MANUALLY-ACTUATED TISSUE RESECTING INSTRUMENTS
20200360042 ยท 2020-11-19
Inventors
Cpc classification
A61B2017/0046
HUMAN NECESSITIES
A61B2017/00389
HUMAN NECESSITIES
A61B2017/32004
HUMAN NECESSITIES
A61B17/320016
HUMAN NECESSITIES
A61B2017/00367
HUMAN NECESSITIES
A61B2017/320024
HUMAN NECESSITIES
A61B17/320783
HUMAN NECESSITIES
International classification
Abstract
A tissue resecting instrument includes a housing, an outer shaft extending distally from the housing and defining a window at a distal end potion thereof, an inner cutting shaft extending through the outer shaft, a drive assembly, a trigger, and an adjustable resistance mechanism. The inner cutting shaft is translatable and/or rotatable relative to the outer shaft. The drive assembly is coupled to the inner cutting shaft and configured to drive the translation and/or rotation thereof. Manual actuation of the trigger actuates the drive assembly to drive the translation and/or rotation of the inner cutting shaft. The adjustable resistance mechanism includes a spring coupled between the trigger and the housing, and a control knob operably coupled to the spring to enable adjustment of a resistance to pivoting of the trigger from an un-actuated position to an actuated position.
Claims
1. A tissue resecting instrument, comprising: a housing; an outer shaft extending distally from the housing and defining a window at a distal end potion thereof; an inner cutting shaft extending through the outer shaft, the inner cutting shaft at least one of translatable or rotatable relative to the outer shaft to cut tissue extending through the window; a drive assembly coupled to the inner cutting shaft and configured to drive the at least one of translation or rotation of the inner cutting shaft; a trigger coupled to the drive assembly, wherein manual actuation of the trigger actuates the drive assembly to drive the at least one of translation or rotation of the inner cutting shaft; and an adjustable resistance mechanism including a spring coupled between the trigger and the housing, and a control knob operably coupled to the spring to enable adjustment of a resistance to pivoting of the trigger from an un-actuated position to an actuated position.
2. The tissue resecting instrument according to claim 1, wherein the spring is a coil spring and wherein adjustment of the resistance to pivoting includes adjusting an initial length of the coil spring.
3. The tissue resecting instrument according to claim 2, wherein the coil spring is coupled at a first end portion thereof to the trigger and wherein a second end portion of the coil spring is movable to adjust the initial length of the coil spring.
4. The tissue resecting instrument according to claim 1, wherein the spring is a torsion spring and wherein adjustment of the resistance to pivoting includes adjusting a relative positioning of first and second legs of the torsion spring.
5. The tissue resecting instrument according to claim 4, wherein the second leg is fixed relative to the housing and wherein the first leg is rotatable about a body of the torsion spring and relative to the second leg to adjust the relative positioning of the first and second legs.
6. The tissue resecting instrument according to claim 1, wherein adjustment of the resistance to pivoting adjusts an initial resistance to the pivoting of the trigger from the un-actuated position to the actuated position.
7. The tissue resecting instrument according to claim 1, wherein adjustment of the resistance to pivoting adjusts a resistance profile through at least a portion of the pivoting of the trigger from the un-actuated position to the actuated position.
8. The tissue resecting instrument according to claim 1, further comprising a vacuum generator coupled to the drive assembly and the inner cutting shaft such that, during at least a portion of the manual actuation of the trigger to drive the drive assembly, the vacuum generator generates vacuum to suction cut tissue through the inner cutting shaft and into the vacuum generator.
9. The tissue resecting instrument according to claim 8, further comprising a tissue collection cartridge configured to releasably engage the housing, the tissue collection cartridge defining a port configured to communicate with the vacuum generator such that, during at least a portion of the manual actuation of the trigger to drive the drive assembly, cut tissue is urged from the vacuum generator through the port into the tissue collection cartridge.
10. The tissue resecting instrument according to claim 1, wherein the trigger is pivotably coupled to the housing and movable relative thereto between the un-actuated position and the actuated position to drive the drive assembly to translate the inner cutting shaft between a more-proximal position and a more-distal position.
11. The tissue resecting instrument according to claim 1, wherein the spring is further configured to bias the trigger towards the un-actuated position.
12. A tissue resecting instrument, comprising: an end effector assembly, including: a proximal hub; an outer shaft extending distally from the proximal hub and defining a window at a distal end potion thereof; and an inner cutting shaft extending through the outer shaft, the inner cutting shaft at least one of translatable or rotatable relative to the outer shaft to cut tissue extending through the window; a handpiece assembly, including: a housing; a drive assembly disposed within the housing and coupled to the inner cutting shaft, the drive assembly configured to drive the at least one of translation or rotation of the inner cutting shaft; and a trigger coupled to the drive assembly, wherein manual actuation of the trigger actuates the drive assembly to drive the at least one of translation or rotation of the inner cutting shaft; and an isolation mechanism operably coupled between the proximal hub and the housing to engage the proximal hub and the housing with one another, wherein the isolation mechanism isolates movement of the housing from the end effector assembly through a range of motion.
13. The tissue resecting instrument according to claim 12, wherein the isolation mechanism includes a ball and socket joint.
14. The tissue resecting instrument according to claim 13 wherein one of the proximal hub or the housing includes a concave surface defining a socket of the ball and socket joint, and wherein the other of the proximal hub or the housing includes a convex surface defining a ball of the ball and socket joint, the ball received within the socket.
15. The tissue resecting instrument according to claim 12, wherein the isolation mechanism includes a bellows.
16. The tissue resecting instrument according to claim 15 wherein a proximal end portion of the bellows is coupled to the housing and wherein a distal end portion of the bellows is coupled to the proximal hub.
17. The tissue resecting instrument according to claim 12, further comprising a connector operably coupling the inner cutting shaft and the drive assembly with one another.
18. The tissue resecting instrument according to claim 17, wherein the connector is configured to enable the drive assembly to drive the at least one of translation or rotation of the inner cutting shaft in each of an aligned position, a yawed position, and a pitched position of the housing relative to the proximal hub.
19. The tissue resecting instrument according to claim 12, wherein the handpiece assembly further includes a vacuum generator coupled to the drive assembly and the inner cutting shaft such that, during at least a portion of the manual actuation of the trigger to drive the drive assembly, the vacuum generator generates vacuum to suction cut tissue through the inner cutting shaft and into the vacuum generator.
20. The tissue resecting instrument according to claim 19, wherein the handpiece assembly further includes a tissue collection cartridge configured to releasably engage the housing, the tissue collection cartridge defining a port configured to communicate with the vacuum generator such that, during at least a portion of the manual actuation of the trigger to drive the drive assembly, cut tissue is urged from the vacuum generator through the port into the tissue collection cartridge.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0020] The above and other aspects and features of the present disclosure will become more apparent in light of the following detailed description when taken in conjunction with the accompanying drawings wherein like reference numerals identify similar or identical elements.
[0021]
[0022]
[0023]
[0024]
[0025]
[0026]
[0027]
[0028]
[0029]
DETAILED DESCRIPTION
[0030] Referring generally to
[0031] With continued reference to
[0032] Referring to
[0033] Outer shaft 120 of end effector assembly 100, includes a proximal end portion 122 fixedly engaged with proximal hub 110. Outer shaft 120 further includes a distal end portion 124 defining a closed distal end 126 and a window 128 proximally-spaced from closed distal end 126. Window 128 provides access to the interior of outer shaft 120 and may be surrounded by a cutting edge 129 about the outer perimeter of window 128 so as to facilitate cutting of tissue passing through window 128 and into outer shaft 120.
[0034] Inner cutting shaft 130 defines a proximal end portion 132 and a distal end portion 134 defining an open distal end 136. Inner cutting shaft 130 defines an annular cutting edge 138 surrounding open distal end 136 so as to facilitate cutting of tissue passing into inner cutting shaft 130 via open distal end 136. Inner cutting shaft 130 is translatable and, in embodiments, translatable and/or rotatable, within and relative to outer shaft 120. More specifically, inner cutting shaft 130 is configured to translate distally and proximally in a reciprocating motion such that annular cutting edge 138 is exposed within window 128 of outer shaft 120 during at least a portion of the reciprocation motion of inner cutting shaft 130 to enable cutting of tissue extending through window 128. As detailed below, suction is provided to facilitate drawing tissue into window 128 and, thus, cutting and removal of tissue through inner cutting shaft 130. Inner drive hub 140 is engaged about proximal end portion 132 of inner cutting shaft 130.
[0035] With momentary reference to
[0036] Referring to
[0037] Handle housing 210 defines a pistol-grip configuration, although other configurations are also contemplated, and includes a barrel portion 212 and a fixed handle portion 214 depending from barrel portion 212. Barrel portion 212 includes a distal port 213a about which proximal hub 110 of end effector assembly 100 is configured to releasably engage handle housing 210, e.g., via snap-fit engagement, with inner cutting shaft 130 and inner drive hub 140 extending through distal port 213a into handle housing 210. Barrel portion 212 also includes a proximal port 213b configured to receive (releasably or permanently) at least a portion of tissue collection cartridge 250, e.g., in threaded engagement, friction-fit engagement, etc. Barrel portion 212 of handle housing 210 houses drive assembly 230 and vacuum generator 240 therein.
[0038] Handle housing 210 supports a pivot 216 therein about which trigger 220 is pivotably coupled, thereby enabling trigger 220 to pivot relative to fixed handle portion 214 of handle housing 210 through an actuation stroke between an un-actuated position, wherein trigger 220 is further-spaced from fixed handle portion 214, and an actuated position, wherein trigger 220 is closer to fixed handle portion 214. The actuation stroke of trigger 220 includes a forward stroke portion involving movement of trigger 220 from the un-actuated position to the actuated position, and a return stroke portion, involving movement of trigger 220 from the actuated position back to the un-actuated position. Fixed handle portion 214 further supports adjustable resistance mechanism 300. Adjustable resistance mechanism 300, as detailed below, is coupled between fixed handle portion 214 and trigger 220 to bias trigger 220 towards the un-actuated position and to provide an adjustable resistance to pivoting of trigger 220 against the bias from the un-actuated position towards the actuated position.
[0039] Trigger 220 includes an upper drive portion 222, an intermediate pivot portion 224, and a lower manipulation portion 226, and may be formed as a single, monolithic piece or may otherwise be formed as a unitary structure. Intermediate pivot portion 224 of trigger 220 is pivotably coupled to handle housing 210 about pivot 216. Upper drive portion 222 of trigger 220 extends upwardly from intermediate pivot portion 224 into handle housing 210 to operably couple to drive assembly 230. More specifically, upper drive portion 222 defines a bifurcated configuration including a pair of spaced-apart upper drive flanges 223 disposed on either side of drive assembly 230 and operably coupled thereto. Lower manipulation portion 226 of trigger 220 extends downwardly from intermediate pivot portion 224 exteriorly from handle housing 210 to enable manual manipulation thereof by a user between the un-actuated and actuated positions.
[0040] Drive assembly 230 of handpiece assembly 200 includes a mandrel 232 engaged about an inner shaft 236 defining a lumen 238 extending therethrough. Mandrel 232 includes a body 233 and pair of longitudinally-spaced rims 234 disposed on body 233 and is configured to receive upper drive flanges 223 of upper drive portion 222 of trigger 220 longitudinally between rims 234 on either side of body 233. In this manner, pivoting of trigger 220 towards the actuated position urges upper drive flanges 223 into the distal rim of the pair of longitudinally-spaced rims 234 to thereby urge mandrel 232 distally through handle housing 210. On the other hand, pivoting of trigger 220 towards the un-actuated position urges drive flanges 223 into the proximal rim of the pair of longitudinally-spaced rims 234 to thereby urge mandrel 232 proximally through handle housing 210.
[0041] Inner drive hub 140 of end effector assembly 100 is configured to releasably engage inner shaft 236 and/or mandrel 232, e.g., via mechanical fastening, friction-fit engagement, magnetic coupling, etc., upon engagement of end effector assembly 100 with handpiece assembly 100 such that inner drive hub 140 is fixed relative to mandrel 232, and such that the interior of inner cutting shaft 130 of end effector assembly 100 is disposed in fluid communication with lumen 238 of inner shaft 236. Of course, in embodiments where end effector assembly 100 is permanently secured to handpiece assembly 200, inner drive hub 140 of end effector assembly 100 is permanently engaged to mandrel 232.
[0042] With inner drive hub 140 fixed relative to mandrel 232, translation of mandrel 232, e.g., in response to pivoting of trigger 220, likewise translates inner cutting shaft 130 through and relative to outer shaft 120. More specifically, pivoting of trigger 220 relative to handle housing 210 between the un-actuated position and the actuated position translates inner cutting shaft 130 through and relative to outer shaft 120 between a more-proximal position (
[0043] With momentary additional reference to
[0044] In embodiments where the end effector assembly, e.g., end effector assembly 1100, includes an inner cutting shaft 1130 configured to both reciprocate and rotate relative to the outer shaft 1120, rather than inner drive hub 140 being fixed relative to mandrel 232, mandrel 232 or inner drive hub 140 may include a helical channel (not shown) defined thereon or otherwise associated therewith and a coupler (not shown) may be fixed within handle housing 210 and engaged within the helical channel. As a result of such a configuration, longitudinal translation of mandrel 232, e.g., in response to actuation of trigger 220, effects both rotation and translation of inner drive hub 140 and, thus, inner cutting shaft 1130.
[0045] Referring again to
[0046] Vacuum generator 240, more specifically, includes a plunger 242 sealingly engaged and slidably disposed within chamber 244. In embodiments, inner shaft 236 defines the push-rod of plunger 242, although other configurations are also contemplated. Plunger 242 is coupled with mandrel 232, e.g., via inner shaft 236 or in any other suitable manner, such that as mandrel 232 is translated through handle housing 210, plunger 242 is similarly translated through chamber 244. More specifically, when mandrel 232 is translated distally, e.g., in response to movement of trigger 220 from the un-actuated position towards the actuated position to move inner cutting shaft 130 from the more-proximal position (
[0047] When mandrel 232 is returned proximally, e.g., in response to movement of trigger 220 from the actuated position back towards the un-actuated position to move inner cutting shaft 130 from the more-distal position (
[0048] Tissue collection cartridge 250, as noted above, is releasably coupled to handle housing 210. Tissue collection cartridge 250, more specifically, may be configured to releasably engage proximal port 213b of handle housing 210 via threaded engagement or other suitable engagement. Tissue collection cartridge 250 includes an outer housing 252 defining a distal port 253 configured to couple, in fluid communication, with chamber 244 of vacuum generator 240 upon engagement of tissue collection cartridge 250 with handle housing 210. In this manner, tissue and fluid suctioned through window 128 of outer shaft 120, open distal end 136 of inner cutting shaft 130, lumen 238 of inner shaft 236 of drive assembly 230, and into chamber 244 of vacuum generator 240, may then be urged into tissue collection cartridge 250. One-way valve 248, as an alternative to being part of vacuum generator 240, may be disposed within distal port 253 of tissue collection cartridge 250.
[0049] Tissue collection cartridge 250 further includes an internal filter 256 disposed within outer housing 252 that is configured to permit passage of fluid therethrough but inhibit the passage of tissue therethrough. An outflow port 258 configured to enable connection of outflow tubing T with tissue collection cartridge 250 enables the fluid that passes through filter 256 to drain out from tissue collection cartridge 250 to a fluid collection reservoir (not shown).
[0050] Referring generally to
[0051] With tissue resecting instrument 10 assembled as detailed above, in use, tissue resecting instrument 10 is inserted into an internal body cavity or organ, e.g., a uterus, such that the distal end portion of end effector assembly 100 is positioned adjacent tissue to be removed. Tissue resecting instrument 10 may be inserted through an endoscope, e.g., a hysteroscope, or other instrument, or may be used independently. Once tissue resecting instrument 10 is positioned as desired adjacent tissue to be removed, tissue resecting instrument 10 is activated by pivoting trigger 220 relative to fixed handle portion 214 of handle housing 210 through the actuation stroke from the un-actuated position to the actuated position and back to the un-actuated position to thereby reciprocate inner cutting shaft 130 through and relative to outer shaft 120 (e.g., from the more-proximal position (
[0052] Once the desired tissue is removed, tissue resecting instrument 10 may be removed from the surgical site. Thereafter, end effector assembly 100 and tissue collection cartridge 250 may be disengaged from handpiece assembly 200. End effector assembly 100 and/or handpiece assembly 200 may then be discarded, sent for reprocessing, or sterilized for reuse. Tissue collection cartridge 250 may be sent to pathology for analyzing the tissue retained therein or may likewise be discarded.
[0053] Referring to
[0054] With reference to
[0055] Spring 340 is fixed, e.g., wrapped around and/or through, relative to internally threaded shaft 310 at a first end portion 342 thereof and is fixed, e.g., wrapped around and/or through, trigger 220 at a second end portion 344. Second end portion 344 of spring 340 is fixed relative to trigger 220 on an opposite side of pivot 216 as compared to lower manipulation portion 226 (see
[0056] As detailed above, rotation of control knob 330 relative to fixed handle portion 214 rotates externally threaded shaft 320 relative to fixed handle portion 214 to, as also detailed above, translate internally threaded shaft 310 through and relative to fixed handle portion 214. More specifically, with second end portion 344 of spring 340 engaged with internally threaded shaft 310, rotation of control knob 330 in a first direction urges internally threaded shaft 310 towards an extended, less-overlapping position relative to externally threaded shaft 320 to transition adjustable resistance mechanism 300 from a first configuration (
[0057] Referring to
[0058] With reference to
[0059] Control member 430, as noted above, includes control knob 432 and control shaft 434 which, in embodiments, may be monolithically or otherwise formed as a unitary component. Control shaft 434 defines external threading and is threadingly engaged within a threaded socket 217 defined within handle housing 210. Control knob 432 is externally disposed of handle housing 210 to enable manual manipulation, e.g., rotation, thereof. More specifically, rotation of control knob 432 relative to handle housing 210 drives control shaft 434 further into handle housing 210 or backs control shaft 434 further out of handle housing 210, depending upon the direction of rotation.
[0060] First leg 414 of torsion spring 410, as noted above, is operably positioned relative to control shaft 434 of control member 430 while second leg 416 of torsion spring 410, as also noted above, is captured within capture block 420 and fixed relative to handle housing 210. More specifically, first leg 414 is positioned such that control shaft 434 abuts a side surface thereof. Thus, rotation of control knob 432 to drive control shaft 434 further into handle housing 210 urges control shaft 434 against first leg 414 to thereby move first leg 414 to rotate in a first direction about body 412 and relative to second leg 416, increasing the initial tension on torsion spring 410. On the other hand, rotation of control knob 432 to back control shaft 434 further out of handle housing 210 pulls control shaft 434 away from first leg 414 to enable first leg to follow control shaft 434, under the bias of torsion spring 410, decreasing the initial tension on torsion spring 410.
[0061] Referring to
[0062] As shown in
[0063] As an alternative or in addition to providing first, second, and third initial resistances in the first, second, and third configurations, respectively, torsion spring 410 may provide second and third different resistance profiles that may be greater and less, respectively, than the first resistance profile on average and/or at each point during actuation over a portion or the entire forward stroke of trigger 220.
[0064] Turning to
[0065] Tissue resecting instrument 2010 includes an isolation mechanism 2500 that couples proximal hub 2110 of end effector assembly 2100 with barrel portion 2212 of handle housing 2210 of handpiece assembly 2200. Isolation mechanism 2500 includes a ball and socket joint configuration wherein one of a proximal portion of proximal hub 2110 of end effector assembly 2100 or a distal portion of barrel portion 2212 of handle housing 2210 defines a concave receiving surface 2510 defining a socket 2512 and the other of the proximal portion of proximal hub 2110 of end effector assembly 2100 or the distal portion of barrel portion 2212 of handle housing 2210 defines a convex protruding surface 2520 defining a ball 2522 configured for receipt within socket 2512. Ball 2522 may be captured within socket 2512 or otherwise coupled thereto to maintain engagement therebetween. With ball 2522 received within socket 2512, handle housing 2210 may yaw and/or pitch within a range of motion relative to proximal hub 2110 and, thus, end effector assembly 2100, without effecting movement, or dampening movement, of end effector assembly 2100. In this manner, isolation mechanism 2500 isolates handle housing 2210 from end effector assembly 2100 over a range of motion to inhibit inadvertent movements of handle housing 2210 from effecting the position of end effector assembly 2100. Such a configuration is advantageous, for example, such that end effector assembly 2100 remains stationary or movement thereof is dampened when the user is actuating trigger 2220 (and inadvertently moves handle housing 2210 while actuation trigger 2200). Movement of handle housing 2210 outside of the range of motion, on the other hand, results in corresponding movement of end effector assembly 2100, thus permitting manual manipulation thereof when desired.
[0066] A locking mechanism (not shown) may be provided to selectively lock proximal hub 2110 relative to barrel portion 2212 of handle housing 2210, thus effectively disabling isolation mechanism 2500 when use thereof is not desired.
[0067] In embodiments, inner drive hub 2140 of end effector assembly 2100 is coupled with inner shaft 2236 of drive assembly 2230 via a connection mechanism 2600, e.g., a ball and socket joint, a flexible tube, a bellows, etc., that enables isolation of motion of handle housing 2210 relative to end effector assembly 2100, as detailed above, while permitting actuation of drive assembly 2230 to rotate and/or translate inner cutting shaft 2130 in each of an aligned, yawed, and/or pitched orientation of handle housing 2210 relative to end effector assembly 2100.
[0068] Turning to
[0069] Tissue resecting instrument 3010 includes an isolation mechanism 3500 that couples proximal hub 3110 of end effector assembly 3100 with barrel portion 3212 of handle housing 3210 of handpiece assembly 3200. Isolation mechanism 3500 includes a bellows 3510 engaged at a proximal end portion 3512 to barrel portion 3212 and at a distal end portion 3514 to proximal hub 3110, thus enabling handle housing 3210 to yaw and/or pitch within a range of motion relative to proximal hub 3110 and, thus, end effector assembly 3100, without effecting movement, or dampening movement, of end effector assembly 3100. In this manner, isolation mechanism 3500 isolates handle housing 3210 from end effector assembly 3100 over a range of motion to inhibit inadvertent movements of handle housing 3210 from effecting the position of end effector assembly 3100. A locking mechanism (not shown) or a rigidizing mechanism (not shown) may be provided to selectively lock proximal hub 3110 relative to barrel portion 3212 of handle housing 3210 or rigidize bellows 3510, respectively, thus effectively disabling isolation mechanism 3500 when use thereof is not desired.
[0070] In embodiments, inner drive hub 3140 of end effector assembly 3100 is coupled with inner shaft 3236 of drive assembly 3230 via a connection mechanism 3600, e.g., a ball and socket joint, a flexible tube, a bellows, etc., that enables isolation of motion of handle housing 3210 relative to end effector assembly 3100, as detailed above, while permitting actuation of drive assembly 3230 to rotate and/or translate inner cutting shaft 3130 in each of an aligned, yawed, and/or pitched orientation of handle housing 3210 relative to end effector assembly 3100.
[0071] From the foregoing and with reference to the various drawings, those skilled in the art will appreciate that certain modifications can be made to the present disclosure without departing from the scope of the same. While several embodiments of the disclosure have been shown in the drawings, it is not intended that the disclosure be limited thereto, as it is intended that the disclosure be as broad in scope as the art will allow and that the specification be read likewise. Therefore, the above description should not be construed as limiting, but merely as exemplifications of particular embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.