic diagram of an illustrative embodiment of the drive mechanism and slider of a retractable surgical cutting device 10 according to one embodiment is shown. Figure 20 As shown, the user has engaged button 18 and has moved it in the indicated direction (towards the distal end). This movement of button 18 causes rack 13 to move in the same direction as button 18. Pinion 6 rotates clockwise through its engagement with rack 13 (as shown). The semi-circular cam 17 of intermittent working wheel 15 is shown nested in semi-circular groove 9, locking it in place after slider 7 moves in the actuation direction (towards the proximal end), as indicated by the directional arrow. It is noteworthy that, apart from sliding button 18, locking slider 7 requires no user action.

[0079] Go to Figure 21 The diagram shows a side view of an illustrative embodiment of the drive mechanism and slider of a retractable surgical cutting device 10 according to one embodiment. Figure 21 The drive mechanism and slider 7 are shown at the midpoint between the two stop / lock positions. A pin 12 on the intermittent working wheel 15 is positioned in a slot 11. As the wheel 15 rotates via the interaction of the pinion 6 and rack 13, it (according to the drive function of the pin 12 engaging with the slot 11) transfers the slider 7 from one position to another (from the furthest position to the nearest position, and vice versa). It should be noted that the semi-circular cam 17 on the wheel 15 has rotated away from the slot 11 and semi-circular recess 9 of the slider 7 so as not to impede the movement of the slider 7 in the proximal direction (from...). Figure 20 (The location shown in the image).

[0080] Reference Figure 22 A side view schematic diagram of an illustrative embodiment of the drive mechanism and slider of a retractable surgical cutting device 10 according to one embodiment is shown. Figure 21 As shown, the drive mechanism has been Figure 20It is fully actuated in the opposite direction as shown. The semi-circular cam 17 of wheel 15 is now nested in the semi-circular groove 21, instead of as shown. Figure 20 As previously shown, it is nested in the semi-circular groove 9. At this time, without any other action from the user, except for sliding the button 18 in the proximal direction, the slider 7 is actuated and locked in the "far" position.

[0081] Although any number of materials can be used to manufacture such an actuation and locking mechanism, it is expected that the mechanism as a whole and its housing can typically be made of injection-molded plastic with reasonable strength, and the individual parts of the medical device to be actuated, such as cutters, blades, scissors, suture threaders, etc., can be made of surgical-grade metals such as stainless steel and nitinol.

[0082] The inventors have conceived various alternative embodiments of the actuation and locking mechanism described herein. For example, as previously described, the slider 7 has a plurality of slots 11 and / or two or more semi-circular grooves 9 and 21 to generate two or more pause / lock stop positions for actuation of the mechanism, wherein locking in the appropriate position is required during intermediate movement phases.

[0083] The embodiment of the actuation and locking mechanism described herein produces a "reverse" effect, wherein movement of button 18 in one direction causes slider 7 to move in the opposite direction. This is because rack 13 and slider 7 are located on opposite sides of pinion 6. An alternative embodiment could place rack 13 and slider 7 on the same side of pinion 6, thereby eliminating the reverse effect and causing slider 7 to move in the same direction as button 18.

[0084] While the actuation and locking mechanism described herein has a linear relationship between the movement of button 18 and the rotation of pinion 6, an alternative implementation is possible where pinion 6 is non-circular and rack 13 has a non-linear shape suitable for engagement with the non-circular pinion. This would cause the motion profile of slider 7 to change relative to the movement of button 18.

[0085] An embodiment of the actuation and locking mechanism illustrates a rack 13, a pinion 6, and an intermittent working wheel 15 acting on a slider 7. An alternative embodiment may be adopted in which more than one rack is moved by a single button 18, and those racks interact with more than one pinion, more than one intermittent working wheel, and more than one slider to actuate more than one mechanism, and the relative timing of these systems can cause multiple movements that can be programmed in a specific sequence to perform a more complex actuation system. For example, if a sheathed scissors is required, wherein the cutting element of the scissors can only be actuated and de-actuated after the sheath has moved to its fully retracted position, and never actuated or de-actuated while the sheath is extended, then a single button 18 can move two racks interacting with two pinions, two intermittent working wheels, and two sliders, wherein these two systems can be timed out of phase with respect to each other in order to program the desired sequence of movements that ensures the actuation and de-actuation of the scissors only occurs after the sheath has retracted (as should be understood by one of ordinary skill in the art in conjunction with a review of this disclosure). Such timing between two systems actuated by the same button can be achieved by changing any number of design parameters, such as the angular timing of each pinion tooth relative to its corresponding rack, changing the pitch diameter and / or number of teeth on each pinion, changing the amplitude of movement generated by pin 12 (the radius around which the pin rotates), and changing the number of slots and semi-circular grooves in the slider (as should be understood by one of ordinary skill in the art in conjunction with a review of this disclosure). While multiple varying motion profiles can be achieved using any number of variations and those multiple motion profiles can be coordinated with each other, the essence of this embodiment is that multiple intermittent mechanisms actuated by a single button can generate multiple motion profiles to create a more complex coordinated motion system among the multiple functions included in the product (as should be understood by one of ordinary skill in the art in conjunction with a review of this disclosure).

[0086] In an alternative implementation, the linearly moving rack 13 actuated by button 18 is replaced by a lever-actuated arc rack, which causes the teeth of the arc rack to rotate the pinion 6.

[0087] All definitions defined and used herein should be understood to take precedence over dictionary definitions, definitions in referenced documents, and / or the general meaning of the defined terms.

[0088] Although various embodiments have been described and illustrated herein, those skilled in the art will readily conceive of various other means and / or structures for performing functions and / or obtaining results and / or one or more of the advantages described herein, and each of such variations and / or modifications is considered to be within the scope of the embodiments described herein. More generally, those skilled in the art will readily understand that all parameters, dimensions, materials, and configurations described herein are exemplary, and actual parameters, dimensions, materials, and / or configurations will depend on the teachings of the invention for one or more specific applications thereof. Those skilled in the art will recognize or be able to determine many equivalent forms of the particular embodiments described herein using only conventional experimentation. Therefore, it should be understood that the foregoing embodiments are given by way of example only, and that embodiments may be practiced in ways other than those specifically described and protected by the claims within the scope of the appended claims and their equivalents. Embodiments of this disclosure relate to each individual feature, system, article of manufacture, material, kit, and / or method described herein. Furthermore, any combination of two or more such features, systems, articles of manufacture, materials, kits, and / or methods is also included within the scope of this disclosure if these features, systems, articles of manufacture, materials, kits, and / or methods are not contradictory.

[0089] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the invention. As used herein, unless the context clearly indicates otherwise, the singular forms “a,” “an,” and “the” are intended to include the plural forms as well. It should also be understood that the terms “comprise” (and any form of “comprise” such as “comprises” and “comprising”), “have” (and any form of “have” such as “has” and “having”), “include” (and any form of “include” such as “includes” and “including”), and “contain” (and any form of “contain” such as “contains” and “containing”) are open-ended copulas. Thus, a method or apparatus that “comprises,” “have,” “includes,” or “contains” one or more steps or elements. Similarly, the elements of a method or apparatus that "comprises," "has," "includes," or "contains" one or more of the features have, but are not limited to, those features. Furthermore, an apparatus or structure constructed in a certain way is constructed at least in that manner, but may also be constructed in ways not listed.

[0090] All means or steps in the following claims, plus corresponding structures, materials, operations, and equivalents of the functional elements, if any, are intended to include any structure, material, or operation for performing the function in combination with other claimed elements as specifically claimed. The invention has been described for purposes of illustration and description, but this description is not exhaustive or intended to limit the invention to the forms disclosed. Many modifications and variations will be apparent to those skilled in the art without departing from the scope and spirit of the invention. The embodiments were chosen and described in order to best explain the principles and practical application of one or more aspects of the invention and to enable others skilled in the art to understand one or more aspects of the invention for various embodiments with various modifications suitable for the particular intended use.

Claims

1. A retractable surgical cutting device, comprising: The handle includes a proximal end, a distal end, an outer surface, and an internal space, and the handle extends along a central longitudinal axis. An actuator is located on the outer surface of the handle and is movable in a first direction to a first actuator position and in a second direction to a second actuator position; A sheath extending along the central longitudinal axis and including a proximal end and a distal end, wherein the proximal end is positioned within the internal space of the handle, and wherein the sheath is configured to move along the first direction to a first sheath position and is configured to move along the second direction to a second sheath position. A shaft, at least partially positioned within the sheath and extending along the central longitudinal axis, and including a proximal end and a distal end, wherein the proximal end is connected to an inner surface of the shank, and the distal end includes a blade; and A drive and locking mechanism is connected to the actuator and the sleeve located within the internal space of the handle, wherein the drive and locking mechanism is configured to move the sleeve in the first direction and lock the sleeve in a first sleeve position in response to movement of the actuator in either the first or second direction, and wherein the drive and locking mechanism is configured to move the sleeve in the second direction and lock the sleeve in a second sleeve position in response to movement of the actuator in the other of the first or second directions. The drive and locking mechanism is configured to convert the continuous linear motion of the actuator into intermittent linear motion of the sheath. The drive and locking mechanism further includes a rack connected to the actuator and having teeth positioned on a surface opposite to the surface connected to the actuator. The rack is positioned within the internal space of the shank and is configured to move together with the actuator. The drive and locking mechanism further includes a small gear with teeth, wherein: The pinion is positioned within the internal space of the shank; The teeth of the pinion mesh with the teeth of the rack; and The pinion is configured to rotate during the movement of the rack. The drive and locking mechanism further includes an intermittent working wheel, which includes a periphery and a first surface and is connected to the pinion, wherein: The pin is positioned adjacent to the periphery on the first surface; A semi-circular cam is positioned on the first surface opposite the pin and at a predetermined distance from the periphery of the wheel; and The intermittent working wheel is configured to rotate during the rotational motion of the pinion.

2. The apparatus of claim 1, wherein when the sheath moves along the first direction to the first sheath position, the blade is configured to be positioned within the distal end of the sheath.

3. The apparatus of claim 1, wherein when the sheath moves along the second direction to the second sheath position, the blade is configured to be positioned at the distal end beyond the sheath.

4. The apparatus of claim 1, wherein the driving and locking mechanism further comprises a slider attached to the proximal end of the sheath within the internal space of the handle, wherein: The slider includes at least two semi-circular grooves and at least one slot located between the at least two semi-circular grooves; When the pin movably engages the at least one slot, the slider and the sheath are configured to move along the first direction or the second direction; as well as When the semi-circular cam movably engages one of the at least two semi-circular grooves, the slider and the sheath are configured not to move along the first or second direction.

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